United States Court of Appeals for the Federal Circuit 

2007-1400 

ABBOTT LABORATORIES, 

Plaintiff-Appellant, 

and 

ASTELLAS PHARMA, INC., 

 Plaintiff-Appellant, 

v. 

SANDOZ, INC., 

Defendant-Appellee, 

and 

SANDOZ GMBH, 

 Defendant, 

and 

TEVA PHARMACEUTICALS USA, INC. and 

TEVA PHARMACEUTICAL INDUSTRIES, LTD., 

 Defendants-Appellees, 

and 

RANBAXY LABORATORIES, LTD. and RANBAXY, INC., 

 Defendants, 

and 

PAR PHARMACEUTICAL COMPANIES, INC. and PAR PHARMACEUTICAL, 

 Defendants. 

---------------------------------------------- 

2007-1446 

LUPIN LIMITED, 

Plaintiff/Counterclaim DefendantAppellee, 
2

and 

LUPIN PHARMACEUTICALS, INC., 

Counterclaim Defendant-Appellee, 

v. 

ABBOTT LABORATORIES, 

 Defendant/Counterclaimant-Appellant, 

and 

ASTELLAS PHARMA, INC., 

Defendant/Counterclaimant-Appellant. 

James F. Hurst, Winston & Strawn LLP, of Chicago, Illinois, argued for all plaintiffsappellants in 2007-1400 and defendants/counterclaimants-appellants in 2007-1446. With him 

on the briefs for Abbott Laboratories were Todd J. Ehlman, Kathleen B. Barry, and Ivan M. 

Poullaos, and Steffen N. Johnson, of Washington, DC. Of counsel on the brief for Abbott 

Laboratories were William F. Cavanaugh, Jr., Jeffrey I.D. Lewis, and Stuart E. Pollack, 

Patterson Belknap Webb & Tyler LLP, of New York, New York. Of counsel was John C. Knapp. 

On the briefs for Astellas Pharma, Inc., were Richard D. Kelly, Stephen G. Baxter and Frank J. 

West, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., of Alexandria, Virginia. 

Meredith Martin Addy, Brinks, Hofer, Gilson & Lione, of Chicago, Illinois, argued for 

defendant-appellee Sandoz, Inc. With her on the brief were Thomas J. Filarski, Mark H. Remus, 

C. Noel Kaman, and Laura A. Lydigsen. Of counsel was Rashad L. Morgan. 

Thomas J. Meloro, Jr., Wilkie Farr & Gallagher LLP, of New York, New York, argued for 

defendants-appellees Teva Pharmaceuticals USA, Inc., et al. With him on the brief was Neal K. 

Feivelson. Of counsel were Michael W. Johnson and Alexander H. Swirnoff. 

Deanne M. Mazzochi, Rakoczy Molino Mazzochi Siwik, LLP, of Chicago, Illinois, argued 

for plaintiff/counterclaim defendant-appellee Lupin Limited and counterclaim defendantappellee, Lupin Pharmaceuticals, Inc. in 2007-1446. With her on the brief were William A. 

Rakoczy, Paul J. Molino, and Amy D. Brody. 

Appealed from: United States District Court for the Northern District of Illinois (07-CV-1721) 

Judge Wayne R. Andersen 

Appealed from: United States District Court for the Eastern District of Virginia (3:06-CV-400) 

Judge Robert E. Payne 
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT 

2007-1400 

ABBOTT LABORATORIES, 

Plaintiff-Appellant, 

and 

ASTELLAS PHARMA, INC., 

 Plaintiff-Appellant, 

v. 

SANDOZ, INC., 

Defendant-Appellee, 

and 

SANDOZ GMBH, 

 Defendant, 

and 

TEVA PHARMACEUTICALS USA, INC. and 

TEVA PHARMACEUTICAL INDUSTRIES, LTD., 

 Defendants-Appellees, 

and 

RANBAXY LABORATORIES, LTD. and RANBAXY, INC., 

 Defendants, 

and 

PAR PHARMACEUTICAL COMPANIES, INC. and PAR PHARMACEUTICAL, 

 Defendants. 
----------------------------------------------- 

2007-1446 

LUPIN LIMITED, 

Plaintiff/Counterclaim DefendantAppellee, 

and 

LUPIN PHARMACEUTICALS, INC., 

Counterclaim DefendantAppellee, 

v. 

ABBOTT LABORATORIES, 

Defendant/CounterclaimantAppellant, 

and 

ASTELLAS PHARMA, INC., 

Defendant/CounterclaimantAppellant. 

Appeals from the United States District Court for the Northern District of Illinois in case 

no. 07-CV-1721, Judge Wayne R. Andersen and the United States District Court for the 

Eastern District of Virginia in case no 3:06-CV-400, Judge Robert E. Payne. 

___________________________ 

 DECIDED: May 18, 2009 

___________________________ 

Before RADER, PLAGER, and BRYSON, Circuit Judges. MICHEL, Chief Judge, and 

RADER, BRYSON, GAJARSA, LINN, DYK, PROST, and MOORE, Circuit Judges, have 

joined Section III.A.2 of the opinion. Dissenting opinion as to Section III.A.2 filed by 

NEWMAN, Circuit Judge, in which MAYER and LOURIE, Circuit Judges, join. 

Dissenting opinion filed by LOURIE, Circuit Judge. SCHALL, Circuit Judge, did not 

participate as a member of the en banc court. 

2007-1400, -1446 2
RADER, Circuit Judge. 

In this case, the same patent, U.S. Patent No. 4,935,507 (the ’507 patent), 

occasions litigation in both the United States District Court for the Eastern District of 

Virginia and the United States District Court for the Northern District of Illinois. The 

Virginia District Court granted the motion of Lupin Ltd. and Lupin Pharmaceuticals Inc. 

(collectively Lupin) for summary judgment of noninfringement. In the other case, the 

Illinois District Court denied a preliminary injunction to Abbott Laboratories, the 

exclusive licensee of the ’507 patent, based on the claim construction from the Eastern 

District of Virginia. 

Because the Eastern District of Virginia correctly construed the claims of the ’507 

patent and correctly discerned no genuine issues of material fact on literal infringement 

of claims 2-5 or infringement by equivalents of claims 1-5, this court affirms its partial 

summary judgment of noninfringement. Likewise, this court affirms the Northern District 

of Illinois’ denial of Abbott’s motion for a preliminary injunction, based in large part on 

the same correct claim construction. 

I. 

Abbott Laboratories, the exclusive licensee of the ’507 patent, markets crystalline 

cefdinir according to the ’507 patent under the trade name Omnicef. The Virginia case 

arose when Lupin sought a declaratory judgment of noninfringement against Abbott 

Laboratories and Astellas Pharma Inc., the owner of the ’507 patent (collectively 

Abbott). The Food and Drug Administration had previously approved Lupin’s 

Abbreviated New Drug Application (ANDA) to market a generic version of Omnicef. 

Lupin’s generic product contains almost exclusively the Crystal B form of crystalline 

2007-1400, -1446 3
cefdinir (cefdinir monohydrate), whereas Abbott’s Omnicef product contains the Crystal 

A form of crystalline cefdinir (cefdinir anhydrate). Further, Lupin makes its products with 

processes other than those claimed in the ’507 patent. For these reasons, Lupin 

brought the Virginia action to clarify that its proposed product would not infringe a valid 

patent. Abbott counterclaimed for infringement. The Eastern District of Virginia 

construed the claims, Lupin Ltd. v. Abbott Laboratories, 484 F. Supp. 2d 448 (E.D. Va. 

2007) (Lupin CC Order), and ultimately granted-in-part Lupin’s motion for summary 

judgment of noninfringement, as to both literal and equivalent infringement for claims 2-

5 and as to equivalent infringement for claim 1, Lupin Ltd. v. Abbott Labs., 491 F. Supp. 

2d 563 (E.D. Va. 2007) (Lupin SJ Order). The parties stipulated to the dismissal without 

prejudice of the remaining claims (invalidity) and counterclaims (literal infringement of 

claim 1). 

 In the Illinois action, Abbott sued Sandoz, Inc. and Sandoz GmbH (collectively 

Sandoz), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries, Ltd. 

(collectively Teva), Ranbaxy Laboratories, Ltd., Ranbaxy, Inc., Par Pharmaceutical 

Companies, Inc., and Par Pharmaceutical (all defendants, collectively, Sandoz and 

Teva) for infringement of the ’507 patent. Like Lupin, Sandoz and Teva had previously 

filed ANDAs, seeking to market generic versions of Omnicef. Abbott sought a 

preliminary injunction in the Illinois case. For purposes of that motion, the parties 

agreed to adopt the Eastern District of Virginia’s claim construction from the Lupin case. 

Abbott Labs. v. Sandoz, Inc., 486 F. Supp. 2d 767 (N.D. Ill. 2007) (Sandoz PI Order). 

Despite this agreement, the parties to the Sandoz case disagreed as to how to interpret 

some of the Eastern District of Virginia’s constructions, necessitating some clarification 

2007-1400, -1446 4
by the Northern District of Illinois. 486 F. Supp. 2d at 770-71 (disputing “Crystal A,” 

“peaks,” and “about,” and seeking construction of “powder X-ray diffraction pattern,” 

which the Eastern District of Virginia had not defined). Ultimately, the Northern District 

of Illinois, based on the claim construction from Virginia, denied the preliminary 

injunction. 

 Both cases arrived at this court on appeal. This court heard the cases together 

and decides them together with this decision. 

II. 

The ’507 patent has five claims, all of which Abbott asserts against Lupin as well 

as Sandoz and Teva. Claim 1 claims crystalline cefdinir, using its chemical name, and 

defining its unique characteristics with powder X-ray diffraction (PXRD) angle peaks: 

1. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-

vinyl-3-cephem.-4-carboxylic acid (syn isomer) which shows the peaks at 

the diffraction angles shown in the following table in its powder X-ray 

diffraction pattern: 

___________________________________________ 

diffraction angle (°) 

 about 14.7°

 about 17.8°

 about 21.5°

 about 22.0°

 about 23.4°

 about 24.5°

 about 28.1°

’507 patent, col.16 ll.13-27. In contrast, claims 2-5 claim crystalline cefdinir, without any 

PXRD peak limitations, but with descriptions of processes used to obtain the crystalline 

cefdinir. Claims 2 and 5 are independent: 

2. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-

vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by 

2007-1400, -1446 5
acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-

hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) 

at room temperature or under warming. 

5. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-

vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by 

dissolving 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-

cephem-4-carboxylic acid (syn isomer) in an alcohol, continuing to stir the 

solution slowly under warming, then cooling the solution to room 

temperature and allowing the solution to stand. 

Id. at col.16 ll.29-34, 43-50. 

These claims use PXRD as a way to claim the structure and characteristics of 

the unique crystalline form. PXRD is a method for identifying and distinguishing 

different crystalline compounds. The method beams X-rays toward a powdered 

chemical. The method then measures the ways the rays reflect or bend upon contact 

with the chemical. The diffraction angles and intensities vary with the type and purity of 

the test compound. A graph then plots the diffraction angle on one axis and the 

intensity on another. These graphs yield a unique “fingerprint” for each crystalline form 

of a chemical. A more sensitive form of X-ray diffraction is single crystal X-ray 

diffraction (SCXRD). As this name suggests, this method uses only a single crystal as a 

sample. SCXRD does not detect intensity, but produces a more precise diffraction 

angle measurement. 

The ’507 patent was not the first cefdinir patent. Rather, Astellas’ prior art U.S. 

Patent No. 4,559,334 (the ’334 patent) describes the discovery of cefdinir as a 

compound demonstrating high antimicrobial activity. ’334 patent, col.11 ll.18-24. The 

’334 patent expired on May 6, 2007. 

The ’507 patent claims priority to Japanese Patent Application No. 62-206199 

(the JP ’199 application), which claimed two crystalline forms of cefdinir, “Crystal A” and 

2007-1400, -1446 6
“Crystal B.” The JP ’199 application claimed Crystals A and B very specifically, defining 

Crystal A by three infrared (IR)-absorption wavelengths and sixteen PXRD angles and 

intensities. In contrast, Crystal B featured five IR-absorption wavelengths and twentyone PXRD angles/intensities. 

Despite using the JP ’199 application for priority, the ’507 patent’s specification 

differs significantly. Specifically, Abbott (actually Fujisawa Pharmaceutical Co., Ltd., 

Astellas’ predecessor in interest) jettisoned the Crystal B disclosure found in the JP ’199 

application and crafted broader claims in its prosecution of the ’507 patent. Because 

the JP ’199 applications defines Crystal A and Crystal B physiochemically rather than 

structurally, the forms actually represent subgenuses of crystalline cefdinir. Thus 

Crystals A and B comprise crystalline forms of varying structures, which in the context 

of this case means varying levels of hydration. 

The Eastern District of Virginia construed the claim terms “crystalline,” “shows,” 

“peaks,” and “about” as follows: 

1) “crystalline” means “Crystal A as outlined in the specification”; 

2) “shows” requires the display of a powder X-ray diffraction pattern which 

demonstrates the existence of the relevant peaks to a scientifically 

acceptable degree of certainty either visually or by other appropriate 

means of data display; 

3) “peaks” is the plural of “peak;” a “peak exists at a powder X-ray 

diffraction angle that corresponds to an intensity measurement greater 

than measurements attributable to “noise” if that angle is immediately 

preceded by and followed by powder X-ray diffraction angle with a lower 

intensity measurement; “noise” refers to those portions of a PXRD pattern 

produced by intrinsic measurement error, and which cannot be associated 

with a scientifically significant quantity of the material which is the subject 

of the PXRD test; 

4) “about” encompasses measurement errors inherently associated with 

powder X-ray diffraction testing. 

2007-1400, -1446 7
Lupin CC Order, 484 F. Supp. 2d at 459, 466. The Eastern District of Virginia also 

concluded that claims 2-5 were product-by-process claims. Id. Later the district court 

concluded that the process terms of claims 2-5, indicated by the phrase “obtainable by,” 

limit the claims to the specified processes and process steps. In reaching that 

conclusion, the trial court followed this court’s opinion in Atlantic Thermoplastics Co. v. 

Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992). Lupin SJ Order, 491 F. Supp. 2d at 567-

68; Lupin Ltd. v. Abbott Labs., No. 3:06-CV-400 (E.D. Va. May 10, 2007) (Lupin PbyP 

Order). In the Lupin appeal, Abbott challenges only the Eastern District of Virginia’s 

constructions of “crystalline” and “obtainable by.” 

III. 

Evaluation of a summary judgment of noninfringement requires two steps: claim 

construction, which this court reviews without deference, Cybor Corp. v. FAS 

Technologies, Inc., 138 F.3d 1448, 1451 (Fed. Cir. 1998) (en banc), and comparison of 

the properly construed claims to the accused product, process, or composition of 

matter, which in the context of summary judgment also occurs without deference, see

Ormco Corp. v. Align Technologies, Inc., 498 F.3d 1307, 1312 (Fed. Cir. 2007). 

