Ex. 2002
`
`EX. 2002
`
`Pozen Inc. v. Par Pharm., Inc.,
`Pozen Inc. v. Par Pharm., Inc.,
`696 F.3d 1151 (Fed. Cir. 2012)
`696 F.3d 1151 (Fed. Cir. 2012)
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 696 F.3d 1151 (Fed. Cir. 2012)
`
`1151
`
`position of the sensor control unit.’’ In-
`stead, the dispute between the parties lies
`in whether ‘‘some movement’’ includes the
`degree of movement in the Shichiri I sys-
`tem such that the sensor need only be
`‘‘somewhat restrained.’’ We conclude that
`it does not.
`The external wires of the Shichiri I sen-
`sor are only ‘‘somewhat restrained’’ be-
`cause they are tethered to a watch-shaped
`assembly and therefore only restrained by
`human arm or wrist movement. This de-
`gree of arm and wrist movement is not
`only significantly greater than the move-
`ment allowable under the Board’s original
`construction of ‘‘substantially fixed,’’ it is
`also greater than the movement described
`in the specification. Indeed, the embodi-
`ments disclosed in the 8509 patent all show
`the above-skin portion of the electrochemi-
`cal sensor maintained in a fixed position.
`Specifically, the specification teaches a
`‘‘support structure 82’’ that ‘‘hold[s], sup-
`port[s], and/or guide[s] the sensor 42 into
`the correct position.’’ 8509 patent col.34
`ll.54–55. While the Board’s original con-
`struction is reasonable in view of the speci-
`fication, the Board’s modified construction
`requiring only a ‘‘somewhat restrained’’
`sensor is not. On remand, the Board
`should apply its original construction of
`‘‘substantially fixed.’’
`
`C. Official Notice
`During reexamination of the 8752 patent,
`the examiner invoked the doctrine of offi-
`cial notice in combination with other pri-
`mary references to reject 157 newly added
`independent and dependent claims. The
`Board affirmed, and now nineteen of these
`official notice-rejection claims are before
`this court on appeal.3 The PTO, however,
`now agrees with Abbott that the examin-
`er’s official notice rejection of these nine-
`teen claims should be remanded and with-
`
`drawn. Therefore, we vacate the Board’s
`rejection of these nineteen claims and re-
`mand to the Board for appropriate further
`proceedings.
`
`III. CONCLUSION
`‘‘electro-
`The Board’s construction of
`chemical sensor’’ and its modified con-
`struction of ‘‘substantially fixed’’ are un-
`reasonable and
`inconsistent with
`the
`specification.
` We therefore vacate the
`Board’s decisions as to the patentability
`of Abbott’s independent claims at issue
`and remand for the Board to apply the
`correct claim constructions. We also va-
`cate the Board’s official notice rejection
`of the nineteen claims before us and re-
`mand to the Board for appropriate fur-
`ther proceedings.
`VACATED–IN–PART
`MANDED.
`
`AND
`
`RE-
`
`,
`
`
`
`
`
`POZEN INC., Plaintiff–Appellee,
`v.
`PAR PHARMACEUTICAL, INC.,
`Defendant–Appellant,
`and
`Dr. Reddy’s Laboratories, Inc.,
`Defendant–Appellant,
`and
`Alphapharm Pty Ltd., Defendant–
`Appellant.
`Nos. 2011–1584, 2011–1585, 2011–1586.
`United States Court of Appeals,
`Federal Circuit.
`Sept. 28, 2012.
`Background: Patentee brought infringe-
`ment action against competitors for in-
`
`3. These include claims 96, 98, 107, 125, 127,
`139, 157, 159, 168, 186, 188, 196, 214, 216,
`
`225, 244, 247–248, and 251 of the 8752 pat-
`ent.
`
`

`
`1152
`
`696 FEDERAL REPORTER, 3d SERIES
`
`fringement of patents relating to a method
`for treating migraines by combining two
`drugs in a single tablet, seeking a perma-
`nent injunction against competitors from
`making, using, selling, offering to sell, or
`importing into the United States accused
`Abbreviated New Drug Application
`(ANDA) products. Following claim con-
`struction, 719 F.Supp.2d 718, the United
`States District Court for the Eastern Dis-
`trict of Texas, Leonard Davis, J., 800
`F.Supp.2d 789, entered judgment in favor
`of patentee, and enjoined competitors.
`Competitors appealed.
