555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`This case was not selected for publication in the
`Federal Reporter.
`
`Not for Publication in West's Federal Reporter. See
`Fed. Rule of Appellate Procedure 32.1 generally
`governing citation of judicial decisions issued on or
`after Jan. 1, 2007. See also Federal Circuit Rule
`32.1 and Federal Circuit Local Rule 32.1. (Find
`CTAF Rule 32.1)
`
`United States Court of Appeals,
`Federal Circuit.
`PFIZER INC., Warner–Lambert Company LLC,
`and C.P. Pharmaceuticals International C.V.,
`Plaintiffs–Appellees,
`and
`Northwestern University, Plaintiff–Appellee,
`v.
`TEVA PHARMACEUTICALS USA, INC. and
`Teva Pharmaceutical Industries, Ltd., Defend-
`ants–Appellants,
`and
`Lupin, Ltd. and Lupin Pharmaceuticals, Inc., De-
`fendants–Appellants,
`and
`Actavis, Inc. and Actavis Elizabeth, LLC, Defend-
`ants–Appellants,
`and
`Cobalt Laboratories, Inc. and Cobalt Pharmaceutic-
`als, Inc., Defendants–Appellants,
`and
`Sun Pharma Global, Inc., Sun Pharmaceutical In-
`dustries, Ltd., and Sun Pharmaceutical Industries,
`Inc., Defendants–Appellants,
`and
`Wockhardt Limited and Wockhardt USA, LLC, De-
`fendants–Appellants,
`and
`Alphapharm Pty. Ltd. and Mylan Pharmaceuticals,
`Inc., Defendants–Appellants.
`
`Nos. 2012–1576, 2012–1601, 2012–1602,
`2012–1603, 2012–1604, 2012–1605, 2012–1607.
`
`Page 1
`
`Feb. 6, 2014.
`
`Background: Owner and licensee of patents related
`to New Drug Application (NDA) for pregabalin
`capsules for adjunctive therapy of partial onset
`seizures and treatment of neuropathic pain associ-
`ated with diabetic peripheral neuropathy, posther-
`petic neuralgia, and fibromyalgia brought infringe-
`ment action against manufacturers of proposed
`pharmaceutical products. Cases were consolidated.
`The United States District Court for the District of
`Delaware, Gregory M. Sleet, Chief Judge, 882
`F.Supp.2d 643, found various claims of the asserted
`patents infringed, and that patents were not invalid.
`Manufacturers appealed.
`
`Holdings: The Court of Appeals, Prost, Circuit
`Judge, held that:
`(1) patent was not invalid for lack of enablement;
`(2) patent was not invalid for lack of written de-
`scription; and
`(3) patent was not invalid due to obviousness.
`
`Affirmed.
`
`West Headnotes
`
`[1] Patents 291
`
`99
`
`291 Patents
`291IV Applications and Proceedings Thereon
`291k99 k. Description of invention in spe-
`cification. Most Cited Cases
`Patent application's disclosure, coupled with
`methods for synthesis and resolution that were
`found to be well-known and routine in the art, suffi-
`ciently enabled person of skill in the art to prepare
`3–isobutylGABA with no more than routine experi-
`mentation, and thus patent related to New Drug Ap-
`plication (NDA) for pregabalin capsules for ad-
`junctive therapy of partial onset seizures and treat-
`ment of neuropathic pain associated with diabetic
`peripheral neuropathy, postherpetic neuralgia, and
`fibromyalgia was not invalid for lack of enable-
`ment. 35 U.S.C.A. § 112(a).
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
`Par v Novartis, IPR 2016-00084
`Page 1 of 11
`
`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`[2] Patents 291
`
`99
`
`291 Patents
`291IV Applications and Proceedings Thereon
`291k99 k. Description of invention in spe-
`cification. Most Cited Cases
`Patent related to New Drug Application (NDA)
`for pregabalin capsules for adjunctive therapy of
`partial onset seizures and treatment of neuropathic
`pain associated with diabetic peripheral neuropathy,
`postherpetic neuralgia, and fibromyalgia was not
`invalid for lack of written description; patent ap-
`plication disclosed structure of 3–isobutylGABA as
`preferred embodiment of invention, and set forth in
`vitro and in vivo data for compound, and described
`method of synthesizing compound. 35 U.S.C.A. §
`112(a).
