## United States Court of Appeals for the Federal Circuit

05-1157

AMGEN INC., Plaintiff-Appellee,

v.

HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC., Defendants-Appellants.

Lloyd R. Day, Jr. , Day Casebeer Madrid & Batchelder LLP, of Cupertino, California, filed a combined petition for panel rehearing and rehearing en banc for plaintiff-appellee. With him on the petition were Edward M. O’Toole , McCracken & Frank, of Chicago, Illinois; Michael F. Borun , Marshall, Gerstein & Borun LLP, of Chicago, Illinois; and Stuart L. Watt , Amgen Inc., of Thousand Oaks, California. Carter G. Phillips , Sidley Austin LLP, of Washingt on, DC, filed a response to the petition for defendants-appellants. With him on the response was Joseph R. Guerra

. Appealed from: United States District C ourt for the District of Massachusetts Judge William G. Young

## United States Court of Appeals for the Federal Circuit

05-1157 AMGEN INC., Plaintiff-Appellee,

v.

HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC., Defendants-Appellants. ON PETITION FOR PANEL REHEARING AND REHEARING EN BANC Before MICHEL, Chief Judge , NEWMAN, MAYER, LOURIE, Circuit Judges , CLEVENGER, Senior Circuit Judge , * RADER, SCHALL, BRYSON, GAJARSA, LINN, DYK, PROST, and MOORE, Circuit Judges

. O R D E R A combined petition for panel rehearing and rehearing en banc was filed by the Appellee, and a response thereto was invit ed by the court and filed by the Appellants. The petition for rehearing was referred to the panel that heard the appeal, and thereafter the petition for rehearing en banc and response were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed. Upon consideration thereof, IT IS ORDERED THAT: (1) The petition for panel rehearing is denied.

* Senior Judge Clevenger, who was on the original panel, participated only in decision on the petit ion for panel rehearing.(2) The petition for re hearing en banc is denied. (3) The mandate of the court will issue on November 29, 2006. MICHEL, Chief Judge , with whom RADE R, Circuit Judge , joins, dissents in the denial of the petition for reheari ng en banc in a separate opinion. NEWMAN, Circuit Judge , dissents in the denial of t he petition for rehearing en banc in a separate opinion. LOURIE, Circuit Judge , concurs in the denial of t he petition for rehearing en banc in a separate opinion. RADER, Circuit Judge , dissents in the denial of t he petition for rehearing en banc in a separate opinion. GAJARSA, Circuit Judge , with whom LINN, and DYK, Circuit Judges , join, concur in the denial of the petition fo r rehearing en banc in a separate opinion. MOORE, Circuit Jud g e , dissent s in the denial of the petition f o r rehearing en banc in a separate opinion.

F O R T H E C O U R T

_______________ ________________________ Date Jan Horbaly C l e r k

cc: Lloyd R. Day, Jr., Esq

. Carter G. P h illips, Esq.

2005-1157 2

## United States Court of Appeals for the Federal Circuit

05-1157

AMGEN INC., Plaintiff-Appellee,

v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC. (now known as Shire Human Genetic Therapies, Inc.), Defendants-Appellants.

MICHEL, Chief Judge , and RADER, Circuit Judge , dissenting from the denial of the petition for rehearing en banc. Rehearing this case en banc would have enabled us to reconsider Cybor 's rule of de novo review for claim construction in light of our eight years of experience with its application. I have come to believe that reconsideration is appropriate and revision may

be advisable. In my view, four practical problems have emerged under the Markman

- Cybor regime: (1) a steadily high reversal rate; (2) a lack of predictability about appellate outcomes, which may confound trial judges and discourage settlements; (3) loss of the comparative advantage often enjoyed by the di strict judges who heard or read all of the evidence and may have spent more time on t he claim constructions than we ever could on appeal; and (4) inundation of our court wi th the minutia of construing numerous disputed claim terms (in multiple claims and patents) in nearly every patent case.Our standard of review of no deference to the trial judge's claim constructions, expressed in Cybor , rests upon the premise that clai m construction is always a purely legal exer cise, devoid of factual conten t. We hav e likened claim cons truction to statutory construction. I believ e that th is analogy is open to serious question. In interpreting statutes, a judge, whether trial or appellate, essentially asks himself/herself, "What does the disputed term mean to me, the judge, as an artisan in the law?" With

claim cons truction, on the other hand, the judge is supposed to inquire, essentially, "How would the average artisan in the re levant field of technology understand the disputed c l aim terms in the context of the rest of the patent, the pr osecution history, and the prior art?"

