Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 1 of 30
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`v.
`
`Aurobindo Pharma Limited and
`Aurobindo Pharma USA Inc.,
`
`
`Defendants.
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals LLC,
`
`
`Defendant.
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`Civil Action No. 14-CV-2497 (PAC)
`
`Civil Action No. 14-CV-2758 (PAC)
`
`v.
`
`Civil Action No. 14-CV-2647 (PAC)
`
`Mylan Inc. and Mylan Pharmaceuticals Inc.,
`
`
`Defendants.
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 2 of 30
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`v.
`
`Orient Pharma Co., Ltd.,
`
`
`Defendant.
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`v.
`
`Zydus Pharmaceuticals (USA) Inc., and Cadila
`Healthcare Ltd. (dba Zydus Cadila),
`
`
`Defendants.
`
`Kowa Company, Ltd.,
`Kowa Pharmaceuticals America, Inc., and
`Nissan Chemical Industries, Ltd.,
`
`
`Plaintiffs,
`
`
`v.
`
`Sawai USA, Inc., and
`Sawai Pharmaceutical Co., Ltd.,
`
`
`Civil Action No. 14-CV-2759 (PAC)
`
`Civil Action No. 14-CV-2760 (PAC)
`
`Civil Action No. 14-CV-5575 (PAC)
`
`
`
`
`Defendants.
`
`
`DEFENDANTS’ JOINT RESPONSIVE CLAIM CONSTRUCTION BRIEF
`
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 3 of 30
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .......................................................................................................... ii 
`
`GLOSSARY OF TERMS .............................................................................................................. iv 
`
`PRELIMINARY STATEMENT .................................................................................................... 1 
`
`ARGUMENT .................................................................................................................................. 3 
`
`I. 
`
`Federal Circuit Precedent Mandates Resolution of the Parties’ Claim Construction
`Disputes............................................................................................................................... 3 
`
`II. 
`
`Defendants Are Not Seeking an Advisory Opinion. ........................................................... 5 
`
`A. 
`
`B. 
`
`Construing the Disputed Terms During Claim Construction Proceedings
`Would Not Result in an Advisory Opinion. ............................................................ 5 
`
`The Case Law on Which Plaintiffs Rely Is Inapplicable. ..................................... 10 
`
`III. 
`
`The ‘336 Patent. ................................................................................................................ 12 
`
`A. 
`
`B. 
`
`Construction of the Disputed Claim Term Is Necessary. ..................................... 12 
`
`Plaintiffs’ Proposed Construction of the Disputed Claim Term in the ‘336
`Patent Is Unsupported and Inconsistent with the Understanding of a
`Person of Ordinary Skill in the Art. ...................................................................... 13 
`
`IV. 
`
`The ‘477 Patent. ................................................................................................................ 19 
`
`CONCLUSION ............................................................................................................................. 22 
`
`
`
`
`i
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`

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`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 4 of 30
`
`TABLE OF AUTHORITIES
`
`Federal Cases 
`
`Bayer AG v. Elan Pharm. Research Corp.,
`212 F.3d 1241 (Fed. Cir. 2000)........................................................................................... 7
`
`Best Mgmt. Prods. v. New England Fiberglass, L.L.C.,
`No. 07-151-JL, 2008 U.S. Dist. LEXIS 39462 (D.N.H. May 12, 2008) .......................... 12
`
`Endo Pharm. Inc. v. Mylan Pharm. Inc.,
`No. 11-717 (JEI/KMW), 2013 U.S. Dist. LEXIS 111004 (D. Del. Aug. 7, 2013) ........... 16
`
`Ill. Computer Research LLC v. HarperCollins Publishers, Inc.,
`No. 10 Civ. 9124(KBF), 2012 WL 163801 (S.D.N.Y. Jan 19, 2012) ................................ 6
`
`In re Cuozzo Speed Techs.,
`787 F.3d 1271 (Fed. Cir. 2015)........................................................................................... 9
`
`Infosint, S.A. v. H. Lundbeck A/S,
`603 F. Supp. 2d 748 (S.D.N.Y. 2009) ......................................................................... 17, 18
`
`Jang v. Boston Scientific Corp.,
`532 F.3d 1330 (Fed. Cir. 2008)................................................................................... 10, 11
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008)........................................................................................... 8
