Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 1 of 19 PageID: 708
`
`
`
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`
`Attorneys for Plaintiffs
`Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc.
`
`OF COUNSEL:
`
`Joseph M. O’Malley, Jr.
`Preston K. Ratliff II
`Bruce M. Wexler
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`
`
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`
`SUMITOMO DAINIPPON PHARMA
`CO., LTD. and SUNOVION
`PHARMACEUTICALS INC.,
`
`
`Plaintiffs,
`
`
`v.
`
`EMCURE PHARMACEUTICALS
`LIMITED et al.,
`
`
`Defendants.
`
`
`
`Civil Action No. 15-280 (SRC) (CLW)
`Civil Action No. 15-281 (SRC) (CLW)
`Civil Action No. 15-6401 (SRC) (CLW)
`(Consolidated)
`
`(Filed Electronically)
`
`
`
`
`
`
`OPENING BRIEF IN SUPPORT
`OF SUNOVION’S CLAIM CONSTRUCTION
`
`
`
`
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 2 of 19 PageID: 709
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION …………………………………………..…………………....... 1
`
`BACKGROUND ……………………………………...…………………………… 4
`
`ARGUMENT ………………………………………………………………………. 7
`
`A. Claim Construction Standards ……………………………………….. 7
`
`B. The Proper Construction of Claim 14………………………………… 10
`
`
`11
`
`
`13
`
`CONCLUSION…...…………………………………………………………...…….. 16
`
`
`1. Defendants Have Admitted That
` Claim 14 Encompasses Lurasidone…………………………….
`
`2. Defendants’ Litigation-Inspired
` Claim Construction Lacks Support …..……………..………….
`
`
`
`
`
`- i -
`
`

`

`
`Pfizer Inc. v. Teva Pharms. USA, Inc.,
`555 F. App’x 961 (Fed. Cir. 2014) ………………………….................
`
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) …………………………………...
`
`
`
`5-6
`
`
`passim
`
`
`3, 8, 14
`
`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 3 of 19 PageID: 710
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Adams Respiratory Therapeutics, Inc. v. Perrigo
`616 F.3d 1283 (Fed. Cir. 2010) ……………………………………..……
`
`
`12-13
`
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`405 F. Supp. 2d 495 (D. Del. 2005),
`aff’d, 457 F.3d 1284 (Fed. Cir. 2006) ……………………………................
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006) …………………………………………
`
`
`9, 11, 13, 15
`
`- ii -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 4 of 19 PageID: 711
`
`
`
`INTRODUCTION
`
`Plaintiffs Sumitomo Dainippon Pharma Co., Ltd. and Sunovion
`
`Pharmaceuticals Inc. (collectively, “Sunovion”) filed this consolidated patent
`
`infringement action under the Hatch-Waxman Act against Defendants InvaGen
`
`Pharmaceuticals, Inc. (“InvaGen”), Emcure Pharmaceuticals Ltd. and Emcure
`
`Pharmaceuticals USA, Inc. (collectively, “Emcure”), and Teva Pharmaceuticals USA,
`
`Inc. and Teva Pharmaceutical Industries Ltd. (collectively, “Teva”) (InvaGen,
`
`Emcure, and Teva, together, “Defendants”), after each filed Abbreviated New Drug
`
`Applications (“ANDAs”) with the Food and Drug Administration (“FDA”) seeking
`
`approval to market generic versions of LATUDA®, Sunovion’s highly successful
`
`medication for treating schizophrenia and bipolar depression. The active moiety in
`
`LATUDA® is a chemical compound known today as lurasidone. Sunovion submits
`
`this brief and the accompanying Declaration of Dr. Stephen G. Davies1 in support of
`
`the proper construction of the sole patent claim at issue − Claim 14 of United States
`
`Patent No. 5,532,372 (“the ’372 patent”).2
`
`This claim construction dispute concerns whether Claim 14 should be
`
`construed in accordance with its plain and ordinary meaning to encompass the
`
`
`1 “Davies Decl. ¶ __” refers to citations to the accompanying June 15, 2016
`Declaration of Dr. Stephen G. Davies.
