Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 1 of 27 PageID #: 988
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 15-272-GMS
`(consolidated)
`
`)))))))))))))
`
`FOREST LABORATORIES, LLC, FOREST
`LABORATORIES HOLDINGS, LTD.,
`MERCK KGAA and MERCK PATENT
`GESELLSCHAFT MIT BESCHRÄNKTER
`HAFTUNG,
`
`Plaintiffs,
`
`v.
`
`ACCORD HEALTHCARE, INC.,
`
`Defendant.
`
`DEFENDANTS’ ANSWERING CLAIM CONSTRUCTION BRIEF
`
`John C. Phillips, Jr. (#110)
`David A. Bilson (#4986)
`PHILLIPS, GOLDMAN MCLAUGHLIN
`& HALL, P.A.
`jcp@pgmhlaw.com
`dab@pgmhlaw.com
`Attorneys for Defendant Accord Healthcare,
`Inc.
`
`Neal C. Belgam (#2721)
`Eve H. Ormerod (#5369)
`SMITH, KATZENSTEIN, & JENKINS LLP
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`Attorneys for Defendants Alembic Global
`Holdings SA, Alembic Pharmaceuticals, Inc.
`and Alembic Pharmaceuticals Ltd.
`
`Dated: July 27, 2016
`1229998/42390
`
`Kenneth Laurence Dorsney (#3726)
`MORRIS JAMES LLP
`kdorsney@morrisjames.com
`Attorneys for Defendants Apotex Corp. and
`Apotex Inc.
`
`R Touhey Myer (#5939)
`CAESAR RIVISE, PC
`tmyer@crbcp.com
`Attorneys for Defendant InvaGen
`Pharmaceuticals Inc.
`
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byrne (#4446)
`POTTER ANDERSON &CORROON LLP
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`sobyrne@potteranderson.com
`Attorneys for Defendant Teva
`Pharmaceuticals
`USA, Inc.
`
`Argentum EX1008
`
`Page 1
`
`

`

`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 2 of 27 PageID #: 989
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`INTRODUCTION .............................................................................................................. 1
`
`LEVEL OF ORDINARY SKILL IN THE ART ................................................................ 1
`
`CONSTRUCTIONS OF DISPUTED CLAIM TERMS..................................................... 2
`
`A.
`
`B.
`
`“administer[ed/ing]” ............................................................................................... 2
`
`“effective amount”.................................................................................................. 3
`
`1.
`
`2.
`
`“effective amount” Refers to Crystalline Modifications of
`Vilazodone HCl. ......................................................................................... 3
`
`An “effective amount” Must “produce” Rather Than Merely
`“promote” the Desired Effect...................................................................... 5
`
`C.
`
`“crystalline modification” and “crystalline”........................................................... 7
`
`1.
`
`2.
`
`3.
`
`“crystalline modification” and “crystalline” Refer to the Specific
`Forms Defined as the Products of the Invention, and Combinations
`thereof as Appropriate................................................................................. 8
`
`The Term “crystalline” Requires Construction......................................... 11
`
`Entirely Crystalline ................................................................................... 12
`
`D.
`
`E.
`
`F.
`
`G.
`
`“exhibits the following XRD data”....................................................................... 13
`
`“corresponding to”................................................................................................ 15
`
`“characteristic peak” ............................................................................................. 16
`
`The Preamble Term “A method of treating” is Not Limiting............................... 19
`
`IV.