Although infringement by equivalency is a question of fact, this court may affirm 

summary judgment “where no reasonable fact finder could find equivalence.” Sage 

Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1423 (Fed. Cir. 1997) (citing WarnerJenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17, 39 n.8 (1997). 

A. Claim Construction 

 Because the claims define the patent right, see Innova/Pure Water, Inc. v. Safari 

Water Filtration Systems, Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004), naturally “the 

2007-1400, -1446 8
claims themselves provide substantial guidance as to the meaning of particular claim 

terms.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). But the 

claims “must be read in view of the specification, of which they are a part.” Markman v. 

Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 

370 (1996). A patent’s specification provides necessary context for understanding the 

claims, and “is always highly relevant to the claim construction analysis.” Phillips, 415 

F.3d at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. 

Cir. 1996)). While equally true in a general sense, sometimes the specification offers 

practically incontrovertible directions about claim meaning. For example, inventors may 

act as their own lexicographers and give a specialized definition of claim terms. See id.

at 1316. Likewise, inventors and applicants may intentionally disclaim, or disavow, 

subject matter that would otherwise fall within the scope of the claim. See id. 

When consulting the specification to clarify the meaning of claim terms, courts 

must take care not to import limitations into the claims from the specification. This court 

has recognized the “fine line between” the encouraged and the prohibited use of the 

specification. Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 

1998). When the specification describes a single embodiment to enable the invention, 

this court will not limit broader claim language to that single application “unless the 

patentee has demonstrated a clear intention to limit the claim scope using ‘words or 

expressions of manifest exclusion or restriction.’” Liebel-Flarsheim Co. v. Medrad, Inc., 

358 F.3d 898, 906 (Fed. Cir. 2004) (quoting Teleflex, Inc. v. Ficosa N. Am. Corp., 299 

F.3d 1313, 1327 (Fed. Cir. 2002)). By the same token, the claims cannot “enlarge what 

is patented beyond what the inventor has described as the invention.” Biogen, Inc. v. 

2007-1400, -1446 9
Berlex Labs., Inc., 318 F.3d 1132, 1140 (Fed. Cir. 2003) (quoting Netword, LLC v. 

Central Corp., 242 F.3d 1347, 1352 (Fed. Cir. 2001)). Thus this court may reach a 

narrower construction, limited to the embodiment(s) disclosed in the specification, when 

the claims themselves, the specification, or the prosecution history clearly indicate that 

the invention encompasses no more than that confined structure or method. See

Liebel-Flarsheim, 358 F.3d at 908. 

 Along with the specification, the prosecution history is “intrinsic evidence” of the 

meaning of the claims, because it “provides evidence of how the [United States Patent 

& Trademark Office (PTO)] and the inventor understood the patent.” Phillips, 415 F.3d 

at 1317. Although often producing ambiguities occasioned by ongoing negotiations 

between the inventor and the PTO, “the prosecution history can often inform the 

meaning of the claim language by demonstrating how the inventor understood the 

invention and whether the inventor limited the invention in the course of prosecution, 

making the claim scope narrower than it would otherwise be.” Id. “[C]lear and 

unmistakable” statements during prosecution may also disavow claim scope. Computer 

Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374 (Fed. Cir. 2008) (quoting 

Purdue Pharma L.P. v. Endo Pharms., Inc., 438 F.3d 1123, 1136 (Fed. Cir. 2006)). 

Again owing in part to the inherent ambiguities of prosecution history, the doctrine of 

prosecution disclaimer only applies to unambiguous disavowals. See id. at 1375. 

1. “crystalline” 

2007-1400, -1446 10
The Eastern District of Virginia’s construction of “crystalline” in claims 1-5 as 

“Crystal A” included the important caveat “as outlined in the specification.” Lupin CC 

Order, 484 F. Supp. 2d at 459. Although the Eastern District noted the parties agreed 

that “crystalline” ordinarily means exhibiting “uniformly arranged molecules or atoms,” 

id. at 454, the court relied on the language of the claims themselves, the specification, 

and the prosecution history to arrive at the more specific meaning recited in the 

specification. 

The ’507 specification states that “Crystal A of the compound (I) [cefdinir] shows 

its distinguishing peaks” at the seven particular PXRD angles enumerated in claim 1. 

’507 patent col.1 ll.51-62. Indeed, the phrase “Crystal A of the compound (I)” appears 

throughout the written description, and the patent offers the following definition: “any 

crystal of the compound (I) which shows substantially the same diffraction pattern [as in 

the table in col.1/claim 1] is identified as Crystal A of the compound (I).” Id. at col.1 l.67-

col.2 l.2. As the Eastern District correctly concluded: 

Had Astellas intended, in the chart found in column 1, to distinguish 

Crystal A from other forms of crystalline cefdinir that also fall within the 

scope of claim 1, it would have listed, at a minimum, an eighth peak 

associated only with Crystal A. However, by listing in column 1 only the 

same seven ‘distinguishing’ peaks featured in Claim 1, Astellas confirmed 

that Crystal A was synonymous with the invention listed in Claim 1. 

 

Lupin CC Order, 484 F. Supp. 2d at 456-57. The problem, within the confines of claim 

1, is that defining “crystalline” as “Crystal A,” where “Crystal A” incorporates the seven 

PXRD peak limitations, arguably renders the remainder of that claim redundant. To 

distinguish the invention, however, the specification refers several times to “Crystal A of 

the compound (I) of the present invention,” see, e.g., ’507 patent, col.2 ll.15-17, and 

offers no suggestion that the recited processes could produce non-Crystal A 

2007-1400, -1446 11
compounds, even though other types of cefdinir crystals, namely Crystal B, were known 

in the art. As noted earlier, the Crystal B formulation actually appears in the parent JP 

’199 application. Thus, Abbott knew exactly how to describe and claim Crystal B 

compounds. Knowing of Crystal B, however, Abbott chose to claim only the A form in 

the ’507 patent. Thus, the trial court properly limited the term “crystalline” to “Crystal A.” 

The trial court’s definition correctly identifies claim 1’s literal scope. 

Unlike claim 1, claims 2-5 do not recite the seven PXRD peaks expressly 

associated with Crystal A in the ’507 specification. Nonetheless, the Eastern District of 

Virginia limited “crystalline” to “Crystal A” in these claims as well, The trial court gave 

two reasons for this limitation. First, “[t]he process steps detailed in those claims 

[claims 2-5] correspond with the processes for making Crystal A disclosed in the 

specification under the heading ‘The Process For Preparing Crystal A of The Compound 

(I).’” Id. at 457 (quoting ’507 patent, col.2 ll.13-14). Second, the parent JP ’199 

application recited these steps “to distinguish between preparations of Crystal A and 

Crystal B.” Id. (citing JP ’199 application, col.6 ll.1-25). 

In limiting “crystalline” to “Crystal A” in claims 1-5, the Eastern District of Virginia 

did not improperly import the preferred embodiment into the claims. Initially, Crystal A is 

the only embodiment described in the specification. As discussed above, the 

specification’s recitation of Crystal A as its sole embodiment does not alone justify the 

trial court’s limitation of claim scope to that single disclosed embodiment. See LiebelFlarsheim, 358 F.3d at 906 (“[T]his court has expressly rejected the contention that if a 

patent describes only a single embodiment, the claims of the patent must be construed 

as being limited to that embodiment.”). In this case, however, the rest of the intrinsic 

2007-1400, -1446 12
evidence, including the prosecution history and the priority JP ’199 application, evince a 

clear intention to limit the ’507 patent to Crystal A as defined by the seven PXRD peaks 

in the specification and in claim 1. 

Initially, the Eastern District of Virginia properly considered the JP ’199 

application as relevant objective evidence of the inventor’s knowledge at the filing of the 

’507 patent. While statements made during prosecution of a foreign counterpart to a 

U.S. patent application have a narrow application to U.S. claim construction, Pfizer Inc. 

v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1290 (Fed. Cir. 2006), in this case the JP ’199 

application is part of the prosecution history of the ’507 patent itself. Indeed the ’507 

patent claims priority from the JP ’199 application. Furthermore, the trial court did not 

rely on attorney argument or amendments during a foreign prosecution as in Pfizer, but 

consulted only the contents of the foreign priority application. The JP ’199 application 

strongly suggests that the ’507 patent intentionally excluded Crystal B compounds. As 

discussed above, the JP ’199 application establishes unequivocally that Abbott knew 

and could describe both Crystal A and Crystal B. Abbott could have retained the 

disclosure of Crystal B to support the broader claims of the ’507 patent, but instead 

disclosed and claimed A alone. 

Furthermore, the prosecution history of the ’507 patent shows a clear and 

intentional disavowal of claim scope beyond Crystal A. Co-inventor Takao Takaya, who 

prepared samples according to Examples 14 and 16 of the prior art ’334 patent and a 

sample of “Crystal A of the present application,” offered a declaration that Crystal A was 

more stable than the prior art samples from the ’334 patent. An analytical chemist, 

Yoshihiko Okamato, corroborated this evidence. J. A. 501-04. Beyond these 

2007-1400, -1446 13
declarations, the applicant specifically limited the invention to Crystal A: “the method of 

preparation of the crystalline form of the presently claimed compounds is not considered 

the heart of the present invention. The crystalline form of the compound represents the 

inventive concept hereof, and it is clear that [the ’334 patent] does not anticipate or 

suggest said crystalline form.” J. A. 511 (Response to Office Action of May 11, 1989, 

received October 27, 1989, at 6). 

Given the exclusive focus on Crystal A in the specification as well as the 

prosecution history of the ’507 patent, the Eastern District of Virginia properly limited 

“crystalline” in claims 1-5 to “Crystal A.” 

2. proper interpretation of product-by process claims1 

 This court addresses Part III.A.2 of this opinion en banc, which addresses the 

proper interpretation of product-by-process claims in determining infringement. 

Claims 2-5 of the ’507 patent begin by reciting a product, crystalline cefdinir, and 

then recite a series of steps by which this product is “obtainable.” The Eastern District 

of Virginia correctly categorized claims 2-5 as product-by-process claims. On appeal, 

Abbott argues that the Eastern District erred in construing the process steps of claims 

2-5 under the rule in Atlantic Thermoplastics, 970 F.2d at 846-47, that “process terms in 

product-by-process claims serve as limitations in determining infringement,” rather than 

in accordance with Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 

1565, 1583 (Fed. Cir. 1991) (“[T]he correct reading of product-by-process claims is that 

 1

 This court, sua sponte, took en banc Section III.A.2 before issuing a panel 

opinion. The following judges join this section of the opinion: Chief Judge Michel and 

Judges Rader, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore. Judges Newman and 

Lourie dissent in separate opinions. Judges Mayer and Lourie join in Judge Newman’s 

dissent. Judge Schall did not participate as a member of the en banc court. 

2007-1400, -1446 14
they are not limited to product prepared by the process set forth in the claims.”). This 

court takes this opportunity to clarify en banc the scope of product-by-process claims by 

adopting the rule in Atlantic Thermoplastics. 

In Atlantic Thermoplastics, this court considered the scope of product-by-process 

claim 26 in the patent at issue: “[t]he molded innersole produced by the method of 

claim 1.” 970 F.2d at 836. The patentee urged that competing, indistinguishable 

innersoles made by a different method nonetheless infringed claim 26. Id. at 838. This 

court rejected the patentee’s position. This court in Atlantic Thermoplastics construed 

product-by-process claims as limited by the process. Id. at 846-7. 

This rule finds extensive support in Supreme Court opinions that have addressed 

the proper reading of product-by-process claims. See Smith v. Goodyear Dental 

Vulcanite Co., 93 U.S. 486, 493 (1877) (“The process detailed is thereby made as 

much a part of the invention as are the materials of which the product is composed.”); 

Goodyear Dental Vulcanite Co. v. Davis, 102 U.S. 222, 224 (1880) (“[T]o constitute 

infringement of the patent, both the material of which the dental plate is made . . . and 

the process of constructing the plate . . . must be employed.”); Merrill v. Yeomans, 94 

U.S. 568 (1877); Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884) 

(BASF); The Wood-Paper Patent, 90 U.S. 566, 596 (1874); Plummer v. Sargent, 120 

U.S. 442 (1887); Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938); see

also Atl. Thermoplastics, 970 F.2d at 839-42 (discussing each of these cases). In 

these cases, the Supreme Court consistently noted that process terms that define the 

product in a product-by-process claim serve as enforceable limitations. In addition, the 

binding case law of this court’s predecessor courts, the United States Court of Customs 

2007-1400, -1446 15
and Patent Appeals (see In re Hughes, 496 F.2d 1216, 1219 (CCPA 1974) 

(acknowledging that “true product claims” are “broader” in scope than product-byprocess claims)), and the United States Court of Claims (see Tri-Wall Containers v. 

United States, 408 F.2d 748, 751 (Ct. Cl. 1969)), followed the same rule. 

This court’s sister circuits also followed the general rule that the defining process 

terms limit product-by-process claims. See, e.g., Hide-Ite Leather v. Fiber Prods., 226 

F. 34, 36 (1st Cir. 1915) (“It is also a well-recognized rule that, although a product has 

definite characteristics by which it may be identified apart from the process, still, if in a 

claim for the product it is not so described, but is set forth in the terms of the process, 

nothing can be held to infringe the claim which is not made by the process.”); Paeco, 

Inc. v. Applied Moldings, Inc., 562 F.2d 870, 876 (3d Cir. 1977) (“A patent granted on a 

product claim describing one process grants no monopoly as to identical products 

manufactured by a different process.”). Indeed, this court itself had articulated that 

rule: “For this reason, even though product-by-process claims are limited by and 

defined by the process, determination of patentability is based on the product itself.” In 

re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) (emphasis added). 

The Supreme Court has long emphasized the limiting requirement of process 

steps in product-by-process claims. In BASF, the Court considered a patent relating to 

artificial alizarine. Specifically, the patent claimed “[a]rtificial alizarine, produced from 

anthracine or its derivatives by either of the methods herein described, or by any other 

method which will produce a like result.” 111 U.S. at 296 (quoting U.S. Patent Reissue 

No. RE 4,321). In turn, the specification generally described a method for making 

artificial alizarine involving anthracine or its derivatives. Alizarine had been in use for 

2007-1400, -1446 16
thousands of years as a red textile dye, traditionally extracted from madder root. Pure 

alizarine has the chemical formula C14H8O4, but “artificial alizarines” available in the 

market at the time of the litigation varied from almost completely pure alizarine, to 

combinations of alizarine and anthrapurpurine, to pure purpurine containing no alizarine 

whatsoever. Id. at 309-10. The defendant’s product contained approximately sixty 

percent anthrapurpurine. Thus both alizarine and artificial alizarines were known in the 

prior art. The Supreme Court clearly articulated some of the scope and validity 

problems that arise when process limitations of product-by-process claims are ignored: 

[The defendant’s product] is claimed by the plaintiff to be the artificial 

alizarine described in No. 4,321, and to be physically, chemically, and in 

coloring properties similar to that. But what that is is not defined in No. 