It seems to me that the claim c onstruction question often cannot be ans wered

without as sessing, at least implicitly, w hat the average artisan knew and how she thought about the particular tech nology when the pat ent claims were written. To make such determinations, the trial judge neces sa rily relies upon prior art documents and

other evidence concer ning the sk ill of the or dinary artis an at the r e levant tim e . Indeed, trial judges are arguably better equipped t han appellate judges to make these factual determinations, especially in close cases. In such instances, perhaps we should routinely give at least some deference to the trial court, given its greater knowledge of the facts. Or, perhaps other adjustments to our current pr actice should be c onsidered.

Whatever our resolut i on, however, I bel ieve the time has c o me for us to

re-ex a mine Cybor 's no deference rule. I hope that we will do so at our next opportunity, and I expect we will.

05-1157 2

## United States Court of Appeals for the Federal Circuit

05-1157

AMGEN INC., Plaintiff-Appellee, v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC. (now known as Shire Human Genetic Therapies, Inc.), Defendants-Appellants.

NEWMAN, Circuit Judge , dissenting from denial of the petition for rehearing en banc

.

The issue for rehearing en banc is the Federal Circuit's reje ction of the district court's construction of the claim term "a therapeutically effective amount." My concern is with this court's methodology and rationale of claim construction, and with the sources on which the panel majority relied (or failed to rely) in a rriving at its changed claim construction. The district court had correctly applied this court's precedent, requiring affirmance.

I In brief, the panel majority construed the cl aims more broadly than the invention that was patented; thus the court i gnored the patentee's purpose of writing claims that avoid the prior art -- a purpose essential to every clai m in every patent -- by now construing the claims so that, as the panel majority recognized, they may read on the prior art. The05-1157 2 patentee's purpose of including the critical limitation to "a therapeutically effective amount" of the genetically engineered eryt hropoietin (EPO) was to dist inguish the prior art EPO isolates, which were not therapeutically effective to "heal or cure," in the district court's

words. Thus this court's claim construc tion diverges from t he specification and the prosecution history, and presents a claim construction that impinges on the prior art and thereby fosters invalidity. From this analytic method of claim constr uction and the denial of rehearing en banc I must, respectfully, dissent. The methodology of claim construction that the court has here adopted raises

issues that were laid to rest in Phillips v. AWH Corp. , 415 F.3d 1303 (Fed. Cir. 2005),

where the en banc court disavowed the view that a patent claim can be construed more broadly than the invention to whic h it gives legal effect. In Phillips that unwarranted breadth was found in claim construction based on general dictionary definitions of claim terms, rather than relying on the specific technical us age in the specification; in this case the unwarranted breadth is found in t he court's claim construction that may embrace the prior art, despite the exclusion of that subjec t matter by the prosecution history. The district court, construing the claims in light of the specification and the prosecution history, constr ued "a therapeutically effectiv e amount" as "a quantity that produces a result that in and of itself helps to heal or cure." That construction was the basis on which the patentee distinguished its genetically engineered EPO from the chemically identical EPO in known isolates of naturally occurring EPO, for the prior art product contained insufficient EPO to heal or cure. Thus the clai m limitation to "a therapeutically effective amount" of EPO was cr itical to allowance. During an extensive prosecution, the applicant stated that05-1157 3 naturally occurring human erythropoietin is not a viabl e human therapeutic product; human recombinant erythropoi etin, on the other hand, has been proven to be clinically effective, and is the first therapeut ic product which can be used to effectively treat the hundreds of thousands of patients who suffer from anemia and other disorder s involving low blood counts. App. No. 113,178, Amendment under Rule 16 at 4, June 5, 1989 (emphasis in original).