`Holdings: The Court of Appeals, Wallach,
`Circuit Judge, held that:
`(1) prior art references did not render pat-
`ents invalid for obviousness;
`(2) district court did not clearly err in
`determining one of the patents satis-
`fied the written description require-
`ment; and
`(3) district court did not clearly err in
`concluding that accused products in-
`fringed one of the patents under doc-
`trine of equivalents.
`Affirmed.
`Clevenger, Circuit Judge, filed an opinion
`dissenting in part.
`
`1. Federal Courts O13
` Patents O249.1
`Patent law provision providing that it
`is an act of infringement to submit an
`application for approval from the Food and
`Drug Administration (FDA) to manufac-
`ture a drug claimed in a patent creates
`case-or-controversy jurisdiction to enable
`the resolution of an infringement dispute
`before the Abbreviated New Drug Applica-
`tion (ANDA) applicant has actually made
`or marketed the proposed product; the
`determination under the provision is the
`same as any other infringement suit to
`inquire whether a product would infringe a
`
`patent if the ANDA product was on the
`market. U.S.C.A. Const. Art. 3, § 2, cl. 1;
`35 U.S.C.A. § 271(e)(2)(A).
`
`2. Federal Courts O758, 850.1
`Court of appeals reviews judgments of
`the district court after a bench trial for
`errors of law and clearly erroneous find-
`ings of fact.
`
`3. Patents O16(2, 3), 36.1(4), 36.2(1)
`To determine if a patent is obvious a
`district court looks to: (1) the scope and
`content of the prior art; (2) differences
`between the prior art and the claims; (3)
`the level of ordinary skill in the art; and
`(4) secondary considerations such as com-
`mercial success and failure of others. 35
`U.S.C.A. § 103(a).
`
`4. Patents O324.5, 324.55(4)
`Obviousness under patent law is a
`question of law, reviewed de novo, based
`upon underlying factual questions which
`are reviewed for clear error following a
`bench trial. 35 U.S.C.A. § 103(a).
`
`5. Patents O101(11)
`Term ‘‘unit dose,’’ in patents relating
`to a method for treating migraines by
`combining two drugs in a single tablet,
`construed as a single drug administration
`entity, necessarily limited the term ‘‘con-
`comitant administration’’ to mean simulta-
`neous administration, because a single
`drug administration entity could not have
`been administered in any other fashion.
`
`6. Patents O36(3)
`There was not clear and convincing
`evidence that patents relating to a method
`for treating migraines by combining two
`drugs in a single tablet were obvious over
`prior art epidemiological survey assessing
`various migraine treatments, so as to ren-
`der the patents invalid; the prior art refer-
`ence revealed the types of treatments used
`and documented the number of unsatisfac-
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 696 F.3d 1151 (Fed. Cir. 2012)
`
`1153
`
`tory results of monotherapy treatment, but
`it did not indicate the relative successes of
`various
`combination
`treatments.
` 35
`U.S.C.A. § 103(a).
`
`7. Courts O96(7)
`Federal Circuit Court of Appeals re-
`views evidentiary determinations under
`the law of the regional circuit.
`
`8. Federal Courts O823
`Fifth Circuit reviews decisions to ad-
`mit or exclude evidence for abuse of dis-
`cretion.
`
`9. Evidence O314(1)
`Under Fifth Circuit law, the residual
`hearsay exception is to be used only rare-
`ly, in truly exceptional cases. Fed.Rules
`Evid.Rule 807, 28 U.S.C.A.
`
`10. Evidence O314(1)
`Under Fifth Circuit law, to admit evi-
`dence under the residual hearsay rule,
`there must be at least circumstantial guar-
`antees of
`trustworthiness.
` Fed.Rules
`Evid.Rule 807, 28 U.S.C.A.
`
`11. Patents O16.25
`Prior art migraine therapy report dis-
`closing the simultaneous delivery of sever-
`al components, including ergotamine, me-
`toclopramide, and naproxen, did not make
`it obvious to substitute sumatriptan for
`ergotamine and remove metoclopramide
`and caffeine as unnecessary, so as to ren-
`der invalid patents relating to a method
`for treating migraines by combining two
`drugs in a single tablet; the prior art refer-
`ence disclosed each drug as having a spe-
`cific purpose, and even though another
`article taught that antiemetics were unnec-
`essary with sumatriptan, that article did
`not provide the motivation to a skilled
`artisan to substitute one agent in place of
`three, and the prior art reference did not
`teach the remaining efficacy limitations,
`since it gave no reason to assume that an
`
`entirely different combination of agents
`would have the same success as the combi-
`nation disclosed, nor did it disclose the
`combination therapy had any added bene-
`fits over any of the components given indi-
`vidually. 35 U.S.C.A. § 103(a).