`
`Largan Precision Co. v. Genius Elec. Optical Co.,
`No. 13-cv-02502-JD, 2014 WL 5358426 (N.D. Cal. Oct. 20, 2014) ................................. 9
`
`MaxLinear, Inc. v. Silicon Labs. Inc.,
`Nos. 12-CV-1161-H-MMD, 12-CV-1765-H-MMD,
`2013 WL 3927739 (S.D. Cal. May 16, 2013) ..................................................................... 4
`
`NanoEnTek, Inc. v. Bio-Rad Labs., Inc.,
`No. C-11-06237 JCS, 2013 WL 256018 (N.D. Cal. Jan. 23, 2013) ................................... 4
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)................................................................................... 3, 4, 5
`
`Pfizer Inc. v. Teva Pharm. USA, Inc.,
`555 F. App’x 961 (Fed. Cir. 2014) ................................................................................... 18
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006)......................................................................................... 18
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)....................................................................................... 8, 9
`ii
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`

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`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 5 of 30
`
`Probatter Sports, LLC v. Sports Tutor Inc.,
`No. 3:05-CV-01975 (VLB), 2014 U.S. Dist. LEXIS, 43124
`(D. Conn. Mar. 31, 2014) .................................................................................................. 12
`
`Program Rewards Solutions LLC v. Points Int’l Ltd.,
`No. 10 Civ. 1561(RJS), 2012 U.S. Dist. LEXIS 12970 (S.D.N.Y. Jan 13, 2012) .......... 4, 9
`
`Rambus, Inc. v. LSI Corp.,
`Nos. C 10-05446 RS, C 10-05449 RS, 2012 WL 4466578
`(N.D. Cal. Sept. 26, 2012) .................................................................................................. 5
`
`SmithKline Beecham Corp. v. Apotex Corp.,
`403 F.3d 1331 (Fed. Cir. 2005)......................................................................................... 18
`
`Superior Indus. v. Masaba, Inc.,
`553 F. App’x 986 (Fed. Cir. 2014) ................................................................................... 11
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999)........................................................................................... 11
`
`Westvaco Corp. v. Viva Magnetics Ltd.,
`No. 00 Civ. 9399 (LTS)(KNF), 2002 U.S. Dist. Lexis 17177
`(S.D.N.Y. Sept. 17, 2002) ................................................................................................. 12
`
`Federal Statutes 
`
`35 U.S.C. § 102 ............................................................................................................................. 10
`
`35 U.S.C. § 103 ............................................................................................................................. 10
`
`35 U.S.C. § 112 ..................................................................................................................... 2, 7, 10
`
`
`
`
`
`
`
`
`
`iii
`
`
`

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`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 6 of 30
`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 6 of 30
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`poTERM|CSéDEFINITION,
`
`GLOSSARY OF TERMS
`
`Zydus Cadila), collectivel
`
`Defendants
`
`Pharmaceuticals
`Defendants/Counterclaim-Plaintiffs Amneal
`LLC (“Amneal”), Aurobindo Pharma Limited and Aurobindo
`Pharma USA Ine.
`(collectively,
`“Aurobindo”), Mylan
`Pharmaceuticals Inc. and Mylan Inc., Orient Pharma Co., Ltd.,
`Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd., Zydus
`Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd.
`(dba
`
`' The ‘336 Patent is not at issue in the related case involving Apotex (Civil Action No. 14-cv-
`7934-PAC). Thus, Apotex takes no position on the ‘336 Patent disputed claim term.
`* The ‘477 Patentis not at issue in the related cases involving Amneal, Apotex and Aurobindo.
`Thus, Amneal, Apotex and Aurobindotake no position on the ‘477 Patent disputed claim term.
`Plaintiffs have also asserted U.S. Patent No. 8,557,993 against one or more Defendants. The
`parties have notidentified any disputed terms for constructionin that patent.
`
`1V
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 7 of 30
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`Pursuant to this Court’s October 17, 2014 Civil Case Management Plan and Scheduling
`
`Order, as amended, Defendants respectfully submit their Joint Responsive Claim Construction
`
`Brief in further support of their proposed constructions of the disputed claimed terms of the
`
`Asserted Patents.