The record in the district court contains evidence, presented by persons experienced in this field of science, that the limitation to "a therapeutically effective amount" distinguishes the genetically engi neered EPO from known EPO isol ates. The district court construed the claims from the viewpoint of the skilled artisan, upon reading and understanding the specification and t he restrictions flowing from the prosecution history. My concern about this court's methodology is that the panel majority does not apply these standard tools of claim construction. The cour t's holding that "a therapeutically effective amount" includes any amount of EPO that exhibits a physiologic effect, whether or not the amount of EPO is adequate to provide therapy for any disorder, imparts to the claims the scope that was excluded during prosecution. Although this court has urged caution in constr uing claims in order to preserve their validity, no precedent or logic requires that when more than one claim construction is available, the court must choose the broader one although it may inva lidate the claim. See Phillips , 415 F.3d at 1327 (court may not construe claims as would be appropriate to preserve their validity unless "after applying all t he available tools of claim construction . . . the claim is still ambiguous"); see also Smith v. Snow , 294 U.S. 1, 14 (1935) ("if the claim were fairly susceptible to two constructions, that should be adopted which will secure to the patentee his actual invention"); Modine Mfg. Co. v. United States Int'l Trade Comm'n , 75 F.3d 1545, 1556 (Fed. Cir. 1996) ("When cl aims are amenable to more than one05-1157 4 construction, they should when reasonably possibl e be interpreted so as to preserve their validity."). Here, the specification and prosecution histor y make clear that th e claimed invention is the "therapeutically effective amount" of engineered recombinant EPO. As was explained to the patent examiner and again in the district court, t he prior art isolates of EPO

were ineffective to heal or cure. Just as the prosecution record cannot enlarge the claims beyond what the inventor has presented as his invention, so the c ourt cannot enlarge the claims beyond the limitations imposed by the patentee. See Phillips , 415 F.3d at 1319 (rejecting definitions broader than the technical usage specific to the in vention). The court in this case has departed from these f undamental principles. We should speak en banc to clarify that it is appropriate, and necessary, to look at what has in fact been invented, prosecuted, and patented, and constr ue the claims accordingly.

II I do not share the view, expressed here by some colleagues, that this court should not intrude upon panel decisions when major errors of claim construction are pointed out on petition for rehearing en banc . The Federal Circuit has a special obligation to provide predictability and consistency in patent adjudication, for our panel decisions are of nationwide effect; indeed, this obligation was a justification for the court's holding, a decade ago, that the district court's claim constr uction receives non-deferential review on appeal. This appellate position imposes on us the obl igation to state the correct law, even on rehearing en banc . If the meaning of "therapeutically effective amount" is treated as a question of law, its correct definition as well as the methodology by which it is defined are squarely within the criteria for rehearing en banc . And if the meaning is recognized as a05-1157 5 case-specific finding of fact, appellate review warrants deference to the trier of fact, a deference here lacking.

III I continue to believe that findings of sci ence/technology-based fa cts in patent cases should receive appellate review on the same basis as other science-based findings, guided by Daubert and the Court's ensuing elaborations. The Court’s and our own precedent require the trial judge to evaluate scientific ev idence and expertise from the viewpoint of a person experienced in the field of science, a fr amework that aptly fi ts evaluation of the technologic content and scope of patents, an analysis whose intermingling of fact and law is well served by the procedures and the adjudi catory skill of the district courts. The Federal Circuit's position that patent interpre tation requires more ri gorous appellate review than other fact/law issues has not well withstood the test of experience. It is time to reopen the question and to rethink, en banc , the optimum approach to a ccuracy, consistency, and predictability in the resolution of patent disputes , with due attention to judicial structure, litigants' needs, and the national interest in invention and innovation.