`
`12. Patents O16.25
`Prior art patient records showing doc-
`tors prescribed a daily dose of naproxen as
`a prophylactic treatment and sumatriptan
`for treating acute migraines did not render
`patents relating to a method for treating
`migraines by combining two drugs in a
`single tablet invalid for obviousness; treat-
`ing doctor testified that he did not recall
`ever prescribing or giving a patient suma-
`triptan and naproxen simultaneously, and
`the records did not suggest that it pro-
`duced longer lasting efficacy or reduced
`migraine relapse, as at least one of the
`patients’ prescriptions was soon altered to
`sumatriptan and an antidepressant, sug-
`gesting the combination of sumatriptan
`and naproxen did not work to relieve mi-
`graine symptoms. 35 U.S.C.A. § 103(a).
`
`13. Patents O16.25
`Prior art case report describing a
`single patient who developed ergotamine-
`induced headaches and subsequently re-
`placed ergotamine with daily administra-
`tion of sumatriptan did not teach a com-
`bination of sumatriptan and naproxen
`provided migraine relief, so as to render
`patents relating to a method for treating
`migraines by combining two drugs in a
`single tablet invalid for obviousness; the
`prior art reference concluded that the
`only effective treatment for the patient
`was sumatriptan and acupuncture, and
`the district court determined that the pri-
`or art reference discouraged combining
`sumatriptan and naproxen to achieve the
`claimed efficacy benefits, teaching away
`from the invention. 35 U.S.C.A. § 103(a).
`
`

`
`1154
`
`696 FEDERAL REPORTER, 3d SERIES
`
`14. Patents O99
`Purpose of patent law’s written de-
`scription requirement is to ensure ade-
`quate disclosure of the
`invention.
` 35
`U.S.C.A. § 112.
`
`15. Patents O99
`A specification adequately describes
`an invention, in satisfaction of patent law’s
`written description requirement, when it
`reasonably conveys to those skilled in the
`art that the inventor had possession of the
`claimed subject matter as of the filing
`date. 35 U.S.C.A. § 112.
`
`16. Patents O324.55(3.1)
`Following a bench trial, the court of
`appeals reviews compliance with patent
`law’s written description requirement, a
`question of fact, for clear error.
` 35
`U.S.C.A. § 112.
`
`17. Patents O99
`District court did not clearly err in
`determining specification for patent relat-
`ing to a method for treating migraines by
`combining two drugs in a single tablet met
`patent law’s written description require-
`ment, despite argument that the limita-
`tions
`‘‘therapeutic package,’’
`‘‘finished
`pharmaceutical container,’’ and ‘‘said con-
`tainer further containing or comprising la-
`beling directing the use of said package in
`the treatment of migraine’’ lacked ade-
`quate written description; district court
`reasoned that dispensing pharmaceutical
`products in containers or packages was not
`a new or unpredictable concept, and that a
`person of ordinary skill in the art would
`know that medications were not simply
`handed out to patients, but, rather, phar-
`maceutical products, like the claimed tab-
`lets, were routinely administered in con-
`tainers or packages. 35 U.S.C.A. § 112.
`
`18. Patents O99
`In order to satisfy patent law’s writ-
`ten description requirement, the disclosure
`
`as originally filed does not have to provide
`in haec verba support for the claimed sub-
`ject matter at issue; nonetheless, the dis-
`closure must convey with reasonable clari-
`ty to those skilled in the art that the
`inventor was in possession of the invention.
`35 U.S.C.A. § 112.
`
`19. Patents O237
`Infringement under the doctrine of
`equivalents allows the patentee to claim
`those insubstantial alterations that were
`not captured in drafting the original patent
`claim but which could be created through
`trivial changes.
`
`20. Patents O237
`The ‘‘all limitations rule’’ restricts pat-
`ent infringement under the doctrine of
`equivalents by preventing its application
`when doing so would vitiate a claim limita-
`tion.
` See publication Words and Phras-
`es for other judicial constructions
`and definitions.
`
`21. Patents O237
`Equivalence, in the context of patent
`infringement under the doctrine of equiva-
`lents, is not an absolute to be considered in
`a vacuum.
`
`22. Patents O230, 237
`The essential inquiry in determining
`patent infringement under the doctrine of
`equivalents is whether the accused product
`or process contains elements identical or
`equivalent to each claimed element of the
`patented invention.