`
`CONCLUSION................................................................................................................. 20
`
`i
`
`Page 2
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 3 of 27 PageID #: 990
`
`TABLE OF AUTHORITIES
`
`CASES
`Andrulis Pharm. Corp. v. Celgene Corp.,
`C.A. No. 13-1644-RGA, 2015 WL 3978578 (D. Del. Jun. 26, 2015),
`aff’d No. 2015-1962, 2016 WL 3755929 (Fed. Cir. July 14, 2016) .................................. 3
`Astrazeneca AB v. Mutual Pharm. Co.,
`384 F.3d 1333 (Fed. Cir. 2004)......................................................................................... 11
`Bates v. Coe,
`98 U.S. 31 (1878).............................................................................................................. 14
`Baxter Healthcare Corp. v. Mylan Labs. Ltd.,
`Nos. 14-cv-7094, et al., 2016 WL 1337279 (D.N.J. Apr. 5, 2016) ............................ 10, 12
`Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc.,
`262 F.3d 1258 (Fed. Cir. 2001)......................................................................................... 16
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 1368 (Fed. Cir. 2001)......................................................................................... 20
`Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc.,
`334 F.3d 1294 (Fed. Cir. 2003)........................................................................................... 8
`Copaxone 40 Mg Consol. Cases, In re,
`C.A. No. 14-1171-GMS, 2016 WL 873062 (D. Del. Mar. 7, 2016) ................................ 20
`Chimie v. PPG Indus.,
`402 F.3d 1371 (Fed. Cir. 2005)......................................................................................... 12
`Pacing Techs., LLC v. Garmin Int’l, Inc.,
`778 F.3d 1021 (Fed. Cir. 2015)............................................................................... 9, 10, 12
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)......................................................................................... 14
`Takeda Pharm. Co. v. Actavis Labs. FL, Inc.,
`C.A. No. 15-451-RGA, 2016 WL 3193188 (D. Del. Jun. 6, 2016).................................... 3
`Vizio, Inc. v. ITC,
`605 F.3d 1330 (Fed. Cir. 2010)......................................................................................... 20
`Williamson v. Citrix Online, LLC,
`770 F.3d 1371 (Fed. Cir. 2014), vacated by 603 F. App’x 1010,
`superseded by 792 F.3d 1339 (Fed. Cir. 2015)................................................................... 8
`Wyeth v. Teva Pharm. USA, Inc.,
`No. 03-cv-1293, 2005 WL 2175440 (D.N.J. Sept. 6, 2005)....................................... 11, 12
`STATUTES
`35 U.S.C. § 102(b) ........................................................................................................................ 13
`35 U.S.C. § 112............................................................................................................................. 11
`
`ii
`
`Page 3
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`

`

`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 4 of 27 PageID #: 991
`
`OTHER AUTHORITIES
`Webster’s Third New International Dictionary (Merriam-Webster, Inc. 1993)............................. 7
`
`iii
`
`Page 4
`
`

`

`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 5 of 27 PageID #: 992
`
`I.
`
`INTRODUCTION
`
`Defendants1 respectfully submit this brief in response to the proposed claim constructions
`
`set forth in the opening brief (D.I. 87) filed by Plaintiffs2 on June 22, 2016, in this Hatch-
`
`Waxman case regarding proposed generic versions of the drug Viibryd®. The patents-in-suit are
`
`U.S. Patent Nos. 7,834,020 (the “’020 patent”), 8,193,195 (the “’195 patent”), 8,236,804 (the
`
`“’804 patent”), and 8,673,921 (the “’921 patent”), which all relate to crystalline forms of the
`
`chemical vilazodone hydrochloride (“HCl”) and their use in treating depression and other
`
`disorders.
`
`II.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`Defendants concur with Plaintiffs’ assertion that a person of ordinary skill in the art
`
`(“POSA”) would have “at least a bachelor’s degree in chemistry, pharmaceutical sciences, or a
`
`related discipline, along with several years of experience working in pharmaceutical solid
`
`product development and/or solid state chemistry.” Plaintiffs’ Opening Claim Constr. Br. at 3
`
`(D.I. 87, June 22, 2016) (“Pls.’ Br.”). In addition, a POSA would have taken the prescribed
`
`number of Good Manufacturing Practice trainings. See Declaration of Piotr H. Karpinksi ¶¶ 17-
`
`18 (July 27, 2016) (“Karpinski Decl.”) (filed concurrently with this motion). For purposes of the
`
`disputed method of treatment claims, a POSA may also be an M.D. with extensive experience in
`
`the study and treatment of mood disorders, including depression. See Karpinski Decl. ¶ 19;
`
`Declaration of Eric Lenze ¶ 6 (July 27, 2016) (“Lenze Decl.”) (filed concurrently with this
`
`motion).