`
`[3] Patents 291
`
`16.25
`
`291 Patents
`291II Patentability
`291II(A) Invention; Obviousness
`291k16.25 k. Chemical compounds. Most
`Cited Cases
`Patent related to New Drug Application (NDA)
`for pregabalin capsules for adjunctive therapy of
`partial onset seizures and treatment of neuropathic
`pain associated with diabetic peripheral neuropathy,
`postherpetic neuralgia, and fibromyalgia was not
`invalid due to obviousness; there was no evidence
`in the record of motivation for a skilled artisan to
`modify gabapentin for further anticonvulsant re-
`search based on prior art, there was nothing in prior
`art references singling out 3–isopropylGABA as
`promising compound to modify due to its anticon-
`vulsant effect, and references failed to identify lead
`compound because they disclosed nothing concrete
`about 3–isopropylGABA or its mechanisms of ac-
`tion, including whether it had anticonvulsive prop-
`erties. 35 U.S.C.A. § 103.
`
`Patents 291
`
`328(2)
`
`291 Patents
`291XIII Decisions on the Validity, Construction,
`
`Page 2
`
`and Infringement of Particular Patents
`291k328 Patents Enumerated
`291k328(2) k. Original utility. Most Cited
`
`Cases
`4,322,440, 5,051,448. Cited as Prior Art.
`
`Patents 291
`
`328(2)
`
`291 Patents
`291XIII Decisions on the Validity, Construction,
`and Infringement of Particular Patents
`291k328 Patents Enumerated
`291k328(2) k. Original utility. Most Cited
`
`Cases
`
`Patents 291
`
`328(4)
`
`291 Patents
`291XIII Decisions on the Validity, Construction,
`and Infringement of Particular Patents
`291k328 Patents Enumerated
`291k328(4) k. Reissue. Most Cited Cases
`5,563,175, 6,001,876. Cited.
`
`41,920. Cited.
`
`Patents 291
`
`328(2)
`
`291 Patents
`291XIII Decisions on the Validity, Construction,
`and Infringement of Particular Patents
`291k328 Patents Enumerated
`291k328(2) k. Original utility. Most Cited
`
`Cases
`6,197,819. Construed and Ruled Valid and In-
`fringed.
`
`*962 Appeals from the United States District Court
`for the District of Delaware in Nos. 09–CV–0307,
`09–CV–0308,
`09–CV–0309,
`09–CV–0310,
`03–CV–0311,
`09–CV–0312,
`09–CV–0313,
`09–CV–0315
`and
`10–CV–0853, Chief
`Judge
`Gregory M. Sleet.Dimitrios T. Drivas, White &
`Case LLP, of New York, NY, argued for plaintiffs-
`appellees Pfizer Inc., et al. With him on the brief
`were Jeffrey J. Oelke, Adam Gahtan, Brendan G.
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
`Par v Novartis, IPR 2016-00084
`Page 2 of 11
`
`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`Woodard, Robert E. Counihan, and Ryan P. John-
`son, for plaintiffs-appellees, Pfizer Inc., et al. Of
`counsel on the brief were Kevin M. Flowers, Mat-
`thew C. Nielsen and Mark H. Izraelewicz, Mar-
`shall, Gerstein & Borun, LLP, of Chicago, IL, for
`plaintiff-appellee Northwestern University.
`
`James F. Hurst, Winston & Strawn, LLP, of Chica-
`go,
`IL,
`argued for defendants-appellants Sun
`Pharma Global, Inc., et al. of counsel was Geoffrey
`P. Eaton, of Washington, DC.
`
`Timothy H. Kratz, McGuireWoods LLP, of Atlanta,
`GA, argued for defendants-appellants Alphapharm
`Pty. Ltd., et al. With him on the brief were Robert
`L. Florence and George J. Barry, III. With him on
`the brief for defendants-appellants Cobalt Laborat-
`ories, Inc., et al. were E. Anthony Figg, Joseph A.
`Hynds, R. Elizabeth Brenner–Leifer and Christina
`Nichole Gifford, Rothwell, Figg, Ernst & Manbeck,
`P.C., of Washington, DC; for defendants-appellants
`Actavis, Inc., et al. were Francis H. Morrison, III,
`and Jonathan A. Harris, Axinn, Veltrop &
`Harkrider LLP, of Hartford, CT; for defendants-ap-
`pellants, Teva Pharmaceuticals USA, Inc., et al.
`were James Galbraith, Antony Pfeffer, Matthew C.