`
`23. Patents O237
`One way of proving infringement un-
`der the doctrine of equivalents is by show-
`ing on a limitation by limitation basis that
`the accused product performs substantially
`the same function
`in substantially the
`same way with substantially the same re-
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 696 F.3d 1151 (Fed. Cir. 2012)
`
`1155
`
`sult as each claim limitation of the patent-
`ed product.
`
`tations warrant little, if any, range of
`equivalents.
`
`24. Patents O324.55(5)
`Court of appeals reviews the district
`court’s patent infringement determinations
`under the doctrine of equivalents for clear
`error.
`
`25. Patents O230
`District court did not clearly err in
`concluding that accused Abbreviated New
`Drug Application (ANDA) products met
`the ‘‘independent dissolution’’ limitation as
`recited in patent relating to a method for
`treating migraines by combining two drugs
`in a single tablet in finding infringement
`under the doctrine of equivalents; although
`there was no direct evidence comparing
`the rate of dissolution of the ANDA prod-
`ucts to that of the agents individually, no
`such actual comparison was necessary, as
`accused infringers provided expert testi-
`mony to show that the sumatriptan dis-
`solved completely and independently from
`the naproxen and that the naproxen dis-
`solved completely and independently from
`the sumatriptan in their ANDA products.
`
`26. Patents O237
`In assessing equivalents, in determin-
`ing patent infringement under the doctrine
`of equivalents, a court considers whether
`the accused products perform substantially
`the same function
`in substantially the
`same way with substantially the same re-
`sult as each claim limitation of the patent-
`ed product.
`
`27. Patents O237
`All claim limitations are not entitled to
`an equal scope of equivalents, for purposes
`of determining patent infringement under
`the doctrine of equivalents; whether the
`result of the All Limitations Rule, prosecu-
`tion history estoppel, or the inherent nar-
`rowness of the claim language, many limi-
`
`28. Patents O230
`Under the doctrine of equivalents, a
`tablet layer with 85% of the agent could be
`fairly characterized as an
`insubstantial
`change from a tablet layer with 90% of the
`agent to satisfy ‘‘substantially all’’ limita-
`tion of patent relating to a method for
`treating migraines by combining two drugs
`in a single tablet, even though claim con-
`struction gave the term ‘‘substantially all’’
`a quantitative definition of ‘‘at least 90%,
`and preferably greater than 95%,’’ where
`patentee never stated that ‘‘at least 90%,
`and preferably greater than 95%’’ should
`be an absolute floor.
`
`29. Patents O230
`District court did not clearly err in
`concluding that accused Abbreviated New
`Drug Application (ANDA) products met
`the ‘‘substantially all’’ limitation in patent
`relating to a method for treating migraines
`by combining two drugs in a single tablet,
`which required substantially all of the na-
`proxen and triptan to be segregated and
`separated for the purpose of independent
`solution, in finding infringement under the
`doctrine of equivalents; although accused
`infringers argued that their ANDA prod-
`ucts did not achieve separate distinct lay-
`ers because one of the layers had both
`agents, the ANDA products contained a
`bilayer tablet, with 100% of one agent in
`one layer, and 85% of the other agent in
`the other layer, and that structure was
`insubstantially different from a bilayer
`tablet with 90% of the total therapeutic
`agent present in the tablet included in a
`single layer, which would have satisfied
`‘‘substantially all’’ limitation as construed
`by the court.
`
`Patents O328(2)
`6,060,499, 6,586,458. Valid.
`
`

`
`1156
`
`696 FEDERAL REPORTER, 3d SERIES
`
`Patents O328(2)
`7,332,183. Valid and Infringed.
`
`Stephen M. Hash, Vinson & Elkins
`LLP, of Austin, TX, argued for plaintiff-
`appellee. With him on the brief were Tra-
`cey B. Davies, Willem G. Schuurman and
`Jennifer Librach Nall; and Stephanie Lol-
`lo Donahue and Rebecca J. Cantor, of New
`York, NY.
`
`Richard J. Berman, Arent Fox LLP, of
`Washington, DC, argued for defendant-
`appellants Par Pharmaceutical, Inc. and
`Alphapharm Pty., Ltd. Of counsel on the
`brief was Thomas J. Parker, Alston &
`Bird, LLP, of New York, NY. Of counsel
`for Par Pharmaceutical, Inc. were Taniel
`Ermano Anderson, Timothy Bucknell, Aziz
`Burgy, Janine A. Carlan, Joshua T. Morris
`and Amy E. Ligler Schoenhard. Of coun-
`sel for Alphapharm Pty., Ltd., was Natalie
`C. Clayton, Alston & Bird, LLP, of New
`York, NY.