`2 “Exh. __” refers to exhibits attached to the accompanying June 15, 2016
`Declaration of Preston K. Ratliff II. Exh. 1 is a true and correct copy of the ’372
`patent.
`
`
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 5 of 19 PageID: 712
`
`
`
`chemical compound lurasidone, as Sunovion proposes, or should instead be limited
`
`and redefined to exclude lurasidone, as Defendants argue. Defendants’ construction is
`
`improper and should be rejected.
`
`After studying Claim 14, the ’372 patent specification, and the ’372 patent
`
`prosecution file history, each of the Defendants admitted that Claim 14 encompassed
`
`lurasidone in their respective Paragraph IV Notice Letters that provoked the filing of
`
`this action. For example, InvaGen did not contest its infringement of Claim 14.3
`
`Similarly, Teva and Emcure did not contest infringement and admitted that Claim 14
`
`covers lurasidone:
`
`• “Claim 14 of the ’372 patent is the narrowest
` claim that covers lurasidone” (Teva);4 and,
`
` •
`
` “the compound of claim 14 of the ’372 patent
` (i.e., lurasidone)” (Emcure).5
`
`Despite their admissions that Claim 14 covers the active moiety lurasidone in their
`
`proposed generic products, Defendants now argue that this Court should adopt a
`
`
`3 InvaGen did not contest its infringement of Claim 14 in its Notice Letter. (Exh. 2,
`InvaGen December 4, 2014 Paragraph IV Notice Letter, at 23-24.) InvaGen further
`confirmed its understanding that Claim 14 encompassed lurasidone when it did not
`submit a L. Pat. R. 3.6(e) Non-Infringement Contention. At the time that such
`contentions were due, InvaGen represented to Sunovion that “it ha[d] no Non-
`infringement contentions.” (Exh. 3, InvaGen L. Pat. R. 3.3, 3.4, and 3.6 Contentions
`at 4.) InvaGen also stated that the compound depicted in Claim 14 is “also known as
`lurasidone.” (Id. at 8-9.)
`4 Exh. 4, Teva July 13, 2015 Paragraph IV Notice Letter at 11-12, 20 (emphasis
`added).
`5 Exh. 5, Emcure December 3, 2014 Paragraph IV Notice Letter at 8-9, 17 (emphasis
`added).
`
`- 2 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 6 of 19 PageID: 713
`
`
`
`contrary construction. Defendants’ construction would exclude lurasidone from the
`
`scope of Claim 14 and improperly limit the claim to a specific 50:50 mixture of two
`
`chemical compounds. As explained in detail below, Defendants’ construction is
`
`unmistakably strained and fueled by a frivolous non-infringement argument that
`
`Defendants contrived long after they provoked the filing of this action.6
`
`The flaw in Defendants’ construction is apparent. If accepted, Defendants’
`
`construction would exclude the ’372 patent inventors’ preferred embodiment of the
`
`chemical compound lurasidone. In its place, Defendants’ construction would import
`
`an unsupported, extraneous claim limitation, and vitiate the lawful protection that the
`
`United States Patent and Trademark Office (“USPTO”) duly granted to the
`
`’372 patent inventors. Not surprisingly, black letter claim construction law does not
`
`permit these illogical results. Moreover, the Federal Circuit has twice rejected a
`
`generic drug manufacturer’s attempt to limit a chemical compound claim in the same
`
`manner now posited by the Defendants in this action.7 Having chosen to copy
`
`
`6 Notably, five months after the January 14, 2015 filing of this action, 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. Further, in connection with a newly-lodged, meritless invalidity argument, both
`InvaGen and Emcure admitted that Claim 14 encompasses lurasidone and acid
`addition salts of lurasidone. (Exh. 6, InvaGen June 18, 2015 Supplemental Notice
`Letter at 12-13 (discussing the “acid addition salts of lurasidone covered by claim[]
`… 14.” (emphasis added)); Exh. 7, Emcure June 16, 2015 Supplemental Notice Letter
`at 13 (same).)
