Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 1 of 31
`
`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 60 Filed 05/08/15 Page 2 of 31
`
`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 OPENING CLAIM CONSTRUCTION BRIEF
`
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 3 of 31
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .......................................................................................................... ii 
`
`PRELIMINARY STATEMENT .................................................................................................... 1 
`
`BACKGROUND ............................................................................................................................ 4 
`
`I. 
`
`II. 
`
`The ‘336 Patent. .................................................................................................................. 5 
`
`The ‘477 Patent. .................................................................................................................. 6 
`
`ARGUMENT ................................................................................................................................ 10 
`
`I. 
`
`II. 
`
`Claim Construction Legal Standards. ............................................................................... 10 
`
`The Disputed Claim Term of the ‘336 Patent. .................................................................. 11 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`Person of Ordinary Skill in the Art. ...................................................................... 13 
`
`Stereochemistry – Generally. ................................................................................ 14 
`
`Stereochemistry of the Compound Disclosed in Claim 1. .................................... 14 
`
`The ‘336 Patent Specification Supports Defendants’ Proposed Construction. ..... 17 
`
`The Prosecution History Supports Defendants’ Proposed Construction. ............. 18 
`
`Plaintiffs’ Proposed Construction Is Ambiguous and Not Supported by the
`Evidence or the Plain Meaning. ............................................................................ 19 
`
`III. 
`
`The Disputed Claim Term of the ‘477 Patent. .................................................................. 19 
`
`CONCLUSION ............................................................................................................................. 25 
`
`
`
`i
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 4 of 31
`
`TABLE OF AUTHORITIES
`
`Federal Cases 
`
`Aventis Pharma Deutschland GmbH v. Lupin, Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007)................................................................................... 14, 16
`
`Hockerson–Halberstadt, Inc. v. Converse Inc.,
`183 F.3d 1369 (Fed. Cir. 1999)......................................................................................... 23
`
`In re GPAC Inc.,
`57 F.3d 1573 (Fed. Cir. 1995)........................................................................................... 13
`
`Infosint, S.A. v. H. Lundbeck A/S,
`603 F. Supp. 2d 748 (S.D.N.Y. 2009) ............................................................................... 16
`
`K-2 Corp. v. Salomon S.A.,
`191 F.3d 1356 (Fed. Cir. 1999)......................................................................................... 10
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................................................................................... 13
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008)......................................................................................... 23
`
`Linear Tech. Corp. v. Int’l Trade Comm’n,
`566 F.3d 1049 (Fed. Cir. 2009)......................................................................................... 21
`
`NeoMagic Corp. v. Trident Microsystems, Inc.,
`287 F.3d 1062 (Fed. Cir. 2002)......................................................................................... 21
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)......................................................................................... 12
`
`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).................................................................................. passim
`
`Pitney Bowes, Inc. v. Hewlett-Packard Co.,
`182 F.3d 1298 (Fed. Cir. 1999)......................................................................................... 11
`
`Serrano v. Telular Corp.,
`111 F.3d 1578 (Fed. Cir. 1997)......................................................................................... 21
`
`TQP Dev., LLC v. Ticketmaster Entm’t, Inc.,
`No. 2:09-CV-00279, 2011 WL 4458430 (E.D. Tex. Sept. 23, 2011) ............................... 12
`
`ii
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 5 of 31
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)............................................................................... 10, 17, 20
`
`
`
`iii
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 6 of 31
`
`Pursuant to this Court’s October 17, 2014 Civil Case Management Plan and Scheduling
`
`Order, Defendants1 respectfully submit their Joint Opening Claim Construction Brief addressing
`
`their proposed constructions of the disputed claimed terms of U.S. Patent Nos. 5,856,336 (“the
`
`‘336 Patent”)2 and 6,465,477 (“the ‘477 Patent”)3 (collectively, the “Asserted Patents”).
`
`PRELIMINARY STATEMENT
`
` The parties dispute the construction of two claim terms, one in each of the Asserted
`
`Patents.4 The disputed terms, along with the parties’ proposed constructions, are as follows:
`
`The Disputed Claim Term of the ‘336 Patent, Claim 1: “A compound of the formula,
`
`
`
` Z= ―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.”