`
`Paul H. Kochanski, Lerner, David, Lit-
`tenberg, Krumholz & Mentlik, LLP, of
`Westfield, NJ, argued for defendant-appel-
`lant, Dr. Reddy’s Laboratories, Inc. With
`him on the brief were Michael H. Teschner
`and Roy H. Wepner.
`
`Before NEWMAN, CLEVENGER, and
`WALLACH, Circuit Judges.
`
`Opinion for the court filed by Circuit
`Judge WALLACH. Dissenting-in-part
`opinion filed by Circuit Judge
`CLEVENGER.
`
`WALLACH, Circuit Judge.
`
`INTRODUCTION
`Par Pharmaceutical, Inc. (‘‘Par’’), Al-
`phapharm Pty Ltd. (‘‘Alphapharm’’), and
`Dr. Reddy’s Laboratories, Inc. (‘‘DRL’’)
`(collectively ‘‘Appellants’’) appeal from the
`final judgment of the United States Dis-
`trict Court for the Eastern District of
`Texas. Following a bench trial, the dis-
`trict court determined that the asserted
`claims of U.S. Patent No. 6,060,499 (filed
`Sept. 11, 1998) (the ‘‘8499 patent’’), U.S.
`Patent No. 6,586,458 (filed Apr. 27, 2000)
`(the ‘‘8458 patent’’), and U.S. Patent No.
`7,332,183 (filed Dec. 22, 2003) (the ‘‘8183
`patent’’) (collectively ‘‘patents-in-suit’’) are
`not invalid as obvious under 35 U.S.C.
`§ 103. The district court also found that
`the patents-in-suit were infringed by Par
`and DRL’s Abbreviated New Drug Appli-
`cation (‘‘ANDA’’) filings. As a result, Par
`and DRL were enjoined from making, us-
`ing, importing, selling or offering to sell
`their generic products
`in the United
`States.1 We affirm the district court’s de-
`cision because it did not err in finding the
`patents-in-suit not invalid and infringed.
`
`BACKGROUND
`Pozen developed a method for treating
`migraines by combining two drugs, suma-
`triptan and naproxen, in a single tablet.
`Pozen Inc. v. Par Pharm., Inc., 800
`F.Supp.2d 789, 796 (E.D.Tex.2011). Su-
`matriptan, a 5–HT receptor agonist, was
`developed in the late 1980s and is widely
`accepted as an effective medicine for mi-
`graines, but it does not prevent the reoc-
`currence of migraine symptoms. Id. at
`797. Naproxen is a well known nonsteroi-
`
`1. After the district court issued its final claim
`construction order, Pozen stipulated to a
`judgment of noninfringement of the 8183 pat-
`ent in favor of Alphapharm. Therefore, Al-
`phapharm’s interest in this appeal is limited
`to the validity of the 8499 and 8458 patents.
`
`Pozen also sued Teva Pharmaceuticals USA,
`Inc. (‘‘Teva’’) for patent infringement on the
`basis of Teva’s ANDA, but the parties settled
`before trial. Pozen Inc. v. Par Pharm., Inc.,
`800 F.Supp.2d 789, 796 n. 1 (E.D.Tex.2011).
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 696 F.3d 1151 (Fed. Cir. 2012)
`
`1157
`
`dal anti-inflammatory drug (‘‘NSAID’’).
`Id. at 798. Pozen, in partnership with
`GlaxoSmithKline (‘‘GSK’’), markets a com-
`bination of sumatriptan and naproxen
`called Treximetb and holds three related
`patents relevant to this appeal. Id. The
`8499 patent claims a method of treating
`migraines comprising co-timely adminis-
`tration of 5–HT agonists and long-acting
`NSAIDs. 8499 patent col.1 ll.13–17. The
`8458 patent is a continuation of the 8499
`patent and claims methods and composi-
`tions combining 5–HT agonists and long-
`acting NSAIDs. 8458 patent col.1 ll.18–20.
`The 8183 patent claims a multilayer phar-
`maceutical tablet with a triptan, such as
`sumatriptan, and a NSAID in separate
`layers that dissolve independently. 8183
`patent col.1 ll.54–57.
`Pozen filed a New Drug Application
`(‘‘NDA’’) to market Treximetb and ob-
`tained approval from the United States
`Food and Drug Administration (‘‘FDA’’) on
`April 15, 2008. Pozen, 800 F.Supp.2d at
`798. Pozen listed the patents-in-suit in its
`NDA as covering Treximetb. The patents
`are included in the FDA’s Approved Drug
`Products with Therapeutic Equivalence
`Evaluations
`(known as
`‘‘the Orange
`Book’’), see 21 U.S.C. § 355(b)(1), indicat-
`ing they could be infringed by the unli-
`censed manufacture, use, or sale of Trexi-
`metb. Pozen, 800 F.Supp.2d at 798.