`7 Pfizer Inc. v. Teva Pharms. USA, Inc., 555 F. App’x 961, 965-66 (Fed. Cir. 2014)
`(nonprecedential) (rejecting Defendant Teva’s attempt to limit a chemical compound
`
`
`- 3 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 7 of 19 PageID: 714
`
`
`
`Sunovion’s proprietary chemical compound lurasidone before the ’372 patent’s
`
`expiration, Defendants’ litigation-inspired attempt to avoid infringement by redefining
`
`Claim 14 should be rejected.
`
`BACKGROUND
`
`
`
`The ’372 patent issued on July 2, 1996 and is a composition-of-matter patent
`
`directed to chemical compounds. (Exh. 1, 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 patent specification. (Exh. 1, Abstract, 3:3-4:44.) Various
`
`embodiments of the ’372 patent are described throughout its specification and several
`
`preferred embodiments are illustrated, such as Compound No. 105. (E.g., Exh. 1,
`
`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. (Davies Decl. ¶ 33.) Lurasidone hydrochloride is the
`
`particular form of lurasidone within LATUDA® and Defendants’ proposed generic
`
`products. (Exh. 2, at 1-2; Exh. 4, at 1-2; Exh. 5, at 1-2.) The ’372 patent states that
`
`the “invention covers the acid addition salt formed between [its chemical compounds]
`
`and an organic or inorganic acid.” (Exh. 1, 4:44-46.)
`
`
`claim to a specific 50:50 mixture of two compounds); Pfizer, Inc. v. Ranbaxy Labs.
`Ltd., 457 F.3d 1284, 1290 (Fed. Cir. 2006) (rejecting another generic drug
`manufacturer’s attempt to limit a chemical compound claim to a specific 50:50
`mixture of two compounds).
`
`- 4 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 8 of 19 PageID: 715
`
`
`
`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.”
`
`(Exh. 1, 4:51-53 (emphasis added).) In other words, the ’372 patent teaches that its
`
`chemical compounds 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. (Davies Decl. ¶ 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. (Exh. 1, 32:1-14.) 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. (Exh. 1, 30:30-31:9.)
`
`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. Such material is referred to as a
`
`“racemic mixture” or “racemate.” Other mixtures of enantiomers, such as a mixture
`
`containing 55% of the (+)-enantiomer and 45% of the (−)-enantiomer, are not racemic
`
`mixtures. In order to obtain one enantiomer separate from its opposite enantiomer, a
`
`chemical separation of the isomers can be undertaken.8 (Davies Decl. ¶ 20.)
`
`
`8 The isomers of enantiomeric pairs are distinguished by the direction that they rotate
`polarized light: “(+)” for dextrorotatory enantiomers, and “(-)” for levorotatory
`enantiomers. For a further background discussion of enantiomers see, e.g., Pfizer,
`
`
`- 5 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 9 of 19 PageID: 716
`
`
`
`In addition to disclosing lurasidone as a preferred embodiment, the ’372 patent
`
`reports in vitro dopamine D2 receptor binding affinity data for lurasidone
`
`hydrochloride. (Exh. 1, 13:2-10, 32:17-23.) The ’372 patent explains that there is a
`
`correlation between anti-psychotic activity and dopamine D2 receptor binding activity.
`
`(Exh. 1, 12:32-38, 13:2-10.) The ’372 patent also teaches that lurasidone
`
`hydrochloride binds to the dopamine D2 receptor and has “excellent anti-psychotic
`
`activity.” (Exh. 1, 12:31-34, 13:2-10, 14:49-51.)
`
`The ’372 patent has 20 claims directed to its novel chemical compounds.
`
`(Exh. 1, 60:35-65:50.) As Teva admitted, Claim 14 of the ’372 patent is the narrowest
`
`claim that covers lurasidone. (Exh. 4, at 20.) Claim 14 is reproduced below.
