## United States Court of Appeals for the Federal Circuit

04-1522

SMITHKLINE BEECHAM CORPORATION and SMITHKLINE BEECHAM, P.L.C.,Plaintiffs/Counterclaim DefendantsAppellants,

and GLAXOSMITHKLINE, P.L.C., Plaintiff/Counterclaim Defendant,

and BEECHAM GROUP, P.L.C., Plaintiff,

v. APOTEX CORPORATION, APOTEX, INC., and TORPHARM, INC., Defendants/Counterclaimants- Appellees.

Ford F. Farabow, Jr. , Finnegan, Henderson, Farabow , Garrett & Dunner, L.L.P., of Washington, DC, argued for plaintiffs/counterclaim defendants-appellants. With him on the brief were Robert D. Bajefsky , Howard W. Levine , Sanya Sukduang , and Jennifer S. Swan

. Hugh L. Moore , Lord, Bissell & Brook LLP, of Chicago, Illinois, argued for defendants/counterclaimant s-appellees. With him on the brief were Scott B. Feder , Hugh S. Balsam , and Kevin M. Nelson . Of counsel were Keith D. Parr and Sara A. Lufrano

. Appealed from: United States District Cour t for the Eastern District of Pennsylvania Judge R. Barclay Surrick

## United States Court of Appeals for the Federal Circuit

04-1522 SMITHKLINE BEECHAM CORPORATION, SMITHKLINE BEECHAM, P.L.C., Plaintiffs/Counterclaim Defendants-Appellants,

and GLAXOSMITHKLINE, P.L.C., Plaintiff/Counterclaim Defendant,

and BEECHAM GROUP, P.L.C., Plaintiff,

v. APOTEX CORPORATION, APOTEX INC., and TORPHARM, INC. Defendants/Counterclaimants-Appellees.

___________________________ DECIDED: February 24, 2006

___________________________ Before NEWMAN, SCHALL, and DYK, Circuit Judges

. Opinion for the court filed by Circuit Judge DYK. Dissenting opinion filed by Circuit Judge NEWMAN. DYK, Circuit Judge

. SmithKline Beecham Corpor ation and SmithKline Beecham , P.L.C. (collectively “SmithKline”) brought suit agains t Apotex Corporation, Apot ex Inc., and Torpharm, Inc. (collectively “Apotex”) for infringement of SmithKline’s patent, U.S. Patent No. 6,113,944(“‘944 patent”). Apotex moved for summary judgment, arguing that the ‘944 patent was invalid. The district court granted summary judgment to Apotex. We agree that the claims of the ‘944 patent are invalid and thus affirm. BACKGROUND This case presents the question w hether SmithKline’s product patent for paroxetine, U.S. Patent No. 4,721,723 (filed Oct. 23, 1986) (“‘723 patent”), anticipated its ‘944 product-by-process patent claimi ng paroxetine made by an allegedly novel process. SmithKline’s ‘723 patent claimed a pharmaceutical product aimed at treating depression. In SmithKline’s own words, t he “‘723 patent disclose[d] a pharmaceutical composition in tablet fo rm containing paroxetine.” 1 J.A. 63. The ‘723 patent also disclosed that the product is “usually presented as a unit dose composition containing from 1 to 200 mg, more usually from 5 to 100 mg, for example 10 to 50 mg such as 12.5, 15, 20, 25 or 30 mg.” ‘723 patent, col. 5, ll. 53-56. In 1992, SmithKline obtained approval fr om the Food and Drug Administration (“FDA”) to market crystalline paroxetine hydroc hloride, which it began to sell under the trade name Paxil®. SmithKline then filed various other related patent applications, including application No. PCT/EP94/04164, on December 14, 1994, which eventually matured into the ‘944 patent. The ‘944 pat ent contained the following two product-byprocess claims:

1 The ‘723 patent claimed, among ot her things, an “anti-depressant pharmaceutical composition comprising an effective anti-depressant amount of crystalline paroxetine hydroc hloride hemihydrate and a pharmaceutically acceptable carrier.” ‘723 patent, col. 10, ll. 39-43.

04-1522 2Claim 1. A pharmaceutical compos ition in tablet form containing paroxetine, produced on a commercia l scale by a process which comprises the steps of: a) dry admixing paroxetine and excipient s in a mixer to form a mixture; or b) dry admixing paroxetine and exci pients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and c) compressing the mixture into tablets. Claim 2. A pharmaceutical composition in tablet form according to claim 1 containing an amount of paroxetine sele cted from 10 mg, 20 mg, 30 mg, 40 mg and 50 mg, wherein the amount of paroxet ine is expressed as the free base, produced on a commercial scale by a process which comprises the steps of: a) dry admixing paroxetine and excipients in a mixer to form a mixture; or b) dry admixing paroxet ine and excipients, compressing the resulting combination into a slug material or ro ller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and c) compressing the mixture into tablets using a single punch or rotary tablet machine. J.A. 483-84 (Certificate of Correction). On March 31, 1998, Apotex, a generic drug manufacture r and defendant here,

submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to market a generic version of Paxil®. In connection with its ANDA, Apotex filed a socalled “paragraph IV certificati on,” which is a statement by the applicant that designated patents claiming either the drug or a use of the drug at i ssue are invalid or will not be infringed by the applicant. 21 U.S.C. § 355( j)(2)(A)(vii)(IV) (2000). Apotex’s paragraph