`Ruedy, and *963 Linnea P. Cipriano, Kenyon &
`Kenyon, LLP, of New York, NY; for defendants-ap-
`pellants Lupin Ltd., et al. were Robert F. Green,
`Caryn C. Borg–Breen, Christopher T. Griffith,
`Elizabeth M. Crompton, Leydig, Voit & Mayer
`Ltd., of Chicago,
`IL;
`for defendants-appellants
`Wockhardt Limited, et al. were Joseph M. Reisman,
`Jay R. Deshmukh, and Thomas P. Krzeminski,
`Knobbe, Martens, Olson & Bear, LLP, of San
`Diego, CA.
`
`Before RADER, Chief Judge, PROST and MOORE
`, Circuit Judges.
`
`PROST, Circuit Judge.
`Defendants–Appellants Teva Pharmaceuticals
`USA, Inc.; Teva Pharmaceutical Industries, Ltd.;
`Lupin, Ltd.; Lupin Pharmaceuticals, Inc.; Actavis,
`
`Page 3
`
`Inc.; Actavis Elizabeth, LLC; Cobalt Laboratories,
`Inc.; Cobalt Pharmaceuticals,
`Inc.; Sun Pharma
`Global, Inc.; Sun Pharmaceutical Industries, Ltd.;
`Sun Pharmaceutical
`Industries,
`Inc.; Wockhardt
`Ltd.; Wockhardt USA, LLC; Alphapharm Pty. Ltd.;
`and Mylan Pharmaceuticals,
`Inc.
`(collectively,
`“Appellants”) appeal from a final judgment of the
`United States District Court for the District of
`Delaware that found various claims of the asserted
`patents FN1 infringed and from the court's holdings
`regarding enablement,FN2 written description,FN3
`and obviousness. Pfizer Inc. v. Teva Pharm. USA,
`Inc., 882 F.Supp.2d 643, 732 (D.Del.2012) ( “ Dis-
`trict Court Opinion ”).
`
`FN1. The asserted patents are: U.S. Patent
`Nos. 6,197, 819 (“'819 patent”); 5,563,175
`(“'175 patent”); 6,001,876 (“'876 patent”);
`and U.S. Reissue Patent No. 41,920 (“RE
`'920 patent”), which is a reissue of the '876
`patent.
`
`FN2. Defendants–Appellants Sun Pharma
`Global, Inc.; Sun Pharmaceutical Indus-
`tries, Ltd.; and Sun Pharmaceutical Indus-
`tries, Inc. (collectively, “Sun”) do not join
`the other Appellants in challenging the dis-
`trict court's enablement determination.
`
`FN3. Sun, alone among the Appellants, as-
`serted a written description invalidity de-
`fense below and now challenges the dis-
`trict court's finding on appeal.
`
`Because we agree with the district court's claim
`construction, we affirm the finding of infringement.
`We also hold that challenged claim 2 of the '819
`patent is not invalid for lack of enablement, insuffi-
`cient written description, or obviousness. Accord-
`ingly, we affirm the judgment of the district court.
`
`BACKGROUND
`Plaintiffs–Appellees Pfizer Inc., CP Pharma-
`ceuticals
`International C.V., Warner–Lambert
`Company LLC,
`and Northwestern University
`(collectively, “Appellees”) sued each of the Appel-
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
`Par v Novartis, IPR 2016-00084
`Page 3 of 11
`
`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`lants under 35 U.S.C. § 271(e)(2)(A) after they sub-
`mitted Abbreviated New Drug Applications
`(“ANDAs”) to the U.S. Food and Drug Administra-
`tion (“FDA”) seeking approval to market a generic
`version of Lyrica®, a prescription drug for treating
`seizures and certain types of pain. Although Ap-
`pellees asserted four patents against Appellants be-
`low, only two patents, the '819 and the RE '920 pat-
`ent, are relevant on appeal. Due to its claim scope
`and the breadth of the injunction entered, the dis-
`position of this appeal rests entirely on a single
`claim: claim 2 of the ' 819 patent.FN4
`
`FN4. Prior to the bench trial, the parties
`stipulated that,
`to the extent
`the district
`court finds claim 2 to be valid and enforce-
`able,
`the Appellants' respective ANDAs
`are covered by the claim under the court's
`claim construction
`and
`the
`proposed
`products infringe. District Court Opinion,
`at 662–63. Likewise, on appeal, the parties
`agree that Appellants' entire case is predic-
`ated upon claim 2, i.e., the other issues are
`moot and Appellants lose the appeal if we
`affirm the district court's findings with re-
`spect
`to claim 2. Oral Argument
`at
`2:41–4:24, 16:50–17:09 available at http://
`oralarguments. cafc. uscourts. gov/ default.