4,321, except that it is the product of the process described in No. 4,321. 

Therefore, unless it is shown that the process of No. 4,321 was followed to 

produce the defendant’s article, or unless it is shown that that article could 

not be produced by any other process, the defendant’s article cannot be 

identified as the product of the process of No. 4,321. Nothing of the kind 

is shown. 

* * * 

If the words of the claim are to be construed to cover all artificial alizarine, 

whatever its ingredients, produced from anthracine or its derivatives by 

methods invented since Graebe and Liebermann invented the bromine 

process, we then have a patent for a product or composition of matter 

which gives no information as to how it is to be identified. Every patent for 

a product or composition of matter must identify it so that it can be 

recognized aside from the description of the process for making it, or else 

nothing can be held to infringe the patent which is not made by that 

process.

Id. at 310 (emphasis added). 

After BASF, the Supreme Court continued to emphasize the importance of 

process steps in evaluating the infringement of product-by-process claims. See, e.g., 

Plummer, 120 U.S. at 448 (“[W]hatever likeness that may appear between the product 

of the process described in the patent and the article made by the defendants, their 

2007-1400, -1446 17
identity is not established unless it is shown that they are made by the same process.”); 

Gen. Elec. Co., 304 U.S. at 373 (“[A] patentee who does not distinguish his product 

from what is old except by reference, express or constructive, to the process by which 

he produced it, cannot secure a monopoly on the product by whatever means 

produced.” (footnote omitted)). 

Thus, based on Supreme Court precedent and the treatment of product-byprocess claims throughout the years by the PTO and other binding court decisions, this 

court now restates that “process terms in product-by-process claims serve as limitations 

in determining infringement.” Atl. Thermoplastics, 970 F.2d at 846-47. As noted earlier, 

this holding follows this court’s clear statement in In re Thorpe that “product by process 

claims are limited by and defined by the process.” 777 F.2d at 697. 

More recently, the Supreme Court has reiterated the broad principle that “[e]ach 

element contained in a patent claim is deemed material to defining the scope of the 

patented invention.” Warner-Jenkinson, 520 U.S. at 19. Although Warner-Jenkinson

specifically addressed the doctrine of equivalents, this rule applies to claim construction 

overall. As applied to product-by-process claims, Warner-Jenkinson thus reinforces the 

basic rule that the process terms limit product-by-process claims. To the extent that 

Scripps Clinic is inconsistent with this rule, this court hereby expressly overrules Scripps 

Clinic. 

The dissenting opinions lament the loss of a “right” that has never existed in 

practice or precedent – the right to assert a product-by-process claim against a 

defendant who does not practice the express limitations of the claim. This court’s en 

banc decision in no way abridges an inventor’s right to stake claims in product-by2007-1400, -1446 18
process terms. Instead this decision merely restates the rule that the defining 

limitations of a claim – in this case process terms – are also the terms that show 

infringement. 

Thus this court does not question at all whether product-by-process claims are 

legitimate as a matter of form. The legitimacy of this claim form was indeed a relevant 

issue in the nineteenth century when Ex parte Painter, 1891 C.D. 200, 200-01 (Comm’r 

Pat. 1891), and some later cases were before the Commissioner of Patents. However, 

this court need not address that settled issue. The issue here is only whether such a 

claim is infringed by products made by processes other than the one claimed. This court 

holds that it is not. 

The jurisprudence of the Court of Customs and Patent Appeals – a court with 

virtually no jurisdiction to address infringement litigation – can shed little light on the 

enforcement of the only claim limitations that an applicant chooses to define the 

invention. Indeed, this court’s venerable predecessor expressed its ambivalence 

towards the relevant infringement analysis: 

The policy of the Patent Office in permitting product-by-process type 

claims to define a patentable product, where necessary, has developed 

with full cognizance of the fact that in infringement suits some courts have 

construed such claims as covering only a product made by the particular 

process set forth in the claim and not to the product per se. 

In re Bridgeford, 357 F.2d 679, 683 n.5 (CCPA 1966). The reference to “some courts” 

in this prior citation, as this court notes en banc, includes the United States Supreme 

Court and every circuit court to consider the question, including this circuit. See also

Jon S. Saxe & Julian S. Levitt, Product-by-Process Claims and Their Current Status in 

Chemical Patent Office Practice, 42 J. Pat. Off. Soc’y 528, 530 (1960) (“[P]roduct-by2007-1400, -1446 19
process claims have met with a most strict interpretation in the courts in infringement 

proceedings . . . . [T]he courts uniformly hold that only a product produced by the claimdesignated process may be held to infringe the claim.”) (citing Gen. Elec. Co., 304 U.S. 

364 and BASF, 111 U.S. at 310). 

 Product-by-process claims, especially for those rare situations when products 

were difficult or impossible to describe, historically presented a concern that the Patent 

Office might deny all product protection to such claims. See In re Butler, 17 C.C.P.A. 

810, 813 (CCPA 1930) (“Process claims are valuable, and appellant thinks he is entitled 

to them; but it is submitted that he should not be limited to control of the process when 

the article which that process produces is new and useful.”). In the modern context, 

however, if an inventor invents a product whose structure is either not fully known or too 

complex to analyze (the subject of this case – a product defined by sophisticated PXRD 

technology – suggests that these concerns may no longer in reality exist), this court 

clarifies that the inventor is absolutely free to use process steps to define this product. 

The patent will issue subject to the ordinary requirements of patentability. The inventor 

will not be denied protection. Because the inventor chose to claim the product in terms 

of its process, however, that definition also governs the enforcement of the bounds of 

the patent right. This court cannot simply ignore as verbiage the only definition supplied 

by the inventor. 

 This court’s rule regarding the proper treatment of product-by-process claims in 

infringement litigation carries its own simple logic. Assume a hypothetical chemical 

compound defined by process terms. The inventor declines to state any structures or 

characteristics of this compound. The inventor of this compound obtains a product-by2007-1400, -1446 20
process claim: “Compound X, obtained by process Y.” Enforcing this claim without 

reference to its defining terms would mean that an alleged infringer who produces 

compound X by process Z is still liable for infringement. But how would the courts 

ascertain that the alleged infringer’s compound is really the same as the patented 

compound? After all, the patent holder has just informed the public and claimed the 

new product solely in terms of a single process. Furthermore, what analytical tools can 

confirm that the alleged infringer’s compound is in fact infringing, other than a 

comparison of the claimed and accused infringing processes? If the basis of 

infringement is not the similarity of process, it can only be similarity of structure or 

characteristics, which the inventor has not disclosed. Why also would the courts deny 

others the right to freely practice process Z that may produce a better product in a better 

way? 

In sum, it is both unnecessary and logically unsound to create a rule that the 

process limitations of a product-by-process claim should not be enforced in some 

exceptional instance when the structure of the claimed product is unknown and the 

product can be defined only by reference to a process by which it can be made. Such a 

rule would expand the protection of the patent beyond the subject matter that the 

inventor has “particularly point[ed] out and distinctly claim[ed]” as his invention, 35 

U.S.C. § 112 ¶ 6. 

Thus, the Eastern District of Virginia correctly applied the rule that the recited 

process steps limit the product-by-process claims 2-5 for any infringement analysis. 

3. “obtainable by” 

2007-1400, -1446 21
In this case, Abbott’s plain language argument, that “obtainable by” introduces an 

optional process, even if “obtained by” would introduce limiting process steps, is also 

unavailing. The BASF case, an analogous situation to this case, controls. As noted 

above, the Supreme Court in BASF considered the following claim language: “Artificial 

alizarine, produced from anthracine or its derivatives by either of the methods herein 

described, or by any other method which will produce a like result.” 111 U.S. at 296 

(emphasis added). The patentee argued that even though the defendant did not make 

artificial alizarine by “either of the methods herein described,” the claim should capture 

the product because of the “or by another method” language. Id. at 309. The Supreme 

Court refused to attach importance to those expansive words: “No. 4,321 furnishes no 

test by which to identify the product it covers, except that such product is to be the result 

of the process it describes.” Id. at 305. Abbott’s claims 2-5, like those in BASF and like 

product-by-process claims in general, do not furnish any test by which to identify the 

cefdinir crystals except that they are the result of their respectively claimed processes. 

As per BASF, Abbott’s claim cannot capture a product obtained by or obtainable by 

processes other than those explicitly recited in the claims. 

If this court were to strip the process elements from the claims, as Abbott would 

urge, for infringement purposes, there would then be nothing to differentiate 

independent claim 2 from independent claim 5. After all, if those claims are not bound 

by the process terms but only “define” the basic cefdinir compound, then each of the 

claims recite the same thing, over and over again. Though Abbott argues that it merely 

intends to give meaning to the word “obtainable,” it instead seeks to have this court 

2007-1400, -1446 22
render meaningless the explicit process limitations that the applicant chose to define its 

invention. 

The intrinsic evidence in this case further rebuts Abbott’s contention that its 

claims are not limited to those products actually obtained by the processes recited. In 

column 2 of the ’507 patent, under the title heading “The Process for Preparing Crystal 

A of the Compound (I),” the patentee used specific language to describe the very two 

processes that are mirrored in claims 2 and 5. ’507 patent col.2 ll.13-51. This language 

is not open-ended, nor does it constitute a mere description of the product by reference 

to the manner in which it can be made, as Abbott argues. By drafting claims 2 and 5 to 

incorporate these specific processes, Abbott made a conscious choice to place process 

requirements on its claimed product. If Abbott had wanted to obtain broader coverage 

for crystalline cefdinir devoid of any process limitations, as it seeks to do here, it could 

have simply done so (if indeed, as it argues, it is really the product that is the heart of 

the invention, not the process). But it did not. The crystals of claims 2 and 5 are simply 

not identifiable other than by the processes disclosed in column 2. This court must 

enforce the ways and terms that a party chooses to define its invention. 

The prosecution history also does not support Abbott’s contention that 

“obtainable by” offers merely an optional set of definitional process conditions. During 

prosecution, Abbott faced obviousness rejections based on application claims 6-9, 

which were process claims that mirrored the very process limitations of issued claims 2-

5. The PTO refused to issue the claims until one set of duplicates was cancelled. 

Abbott’s action in cancelling claims 6-9 demonstrates its acquiescence to the PTO’s 

view that the process elements of claims 2-5 are critical parts of those claims. In 

2007-1400, -1446 23
addition, in a response to the PTO’s office action, Abbott chose to differentiate a cited 

§ 103 reference, Takaya, on the basis that Abbott’s claimed processes are different. 

For these reasons, the applicant’s statement in the file wrapper that “the method of 

preparation . . . is not considered the heart of the present invention” should not be 

afforded undue gravitas. The process limitations cannot be haphazardly jettisoned for 

an infringement analysis when they were so important in the patentability analysis. 

In sum, a patentee’s use of the word “obtainable” rather than “obtained by” 

cannot give it a free pass to escape the ambit of the product-by-process claiming 

doctrine. Claims that include such ambiguous language should be viewed extremely 

narrowly. If this court does not require, as a precondition for infringement, that an 

accused infringer actually use a recited process, simply because of the patentee’s 

choice of the probabilistic suffix “able,” the very recitation of that process becomes 

redundant. This would widen the scope of the patentee’s claims beyond that which is 

actually invented—a windfall to the inventor at the expense of future innovation and 

proper notice to the public of the scope of the claimed invention. For all the above 

reasons, the Eastern District of Virginia correctly construed the process limitations 

beginning with “obtainable by” in claims 2-5 as limiting the asserted claims to products 

made by those process steps. 

B. Summary Judgment 

In the Lupin case, the Eastern District of Virginia granted summary judgment of 

noninfringement of claims 2-5, both literal and by equivalents, and of claim 1 by 

equivalents. Lupin SJ Order. Literal infringement of claim 1, i.e., whether Lupin’s 

generic cefdinir product contains any Crystal A, is therefore not a live issue on appeal. 

2007-1400, -1446 24
As for claims 2-5, the Eastern District noted that “Abbott and Astellas have conceded 

that literal infringement of Claims 2-5 cannot be established if the product-by-process 

analysis is performed pursuant to Atlantic Thermoplastics,” given that “Abbott and 

Astellas have presented no evidence that Lupin is practicing the process steps set forth 

in Claims 2-5.” Lupin SJ Order, 491 F. Supp. 2d at 568. Because the Eastern District 

correctly applied the rule from Atlantic Thermoplastics and likewise properly construed 

the limiting process terms in claims 2-5, only infringement by equivalents of claims 1-5 

remains before this court. 

Infringement analysis under the doctrine of equivalents proceeds element-byelement; a generalized showing of equivalency between the claim as a whole and the 

allegedly infringing product or process is not sufficient to show infringement. See

Warner-Jenkinson, 520 U.S. at 29 (“the doctrine of equivalents must be applied to 

individual elements of the claim, not to the invention as a whole”). The primary test for 

equivalency is the “function-way-result” or “triple identity” test, whereby the patentee 

may show an equivalent when the accused product or process performs substantially 

the same function, in substantially the same way, to achieve substantially the same 

result, as disclosed in the claim. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 

U.S. 605, 608 (1950). But, because “[d]ifferent linguistic frameworks may be more 

suitable to different cases,” Warner-Jenkinson, 520 U.S. at 40, the function-way-result 

test is not the only test for equivalency. Equivalency may also be proven where the 

differences between the invention as claimed and the accused product or process are 

insubstantial. Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512, 1517-18 

(Fed. Cir. 1995) (en banc), rev’d on other grounds, 520 U.S. 17 (1997). In no case, 

2007-1400, -1446 25
however, may the doctrine of equivalents ignore the individual claim elements. See

Warner-Jenkinson, 520 U.S. at 40 (requiring “a special vigilance against allowing the 

concept of equivalence to eliminate completely any such [individual] elements”). 

Because “crystalline” in claims 1-5 is limited to “Crystal A” as defined by the 

seven PXRD peaks enumerated in claim 1 and in the specification of the ’507 patent, 

the doctrine of equivalents cannot capture crystals that are not themselves equivalent to 

Crystal A. In turn, the bounds of Crystal A equivalents cannot ignore the limits on 

Crystal A in the ’507 patent, which as discussed above, includes a conscious decision 

to distinguish Crystal B from the claimed invention. To recall, the applicant removed 

Crystal B from the US prosecution of the parent JP ’199 application. The ’507 patent 

indisputably describes and claims Crystal A, and not Crystal B. The ’507 patent, of 

course, could have claimed the known Crystal B formulation which was known to the 

inventors because it appeared in their priority JP ’199 application. The applicants chose 

not to claim Crystal B. Thus Crystal B compounds, most relevantly cefdinir 

monohydrate, fall outside the scope, literal or equivalent, of claims 1-5 of the ’507 

patent. 