IV certification claimed t hat the ‘944 patent was invalid . Pursuant to 35 U.S.C. § 271(e)(2), which makes submitting an ANDA an act of infringement, SmithKline brought suit against Apotex, alleging infringement of the ‘944 paten t. Apotex counterclaimed that the ‘944 patent was invalid and in due course moved for summary judgment of invalidity.

04-1522 3In its decision, the district court held t he ‘944 patent anticipated and thus invalid. The district court appeared to view the question of anticipation as turning on the scope of the ‘944 patent, namely whet her the patent should be viewed as claiming paroxetine without regard to the process by which it wa s made or whether the process steps were

to be treated as claim limitations. The distri ct court perceived a conflict in this respect

between our decisions in Scripps Clinic & Research Foundation v. Genentech, Inc. , 927 F.2d 1565 (Fed. Cir. 1991) (which the district court viewed as holding that the process steps were not claim limitations) and Atlantic Thermoplastics Co., Inc. v. Faytex Corp. , 970 F.2d 834 (Fed. Cir. 1992) (which the dist rict court viewed as holding that the process steps were claim limitations). The district court concluded that it was bound to follow the earlier Scripps decision, finding that Scripps required it to “evaluate the validity of the [‘944 patent’s] claims by refer ence to the products claimed therein, without the process limitations of t hose claims.” J.A. 61. Be cause the ‘723 patent disclosed tablets containing paroxetine, including in t he dosages specified in claim 2 of the ‘944 patent, the court determined that the ‘723 patent anticipat ed the ‘944 patent. In holding the ‘944 patent antic ipated, the district cour t found that the product claimed by the ‘944 patent was the same product disclosed by the ‘723 patent, despite SmithKline’s arguments that t he paroxetine tablets claimed by the ‘944 patent were different because they lacked a pink hue, did not contain spherical granules, and had a different content uniformity. The court stat ed that these characte ristics were “not required by the patent claims or specification” and that t he “product characteristics now cited by SmithKline are insufficient to disti nguish the product of the ‘944 Patent from the products claimed in the ‘723 Patent.” J.A. 64-65. The court ther efore granted Apotex’s

04-1522 4summary judgment motion. Pursuant to Fed. R. Civ. P. 54(b), the court entered a separate judgment with respect to the invalidity of the ‘944 patent. SmithKline timely appealed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). DISCUSSION On appeal, SmithKline argues that the district c ourt improperly “ignored the process limitations of the two product-by-process claims in the ‘944 patent” when it determined validity. SmithKline’s Br. at 17, 23-24, 27. In ot her words, if the district court had treated the process steps recited in the ‘944 patent as cl aim limitations, it would have found that the ‘723 patent did not anticipate the ‘944 patent, or that there was a genuine issue of fact over whether the ‘723 patent discl osed those process

limitations. SmithKline misunderstands the nature of anticipation. As set forth below, once a product is fully disclosed in the art, future cl aims to that same product are precluded, even if that product is claimed as made by a new process.

I A product-by-process claim is “one in whic h the product is defined at least in part in terms of the method or proc ess by which it is made.” Bonito Boats, Inc. v. Thunder Craft Boats, Inc. , 489 U.S. 141, 158 n. (1989) (quoting D. Chisum, Patents § 8.05, at 8- 67 (1988)). While the patent statute does not provide for product-by-process claims, the courts have long recognized the appropriateness of such claims. See, e.g. , In re Thorpe , 777 F.2d 695, 697 (Fed. Cir. 1985); In re Brown , 459 F.2d 531, 535 (C.C.P.A. 1972); In re Steppan , 394 F.2d 1013, 1018 (C.C.P.A. 1967) . The purpose of productby-process claims is to allow inventors to claim “an otherwise patentable product that

04-1522 5resists definition by other than the process by which it is made.” In re Thorpe , 777 F.2d at 697. Thus, an inventor will not be forecl osed from the benefits of the patent system simply because a product is difficult to describe in words, or its stru cture is insufficiently understood. Today, however, product-by-process claims are used by inventors even if

the invention could have been de scribed independent of the process. 2 This court has previously considered t he scope of product-by-process claims. In Scripps , we held that the product-by-process clai ms at issue were not limited by the process steps within those cl aims. 927 F.2d at 1583. Ther e, the patent concerned a protein, Factor VIII:C, ess ential to blood clotting. Id. at 1568. The patent contained product-by-process claims directed at the product made in accor dance with a particular process, also claimed in the patent. Id. at 1570. The court found that Factor VIII:C that was produced by a different process woul d nonetheless infringe the product-by-process

claims because: In determining patentability we construe the product as not limited by the process stated in the claims. Since claims must be construed the same way for validity and for infringement, t he correct reading of the product-byprocess claims is that they are not limited to prod uct prepared by the process set forth in the claims.