`
`1 The “Defendants” are Accord Healthcare, Inc., Alembic Global Holding SA, Alembic
`Pharmaceuticals Inc., Alembic Pharmaceuticals Ltd., Apotex Inc., Apotex Corp., Teva
`Pharmaceuticals USA, Inc., and InvaGen Pharmaceuticals Inc.
`2 The Plaintiffs are Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd., Merck
`KGaA, and Merck Patent Gesellschaft mit beschränkter Haftung.
`
`Page 5
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`

`

`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 6 of 27 PageID #: 993
`
`III.
`
`CONSTRUCTIONS OF DISPUTED CLAIM TERMS
`
`A.
`
`“administer[ed/ing]”
`
`Claim
`Term
`“administer”
`“administered”
`“administering”
`
`Patent & Claim
`
`’020 patent, claim 2
`’195 patent, claims 1-2
`’804 patent, claim 1
`’921 patent, claims 10, 12-
`14
`
`Plaintiffs’
`Construction
`Plain meaning/no
`construction required
`
`Defendants’
`Construction
`Deliver[ed/ing] into
`the body
`
`The point of the claims at issue is to “treat” a patient with a drug. The treatment will not
`
`happen unless the drug enters the patient’s body; merely distributing the drug to the patient is not
`
`enough. Plaintiffs point to a doctor prescribing the medication to a patient as an example of
`
`“administer[ed/ing].” However, alone, a doctor’s prescription note does not treat a condition.
`
`See Lenze Decl. ¶¶ 29-31. Dr. Thase’s claim that a pharmacist may “administer” medication
`
`simply by filling the prescription similarly fails to treat a condition. See Declaration of Michael
`
`Thase ¶ 48 (D.I. 89, June 22, 2016); Lenze Decl. ¶¶ 30-31. The patient is treated only after
`
`ingestion of the prescribed medication. See Lenze Decl. ¶¶ 30-31. Moreover, under Plaintiffs’
`
`definition, even a mail carrier could be considered to have administered medication upon
`
`delivering mail-order medicine to a patient. No POSA would interpret “administer[ed/ing]” so
`
`broadly, nor did the intrinsic record. See id. ¶¶ 29-31. Plaintiffs’ construction should be rejected
`
`because it is overly broad and eliminates a necessary step (getting the drug into the body) for
`
`treatment to occur.
`
`Despite Plaintiffs’ and Dr. Thase’s unsupported assertions, “providing a patient a drug or
`
`treatment for therapeutic purpose” is not the plain meaning that a POSA, reading the patents-in-
`
`suit would attribute to “administer[ed/ing].” See Lenze Decl. ¶¶ 29-31. The specification never
`
`describes writing or filling a prescription as a route of administration. Rather, it describes the
`
`2
`
`Page 6
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 7 of 27 PageID #: 994
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`“Products of the Invention” as being formulated into “conventional forms of administration,
`
`including peroral and parenteral forms.” ’804 patent 15:29-32. The phrase “peroral and
`
`parenteral forms of administration” describes the path taken by the drug into the body.
`
`Defendants’ construction properly construes “administer[ed/ing]” in a way that is consistent with
`
`the scope of the claims, the logical interpretation of a POSA and the plain meaning of the term.
`
`Accordingly, as this Court has recently held and the Federal Circuit has recently affirmed,
`
`“administer[ed/ing]” should be construed as “deliver[ed/ing] into the body.” Takeda Pharm. Co.
`
`v. Actavis Labs. FL, Inc., C.A. No. 15-451-RGA, 2016 WL 3193188, at *2-3 (D. Del. Jun. 6,
`
`2016); Andrulis Pharm. Corp. v. Celgene Corp., C.A. No. 13-1644-RGA, 2015 WL 3978578, at
`
`*2-3 (D. Del. Jun. 26, 2015), aff’d No. 2015-1962, 2016 WL 3755929 (Fed. Cir. July 14, 2016)
`
`(per curiam).