The parties agree that the “bulk” of Lupin’s cefdinir product is Crystal B, not 

Crystal A. The degree to which Lupin’s product may or may not also contain Crystal A 

is the central inquiry regarding the alleged literal infringement of claim 1, which is not 

part of the present appeal. Abbott cannot extend its exclusive right in the ’507 claims 

under the doctrine of equivalents to embrace known but unclaimed subject matter. In 

other words, Abbott effectively disclaimed Crystal B during prosecution of the ’507 

patent, by removing the Crystal B disclosure from the parent JP ’199 application and 

2007-1400, -1446 26
emphasizing the sole teaching of Crystal A in communications with the PTO as well as 

in the ’507 specification itself. Abbott cannot now recapture that unclaimed subject 

matter under the doctrine of equivalents because the Eastern District properly 

interpreted claims 2-5 to limit “crystalline” to Crystal A. To expand that claim term to 

embrace Crystal B would ignore the specific claim limitations of the ’507 patent. 

Alternatively this court notes that this case seems to fit within the dedication 

doctrine that forecloses invocation of the doctrine of equivalents. The patent applicant 

clearly knew of the Crystal B forms of the claimed invention because it claimed and 

disclosed them in its Japanese priority application. Yet it declined to claim an 

embodiment expressly disclosed in its priority document, thus dedicating that 

embodiment to the public and foreclosing any recapture under the doctrine of 

equivalents. See Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1054 

(Fed. Cir. 2002). 

During prosecution, Abbott chose to eschew Crystal B and focus exclusively on 

Crystal A compounds. Without a complete record and no arguments about validity 

before this court on appeal, this court cannot speculate on the reasons for this choice. 

Nonetheless, the parties hotly contest whether Example 14, which reports obtaining 

“crystals” not specifically identified or described, and/or Example 16 of the ’334 patent 

enable cefdinir monohydrate, i.e. Crystal B type crystals. 

Beyond the attempt to reinflate the claims to encompass Crystal B based on 

mathematical comparisons of the PXRD peak patterns of Crystal A and Crystal B, 

Abbott also asserts that Lupin effectively admitted infringement by equivalents when it 

claimed before the Food and Drug Administration that its cefdinir generic was a 

2007-1400, -1446 27
bioequivalent to Abbott’s Omnicef product. While bioequivalency may be relevant to the 

function prong of the function-way-result test, bioequivalency and equivalent 

infringement are different inquiries. Bioequivalency is a regulatory and medical concern 

aimed at establishing that two compounds are effectively the same for pharmaceutical 

purposes. In contrast, equivalency for purposes of patent infringement requires an 

element-by-element comparison of the patent claim and the accused product, requiring 

not only equivalent function but also equivalent way and result. Different attributes of a 

given product may thus be relevant to bioequivalency but not equivalent infringement, 

and vice versa. As the Northern District of Illinois observed in the Sandoz case, “[i]f 

bioequivalency meant per se infringement, no alternative to a patented medicine could 

ever be offered to the public during the life of a patent.” Sandoz PI Order, 486 F. Supp. 

2d at 776. Thus, while potentially relevant, the bioequivalency of an accused product 

with a product produced from the patent at issue is not sufficient to establish 

infringement by equivalents. 

Because Crystal B is not an equivalent of Crystal A, the Eastern District of 

Virginia did not err in granting summary judgment of noninfringement of claims 2-5, both 

with respect to literal and equivalent infringement, and with respect to equivalent 

infringement of claim 1. 

IV. 

This court reviews the grant or denial of a preliminary injunction for abuse of 

discretion. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. 

Cir. 2001). A district court may enter a preliminary injunction based on its consideration 

of four factors: “(1) the likelihood of the patentee’s success on the merits; (2) irreparable 

2007-1400, -1446 28
harm if the injunction is not granted; (3) the balance of hardships between the parties; 

and (4) the public interest.” Erico Int’l Corp. v. Vutec Corp., 516 F.3d 1350, 1353-54 

(Fed. Cir. 2008) (quoting PHG Techs., LLC v. St. John Cos., Inc., 469 F.3d 1361, 1365 

(Fed. Cir. 2006). 

Sandoz and Teva’s Omnicef generic products, like Lupin’s, are also at least 

primarily cefdinir monohydrate, a Crystal B compound. Sandoz PI Order, 486 F. Supp. 

2d at 769. Before the Northern District of Illinois, the parties to the Sandoz litigation 

disputed whether Sandoz and Teva’s products also contained small amounts of cefdinir 

anhydrate, i.e., Crystal A, which would fall within the literal scope of claim 1 of the ’507 

patent. Working primarily from the Eastern District of Virginia’s claim construction, to 

which the parties to the Sandoz litigation agreed would bind their litigation as well for 

purposes of the preliminary injunction motion, the Northern District of Illinois denied 

Abbott’s motion for a preliminary injunction, finding that Abbott was unlikely to prevail on 

the merits at trial. 

This court detects no abuse of discretion in the Northern District of Illinois’ 

preliminary injunction denial. As described above, the ’507 patent is properly construed 

to exclude Crystal B, both as to literal and equivalent infringement. Thus, this court 

need not delve into the Northern District of Illinois’ clarifications of the Eastern District of 

Virginia’s claim constructions. The Northern District of Illinois succinctly concluded: 

“[w]e know that Crystal B was known to the plaintiffs because it had been included in 

the Japanese ‘199 patent. Thus we conclude that the plaintiffs deliberately excluded 

from the definition of Crystal A, cefdinir monohydrate, which is Crystal B.” Id. at 775. 

2007-1400, -1446 29
As to the alleged presence of small amounts of Crystal A in Sandoz and Teva’s 

products, Abbott’s evidence did not persuade the Northern District of Illinois. Id. This 

court perceives that decision as well within the trial court’s discretion. As additional 

support, the Northern District observed that there was no evidence that any trace 

amounts of cefdinir anhydrate, i.e. Crystal A, in Sandoz and Teva’s products “could be a 

contributing factor in the efficacy” and that even “if there is a small amount of cefdinir 

anhydrate in defendants’ products, we do not conclude that this could cause literal 

infringement.” Id. While these may be misstatements of the law, because de minimis

infringement can still be infringement, see 35 U.S.C. § 271(a); see also SunTiger, Inc. 

v. Sci. Res. Funding Group, 189 F.3d 1327, 1336 (Fed. Cir. 1999) (“If a claim reads 

merely on a part of an accused device, that is enough for infringement.”), this court 

need not reach that issue in a preliminary injunction context which affords the trial court 

broad leeway to discern a “likelihood of success.” Likewise the district court may have 

overstated the relevance of efficacy, because the ’507 patent contains no claim 

limitations relating to efficacy. But these misstatements were harmless because they 

merely formed an alternative basis for the Northern District of Illinois’ reasonable 

assessment of the evidence proffered by Abbott for its preliminary injunction motion. As 

noted, this court sustains the trial court’s discretion based primarily on its administration 

of the proper claim construction and its finding that Abbott was not likely to show 

Sandoz and Teva’s products contained any Crystal A at all. 

CONCLUSION 

 The Eastern District of Virginia correctly construed the ’507 patent’s recitation of 

“crystalline” in each of the asserted claims as limited to Crystal A, as outlined in the 

2007-1400, -1446 30
2007-1400, -1446 31

specification. Because Abbott scrubbed all references to Crystal B in the ’507 patent’s 

specification, which were present in the ’507 patent’s parent foreign application, Abbott 

clearly demonstrated its intent to limit the ’507 patent to Crystal A. This intent was 

further underscored by comments made during prosecution. As such, Abbott is unable 

to recapture Crystal B through broad claim language or under the doctrine of 

equivalents. The Eastern District of Virginia therefore properly concluded on summary 

judgment that Lupin’s cefdinir product did not infringe claims 1-5 literally or claims 2-5 

by equivalency. Similarly, the Northern District of Illinois did not abuse its discretion in 

declining to enter a preliminary injunction against Sandoz and Teva’s cefdinir products. 

AFFIRMED

COSTS 

Each party shall bear its own costs. 
United States Court of Appeals for the Federal Circuit 

2007-1400 

ABBOTT LABORATORIES, 

Plaintiff-Appellant, 

and 

ASTELLAS PHARMA, INC., 

 Plaintiff-Appellant, 

v. 

SANDOZ, INC., 

Defendant-Appellee, 

and 

SANDOZ GMBH, 

 Defendant, 

and 

TEVA PHARMACEUTICALS USA, INC. and 

TEVA PHARMACEUTICAL INDUSTRIES, LTD., 

 Defendants-Appellees, 

and 

RANBAXY LABORATORIES, LTD. and RANBAXY, INC., 

 Defendants, 

and 

PAR PHARMACEUTICAL COMPANIES, INC. and PAR PHARMACEUTICAL, 

 Defendants. 

----------------------------------------------- 
2007-1446 

LUPIN LIMITED, 

Plaintiff/Counterclaim DefendantAppellee, 

and 

LUPIN PHARMACEUTICALS, INC., 

Counterclaim DefendantAppellee, 

v. 

ABBOTT LABORATORIES, 

Defendant/CounterclaimantAppellant, 

and 

ASTELLAS PHARMA, INC., 

Defendant/CounterclaimantAppellant. 

Appeals from the United States District Court for the Northern District of Illinois in case 

no. 07-CV-1721, Judge Wayne R. Andersen and the United States District Court for the 

Eastern District of Virginia in case no 3:06-CV-400, Judge Robert E. Payne. 

NEWMAN, Circuit Judge, with whom Circuit Judges MAYER and LOURIE join, 

dissenting from en banc Section III.A.2. 

The court today acts en banc to overturn a century of precedent and practice, 

and holds that a new product that is difficult to describe without reference to how it was 

made, but that is nonetheless a new and unobvious product, cannot be protected as a 

product if its description is aided by reference to how it was made. Heretofore a new 

product whose structure was not fully known or not readily described could be patented 

2007-1400, -1446 2
as a product by including in the product description sufficient reference to how it can be 

made, to distinguish the new product from prior art products. Patentability was 

determined as a product, independent of any process reference in the claim, and 

validity and infringement were based on the product itself. This expedient for patenting 

products whose structure was not fully known at the time of filing the patent application 

has been called the “rule of necessity.” It was pragmatic, fair, and just, for it attuned 

patent law and practice to the realities of invention. 

Today the court rejects this expedient and discards this practice, ruling that all 

claims containing a process term under the rule of necessity now must be construed, for 

purposes of infringement, as limited to use of any process term that was used to assist 

in defining the product. That is, such a product is not patented as a product, however it 

is produced, but is limited to the process by which it was obtained. This is a new 

restraint on patents for new products, particularly today’s complex chemical and 

biological products whose structure may be difficult to analyze with precision. It is a 

change of law with unknown consequences for patent-based innovation. 

The court acts sua sponte, without explanation of what policy is intended to be 

served by this change, without consideration of the technologies that may be adversely 

affected by elimination of this expedient, without notice to those whose property rights 

may be diminished. In so doing, the court departs from statute, precedent, and practice. 

This change is as unnecessary as it is flawed, gratuitously affecting inventions past, 

present, and future. I respectfully dissent. 

2007-1400, -1446 3
DISCUSSION 

For most product inventions, the process by which the product was made, 

whether or not the process is itself a patentable invention, is not stated in the product 

claims. However, as the variety and complexity of invention and technology have 

increased, various forms of product claims with process terms have been used in 

specific circumstances, depending on the nature of the invention.1 The form here at 

issue relates to product claims for new and unobvious products whose structure is not 

fully known, and for which process parameters are used to aid in defining the product. 

This claiming expedient has been recognized since at least 1891. 

The court today overturns this expedient for all circumstances, brooking no 

exception. Acting en banc for the purpose, the court rules that if any process term or 

descriptive aspect is included in a product claim to aid in distinguishing a new product, 

the claim cannot be infringed by the identical product unless the same process aspect is 

used in making the accused product. The court holds that it is irrelevant whether the 

product is new or was known, irrelevant whether the product could have been fully 

described by its structure at the time of the patent application, irrelevant whether the 

particular invention is a new product or is actually a process. The court adopts a 

simplistic universal rule, thereby targeting a small but significant class of inventions. 

The effect of this decision on innovation in complex fields of science and technology is 

unknown to the court, for we have had no advice on the consequences of this change of 

 1

 As discussed by Eric P. Mirabel, Product-By-Process Claims: A Practical 

Perspective, 68 J. Pat. & Trademark Off. Soc’y 3, 3-4 (1986), the various forms of 

product-by-process claims include “true” product-by-process claims, product claims with 

a process limitation, product claims with a process-derived structural element, and 

product claims with functional terms. 

2007-1400, -1446 4
law. My dissent is directed as much to the court’s procedure, as to the substance of the 

court’s decision. 

I 

PROCEDURE 

The court has given no notice of this impending en banc action, contrary to the 

Federal Rules of Appellate Procedure and contrary to the Federal Circuit’s own 

operating procedures. The en banc court has received no briefing and held no 

argument, although the Federal Rules so require. The communities of inventors, 

innovators, and the public who may be affected by this change of law have had no 

opportunity to be heard. The court has received no information concerning the effect on 

patents that were granted based on this long-established practice, no advice on what 

kinds of inventions may now lie fallow because they are unprotected. Nor does the 

court explain its suspension of the standards of judicial process. 

The Federal Rules have the force of law. 28 U.S.C. §2072. Federal Rules of 

Appellate Procedure 34 and 35 are here implicated. Rule 34 provides that “oral 

argument must be allowed in every case” unless certain specific exceptions exist: 

Rule 34(a)(2) Standards. Oral argument must be allowed in every case 

unless a panel of three judges who have examined the briefs and record 

unanimously agrees that oral argument is unnecessary for any of the 

following reasons: 

(A) the appeal is frivolous; 

(B) the dispositive issue or issues have been authoritatively 

decided; or 

(C) the facts and legal arguments are adequately presented in 

the briefs and record, and the decisional process would not be 

significantly aided by oral argument. 

Applying the Rule 34 standards, it is clear that (A) this appeal is not frivolous and (B) the 

dispositive issue has not been authoritatively decided, for it is currently being addressed 

2007-1400, -1446 5
en banc. There has been (C) no briefing and no record to the court, and this is not a 

case in which the decisional process would not be aided by oral argument. The en 

banc court has heard no argument, and has received neither written nor oral exploration 

of the diverse aspects of this long-established claiming practice. 

Federal Rule of Appellate Procedure 35 has also failed of compliance. That rule 

recognizes the exceptional nature of en banc hearing or rehearing, and identifies the 

two circumstances warranting such procedure: 

Rule 35(a) . . . An en banc hearing or rehearing is not favored and 

ordinarily will not be ordered unless: 

(1) en banc consideration is necessary to secure or maintain 

uniformity of the court’s decisions; or 

(2) the proceeding involves a question of exceptional importance. 

When an en banc hearing or rehearing is ordered sua sponte by the court, whether for 

uniformity of decision or on a question of exceptional importance, the hearing or 

rehearing must receive the appellate process set by the Rules. 