Id. at 1583. A year later this court decided Atlantic Thermoplastics . There, we held that the process steps in a product-by-process claim do serve as claim limitations. 970 F.2d at 846-47. The patent in Atlantic Thermoplastics concerned shock absorbing shoe

2 See 3 Chisum on Patents § 8.05[2][c] (2003 ed.) (explaining that the Patent and Trademark Office (“PTO”) has rejected t he “necessity rule” which permitted product-by-process claims only in cases where the product was otherwise undefinable; instead, the PTO has opted to allow product-by-process claims so long as the definiteness requirement is met).

04-1522 6innersoles. Id. at 835. The patentee argued t hat the defendant had infringed its product-by-process claim. Id. at 836. Finding that the a ccused products were made by a different process than that claimed in t he patent’s product-by-pro cess claim, the court determined that the patent did not extend to cover the product as made by any process.

Id. at 846-47. This court stat ed that “[i]n light of Suprem e Court caselaw and the history of product-by-process claims, this court acknowledges that infringement analysis proceeds with reference to t he patent claims. Thus, process terms in product-byprocess claims serve as limitations in determining infringement.” Id. A sharply divided court denied rehearing en banc of Atlantic Thermoplastics , with four judges dissenting in four separate opinions. See 970 F.2d 834, rehearing en banc

denied , 974 F.2d 1299 (concurring opinion), 974 F. 2d 1279 (dissenting opinions). Judge Newman, joined by Judges Rich and Lourie, urged that the panel in Atlantic Thermoplastics had incorrectly adopted a blanket rule that the process steps of a product-by-process claim should be automatically treated as claim lim itations. 974 F.2d at 1282-83. In their view, the process steps should sometimes be treated as claim limitations and sometimes not, depending on the “class of claim” at issue. Id. at 1284. Some commentators, like the district court here, have perceived a conflict

between Scripps , where the court construed the pr oduct-by-process claims without reference to the process steps, and Atlantic Thermosplastics , where the court read the process steps as claim limitations. 3 We need not address this controversy here. The

3 See Trs. of Columbia Univ. v. Roche Diagnostics GMBH , 126 F. Supp. 2d 16, 31 (D. Mass. 2000) (noting that after Scripps and Atlantic Thermoplastics , the district court is left in the unenviable posit ion of choosing the better rule); DeKalb Genetics Corp. v. Northrup King Co. , No. 96 C 50169, 1997 WL 587492, *2 (N.D. Ill. Aug. 14, 1997) (finding that Scripps and Atlantic Thermoplastics are “in seeming conflict”);

04-1522 7issue here does not turn on how broadly or narrowly we construe the ‘944 patent’s claims, for it is undisputed that the product that is the subject of t he patent’s claims is paroxetine. Rather t he issue is whether the ‘723 patent anticipated the ‘944 product-byprocess patent, when the ‘723 patent broadly claimed paroxet ine without regard to the process by which it was made. 4 Thus, the ultimate issue is simply whether the prior art disclosure of a product precludes a future clai m to that same product when it is made by an allegedly novel process. 5

II Regardless of how broadly or narrowly one construes a product-by-process claim, it is clear that such claims are always to a product, not a process. It has long

been established that one cannot avoid antici pation by an earlier product disclosure by claiming the same product more narrowly, that is, by claiming the product as produced by a particular process. Th is was the exact issue in In re Thorpe . There, the patent concerned a composition that was used in car bonless copy paper system s. 777 F.2d at

Tropix, Inc. v. Lumigen, Inc. , 825 F. Supp. 7, 8 (D. Mass. 1993) (noting the “disagreement” between Scripps and Atlantic Thermoplastics ); see also 3 Chisum on Patents § 8.05[1][b] (“Federal Circuit panel dec isions in 1991 and 1992 differed over whether a product-by-process claim can be infringed by a product not made by a specified process.”); Conflicts in Federal Circu it Patent Law Decisions , 11 Fed. Cir. B.J. 723, 765 (2002) (describing controversy).

4 The ‘723 patent also contained a separat e process claim for the preparation of the paroxetine; however, this cl aim has not been implicated here. See ‘723 patent, col. 10, ll. 36-38.

5 Although we have previously held the ‘723 patent invalid, SmithKline Beecham Corp. v. Apotex Corp. , 403 F.3d 1331, 1346 (Fed. Cir. 2005), it can still, of course, anticipate a later product patent. By virtue of publication, the ‘723 patent has become prior art. 1 Chisum on Patents § 3.06 (2003 ed.) (“A United States patent is published on the date it is issued and thereby becomes a printed publication within the meaning of Section 102(a) as well as a patent.”).