`
`B.
`
`“effective amount”
`
`Claim
`Term
`“effective
`amount”
`
`Patent & Claim
`
`’195 patent, claims 1-2
`’804 patent, claim 1
`’921 patent, claims 13-
`14
`
`Plaintiffs’
`Construction
`Amount sufficient
`to promote a
`therapeutic effect
`
`Defendants’
`Construction
`An amount of the specified
`crystalline modification of
`vilazodone HCl sufficient to
`produce the desired effect
`
`1.
`
`“effective amount” Refers to Crystalline Modifications of Vilazodone
`HCl.
`
`Defendants agree with Plaintiffs that the “patents-in-suit relate to crystalline forms of the
`
`compound vilazodone HCl.” Pls.’ Br. at 1 (emphasis added). Each of the claims of the patents-
`
`in-suit which recites an “effective amount” refers to an effective amount of a specified crystalline
`
`modification of vilazodone HCl:
`
`’804 patent, claim 1 recites “a pharmaceutical composition comprising an
`effective amount of [vilazadone hydrochloride] . . . in crystalline modification
`IV.”
`
`3
`
`Page 7
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 8 of 27 PageID #: 995
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`’195 patent, claim 1 recites “an effective amount of a compound which is a
`crystalline hydrochloride salt”; claim 2 depends from claim 1.
`
`’921 patent, claim 13 recites “administering to the patient in need thereof an
`effective amount of a compound, wherein the compound is 1-[4-(5-cyanoindol-
`3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride
`monohydrate in its crystalline modification (V)”; claim 14 depends from claim
`13.
`
`In every instance in which an “effective amount” is referenced in the patents-in-suit, it
`
`refers to crystalline vilazodone HCl. Plaintiffs concede that “[e]ach of the claims at issue
`
`explicitly identifies what substance must be present in an ‘effective amount.’” Pls.’ Br. at 16. In
`
`every instance, the claimed substance is a crystalline modification of vilazodone HCl.
`
`Plaintiffs argue that “[c]laim 1 [of the ’195 patent] does not recite an effective amount of
`
`a ‘crystalline modification,’ but rather an effective amount of ‘a crystalline hydrochloride salt’ of
`
`vilazodone.” Id. This argument supports Defendants’ proposed construction because a
`
`crystalline hydrochloride salt of vilazodone is a crystalline modification of vilazodone HCl –
`
`even under Plaintiffs’ proposed construction of “crystalline modification” to mean a “crystalline
`
`form.” See id. at 4. Further, a POSA reviewing the claims would need to understand what
`
`particular forms of crystalline vilazodone they are directed to, because the specific form being
`
`administered can have a direct impact on the amount sufficient to cause a therapeutic effect in
`
`the patient. See Lenze Decl. ¶¶ 24-26. A POSA reviewing claim 1 of the ’195 patent would
`
`understand the claim to be limited to the forms of crystalline vilazodone disclosed in the patent.
`
`See id. ¶ 26.
`
`Plaintiffs’ argument that an “effective amount” is not limited to the specified crystalline
`
`modifications of vilazodone HCl is simply incorrect. Under Plaintiffs’ construction, a
`
`composition containing vilazodone that is effective in treating any of the disorders disclosed in
`
`the patents-in-suit but which contains only a trace amount of any of the specifically recited
`
`4
`
`Page 8
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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 9 of 27 PageID #: 996
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`crystalline modifications of vilazodone HCl would be considered an effective amount. Dr.
`
`Thase suggests that the crystalline forms being administered may be one step in a drug treatment
`
`regimen including other drugs that in combination produce an effect, however the claims clearly
`
`do not attempt to claim such a regimen. See Lenze Decl. ¶ 27. The claims specifically require
`
`an effective amount of crystalline modifications of vilazodone HCl. Thus, the desired effect of
`
`treating one or more of the disorders disclosed in the patents-in-suit must be produced by a
`
`claimed crystalline modification of vilazodone HCl, not some other pharmaceutical composition
`
`or some other unclaimed form(s) of vilazodone HCl.