`
`PRELIMINARY STATEMENT
`
`Plaintiffs’ primary argument relevant to claim construction is that the Court should not
`
`engage in any claim construction at all. This position ignores that a fundamental dispute exists
`
`between the parties as to the meaning of the two claim terms at issue. With respect to the
`
`chemical structure of claim 1 of the ‘336 Patent, the parties’ opening submissions make clear that
`
`there is a dispute as to what chemicals are included within the claim’s scope. Defendants believe
`
`that claim 1 necessarily includes each optical isomer of the structure identified therein, and all
`
`mixtures thereof, as supported by the claim’s plain language as understood by a person of
`
`ordinary skill in the art. Plaintiffs, on the other hand, argue the claim may or may not include
`
`each optical isomer.
`
`With respect to the phrase “an aqueous solution or dispersion of the pharmaceutical
`
`composition has pH of from 6.8 to 7.8” in the ‘477 Patent, again, there is a dispute between the
`
`parties. Defendants argue that the claim language and specification make clear that the aqueous
`
`solution or dispersion whose pH is being measured is made from a unit dose of a solid
`
`preparation of the pharmaceutical composition dissolved in 1 to 10 mL of water, as supported by
`
`the intrinsic evidence. While somewhat unclear, it appears that Plaintiffs disagree with this
`
`notion and believe that something other than a unit dose of the pharmaceutical composition
`
`should be dissolved in 1 to 10 mL of water.
`
`Thus, there is a dispute between the parties as to the scope of these terms that requires
`
`resolution at the claim construction stage.
`
`1
`
`
`

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`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 8 of 30
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`Plaintiffs’ argument that the Defendants are improperly asking the Court for nothing
`
`more than an advisory opinion on the meaning of the two claim terms is simply wrong. Rather,
`
`as Defendants have advised Plaintiffs, the scope of the compound at issue in claim 1 of the ‘336
`
`Patent bears directly on the invalidity issues in these actions. The claim scope can inform, for
`
`example, whether or not the patent meets the requirements of 35 U.S.C. § 112. Defendants also
`
`have advised Plaintiffs that the construction of the phrase “an aqueous solution of dispersion of
`
`the pharmaceutical composition has pH of from 6.8 to 7.8” in the ‘477 Patent is relevant to
`
`infringement issues in the case. It is self-evident that determining what material is to be
`
`dissolved or dispersed to create the solution or dispersion for pH testing and how that material
`
`is dissolved or dispersed directly influences the question of whether Defendants’ respective
`
`ANDA products infringe the ‘477 Patent. Likewise, Plaintiffs cannot be heard to complain they
`
`lack sufficient detail on how claim construction might impact non-infringement and invalidity
`
`issues when Plaintiffs demanded the Court waive the Local Patent Rule obligations for early
`
`contentions and advocated for a belated disclosure of infringement and invalidity contentions.
`
`(ECF Nos. 49, 52 (Civil Action No. 14-cv-2647-PAC)). Plaintiffs cannot legitimately argue that
`
`Defendants seek an “advisory opinion” when both terms Defendants seek to construe bear
`
`directly on invalidity and non-infringement issues in these actions.
`
`Plaintiffs’ arguments on the merits of the parties’ proposed constructions are equally
`
`flawed. For both terms at issue, Plaintiffs selectively quote from the specification and distort
`
`Defendants’ proposed constructions when attempting to argue for Plaintiffs’ constructions. The
`
`plain and ordinary meaning of the claims terms, as understood by a person of ordinary skill in the
`
`art, and/or the intrinsic evidence amply support Defendants’ constructions. The same cannot be
`
`said of the constructions Plaintiffs propose. As such, Defendants’ proposed constructions are not
`
`2
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 9 of 30
`
`only correct, they are necessary to resolve an outstanding controversy that would impact the
`
`claims and defenses in these actions. Defendants, thus, respectfully request that the Court adopt
`
`Defendants’ proposed constructions.
`
`ARGUMENT
`
`I.
`
`Federal Circuit Precedent Mandates Resolution of the Parties’ Claim Construction
`Disputes.
`
`While a court is not required to construe every term recited in a patent claim, when, as
`
`here, “the parties present a fundamental dispute regarding the scope of a claim term, it is the
`
`court’s duty to resolve it.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351,
`
`1362 (Fed. Cir. 2008) (emphasis added).
`
`The parties have a clear disagreement on the claim scope of two disputed claim terms.