04-1522 8696. The composition was know n in the prior art, but was previously made using zinc dibenzoate. In a product-by-process claim, Thorpe claimed the same composition made by a process that used zinc oxide and benz oic acid, rather than zinc dibenzoate. The court upheld the PTO’s re jection of the claim. Id. at 698. It held that “[i]f the product in a product-by-process claim is the sa me as or obvious fr om a product of the prior art, the claim is unpat entable even though the prior product was made by a different process.” Id. at 697. In re Thorpe has never been overruled and has been followed for many years by the PTO. 6 The current MPEP states: [Even] though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process clai m is the same as or obvious from a product of the prior art, the clai m is unpatentable even though the prior product was made by a different process. MPEP § 2113 (8th ed., Rev. 2, May 2004) (quoting In re Thorpe , 777 F.2d at 698).

At the time of In re Thorpe , the rule as articulated was hardly new. Long before In re Thorpe , our predecessor court, the Court of Customs and Patent Appeals, consistently held that product-by-process clai ms could not validly claim products already

known in the art. See In re Fessmann , 489 F.2d 742, 744-45 (C.C.P.A. 1975); In re

Johnson , 394 F.2d 591, 594-95 (C.C.P.A. 1968); In re Stephens , 345 F.2d 1020, 1023

6 The 1987 revision of the PTO’s Manual of Patent Examining Procedure (“MPEP”) stated the rule for product-by-process claims as follows: “When the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claim ed in a product-by-process claim, a rejection . . . is appropriate.” Atlantic Thermoplastics Co., Inc. , 974 F.2d at 1288 (denial of rehearing en banc ) (quoting MPEP § 706.03(e) (5th ed., Rev. 6, Oct. 1987)) (Newman, J., dissenting). Later revisions of the MPEP contain the i dentical quote. See, e.g. , MPEP § 2113 (6th ed., Rev. 3, July 1997); MPEP § 2113 (7th ed., Rev. 1, Feb. 2000); MPEP § 2113 (8th ed., Rev. 1, Feb. 2003).

04-1522 9(C.C.P.A. 1965) (“We think it well settled that the presence of process limitations in product claims, which product does not otherwis e patentably distinguish over the prior art, cannot impart patentabilit y to that product.”); In re Dilnot 300 F.2d 945, 950 (C.C.P.A. 1962) (“The addition of a method step in a product claim, which product is not patentably distinguishable from the prior art, cannot impar t patentability to the old product.”); In re Moeller , 117 F.2d 565, 567 (C.C.P.A. 1941) (“[ T]he article itself must be inventive and patentably distinct from such articles disclosed in the prior art.”); In re

Ewert , 77 F.2d 498, 499 (C.C.P.A. 1935); In re Brawn , 77 F.2d 362, 363 (C.C.P.A. 1935); In re Harvey , 71 F.2d 200, 201 (C.C.P.A. 1934). This rule is also supported by earlier S upreme Court cases. For example, in Cochrane v. Badische Anilin & Soda Fabrik , 111 U.S. 293 (1884) (“ BASF ”), natural alizarine was already known in the art. Id. at 311. However, BASF obtained a patent covering artificial alizarine, as pr oduced by a bromine r eaction process. Id. at 296. The accused infringer, Cochrane, then sold artifici al alizarine made by a different, sulfuric acid reaction process. Id. at 309. The Court reasoned t hat if the BASF patent were construed to cover the product itself, it woul d be invalid because the product was old.

Id. at 311-12. The Court stat ed that “[w]hile a new proc ess for producing it was patentable, the product itself could not be patented, even though it was a product made artificially for the first time. . . .” Id. at 311. As the Atlantic Thermoplastics panel recognized, the BASF court thus held that “a patent applicant could not obtain exclusive rights to a product in the prio r art by adding a process limitation to the product claim.” Atlantic Thermoplastics , 970 F.2d at 841 (citing BASF , 111 U.S. at 311); see also TriWall Containers, Inc. v. United States , 408 F.2d 748, 750-51 (Ct. Cl. 1969), cert. denied ,

04-1522 10396 U.S. 828 (1969) (following BASF , and stating that “the addi tion of a method step in a product claim, which product is not patent ably distinguishable from the prior art, cannot impart patentability to the old product”). This understanding of BASF has been recognized by leading commentators. See, e.g. , 3 Chisum on Patents § 8.05[3] (2003 ed.) (citing BASF for the proposition that “[e]ven through a product may be claimed in terms of the process of maki ng it, the product still must be new in structural terms in order to meet the novelty requirement.”). Other Supreme Court cases have reached the

same conclusion. See Gen. Elec. Co. v. Wabash Appliance Corp. , 304 U.S. 364, 373 (1938) (“Although in some instances a clai m may validly describe a new product with some reference to the method of producti on, 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 monopol y on the product by whatever means produced.”); Wood-Paper Patent , 90 U.S. 566, 596 (1874). As this history of cases from the S upreme Court, our court, and our predecessor court make clear, anticipation by an ear lier product patent cannot be avoided by claiming the same product more narrowly in a product-process claim. It makes no difference here whether the ‘944 patent’s product-by-process claims are construed broadly to cover the product made by any proc ess or narrowly to cover only the product made by a dry admixing proce ss. Either way, anticipat ion by an earlier product disclosure (which disclosed the product itself) cannot be avoided. While the process set forth in the product-by-process claim may be new , that novelty can only be captured by obtaining a process claim. We agree with the district court’s conclusion that the ‘723