`
`Accordingly, the term “effective amount” as used in the patents-in-suit should be
`
`construed to mean “an amount of the specified crystalline modification of vilazodone HCl
`
`sufficient to produce the desired effect.”
`
`2.
`
`An “effective amount” Must “produce” Rather Than Merely
`“promote” the Desired Effect.
`
`The parties further disagree about whether an effective amount of a crystalline
`
`modification of vilazodone HCl must “produce” or merely “promote” a desired effect.
`
`Plaintiffs argue that “[c]linicians understand that virtually no medicine is effective 100%
`
`of the time or in 100% of patients.” Pls.’ Br. at 16. However, a clinician would consider an
`
`“effective amount” or “efficacious dose” of a drug to be an amount necessary to produce or
`
`cause the desire effect. See Lenze Decl. ¶¶ 21-22. If the Plaintiffs’ proposed construction is
`
`correct then the amount necessary to “promote” an effect would be largely irrelevant, because
`
`simply introducing a drug that is known to potentially cause a therapeutic effect in some patients
`
`would be “promoting” a result. See id. ¶ 23.
`
`As referenced above, Plaintiffs further argue that a drug product or treatment regimen
`
`may include two or more components, each of which contributes to – or promotes – the desired
`
`5
`
`Page 9
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 10 of 27 PageID #: 997
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`effect, and that in such a therapy, there may be an effective amount of each component even if no
`
`component alone is present in an amount sufficient to produce the desired effect. See Pls.’ Br. at
`
`17. Again, this argument is irrelevant to the claims of the patents-in-suit. The pertinent claims
`
`recite an effective amount of specified crystalline modifications of vilazodone HCl. No other
`
`pharmaceutical substances are recited in the claims, and the “effective amount” is directed solely
`
`to the specified crystalline modifications of vilazodone HCl. Thus, the claim language itself
`
`requires that the effective amount be of the claimed composition, i.e., the specified crystalline
`
`modifications of vilazodone HCl.
`
`Put simply, if a particular amount of a specified crystalline modification of vilazodone
`
`HCl is administered to a patient, and that amount of that crystalline modification of vilazodone
`
`HCl does not produce the desired effect, that particular amount cannot be considered an effective
`
`amount. Accordingly, an “effective amount” of a specified crystalline modification of
`
`vilazodone HCl as used in the patents-in-suit means an amount of the specified crystalline
`
`modification of vilazodone HCl sufficient to produce the desired effect.
`
`Conversely, if the Court were to adopt Plaintiffs’ proposed claim construction such that
`
`an effective amount need only contribute to a desired effect, such a claim construction might
`
`cover a composition in which the vilazodone is essentially completely in another form (e.g., a
`
`different crystalline modification) but which includes merely a trace amount of the specified
`
`crystalline modifications of vilazodone HCl.
`
`As explained in Defendants’ opening claim construction brief, Plaintiffs’ proposed
`
`construction of “effective amount” clearly goes against the plain language of claim 1 of the ’804
`
`patent, which specifically recites crystalline modification Form IV of vilazodone. See Defs.’
`
`Opening Claim Constr. Br. at 6 (D.I. 86, June 22, 2016) (“Defs.’ Br.”). For example, if a 10 mg
`
`6
`
`Page 10
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 11 of 27 PageID #: 998
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`tablet contained 0.01 mg of vilazodone crystalline modification Form IV and 9.99 mg of a
`
`different crystalline modification form of vilazodone, then under Plaintiffs’ proposed
`
`construction, Plaintiffs would assert that the 0.01 mg of crystalline modification Form IV
`
`contributes to (and therefore “promotes”) the patient’s treatment. But, the clear meaning of
`
`claim 1 of the ’804 patent requires that the vilazodone crystalline modification Form IV itself be
`
`present in an effective amount, not merely in trace amounts.
`
`Contrary to Plaintiffs’ assertion, Defendants’ construction is not inconsistent with the
`
`parties’ agreed construction of “treating” as “attempting to cause a therapeutic effect on.” See Jt.
