Case: 17-1798 Document: 36 Page: 1 Filed: 06/26/2017
`
`2017-1798, -1799, -1800
`United States Court of Appeals
`for the Federal Circuit
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`SUNOVION PHARMACEUTICALS INC.,
`Plaintiffs-Appellees,
`
`v.
`EMCURE PHARMACEUTICALS LIMITED, HERITAGE PHARMA
`LABS INC., fka Emcure Pharmaceuticals USA Inc., INVAGEN
`PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES, LTD.,
`Defendants-Appellants.
`
`
`
`
`
`Appeals from the United States District Court for the District of New Jersey
`in Nos. 2:15-cv-00280-SRC-CLW, 2:15-cv-00281-SRC-CLW,
`2:15-cv-06401-SRC-CLW, Judge Stanley R. Chesler.
`
`PRINCIPAL BRIEF OF PLAINTIFFS-APPELLEES
`
`Preston K. Ratliff II
`Joseph M. O’Malley, Jr.
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`Stephen B. Kinnaird
`PAUL HASTINGS LLP
`875 15th Street, N.W.
`Washington, DC 20005
`(202) 551-1700
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102
`(973) 286-6700
`
`
`June 26, 2017
`
`Attorneys for Plaintiffs-Appellees
`
`
`
`
`
`
`
`

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`Case: 17-1798 Document: 36 Page: 2 Filed: 06/26/2017
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`
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`CERTIFICATE OF INTEREST
`Counsel for Plaintiffs-Appellees certifies the following:
`1. The full name of every party or amicus represented by me is:
`Sumitomo Dainippon Pharma Co., Ltd.
`Sunovion Pharmaceuticals Inc.
`
`
`2. The names of the real parties in interest represented by me are:
`Sumitomo Dainippon Pharma Co., Ltd.
`Sunovion Pharmaceuticals Inc.
`
`
`3. All parent corporations and any publicly held companies that own 10 percent or
`more of the stock of the party or amicus curiae represented by me are:
`Sumitomo Dainippon Pharma Co., Ltd.: Sumitomo Chemical Co., Ltd.;
`Sunovion Pharmaceuticals Inc.: Dainippon Sumitomo Pharma America
`Holdings, Inc., Sumitomo Dainippon Pharma Co., Ltd., Sumitomo Chemical
`Co., Ltd.
`
`
`4. The names of all law firms and the partners or associates that appeared for
`Sumitomo Dainippon Pharma Co., Ltd. and Sunovion Pharmaceuticals Inc. in
`proceedings before the district court or are expected to appear in this Court are:
`PAUL HASTINGS LLP: Preston K. Ratliff II, Joseph M. O’Malley, Jr.,
`Bruce M. Wexler, Imtiaz Yakub, Nao Takada, Mi Zhou, Leo C. DeSesso,
`Mark Russell Sperling, and Stephen B. Kinnaird
`
`SAUL EWING LLP: Charles M. Lizza and William C. Baton
`
`
`Date: June 26, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By: /s/ Preston K. Ratliff II
` Preston K. Ratliff II
` PAUL HASTINGS LLP
` 200 Park Avenue
`
` New York, NY 10166
` (212) 318-6000
`
`
`
`
`
`
`
`
`
`

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`Case: 17-1798 Document: 36 Page: 3 Filed: 06/26/2017
`
`TABLE OF CONTENTS
`
`
`Page
`
`STATEMENT OF RELATED CASES .................................................................... 1
`
`STATEMENT OF THE ISSUE ON APPEAL ......................................................... 1
`
`STATEMENT OF THE CASE ................................................................................. 1
`
`A.
`
`B.
`
`C.
`
`Background of Enantiomers ........................................................................... 2
`
`The ’372 Patent ............................................................................................... 3
`
`Prosecution History of the ’372 Patent ........................................................... 6
`
`D. Defendants’ Claim Construction Admissions ................................................ 8
`
`E.
`
`The District Court’s Claim Construction ..................................................... 11
`
`1.
`
`2.