`
`
`
`
`1 “Defendants” herein collectively
`include Defendants/Counterclaim-Plaintiffs Amneal
`Pharmaceuticals LLC (“Amneal”), Aurobindo Pharma Limited and Aurobindo Pharma USA Inc.
`(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 Zydus Cadila).
`2 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.
`3 The ‘477 Patent is not at issue in the related cases involving Amneal, Apotex and Aurobindo.
`Thus, Amneal, Apotex and Aurobindo take 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 not identified any disputed terms for construction in that patent.
`4 Pursuant to the Court’s October 17, 2014 Order that the Markman hearing will not include
`claim construction/claim scope issues relating to indefiniteness. (ECF No. 44 at 1 (Civil Action
`No. 14-cv-2647-PAC)). Defendants reserve their rights to raise indefiniteness arguments with
`respect to the patents-in-suit during the course of this litigation.
`
`1
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 7 of 31
`
`Plaintiffs’ Proposed Construction
`
`Defendants’ Proposed Construction
`
`No construction necessary, but to the extent the
`Court finds any construction necessary:
`
`“A genus5 including each optical isomer of
`the formula
`
`“A compound having the following structure:
`
`
`
`
`
`Z=
`―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.
`
`Z=
`―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.
`and all mixtures thereof.”
`
`
`The Disputed Claim Term of the ‘477 Patent, Claim 1: “an aqueous solution or
`
`dispersion of the pharmaceutical composition has pH of from 6.8 to 7.8”
`
`Plaintiffs’ Proposed Construction
`
`Defendants’ Proposed Construction
`
`“A unit dose of a solid preparation of the
`pharmaceutical composition has pH from 6.8
`to 7.8 when dissolved or dispersed in 1 to 10
`mL of pure water”
`
`No construction necessary, but to the extent the
`Court finds any construction necessary, the term
`“pH” :
`
`“indicates the pH value to be determined in
`such a manner that a unit dose of a solid
`preparation comprising NK-104 or its salt or
`ester is sampled and dissolved or dispersed in
`from 1 to 10 ml of pure water, and the pH of the
`resulting aqueous solution or dispersion is
`measured.” (See ‘477 patent, Col. 2, ll 56-61)
`
`
`While Plaintiffs assert no construction of the above terms is necessary, as Defendants
`
`discuss below, the parties have key disagreements regarding claim scope that may impact
`
`noninfringement and/or invalidity, rendering it necessary to construe the respective terms.
`
`
`5 A “genus” refers to a group, as opposed to a single compound or optical isomer.
`
`2
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 8 of 31
`
`The ‘336 Patent claim construction dispute involves whether the chemical drawing of
`
`claim 1 is limited to a single structure, or multiple isomer structures and mixtures. The
`
`constructions of the ‘477 Patent present two issues: (1) what material is subjected to the pH
`
`measurement; and (2) what pH range do the claims truly permit. Plaintiffs’ proposed
`
`constructions fail to address the relevant issues and/or inject further ambiguity rather than clarity.
`
`Defendants’ proposed constructions invoke the plain and ordinary meaning of the claim
`
`language, and are fully consistent with the relevant intrinsic evidence and viewpoint of the
`
`ordinarily-skilled artisan from the relevant time period.
`
`For claim 1 of the ‘336 Patent, Defendants’ proposed construction makes clear that the
`
`plain and ordinary meaning of the recited chemical structure encompasses all isomers of the as-
`
`drawn structure and mixtures thereof. Defendants’ proposed construction is supported by a
`
`person of ordinary skill in the art’s plain reading of the chemical structure, as well as the intrinsic
`
`record, notably the ‘336 Patent’s specification. On the other hand, Plaintiffs’ proposed
`
`construction merely substitutes claim 1’s “of the formula” with the phrase, “having the following
`
`structure.” This construction is non-responsive because the dispute is over the scope of
`
`compounds that the illustrated structure conveys, not the meaning of the word “formula.” (See
`
`infra Argument Section II).
`
`As for the ‘477 Patent, the claim language requires that “an aqueous solution or
`
`dispersion of the pharmaceutical composition has pH of from 6.8 to 7.8.” All parties agree that
`
`the pH measurement must be performed in accordance with the specification’s specific testing
`
`methodology, and that this should be incorporated into the claim construction. Such
`
`methodology requires measuring pH by dissolving or dispersing a unit dose of a solid
`
`3
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 9 of 31
`
`preparation in 1 to 10 mL of pure water, then testing the resulting aqueous solution or dispersion
`
`for pH. (Burns Decl.6 Ex. 2, the ‘477 Patent at col. 2, ll. 56-61 (MYLAN(Pitav)009400)).