I agree that en banc review is appropriate, for this apparent conflict in our 

precedent has existed since 1992. Now that the court has undertaken to resolve the 

conflict, the withholding of public notice, or even notice to the parties to this case, is 

devoid of justification. The question is of importance, but there has been no assertion of 

urgency sufficient to require bypassing the standard appellate procedures. The breadth 

of the en banc court’s ruling, the solidity of the precedent now overruled, the importance 

of the technologies affected, and the untold issued patents that are now placed in limbo, 

require this court’s compliance with Federal Rules 34 and 35. 

The Federal Circuit has recognized that it can benefit from the advice of those 

knowledgeable in the law and its purposes, in the areas of our nation-wide 

2007-1400, -1446 6
responsibility. Patent law has a direct impact on innovation, industry, and technological 

advance, and when an en banc ruling may change the law affecting some areas of 

technology and the industries based thereon, this court has routinely sought to be 

informed, by the parties and amici curiae, of relevant concerns. When the impact of a 

sua sponte change of law transcends the interests of the parties to the specific case, 

notice to the interested public, as well as to the parties, is fundamental to due and fair 

process. The Federal Circuit’s Internal Operating Procedure (IOP) 14 was adopted to 

implement these principles: 

IOP 14.3(c) If the sua sponte petition for hearing en banc is granted, a 

committee of judges appointed by the chief judge, which shall normally 

include the judge who initiated the poll, shall within seven working days 

(fourteen working days between June 21 and September 11) transmit on a 

vote sheet to the judges who will sit en banc an order setting forth the 

questions proposed to be addressed by the court en banc. The clerk shall 

provide notice that a majority of the judges in regular service has acted 

under 28 U.S.C. §46 and Fed. R. App. P. 35(a) to order the appeal to be 

heard en banc, and indicate any questions the court may wish the parties 

and amici to address. Notice shall be given that the court en banc shall 

consist of all circuit judges in regular service who are not recused or 

disqualified. Additional briefing and oral argument will be ordered as 

appropriate. 

United States Court of Appeals for the Federal Circuit, Internal Operating Procedures at 

40, available at http://www.cafc.uscourts.gov/pdf/IOPs122006.pdf. This IOP has not 

been followed. No notice was given, even to the parties, that the court had ordered this 

question to be reheard en banc; nor did the court advise the parties or the public as to 

the aspects being addressed for en banc decision. The court is acting sua sponte, 

without notice and without argument and without an opportunity for participation. By 

bypassing this court’s standard operating procedure, as well as violating the Federal 

Rules of Appellate Procedure, the court has deprived itself of input concerning the 

2007-1400, -1446 7
experience of precedent, of advice as to how this change of law may affect future 

innovation, and of guidance as to the effect on existing property rights. 

II 

PRECEDENT AND PRACTICE 

The court’s opinion does not mention the long-established precedent that it is 

overturning. This is not a simple conflict between isolated rulings of the Federal Circuit; 

it is a change of law and practice with roots in century-old decisions. I start with this 

precedent, for the expedient of what came to be called the “rule of necessity” originated 

in the recognition, by the courts and the Patent Office, that not all new products could 

be fully described by their structure, due to the state of scientific knowledge or available 

analytical techniques. It was also recognized, over a century ago, that sufficient 

distinction from prior art products could sometimes be achieved by reference to how the 

product was made. Thus the courts and patent administrators established the 

exception that permitted inclusion in a product claim of sufficient recitation of how the 

product was made, to aid in identifying the product and distinguishing it from the prior 

art. This claim form was loosely called a “product-by-process” form, although that term 

includes a variety of situations, see n.1 supra, having diverse legal consequences. The 

only form here at issue is that in which the product is new and its structure is not fully or 

readily known, such that its definition as a product is aided by referring to how it was 

made. Since before 1891, this has been an accepted way to claim products as 

products, recognizing that this is an exception to the general rule that new products are 

claimed without reference to the process by which they are produced. 

2007-1400, -1446 8
This exception was discussed in 1891 in Ex parte Painter, the Commissioner of 

Patents explaining that when there is entitlement to a patent on a new article of 

manufacture, it can be claimed by reference to the process of producing it, when the 

inventor lacks other language to “define and discriminate” the invention: 

It requires no argument to establish the proposition that as a rule a claim 

for an article of manufacture should not be defined by the process of 

producing that article. On the other hand, when a man has made an 

invention his right to a patent for it, or his right to a claim properly defining 

it, is not to be determined by the limitations of the English language. 

When the case arises that an article of manufacture is a new thing, a 

useful thing, and embodies invention, and that article cannot be properly 

defined and discriminated from prior art otherwise than by reference to the 

process of producing it, a case is presented which constitutes an 

exception to the rule. 

1891 C.D. 200, 200-01 (Comm’r Pat. 1891). The Commissioner cited, as an earlier 

example of this exception, the claim in Globe Nail Co. v. U.S. Horse Nail Co., 19 F. 819 

(C.C.D. Mass. 1884) (sustaining validity of claim directed to horse-shoe nail claimed by 

reference to its process of manufacture, and finding it infringed by the accused nail 

having only a “trivial and unsubstantial variation” from the claimed product). In contrast, 

where the patent application made clear that the product could be described by its 

structure, the Patent Office ruled that the exception did not apply. See, e.g., Ex parte 

Scheckner, 1903 C.D. 315, 315-16 (Comm’r Pat. 1903) (sustaining rejection of claim 

directed to an etched printing-plate that “specifies certain steps by means of which the 

etching is accomplished” because other claims “define the plate in terms of its 

structure”). 

This expedient has been discussed in various judicial decisions. In all cases the 

issue has not been whether this expedient was available, for its availability was not 

challenged; the issue was simply its application to the particular facts. For example, at 

2007-1400, -1446 9
a time when it heard direct appeals from Patent Office rulings, the D.C. Circuit remarked 

on this “only exception” to the general rule of product claiming, stating: 

It is a well-settled rule of patent law that claims for a product which is 

defined by the process of producing it will not be allowed; and the only 

exception to this rule seems to be in cases where the product involves 

invention and cannot be defined except by the process used in its 

creation. In extreme cases of this character, the product may be allowed; 

but that is not this case, especially in view of the broad claims allowed 

appellant in his copending application . . . . 

In re Brown, 29 F.2d 873, 874 (D.C. Cir. 1928) (emphasis added). 

The Court of Customs and Patent Appeals discussed precedent involving claims 

for processes and products in various factual situations, and summarized that: 

Where it is possible to define a product by its characteristics, the practice 

is clearly settled that this should be done. Where, however, the product is 

novel and involves invention and cannot be defined except by the steps of 

the process involved in its creation, there are cases holding that such a 

claim may be allowed, and it has been sustained by a Court. 

In re Butler, 37 F.2d 623, 626 (CCPA 1930) (emphasis added) (quoting Ex Parte 

Feisenmeier, 1922 C.D. 18 (Comm’r Pat. 1922)). The CCPA then found this rule 

inapplicable to the facts of Butler’s invention, explaining that “the record at bar does not 

meet this requirement [that the product was new].” Id.

In In re Lifton, 189 F.2d 261 (CCPA 1951), the CCPA again commented on this 

exception for product claims, stating that when “proper article claims” were possible 

they must be used, with the exception of when such claims are “impossible”: 

This court has uniformly held that a claim for an article must define the 

article by its structure and not by the process of making it. The one 

exception to this rule, where the invention is the article and it is impossible 

to otherwise define it, is clearly ruled out in the present case because 

appellant has demonstrated the possibility of proper article claims by 

including several devoid of process limitations. 

2007-1400, -1446 10
Id. at 263 (emphasis added, citations omitted). The court again recognized “the one 

exception,” holding once again that it does not apply when the product can be described 

independently of the process of making it. 

These inquiries into the facts warranting application of the exception demonstrate 

that the rule of necessity was seldom applied, but was nonetheless recognized both by 

the courts and the Patent Office. Decisions of the Patent Office Board of Appeals 

illustrate the practice. See, e.g., Ex parte Pfenning, 65 U.S.P.Q. 577 (Pat. Off. Bd. App. 

1945) (allowing claim “directed to a product which results from the method of claim 9” in 

light of applicant’s argument that “it is impossible in the instant case to define the 

product adequately in terms of the elements which compose it or in terms of its physical 

characteristics”); Ex parte Lessig, 57 U.S.P.Q. 129 (Pat. Off. Bd. App. 1943) (allowing 

claim for a “product containing vulcanized rubber” strongly adhered to fibers which “has 

been prepared by the process of claim 4” because “it is not possible to otherwise 

distinguish over the art of record”). 

Commentators have explained that this claiming practice became of increasing 

importance as the complex sciences blossomed. See, e.g., Mark D. Passler, Productby-Process Patent Claims: Majority of the Court of Appeals for the Federal Circuit 

Forgets Purpose of the Patent Act, 49 U. Miami L. Rev. 233, 233 n.3 (1994) (“Such 

claims are often used by companies to patent complex drug or chemical products 

whose structure is not completely understood and, therefore, can only be accurately 

described by the process through which it is made.”). It is well known that the full 

structure of some chemical and biological products is not always known at the time the 

2007-1400, -1446 11
patent application is filed. Indeed, it is a tenet of the scientific method that explanation 

and theory tend to follow, not precede, the observation of a development in the science. 

The CCPA continued to recognize the use of process terms to aid in describing 

new products—the form of claim sometimes called a “pure” product-by-process claim, 

see n.1 supra—and repeatedly ruled that such claims are properly viewed as product, 

not process, claims. The court also disallowed such claims where the product itself was 

not novel and unobvious. The court confirmed that such a claim, when justified for a 

novel and unobvious product, is properly construed as encompassing the full scope of a 

product claim. For example, in In re Bridgeford, 357 F.2d 679 (CCPA 1966), the court 

again explained that a new product may be defined by the process of making it if there 

is no other way to describe the product, stressing that “the invention so defined is a 

product and not a process,” id. at 682. The Bridgeford court relied on this view of the 

scope of the product-by-process claims in a related patent, and held unpatentable for 

double patenting claims that defined the “product per se.” Id. at 680. The court 

explained that product-by-process claims are true product claims, and overruled the 

suggestion in In re Freeman, 166 F.2d 178, 181 (CCPA 1948), that product-by-process 

claims are “dependen[t] . . . on process limitations” and therefore coextensive with 

process claims. Bridgeford, 357 F.2d at 683 n.6 (“While there is some language in 

Freeman to support the contention that a product-by-process type claim differs only ‘in 

scope’ from a process type claim and they therefore ‘are directed to a single invention,’ 

(166 F.2d at 181) so far as this is inconsistent with our holding here it must be 

overruled.”). 

2007-1400, -1446 12
My colleagues misstate the holding of Bridgeford, for Bridgeford directly 

contravenes today’s holding. In Bridgeford the CCPA noted that “some courts” have 

construed claims with process steps as limited to the recited process, id. at 683 n.5, 

apparently without inquiring whether the rule of necessity justified full product scope for 

the invention at issue. The CCPA’s observation that patents are construed 

inconsistently in other courts cannot be taken, as apparently do my colleagues, as error 

by the CCPA. To the contrary, the inconsistency among courts led eventually to 

consolidation.2

Again in In re Brown, 459 F.2d 531 (CCPA 1972), the CCPA explained that 

product-by-process claims are product claims, not process claims, and that the 

patentability of the product must be established independently of the process by which it 

is identified. See id. at 535 (“[I]n spite of the fact that the claim may recite only process 

limitations, it is the patentability of the product claimed and not of the recited process 

steps which must be established.”). 

Other decisions discussing application of this expedient to claims directed to 

complex new products include In re Pilkington, 411 F.2d 1345, 1349 (CCPA 1969) 

(“While we are satisfied that the references of record do not anticipate appellant’s glass 

or demonstrate that it would be obvious, the differences between that glass and the 

glass of the prior art do not appear to us to be particularly susceptible to definition by 

the conventional recitation of properties or structure.”), and In re Fessmann, 489 F.2d 

 2

 The Hruska Commission Report, which informed the debate that 

eventually led to the formation of our court, described the varying attitudes towards 

patents held by the regional courts of appeal and the variations in patent rulings among 

the circuits. See Commission on Revision of the Federal Court Appellate System 

Structure and Internal Procedures: Recommendations for Change, 67 F.R.D. 195, 370 

(1975). 

2007-1400, -1446 13
742, 743 (CCPA 1974) (affirming obviousness rejection of product-by-process claim 

directed to a “liquid smoke” product, but observing that prior art compositions “are 

complex mixtures of the chemical compounds which can be derived from wood” which 

“defy simple characterization and this fact presumably accounts for the use of productby-process claims”). The need for this expedient, and the proper scope afforded such 

claims, is summarized in the treatise Walker on Patents: 

[P]atent rights over a chemical product are typically independent of the 

process by which the product is made, and are particularly valuable 

because of this fact. This independence is normally accomplished by 

defining the product in terms of its structural features alone, with no 

reference in the claims to process steps whatsoever. The state of 

chemical technology, however, is sometimes too limited for a structural 

description of this type to be made. The structure of some chemicals, 

especially those including elaborate polymer chains, cannot be accurately 

determined. The same chemicals, however, may be both economically 

valuable and technologically reproducible, in the sense that they can be 

reliably made by subjecting a particular set of raw materials to a particular 

set of process steps. 

* * * 

The law reacted to these difficulties by making it easier to obtain 

traditional product protection over this special class of chemicals. The 

inventor was allowed to describe such a chemical in terms of how one 

gained possession of it, that is, by way of the process steps by which it 

was made. Once he did so, the law preserved to the inventor the fullest 

measure of product-only protection that it could; it treated the process 

recitations as proxies for the direct recitations of structure that could not 

be made. Such a claim was therefore equivalent to one stated in terms of 

structure only. It would broadly dominate all methods by which the 

chemical could be made or used. At the same time, it carried the same 

dangers of running afoul of the art: it would be anticipated if the chemical 

had been produced previously, even if by a method other than what the 

inventor disclosed. 

1 Moy’s Walker on Patents §4:74 (4th ed. 2008) (emphases added). 

The en banc court appears to misunderstand this precedent, for my colleagues 

now state that “binding case law” of the Court of Customs and Patent Appeals and the 

Court of Claims mandates a single rule for all claims that contain any process terms, 

2007-1400, -1446 14
whether the product is novel or known, citing In re Hughes, 496 F.2d 1216 (CCPA 

1974), for this proposition. However, Hughes does not state this proposition; Hughes

stands for the contrary proposition. In Hughes the question was the patentability of 

claims directed to “shakes” as are used in roofing, as follows: 

12. Shakes manufactured from a shake bolt by the process of making a 

plurality of cuts into and across the shake bolt to an extent to establish 

predetermined tip lengths, and splitting the weather end portions of the 

shakes from the bolt by starting the splits at the inner ends of the cuts and 

continuing the splits to the end of the bolt. 