`
`
`
`
`The two-dimensional drawing in Claim 14 represents lurasidone, lurasidone’s
`
`
`
`enantiomer, as well as mixtures of these enantiomers. (Davies Decl. ¶ 27.)9 The text
`
`
`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).
`9 InvaGen concedes that lurasidone is represented by the structure in Claim 14. In its
`L. Pat. R. 3.3, 3.4, and 3.6 Contentions, InvaGen points to Claim 14 and states “[t]his
`compound is also known as lurasidone.” (Exh. 3, at 8-9.)
`
`- 6 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 10 of 19 PageID: 717
`
`
`
`“or an acid addition salt thereof” refers to the ’372 patent’s teaching that the invention
`
`additionally covers acid addition salts of its claimed compounds, such as lurasidone
`
`hydrochloride. (Davies Decl. ¶ 42.) Teva agrees and has admitted that “a person of
`
`ordinary skill in the art would conclude that the structure in claim 14 covers both the
`
`(+) isomer of Compound No. 101 (Compound No. 104) and the (-) isomer of
`
`Compound No. 101 (Compound No. 105).” (Exh. 4, at 11.) As explained above,
`
`Compound No. 105 is lurasidone hydrochloride and Compound No. 104 is
`
`lurasidone’s enantiomer in a hydrochloride salt form.
`
`The ’372 patent prosecution file history confirms that the USPTO also
`
`understood Claim 14 to encompass lurasidone. 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. (Exh. 8, at
`
`LATUDA-00000851-52.) After reviewing Sunovion’s application, the PTO granted a
`
`term extension pursuant to 35 U.S.C. § 156. (Exh. 9, LATUDA-00000970-71.)
`
`A. Claim Construction Standards
`
`ARGUMENT
`
`Because the Court is well-versed in the law of claim construction, Sunovion
`
`highlights here claim construction principles that are most pertinent to the parties’
`
`dispute. When construing a claim term, courts are tasked with identifying the term’s
`
`plain and ordinary meaning as understood by a person of ordinary skill in the art.
`
`- 7 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 11 of 19 PageID: 718
`
`
`
`Pfizer v. Teva, 555 F. App’x at 965. There are two exceptions to this general rule: (1)
`
`when a patentee sets out a special definition that differs from the meaning the claim
`
`term would otherwise possess or (2) when the patentee disavows the full scope of a
`
`claim term either in the specification or prosecution. Id. If a patentee has not
`
`subscribed a special definition to a claim term or clearly disavowed the full scope of
`
`the claim term, it is inappropriate to import limitations into the claim. Id. at 965-66.
`
`The Federal Circuit has been particularly mindful of these fundamental
`
`principles when construing patent claims directed to chemical compounds. For
`
`example, when Defendant Teva tried to limit a chemical compound claim to a racemic
`
`mixture to avoid infringement, as Defendants attempt here, the Federal Circuit
`
`rejected that illogical construction. Id.10 The Federal Circuit reasoned that there was
`
`nothing in the plain language of the claim to warrant narrowing the claim to a racemic
`
`mixture. Id. at 965. The Federal Circuit also emphasized that absent “a clear
`
`disavowal” or lexicographic definition in the specification or prosecution history, it is
`
`improper to import a racemic limitation. Id. Similarly, in Pfizer v. Ranbaxy, the
`
`Federal Circuit rejected a generic drug manufacturer’s attempt to limit a chemical
`
`compound claim to a racemic mixture based on, among other things, examples in the
`
`patent specification in hopes of avoiding infringement. Pfizer v. Ranbaxy, 457 F.3d at
`
`1288-90.
`
`
`10 Pursuant to the Federal Circuit’s local rules, a nonprecedential opinion, although
`not binding, may be cited and relied upon for persuasive authority.
`
`- 8 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 12 of 19 PageID: 719
`
`
`
`Claims are “read in view of the specification, of which they are a part.”