`
`First, for the ‘336 Patent, the parties’ dispute centers on whether the chemical drawing of claim 1
`
`necessarily includes each optical isomer of the structure depicted in claim 1 and all mixtures
`
`thereof (Defendants’ construction). In other words, the Court is asked to resolve the question:
`
`what is the scope of chemical compounds covered by the claim? Second, for the ‘477 Patent, the
`
`parties dispute what material is dissolved or dispersed in order to generate the aqueous solution
`
`or dispersion for pH measurement.3 The Federal Circuit precedent is clear. There is a dispute
`
`between the parties as to the scope of a claim term; hence, this Court must resolve the dispute.
`
`O2 Micro, 521 F.3d at 1361.
`
`
`3 If the claim term is not construed at all, this further raises an issue of how the material is
`dissolved or dispersed in order to generate the aqueous solution or dispersion for any testing.
`
`3
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 10 of 30
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`Plaintiffs cite to O2 Micro to support their position (see, e.g., Plaintiffs’ Br.4 at 8) that the
`
`Court need not construe the claim terms. Plaintiffs’ reliance on O2 Micro is misplaced.
`
`Contrary to Plaintiffs’ suggestion, O2 Micro demonstrates that the Court should construe the
`
`claim terms now. The parties in O2 Micro disagreed at their Markman hearing about whether or
`
`not to construe the phrase “only if.” O2 Micro, 521 F.3d at 1357. The district court declined to
`
`construe the phrase, concluding that “only if” had a “well-understood definition, capable of
`
`application by both the jury and this court.” Id. On appeal, the Federal Circuit reversed,
`
`remanding the case to the trial court for a construction of the phrase “only if.” The Federal
`
`Circuit observed that, “[a] determination that a claim term ‘needs no construction’ or has the
`
`‘plain and ordinary meaning’ may be inadequate when a term has more than one ‘ordinary’
`
`meaning or when reliance on a term’s ‘ordinary’ meaning does not resolve the parties’ dispute.”
`
`Id. at 1361.
`
`Since O2 Micro, courts have consistently decided to construe terms if there is any dispute
`
`as to their scope. See, e.g., Program Rewards Solutions LLC v. Points Int’l Ltd., No. 10 Civ.
`
`1561(RJS), 2012 U.S. Dist. LEXIS 12970, at *14 (S.D.N.Y. Jan 13, 2012) (relying on O2 Micro
`
`and noting that “[b]ecause the parties have not yet made motions for summary judgment, and it
`
`is therefore premature to determine that any particular term will or will not be dispositive, the
`
`Court will construe all disputed terms”)5; this case requires nothing different. Here, as in O2
`
`
`4 References to “Plaintiffs’ Br.” are to Plaintiffs’ Opening Claim Construction Brief, submitted
`on May 8, 2015 (ECF No. 80 (Civil Action No. 14-cv-2647-PAC)).
`5 See also MaxLinear, Inc. v. Silicon Labs. Inc., Nos. 12-CV-1161-H-MMD, 12-CV-1765-H-
`MMD, 2013 WL 3927739, at *3, *5, *9-10, *12, *14-18, *20-22 (S.D. Cal. May 16, 2013)
`(“Because the parties dispute the construction of this term, the Court resolves the parties’
`dispute.”); NanoEnTek, Inc. v. Bio-Rad Labs., Inc., No. C-11-06237 JCS, 2013 WL 256018, at
`*4 (N.D. Cal. Jan. 23, 2013) (construing scope of disputed terms because “even if a claim term
`has a plain and ordinary meaning, the court should construe the term if construction is required
`
`
`4
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 11 of 30
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`Micro, the parties dispute the scope of what is encompassed by the claim language in the ‘336
`
`and ‘477 Patents. Thus, O2 Micro and its progeny require the Court to resolve the dispute as to
`
`the claims’ scope. O2 Micro, 521 F. 3d at 1361.
`
`II.
`
`Defendants Are Not Seeking an Advisory Opinion.
`
`A.
`
`Construing the Disputed Terms During Claim Construction Proceedings
`Would Not Result in an Advisory Opinion.
`
`Despite the existence of a fundamental dispute concerning the two disputed claim terms,
`
`Plaintiffs argue that Defendants seek an impermissible advisory opinion because Defendants
`
`have failed to show how any claim construction determination would relate to issues in this
`
`case. (Plaintiffs’ Br. at 7-9, 12-13, 18). This is incorrect.