`
`Claim Constr. Charts, Ex. A (D.I. 80-1, May 25, 2016). To “cause” is to “bring[] about an
`
`effect.” Webster’s Third New International Dictionary 356 (Merriam-Webster, Inc. 1993).
`
`Defendants’ proposed claim construction – which recites to “produce” or cause a desired effect –
`
`is more accurate than Plaintiffs’ proposed construction that the claimed crystalline modification
`
`of vilazodone merely “promote” (i.e., “encourage” or “contribute to”) a desired effect.
`
`Accordingly, the term “effective amount” as used in the patents-in-suit should be
`
`construed to mean “an amount of the specified crystalline modification of vilazodone HCl
`
`sufficient to produce the desired effect.”
`
`C.
`
`“crystalline modification” and “crystalline”
`
`Claim
`Term
`“crystalline
`modification”
`or
`“crystalline”
`
`Patent & Claim
`
`’020 patent, claim 1
`’195 patent, claim 1
`’804 patent, claim 1
`’921 patent, claims 1, 5, 11,
`13
`
`Plaintiffs’
`Construction
`Crystalline form (for
`“crystalline
`modification”), plain
`meaning/no
`construction required
`(for “crystalline”)
`
`Defendants’
`Construction
`Entirely in
`crystalline form
`comprising only
`Form I to XVI, and
`combinations
`thereof (as
`appropriate)
`
`7
`
`Page 11
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 12 of 27 PageID #: 999
`
`1.
`
`“crystalline modification” and “crystalline” Refer to the Specific
`Forms Defined as the Products of the Invention, and Combinations
`thereof as Appropriate.
`
`The specification unequivocally states that Forms I, II, III, IV, V, VI, VII, VIII, IX, X,
`
`XI, XIII, XIV, XV, and XVI are the “products of the invention.” See ’921 patent 14:58-63.
`
`Plaintiffs’ position that these forms are merely “exemplary” or “preferred embodiments”
`
`contrasts with the clear language of the patent designating these forms as the invention itself.
`
`The fact that the term “crystalline modifications,” is utilized would inform a POSA that multiple
`
`forms are being claimed, and a POSA would look to the patents to identify the exact forms being
`
`claimed. See Karpinksi Decl. ¶ 22.
`
`Plaintiffs cite (at 9) Williamson v. Citrix Online, LLC, 770 F.3d 1371 (Fed. Cir. 2014),
`
`and Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294 (Fed. Cir. 2003), in support
`
`of their argument that the claims should not be limited to the products of the invention. But
`
`these cases are inapposite. In Williamson,3 the court concluded that the specification’s disclosure
`
`of certain examples and embodiments were “consistently described in terms of preference,” and
`
`the specification never limited the invention to these examples. 792 F.3d at 1347. In Brookhill-
`
`Wilk, the court acknowledged that one “object” of the invention was to perform an operation on a
`
`patient at a distance, but there was no language in the specification limiting the use of the
`
`invention to outside the operating room. See 334 F.3d at 1301.
`
`In the present case, however, the crystalline forms of vilazodone are designated as the
`
`products of the invention for the patents-in-suit, not merely examples or objectives. They are the
`
`invention. As articulated in Defendants’ opening brief, the specification admits that a prior
`
`3 Defendants note that the Williamson opinion cited by Plaintiffs was vacated by 603 F.
`App’x 1010, superseded by 792 F.3d 1339 (Fed. Cir. 2015).
`
`8
`
`Page 12
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`

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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 13 of 27 PageID #: 1000
`
`patent – U.S. Patent No. 5,532,241 of Bottcher et al. (“Bottcher”) – disclosed crystalline
`
`vilazodone generally. See Defs.’ Br. at 7-8. However, the detailed descriptions of the patents-in-
`
`suit claim that “the specific crystalline forms of the present invention have certain advantages
`
`over the product obtained according to U.S. Pat. No. 5,532,241.” ’921 patent 5:4-6 (emphasis
`
`added).
`
`The specification discloses that:
`
`by use of the crystalline forms of the present invention, it is possible to obtain
`galenic formulations having improved homogenicity, stability, purity and
`uniformity from one batch to the other.