## United States Court of Appeals for the Federal Circuit

05-1157 AMGEN INC., Plaintiff-Appellee,

v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC., Defendants-Appellants.

LOURIE, Circuit Judge concurring.

I concur in the decision of the court not to rehear this case en banc. I do so, even though I agree that the panel erred in construing the claim limitation "a therapeutically effective amount." In my vi ew, the panel dissent by Chief Judge Michel was correct, as was the decision by the dist rict court and the curr ent dissent by Judge Newman. However, I do not be lieve that every error by a panel is enbancabl e. A panel

is entitled to err without the full court descending upon it.

Federal Rule of A ppellate Procedure 35(a) provides that "[a]n en banc hearing or rehearing is not favored and ordinarily will not be ordered unless: (1) en banc consideration is necessary to secure or main tain uniformity of the court's decisions; or (2) the proceeding involves a question of ex ceptional importance." Our Internal Operating Procedures (“IOPs”) state that "[a]mong the reasons for en banc actions are: (1) necessity of securing or maintaining unif ormity of decision; (2) involvement of a question of exceptional importance; (3) necessity of overruling a prior holding of this ora predecessor court expressed in an opinion hav ing precedential status ; or (4) the initiation, continuation, or resolution of a conflict with another circuit." IOP 13(2).

This issue is thus enbanc able only on the uniformity or exceptional importance grounds. However, the interpretation of "a therapeutically e ffective amount" wit h respect to this particular patent specificatio n seems to me to be case-specific, and it does not therefore raise a questi on of uniformity of decision or exceptional importance. The term, while in my view incorrectly cons trued by the majority of the panel, does not necessarily apply to s pecifications of other patents. In addition, while the res u lt may be of exceptional importance to the parties, it does not s eem to be s o to the law. I therefore concur in the dec ision of the c o urt not to rehear the case en banc, although I disagree with t he majority's holding.

05-1157 2

## United States Court of Appeals for the Federal Circuit

05-1157 AMGEN INC., Plaintiff-Appellee,

v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC. (NOW KNOWN AS Shire Human Genetic Therapies, Inc.), Defendants-Appellants.

RADER, Circuit Judge , dissenting from denial of the petition for rehearing en banc. I agree with the reasoning of Chie f Judge Michel's and Judge Newman’s dissents. Like them, I urge this court to accord deference to the factual components of

the lower court’s claim construction. Under current law, this court accords no deference

whatsoever to a district court’s claim construction. Cybor Corp. v. FAS Techs., Inc. , 138 F.3d 1448, 1451, 1455-56 (Fed. Cir. 1998) (“[C]l aim construction, as a purely legal issue, is subject to de novo review on appeal.”). The Supreme Court recognized that, far from a “purely legal issue,” claim cons truction “falls somewhere between a pristine legal standard and a simple historical fact.” Markman v. Westview Instruments, Inc. , 517 U.S. 370, 388 (1996). Quoting the Supreme Court, this c ourt agreed with the Supreme Court’s recognition that “the fact/law distinction at times has turned on a determination that, as a matter of sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.” Cybor, 138 F.3d at 1455. In this case, thedistrict court’s analys is of “therapeutically e ffective amount” deserv ed greater deference. As is often the case, the district court wa s better positioned than this court to reach the proper construction. After all the district court has more tools, more time, and more direct contact with factual evid ence than t h is appellate body. Id. at 1477 (Rader, J., dissenting) (“Trial judges c an spend hundreds of hours r eading and rereading all kinds of source material, receiving tutorials on t e chnology from leading scientis t s, formally questioning technical experts and testing their understanding against that of various experts, examining on site t he operation of the principles of the cl aimed invention, and deliberating over the meaning of the claim language. If distri ct judges are not satisfied with the proofs proffered by the parties, they are not bound to a prepared record but may compel additional presentations or even employ their own court-appointed expert.”). Indeed, in this case, the trial cour t held a nine-day trial, including testimony of