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) (internal
`
`quotation mark omitted). “The construction that stays true to the claim language and
`
`most naturally aligns with the patent’s description of the invention will be, in the end,
`
`the correct construction.” Id. at 1316 (internal quotation mark omitted).
`
`
`
`Extrinsic evidence is “less significant than the intrinsic record in determining
`
`the legally operative meaning of claim language.” Phillips, 415 F.3d at 1317 (internal
`
`quotation marks omitted). Extrinsic evidence in the form of expert testimony can be
`
`useful to a court for, among other things, providing background on the technology at
`
`issue and to ensure that the court’s understanding of the technical aspects of the patent
`
`is consistent with that of a person of skill in the art. Id. at 1318. Conclusory and
`
`unsupported assertions by experts as to the definition of a claim term are not useful to
`
`a court. Id.
`
`- 9 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 13 of 19 PageID: 720
`
`
`
`B.
`
`The Proper Construction of Claim 14
`
`Claim Term
`“The imide compound of the
`formula:
`
`
`
`“or an acid addition salt thereof”
`
`
`
`Sunovion’s
`Construction
`plain meaning −
`refers to lurasidone,
`lurasidone’s
`enantiomer, as well
`as mixtures thereof
`
`Defendants’
`Construction
`A racemic mixture
`of two enantiomers
`of which the
`structural formula is
`representative
`
`plain meaning –
`includes, for
`example, lurasidone
`hydrochloride
`
`Defendants disagree
`that this term
`encompasses
`lurasidone
`hydrochloride and
`refuse to provide a
`construction
`
`The parties dispute whether Claim 14 encompasses lurasidone, as Sunovion
`
`
`
`
`proposes, or excludes lurasidone and is narrowly limited to a racemic mixture, as
`
`Defendants argue. The parties also dispute whether the term “or an acid addition salt
`
`thereof” refers, for example, to the particular form of lurasidone within Defendants’
`
`proposed generic products (lurasidone hydrochloride), as Sunovion proposes. Despite
`
`the parties’ current disagreement as to the plain and ordinary meaning of this claim
`
`term, Defendants have refused to provide any construction for this term. (D.I. 81,
`
`Joint Claim Construction and Prehearing Statement at 4.)
`
`- 10 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 14 of 19 PageID: 721
`
`
`
`
`
`1.
`
`Defendants Have Admitted That Claim 14 Encompasses Lurasidone
`
`The proper construction of Claim 14 is evident from Defendants’ pre-litigation
`
`admissions. In their respective Paragraph IV Notice Letters that provoked the filing
`
`of this action, none of the Defendants contested infringement of Claim 14, thereby
`
`acknowledging that lurasidone − more specifically lurasidone hydrochloride − is the
`
`active ingredient in their proposed generic products and is covered by the claim. (See
`
`supra p. 2, notes 3-5.) Defendants reached this logical conclusion based on the
`
`intrinsic evidence, which is the principle source for a proper claim construction
`
`analysis. See Phillips, 415 F.3d at 1315 (“[T]he best source for understanding a
`
`technical term is the specification from which it arose, informed, as needed, by the
`
`prosecution history.” (internal quotation marks omitted)). For example, Teva’s July
`
`13, 2015 Paragraph IV Notice Letter includes a section entitled “Claim Construction”
`
`where Teva analyzed Claim 14 as well as the ’372 patent specification, and concludes
`
`that Claim 14 covers lurasidone hydrochloride (Compound No. 105).11 (Exh. 4, at 8-
`
`11.)
`
`The proper construction of Claim 14 is grounded in the plain language of the
`
`claim and the intrinsic record as understood by those skilled in the art. The
`
`’372 patent specification explains that the claim term “[t]he imide compound of
`
`
`11 InvaGen’s and Emcure’s Supplemental ’372 Patent Notice Letters further expose
`the fallacy of Defendants’ current construction. In those letters, InvaGen and Emcure
`did not contest infringement of Claim 14 and admitted that Claim 14 covers
`lurasidone salts. (Exh. 6, at 2, 12-13; Exh. 7, at 2, 13.)