`
`The District Court’s Analysis of the Intrinsic Evidence .................... 11
`
`The District Court’s Rejection of
`Defendants’ Claim Construction Arguments ..................................... 13
`
`SUMMARY OF ARGUMENT .............................................................................. 16
`
`ARGUMENT .......................................................................................................... 19
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Standard of Review....................................................................................... 19
`
`The District Court Correctly Construed Claim 14 ....................................... 19
`
`The District Court’s Construction Is Consistent
`With Defendants’ Claim Construction Admissions ..................................... 22
`
`The District Court Correctly Deemed Irrelevant
`Defendants’ Arguments Regarding an Alleged
`Common Shorthand for Identifying Racemic Mixtures ............................... 24
`
`Defendants’ Misinterpretation of the ’372 Patent and Its
`Prosecution History Do Not Support Their Assertions of Error .................. 30
`
`CONCLUSION ....................................................................................................... 34
`
`CERTIFICATE OF COMPLIANCE ...................................................................... 35
`
`CERTIFICATE OF SERVICE ............................................................................... 36
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`Case: 17-1798 Document: 36 Page: 4 Filed: 06/26/2017
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`
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`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Adams Respiratory Therapeutics, Inc. v. Perrigo,
`616 F.3d 1283 (Fed. Cir. 2010) .................................................................... 21, 34
`Eli Lilly & Co. v. Zenith Goldline Pharms., LLC,
`No. IP 99-38-C HK
`2001 WL 1397304 (S.D. Ind. Oct. 29, 2001) ............................................... 28, 29
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`405 F. Supp. 2d 495 (D. Del 2005)
`aff’d, 457 F.3d 1284 (Fed. Cir. 2006) ................................................................... 3
`Pfizer, Inc. v. Ranbaxy Labs., Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006) ........................................................ 17, 26, 27, 29
`Pfizer Inc. v. Teva Pharms. USA., Inc.,
`555 F. App’x 961 (Fed. Cir. 2010) ......................................................... 17, 18, 28
`Phillips v. AWH Corp.,
`415 F. 3d 1303 (Fed. Cir. 2005) ................................................................... 16, 23
`Teva Pharms USA, Inc. v. Sandoz, Inc.,
`135 S. Ct. 831 (2015) .................................................................................... 19, 25
`Other Authority
`Manual of Patent Examining Procedure § 803 (Jan. 1995) ....................................... 7
`
`
`
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`Case: 17-1798 Document: 36 Page: 5 Filed: 06/26/2017
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`
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`TABLE OF ABBREVIATIONS
`
`“the ’372 patent”
`
`U.S. Patent No. 5,532,372
`
`“Appellants” or
`“Defendants”
`
`Appellants Emcure Pharmaceuticals Limited, Heritage
`Pharma Labs Inc., fka Emcure Pharmaceuticals USA Inc.;
`InvaGen Pharmaceuticals, Inc.; and Teva Pharmaceuticals
`USA, Inc., Teva Pharmaceutical Industries, Ltd.
`
`“Appellees” or
`“Sunovion”
`
`Appellees Sumitomo Dainippon Pharma Co., Ltd. and
`Sunovion Pharmaceuticals Inc.
`
`“DBr.”
`
`“Emcure”
`
`Appellants’ Opening Brief
`
`Appellants Emcure Pharmaceuticals Limited, Heritage
`Pharma Labs Inc., fka Emcure Pharmaceuticals USA Inc.
`
`“InvaGen”
`
`Appellant InvaGen Pharmaceuticals, Inc.
`
`“Teva”
`
`Appellants Teva Pharmaceuticals USA, Inc., Teva
`Pharmaceutical Industries, Ltd.
`
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`
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`STATEMENT OF RELATED CASES
`Appellees Sumitomo Dainippon Pharma Co., Ltd. and Sunovion
`
`Pharmaceuticals Inc. (collectively, “Sunovion”) have asserted the ’372 patent in
`
`two other cases: Sumitomo Dainippon Pharma Co., Ltd., et al. v. Amneal
`
`Pharmaceuticals LLC, 2:16-cv-04596-SRC-CLW (D.N.J.) (“the Amneal case”)
`
`and Sumitomo Dainippon Pharma Co., Ltd., et al. v. MSN Laboratories Private
`
`Ltd., et al., 2:17-cv-01010-SRC-CLW (D.N.J.) (“the MSN case”). The defendant
`
`in the Amneal case has agreed to a final judgment of infringement and an
`
`injunction that is not affected by the outcome of this Appeal. It is too early to
`
`determine whether the outcome of this Appeal will have any effect on the MSN
`
`case because that case is in its initial stages.
