Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 1 of 27 PageID #: 715
`
`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’ OPENING 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: June 22, 2016
`1227150 / 42390 (cons.)
`
`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
`
`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 EX1007
`
`Page 1
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`

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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 2 of 27 PageID #: 716
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`INTRODUCTION .............................................................................................................. 1
`
`LEGAL AUTHORITY ....................................................................................................... 1
`
`CONSTRUCTIONS OF DISPUTED CLAIM TERMS..................................................... 2
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`The Correct Construction of “Administer[ed/ing]” is “Deliver[ed/ing] into
`the body.”................................................................................................................ 2
`
`The Correct Construction of “Effective Amount” is “An Amount of the
`Specified Crystalline Modification of Vilazodone HCl Sufficient to
`Produce the Desired Effect.”................................................................................... 4
`
`The Correct Construction of “Crystalline Modification” or “Crystalline” is
`“Entirely in Crystalline Form Comprising Only Form I to XVI, and
`Combinations Thereof (as Appropriate).” .............................................................. 6
`
`1.
`
`2.
`
`The Claim Language and Specification Support Defendants’
`Constructions. ............................................................................................. 7
`
`The Prosecution Histories Support Defendants’ Construction. .................. 9
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`Prosecution History of the ’020 Patent. ............................................ 9
`
`Prosecution History of the ’195 Patent. .......................................... 10
`
`Prosecution History of the ’804 Patent. .......................................... 10
`
`Prosecution History of the ’921 Patent. .......................................... 11
`
`Forest May Not Seek To Have the Claims Construed More
`Broadly Than the Positions Taken During Prosecution.................. 11
`
`The Correct Construction of “Exhibits the Following XRD Data” is “Must
`Show All the Following Peaks and Intensities.”................................................... 12
`
`The Correct Construction of “Corresponding to” is “Matching the Precise
`Values Recited in the Claims.” ............................................................................. 15
`
`The Correct Construction of “Characteristic Peak[]” is “A Powder XRD
`Peak Having Intensity ≥ 3*noise, Which Serves to Identify the Crystalline
`Modification.”....................................................................................................... 17
`
`G.
`
`Preambles are Not Limiting.................................................................................. 18
`
`IV.
`
`CONCLUSION................................................................................................................. 20
`
`i
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`Page 2
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`

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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 3 of 27 PageID #: 717
`
`TABLE OF AUTHORITIES
`
`CASES
`Abbott Labs. v. Baxter Pharm. Prods., Inc.,
`334 F.3d 1274 (Fed. Cir. 2003)........................................................................................... 5
`ACTV, Inc. v. Walt Disney Co.,
`346 F.3d 1082 (Fed. Cir. 2003)........................................................................................... 2
`Andrulis Pharm. Corp. v. Celgene Corp.,
`C.A. No. 13-1644-RGA, 2015 WL 3978578 (D. Del. June 26, 2015),
`appeal docket, No. 15-1962 (Fed. Cir. Sept. 1, 2015) ........................................................ 3
`Aspex Eyeware, Inc. v. Marchon Eyewear, Inc.,
`672 F.3d 1335 (Fed. Cir. 2012)......................................................................................... 18
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006)........................................................................................... 19
`Braintree Labs., Inc. v. Novel Labs., Inc.,
`749 F.3d 1349 (Fed. Cir. 2014)......................................................................................... 19
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002)........................................................................................... 19
`Digital Biometrics, Inc. v. Identix, Inc.,
`149 F.3d 1335 (Fed. Cir. 1998)........................................................................................... 2
`Jeneric/Pentron, Inc. v. Dillon Co.,
`205 F.3d 1377 (Fed. Cir. 2000)......................................................................................... 12
`Medical Research Inst. v. Bioengineering Supplements & Nutrition, Inc.,