`
`Where the parties first appear to diverge, as illustrated below, involves what “a unit dose
`
`of a solid preparation” is made of. Defendants’ construction confirms the claim language, which
`
`requires that a “unit dose of a solid preparation” be made of the pharmaceutical composition.
`
`Plaintiffs’ construction appears to want to broaden what is subjected to pH measurements
`
`beyond the pharmaceutical composition to “NK-104 or its salt or ester,” i.e., merely the active
`
`ingredient. Doing so would effectively read-out the term “pharmaceutical composition” from the
`
`claim itself and runs contrary to other disclosures in the specification. (See infra Argument
`
`Section III).
`
`The parties next appear to diverge because Plaintiffs’ definition relative to the ‘477
`
`Patent excludes the explicitly recited pH range of “from 6.8 to 7.8.” Defendants’ construction
`
`confirms that the measured pH result taken from testing an aqueous solution of the
`
`pharmaceutical composition must fit within the pH range claimed. (See infra Argument Section
`
`III).
`
`Accordingly, Defendants respectfully request that the Court adopt their proposed
`
`constructions for the reasons further discussed below.
`
`BACKGROUND
`
`Plaintiffs contend that each of the pitavastatin calcium tablet products that are the subject
`
`of the relevant Abbreviated New Drug Applications (“ANDA”) in this litigation infringe one or
`
`more claims of the Asserted Patents. Pitavastatin calcium salt, the active ingredient in the
`
`
`6 References to “Burns Decl.” are to the Declaration of Thomas R. Burns in Support of
`Defendants’ Joint Opening Claim Construction Brief, submitted contemporaneously herewith.
`
`4
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 10 of 31
`
`pitavastatin calcium tablet products, belongs to a family of molecules commonly known as
`
`“statins,” which are generally known to lower cholesterol. The prior art discloses that statins,
`
`including pitavastatin, lower cholesterol by inhibiting an enzyme known as 3-hydroxy-3-
`
`methylglutaryl-coenzyme A reductase (i.e., HMG-CoA reductase).
`
`I.
`
`The ‘336 Patent.
`
`The ‘336 Patent is entitled “Quinoline Type Mevalonolactones.” (Burns Decl. Ex. 1, the
`
`‘336 Patent at Cover (MYLAN(Pharms)009114)). The ‘336 Patent contains two claims. Claim
`
`1 recites7:
`
`“A compound of the formula,
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.”
`
`(Id. at col. 32, ll. 22-36 (MYLAN(Pitav)009130)).
`
`The ‘336 Patent specification states that “[t]he present invention relates to novel
`
`mevalonolactones having a quinoline ring, processes for their production, pharmaceutical
`
`compositions containing them and their pharmaceutical uses . . . .” (Burns Decl. Ex. 1, the ‘336
`
`Patent, at col. 1, ll. 6-11 (MYLAN(Pitav)009115)). The specification further notes that “these
`
`compoundsmay [sic] have at least one or two asymmetric carbon atoms and may have at least
`
`
`7 Claim 2 of
` “A method for reducing hyperlipidemia,
`the ‘336 Patent recites:
`hyperlipoproteinemia or atherosclerosis, which comprises administering an effective amount of
`the compound of formula A as defined in claim 1.” (Burns Decl. Ex. 1, the ‘336 Patent at col.
`32, ll. 37-40 (MYLAN(Pitav)009130)).
`
`5
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 11 of 31
`
`two to four optical isomers. The compounds of the formula I include all of these optical
`
`isomers and all of the mixtures thereof.” (Id. at col. 2, l. 66 – col. 3, l. 2 (emphasis added)
`
`(MYLAN(Pitav)009115-16)). Defendants seek to have the claim 1 structure construed
`
`consistent with the specification to include all of the optical isomers and the mixtures thereof.
`
`II.
`
`The ‘477 Patent.