This claim had been rejected as an improper product-by-process claim, on the ground 

that the product could be described without including process steps. The Hughes court 

acknowledged the general rule against product-by-process claiming, but also explained 

the “proper exception to the general rule” as first set forth in Painter, as follows: 

[T]he Commissioner of Patents enunciated the general rule that a product 

should not be defined in terms of the process of making it. In Painter, a 

proper exception to the general rule was found on the ground that the 

product could not be properly defined and discriminated from the prior art 

otherwise than by reference to the process of producing it. This basic rule 

and the exception have been recognized and followed continuously by the 

Patent Office and the Courts. 

Hughes, 496 F.2d at 1218 (quoting approvingly the Solicitor’s argument). The court 

reaffirmed that “in spite of the fact that a product-by-process claim may recite only 

process limitations, ‘it is the product which is covered by the claim and not the recited 

process steps.’” Id. Contrary to my colleagues’ statement, Hughes did not eliminate this 

form of claim, or change its role as a product claim. Indeed, the Hughes court applied 

the exception and reversed the Board’s rejection of a product-by-process claim, stating: 

We agree with appellant that the [general] rule should not be applied to 

the situation before us. We have been shown no true product claim which 

describes appellant’s invention, in the words of the solicitor, “in terms of 

structure or physical characteristics.” When an applicant seeks to 

2007-1400, -1446 15
describe his invention by a product-by-process claim because he finds 

that his invention is incapable of description solely by structure or physical 

characteristics, it is incumbent upon the Patent Office to indicate where, or 

how, the applicant’s invention is, or may be, so described. 

Id. at 1219. My colleagues could hardly have selected less apt support for their 

construction of product-by-process claims, for Hughes explicitly states that such claims 

are for the product, not the process. 

In addition to misstating precedent of the CCPA, the en banc court also 

mischaracterizes the decisions of our predecessor the Court of Claims, stating that the 

Court of Claims’ decisions support today’s ruling. The court cites Tri-Wall Containers v. 

United States, 408 F.2d 748 (Ct. Cl. 1969), for this purpose. That citation, too, is 

mysterious, for in Tri-Wall Containers the court found that the claimed product was not 

“new” because it had been on sale for more than the permitted period, although the 

product that was on sale had been made by a different process than the process stated 

in the claim. The Court of Claims stated that the evidence showed that “the prior art 

product and the claimed product are structurally identical,” id. at 751, and explained that 

a known product cannot be patented by including process terms in the claim: 

It is well established that a product claimed as made by a new process is 

not patentable unless the product itself is new. The Wood-Paper Patent,

90 U.S. (23 Wall.) 566, 596, 23 L. Ed. 31 (1874), Cochrane v. Badische 

Anilin & Soda Fabrik [“BASF”], 111 U.S. 293, 311, 4 S. Ct. 455, 28 L. Ed. 

433 (1984). . . . 

. . . . 

More recent cases point out that the addition of a method step in a 

product claim, which product is not patentably distinguishable from the 

prior art, cannot impart patentability to the old product. Jungerson v. 

Baden, 69 F. Supp. 922, 928 (D.C.S.D.N.Y. 1947), aff’d, 166 F.2d 807 (2d 

Cir. 1948), aff’d, 335 U.S. 560, 69 S. Ct. 269, 93 L. Ed. 235 (1949); In re 

Stephens, 345 F.2d 1020, 1023, 52 CCPA 1409 (1965). 

2007-1400, -1446 16
Tri-Wall Containers, 408 F.2d at 750-51. This case applied the standard rule that old 

products cannot be patented—it contains no statement limiting the scope of claims that 

include process aspects to aid in describing new products. The Supreme Court cases 

cited in Tri-Wall are all directed to new processes for making old products—these are 

the same cases that the en banc court today incorrectly applies to new products, as I 

discuss post. 

Contrary to my colleagues’ statement, CCPA and Court of Claims precedent do 

not support today’s en banc thesis. Our predecessor courts understood the complexity 

of patenting, and the CCPA consistently implemented the expedient whereby process 

terms contributed to the description of complex new products of incompletely known 

structure. These courts recognized the independence of product claims for new 

products, and did not limit such claims to the specific process steps that were used to 

aid in describing the product.3

With the advent of the Federal Circuit, this court continued to apply these 

principles. In In re Thorpe, 777 F.2d 695 (Fed. Cir. 1985), the court explained that 

 3

 The en banc court impugns the CCPA’s experience. Maj. op. at 18 

(stating that the CCPA had “virtually no jurisdiction to address infringement litigation”). 

The CCPA for many years addressed infringement litigation, in appeals from the 

International Trade Commission and its predecessor tribunals. E.g., Sealed Air Corp. v. 

Int’l Trade Comm’n, 645 F.2d 976 (CCPA 1981) (issues of validity and infringement); 

Hale Fire Pump Co. v. Tokai, Ltd., 614 F.2d 1278 (CCPA 1980) (issues of validity, 

scope, and infringement); In re Orion, 71 F.2d 458 (CCPA 1934) (issues of jurisdiction 

and infringement). 

Our predecessor’s legal and scholarly distinction in the field of patent law, and 

the high regard in which Congress and the innovation communities held the 

jurisprudence of the CCPA were a critical foundation for formation of the Federal Circuit 

and its charge to reinvigorate the role of the patent system in service to the nation’s 

technological innovation. See 125 Cong. Rec. 23,462 (1979) (statement of Sen. 

DeConcini) (“It is a reflection of high esteem which Congress has for the sitting judges 

of the Court of Claims and Court of Customs and Patent Appeals that these judges will 

become the first judges of the new Court of the Federal Circuit.”). 

2007-1400, -1446 17
product-by-process claims are anticipated when the product existed in the prior art, 

even if the product was made by a different process. My colleagues are mistaken in 

stating that Thorpe held that all such claims are to be construed as process claims, 

even when the product is new and the rule of necessity justifies this mode of describing 

the invention. In Thorpe the product was not new; it was a known color developer for 

carbonless paper copy systems, and this court held that the PTO correctly rejected the 

claim to “the product of the process of claim 1,” explaining that since the product was 

old it could not be claimed as a product, whether or not process steps are recited in the 

claim. 

The facts of Thorpe did not concern the exception and expedient where process 

terms are invoked to describe a new product of complex structure. This exception is 

rarely invoked. The general rule requiring claims to have a process-free definition of the 

structure of a new product accommodates most inventions. Some recent exceptions 

are seen in emerging aspects of biotechnology. For example, in Amgen, Inc. v. Chugai 

Pharmaceuticals Co., 706 F. Supp. 94 (D. Mass. 1989), aff’d in relevant part, 927 F.2d 

1200 (Fed. Cir. 1991), the district court considered the following claim: 

4. A procaryotic or eucaryotic host cell transformed or transfected with a 

DNA sequence according to claim 1, 2 or 3 in a manner allowing the host 

cell to express erythropoietin. 

Id. at 108. The district court found claim 4 “ambiguous,” explaining that while it is 

directed to a new product—this host cell—the words “transformed or transfected” 

appear to invoke a process. The district court recognized that “[i]n the traditional patent 

framework, a product is wholly separate and distinct from a process.” Id. at 107. The 

court observed that “[a] product patent gives the patentee the right to restrict the use 

2007-1400, -1446 18
and sale of the product regardless of how and by whom it was manufactured,” while “[a] 

process patentee’s power extends only to those products made by the patented 

process.” Id. (quoting United States v. Studiengesellschaft Kohle, 670 F.2d 1122, 1127-

28 (D.C. Cir. 1981)). The district court, affirmed by the Federal Circuit, found this claim 

to be valid and infringed as a product claim, and although many issues and arguments 

were present in this litigation, the applicability of the venerable rule of necessity was not 

at issue. 

In Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. 

Cir. 1991), the Federal Circuit addressed the interpretation and scope of claims 

exemplified by claim 13: 

13. Highly purified and concentrated VIII:C prepared in accordance with 

the method of claim 1. 

Claim 1 set forth the method referred to in claim 13, as follows: 

1. An improved method of preparing Factor VIII procoagulant activity 

protein [VIII:C] comprising the steps of 

(a) adsorbing a VIII:C/VIII:RP complex from a plasma or 

commercial concentrate source onto particles bound to a monoclonal 

antibody specific to VIII:RP, 

(b) eluting the VIII:C, 

(c) adsorbing the VIII:C obtained in step (b) in another adsorption to 

concentrate and further purify same, 

(d) eluting the adsorbed VIII:C, and 

(e) recovering highly purified and concentrated VIII:C. 

It was not disputed that the product was a new product, that the “highly purified and 

concentrated” blood clotting Factor VIII:C had not previously been obtained, and that a 

complete structural identification of Factor VIII:C was not available. The defendant 

Genentech had made its commercial Factor VIII:C not by the method set forth in claim 

1, but by using a sample of the Scripps product to “clone” Factor VIII:C protein using 

2007-1400, -1446 19
recombinant DNA techniques. One question presented in the case was whether claims 

such as claim 13 were infringed by the same product produced by a different method, or 

whether such claims were infringed only if the accused infringer used the process of 

claim 1. 

Scripps stressed that its product was novel and enabled and was patentable as a 

product, although the full structure of Factor VIII:C was not available at that stage of the 

science. The court addressed whether claims exemplified by claim 13, properly 

construed, were product claims, or whether they were limited to the specific processes 

in the process claims to which they referred. This court held that the claims were 

product claims. The court held that since claims are construed the same way for 

infringement as for validity, the question was whether the Genentech product was the 

same as the claimed product, not whether they were produced by the same process. 

The court remanded to the district court for this factual determination. Scripps, 927 F.2d 

at 1584. 

After Scripps was decided, a panel of this court decided an appeal concerning 

plastic innersoles for shoes. In Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 

834 (Fed. Cir. 1992), the claims at issue were represented by: 

Claim 24. The product produced by the method of claim 1. 

In turn, claim 1 was as follows: 

1. In a method of manufacturing a shock-absorbing, molded innersole for 

insertion in footwear, which method comprises: 

(a) introducing an expandable, polyurethane into a mold; and 

(b) recovering from the mold an innersole which comprises a 

contoured heel and arch section composed of a substantially open-celled 

polyurethane foam material, the improvement which comprises: 

(i) placing an elastomeric insert material into the mold, the 

insert material having greater shock-absorbing properties and being 

2007-1400, -1446 20
less resilient than the molded, open-celled polyurethane foam 

material, and the insert material having sufficient surface tack to 

remain in the placed position in the mold on the introduction of the 

expandable polyurethane material so as to permit the expandable 

polyurethane material to expand about the insert material without 

displacement of the insert material; and 

(ii) recovering a molded innersole with the insert material 

having a tacky surface forming a part of the exposed bottom 

surface of the recovered innersole. 

The panel held that a claim in the form of claim 24 always requires use of the 

referenced method, and that it is irrelevant whether the product was new or known. The 

court stated that the rule of necessity, as applied in Scripps, is contrary to Supreme 

Court rulings. The panel stated that the decision in Scripps is incorrect. A majority of 

the Federal Circuit declined to resolve the conflict en banc, resulting in several further 

opinions. E.g., Atlantic Thermoplastics Co. v. Faytex Corp., 974 F.2d 1279 (Fed. Cir. 

1992) (dissents of Chief Judge Nies and Judges Rich, Newman, and Lourie from denial 

of rehearing en banc). Judge Rich wrote: 

[T]his whole excursion was unnecessary because the patentee admitted 

that claim 24, the product-by-process claim, was limited to the process. 

The claim read: “The molded innersole produced by the method of claim 

1.” There was, therefore, no occasion to review the law to determine how 

the claim should be construed. . . . We are not here to provide 

restatements of the law. Such restatements should not be made without 

an opportunity for all affected parties to be heard from. The affected 

parties here are not the vendors of inner soles but largely the entire 

chemical industry, particularly the pharmaceutical manufacturers. 

Id. at 1280 (Rich, J., dissenting from denial of rehearing en banc). 

Most trial courts continued to recognize the rule of necessity. For example, in 

Trustees of Columbia University v. Roche Diagnostics GmbH, 126 F. Supp. 2d 16 (D. 

Mass. 2000), the district court considered claims such as the following. 

72. A eukaryotic cell into which foreign DNA I has been inserted in 

accordance with the process of claim 54. 

2007-1400, -1446 21
The court referred to the Scripps/Atlantic conflict, concluded that the earlier panel 

decision controlled under the Federal Circuit’s rule, see Newell Companies, Inc. v. 

Kenney Manufacturing Co., 864 F.2d 757, 765 (Fed. Cir. 1988) (“This court has adopted 

the rule that prior decisions of a panel of the court are binding precedent on subsequent 

panels unless and until overturned in banc.”), and applied the Scripps ruling, holding 

that the new cell was not limited by the process by which it was made. 

The PTO also continued to apply the rule of necessity. In instructing examiners 

that products should whenever possible be described without reference to how they 

were made, the PTO continued to point out the exception that patentability as a product 

is not foreclosed when independent description is not available. The Manual of Patent 

Examining Procedure (MPEP) instructs the examiner to consider the structure implied 

by any process steps in the claim: 

The structure implied by the process steps should be considered 

when assessing the patentability of product-by-process claims over the 

prior art, especially where the product can only be defined by the process 

steps by which the product is made, or where the manufacturing process 

steps would be expected to impart distinctive structural characteristics to 

the final product. 

MPEP §2113 (8th ed., July 2008 rev.). This has been the practice since at least Ex 

parte Painter in 1891. I am surprised at the en banc court’s casual misstatement about 

“the treatment of product-by-process claims throughout the years by the PTO,” maj. op. 

at 17, for the statement is directly contrary to the treatment of such claims throughout 

the years by the PTO. 

The en banc court’s insistence that one universal rule should now be applied is 

contrary to the entire body of decisional law, including the Supreme Court cases cited 

by my colleagues. As I next discuss, in most of the cited cases the product was not a 

2007-1400, -1446 22
new product and thus was not patentable as a product, whether or not any process term 

was included in the claim. The Court consistently held that when the product was old 

and only the process was a patentable invention, a claim for the “product of that 

process” could not cover the old product made by a different process. That is, and has 

always been, the law. I comment briefly on the Court’s cases that my colleagues 

misinterpret and misapply: 

Cochrane v. BASF

The en banc opinion relies primarily on Cochrane v. Badische Anilin & Soda 

Fabrik, 111 U.S. 293 (1884) (“BASF”), even though my colleagues acknowledge that 

the product in that case was the well-known dye alizarine. The patent before the Court 

was a reissue patent that claimed artificial alizarine in the following way: 

Artificial alizarine, produced by either of the methods herein described, or 

by any other method which will produce a like result. 

The Court held that since alizarine was a known product, the claim was limited to the 

patentee’s two processes, stating: 

It was an old article. While a new process for producing it was patentable, 

the product itself could not be patented, even though it was a product 

made artificially for the first time, in contradistinction from being eliminated 

from the madder root. Calling it artificial alizarine did not make it a new 

composition of matter, and patentable as such, by reason of its having 

been prepared, artificially, for the first time, from anthracite, if it was set 

forth as alizarine, a well-known substance. Wood Paper Patent, 23 Wall. 