`No. 605-cv-417, 2007 WL 128937 (E.D. Tex. Jan. 12, 2007) ........................................... 3
`Microsoft Corp. v. Multi-Tech Sys., Inc.,
`357 F.3d 1340 (Fed. Cir. 2004)........................................................................................... 2
`Minnesota Mining & Mfg. Co. v. Chemque, Inc.,
`303 F.3d 1294 (Fed. Cir. 2002)........................................................................................... 5
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)....................................................................................... 1, 2
`Renishaw PLC v. Marposs Societa’ per Azioni,
`158 F.3d 1243 (Fed. Cir. 1998)........................................................................................... 9
`Rheox, Inc. v. Entact, Inc.,
`276 F.3d 1319 (Fed. Cir. 2002)........................................................................................... 2
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997)........................................................................................... 19
`Southwall Techs., Inc. v. Cardinal IG Co.,
`54 F.3d 1570 (Fed. Cir. 1995)..................................................................................... 14, 17
`
`ii
`
`Page 3
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`

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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 4 of 27 PageID #: 718
`
`Springs Window Fashions LP v. Novo Indus., L.P.,
`323 F.3d 989 (Fed. Cir. 2003)............................................................................................. 2
`TomTom, Inc. v. Adolph,
`790 F.3d 1315 (Fed. Cir. 2015)................................................................................... 19, 20
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)............................................................................................. 8
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997).............................................................................................................. 1
`STATUTES
`35 U.S.C. § 112....................................................................................................................... 15, 16
`OTHER AUTHORITIES
`Webster’s Third New International Dictionary (Merriam-Webster, Inc. 1993) ....................................6
`
`iii
`
`Page 4
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 5 of 27 PageID #: 719
`
`I.
`
`INTRODUCTION
`
`Defendants1 in this Hatch-Waxman patent case seek approval from the U.S. Food and
`
`Drug Administration (“FDA”) to market generic versions of the drug Viibryd®. Forest2 alleges
`
`that Defendants infringe four Orange Book-listed patents that relate to crystalline forms of the
`
`chemical vilazodone hydrochloride (“HCl”), and their use in treating depression and other
`
`disorders. Vilazodone HCl is an old compound, well known in the prior art and well known for
`
`the treatment of depression and other disorders. 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”). While Forest maintains that nearly none of the terms in these
`
`patents’ claims require interpretation, the claims contain ambiguities that can be resolved only
`
`through review of the intrinsic evidence, including the patents’ specifications and prosecution
`
`histories before the U.S. Patent and Trademark Office (“PTO”).
`
`II.
`
`LEGAL AUTHORITY
`
`Claim language is given the meaning it would have to one of ordinary skill in the relevant
`
`art at the time the application was filed, in view of the patent specification. See Phillips v. AWH
`
`Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc). “Each element contained in a patent
`
`claim is deemed material to defining the scope of the patented invention.” Warner-Jenkinson
`
`Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997). “Like the specification, the prosecution
`
`history provides evidence of how the PTO and the inventor understood the patent” and “whether
`
`the inventor limited the invention in the course of prosecution, making the claim scope narrower
`
`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 “Forest” 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 86 Filed 06/22/16 Page 6 of 27 PageID #: 720
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`than it would otherwise be.” Phillips, 415 F.3d at 1317. A court “cannot construe the claims to
`
`cover subject matter broader than that which the patentee itself regarded as comprising its
`
`inventions and represented to the PTO.” Microsoft Corp. v. Multi-Tech Sys., Inc., 357 F.3d
`
`1340, 1349 (Fed. Cir. 2004). Arguments and amendments made during prosecution “to
`
`overcome prior art can lead to narrow claim interpretations because ‘[t]he public has a right to
`
`rely on such definitive statements.’” Rheox, Inc. v. Entact, Inc., 276 F.3d 1319, 1325 (Fed. Cir.
`
`2002) (quoting Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1347 (Fed. Cir. 1998)).
`
`“The prosecution history constitutes a public record of the patentee’s representations concerning
`
`the scope and the meaning of the claims, and competitors are entitled to rely on those
`
`representations when ascertaining the degree of lawful conduct.” Springs Window Fashions LP
`
`v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed. Cir. 2003).