`
`The ‘477 Patent is entitled “Stable Pharmaceutical Composition.” (Burns Decl. Ex. 2, the
`
`‘477 Patent at MYLAN(Pitav)009397). The “Field of the Invention” states, in relevant part, that
`
`“[t]he present invention relates to a pharmaceutical composition with high stability and, more
`
`precisely, to a pharmaceutical composition comprising an HMG-CoA reductase inhibitor of
`
`which the stability varies depending on pH . . . .” (Id. at col. 1, ll. 9-12 (emphasis added)
`
`(MYLAN(Pitav)009400)). The specification further notes that “[a]n object of the present
`
`invention is to provide a pharmaceutical composition comprising NK-104, or its salt or ester, of
`
`which the aqueous solution or dispersion has pH of from 6.8 to less than 8, preferably has pH of
`
`from 6.8 to 7.8.” (Id. at col. 2, ll. 35-38 (emphasis added) (MYLAN(Pitav)009400)). The
`
`specification specifically states that:
`
`The pH as referred to herein indicates the pH value to be determined in
`such a manner that a unit dose of a solid preparation comprising NK-
`104 or its salt or ester is sampled and dissolved or dispersed in from 1 to
`10 mL of pure water, and the pH of the resulting aqueous solution or
`dispersion is measured.
`
`(Id. at col. 2, ll. 56-61 (emphasis added) (MYLAN(Pitav)009400)). The specification makes
`
`clear that the pH of an aqueous solution of the pharmaceutical composition, not anything else, is
`
`what requires measurement: “A basic substance may be added to the pharmaceutical
`
`composition comprising NK-104 to control the pH of the composition. . . .” (Id. at col. 2, ll. 62-
`
`64 (emphasis added) (MYLAN(Pitav)009400); see also id. at col. 4, ll. 6-15 (“The necessary
`
`amount of the basic substance to be added to the composition of the invention in order to make
`
`6
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 12 of 31
`
`the aqueous solution or dispersion of the composition have [a] pH of from [about] 6.8 to less
`
`than 8 . . . .” (emphasis added) (MYLAN(Pitav)009401)).
`
`The specification lists various forms of solid preparations of the “pharmaceutical
`
`composition of the present invention,” including, “tablets, granules, powders, troches, capsules,
`
`chewables, film-coated preparations of these, and even sugar-coated preparations thereof.”
`
`(Burns Decl. Ex. 2, the ‘477 Patent at col. 3, ll. 25-30 (MYLAN(Pitav)009401)). Furthermore,
`
`each Example in the specification uses pharmaceutical compositions in tablet form; each further
`
`discloses the measurement of the pH of a 5% suspension of those tablets, which suspension was
`
`prepared by taking a unit dose, i.e., one tablet, and dispersing it in 1 to 10 ml of pure water,
`
`specifically 2.4 ml of pure water. (See id. at col. 6, ll. 29-31 (MYLAN(Pitav)009402); id. at col.
`
`6, ll. 53-55 (MYLAN(Pitav)009402); id. at col. 7, ll. 29-30 (MYLAN(Pitav)009403); id. at col.
`
`7, ll. 52-53 (MYLAN(Pitav)009403); id. at col. 8, ll. 20-21 (MYLAN(Pitav)009403); id. at col.
`
`8, ll. 43-44 (MYLAN(Pitav)009403); id. at col. 9, ll. 5-6 (MYLAN(Pitav)009404); id. at col. 9,
`
`ll. 35-36 (MYLAN(Pitav)009404); id. at col. 10, ll. 1-2 (MYLAN(Pitav)009404)).
`
`Table 7 of the ‘477 patent makes clear that the “unit dose of a solid preparation” that was
`
`subjected to pH testing was the entire pharmaceutical composition, namely tablets:
`
`
`
`7
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 13 of 31
`
`
`
`(Burns Decl. Ex. 2, the ‘477 Patent at col. 9, ll. 1-30 (Example 10, Table 7) (emphasis added)
`
`(MYLAN(Pitav)009404); see also id. at col. 6, ll. 29-37 (Test 1) (noting the pH of “a 5%
`
`suspension of tablets produced in any of Examples 2 to 5 (the suspension was prepared by
`
`suspending one tablet in 2.4 ml of pure water) was measured”) (MYLAN(Pitav)009402)).
`
`Regarding the claimed pH range, original claim 1 of the application that led to the ‘477
`
`Patent read as follows:
`
`1.