`
`STATEMENT OF THE ISSUE ON APPEAL
`The issue on appeal is whether the district court correctly ruled that
`
`Claim 14 of the ’372 patent should be construed according to well-established
`
`claim construction principles to encompass the chemical compound lurasidone
`
`(a preferred embodiment of the patent), or should instead be construed to exclude
`
`lurasidone, as Appellants Emcure, InvaGen, and Teva argue.
`
`STATEMENT OF THE CASE
`This case arises from a consolidated patent infringement action brought
`
`under the Hatch-Waxman Act against three generic drug manufacturers: Emcure,
`
`InvaGen, and Teva. Emcure, InvaGen, and Teva each filed Abbreviated New
`
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`Case: 17-1798 Document: 36 Page: 7 Filed: 06/26/2017
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`
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`Drug Applications with the Food and Drug Administration (“FDA”) seeking
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`approval to market generic versions of LATUDA®, Sunovion’s highly successful
`
`medication for treating schizophrenia and bipolar depression. The active
`
`ingredient in LATUDA® is a chemical compound known today as lurasidone.
`
`Citing the ’372 patent specification and prosecution history, the district court
`
`construed Claim 14 to encompass lurasidone. (Appx30.) The district court found
`
`that Defendants’ proposed construction, which excludes lurasidone and limits
`
`Claim 14 to one specific 50:50 mixture of two chemical compounds, conflicts with
`
`the patent specification’s teachings and prosecution history. (Appx30.) The sole
`
`issue on appeal is the propriety of the district court’s claim construction.
`
`A. Background of Enantiomers
`Chemical compounds can encompass structurally identical compounds that
`
`differ only in that one isomer, called an enantiomer, is a mirror image of the other
`
`and the mirror images cannot be superimposed. (Appx485-487 (¶¶ 11-19).) When
`
`chemists synthesize an organic compound that has a stereogenic carbon, the
`
`material that they obtain, depending on the synthesis process used, may contain an
`
`equal mixture of two enantiomers, such that it contains exactly 50% of
`
`the (+)-enantiomer and exactly 50% of the (−)-enantiomer. (Appx488 (¶ 20).)
`
`Such material is referred to as a “racemic mixture” or “racemate.” (Appx488
`
`(¶ 20).) Other mixtures of enantiomers, such as a mixture containing 55% of
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`Case: 17-1798 Document: 36 Page: 8 Filed: 06/26/2017
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`the (+)-enantiomer and 45% of the (−)-enantiomer, are not racemic mixtures.
`
`(Appx488 (¶ 20).) As explained below, the chemical compound lurasidone is not a
`
`racemic mixture.
`
`An enantiomer can be chemically separated from its opposite enantiomer.
`
`(Appx488 (¶ 20).) The isomers of enantiomeric pairs are distinguished by the
`
`direction that they rotate polarized light: “(+)” for dextrorotatory enantiomers, and
`
`“(−)” for levorotatory enantiomers. (Appx488 (¶ 19).) For a further background
`
`discussion of enantiomers see, e.g., Pfizer, Inc. v. Ranbaxy Labs. Ltd., 405 F. Supp.
`
`2d 495, 502-03 (D. Del. 2005), aff’d, 457 F.3d 1284, 1290 (Fed. Cir. 2006).
`
`B.