`aspx? fl =2012–1576.mp3. Accordingly,
`we limit our review of the district court's
`findings and determinations to claim 2.
`
`*964 The broadest
`in scope of the asserted
`2
`recites:
`claims,
`claim
`“4–amino3–(2–methylpropyl) butanoic acid, or a
`pharmaceutically acceptable salt thereof.” '819 pat-
`ent col. 27 ll. 32–33. The district court construed
`the term “4–amino3–(2–methylpropyl) butanoic
`acid” FN5 to mean “the chemical compound
`4–amino–3–(2–methylpropyl)
`butanoic
`acid,”
`without limitation as to stereochemical form.FN6
`Inc., No.
`Pfizer
`Inc.
`v. Teva Pharm. USA,
`09–CV–307 (D.Del. Oct. 13, 2010), ECF No. 100
`(“Markman Order ”).
`
`FN5.
`
`4–amino–3–(2–methylpropyl)
`
`Page 4
`
`butanoic acid is also known in the chemic-
`al nomenclature as 3–isobutylGABA.
`
`FN6. Stereochemical form refers to the
`three-dimensional structure of molecules.
`In organic chemistry, stereoisomers are
`compounds with the same molecular for-
`mula or atomic composition, but different
`spatial arrangements. Enantiomers are a
`pair
`of
`stereoisomers
`that
`are
`non-
`superimposable mirror images of each oth-
`er and often have distinct physical proper-
`ties. Enantiomeric pairs
`include
`com-
`pounds that have one or more stereogenic
`centers, i.e., carbon atoms with four non-
`identical substituent atoms or groups of
`atoms. These compounds are thus said to
`be chiral.
`
`To distinguish between different enan-
`tiomers of the same compound, chemists
`use various naming conventions. Enan-
`tiomers are called optical
`isomers be-
`cause they rotate plane-polarized light in
`a particular direction. If the light rotates
`clockwise,
`then
`that
`enantiomer
`is
`labeled (+); its counterpart will rotate the
`light counter-clockwise and is labeled
`(-). A different nomenclature labels each
`stereogenic center (R) or (S) according
`to a set of scientific rules. A racemate
`(or racemic mixture) is an equal mixture
`of two enantiomers and therefore is not
`optically active (i.e., will not
`rotate
`plane-polarized light in either direction
`because
`its
`constituent
`enantiomeric
`pairs cancel one another out). Racemates
`are typically designated (R, S) because
`they
`are
`comprised
`of
`both R-
`enantiomers and S-enantiomers.
`
`Pregabalin, the active ingredient in Lyrica®, is
`the Senantiomer of 3–isobutylGABA.FN7 It is spe-
`cifically disclosed by claim 1 of the '819 patent as
`“[a]
`compound
`of
`the
`formula
`S–(+)–4–amino–3–(2–methypropyl) butanoic acid
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
`Par v Novartis, IPR 2016-00084
`Page 4 of 11
`
`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`as a single optical isomer.” '819 patent col. 27 ll.
`29–31. The district court construed the claim to
`mean “4–amino3–(2–methylpropyl) butanoic acid
`in the single S-(+) isomer form only, free of the R-
`(-) isomer form.” Markman Order, at 1.
`
`FN7. In pharmacology, often only one en-
`antiomer of a chemical compound is re-
`sponsible for certain desired therapeutic ef-
`fects, while the other enantiomer is less ef-
`fective or inactive. This well-known phe-
`nomenon is attributable to the distinct
`physical structures of enantiomers. With
`respect
`to 3–isobutylGABA,
`the Senan-
`tiomer is the pharmaceutically useful ste-
`reoisomer for the treatment of seizures and
`pain, while the R-enantiomer is less potent.
`
`consolidated
`in the
`a bench trial
`After
`Hatch–Waxman action, the district court held, inter
`alia, that claim 2 is not invalid for lack of enable-
`ment, insufficient written description, or obvious-
`ness. District Court Opinion, at 732. Because the
`Appellants stipulated to infringement,
`the court
`thereafter enjoined them from commercially manu-
`facturing, using, offering for sale, or selling their
`proposed products prior to December 30, 2018—the
`expiration date of the '819 patent after the FDA's
`extension of its term under 35 U.S.C. § 156. See id.