04-1522 11patent disclosure anticipated t he identical product claimed by the ‘944 patent even though that product was produced by an allegedly novel process. 7

III In the district court, the parties differ ed on a second issue, that is, whether the product produced by the process claimed in the ’944 patent was, in fact, a different product than that disclosed in the ‘723 patent. If those product-by-process claims produced a different product t han that disclosed by the ‘723 patent, there would be an argument that the ‘ 723 patent disclosure di d not anticipate. In re Luck , 476 F.2d 650, 653 (C.C.P.A. 1973). On this appeal, in respons e to Apotex’s argum ent that the issue had been waived by failure to include it in t he opening brief, SmithKline did not point out in its reply brief where the issue had been presented in its opening brief. Questioned by this court at oral argument as to whether this second issue has been properly preserved on appeal, SmithKline urged that it had raised this issue on appeal and was challenging the district court’s finding regarding the novel ty of the product claimed by the ‘944 patent. We conclude that this issue has been waived for failure to brief it on appeal. Our law is well establis hed that arguments not rais ed in the opening brief are

waived. See Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc. , 424 F.3d 1293, 1320-21 n.3 (Fed. Cir. 2005). SmithKline’s opening brief focused on the perceived

conflict between Scripps and Atlantic Thermoplastics to the exclusion of arguments that the product produced by the allegedly novel process was novel. Indeed, SmithKline

7 Contrary to the dissent’s suggestion, the court does not hold that a claim to a product is never limited by pr ocess limitations. We simply hold that a prior art disclosure of a product precludes a future claim to that same product, even if it is made by an allegedly novel process. We take no position on whether a product-by-process claim is construed with reference to the process steps.

04-1522 12argued that “this Court should address only the issue that provided the basis for the district court—its incorrect interpretation of the product-by-proce ss claims of the ‘944 patent.” SmithKline’s Br. at 30. SmithKline failed to incl ude in the Argument section of its opening brief an argument that, contrary to the district court’s finding, the product claimed in the ‘944 patent is it self different from that discl osed in the ‘723 patent. To be sure, there are various places in its openi ng brief where SmithK line alluded that the paroxetine tablets claimed in the ‘944 patent were different from tablets disclosed in the prior art and expressed its dis agreement with the district c ourt’s determination that the product produced by the ‘944 patent was not new. In its Ar gument section, SmithKline stated “there were numerous factual disput es between the parties, including the scope and content of the prior art, and the unexpect ed improvement of t he claimed invention over the prior art.” SmithKli ne’s Br. at 19. Similarly, on page 27 of its brief, SmithKline

stated: Here, the district court held that “t he product of the ‘ 944 Patent cannot be distinguished from the parox etine tablets in the prio r art . . . .” (A64.) Accordingly, although SB’s disagrees wit h that determination , if the district court was determined to follow Scripps , it should have then considered the process limitations of the product-by-p rocess claims of the ‘944 patent as essential limitations in determining validity. SmithKline’s Br. at 27 (emphasis added). 8 In a footnote to th is sentence, SmithKline further noted that the ‘944 pat ent’s tablets have a “signifi cantly reduced tendency to pink, and have a different ‘finger print’ than tablets made by a [prior art] wet granulation process. The district court erroneously believed it did not need to consider such

8 In various other places, SmithKline noted its disagreement with the district court’s decision and stated in conclusory fa shion that factual disputes “should have precluded the district court from entering summary judgment.” See, e.g. , SmithKline’s Br. at 2, 13-14.

04-1522 13differences because they were not literally re cited in the claim. This was an error of

law.” Id. at n.8. This footnote is the only statem ent that even approaches a substantive argument on novelty in the entire Argument se ction of SmithKline’s opening brief.

We find that these mere statements of di sagreement with the dist rict court as to the existence of factual disputes do not amount to a developed argument. See, e.g. , Anderson v. City of Boston , 375 F.3d 71, 91 (1st Cir. 2004) (“When a party includes no developed argumentation on a point . . . we tr eat the argument as waived under our well established rule.”); Tolbert v. Queens Coll. , 242 F.3d 58, 75 (2d Cir. 2001) (“It is a settled appellate rule that issues adverted to in a perfunctory manner, unaccompanied by some effort at developed argumentation, are deemed waived.”) (internal quotation marks omitted); United States v. Elder , 90 F.3d 1110, 1118 (6th Cir. 1996) (same);

Laborers’ Int’l Union of N. Am . v. Foster Wheeler Corp. , 26 F.3d 375, 398 (3d Cir. 1994), cert denied , 513 U.S. 946 (1994) (“An issue is wa ived unless a party raises it in its opening brief, and for those purposes ‘a pa ssing reference to an issue . . . will not suffice to bring that issue before this court.’”) (quoting Simmons v. City of Philadelphia , 947 F.2d 1042, 1066 (3d Cir. 1991), cert. denied , 503 U.S. 985 (1992)); United States v.