`
`- 11 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 15 of 19 PageID: 722
`
`
`
`the formula:
`
`”
`
`encompasses lurasidone, lurasidone’s enantiomer, as well as mixtures thereof.
`
`(Davies Decl. ¶ 34.) As Teva admitted, “Claim 14 of the ’372 patent is the narrowest
`
`claim that covers lurasidone.” (Exh. 4, at 20.)12
`
`Along with the explicit teachings in the ’372 patent that its invention involves
`
`the “stereo and optical isomers” of its chemical compounds and “their mixtures as
`
`well,” (Exh. 1, 4:51-53), the ’372 patent illustrates a series of preferred embodiments,
`
`including lurasidone hydrochloride (Compound No. 105), lurasidone’s enantiomer in
`
`a hydrochloride salt form (Compound No. 104), and a mixture of this enantiomeric
`
`pair in a hydrochloride salt form (Compound No. 101). (Exh. 1, 30:30-32:23
`
`(Example 1-(a) – Example 1-(e)).) Moreover, the ’372 patent provides in vitro data
`
`further illustrating lurasidone as a preferred embodiment. (Exh. 1, 12:31-13:10,
`
`14:56-59.) These teachings, together with the plain language of Claim 14,
`
`demonstrate that Claim 14 does not exclude lurasidone. Adams Respiratory
`
`Therapeutics, Inc. v. Perrigo, 616 F.3d 1283, 1290 (Fed. Cir. 2010) (“A claim
`
`
`12 See also Exh. 3, at 8-9 (stating that the compound depicted in the Claim 14 is “also
`known as lurasidone.”)
`
`- 12 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 16 of 19 PageID: 723
`
`
`
`construction that excludes the preferred embodiment is rarely, if ever, correct and
`
`would require highly persuasive evidentiary support.” (internal quotation mark
`
`omitted)). Moreover, these teachings demonstrate that Claim 14 is not narrowly
`
`drawn to a racemic mixture. Rather, Claim 14 encompasses lurasidone, lurasidone’s
`
`enantiomer, and mixtures thereof. (Davies Decl. ¶ 34.) In light of these teachings in
`
`the ’372 patent and the plain language of Claim 14, it is not surprising that Defendants
`
`conceded in their Paragraph IV Notice Letters that Claim 14 covers lurasidone.
`
`The claim term “or an acid addition salt thereof” should also be construed to
`
`have its plain and ordinary meaning. (Davies Decl. ¶ 39.) The ’372 patent teaches
`
`that its “invention covers the acid addition salt formed between [its novel chemical
`
`compounds] and an organic or inorganic acid … [such as,] hydrochloric acid.”
`
`(Exh. 1, 4:44-50; Davies Decl. ¶ 40.) In the case of lurasidone, its hydrochloric acid
`
`addition salt is lurasidone hydrochloride which is described as Compound No. 105 in
`
`the ’372 patent as a preferred embodiment. (Davies Decl. ¶ 42.)
`
`
`
`
`
`2.
`
`Defendants’ Litigation-Inspired Claim Construction Lacks Support
`
`Defendants’ current construction seeks to exclude the ’372 patent inventors’
`
`preferred embodiment lurasidone from Claim 14 and narrowly limit the claim to a
`
`racemic mixture exemplified in the patent specification. In so doing, Defendants’
`
`proposal ignores well-established claim construction canons that do not permit the
`
`importation of limitations from patent specifications, file histories, or extrinsic
`
`sources. Phillips, 415 F.3d at 1323. Moreover, the same litigation-inspired ploy to
`
`- 13 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 17 of 19 PageID: 724
`
`
`
`avoid infringement has been rejected by two panels of Federal Circuit judges. Pfizer
`
`v. Teva, 555 F. App’x at 964-66; Pfizer v. Ranbaxy, 457 F.3d at 1288-90.