artisans inf o rmed of the meaning of “therapeut ically effective amount” at the time of invention. The trial court, whil e noting that it did not rely on expert testimony to construe the claim, specifically noted that such test imony offered during the trial fully supported

the district court's claim constr uction. Given this c ourt’s ru le tow a rd lim ited reliance on extrinsic evidence in claim cons truction, Forest Labs., Inc. v. Abbott Labs. , 239 F.3d 1305, 1311 (Fed. Cir. 2001) (citing Vitronics Corp. v. Conceptronic, Inc. , 90 F.3d 1576, 1584 (Fed. Cir. 1996) )

, district court judges have lear ned to dis c laim any reliance on

ex pert testimony. Yet, in this case the tr ial court took testimony for nine day s – hardly necessary if the judge was merely readi ng and relying upon the intrinsic patent

document alone.

05-1157 2The district court’s construction of “therapeut ically effective amou nt” also falls in line with prior opinions of this court and suggests that artisans in this field would accord the term its customary usage. Geneva Pharm. v. GlaxoSmithKline , 349 F

. 3d 1373, 1383 (Fed. Cir. 2003) (finding that “e ffective amount” is a common and generally acceptable term for pharmaceutical c l ai ms and is not ambiguous or indefinite); Abbot t Labs. v. Baxter Pharm

. Prods., Inc. , 344 F.3d 1274, 1278 (Fed. Cir. 2003) (Because the patentee did not deviate from the accustomed meaning of t he disputed claim term, the term “effective amount” is construed in view of its ordinary and customary meaning). Thus, I would grant en banc review.

05-1157 3

## United States Court of Appeals for the Federal Circuit

05-1157

AMGEN INC., Plaintiff-Appellee,

v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC. (now known as Shire Human Genetic Therapies, Inc.), Defendant-Appellants.

GAJARSA, LINN and DYK, Circuit Judges , concurring in the denial of the petition for rehearing en banc.

We concur in the denial of rehearing en banc. Our concurrence should not be read as an endorsement of the panel’s claim construction in th is particular case, nor as an unqualified endorsement of the en banc decision in Cybor Corp v. FAS Techs., Inc. , 138 F.3d 1448 (Fed. Cir. 1998). In an appropria te case we woul d be willing to reconsider limited aspects of the Cybor decision. In our view an appropriate case would be the atypical case in which the language of the claims , the written description, and the prosecution history on their face did not resolve the question of claim interpretation, and the district court found it necessary to re solve conflicting expert evidence to interpret particular claim terms in the field of the art. This is not such a case.In this case the district court expl ic itly and repeatedly disavowed relianc e on extrinsic expert evidence in construing the claim term “therapeutically effective.” The district court noted that “[d] emonstrative exhibits wer e presented and references wer e made to certain expert testimony, but ex trinsic evidenc e was not admitted.” Amgen Inc. v. Hoechst Marion Roussel, Inc. , 339 F. Supp. 2d 202, 222 (D. Mass. 2004). Ultimately , the district court concluded: While the expert testimony does support the plain and ordinary m eaning of the term since it defines what ‘cur e’ means in the context of anemia patients, the Court will not rely on it to cons true the claim, because even the Altiris [Inc. v. Symantex Corp. , 318 F.3d 1363 (F ed. Cir. 2003)] court made clear that it was looking to expert testimony merely to understand the technology—not to construe the term itself. Amgen , 339 F. Supp. 2d at 230 n.27; see id. at 233 n.29 (noting that extrinsic evidenc e was not being used “to define the term”). 1

The distric t court proceeded to constr ue the claim “therapeutically effective”

without res o rt to extrinsic expert evidenc e. It first “look[ed] to the plain and ordinar y meaning of the words of the patent claim,” id. at 229, then “review[ed] the specification to determine whether the patent ee has us ed term s in a manner incons istent with the ordinary m eaning or has become his own lexicographer,” id. at 232, and finally “consider[ed] the prosecution history to det ermine whether the appli cant ha[d] made any express representations r egarding the claim’s scope,” id. at 238. No deference is due a district court’s legal interpretation of the claim language, written description, and prosecution history that an appellate c ourt is equally competent to interpret.