`
`[1] Appellants are generic pharmaceu-
`tical manufacturers who filed ANDAs with
`the FDA seeking approval to market ge-
`neric forms of Treximetb before the expi-
`
`2. It is ‘‘an act of infringement to submit TTT
`an application’’ for approval from the FDA to
`manufacture ‘‘a drug claimed in a patent.’’
`35
`U.S.C.
`§ 271(e)(2)(A).
` Section
`271(e)(2)(A) provides that an ANDA consti-
`tutes an artificial act of infringement for
`which the applicant may be liable. Warner–
`Lambert, 316 F.3d at 1365. It ‘‘creates case-
`or-controversy jurisdiction to enable the reso-
`lution of an infringement dispute before the
`
`ration of Pozen’s patents. Id.; see 21
`U.S.C. § 355(b)(2), (j)(2). Appellants filed
`their application certifying that the patents
`listed in the Orange Book are ‘‘invalid or
`will not be infringed’’ by the generic prod-
`ucts.
` 21 U.S.C. § 355(j)(2)(A)(vii)(IV);
`Pozen, 800 F.Supp.2d at 798–99; Such a
`certification constitutes an artificial act of
`infringement.
` 35 U.S.C. § 271(e)(2);
`Warner–Lambert Co. v. Apotex Corp., 316
`F.3d 1348, 1365 (Fed.Cir.2003). Thereaf-
`ter, Pozen filed complaints against Appel-
`lants for infringement of claim 15 of the
`8499 patent; claims 11, 12, 24, 26, 27, 29,
`and 30 of the 8458 patent; and claim 2 of
`the 8183 patent under the Hatch–Waxman
`Act.2 35 U.S.C. § 271(e)(2)(A); Pozen, 800
`F.Supp.2d at 799.
`
`A. The Relevant 8499 Patent Claims
`The district court found Appellants’
`ANDA products directly infringe Claim 15
`of the 8499 patent, which depends on claim
`5 and reads:
`5. A therapeutic package for dispens-
`ing to, or for use in dispensing to, a
`migraine patient, which comprises:
`(a) one or more unit doses, each such
`unit dose comprising:
`(i) a 5–HT agonist and
`(ii) a long-acting, non-steroidal, anti-
`inflammatory drug (LA–NSAID);
`wherein the respective amounts of said
`5–HT agonist and said LA–NSAID in
`said unit dose are effective, upon con-
`comitant administration to said patient
`of one or more of said unit doses, to
`
`ANDA applicant has actually made or market-
`ed the proposed product.’’ Id.; see Glaxo,
`Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569
`(Fed.Cir.1997).
` The determination under
`§ 271 is the same as any other infringement
`suit to inquire whether a product would in-
`fringe a patent if the ANDA product was on
`the market. Warner–Lambert, 316 F.3d at
`1365.
`
`

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`
`reduce migraine relapse or produce
`longer lasting efficacy compared to the
`administration of said 5–HT agonist in
`the absence of said LA–NSAID or the
`administration of said LA–NSAID in the
`absence of said 5–HT agonist, and
`(b) a finished pharmaceutical container
`therefor, said container containing said
`unit dose or unit doses, said container
`further containing or comprising label-
`ing directing the use of said package in
`the treatment of migraine.
`TTTT
`15. The improvement, method, or com-
`position of claims 1, 2, 3, 4, 5, 6, 7, or 8,
`wherein said 5–HT agonist is sumatrip-
`tan, said LA–NSAID is naproxen and
`the unit dosage form is an oral unit
`dosage form comprising sumatriptan in
`an amount greater than 15 mg, and na-
`proxen in an amount greater than 200
`mg.
`8499 patent col.14 ll.1–19; col.15 ll.12–17.