Dunkel , 927 F.2d 955, 956 (7th Cir. 1991) (“ A skeletal ‘argument’, really nothing more than an assertion, does not pres erve a claim. . . . Especially not when the brief presents a passel of other arguments . . . . Judges are not like pigs, hunting for truffles buried in briefs.”). Further, arguments raised in f ootnotes are not preserved. See Cross Med. Prods., Inc. , 424 F.3d at 1320-21 n.3 (holding that an argument raised in a footnote in an opening brief was waived as not properly raised); Fuji Photo Film Co. v. Jazz Photo

04-1522 14Corp. , 394 F.3d 1368, 1375 n.4 (Fed. Cir. 2005) (finding that an argument raised in a footnote in an opening cross-appeal brief and then more fully in the reply brief, was not properly raised); Graphic Controls Corp. v. Utah Med. Prods. , 149 F.3d 1382, 1385 (Fed. Cir. 1998) (finding that an argument raised in a footnote which in turn referenced the full argument in t he appendix was not preserved) (citing Fed. R. of App. P. 28(a)(6) which then stated that “[t] he argument [in the appellant’s brief] must contain the contentions of the appellant on the issues presented, and the r easons therefor, with citations to the authorities . . . and parts of the record relied on . . . .”). 9 Therefore, SmithKli ne has not established that the district court erred in its ultimate judgment holding the ‘944 patent anticipated by the ‘723 patent.

CONCLUSION For the foregoing reasons, the decision below is affirmed.

AFFIRMED COSTS

No costs.

9 As we held in Becton Dickenson and Co. v. C.R. Bard, Inc. , 922 F.2d 792, 800 (Fed. Cir. 1990), this court nonetheless has di scretion to consider arguments that are not properly raised in the opening brief. But here, as in Becton , we see no reason to exercise that discretion.

04-1522 15

## United States Court of Appeals for the Federal Circuit

04-1522

SMITHKLINE BEECHAM CORPORATION, SMITHKLINE BEECHAM, P.L.C., Plaintiffs/Counterclaim Defendants-Appellants,

and GLAXOSMITHKLINE, P.L.C., Plaintiff/Counterclaim Defendant,

and BEECHAM GROUP, P.L.C., Plaintiff,

v. APOTEX CORPORATION, APOTEX INC., AND TORPHARM, INC., Defendants/Counterclaimants-Appellees.

NEWMAN, Circuit Judge , dissenting.

The law of "anticipation" does not change in the special situation where claims contain both product and process limitations. The panel majority perpetuates a confusing misunderstanding of precedent governing product-by-process claims, ignoring the opportunity and need for clarification.04-1522 2 In this case the district court found "antic ipation" based on a claim construction that

erased critical limitations of the claim. At issue are claims that require the use of a specified process for the commercial production of t ablets of the known pharmaceutical product paroxetine (Paxil®). The clai ms are simple and straightforward, and state the processing steps that produce the stabilized tableted product, as follows: 1. A pharmaceutical composition in tablet form containing paroxetine, produced on a commercial scale by a proc ess which comprises the steps of: a) dry admixing paroxet ine and excipients in a mixer to form a mixture; or b) dry admixing paroxetine and ex cipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and c) compressing the mixture into tablets. 2. A pharmaceutical composition in tablet form according to claim 1 containing an amount of paroxetine selected from 10 mg, 20 mg, 30 mg, 40 mg and 50 mg, wherein the amount of par oxetine is expressed as the free base, produced on a commercial scale by a process which comprises the steps of: a) dry admixing paroxet ine and excipients in a mixer to form a mixture; or b) dry admixing paroxetine and ex cipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and c) compressing the mixture into tabl ets using a single punch or rotary tablet machine. The general rule of infringement is that every claim limitati on or its equivalent must be represented in the accused activity. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co. , 520 U.S. 17, 29 (1997) ("Each element contained in a patent claim is deemed material in defining the scope of the patented in vention.") That which infri nges if later, anticipates if earlier. Peters v. Active Manufacturing Co. , 129 U.S. 530, 537 (1889); Door-Master Corp. v. Yorktowne, Inc. , 256 F.3d 1308, 1312 (Fed. Cir. 2001) ("'[t] hat which infringes, if later, would anticipate, if ear lier'") (quoting Peters ). These rules, like all rules, have generated04-1522 3 exceptions, but the exceptions in connection with "anticipation" of claim content are rare, and represent a pragmatic adjustment to the needs of science, not law. Such an exception exists for inventions directed to a novel product that, although patentable as a product, cannot be adequately described other than by the way it was made; the process may or may not itself be nov el, but that aspect is deemed irrelevant to the claim to the new product. This exc eption was created to accommodate the rare circumstances to which it has been appli ed, as illustrated in In re Thorpe , 777 F.2d 695 (Fed. Cir. 1985) and Scripps Clinic & Re search Foundation v. Genentech, Inc. , 927 F.2d 1565 (Fed. Cir. 1991). Yet the courts, includi ng my colleagues on this panel, do not appear to have understood the role of the exception, as illustrated in the holding in this case. Thus my colleagues today adopt a one-rule-fits-all rule for claims with process limitations, a rule that is seriously flawed. Instead of taki ng this opportunity to clarify the confusion surrounding this issue, the court exacerbat es it. I must, respectfully, dissent.