`
`As an initial matter, to the extent Plaintiffs suggest Defendants were somehow obligated
`
`to disclose detailed non-infringement and invalidity contentions at this stage of the litigation,
`
`Plaintiffs are wrong and are in no position to complain. Throughout the meet and confer process
`
`leading to the parties’ submission of the Joint Claim Construction Statement (ECF No. 76 (Civil
`
`Action No. 14-cv-2647-PAC)), Defendants informed Plaintiffs that (i) resolution of the disputed
`
`claim terms related to the issues of patent invalidity and non-infringement; and (ii) construction
`
`of the disputed terms was sought to clarify the language of the disputed claims and to ensure that
`
`the actions would proceed in a more orderly manner. That Plaintiffs profess a lack of
`
`satisfaction with the level of specificity Defendants provided, and essentially want invalidity and
`
`non-infringement contentions now, does not eliminate the necessity of claim construction.
`
`
`to resolve a dispute about the scope of the asserted claims, which is a question of law to be
`decided by the Court”); Rambus, Inc. v. LSI Corp., Nos. C 10-05446 RS, C 10-05449 RS, 2012
`WL 4466578, at *8 (N.D. Cal. Sept. 26, 2012) (construing disputed terms because in light of
`dispute, the “term cannot simply be left for the jury, as is; it must be construed”).
`
`5
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 12 of 30
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`Moreover, Plaintiffs fail to acknowledge that Plaintiffs, over Defendants’ objection,
`
`asked the Court to forego having the parties provide invalidity and infringement contentions until
`
`much later in discovery. By the very schedule advocated by Plaintiffs, Defendants have
`
`complied with all their disclosure obligations. Months ago, Plaintiffs argued against the
`
`application of Local Patent Rules 6-7, which would have required the parties to have exchanged
`
`contentions by now. (Suppl. Burns Decl.6 Ex. 6, 10/6/14 Tr. at 9-11, 32-35). Accommodating
`
`Plaintiffs’ request, the Court ordered that Local Civil Rule 33.3(c), rather than Local Patent Rule
`
`6, applied to the issue. (Suppl. Burns Decl. Ex. 7, 10/17/14 Order). As such, because the parties
`
`are not required to disclose their contentions until later in discovery, the Court should reject
`
`Plaintiffs’ complaint that construction is unnecessary because Defendants have purportedly not
`
`provided detailed disclosures concerning the relevance of construction. Plaintiffs cannot, on the
`
`one hand, seek to defer the parties’ exchange of contentions, and then, on the other, use the fact
`
`that the parties have not exchanged contentions to defer claim construction.7
`
`Further, contrary to Plaintiffs’ assertions (Plaintiffs’ Br. at 6), there is sufficient context
`
`to understand how claim construction may affect the issues in this case. This is a Hatch-
`
`Waxman litigation relating to the pitavastatin calcium tablet products that are the subject of each
`
`of the Defendants’ respective ANDAs. As such, Plaintiffs cannot credibly claim that it is
`
`deprived of the context provided by each of Defendants’ ANDA products. To the contrary,
`
`Defendants’ ANDA in this case properly informs the claim construction analysis. See Bayer AG
`
`6 References to “Suppl. Burns Decl.” are to the Supplemental Declaration of Thomas R. Burns
`submitted contemporaneously herewith
`in support of Defendants’ Responsive Claim
`Construction Brief.
`7 Even where infringement and invalidity contentions are exchanged, “a necessary and
`preliminary step to reaching the merits of the parties’ respective contentions is to determine the
`scope and meaning of the patent claims at issue.” Ill. Computer Research LLC v. HarperCollins
`Publishers, Inc., No. 10 Civ. 9124(KBF), 2012 WL 163801, at *1 (S.D.N.Y. Jan 19, 2012).
`
`6
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 13 of 30
`
`v. Elan Pharm. Research Corp., 212 F.3d 1241, 1248-50 (Fed. Cir. 2000) (discussing how it is
`
`only the ANDA submitted to the U.S. Food and Drug Administration that defines the accused
`
`product).
`
`In addition, before these actions even commenced, Defendants provided Plaintiffs with
`
`the detailed bases concerning why they believe the asserted patents are invalid, unenforceable
`
`and/or not infringed by their respective ANDA products, as required under the Hatch-Waxman
`
`Act. With respect to the ‘336 Patent, the Defendants’ respective notice letters disclosed that the
`
`‘336 Patent claims are invalid for several reasons, including, for example, that they are invalid
`
`under 35 U.S.C. § 112. The scope (i.e., construction) of the claim may affect each of these
`
`invalidity arguments. For example, Mylan Pharms’ notice letter specifically discussed 35 U.S.C.