`
`The ’372 Patent
`The ’372 patent issued on July 2, 1996 and is a composition patent directed
`
`to chemical compounds. (Appx70, Appx71 (1:6-8).) The ’372 patent teaches that
`
`its claimed chemical compounds are useful antipsychotic agents having a novel
`
`chemical formula set out in the specification. (Appx70 (Abstract), Appx72 (3:3-
`
`4:68).) Various embodiments of the ’372 patent are described throughout its
`
`specification and several preferred embodiments are illustrated, such as Compound
`
`No. 105. (E.g., Appx85 (30:30-32:23).) Example 1-(e) of the ’372 patent
`
`discloses Compound No. 105, which is known today as lurasidone in the form of a
`
`hydrochloric acid addition salt, or lurasidone hydrochloride. (Appx77 (14:56-60),
`
`Appx86 (32:17-22), Appx492-493 (¶¶ 33-34).) Lurasidone hydrochloride is the
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`particular form of lurasidone within both LATUDA® and Defendants’ proposed
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`generic products. (Appx442-443, Appx450-451, Appx460-461.) The ’372 patent
`
`states that the “invention covers the acid addition salt formed between [its
`
`chemical compounds] and an organic or inorganic acid.” (Appx72 (4:44-46).)
`
`The ’372 patent also states that its chemical compounds “can have stereo
`
`and optical isomers, and this invention involves these isomers or their mixtures as
`
`well.” (Appx72 (4:51-53) (emphasis added).) In other words, the ’372 patent
`
`teaches that its chemical compounds encompass enantiomers as well as mixtures of
`
`enantiomers. (Appx490-491 (¶¶ 28-29).) In the case of lurasidone, its enantiomer
`
`is illustrated in Example 1-(d) of the ’372 patent as Compound No. 104 in the form
`
`of a hydrochloric acid addition salt. (Appx86 (32:1-14), Appx491 (¶ 30).) Further,
`
`the ’372 patent illustrates a mixture of lurasidone and its enantiomer in a
`
`hydrochloric acid addition salt form in Example 1-(a) as Compound No. 101.
`
`(Appx85-86 (30:30-31:9), Appx491 (¶ 30).)
`
`In addition to describing its claimed chemical compounds, the ’372 patent
`
`discloses specific examples of “preferred embodiments.” (Appx77 (14:56-59),
`
`Appx85-86 (30:30-32:23), Appx492 (¶ 34).) Example 1 of the ’372 patent, for
`
`example, includes:
`
` lurasidone in the form of a hydrochloride (Compound No. 105);
` lurasidone’s enantiomer in the form of a hydrochloride
`(Compound No. 104);
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` lurasidone’s enantiomer in the form of an L-tartrate
`(Compound No. 102);
` lurasidone in the form of a D-tartrate (Compound No. 103); and
` the mixture in the form of a hydrochloride (Compound No. 101).
`(Appx85-86 (30:30-32:23), Appx491-492 (¶¶ 30-33).) During his deposition,
`
`Defendants’ expert, Stephen W. Baldwin, Ph.D., agreed that all of these
`
`compounds are preferred embodiments of the ’372 patent. (Appx1361 (223:4-24).)
`
`In addition to disclosing lurasidone as a preferred embodiment,
`
`the ’372 patent reports dopamine D2 receptor binding affinity data for lurasidone
`
`hydrochloride. (Appx77 (13:2-10).) According to the specification, there is a
`
`correlation between antipsychotic activity and dopamine D2 receptor binding
`
`activity. (Appx76 (12:31-34).) The specification also teaches that lurasidone
`
`hydrochloride binds to the dopamine D2 receptor and has “excellent antipsychotic
`
`activity.” (Appx76-77 (12:31-34, 13:2-10, 14:49-51).)
`
`The ’372 patent has 20 claims directed to its novel chemical compounds.
`
`(Appx100-103 (60:35-65:50).) Claim 14 of the ’372 patent is the narrowest claim
`
`that covers lurasidone. (Appx102, Appx459.) Claim 14 is reproduced below.
`
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`The district court construed the two-dimensional drawing in Claim 14 to
`
`mean “lurasidone, lurasidone’s enantiomer, as well as mixtures of these
`
`enantiomers.” (Appx30.) The terminal clause “or an acid addition salt thereof”
`
`refers to the specification’s teaching that the invention additionally covers acid
`
`addition salts of its claimed compounds, such as lurasidone hydrochloride.
`
`(Appx26.)
`
`C.