`
`The Defendants’ proposed constructions are the most faithful to the intrinsic evidence
`
`and the understanding of a person of ordinary skill in the art.
`
`III.
`
`CONSTRUCTIONS OF DISPUTED CLAIM TERMS
`
`A.
`
`The Correct Construction of “Administer[ed/ing]” is “Deliver[ed/ing] into
`the body.”
`
`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
`
`Forest’s
`Construction
`Plain meaning/no
`construction required
`
`Defendants’
`Construction
`Deliver[ed/ing] into
`the body
`
`“[T]he analytical focus of claim construction must begin, and remain centered, on the
`
`language of the claims themselves.” ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed.
`
`Cir. 2003). Each claim that recites “administer[ed/ing]” is directed to a method of treating a
`
`patient. Moreover, several of those claims specify “wherein [a/the] . . . disorder is treated in the
`
`2
`
`Page 6
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 7 of 27 PageID #: 721
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`patient.” See ’195 patent, claim 1; ’804 patent, claim 1 (emphasis added). Thus, the claimed
`
`treatment methods target “disorders” that are “in” the body. The only way to treat a disorder in
`
`the body with a pharmaceutical compound is to deliver it into the body. Accordingly,
`
`Defendants’ construction “delivered [or delivering] into the body” of a patient – is consistent
`
`with the ordinary meaning of the terms in the context of the patents-in-suit.
`
`In similar cases, other courts have construed “administer[ed/ing]” to mean delivering into
`
`the body. See, e.g., Andrulis Pharm. Corp. v. Celgene Corp., C.A. No. 13-1644-RGA, 2015 WL
`
`3978578 (D. Del. June 26, 2015) (construing “administering” in claimed “method of treatment of
`
`neoplastic diseases in a mammal, which comprises administering to said afflicted mammal” as
`
`“delivering into or onto a [mammal’s] body”), appeal docket, No. 15-1962 (Fed. Cir. Sept. 1,
`
`2015); Medical Research Inst. v. Bioengineering Supplements & Nutrition, Inc., No. 605-cv-417,
`
`2007 WL 128937, at *1, 7 (E.D. Tex. Jan. 12, 2007) (construing “administering” in claimed
`
`“method of treating atherosclerosis in a human patient” as “delivering the formulation-in-
`
`question into a person’s body”).
`
`The specification further confirms Defendants’ construction. The specification discloses
`
`several different ways that the claimed drugs may be administered stating that “the Products of
`
`the Invention can be formulated into the conventional forms of administration, including peroral
`
`and parenteral forms of administration. Tablets or capsules are preferred formulations.” ’804
`
`patent 15:29-32. The phrases “forms of administration, including peroral and parenteral” and
`
`“[t]ablets or capsules” describe routes of administration, or in other words, paths taken by the
`
`drug to get into the body.
`
`To the extent that Forest suggests that the plain and ordinary meaning of
`
`“administer[ed/ing]” is “provide[ed/ing],” that implicit construction should be rejected. A
`
`3
`
`Page 7
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 8 of 27 PageID #: 722
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`disorder cannot be treated merely by “providing” a drug to a patient – the drug must enter into
`
`the patient’s body. The Court should not adopt a plain and ordinary meaning that implicitly
`
`construes the “administer[ed/ing]” terms to encompass the scenario in which a composition
`
`containing a pharmaceutical compound is handed or prescribed to a patient suffering from a
`
`disorder, but is never taken by the patient and therefore never enters into the body. In such an
`
`instance, the disorder was not treated and the claim is not satisfied.
`
`Forest relies on a passage in the specification stating that the “present invention further
`
`provides a method for treating and/or preventing any one or more of the Disorders by
`
`administering an effective and/or prophylactic amount of the Products of the Invention to a
`
`patient in need thereof.” ’804 patent 15:64-67. However, as explained above, the disorders
`
`cannot be treated, nor can a dosage be “effective” or “prophylactic,” if the pharmaceutical
`
`composition never enters the patient’s body. Accordingly, the administer[ed/ing] terms should
`
`be construed to mean “deliver[ed/ing] into the body.”