1 See also id. at 226 (noting that expert test imony “is extrinsic ev idence to which resort ought to be had only ‘ if necessary ’”); id. at 231 n.28 (“[T]he Court cannot rely on expert testimony to help construe t he term ‘therapeutically effective’ unless absolutely necessary.”)

05-1157 2Since the district court did not rest its in terpretation on f a ctual findings concer ning conflicting expert evidence and neither the panel majority nor the dissent addr essed this issue, we do not believe that this is the appr opriate cas e in which t o reconsider aspects of the Cybo r decision.

05-1157 3

## United States Court of Appeals for the Federal Circuit

05-1157 AMGEN INC., Plaintiff-Appellee,

v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.)

and TRANSKARYOTIC THERAPIES, INC., Defendants-Appellants.

MOORE, Circuit Judge , dissenting from the denial of the petition for rehearing en banc.

I dissent from this court’s denial of t he petition for rehearing en banc. First, let me begin by saying that under the court’s pr esent standard of de novo review, in my opinion the district court’s construction of “a therapeutically effective amount” was

correct. I need not articulate all the reasons that the claims, specification, prosecution history, and extrinsic evidence all support the interpretation given by the district court— the district court’s own opini on and the panel dissent by Chief Judge Michel effectively do so. If the only issue were one of case-s pecific mistake, I would concur in the

decision not to hear the case en banc. Fede ral Rule of Appellate Procedure 35(a) and our Internal Operating Procedures limit the use of en banc.

I dissent because I believe this court should have taken this case en banc to reconsider its position on deference to distri ct court claim construction articulated in Cybor Corp. v. FAS Tech., Inc. , 138 F.3d 1448, 1454-55 (Fed. Cir. 1998) (holding that claim construction was purely a matter of law and therefore subject to de novo review). Five judges of this court have written opi nions in this case expressing disagreementwith the two judge panel majority’s clai m c onstruction even under the de novo standard of review. In this case, the district court constr ued the term “a therapeutically effective

amount” with the assistance of a technica l advisor (an MIT Professor) and a Spec ial Master. The district court opi nion explains that the term was constr ued us ing t he patent claims, the specification, the prosecution hi story, three different dictionaries , and prior

art. 1 The opinion also explains t hat the cl aim construction is supported by t he expert testimony presented by the parties in this case, 2 but then disavows using it to “define

the term” or “construe the term” i n stead stati ng that it is being us ed to “understand the technology. ” 3

I commend the district court for its t horough, detailed, though tful, and competent efforts in construing this cl aim limitation. The district court did everything we hav e asked it to do, and in my opinion, did it co rrectly. While this m a y not be a bas is for taking the case en banc, recons ideration of the defer ence accorded to the dis t rict court

in this case would hav e been. Therefore, I w ould grant en banc review.

1 Dictionaries, technical treatises, and prior art disclosures are extrinsic evidenc e relied upon by the district court to construe this term. See Am gen, Inc. v. Hoechst M a rion Rous sel, Inc. , 339 F. Supp.2d 202, 226-228 (D. Mass. 2004) (detailing the dictionary definitions); Id. at 244 n.46 (explain ing that the prior art disclosed to th e patent examiner also supports the district cour t’s interpretation). When the district court disavows use of extrinsic evidenc e, it seems to be focusing on expert testimony. 2 Id. at 244-45 n.47 (finding that “two crucial witness e s for the defense conceded” points whic h support the dist rict court’s claim construction). 3 The district court goes on to point out that the Federal Circuit pr ecedent has created a “conundrum” by: “d iscouraging resort to extr ins i c evidence while at the same time urging courts to begin claim construction by considering the plain and customary meaning of a te rm as understood by one skilled in the art.” Id. at 226 n.23.

05-1157 2