`
`B. The Relevant 8458 Patent Claims
`The district court found Appellants’
`ANDA products directly infringe claims
`11, 12, and 24, which depend on claim 3, as
`well as claims 26, 27, 29, and 30, which
`specify sumatriptan is the 5–HT agonist
`and naproxen is the LA–NSAID used in
`various dosages. Pozen, 800 F.Supp.2d at
`806. Representative claim 3 states:
`in
`3. A pharmaceutical composition
`unit dosage form, useful in treating a
`migraine headache patient, which com-
`prises:
`(a) a 5–HT agonist, wherein said 5–
`HT agonist is a triptan; and
`(b) a long-acting, non-steroidal, anti-
`inflammatory drug (LA–NSAID),
`wherein said LA–NSAID has a phar-
`macokinetic half-life of at
`least 4
`hours and a duration of action of at
`least 6 hours;
`wherein the respective amounts of said
`5–HT agonist and said LA–NSAID in
`
`said composition are effective, upon con-
`comitant administration to said patient
`of one or more of said unit dosage forms
`of said composition, to produce longer
`lasting efficacy compared to the admin-
`istration of said 5–HT agonist in the
`absence of said LA–NSAID or the ad-
`ministration of said LA–NSAID in the
`absence of said 5–HT agonist.
`8458 patent col.12 ll.29–45.
`C. The Relevant 8183 Patent Claims
`The district court held that under the
`doctrine of equivalents Par and DRL’s
`ANDA products infringe claim 2 of the
`8183 patent, which is dependent on claim 1,
`and reads:
`1. A multilayer pharmaceutical tablet
`comprising naproxen and a triptan and,
`wherein:
`a) substantially all of said triptan is in
`a first layer of said tablet and substan-
`tially all of said naproxen is in a second,
`separate layer; and
`b)said first layer and said second lay-
`er are in a side by side arrangement
`such that the dissolution of said naprox-
`en occurs independently of said triptan.
`2. The tablet of claim 1, wherein said
`naproxen is in the form of naproxen
`sodium between 200 and 600 mg.
`8183 patent col.18 ll.30–39. The court con-
`strued the phrase ‘‘substantially all of said
`triptan is in a first layer of said tablet and
`substantially all of said naproxen is in a
`second, separate layer’’ as meaning ‘‘[a]t
`least 90%, and preferably greater than
`95%, of the total triptan present in the
`tablet is included within one distinct layer
`and at least 90%, and preferably greater
`than 95%, of the naproxen present in the
`tablet is included within a second distinct
`layer.’’ Pozen, 800 F.Supp.2d at 809. The
`parties agreed that the claim term ‘‘disso-
`lution of said naproxen occurs indepen-
`dently of said triptan’’ means ‘‘[d]issolution
`of naproxen TTT and triptan from the mul-
`tilayer tablet TTT occurs
`in the same
`
`

`
`POZEN INC. v. PAR PHARMACEUTICAL, INC.
`Cite as 696 F.3d 1151 (Fed. Cir. 2012)
`
`1159
`
`amount of time K 10% as when the same
`amount of naproxen TTT and triptan are
`given separately.’’ Joint Appendix (‘‘J.A.’’)
`653.
`D. Procedural History
`Based on the ANDA filings, Pozen filed
`suit against Appellants for infringement of
`the 8499, 8458, and 8183 patents and asked
`for a permanent injunction against Appel-
`lants from making, using, selling, offering
`to sell or importing into the United States
`their ANDA products until the patents-in-
`suit expire. Pozen, 800 F.Supp.2d at 799.
`The lawsuit triggered a 30–month stay of
`FDA approval for Appellants’ ANDAs.
`Id.
`Following the claim construction hear-
`ing, the district court conducted a five-day
`bench trial regarding Pozen’s infringement
`claims and Appellants’ noninfringement,
`invalidity, and unenforceability defenses
`and counterclaims.
` The district court
`held, in part, that the patents were not
`invalid because they were neither antici-
`pated nor obvious in light of the prior art,
`that Appellants’ ANDA products infringed
`the 8499 and 8458 patents, and that Par
`and DRL’s ANDA products infringed the
`8183 patent. Id. Furthermore, the district
`court held that the 8499 patent claims as-
`serted were not invalid due to lack of
`written description. Id. at 821–22. Ac-
`cordingly, the district court enjoined Par,
`
`3. Par and Alphapharm filed a joint brief,
`Brief for Defendants–Appellants Par Pharma-
`ceutical, Inc. and Alphapharm Pty Ltd.
`(‘‘Par’s Br.’’) and DRL submitted a separate
`brief, Brief for Defendant–Appellant Dr. Red-
`dy’s Laboratories, Inc. (‘‘DRL’s Br.’’), adopt-
`ing in accordance with Fed. R.App. P. 28(i)
`Par and Alphapharm’s arguments with regard
`to invalidity of the 8499, 8458, and 8183 pat-
`ents over the prior art, DRL’s Br. at 1.
`
`4. The following references will be discussed
`below: Parma, E., et al., The Treatment of
`Migraine: A Study in General Medicine, 11
`Ricerca & Practica 1995, at 64 (‘‘Parma’’);
`Saadah, H., Abortive Migraine Therapy With
`
`Alphapharm, and DRL from making or
`selling their respective ANDA products.