`at 656, 730, 732.
`
`This appeal followed. We have jurisdiction un-
`der 28 U.S.C. § 1295(a)(1).
`
`DISCUSSION
`I. CLAIM CONSTRUCTION AND INFRINGE-
`MENT
`Claim construction is an issue of law that we
`review de novo. *965Cybor Corp. v. FAS Techs.,
`Inc., 138 F.3d 1448, 1454–55 (Fed.Cir.1998) (en
`banc). In construing a claim term, we look at the
`term's plain and ordinary meaning as understood by
`a person of ordinary skill in the art. Phillips v. AWH
`Corp., 415 F.3d 1303, 1313 (Fed.Cir.2005) (en
`banc). There are two exceptions to this general rule:
`(1) when a patentee sets out a definition and acts as
`
`Page 5
`
`her own lexicographer, or (2) when the patentee
`disavows the full scope of a claim term either in the
`specification or during prosecution. Thorner v.
`Sony Computer Entm't Am., LLC, 669 F.3d 1362,
`1365 (Fed.Cir.2012). The subsequent infringement
`analysis is reviewed for clear error after a bench tri-
`al. Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286,
`1289 (Fed.Cir.2006).
`
`Appellants argue that the district court erred in
`construing claim 2 of the ' 819 patent
`to cover
`3–isobutylGABA generally. They contend that the
`proper construction of claim 2 is that it covers only
`racemic (i.e., a 50:50 mixture of S- and R-
`enantiomers of) 3–isobutylGABA. Appellants con-
`tend that the patent specification, prosecution his-
`tory, and applicant declarations submitted to the
`U.S. Patent and Trademark Office (“PTO”) support
`a narrower construction of the claimed compound
`as a racemic mixture. Finally, they argue that be-
`cause their proposed products contain non-racemic
`mixtures, they do not infringe.
`
`Appellees counter that a narrower construction
`would ignore the plain, clear, and specific language
`of the claim, which places no limitation on the
`claimed chiral compound. Appellees submit that the
`patentee's inclusion of test results of the com-
`pound's racemate in the specification, juxtaposed
`with the lack of a racemic limitation in the claim
`language, demonstrates the patentee's intent not to
`limit the compound being claimed to its racemate.
`Appellees also point out that at trial, Appellants'
`own
`expert
`admitted
`that
`claim 2
`covers
`“3–isobutylGABA in any isomeric form,” that is,
`“the form is not defined.” J.A. 20658.
`
`We perceive no error in the district court's con-
`struction. The plain language of the claim does not
`include the narrowing limitation that the Appellants
`desire.
`The
`patent
`specification
`discusses
`4–amino–3–(2–methylpropyl) butanoic acid as the
`“preferred compound” generally and without regard
`to its stereochemistry. See, e.g., '819 patent col. 3 ll.
`65–67. The specification makes clear that the pat-
`entee
`expressly
`used
`the word
`“racemate,”
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
`Par v Novartis, IPR 2016-00084
`Page 5 of 11
`
`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`“racemic,” or its standard prefix (R, S) to refer to
`the chiral compound's racemate. See, e.g., '819 pat-
`ent col. 7 l. 39, col. 9 l. 25, col. 13 l. 23. Likewise,
`the patentee used standard prefixes (R) or (S) to
`designate a particular enantiomer of the compound.
`See, e.g., '819 patent col. 4 ll. 7–15, col. 5 ll. 34–40,
`col. 7 l. 39, col. 13 l. 24. Because the patentee in-
`cluded no such references or prefixes in claim 2, it
`should not be so limited.
`
`Appellants also note that Tables 1 and 2 in the
`specification report test results pertaining only to
`the compound's racemate, but not other mixtures
`with differing enantiomeric compositions. See '819
`patent tables 1, 2. Appellants contend that this lim-
`ited association of the subject matter of claim 2
`with only racemic 3–isobutylGABA warrants a nar-
`rower construction. We disagree. Absent a clear
`disavowal or lexicographic definition in the spe-
`cification or the prosecution history, the reporting
`of test results limited to a racemate does not war-
`rant importing a racemic limitation into claim 2.
`Moreover, rather than listing 3–isobutylGABA in
`Tables 1 and 2 without specifying its form, the pat-
`entee used the prefix (R, S) to specify that the com-
`pound being tested was a racemic mixture. Contrary
`to Appellants' suggestion, the patentee's use of the
`prefix in the tables demonstrates*966 that it knew
`how to specify racemic 3–isobutylGABA as distin-
`guished from the compound generally and chose
`not to do so in claim 2.