I CLAIM CONSTRUCTION The SmithKline inventors in the '944 patent describe the production of a stabilized paroxetine tablet by a specifi ed process that reduces or elim inates the formation of a pinkcolored catechol-based impurity. They clai m the commercial paroxetine tablets produced by and limited to the specified proce ss. That is their invention. They do not assert that the claims cover every form of paroxetine howev er it is produced, and they report that paroxetine is well known. T he district court, citing the c onfusion of conflicting Federal Circuit precedent, held that the process steps in the '944 clai ms are not claim limitations, whereby the court held the claim invalid becaus e paroxetine itself is a known compound.04-1522 4 It is not the law that process limitations in product claims are not claim limitations. It is not the law that process limitations are ignored in construi ng claims, whatever the nature of the invention. Claims stat e the invention for which a patent is sought. See 35 U.S.C. §112 ¶2 (claims state "the subject matter which t he applicant regards as his invention"). All claims are construed in light of the specification: the observer looks to the specification to ascertain what has been invented, and under stands the claim accordingly. See Phillips v. AWH Corp. , 415 F.3d 1303 (Fed. Cir. 2005) ( en banc ). This rule is not suspended when product and process limitations appear in the same claim. No precedent so requires, and no policy is served by this creative new rule. Claim construction is a fact-dependent, invention- oriented exercise in logic and law. It requires judicial awareness that patent claims are directed to inventions which come in great variety. There is no need for judges to create one-type-fits-all pigeonholes for claims, even for claims containing process limitations. When product and process limitation appear in the same claim it is generally

because these limitations serve to define and distinguish the in vention. Practitioners well understand the variety of types of claims that may contain both product and process limitations. As discussed by E.P. Mirabel, Product-by-Process Claims: A Practical Perspective , 68 J. Pat. & Trademark Off. Soc'y 3 (1986), the most prevalent types are (1) claims where the product is defi ned by the way it is made; (2) claims to a product that is limited by process steps, and (3) claims where a process limitation is a "structural" part of the product (e.g. , a molded plastic). Failure to underst and such distinctions led this court

into debate at the ti me of Scripps Clinic , supra , and Atlantic Thermoplastics Co. v. Faytex Corp. , 970 F.2d 834 (Fed. Cir. 1992), a debate that rema ins of concern to practitioners and04-1522 5 courts, see notes 3 and 6 in the majority opinion. The panel majority, apparently itself misunderstanding the distinctions debated in thos e cases, both prolongs the confusion and misapplies the law to the facts of this case. This court has sharpened the principles of claim construction, in fulfilling its assignment to bring national uniformity to pat ent principles. Thus the court reaffirmed en banc in Phillips that claims are construed in light of the specificat ion, recognizing that the claims reflect the invention that is set forth in the specification. That is how we, our predecessor courts, and the Supreme Court, hav e always construed clai ms. For example, in Cochrane v. Badische Anilin & Soda Fabrik. , 111 U.S. 293 (1884), the Court explained

that claims to a new met hod of producing a known compound are limited to the new method, and do not cover the k nown compound however it is pr oduced. In the case of General Electric Co. v. Wabash Appliance Corp. , 304 U.S. 364, 373 (1938), the Court indicated that process limitati ons limit the claims to produc ts produced by those processes unless the product itself is pat entable, stating: "A lthough in some instances a claim may validly describe a new product with some referenc e to the method of production, a patentee who does not distinguish his product from what is old except by re ference, express or constructive, to the process by which he produced it, cannot secure a monopoly on the product by whatever means produced. " And in Merrill v. Yeomans , 94 U.S. 568 (1877), the Court explained that the principal consideration is whether the invention is the product itself, or the product made by a parti cular method. The Court recognized the diversity of situations in which product claims can c ontain process limitations, stating that: If the product is meant, the words "b y treating them substantially as hereinbefore described" are useless. They are not only useless, but embarrassing; for, by the well-settled ru les of construing all instruments,04-1522 6 some importance must be attached to them; and, if they are to be regarded at all, they must either refer to the process of making the oils for which the applicant is claiming a patent, or they are intended to limit his claim for a patent for the product to that product onl y, when produced by treating the oils in the manner before described.