`
`Prosecution History of the ’372 Patent
`During the prosecution of the ’372 patent, the inventors stated their intention
`
`to claim, among other things, lurasidone, lurasidone’s enantiomer, as well as
`
`mixtures of these enantiomers. The ’372 patent issued from U.S. Application
`
`No. 08/113,320 (“the ’320 application”), which is a continuation application of
`
`U.S. Patent Application No. 07/726,172 (“the ’172 application”). (Appx70.) On
`
`March 1, 1993, the ’372 patent inventors amended the ’172 application to include
`
`Application Claims 11-27. (Appx951-959.) Application Claim 27 ultimately
`
`issued as Claim 14 of the ’372 patent. (Appx958.)
`
`On December 29, 1994, in the ’320 application, the inventors submitted a
`
`declaration from a scientist to support the patentability of the then claimed
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`chemical compounds of Application Claims 11-27:
`
`From [the Declaration by Dr. Yukihiro Ohno] it is
`apparent that the claimed compound (e.g. Compound
`No. 101) increased punished responding significantly
`at 10 and 30 mg/kg in comparison with the control,
`and its potency at 10 mg/kg is almost the same level
`as the commercial antianxiety drug (e.g. Diazepam).
`Applicants submit that the test results reported in the
`specification and in the attached Declaration of
`Dr. Ohno, taken together with the knowledge of those
`skilled in the art as evidenced by the scientific
`literature, are sufficient to establish the utility of the
`claimed compounds as required by 35 U.S.C. 101.
`(Appx983 (emphases added).)
`
`On February 28, 1995, the patent examiner issued a restriction or election
`
`requirement in the ’320 application. (Appx960-962.) A restriction or election
`
`requirement is not a rejection. It is a routine procedure used by patent examiners
`
`to reduce burdens that may arise in applications having more than one patentably
`
`distinct invention. See January 1995 Manual of Patent Examining Procedure
`
`§ 803.
`
`On March 30, 1995, in response to the restriction or election requirement,
`
`the applicants stated:
`
` “In particular, it is applicants’ desire to elect a group
`which encompasses Compound No. 101, namely
`Example 1 in the application.”
`
` “the applicants provisionally elect the species of
`Compound No. 101, namely Example 1”
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`(Appx965 (emphases added).)
`
`As explained above, Example 1 is not limited to a single compound. (See
`
`supra pp. 4-5.) Example 1 exemplifies Compound Nos. 101, 102, 103, 104, and
`
`105. Compound No. 105 is lurasidone hydrochloride, Compound No. 104 is
`
`lurasidone’s enantiomer as a hydrochloride salt, and Compound No. 101 is a
`
`mixture of lurasidone and lurasidone’s enantiomer as a hydrochloride salt.
`
`(Appx85-86 (30:30-32:23).)
`
`Sunovion also informed the United States Patent and Trademark Office
`
`(“USPTO”) that Claim 14 encompassed the chemical compound known today as
`
`lurasidone. (Appx476-477.) Specifically, given the lengthy FDA regulatory
`
`review period for approving LATUDA® as a drug, Sunovion identified Claim 14 of
`
`the ’372 patent to the USPTO as covering the drug’s active ingredient lurasidone in
`
`support of an application for a patent term extension. (Appx476-477.) After
`
`reviewing Sunovion’s application, the USPTO granted a term extension pursuant
`
`to 35 U.S.C. § 156. (Appx478-480.)
`
`D. Defendants’ Claim Construction Admissions
`Prior to the filing of Sunovion’s infringement action, each of Defendants
`
`Emcure, InvaGen, and Teva sent Sunovion a “Paragraph IV Notice Letter”
`
`describing the bases for their belief that they could market generic lurasidone
`
`products before the expiration of the ’372 patent. (Appx442, Appx450, Appx461-
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`462.) While Emcure, InvaGen, and Teva contested the validity of the ’372 patent,
`
`they each concluded independently that they infringed Claim 14. (E.g., Appx444-
`
`445, Appx447-449, Appx459, Appx466.) Importantly, this concession was made
`
`after Defendants studied Claim 14, the ’372 patent specification, and
`
`the ’372 patent prosecution history. (E.g., Appx444-445, Appx446-447, Appx454-
`
`457, Appx463-465.) In Teva’s and Emcure’s Paragraph IV Notice Letters and in
`
`InvaGen’s Invalidity Contentions, each Defendant admitted that Claim 14
`
`encompassed lurasidone:
`
` “Claim 14 of the ’372 patent is the narrowest claim
`that covers lurasidone” (Teva);
`
` “the compound of claim 14 of the ’372 patent (i.e.,
`lurasidone)” (Emcure); and,
`
` “Claim 14 of the ’372 Patent is directed to the imide
`compound . . . also known as lurasidone.”