`
`Indeed, the district court correctly observed in
`its claim construction order that “when the patentee
`identified the racemate in the specification, it used
`a prefix (R, S) that does not appear in the disputed
`claim.” Markman Order, at 1 n. 2. The court also
`correctly noted that the prosecution history cited to
`by the Appellants also “does not evince a disclaim-
`er of non-racemic forms,” id., to warrant departure
`from the general rules of claim construction. There
`is no basis elsewhere in the intrinsic record to sup-
`port Appellants' suggestion that the absence of an
`(R) or (S) prefix in claim 2 specifically signals the
`racemate, rather than the compound without limita-
`
`Page 6
`
`tion as to stereochemical form or composition. Ac-
`cordingly, we affirm the district court's construc-
`tion.
`
`Because claim 2 was correctly construed to in-
`clude 3–isobutylGABA regardless of its enantio-
`meric forms and infringement was stipulated to by
`the Appellants under this construction, we also af-
`firm the finding of infringement.
`
`II. ENABLEMENT
`Enablement is a question of law that we review
`without deference, based on underlying factual in-
`quiries that we review for clear error after a bench
`trial. Cephalon, Inc. v. Watson Pharm., Inc., 707
`F.3d 1330, 1336 (Fed.Cir.2013). To be enabling un-
`der 35 U.S.C. § 112(a), a patent's specification must
`describe the invention and the manner and process
`of making and using it, in such full, clear, concise,
`and exact terms, as to allow any person skilled in
`the art “to make and use the full scope of the
`claimed invention without undue experimentation.”
`MagSil Corp. v. Hitachi Global Storage Techs.,
`Inc., 687 F.3d 1377, 1380 (Fed.Cir.2012) (internal
`quotation marks omitted).
`
`[1] The '819 patent, issued on March 6, 2001,
`claims priority to U.S. Patent Application Serial
`No. 07/618,692 (“'692 application”), which was
`filed on November 27, 1990. '819 patent col. 1 ll.
`6–12. The district court held that, based on its con-
`struction, claim 2 is sufficiently enabled by the '692
`application because “a person of skill in the art
`could have relied upon [the] application's disclosure
`to prepare 3–isobutylGABA ... [with] no more than
`routine experimentation.” District Court Opinion,
`at 655.
`Appellants FN8 contend that because claim 2
`construed to cover
`all
`compositions of
`was
`3–isobutylGABA, without limitation as to isomeric
`form, to be sufficiently enabling the '692 applica-
`tion must teach a skilled artisan how to prepare
`every conceivable mixture of 3–isobutylGABA's
`enantiomers. Although the parent application ac-
`knowledges that hundreds of permutations of non-
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
`Par v Novartis, IPR 2016-00084
`Page 6 of 11
`
`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`racemic mixtures of 3–isobutylGABA exist, see
`J.A. 3010–13, Appellants assert that it fails to dis-
`close how to prepare them. Appellants also contend
`that
`the '692 application provides nothing more
`than boilerplate language pointing to unspecified
`prior art as the basis for making the claimed inven-
`tion, and fails to disclose the required starting ma-
`terials, reaction conditions, and other working ex-
`amples.
`
`FN8. Reference to Appellants in this sec-
`tion does not include Sun, who does not
`join the other Appellants in challenging the
`district court's enablement determination.
`
`We are not persuaded by Appellants' argu-
`ments. First, there is no requirement that a specific-
`ation must “disclose what
`is routine and well
`known in the art.” *967Genentech, Inc. v. Novo
`Nordisk A/S, 108 F.3d 1361, 1366 (Fed.Cir.1997).
`Second, as the district court found, there is no dis-
`pute in the record that the co-inventors of the '819
`patent were the first to create and claim the chemic-
`al compound 3–isobutylGABA. District Court
`Opinion, at 689. It is also undisputed that the parent
`application discloses the method for synthesizing
`the compound and states that
`the compound's
`“enantiomers may be prepared or isolated by meth-
`ods already well known in the art.” J.A. 3012–14.
`The district court found support for this fact in the
`prior art, the prosecution history, and witnesses' tri-
`al
`testimonies. See District Court Opinion, at
`683–87;
`see also J.A. 3012–14, 21196–203,
`21168–69, 21172–80, 20622–24, 21205–06. The
`court also acknowledged that the same conclusion
`was reached by the PTO Examiner, who withdrew
`an enablement rejection on that very basis during
`prosecution of the patent. District Court Opinion, at
`689 n. 41.