560, 593 [(1874)]. There was therefore no foundation for reissue No. 

4,321, for the product, because, on the description given, no patent for the 

product could have been taken out originally. 

111 U.S. at 311-12. The Court accordingly limited the claim to the two processes 

described in the patent, and in the portion of BASF quoted by my colleagues, the Court 

discussed the proofs needed to show infringement: 

2007-1400, -1446 23
[U]nless it is shown that the process of [the specification] was followed to 

produce the defendants’ article, or unless it is shown that the article could 

not be produced by any other process, the defendants’ article cannot be 

identified as the product of the process of [the specification]. Nothing of 

the kind is shown. 

Id. at 310. The Court did not state, or imply, despite my colleagues’ contrary theory, 

that a claim to a new and complex product that is of necessity defined and distinguished 

by the process by which it was made, can never be infringed unless that specific 

process is practiced. There was no issue in BASF of a product that could not be 

defined without reference to how it was made. The BASF Court, providing guidance, 

remarked on the importance of independent description of a patented product, in the 

following sentence cited by my colleagues: 

Every patent for a product or composition of matter must identify it so that 

it can be recognized aside from the description of the process for making 

it, or else nothing can be held to infringe the patent which is not made by 

that process. 

Id. at 310. This statement is indeed the general rule, as stated by the Patent 

Commissioner several years later in Ex parte Painter. However, BASF did not present 

the situation for which the expedient of necessity was created, for as the Court stated, 

the invention was “a process for preparing alizarine, not as a new substance prepared 

for the first time, but as the substance already known as alizarine, to be prepared, 

however, by the new process, which process is to be the subject of the patent, and is 

the process of preparing the known product alizarine from anthracine.” Id. at 308-09. 

This was not an instance of a new product describable only in terms of its 

process of manufacture. The BASF decision lends no support to today’s en banc rule 

that every product claim that mentions a process step is always restricted to that 

2007-1400, -1446 24
process, with no exception, no expedient, no preservation of the distinctions among 

forms of claim based on the nature of the invention. 

The Goodyear Dental cases

The en banc court also states that its new ruling is supported by two cases 

relating to a patent on the use of vulcanized rubber to form a plate for holding dentures, 

Smith v. Goodyear Dental Vulcanite Co., 93 U.S. (3 Otto) 486 (1876), and Goodyear 

Dental Vulcanite Co. v. Davis, 102 U.S. (12 Otto) 222 (1880). Review of these cases 

reveals no support for the en banc court’s statement of their holdings. The claim at 

issue was: 

The plate of hard rubber or vulcanite, or its equivalent, for holding artificial 

teeth, or teeth and gums, substantially as described. 

Davis, 102 U.S. (12 Otto) at 223. The claim was written in the then-standard format of 

incorporating the description in the specification through the phrase “substantially as 

described.” This was not a product-by-process or product-of-the-process claim at all, 

for the claim contains no process distinction or limitation, but simply refers to the 

description in the specification. Nonetheless, the en banc majority appears to state that 

these cases mean that the Supreme Court requires that all claims for products whose 

method of production is set forth in the specification—as is required by the description 

and enablement requirement—cannot be infringed unless that method is used. 

That is not what the Goodyear Dental cases said. The Court referred to the 

position of Goodyear Dental Vulcanite that its patent covered all dental plates made of 

vulcanized rubber, and held, upon reviewing the specification and the prior art, that the 

process of manufacture was what distinguished this dental plate from the prior art dental 

plates, and concluded: “The invention, then, is a product or manufacture made in a 

2007-1400, -1446 25
defined manner. It is not a product alone, separated from the process by which it is 

created.” Smith, 93 U.S. (3 Otto) at 493. Were the claim not limited to this process, the 

Court concluded that the claim would not have been patentable. See id. at 492 (holding 

that if the patent were for a “mere substitution of vulcanite for other materials, which had 

previously been employed as a base for artificial sets of teeth” then it “constituted no 

invention”). Four years later, considering the same patent in Davis, the Court 

emphasized that the claim was limited to use of vulcanized rubber or its equivalent, and 

held that since the accused infringer made its dental plate with celluloid, there could not 

be infringement. See 102 U.S. (12 Otto) at 228-30. 

The court today cites these cases as definitive of the interpretation of claims with 

process elements, although the only process referent is the phrase “substantially as 

described.” This flawed reasoning was disposed of in 1890 in the classic Robinson on

Patents, and until now has not reappeared: 

In stating Claims certain phrases are frequently employed to which a 

special importance seems to be attached by applicants. Among these are 

the phrase “substantially as described” and others of the same meaning. 

These phrases import the same thing when used in a Claim as when 

elsewhere employed. They are neither necessary nor technical. The 

reference they make to the Description is always implied, and relates only 

to the essential features of the invention as therein delineated. They add 

nothing, therefore, to the certainty of the Claim, nor do they detract from it 

unless the claimant carelessly inserts them as a substitute for a more 

clear and definite statement of his invention. 

II W.C. Robinson, Robinson on Patents 517 (1890) (footnotes omitted). 

Merrill v. Yeomans

My colleagues also rely on Merrill v. Yeomans, 94 U.S. (4 Otto) 569 (1877). 

Again, the relevance is remote. The Merrill Court explained that the issue was the 

“correct construction of plaintiff’s patent,” id. at 569, construing the following claim: 

2007-1400, -1446 26
[T]he above-described new manufacture of the deodorized heavy 

hydrocarbon oils, suitable for lubricating and other purposes, free from the 

characteristic odors of hydrocarbon oils, and having a slight smell like fatty 

oil, from hydrocarbon oils, by treating them substantially as hereinbefore 

described. 

Id. at 570. The Court examined the specification to determine what was invented, and 

found that the invention was directed solely to a process, not to a product. The Court 

then concluded that the claim’s usage “new manufacture” referred to the manufacturing 

process, and not to the product. The claim was thus a process claim, and no “productby-process” issue was presented. The Court concluded that the defendant’s oil, which 

was made by a different process, did not infringe. 

The Merrill Court discussed its practice of looking to the patent application and 

interpreting the claim in light of what was “really invented”: 

[W]here it appears that a valuable invention has really been made, this 

court, giving full effect to all that is found in the application on which the 

Patent Office acted, will uphold that which was really invented, and which 

comes within any fair interpretation of the patentee’s assertion of claim. 

Id. at 573. This approach is inimical to the en banc court’s theory that it is irrelevant 

what the patentee describes as his invention, and that if a process step is mentioned in 

the claim or “substantially described” in the specification, the claim always requires 

performance of that step. Although the Court in Merrill was not confronted with a 

situation of indescribable product or necessity bred of complexity—indeed no product at 

all was claimed—neither did the Court hold that every product invention must be limited 

by the process that produced the product. 

The Wood Paper Patent case

The list of Supreme Court cases relied on by my colleagues continues with The 

Wood Paper Patent, 90 U.S. 566, 596 (1874), where claims with the standard 

2007-1400, -1446 27
“substantially as described” language were construed in two reissue patents relating to 

the pulping of wood to make paper. The Court explained that one reissue patent was 

for “a product or manufacture, and not for the process by which the product may be 

obtained,” and the other “for a process and not for its product.” Id. at 593. The Court 

examined the prior art and concluded that the claim for the product could not be 

sustained, because the product produced by the inventor’s new pulping process was 

not new: 

Paper-pulp obtained from various vegetable substances was in common 

use before the original patent was granted to Watt & Burgess, and 

whatever may be said of their process for obtaining it, the product was in 

no sense new. The reissued patent, No. 1448, is, therefore, void for want 

of novelty in the manufacture patented. 

Id. at 596. The Court then discussed the reissue patent for the “process and not for its 

product,” and held this reissue void because it claimed a different invention than in the 

original patent. The Court also discussed several other patents directed to boilers used 

to produce paper-pulp, and to a process for bleaching straw. Nothing in this case 

concerns the product-by-process issue on which the court is today acting. 

I cannot discern why the en banc court relies on The Wood Paper Patent case as 

invalidating Scripps, and the court has not attempted to explain. 

Plummer v. Sargent

The en banc court also relies on Plummer v. Sargent, 120 U.S. 442 (1887), 

which again provides no support for my colleagues’ thesis. This case again illustrates 

the Court’s practice of reviewing what the patentee stated he invented as set forth in the 

specification in light of the prior art. The claim in Plummer was for a “new manufacture,” 

“substantially as described”: 

2007-1400, -1446 28
What I claim and desire to procure by letters patent is the new 

manufacture hereinabove described, consisting of iron ornamented in 

imitation of bronze by the application of oil and heat, substantially as 

described. 

Id. at 445. The trial court had found non-infringement because the defendant had used 

a prior art process for bronzing iron. This prior process was work of F.W. Brocksieper, 

an employee of the defendant’s predecessor company. The Supreme Court affirmed, 

stating that the claims were limited to the process described in the specification: 

It seems necessarily to follow from this view either that the Tucker patents 

are void by reason of anticipation practiced by Brocksieper, or that the 

patented process and product must be restricted to exactly what is 

described . . . . 

Id. at 449. The Court thus limited the claims to the process described by the patentee, 

not because of any rule about limiting a product to how it was made in the specification, 

but to sustain validity of the patent in view of the Brocksieper prior art. The decision in 

Plummer is unrelated to any rule of claim construction based on whether process terms 

are included in the claim. 

These nineteenth-century cases do not relate to the en banc court’s new 

universal rule of claim construction, whereby all product claims having process terms 

are treated as process claims, whatever the nature of the product, whatever the need 

for process descriptors, or any other factor that precedent shows to be relevant to the 

exception that is here at issue as to the use of and construction of such claims. Nor do 

any more recent Court cases. 

General Electric v. Wabash

My colleagues also cite General Electric Co. v. Wabash Appliance Corp., 304 

U.S. 364 (1938), although the relevance of this case is, again, not apparent, for it 

2007-1400, -1446 29
involved no product-by-process claims, but rather claims that recite the properties of the 

product. A typical claim is claim 25, which describes an electric lamp filament 

composed of tungsten grains of a size and shape that prevents sagging of the filament: 

25. A filament for electric incandescent lamps or other devices, composed 

substantially of tungsten and made up mainly of a number of 

comparatively large grains of such size and contour as to prevent 

substantial sagging and offsetting during a normal or commercially useful 

life for such a lamp or other device. 

Id. at 368. The Court held this claim “invalid on its face” for failing to provide a “distinct 

and definite statement of what he claims to be new, and to be his invention.” Id. at 369. 

The Court stated that the description of the grains as “of such size and contour as to 

prevent substantial sagging and offsetting” was “inadequate as a description of the 

structural characteristics of the grains.” Id. at 370. The Court also criticized the use of 

functional language in the claim, stating that such terms were too indefinite to provide 

clear guidance. Id. at 371. There was no issue of whether process steps in the claims 

were regarded as limiting, for there were no process steps in the claims. Instead, the 

Court stated that even the implicit inclusion of process steps could not save the claim, 

because the description of the process in the specification was inadequate: 

Even assuming that definiteness may be imparted to the product claim by 

that part of the specification which purportedly details only a method of 

making the product, the description of the Pacz process is likewise silent 

as to the nature of the filament product. 

Id. at 373. The Court held the patent invalid for lack of a “distinct and definite” 

description of the invention, for the court “doubted whether one who discovers or 

invents a product he knows to be new will ever find it impossible to describe some 

aspect of its novelty.” Id. Whatever the inadequacies in the Pacz description of his 

invention, the Court’s optimistic view of scientific capability cannot be deemed to have 

2007-1400, -1446 30
barred all recourse to the rule of necessity when it is warranted, or to have voided the 

ensuing seventy-one years of Patent Office and judicial recognition of this pragmatic 

expedient. 

No Supreme Court case discussed the problems of complexity and structural 

analysis that warrant this expedient, or created a legal solution to these problems. It is 

inappropriate, unsupported by law or precedent, and contrary to the purposes of patent 

systems, for this court now to rule that such products cannot be patented as products. 

Regional circuit decisions

My colleagues also rely on some decisions of the regional circuits preceding this 

court’s formation, announcing that “our sister circuits also followed the general rule that 

the defining process terms limit product-by-process claims,” and citing two cases, one 

decided in 1915 and one in 1977. These cases do not support the en banc court’s 

opinion,4

 and raised no issue of an expedient based on necessity. 

 4

 It is curious to observe this en banc court extolling decisions of the 

regional circuits as authoritative, while it disregards the decisions of our predecessor 

courts and of this court. This court was created to remove patent law questions from 

the regional circuit courts. See H.R. Rep. 96-1300, at 20 (1980) (“Directing patent 

appeals to the new court will have the beneficial effect of removing these unusually 

complex, technically difficult, and time-consuming cases from the dockets of the 

regional courts of appeals. . . . [T]he central purpose is to reduce the widespread lack of 

uniformity and uncertainty of legal doctrine that exist in the administration of patent 

law.”); see also Federal Courts Improvement Act of 1979: Hearings Before the 

Subcomm. on Improvements in Judicial Machinery of the Comm. on the Judiciary, U.S. 

Senate, 96th Cong. 197 (1979) (statement of Hon. Henry J. Friendly) (“What is needed 

is a group of judges, some but not all patent lawyers, with scientific training and interest, 

aided both by law clerks of similar bent and by a staff of experts in a variety of 

technologies, such as the Court of Customs and Patent Appeals has had for years and 

the courts of appeals in the very nature of things, cannot . . . ”). To cite two regional 

circuit decisions, while jettisoning the precedents of the court uniquely qualified to 

address patent questions and selected to supplant the regional circuits, is puzzling. 

2007-1400, -1446 31
In Hide-Ite Leather Co. v. Fiber Products Co., 226 F. 34 (1st Cir. 1915), the 

appeal was of two process claims for making leatherboard, and a product claim for 

leatherboard “made from pulp” and reciting the second step in the process claims plus 

the reference “substantially as described.” The accused infringer did not use the same 

first step of the process. The court found that the invention was for a process, not a 

product, and therefore that the product claim was not infringed. 

My colleagues also cite Paeco, Inc. v. Applied Moldings, Inc., 562 F.2d 870, 876 

(3d Cir. 1977), in which the court used the specification to resolve an ambiguity in the 

language of a product claim relating to “replica wooden beams” made of foamed 

urethane. The court reviewed whether ambiguous claim language required a closed or 

open mold, for this determined the question of anticipation based on a prior art 

reference that used an open mold. Thus the court stated that the manufacturing 

process described in the specification was “of paramount importance,” and construed 

the claim in light of that process as requiring a closed mold, thus preserving the claim’s 

validity as against the prior art that used and open mold. The sentence quoted by my 

colleagues out of its context, does not relate to the en banc court’s new rule concerning 

process terms in product claims, and the Paeco case raised no question of whether the 

product was capable of description apart from the process. 