`
`§ 112 enablement arguments in the context of the genus of claim 1 and individual stereoisomers
`
`within the genus—language that is directly tied to Defendants’ proposed construction. Mylan
`
`Pharms’ notice letter also discussed how claims 1 and 2 of the ‘336 Patent are invalid based on
`
`the specification failing to enable the synthesis and/or preparation of the genus of claim 1 or any
`
`individual stereoisomers within the genus. That notice letter further discussed the invalidity of
`
`claim 2 for lack of enablement at least because the specification of the ‘336 Patent does not
`
`demonstrate in any way that administration of the compounds falling within the genus of claim 1
`
`are capable of reducing hyperlipidemia, hyperlipoproteinemia or atherosclerosis.8
`
`Some Defendants also disclosed that they would not infringe the claims of the ‘336
`
`Patent. With regard to infringement, the claim scope will determine which particular chemical
`
`
`8 Defendants will make Mylan Pharms’ notice letter or relevant excerpts of the same available to
`the Court should the Court be inclined to entertain Plaintiffs’ disclosure argument and find it
`helpful to review such material.
`
`7
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 14 of 30
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`isomers are encompassed in the claim. This may impact whether Defendants’ respective ANDA
`
`products fall inside or outside the scope of the patent’s claims.
`
`With respect to the phrase “an aqueous solution or dispersion of the pharmaceutical
`
`composition has pH of from 6.8 to 7.8,” Plaintiffs concede that at least Sawai explicitly placed
`
`Plaintiffs on notice of its proposed construction concerning claim 1 of the ‘477 Patent.
`
`(Plaintiffs’ Br. at 18 n.8). Further, Plaintiffs concede that two other Defendants asserted non-
`
`infringement of claim 1 of the ‘477 Patent in their notice letters. (Id.).
`
`In order to determine whether Defendants’ respective ANDA products meet the pH
`
`limitation of claim 1 of the ‘477 Patent, and thus whether they infringe the claim, it is obviously
`
`necessary to understand how pH is to be determined. To determine pH, it is necessary to identify
`
`what material is being dissolved or dispersed, and how that material is dissolved or dispersed to
`
`create the aqueous solution or dispersion for testing. Defendants’ concern is that Plaintiffs will
`
`attempt to use their pH-alone construction, which does not involve dissolving or dispersing the
`
`“pharmaceutical composition,” to apply pH measurements to solutions or dispersions of
`
`materials beyond the accused tablet products. For instance, does Plaintiffs’ construction permit
`
`simply dissolving or dispersing the active ingredient alone and then testing the resulting solution
`
`for pH in order to determine infringement? Allowing this would be improper, particularly given
`
`that “the context in which a term is used in the asserted claim can be highly instructive.” Phillips
`
`v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005); see also Kyocera Wireless Corp. v. Int’l
`
`Trade Comm’n, 545 F.3d 1340, 1347 (Fed. Cir. 2008). It is, therefore, disingenuous for
`
`Plaintiffs to now argue that Defendants failed to identify any substantive issues relating to
`
`infringement that depended upon construction of the disputed claim term of the ‘477 Patent.
`
`8
`
`
`

`

`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 15 of 30
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`It is clear that the parties have a dispute concerning the scope of the patent claims at issue
`
`and that determination of claim scope will have a bearing on at least the parties’ invalidity and
`
`non-infringement positions, including as described herein. Thus, construing the two terms at
`
`issue hardly amounts to the “advisory opinion” that Plaintiffs claim it will be.9 To the contrary,
`
`these constructions will likely bear directly on the issues in the case.
`
`Finally, Plaintiffs’ argument that Mylan Pharms’ pending inter partes review (“IPR”)10
`
`petition supports that construction of the ‘336 Patent is unnecessary, (Plaintiffs’ Br. at 12-13), is
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`not only misleading but incorrect. First, Plaintiffs fail to acknowledge that the standards relevant
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`to the IPR, as opposed to in this Court,11 are different. Importantly, for the IPR, “the challenged
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`claims must be given their broadest reasonable interpretation in light of the specification of the
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`‘336 Patent.” (Suppl. Burns Decl. Ex. 8, Petition at 15). Under that standard, Mylan Pharms
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`indicated that no terms or phrases required construction in its petition. Mylan Pharms further
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`9 Where, as here, the accused products are known and available for review, courts have
`determined that where it is not yet known whether “any particular term will or will not be
`dispositive, the Court will construe all disputed terms.” Program Rewards Solutions, 2012 U.S.