`
`B.
`
`The Correct Construction of “Effective Amount” is “An Amount of the
`Specified Crystalline Modification of Vilazodone HCl Sufficient to Produce
`the Desired Effect.”
`
`Claim
`Term
`“effective
`amount”
`
`Patent & Claim
`
`’195 patent, claims 1-2
`’804 patent, claim 1
`’921 patent, claims 13-
`14
`
`Forest’s
`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
`
`“Effective amount” should be construed to mean “an amount of the specified crystalline
`
`modification of vilazodone HCl sufficient to produce the desired effect.” In contrast, Forest
`
`appears to take the position that “effective amount” relates to the total amount of vilazodone,
`
`even if only a minuscule portion is the recited crystalline modification. Forest’s argument is
`
`incorrect as a matter of law.
`
`4
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`Page 8
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 9 of 27 PageID #: 723
`
`In Abbott Laboratories v. Baxter Pharmaceutical Products, Inc., 334 F.3d 1274 (Fed.
`
`Cir. 2003), the Federal Circuit reviewed a district court’s construction of the claim term
`
`“effective amount.” The Federal Circuit held:
`
`[T]his court notes that the term “effective amount” has a customary usage. Under
`this usage, the term would mean “the amount of Lewis acid inhibitor that will
`prevent the degradation of sevoflurane by a Lewis acid.” See Minn. Mining &
`Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1299, 1304 (Fed. Cir. 2002) (affirming
`the district court’s construction of the claim term “effective amount” to mean “a
`sufficient amount of the specified component to form an encapsulant having the
`specified properties under the specified conditions, if any”).
`
`Id. at 1277-78.
`
`Thus, the customary usage of an “effective amount” means an amount of recited
`
`substance sufficient to produce the desired effect. Id. In this case, “effective amount” therefore
`
`means “an amount of the specified crystalline modification of vilazodone HCl sufficient to
`
`produce the desired effect.” That is, the specifically recited crystalline modification of
`
`vilazodone, must, in itself, be a sufficient amount to bring about the desired effect.
`
`Additionally, the parties dispute what it means to be effective. Defendants assert that an
`
`effective amount of the crystalline form is an amount sufficient to produce the desired effect,
`
`whereas Forest asserts that an effective amount is an amount sufficient to promote a therapeutic
`
`effect. But, the ’804 patent states that “[t]he present invention further provides a method for
`
`treating and/or preventing any one or more of the Disorders by administering an effective and/or
`
`prophylactic amount of the Products of the Invention to a patient in need thereof.” ’804 patent
`
`15:64-67 (emphasis added). Similarly, claim 1 of the ’804 patent recites “A method of treating a
`
`major depressive disorder, the method comprising: administering to a patient in need thereof a
`
`pharmaceutical composition comprising an effective amount of . . . [vilazodone] in crystalline
`
`modification IV . . . wherein the major depressive disorder is treated in the patient.” See
`
`also ’195 patent, claim 1. Thus the claims require the effective amount of the specifically recited
`
`5
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`Page 9
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 10 of 27 PageID #: 724
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`crystalline form of vilazodone itself be sufficient to treat the disclosed disorder. The parties have
`
`stipulated that “treating” means “attempting to cause a therapeutic effect on” and that “is treated
`
`in the patient” means “an attempt is made to cause a therapeutic effect in the patient.” Joint
`
`Claim Construction Charts, Ex. A at 1 (D.I. 80-1, May 25, 2016) (emphases added). To “cause”
`
`is to “bring[] about an effect.” Webster’s Third New International Dictionary 356 (Merriam-
`
`Webster, Inc. 1993). Accordingly, Defendants’ proposed claim construction – which recites “to
`
`produce” or cause a desired effect – is more accurate than Forest’s suggestion that the drug must
`
`only be present in an amount sufficient “to promote” (i.e., to encourage) a therapeutic effect.