`
`In the Pfizer decisions, Defendant Teva and another generic drug manufacturer
`
`argued that patent examples, statements from the patent prosecution file history, and
`
`even the patentee’s depiction of the chemical compound supported limiting the claim
`
`to a racemic mixture. Pfizer v. Teva, 555 F. App’x at 965-66; Pfizer v. Ranbaxy, 457
`
`F.3d at 1288-90. The Federal Circuit dismissed such arguments and refused to limit
`
`the claims to a racemic mixture because there was no clear indication that the
`
`patentees disavowed the full scope of their claims. Pfizer v. Teva, 555 F. App’x at
`
`965-66; see also Pfizer v. Ranbaxy, 457 F.3d at 1289.13
`
`Similarly, the ’372 patent inventors did not limit Claim 14. A person of
`
`ordinary skill would take particular note of the ’372 patent’s explicit teaching that its
`
`chemical compounds “can have stereo and optical isomers, and this invention
`
`involves these isomers or their mixtures as well.” (Exh. 1, 4:51-53 (emphasis added);
`
`Davies Decl. ¶ 29.) A person of skill would also take note of the ’372 patent’s
`
`self-described “preferred embodiments” that were “illustratively shown” in the
`
`specification, such as lurasidone. (Exh. 1, 14:56-59, 30:30-32:23; Davies Decl. ¶ 34.)
`
`Further, a person of skill would note that of the 20 claims in the ’372 patent, Claim 14
`
`
`13 The court in Pfizer v. Teva noted that Teva’s own expert admitted that the claim
`was not limited to a racemate. 555 F. App’x at 965. In the present action, Teva itself
`as well as each of the other Defendants, have admitted that Claim 14 covers
`lurasidone.
`
`- 14 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 18 of 19 PageID: 725
`
`
`
`includes a two-dimensional drawing targeted to lurasidone, lurasidone’s enantiomer,
`
`and mixtures thereof. Accordingly, a person of skill would understand that Claim 14
`
`is drafted to encompass lurasidone. (Davies Decl. ¶ 34.)14
`
`
`
`Defendants would have this Court believe that the inventors of the ’372 patent
`
`went out of their way to disclose lurasidone as a preferred embodiment throughout the
`
`patent specification, but specifically excluded it from Claim 14. Defendant’s
`
`argument is illogical because it would exclude a preferred embodiment − lurasidone −
`
`in the face of the ’372 patent’s teaching that “[t]his invention involves” stereo and
`
`optical isomers of its chemical compounds. (Exh. 1, 4:51-53.) Further, Defendants’
`
`argument is undermined by their own pre-litigation admissions and the USPTO’s
`
`acknowledgement that Claim 14 covers lurasidone when it awarded Sunovion a patent
`
`term extension pursuant to 35 U.S.C. § 156.
`
`
`14 Defendants ignore the ’372 patent specification’s explicit statement that the
`examples, including Example 1-(a), are illustrative. See Pfizer v. Ranbaxy, 457 F.3d
`at 1290. Further, Defendants ignore the “repeated[] warn[ings]” by the Federal
`Circuit against “confining the claims to [a specific] embodiment[].” Phillips, 415
`F.3d at 1323.
`
`- 15 -
`
`

`

`Case 2:15-cv-00280-SRC-CLW Document 90 Filed 06/15/16 Page 19 of 19 PageID: 726
`
`
`
`CONCLUSION
`
`For the foregoing reasons, Sunovion respectfully requests that the Court
`
`adopt its construction of the disputed claim term of the ’372 patent.
`
`s/ William C. Baton
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Of Counsel:
`
`Joseph M. O’Malley, Jr.
`Preston K. Ratliff II
`Bruce M. Wexler
`PAUL HASTINGS LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
`
`Attorneys for Plaintiffs
`Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc.
`
`
`
`Dated: June 15, 2016
`
`
`By:
`
`
`
`
`
`
`
`
`- 16 -
`
`