`(InvaGen).
`(Appx459 (emphasis added), Appx466 (emphasis added), Appx448-449 (emphasis
`
`added).)
`
`Moreover, Teva’s Paragraph IV Notice Letter includes an entire section
`
`devoted to and entitled “Claim Construction.” (Appx454-457.) Consistent with
`
`the district court’s ruling, Teva concludes in this section of its Paragraph IV Notice
`
`Letter that Claim 14 encompasses lurasidone. (Appx457.)
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`In addition, five months after the January 14, 2015 filing of Sunovion’s
`
`infringement case, InvaGen and Emcure sent Sunovion nearly identical
`
`“Supplemental” Paragraph IV Notice Letters regarding the ’372 patent wherein
`
`they again did not contest infringement of Claim 14. (Appx467-470, Appx471-
`
`473.) Once again, InvaGen and Emcure stated that Claim 14 encompasses
`
`lurasidone and acid addition salts of lurasidone. (Appx469-470 (discussing the
`
`“acid addition salts of lurasidone covered by claim[] . . . 14.” (emphasis added)),
`
`Appx473 (stating the same).)
`
`Although the district court did not base its claim construction on these
`
`admissions from Defendants, it did note that Emcure, InvaGen, and Teva changed
`
`their position for the claim construction proceedings. (Appx28 (n.8).) Notably,
`
`Defendants tried to conceal their admissions from their claim construction expert
`
`Dr. Baldwin. Dr. Baldwin testified at his deposition that he saw the reference to
`
`Defendants’ admissions in Sunovion’s opening claim construction brief before the
`
`district court, but Emcure, InvaGen, and Teva told him those were documents he
`
`did not need to read:
`
`Q. And after seeing that, did you review documents
`that plaintiffs were citing to concerning plaintiffs’
`assertion that defendants have already conceded that
`Claim 14 covers lurasidone?
`A.
`I reviewed no other documents, no.
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`Q. You weren’t curious to see what was the basis for
`plaintiffs’ statements in that regard?
`A.
`I mean I did ask is this a document I should be
`reading and they said you don’t need to.
`(Appx1349 (135:13-136:23) (emphases added).)
`
`After reviewing Teva’s and Emcure’s Paragraph IV Notice Letters,
`
`Dr. Baldwin testified at his deposition that Teva and Emcure had admitted that
`
`lurasidone was covered by Claim 14. (Appx1348-1352 (133:21-134:14, 139:10-
`
`142:5, 143:3-146:17).)
`
`E.
`
`The District Court’s Claim Construction
`1.
`The District Court’s Analysis of the Intrinsic Evidence
`
`The district court construed Claim 14 to encompass lurasidone, ruling that
`
`the two-dimensional drawing depicted in Claim 14 means: “lurasidone,
`
`lurasidone’s enantiomer, as well as mixtures of these enantiomers.” (Appx30.)
`
`The district court’s claim construction ruling was based on well-established claim
`
`construction principles. The district court stated that it considered first the intrinsic
`
`evidence to resolve the claim construction dispute. (Appx28.) The district court
`
`reviewed the ’372 patent specification, noting in particular the patent’s abstract and
`
`the detailed description of the claimed inventions in columns 3 and 4 of the patent.
`
`(Appx28.)