`
`Id. 5:22-25. The specification goes on to describe each of Forms I, II, III, IV, V, VI, VII, VIII,
`
`IX, X, XI, XIII, XIV, XV, and XVI of crystalline vilazodone as the “products of the invention.”
`
`In each instance, the particular form is described as “according to the invention,” further
`
`elucidating that the forms are not merely illustrative, but are the inventions of the patents-in-suit.
`
`Id. 5:26; 6:13, 65; 7:40, 65; 8:41; 9:35; 10:25, 65; 11:58; 12:42, 13:14, 41, 52; 14:4, 9, 34.
`
`The Federal Circuit recently confirmed that:
`
`claim terms are construed in light of the specification and prosecution history, not
`in isolation. The specification and prosecution history compel departure from the
`plain meaning in only two instances: lexicography and disavowal.
`
`Pacing Techs., LLC v. Garmin Int’l, Inc., 778 F.3d 1021, 1024 (Fed. Cir. 2015) (internal citation
`
`omitted). In Pacing, the Federal Circuit acknowledged that the claim term at issue – “repetitive
`
`motion pacing system for pacing a user” – did not in itself require the claimed system to pace the
`
`user by playing back the pace information using a certain tempo. Id. However, the Federal
`
`Circuit affirmed the district court’s construction of the disputed term to mean a system “having a
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`data storage and playback device that is adapted to producing a sensible tempo.” The Federal
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`Circuit found that the specification “clearly and unmistakably” limited the patented system when
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`it stated that “objects and features of the present invention are accomplished, as embodied and
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`fully described herein, by a repetitive motion pacing system that includes . . . a data storage and
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`playback device adapted to producing the sensible tempo.” Id. at 1025.
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`In Baxter Healthcare Corp. v. Mylan Laboratories Ltd., the district court construed the
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`phrase “injectable, aqueous pharmaceutical composition,” to mean “a stable, ready-to-use
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`aqueous parenteral solution.” Nos. 14-cv-7094, et al., 2016 WL 1337279, at *13-17 (D.N.J. Apr.
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`5, 2016). In doing so, the district court cited the fact that the patent itself was called “READY-
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`TO-USE ESMOLOL SOLUTION” and defined the solution by reference to its stable and ready-
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`to-use aspects throughout the specification. Id. at *14. The court cited repeated references to the
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`“present invention” being described as “ready-to-use” and “stable,” concluding that:
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`Indeed, the language of the specification squarely matches the circumstances
`identified by the Federal Circuit as limiting claim scope, because the disclosure
`repeatedly defines the “present invention” or “product” as stable and ready-to-use,
`and disparages the instability and dilution requirement (or, non-ready-to-use
`preparation) of prior art esmolol compositions. This Court can scarcely imagine
`disclosures more concise and unequivocal than expressed in the specification of
`the ’094 Patent.
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`Id. at *14-15.
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`In this case, each of the patents-in-suit is titled “Polymorphic forms of 1-[4-(5-
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`cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride,” indicating
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`that particular forms are the subjects of these patents. As described in Defendants’ opening brief
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`and above, the specific forms of crystalline vilazodone are consistently referred to as the
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`“products of the invention,” in the specification, similar to the specifications in Pacing and
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`Baxter. Further, the patents themselves were allowed by the U.S. Patent and Trademark Office
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`over the prior art, because the alleged invention was directed to specific forms of crystalline
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`vilazodone, which the prior art did not teach. See Defs.’ Br. at 9-11. Plaintiffs’ attempt to
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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 15 of 27 PageID #: 1002
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`broaden the scope of its claims to encompass any or all forms of crystalline vilazodone would
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`contradict the prosecution history of the patents, as well as render the claims indefinite under 35
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`U.S.C. § 112.
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`2.
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`The Term “crystalline” Requires Construction.