`
`In view of the finding that enantiomer separa-
`tion methods are well-known and routine to a per-
`son of ordinary skill, we agree with the district
`court
`that
`the inventors were not
`required to
`provide a detailed recipe for preparing every con-
`ceivable permutation of the compound they inven-
`
`Page 7
`
`ted to be entitled to a claim covering that com-
`pound. Where a claim has been construed to cover a
`chemical compound, the specification is not defi-
`cient merely because it does not disclose how to
`prepare a particular form or mixture—among hun-
`dreds of possible permutations—of that compound.
`See In re Hogan, 559 F.2d 595, 606 (CCPA 1977)
`(noting that
`requiring such specific disclosures
`would “impose an impossible burden on invent-
`ors”).
`
`Instead, claim 2 satisfies the requirements un-
`der § 112(a) because the '692 application's disclos-
`ure, coupled with the methods for synthesis and res-
`olution that were found to be well-known and
`routine in the art, is sufficiently enabling. The dis-
`trict court's legal determination of enablement was
`not incorrect. Its factual findings are not clearly er-
`roneous. We therefore affirm the determination that
`claim 2 is not invalid for lack of enablement.
`
`III. WRITTEN DESCRIPTION
`Compliance with the written description re-
`quirement is a question of fact reviewed for clear
`error following a bench trial. Lampi Corp. v. Am.
`Power Prods., 228 F.3d 1365, 1378 (Fed.Cir.2000).
`A party alleging that a patent is invalid for lack of
`written description has the burden of establishing
`by clear and convincing evidence that a patent dis-
`closure does not reasonably convey to a skilled ar-
`tisan that
`the inventor was in possession of the
`claimed invention at the time of the patent applica-
`tion. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598
`F.3d 1336, 1351 (Fed.Cir.2010) (en banc).
`
`[2] The district court found claim 2 of the '819
`patent not invalid for lack of written description.
`The court found the '692 application to have ex-
`pressly claimed 3–isobutylGABA in both racemic
`and non-racemic mixtures, and detailed the invent-
`or's method for synthesizing the compound. District
`Court Opinion, at 702. The court also found the
`parent application to have included seven claims
`specifically directed to the compound or its use in
`pharmaceutical compositions or methods of treat-
`ment, as well as repeatedly identified it as the pre-
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
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`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`ferred embodiment of the invention. Id. The court
`noted the testimony of the other Appellants' enable-
`ment expert in which he admitted that “chemists
`would understand what the disclosure” in the '692
`application meant, id., as well as Sun's dearth of
`evidence at trial, before concluding that the applica-
`tion's descriptions*968 were more than sufficient to
`meet the written description standard. Id.
`
`Sun alone presses a written description argu-
`ment on appeal. First, Sun argues that although the
`'692 application discloses a chemical synthesis
`method for the racemate of 3–isobutylGABA, see
`J.A. 21263–64, 20768, it discloses nothing towards
`the isolation of the enantiomers, even though claim
`2 of the '819 patent has been construed to encom-
`pass all forms of the compound. Second, according
`to Sun, despite the patentee describing the separa-
`tion of the racemate (i.e., isolation of the enan-
`tiomers) as anything but routine in later applica-
`tions, at the time of the '692 application, both in-
`ventors readily admitted that they had not yet separ-
`ated the racemic mixture to obtain a purified enan-
`tiomer. See J.A. 20814–18. Taken together, Sun
`contends,
`these facts establish that
`the inventors
`had not actually invented 3–isobutylGABA in all of
`its forms in 1990.
`
`Sun's position on written description is surpris-
`ingly similar to the other Appellants' position on
`enablement. Sun conflates the disclosure require-
`ment for claim 2 with that for claim 1: it argues that
`because the inventors had not sufficiently described
`the narrower claim 1 (to pre-bagalin) they could not
`have sufficiently described the broader claim 2 (to
`3–isobutylGABA).