`
`Forest’s proposed definition also leads to illogical results. Take, for example, a tablet
`
`containing 10 mg of vilazodone. If 0.01 mg in the tablet is crystalline Form IV vilazodone, and
`
`9.99 mg is a different form, Forest might allege that the 0.01 mg of crystalline Form IV
`
`contributes to (and therefore “promotes”) the patient’s treatment. But this clearly goes against
`
`the plain language of claim 1 of the ’804 patent, which requires that the crystalline Form IV
`
`vilazodone itself be present in an effective amount. Forest would, in essence, have the Court re-
`
`write the claim as though it had been written “an effective amount of vilazodone, the vilazodone
`
`comprising at least a trace of crystalline Form IV vilazodone.”
`
`C.
`
`The Correct Construction of “Crystalline Modification” or “Crystalline” is
`“Entirely in Crystalline Form Comprising Only Form I to XVI, and
`Combinations Thereof (as Appropriate).”
`
`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
`
`Forest’s
`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)
`
`6
`
`Page 10
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`

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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 11 of 27 PageID #: 725
`
`“Crystalline modification” or “crystalline” refers to the specific crystalline forms of
`
`vilazodone disclosed in the patent and described by the patentees as the “products of the
`
`invention.” Forest’s argument that these terms may encompass other forms, particularly a form
`
`that is not crystalline, belies the plain language of the claims and the prosecution history of the
`
`patents.
`
`1.
`
`The Claim Language and Specification Support Defendants’
`Constructions.
`
`Forest concedes that the term “crystalline modification” refers to a crystalline form of
`
`vilazodone, but disputes that this term should be construed to only refer to forms of crystalline
`
`vilazodone disclosed in the patent. Forest’s effort to broaden the scope of the patents-in-suit has
`
`no basis in the claim terms or specification.
`
`First, the claim language itself proves that “crystalline” or “crystalline modification”
`
`must be referring to the specific forms found by the patentees. As used in claim 1 of the ’020
`
`patent, claim 1 of the ’804 patent, and claims 5, 11, and 13 of the ’921 patent, “crystalline
`
`modification,” is followed by a Roman numeral, either “IV” or “(V).” In claim 1 of the ’020
`
`patent and claim 1 of the ’804 patent, the Roman numeral is followed by a parenthetical further
`
`stating “(Form IV).” If these references are not to the specific forms found in the patent, as
`
`Forest’s constructions propose, then these references are simply nonsensical.
`
`Second, the specification, which is shared by all the patents-in-suit, makes it clear that the
`
`patents relate to specific forms of crystalline vilazodone. See Vitronics Corp. v. Conceptronic,
`
`Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (patent specification “is always highly relevant to the
`
`claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning
`
`of a disputed term.”). Forest admits that a prior art patent, U.S. Patent No. 5,532,241 (the “’241
`
`patent”), discloses vilazodone specifically as a mixture of amorphous and crystalline HCl salt.
`
`7
`
`Page 11
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 12 of 27 PageID #: 726
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`The patent states in the Background that the ’241 patent discloses the free base and its
`
`conversion to the HCl salt. See ’921 patent 1:35-57. It also states that “[t]here is no clear
`
`teaching elsewhere in the document [’241 patent] of any alternative route or modification to the
`
`process which would generate new crystal modifications of [vilazodone] or new solvates or
`
`hydrates of [vilazodone] in different crystal modifications.” Id. 1:57-64 (emphases added). The
`
`patent continues:
`
`Certain crystalline, i.e. morphological forms of pharmaceutical compounds may be
`of interest to those involved in the development of a suitable dosage form because
`if the morphological form is not held constant during clinical and stability studies,
`the exact dosage used or measured may not be comparable from one lot to the
`next. . . . Therefore, it is imperative to assure that either a single morphological
`form or some known combination of morphological forms is present.