In addition to these two cases inaptly cited by the en banc court, other regional 

circuit decisions also contradict this court’s new thesis. In Dunn Wire-Cut Lug Brick Co. 

v. Toronto Fire Clay Co., 259 F. 258 (6th Cir. 1919), the court stated: “Certain it is, in 

view of the weight of authority and the latest decisions, that the inventor of a new and 

2007-1400, -1446 32
useful product or article of manufacture may have a patent which covers it and gives a 

monopoly upon it regardless of great variations in the method of making.” Id. at 261. 

In Buono v. Yankee Maid Dress Corp., 77 F.2d 274 (2d Cir. 1935) (L. Hand, J.), 

the court held invalid a product claim for a kind of “blind stitch” used in sewing, because 

the invention lay only in the process of producing the stitch, which itself “was not new.” 

Id. at 279. While the stitch had not been claimed as the product of a particular machine 

or process, the court remarked on the conceivability of patenting such a product “merely 

as the product of a machine or process, even though it were anticipated if made in other 

ways,” id., observing that such a claim might serve a useful purpose in protecting 

against products that were produced by the same machine or process abroad and then 

imported. Of such a claim, wherein the product itself was anticipated but the process 

was new, the court stated “it would in that case not be infringed by anything but the 

product of the . . . process.” Id. This routine statement of established law does not 

mean that when the product is itself new and useful and unobvious, it cannot be claimed 

as a product but must be tied to the machine that made it. 

Judge Hand emphasized that this example related only to situations where the 

product itself was not new. The opinion explained that to be claimed as a product, the 

product “must be new as such, that is, regardless of the process or machine which 

makes it; and it must stand upon its own invention, again independently of the machine 

or process which makes it.” Id. This was also the CCPA’s view of product claims, 

providing the precedent carried forward to, and binding upon the Federal Circuit.5

 5

 There has been extensive commentary on this class of claim. See, e.g., 

Jon S. Saxe & Julian S. Levitt, Product-by-Process Claims and Their Current Status in 

Chemical Patent Office Practice, 42 J. Pat. Off. Soc’y 528, 559 (1960) (“Except in the 

2007-1400, -1446 33
III 

THE EN BANC RULING 

Defying precedent, the en banc court adopts for all situations “the basic rule that 

the process terms limit product-by-process claims,” maj. op. at 17, whether the product 

is novel or known, and whether or not the new product could not have been fully 

described by its structure alone. The court eliminates the long-accepted expedient for 

new products whose structure is not fully known. While the Scripps decision is the only 

decision that is mentioned as “expressly overruled,” maj. op. at 17, Scripps is only one 

of many cases now discarded. 

The en banc majority’s response to the dissenters is to state that “the inventor is 

absolutely free to use process steps to define this product” if its “structure is either not 

fully known or too complex to analyze,” maj. op. at 19, but to eliminate the premise that 

the inventor thereby obtains a product claim, not a process claim. According to the 

majority, a patentee can continue to obtain product claims using process descriptors, 

but such product claims are treated as process claims for infringement. The applicant 

would still have to demonstrate patentability of the new product as a product 

(independent of the process), while enforcement of the patent against an identical 

product would be limited to the infringer’s use of the process steps used as a descriptor. 

For the first time, claims are construed differently for validity and for infringement. 

 

chemical arts, a claim to a product must be in terms of the product’s objective physical 

and chemical characteristics; but where these are unknown or impossible to express, a 

claim may define a product in terms of the process by which it is made. This productby-process exception is to be distinguished from the use of process terminology as 

descriptive of a state of being.”); Brian S. Tomko, Scripps or Atlantic: The Federal 

Circuit Squares Off Over the Scope of Product-by-Process Patents, 60 Brook. L. Rev. 

1693, 1696 (1995) (the Atlantic decision “pared the scope of a product-by-process 

patent to that of a glorified process patent”). 

2007-1400, -1446 34
It has been an inviolate rule that patent claims are construed the same way for 

validity and for infringement. See, e.g., Amgen Inc. v. Hoechst Marion Roussel, Inc., 

324 F.3d 1313, 1330 (Fed. Cir. 2003) (“It is axiomatic that claims are construed the 

same way for both invalidity and infringement.”); Amazon.com, Inc. v. 

Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001) (“Because the claims 

of a patent measure the invention at issue, the claims must be interpreted and given the 

same meaning for purposes of both validity and infringement analyses.”); C.R. Bard, 

Inc. v. M3 Systems, Inc., 157 F.3d 1340, 1363 (Fed. Cir. 1998) (“Claims must be 

interpreted the same way for determining infringement as was done to sustain their 

validity.”); Southwall Technologies, Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. 

Cir. 1995) (“Claims may not be construed one way in order to obtain their allowance and 

in a different way against accused infringers.”); Beachcombers, International, Inc. v. 

WildeWood Creative Products, Inc., 31 F.3d 1154, 1163 (Fed. Cir. 1994) (“We have 

already interpreted the claims for purposes of assessing their validity. The same claim 

interpretation of course applies to the infringement analysis.”); Scripps Clinic & 

Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1583 (Fed. Cir. 1991) (“claims 

must be construed the same way for validity and for infringement”); Smithkline 

Diagnostics, Inc. v. Helena Laboratories Corp., 859 F.2d 878, 882 (Fed. Cir. 1988) 

(“The claims of the ’970 patent measure the invention at issue; thus, the claims must be 

interpreted and given the same meaning for purposes of both validity and infringement 

analyses.”); see also 5A Chisum on Patents §18.01 (2007) (“A fundamental tenet of 

patent law is that a claim must be interpreted consistently for purposes of infringement 

and validity.”); id. §18.03[2][h] (collecting cases). 

2007-1400, -1446 35
As interpreted for validity, the claims obtained under the expedient of necessity 

are product claims, and are subject to the requirements of novelty, unobviousness, and 

all other requirements for new products, independent of how the products can be made. 

My colleagues hold that these are product claims for validity, but process claims for 

infringement. Departure from the rule that forbids such deviation requires sound 

reason, and fuller exploration than the cursory brush-off dispensed by my colleagues. 

I do agree with my colleagues that their logic is “simple.” Maj. op. at 19. 

However, today’s inventions are not simple. The needs of inventions of the past and 

present, and more so the future, are not simple. The public interest in invention and 

development of today’s complex sciences, is not simple. The en banc court’s “simple” 

hypothetical about “compound X, obtained by process Y,” is simply irrelevant to the 

issues we must resolve. Scientists know that it is often easier to show that two products 

are the same, than to decipher their chemical or biological structure; for example, in the 

case at bar, comparing the X-ray diffraction patterns and absorption spectra could show 

that the products are the same, although their exact crystal structure is undefined. 

However, my colleagues announce that the only way to establish whether the accused 

compound is the same as the patented compound is by inquiring whether they were 

prepared by the same method. Maj. op. at 19-20 (“[W]hat analytical tools can confirm 

that the alleged infringer’s compound is in fact infringing, other than a comparison of the 

claimed and accused infringing processes?”). That question has many answers, now 

stated to be irrelevant. 

While the section of this opinion decided by the en banc court is largely directed 

to its reversal of precedent, the implementation of its ruling remains with the original 

2007-1400, -1446 36
panel. The panel decision enlarges the en banc ruling, further binding this court. The 

claims at issue state processes by which the new crystal form is “obtainable,” although 

the specification states that other methods might be used. The panel rules that a claim 

“cannot capture a product obtained by or obtainable by processes other than those 

explicitly recited in the claims.” maj. op. at 21, finding authority in BASF, which I have 

discussed ante. My colleagues thus continue to misapply the Court’s ruling in BASF, 

where the Court stated repeatedly that the product in that case was a known product. 

BASF, 111 U.S. at 311 (“It was an old article.”). In BASF the Court responded to the 

patentee’s argument that it was entitled to cover all artificial alizarine made by any 

process, by observing that the patentee had not shown how the infringing and patented 

products “can be recognized,” id. at 310, an aspect at the opposite pole from the case at 

bar, where the patentee provided elaborate details as to how the patented and accused 

crystal forms can be recognized. 

The panel also states that “the applicant’s statement in the file wrapper that ‘the 

method of preparation . . . is not considered the heart of the present invention’ should 

not be afforded undue gravitas.” Maj. op. at 22. This too is an aberration of precedent, 

and is contrary to the many rulings of the Supreme Court and this court that afford due 

gravitas to the applicant’s statement of what has been invented. See, e.g., BASF, 111 

U.S. at 308 (“It is very plain that the specification of the original patent, No. 95,465, 

states the invention to be a process for preparing alizarine, not as a new substance 

prepared for the first time, but as the substance already known as alizarine, to be 

prepared, however, by the new process, which process is to be the subject of the 

patent . . . .”); Plummer v. Sargent, 120 U.S. at 443 (quoting specification of companion 

2007-1400, -1446 37
patent, where inventor stated “My invention consists in a process of covering iron with a 

very thin coating of oil, and then subjecting it to heat, the effect of which is to leave upon 

the iron a firm film, which is very durable, and gives the iron a highly ornamental 

appearance, like that of bronze”). The Federal Circuit’s emphasis on the importance of 

the specification has been repeatedly stated. E.g., Phillips v. AWH Corp., 415 F.3d 

1303, 1315 (Fed. Cir. 2005) (en banc) (“[T]he specification is always highly relevant to 

the claim construction analysis. Usually, it is dispositive; it is the single best guide to the 

meaning of a disputed term.” (internal quotation marks omitted)). 

The en banc court appears to misjudge the implications of its ruling, for the court 

states that it is now making available to “others the right to freely practice process Z [a 

different process] that may produce a better product in a better way.” Maj. op. at 20. If 

others can indeed make a better product, this expedient presents no impediment. That 

is not the issue of this case. The issue is the right to make the same product, by 

making a process change that does not change the product. By now assuring that right, 

the exclusionary value of the claim to a new product is lost. 

The purpose of the rule of necessity is to allow inventors of complex new 

products to obtain the patent scope to which their invention is entitled—the scope of the 

novel product they invented, no more and no less. The majority’s change of law simply 

imposes unfairness as well as legal error on patent-supported advances. 

SUMMARY 

Precedent establishes that the correct construction of claims that recite process 

steps depends, like all claim construction, on what has been invented. No single rule 

fits all inventions. The construer must view the claims in light of the description of the 

2007-1400, -1446 38
2007-1400, -1446 39

invention in the specification, the prior art, and the prosecution history. In the complex 

law and practice of patents and inventions, the special expedient here of concern arises 

when the precise structure of a new product is not known from the information available 

when the patent application was filed. The law has enabled and endorsed this 

expedient of describing a product in order to claim it as a product, whereby validity and 

infringement are determined as a product, independent of any process term that was 

used to aid in defining the product. This expedient does not enlarge patent scope; it 

simply permits patenting what has been invented. A narrow but clear body of law has 

evolved to accommodate this need of complex technologies. This entire body of law is 

today overturned, sua sponte and without a hearing, without any participation of those 

affected, without identification of the intended benefits. I respectfully dissent from the 

en banc court’s rulings, as well as the procedure by which they were reached. 
United States Court of Appeals for the Federal Circuit 

 

2007-1400 

ABBOTT LABORATORIES, 

Plaintiff-Appellant, 

and 

ASTELLAS PHARMA, INC., 

 Plaintiff-Appellant, 

v. 

SANDOZ, INC., 

Defendant-Appellee, 

and 

SANDOZ GMBH, 

 Defendant, 

and 

TEVA PHARMACEUTICALS USA, INC. and 

TEVA PHARMACEUTICAL INDUSTRIES, LTD., 

 Defendants-Appellees, 

and 

RANBAXY LABORATORIES, LTD. and RANBAXY, INC., 

 Defendants, 

and 

PAR PHARMACEUTICAL COMPANIES, INC. and PAR PHARMACEUTICAL, 

 Defendants. 

----------------------------------------------- 

2007-1446 

LUPIN LIMITED, 
Plaintiff/Counterclaim DefendantAppellee, 

and 

LUPIN PHARMACEUTICALS, INC., 

Counterclaim DefendantAppellee, 

v. 

ABBOTT LABORATORIES, 

Defendant/CounterclaimantAppellant, 

and 

ASTELLAS PHARMA, INC., 

Defendant/CounterclaimantAppellant. 

Appeals from the United States District Court for the Northern District of Illinois in case 

no. 07-CV-1721, Judge Wayne R. Andersen and the United States District Court for the 

Eastern District of Virginia in case no 3:06-CV-400, Judge Robert E. Payne. 

LOURIE, Circuit Judge, dissenting from en banc Section III. A. 2. 

 I respectfully dissent from the court’s en banc holding in Section III. A. 2 that 

product-by-process claims always require use of the recited process in order to be 

infringed. 

 I agree that there is substantial Supreme Court precedent that holds that productby-process claims require use of the recited process for there to be infringement. 

However, many of those cases applied overly broad language to fact situations 

involving old products or used vague language that makes it difficult to determine 

2007-1400, -1446 2
whether the products were old or new. Clearly, however, when a product is old, a 

product-by-process claim cannot be interpreted as a claim to the product made by any 

means. The product is old and unpatentable per se. BASF in fact involved an old 

product. See Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884) (“It 

was an old article.”). 

There is arguably a different situation that should apply to chemical-biological 

products today than to mechanical products of more than a century ago. When a 

product is new and the inventor claims it by a process of preparation, I fail to see why 

the product-by-process claim should not be interpreted as a product claim that can be 

infringed even when the product is made by means other than that recited in the claim. 

Supreme Court precedent dealing with old products, while utilizing broad language, 

does not foreclose that possibility. The Court years ago did not have occasion to 

consider today’s innovations or decide whether a distinction should be made between a 

new chemical-biological product and an old product made by a new process. 

And there may be differing results depending upon the exact wording of a claim 

at issue. For example, a claim reading “when made by” might only be infringed when 

the recited process is used by the accused, as it is situational. On the other hand, a 

claim reading “obtainable by” refers to capability, so it might not require use of the 

process to infringe. “Obtained by” is ambiguous. Bright lines have their uses, but 

judging should take account of differing circumstances. In addition, of course, in order 

to sustain any claim for infringement, a patent owner must prove that an accused 

product is the same as that covered by an asserted claim. If the reason a product was 

claimed by its process was that its structure was unknown, then, if, at the time 

2007-1400, -1446 3
2007-1400, -1446 4

infringement is asserted, there still is no means to ascertain structurally whether the 

accused product is the same as that claimed, the infringement claim fails. However, 

that should not mean that a new product claimed by a process of preparation cannot 

ever be infringed when made by another process. 

 It may be that with today’s analytical techniques there is little need for productby-process claims. After all, claim 1 of the Abbott patent is a claim to a compound, not 

only by name, but also by certain of its characteristics. A claim to a product defined by 

its characteristics or properties surely is a proper claim. 

However, product-by-process issues still seem to come before us and I would 

make a distinction between old products and new products in interpreting product-byprocess claims. Accordingly, I respectfully dissent from the court’s en banc holding.