Merrill , 94 U.S. at 571. These early cases nicely illustrate the fundamentals of modern-day claim construction in light of the spec ification; they are not a pronouncement that it is proper to ignore process limitations in product claims. To the contrary, all of these cases state the obverse of the panel majority's view. These long-standing rules of claim construction have had many iterations, such as summarized by our predecessor court in In re Luck , 476 F.2d 650, 653 (CCPA 1973), that "to the extent these process limitati ons distinguish the product over the prior art, they must be given t he same consideration as traditional product characteristics." That is, the pr ocess limitations cannot be ignored. While a patentee can choose how to claim his invention, the choice must be commensurate with the nature of t he invention. Perhaps this is where the court lost its focus in the debate on Scripps and Atlantic Thermoplastics . When correctly viewed, these two decisions are not in conflict; they simply deal with different situations, as I have previously advised. See Id. , 974 F.2d at 1282-84 (Newm an, Rich and Lourie, JJ., dissenting from the denial of rehearing en banc ). To the extent t hat these differences remain unclear, it is time for clarity. In Scripps the invention was a novel protein (the blood clotting factor VIII:C) of

unknown structure based on the sci ence as it then existed. Applying precedent, this court held that the product claims char acterized by the specific activity of the product were not limited to the method of production, and re manded for determination of infringement.04-1522 7 Although advances of science have diminished the reason for such claims, this recognition of the complexity of this important new scienc e filled a pragmatic need. I will not reprise the old debate. What is important, now that the issue is again befor e us, is that it be correctly

resolved. The district court held that the process limit ations in claims 1 and 2 do not limit the claims, such that the claims are simply dire cted to paroxetine, a known product, in the belief that Federal Circuit precedent so required. The court stat ed: "separated from the process limitations, claim 1 of the '944 Patent is a 'pharmaceutical composition in tablet form containing paroxetine,'" a produc t of the prior art, and held the claims invalid on the ground of anticipation. My colleagues repeat this error. The fundamentals of claim analysis require that all of the claim lim itations limit the claim. We have so held in myriad decisions. The panel majority's holding that a claim to a product is never limited by the process limitations in the claim is an extraordinarily mischievous holding, for there are thousands of patents with such claims. It is for the inventor, not the judge, to st ate what has been invented and to choose how to claim it. Our system of patents absorbs a glorious variet y of human ingenuity, and each year well over a hundred thousand patents are granted, each claiming a different invention, each including

claim limitations that the patentee is entitled to rely upon to distinguish the invention and avert "anticipation." Although my colleagues st ate that "[b]oth the district court and SmithKline misunderstand the natur e of anticipation," maj. op. at 5, I fear that the misunderstanding is on the part of others. The term "anticipation" in patent usage m eans that the invention was previously known to the public; that is, that it previously existed in t he precise form in which it is04-1522 8 claimed, including all of the limitations in the claim. It is not correct that, as a rule of claim construction, a claim that contains product and process limitations is free of the process limitations, whatever the nature of the invention. The dist rict court felt constrained to apply the holding in Scripps to the quite different facts of this case, a constraint for which this court must take responsibility by refusing to clarify the growing uncertainty. When the process limitations in a claim distinguish the invention as a whole from the prior art, when they are material to the invention as set forth by the inventor, the claim cannot be "anticipated" by prior art that does not have all of the limitations in the claim. Helifix Ltd. v. Blok-Lok, Ltd. , 208 F.3d 1339, 1346 (Fed. Cir . 2000) (anticipating reference must disclose "each and every limitation of the claimed invention"); Gener al Electric Co. v. Nintendo Co. , 179 F.3d 1350, 1356-57 (Fed. Cir. 1999) ("To antici pate a claim, a reference must disclose every element of the challenged claim and enable one skilled in the art to make the anticipating subject matter."). Applying the law correctly, the claims here at issue cannot be found on summary judgment to be anticipated.

II RULE 54(B) AND SUMMARY JUDGMENT The issue on this Rule 54(b) appeal of a summary judgment of anticipation related solely to the question of whether the process steps in the claims ar e limitations to the claims, for it is not disputed that if they are, the claims are not "anticipated." In such case, remand would be the next step, to consider other issues that were not part of the Rule 54(b) judgment. In their opi nion, my colleagues volunteer that various issues not04-1522 9 mentioned in the summary j udgment are deemed "waived," appar ently because they were not fully briefed and argued on this appeal. It is surely procedurally incorrect to r equire that issues not properly before us because not decided by the di strict court, must nonetheless be briefed and argued on appeal. According to the panel majority, when the appellant sticks to the issues on appeal he risks a waiver of the non-issues; and when he argues non-issues he risks a scolding. This appellant tried to satisfy both factions, and received both punishments. The reference to "pigs hunting for truffles buried in brie fs," maj. op. at 14, is misdirected.