`Dist. LEXIS 12970, at *14; see also Largan Precision Co. v. Genius Elec. Optical Co., No. 13-
`cv-02502-JD, 2014 WL 5358426, at *4 (N.D. Cal. Oct. 20, 2014) (construing claims where “it is
`by no means clear at this point in the case that no issue of infringement or invalidity turns on the
`disputed claim constructions”).
`10 Mylan Pharms filed an IPR petition before the Patent Trial and Appeal Board concerning the
`‘336 Patent. In its IPR petition, Mylan Pharms alleged that claims 1 and 2 of the ‘336 Patent are
`invalid under 35 U.S.C. §§ 102 and 103. No other grounds of invalidity or non-infringement
`were presented in the petition.
`11 Compare In re Cuozzo Speed Techs., 787 F.3d 1271, 1281-82 (Fed. Cir. 2015) (the Patent
`Trial and Appeal Board construes disputed claims according to their broadest reasonable
`interpretation for the determination of whether to institute IPR proceedings, and for the
`proceedings themselves after institution), with Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.
`Cir. 2005) (when construing a disputed patent’s claim terms, the court adopts a construction
`based on what a person having ordinary skill in the relevant art would understand the claims to
`mean as of the time of invention).
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`9
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`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 16 of 30
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`clearly confirmed that “Petitioner’s position regarding the scope of the claims should not be
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`taken as an assertion regarding the appropriate claim scope in other adjudicative forums.”
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`(Suppl. Burns Decl. Ex. 8, Petition at 15 n.7).
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`Furthermore, the IPR proceedings are necessarily limited to obviousness or anticipation
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`issues arising under 35 U.S.C. § 102 or 103, as Plaintiffs acknowledge. (See Plaintiffs’ Br. at 13
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`(stating that “at least one Defendant has acknowledged that for § 102 and § 103 validity
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`purposes, no construction of the ‘336 Patent claims is necessary. It makes no sense for this
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`Court to construe a claim that does not need construction.”)). In other words, invalidity defenses
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`under 35 U.S.C. § 112 (for lack of enablement or lack of written description) or non-
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`infringement defenses cannot be raised in IPR proceedings. As such, focusing on arguments in
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`the IPR proceedings to determine the relevancy of claim construction issues here is not only
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`irrelevant, it is far too limiting. As discussed above, Defendants have clearly put Plaintiffs on
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`notice of § 112 and non-infringement defenses to the ‘336 Patent.
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`Thus, even if relevant, nothing in Mylan Pharms’ IPR petition supports foregoing
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`construction of the disputed claim term in the ‘336 Patent or Plaintiffs’ suggestion that any
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`Defendant has waived the right to pursue construction in litigation.
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`B.
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`The Case Law on Which Plaintiffs Rely Is Inapplicable.
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`In support of their argument that construction of the disputed terms would result in an
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`“advisory opinion,” Plaintiffs tellingly do not cite a single case where a court delayed claim
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`construction where, as here, the accused products were known and had been identified. None of
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`Plaintiffs’ cases are instructive concerning the circumstances here.
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`For example, Plaintiffs rely heavily on Jang v. Boston Scientific Corp., 532 F.3d 1330
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`(Fed. Cir. 2008) to argue that they lack any context with respect to the proposed constructions
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`and the issues in this case. (Plaintiffs’ Br. at 8). This position is both incorrect and sorely
`10
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`Case 1:14-cv-02758-PAC Document 67 Filed 06/10/15 Page 17 of 30
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`misplaced. Jang pertained to appellate review of a consent judgment based on a stipulation of
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`infringement following a claim construction ruling. The issue in Jang was not whether a district
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`court had authority to make a claim construction ruling, but that the stipulation “did not explain
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`whether Jang’s success on appeal in overturning any particular claim construction issue would,
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`in fact, affect the infringement dispute.” Jang, 532 F.3d at 1331, 1334-37. That is not the case
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`here.12 Unlike in Jang, there is no infringement stipulation in these actions. Further, Plaintiffs
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`have Defendants’ respective