`
`The district court pointed out the specification’s teaching that its chemical
`
`compounds “can have stereo and optical isomers, and this invention involves these
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`isomers or their mixtures as well.” (Appx28.) The court explained that this
`
`teaching at column 4, lines 51-53 is “important intrinsic evidence that the
`
`applicants understood all the imide compounds (I) in all claims to have stereo and
`
`optical isomers, and that such isomers, as well as mixtures of isomers, fall within
`
`the scope of the claims.” (Appx28 (emphases added).) The district court also
`
`recognized that Defendants’ proposed construction seeking to limit Claim 14 to
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`one specific 50:50 mixture of two chemical compounds conflicted “irreconcilably”
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`with the “important” intrinsic evidence at column 4, lines 51-53 in the
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`specification. (Appx28-29.) In addition, the district court determined that
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`Defendants did not identify “any expression of manifest restriction that might
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`allow their proposed construction to escape the impact of this statement.”
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`(Appx29.)
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`The district court also considered the prosecution history. The district court
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`noted that it had reviewed each of the statements cited by Defendants as
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`purportedly claim-limiting. (Appx25-26.) In particular, those statements include
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`the statement regarding the Ohno Declaration quoted above and statements made
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`by the applicants in response to the restriction or election requirement that are also
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`quoted above. (See supra pp. 7, Appx25 (n.7).) The court concluded that the cited
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`statements support Sunovion’s proposed construction and do not support limiting
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`Claim 14 to one specific 50:50 mixture of two chemical compounds. (Appx25,
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`Appx29.) Further, the court determined that “Defendants have not pointed to any
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`expressions of manifest exclusion or restriction in the patent which could justify
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`restricting claim 14 to any particular embodiment.” (Appx27.)
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`2.
`The District Court’s Rejection of
`Defendants’ Claim Construction Arguments
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`In construing Claim 14, the district court rejected the extrinsic evidence that
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`allegedly supported Defendants’ proposed construction. (Appx23-24.)
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`Specifically, Emcure, InvaGen, and Teva relied on two book excerpts to argue that
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`Claim 14 depicts a single enantiomer, and that a drawing of a single enantiomer is
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`a common shorthand for a racemic mixture. (Appx23.) During his deposition,
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`Defendants’ expert Dr. Baldwin conceded that the book excerpts were not
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`available to the person of ordinary skill because they were not published until
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`many years after the July 5, 1991 patent application that led to the ’372 patent was
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`submitted to the USPTO. (Appx1353 (150:7-151:5, 151:25-152:9).) The first
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`extrinsic document, Organic Chemistry by Jones, was published in 1997, six years
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`after the July 5, 1991 patent application was filed. (Appx1015-1016 (¶ 27).) The
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`second extrinsic document, the sixth edition of Organic Chemistry: Structure and
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`Function by Vollhardt & Schore, was published in 2010, nearly 20 years after the
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`application was filed. (Appx1015-1016 (¶ 27).) Further, Dr. Baldwin confirmed
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`that the paragraph he cited in Vollhardt & Schore did not appear in earlier editions
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`of that publication that he had reviewed. (Appx1354 (156:22-157:16).) In
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`Case: 17-1798 Document: 36 Page: 19 Filed: 06/26/2017
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`addition, Dr. Baldwin confirmed during his deposition that Vollhardt & Schore
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`concerns “conventions of writing chemical equations where racemates are
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`involved,” but Claim 14 does not contain a chemical equation. (Appx1015 (¶ 27),
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`Appx1355 (158:8-17).)
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`The district court made an evidentiary finding that the extrinsic sources
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`relied on by Defendants did not support their proposed construction. (Appx23-24.)
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`With respect to Jones, the district court concluded that “if anything, [it] supports
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`the contrary proposition that a drawing of a single enantiomer has an ambiguous
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`meaning.” (Appx24.) With respect to Vollhardt & Schore, the district court
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`determined that this extrinsic document was irrelevant because it dealt only with
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`chemical equations. (Appx24.) In doing so, the district court’s opinion is
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`consistent with Defendants’ expert Dr. Baldwin’s opinion that Claim 14 does not
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`contain a chemical equation. (Appx24, Appx1355 (158:14-17).)