`
`But written description does not require invent-
`ors, at the time of their application for a patent, to
`reduce to practice and be in physical possession of
`every
`species
`(e.g.,
`the
`S-enantiomer
`of
`3–isobutylGABA) of a genus (3–isobutylGABA)
`claim. For claims to a chemical compound, an ap-
`plication satisfies the written description require-
`ment when it details “relevant identifying charac-
`teristics” such that
`the compound can be distin-
`
`Page 8
`
`guished from other compounds. In re Wallach, 378
`F.3d 1330, 1333, 1335 (Fed.Cir.2004). Here, the
`'692 application not only disclosed the structure of
`3–isobutylGABA as the preferred embodiment of
`the invention, see J.A. 3018–19, 20764:11–14,
`3011, but also set forth in vitro and in vivo data for
`the compound, J.A. 3025–29, 20766:19–21, and de-
`scribed a method of synthesizing the compound,
`J.A. 3012–14, 20900. As the district court correctly
`found, such a description is sufficient for persons of
`ordinary skill in the art to recognize that the invent-
`or invented what is claimed. Union Oil Co. of Cal.
`208 F.3d
`989,
`997
`v. Atl. Richfield Co.,
`(Fed.Cir.2000)
`
`We therefore affirm the finding that the '692
`application provided an adequate written descrip-
`tion for claim 2 under § 112(a).
`
`IV. OBVIOUSNESS
`The determination of obviousness is a legal
`conclusion based on underlying facts. Allergan, Inc.
`726
`F.3d
`1286,
`1290–91
`v.
`Sandoz
`Inc.,
`(Fed.Cir.2013). After a bench trial, we review the
`district court's factual findings for clear error and
`its conclusions of law de novo. Honeywell Int'l, Inc.
`609
`F.3d
`1292,
`1297
`v. United
`States,
`(Fed.Cir.2010). A patent claim is invalid for obvi-
`ousness if “the differences between the claimed in-
`vention and the prior art are such that the claimed
`invention as a whole would have been obvious be-
`fore the effective filing date of the claimed inven-
`tion to a person having ordinary skill in the art to
`which the claimed invention pertains.” 35 U.S.C. §
`103. The “underlying factual considerations in an
`obviousness analysis include the scope and content
`of the prior art, the differences between the prior art
`and the claimed invention, the level of ordinary
`skill in the art, and any relevant secondary consid-
`erations [,]” which include “commercial success,
`long-felt but unsolved needs, failure of others, and
`unexpected results.” Allergan, 726 F.3d at 1290–91
`(citations omitted). Patent*969 invalidity must be
`established by clear and convincing evidence. Mi-
`crosoft Corp. v. i4i Ltd. P'ship, ––– U.S. ––––, 131
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`NOVARTIS EXHIBIT 2079
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`

`
`555 Fed.Appx. 961, 109 U.S.P.Q.2d 1652
`(Cite as: 555 Fed.Appx. 961)
`
`S.Ct. 2238, 2242, 180 L.Ed.2d 131 (2011).
`
`[3] The district court concluded that the evid-
`ence presented by Appellants at trial was insuffi-
`cient to render claim 2 invalid under § 103. The
`district court held that claim 2 would not have been
`obvious in view of the three prior art references
`cited by Appellants: U.S. Patent No. 4,322,440
`(“Fish”), U.S. Patent No. 5,051,448 (“Shashoua”),
`and a 1962 article published at pages 598 through
`603 in the Bulletin de la Société Chimique de
`France (“Colonge”). It found that these references
`did
`not
`teach
`skilled
`artisans
`to
`select
`3–isobutylGABA for
`its anticonvulsant activity.
`District Court Opinion, at 667. Specifically,
`the
`court
`found that Appellants provided neither
`“information detailing what [chemical] structures
`were
`important
`for
`anticonvulsant
`activity
`[research]
`in 1990” nor “teachings
`from the
`Colonge, Fish, and Shashoua references, which, in-
`dividually or combined, would have directed one
`skilled in the art” to arrive at the claimed invention,
`to substitute alkyl groups FN9 at GABA's
`i.e.,
`3–position.FN10 Id. The court also determined that
`various secondary considerations—namely, unex-
`pected results, long felt but unmet need, commer-
`cial success, and industry recognition—strongly
`supported the conclusion of nonobviousness. Id. at
`667–72.
`
`FN9. An alkyl group is a carbon chain of
`varying length and orientation. Isobutyl is
`a four-carbon alkyl group with a specific
`carbon configuration. There are potentially
`infinite alkyl groups.
`
`“gamma
`for
`FN10. GABA stands
`aminobutyric acid,” which is a neurotrans-
`mitter that can cause seizures when its
`levels in the brain are abnormally low.
`GAB