`
`Id. 2:6-18 (emphasis added).
`
`And the patent relates the term “crystalline modifications” to the terms “solvate,”
`
`“hydrate,” and “anhydrate,” stating:
`
`Accordingly, the present invention provides solvates of [vilazodone] in crystalline
`modifications and their use.” Id. 2:44-47.
`
`The present invention furthermore provides [vilazodone] hydrates in crystalline
`modifications and their use.” Id. 2:56-59.
`
`The present invention also provides [vilazodone] anhydrates in crystalline modifications
`and their use.” Id. 3:1-4.
`
`It therefore follows that the term “crystalline” or “crystalline modifications” refers to the
`
`specific solvate, hydrate, and anhydrate polymorphs found in these specific patents. This is not
`
`an all-encompassing term covering any crystalline vilazodone HCl.
`
`The patentees summarize the invention as consisting of specific forms of pure crystalline
`
`vilazodone designated I, II, III, IV, V, VI, VII, VIII, IX, X, XI, XIII, XIV, XV, and XVI. See id.
`
`2:25-40. The patents further state that “[t]hroughout the specification, the term “Form” is
`
`generally used as a synonym for the term “modification” or “crystalline modification.” Id. 2:41-43.
`
`8
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`Page 12
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 13 of 27 PageID #: 727
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`In the detailed description of the invention the “products of the invention” are defined to
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`be the specific forms of crystalline vilazodone described by the patent: Forms I, II, III, IV, V,
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`VI, VII, VIII, IX, X, XI, XIII, XIV, XV, and XVI. See id. 14:58-63. As stated by the Federal
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`Circuit:
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`Ultimately, the interpretation to be given a term can only be determined and
`confirmed with a full understanding of what the inventors actually invented and
`intended to envelop with the claim. 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.
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`Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (internal
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`citation omitted). Because the patents-in-suit plainly state that these specific forms of crystalline
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`vilazodone are the invention covered by the patents, the claims should be construed to only cover
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`those crystalline forms.
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`2.
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`The Prosecution Histories Support Defendants’ Construction.
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`The prosecution histories of the patents-in-suit establish that the patentees considered
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`their invention to be limited to the specific, disclosed forms of crystalline vilazodone.
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`a.
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`Prosecution History of the ’020 Patent.
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`The PTO rejected the central claim of the ’020 patent, claim 1, as anticipated by the ’241
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`patent. In rejecting the claim, the PTO stated that the applicants admitted that the ’241 patent
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`disclosed in its Example 4 a mixture of amorphous and crystalline vilazodone HCl. See ’020
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`patent history, 4/28/2008 Office Action Summary at 5 (VB0000271); ’020 patent 1:50-57. To
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`overcome this rejection, the patentees amended claim 1 to specifically recite the Form IV
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`polymorph of vilazodone HCl, and deleted a reference to amorphous 1-[4-(5-cyanoindol-3-
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`yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. See ’020 patent history,
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`3/18/2010 Reply (VB0000253-262). On this basis, the PTO allowed the claims. See ’020 patent
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`9
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`Page 13
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 14 of 27 PageID #: 728
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`history, 4/28/2008 Notice of Allowance and Fee(s) Due (VB0000212-214); ’020 patent history,
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`6/18/2010 Notice of Allowability (VB0000215-217).
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`b.
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`Prosecution History of the ’195 Patent.
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`The PTO rejected certain claims of the ’195 patent on various grounds, including
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`obviousness-type double patenting. ’195 patent history, VB0000797-811. But the PTO also
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`allowed certain claims that recited specific forms of crystalline vilazodone, stating:
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`The closest prior art is considered to be US 5532241, issued 07/02/1996. It
`discloses 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-
`piperazine hydrochloride at col. 11, Example 4. The ’241 Patent, however, fails
`to teach or suggest a crystalline form of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-
`carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. Therefore, the ’241 Patent
`fails to anticipate or render obvious claims reciting specific crystalline forms of 1-
`[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`hydrochloride.