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`The district court further found Defendants’ argument that Claim 14 is
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`limited to Compound No. 101 to be contrary to (a) the terminal clause of Claim 14,
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`which states “or an acid addition salt” and (b) the specification’s teaching at
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`column 4, lines 44-46 that the invention covers other acid addition salts such as
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`hydrobromic and sulfuric acid addition salts. (Appx26.) In other words, the
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`district court found that Claim 14 could not be limited to Compound No. 101,
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`which is a hydrochloric acid addition salt, when the specification and claim
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`Case: 17-1798 Document: 36 Page: 20 Filed: 06/26/2017
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`language itself says the claimed compounds do not have to be one particular acid
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`addition salt but can be acid addition salts other than the hydrochloric acid addition
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`salt. (Appx26.)
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`The district court also noted that Defendants’ construction did not have any
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`basis in law. (Appx21-22.) For example, the district court observed that Emcure,
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`InvaGen, and Teva did not claim that the ordinary meaning of Claim 14 is a
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`racemic mixture. (Appx21.) Further, the court found that Defendants did not
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`argue that their proposed construction was based on lexicography or claim
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`disavowal. (Appx21-22.) Instead, Defendants advocated for their proposed
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`construction based on the Jones and Vollhardt & Schore book excerpts that the
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`district court found unpersuasive. (Appx20-24.)
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`After the district court’s claim construction ruling, each of the Defendants
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`stipulated to infringement and conceded that Claim 14 is valid and enforceable.
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`The district court entered a Final Judgment and Order of Permanent Injunction as
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`to Emcure and Teva on February 14, 2017, and as to InvaGen on February 28,
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`2017. (Appx1-9, Appx10-16.)
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`On appeal, Defendants state throughout their principal brief that (a) the
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`parties agree at least in part as to the scope of Claim 14 of the ’372 patent and
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`(b) the parties agree that Claim 14 depicts only one particular enantiomer. (E.g.,
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`DBr. 2-3, 16-17, 19.) This is incorrect. (See Appx27-28.) Sunovion reached no
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`Case: 17-1798 Document: 36 Page: 21 Filed: 06/26/2017
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`such agreements with Defendants and maintains that the drawing depicted in
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`Claim 14, as properly construed by the district court, represents “lurasidone,
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`lurasidone’s enantiomer, as well as mixtures of these enantiomers.”
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`SUMMARY OF ARGUMENT
`This Appeal concerns whether the district court correctly ruled that Claim 14
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`of the ’372 patent should be construed to encompass the chemical compound
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`lurasidone (a preferred embodiment of the patent), or should instead be construed
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`to exclude lurasidone and limited to one specific 50:50 mixture of two chemical
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`compounds. As explained below, the district court’s construction was correct and
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`should be affirmed.
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`Understanding that the specification is the single best guide to the meaning
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`of a disputed term, the district court relied on the ’372 patent specification as well
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`as the plain language of the claim to construe Claim 14. (Appx18-19 (citing
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`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc)), Appx28-30.) In
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`particular, the district court found as “impact[ful]” evidence the ’372 patent
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`specification’s explicit teaching that its disclosed compounds “can have stereo and
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`optical isomers, and this invention involves these isomers or their mixtures as
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`well.” (Appx28-29 (emphasis added).) The district court explained that this
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`teaching is “important intrinsic evidence that the applicants understood all the
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`imide compounds (I) in all claims to have stereo and optical isomers, and that such
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`isomers, as well as mixtures of isomers, fall within the scope of the claims.”
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`(Appx28 (emphases added).)
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`The district court also analyzed the patent prosecution history cited by the
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`parties and determined that it demonstrates that the inventors intended Claim 14 to
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`encompass a genus of compounds. (Appx25, Appx29-30.) As the court
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`determined, this genus includes “lurasidone, lurasidone’s enantiomer, as well as
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`mixtures of these enantiomers.” (Appx30.)
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`On appeal, Emcure, InvaGen, and Teva argue that the district court
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`committed a “host of legal errors” in adopting a construction they each agreed with
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`at the time they sent their Paragraph IV Notice Letters. (DBr. 17, 27.)
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`Specifically, Defendants argue that the court erred by disregarding the alleged
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`common usage of depicting a single enantiomer as shorthand for a racemic
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`mixture. (DBr. 18, 33.) As the court explained, however, the evidence that
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`Defendants relied on was irrelevant and contradicts Defendants’ ass