`Id. at 826. Par, Alphapharm, and DRL
`filed a timely appeal.3 We have jurisdic-
`tion over the appeals pursuant to 28 U.S.C.
`§ 1295(a)(1).
`
`DISCUSSION
`A. Standard of Review
`[2] This court reviews judgments of
`the district court after a bench trial ‘‘for
`errors of law and clearly erroneous find-
`ings of fact.’’ Zenon Envtl., Inc. v. U.S.
`Filter Corp., 506 F.3d 1370, 1377 (Fed.Cir.
`2007) (citations and
`internal quotation
`marks omitted).
`Appellants challenge the validity of the
`8499 and 8458 patents in light of four prior
`art references.4 Appellants also challenge
`the validity of the 8183 patent in light of
`the 8499 patent and prior art.5 Appellants
`ask this court to hold the 8499 patent
`invalid for lack of written description. Ad-
`ditionally, Appellants challenge the district
`court’s infringement determination as to
`the 8183 patent. We address each argu-
`ment in turn.
`
`B. Invalidity
`1. The 8499 And 8458 Patents
`Are Not Obvious
`[3, 4] A party asserting invalidity must
`present clear and convincing evidence to
`
`Oral Naproxen Sodium Plus Metoclopramide
`Plus Ergotamine Tartrate With Caffeine, 32
`Headache 1992, at 95 (‘‘Saadah’’); Raskin,
`N., Acute and Prophylactic Treatment of Mi-
`graine: Practical Approaches and Pharmaco-
`logic Rationale, 43 Neurology, June 1993, at
`839 (‘‘Raskin’’); Henry Ford Hospital, Patient
`Records; Catarci et al., Ergotamine–Induced
`Headache Can Be Sustained By Sumatriptan
`Daily Intake, 14 Cephalalgia 1994, at 374
`(‘‘Catarci’’).
`
`5. Bandelin, R., Compressed Tablets by Wet
`Granulation, 179 Herbert Lieberman et al.
`eds. (2d ed. 1989) (‘‘Bandelin’’).
`
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`
`overcome a patent’s presumption of validi-
`ty. 35 U.S.C. § 282; Microsoft Corp. v.
`i4i Ltd. P’ship, ––– U.S. ––––, 131 S.Ct.
`2238, 2245, 180 L.Ed.2d 131 (2011). A
`patent claim is invalid as obvious ‘‘when
`‘the differences between the subject mat-
`ter sought to be patented and the prior art
`are such that the subject matter as a
`whole would have been obvious at the time
`the invention was made to a person having
`ordinary skill in the artTTTT’ ’’ KSR Int’l
`Co. v. Teleflex Inc., 550 U.S. 398, 406, 127
`S.Ct. 1727, 167 L.Ed.2d 705 (2007) (quot-
`ing 35 U.S.C. § 103(a)). To determine if a
`patent is obvious the district court looks
`to: (1) the scope and content of the prior
`art; (2) differences between the prior art
`and the claims; (3) the level of ordinary
`skill in the art; and (4) secondary consid-
`erations such as commercial success and
`failure of others. Graham v. John Deere
`Co., 383 U.S. 1, 17, 86 S.Ct. 684, 15
`L.Ed.2d 545 (1966). ‘‘ ‘Obviousness is a
`question of law, reviewed de novo, based
`upon underlying factual questions which
`are reviewed for clear error following a
`bench trial.’ ’’ Aventis Pharma Deutsch-
`land GmbH v. Lupin, Ltd., 499 F.3d 1293,
`1300 (Fed.Cir.2007) (quoting Alza Corp. v.
`Mylan Labs., Inc., 464 F.3d 1286, 1289
`(Fed.Cir.2006)).
`
`The district court found that the prior
`art references did not invalidate the 8499
`and 8458 patents. Specifically, the district
`court reasoned that the references did not,
`separately or combined, ‘‘teach or suggest
`the simultaneous administration of suma-
`triptan and naproxen. Nor TTT otherwise
`disclose to one of ordinary skill in the art
`that the combination of sumatriptan and
`naproxen produces a longer lasting effica-
`cy reducing migraine relapse compared to
`the administration of naproxen or suma-
`triptan alone.’’ Pozen, 800 F.Supp.2d at
`819.
`
`As an initial matter, Par argues that the
`district court erred because it failed to
`apply the term ‘‘concomitant administra-
`tion’’ to include simultaneous and sequen-
`tial administrat