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`In each claim of the patents-in-suit, the term “crystalline” is paired with either the word
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`“modification,” or “form,” with the exception of claim 1 of the ’195 patent. “[C]rystalline” has
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`been included as a separate term for construction to address this claim. For the same reasons that
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`“crystalline modification” should be construed to refer to the specific forms that are the products
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`of the invention, “crystalline” as used in this term should be construed the same way. This is
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`regardless of the fact that “crystalline,” may have an ordinary meaning that may differ from such
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`a construction.
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`For example, in Wyeth v. Teva Pharmaceuticals USA, Inc., the district court construed the
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`term “extended release formulation” to mean a formulation containing certain specific
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`ingredients. No. 03-cv-1293, 2005 WL 2175440 (D.N.J. Sept. 6, 2005). Although the court
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`acknowledged that the claim term on its face implied a broader construction that did not include
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`specific ingredients, it found that the narrow definition given to the term in the specification
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`overcame that presumption. See id. at *4. In support of its construction, the court cited
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`statements in the specification such as “the invention comprises,” “formulations of this invention
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`comprise,” and the “extended release formulations of this invention are,” all of which were
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`followed by the specific ingredients the court construed the term to include. Id. at *5. The court
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`rejected the patentee’s argument that these statements merely identified preferred embodiments,
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`and found that the statements definitively limited the formulations of the invention to specific
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`ingredients. See id.; see also Astrazeneca AB v. Mutual Pharm. Co., 384 F.3d 1333, 1341 (Fed.
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`Cir. 2004) (specification of the patent overcomes any ordinary meaning of “solubilizer”).
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`For the same reasons the courts in Wyeth, Baxter, and Pacing (discussed above) narrowly
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`construed terms that were open to more general interpretation, the term “crystalline” in claim 1
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`of the ’195 patent should be construed to be more limiting than simply a general crystalline form
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`of vilazodone as proposed by Plaintiffs. Like in Wyeth, the specification makes clear that the
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`only forms of crystalline vilazodone within the scope of the patent are the forms specifically
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`disclosed, and the prosecution history of the ’195 patents supports such a construction. See
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`Defs.’ Br. at 10; Karpinski Decl. ¶ 25. If “crystalline,” as used in claim 1 of the ’195 patent is
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`interpreted to mean any possible form of crystalline vilazodone, then the patent would claim
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`much more than is disclosed in the specification, which explicitly designates the particular forms
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`to be the “products of the invention.” Such a construction would clearly be improper. See
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`Chimie v. PPG Indus., 402 F.3d 1371, 1379 (Fed. Cir. 2005) (claims of a patent are not entitled
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`to a broader scope than an embodiment described in a specification as the invention itself);
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`Karpinski Decl. ¶ 26 (a POSA would understand “crystalline” as used in the ’195 patent claim 1
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`to be referring to one or more of the 15 forms disclosed in the patent).
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`3.
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`Entirely Crystalline
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`Plaintiffs argue that “crystalline” as used in the patents-in-suit should be construed to
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`encompass materials that are not entirely crystalline. Such a construction goes against the plain
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`language of the claims and the understanding of a POSA reviewing them. A POSA would
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`understand the term “crystalline” to refer to materials that are composed solely of crystals, and
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`that do not contain amorphous material. See Karpinski Decl. ¶ 20. A POSA reviewing claim 1
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`of the ’195 patent would understand that claim’s recitation of “a compound which is crystalline”
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`to mean that the claimed compound is entirely crystalline. See id. ¶ 21. If the intention had been
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`to claim a compound containing potentially both crystalline and amorphous material, a POSA
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`would expect the compound to be recited as a mixture of the two types of material, not as solely
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`Case 1:15-cv-00272-GMS Document 93 Filed 07/27/16 Page 17 of 27 PageID #: 1004
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`“crystalline.” See id.
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`Plaintiffs further argue that it is redundant to define “crystalline vilazodone” in any as
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`“entirely crystalline.” Pls.’ Br. at 8. Defendants maintain that it is useful to clarify for purposes
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`of possible infringement arguments that the vilazodone included in the ANDA products at issue
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`must be “entirely crystalline.” Defendants’ position is supported by the prosecution history, in
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`whic