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`’195 patent history, 11/12/2010 Office Action Summary at 13-14 (VB0000810-11).
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`c.
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`Prosecution History of the ’804 Patent.
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`The PTO rejected claim 1 of the ’804 patent as anticipated by the ’241 patent. See ’804
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`patent history, 5/4/2011 Office Action Summary (VB0001387-1396). The PTO stated that the
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`’241 patent disclosed the use of crystalline vilazodone in treating depressive disorders, stating
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`“[’241 patent] teaches a method of using the compound 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-
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`carbamoyl-benzofuran-5-yl)-piperazine in its crystalline HCl salt, monohydrate, hemihydrate[,]
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`or composition form.” Id. at 5-6 (VB0001392-93). In its response, applicant did not refute the
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`PTO’s assertion that the ’241 patent disclosed a crystalline HCl salt of vilazodone, and the
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`applicant instead amended claim 1 to recite a particular polymorph (Form IV) of crystalline
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`vilazodone, as well as citing the specific characteristic peaks of the polymorph. See ’804 patent
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`history, 2/9/2012 Amendment and Response to Non-Final Office Action at 2 (VB0001298).
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 15 of 27 PageID #: 729
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`Applicant stated specifically that “the ’241 patent fails to teach or suggest the polymorphic form
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`IV as set forth in the amended claims.” Id. at 4 (VB0001300).
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`d.
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`Prosecution History of the ’921 Patent.
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`In allowing the claims of the ’921 patent, the PTO again identified the ’241 patent as the
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`closest prior art, but allowed the claims because the ’241 patent did not teach the specific forms
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`being claimed by applicants:
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`The closest prior art is U.S. Patent no. 5,532,241, which does not teach the
`claimed crystalline forms. This reference does not encompass the scope of the
`instant application. This reference lacks [the] identical or obvious crystalline
`forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-
`piperazine. A person of ordinary skill in the art would not have expected that
`making modifications would retain identical activity as disclosed in the prior art.
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`’921 patent history, 12/2/2013 Notice of Allowability at 2 (VB0001687).
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`e.
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`Forest May Not Seek To Have the Claims Construed More
`Broadly Than the Positions Taken During Prosecution.
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`As set forth above, during prosecution of the patents-in-suit, the PTO repeatedly
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`confirmed that only the specific forms of crystalline vilazodone were patentable over the ’241
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`patent’s general disclosure of crystalline vilazodone, and rejected claims as either anticipated or
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`obvious due to the ’241 patent if stated in more general terms. At no point did patentees contest
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`the PTO’s rejections on these grounds, and in fact they often amended the claims to identify an
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`individual form identified by its Roman numeral. Forest may not now seek to expand the scope
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`of the claims to encompass forms not disclosed in the patent, as that position is contrary to the
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`position it maintained to achieve approval by PTO. See Jeneric/Pentron, Inc. v. Dillon Co., 205
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`F.3d 1377, 1382 (Fed. Cir. 2000) (plaintiff may not rely on specific descriptions of its invention
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`to distinguish itself from prior art, then later construe its claims more broadly during an
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`infringement action).
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`11
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`Page 15
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`Case 1:15-cv-00272-GMS Document 86 Filed 06/22/16 Page 16 of 27 PageID #: 730
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`D.
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`The Correct Construction of “Exhibits the Following XRD Data” is “Must
`Show All the Following Peaks and Intensities.”
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`Claim
`Term
`“exhibits
`the
`following
`XRD data”
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`Patent & Claim
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`’020 patent, claim
`1
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`Forest’s
`Construction
`Displays X-ray diffraction pattern
`consistent with the following values,
`with experimental error ranges
`(e.g., +/- 0.1o for two-theta values)
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`Defendants’
`Construction
`Must show all the
`following peaks
`and intensities
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`Forest is attempting to read the claimed peak intensities entirely out