`
`A pharmaceutical composition comprising (E)-
`3,5,dihydroxy-7-[4’-4’’-fluorophenyl-2’cyclopropyl-
`quinolin-3’-yl]-6-heptenoic acid or its salt or ester, and a
`pharmaceutically acceptable carrier, of which aqueous
`solution or dispersion has pH of from 6.8 to less than 8.
`
` (Burns Decl. Ex. 3, the ‘477 Patent prosecution history, Original Application at 21 (emphasis
`
`added) (MYLAN(Pitav)009432)). In the first Office Action, however, the U.S. Patent and
`
`Trademark (“PTO”) Examiner rejected the majority of the originally-presented claims, including
`
`claim 1, as anticipated by U.S. Patent No. 5,356,896 to Kabidi (“Kabidi”). (Id., 1/18/2001 Office
`
`Action at 3-4 (MYLAN(Pitav)009452-53)). According to the Examiner, the claims were
`
`anticipated since Kabidi discloses stabilization of a structurally similar statin—namely,
`
`fluvastatin—by an alkaline stabilization medium imparting a pH of 8. (Id.). In response to the
`
`Office Action, Applicants argued that the proposed claims were distinct from Kabidi because the
`
`8
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 14 of 31
`
`Kabidi compositions had a “pH of at least 8.”
`
` (Id., 7/19/2001 Amendment at 4
`
`(MYLAN(Pitav)009487)). However, Applicants argued that the compositions of the invention
`
`having “a pH of from 6.8 to less than 8” provided “surprising performance results.” (Id.).
`
`Applicants’ arguments did not persuade the Examiner.
`
`In the second Office Action, the Examiner maintained the rejection of the claims based
`
`on Kabidi. (Burns Decl. Ex. 3, the ‘477 Patent prosecution history, 9/25/2001 Office Action at 2
`
`(MYLAN(Pitav)009491)). The Examiner also rejected originally-presented claim 1 as indefinite
`
`because there was insufficient antecedent basis for the limitation “of which the aqueous solution
`
`or dispersion has pH of from 6.8 to less than 8,” since there was no aqueous solution recited. (Id.
`
`at 3 (MYLAN(Pitav)009492)).
`
`In response to the second Office Action, Applicants amended claim 1 to limit the recited
`
`pH range to “6.8 to 7.8,” and to clarify that the “aqueous solution or dispersion” being measured
`
`for pH was specifically that “of the pharmaceutical composition”:
`
`1.
`
`A pharmaceutical composition comprising (E)-3,5,dihydroxy-7-
`[4’-4’’-fluorophenyl-2’cyclopropyl-quinolin-3’-yl]-6-heptenoic
`acid or its salt or ester, and a pharmaceutically acceptable carrier,
`of which aqueous solution or dispersion of the pharmaceutical
`composition has pH of from 6.8 [to less than 8] 7.8.
`
`(Burns Decl. Ex. 3, the ‘477 Patent prosecution history, 2/4/2002 Amendment at 6 (bold
`
`emphasis added) (MYLAN(Pitav)009505)). Thus, Applicants not only made clear the
`
`pharmaceutical composition is what would be placed in aqueous solution/dispersion for testing,
`
`but deliberately reduced the upper level of the claimed pH range to avoid prior art.
`
`Applicants continued to distinguish the claimed invention over Kabidi by touting the
`
`benefit of its formulations as having “superior stability,” particularly when the “pharmaceutical
`
`composition [has] a pH in the range of about 6.8 to 7.8.” (Burns Decl. Ex. 3, the ‘477 Patent
`
`prosecution history, 2/4/2002 Amendment at 2-5 (emphasis added) (MYLAN(Pitav)009501-04)).
`9
`
`
`

`

`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 15 of 31
`
`In extoling the virtues of the invention, Applicants pointed to Table 7, set out above, which
`
`discussed testing the entire pharmaceutical composition, namely tablets.
`
` (Id. at 3
`
`(MYLAN(Pitav)009502)).
`
`Only after these amendments and arguments did the Examiner allow the claims. (Burns
`
`Decl. Ex. 3,
`
`the ‘477 prosecution history, 5/2/2002 Notice of Allowability at 1
`
`(MYLAN(Pitav)009511)).
`
` The
`
`intrinsic record confirms
`
`the claim means
`
`that
`
`the
`
`pharmaceutical composition is subjected to the solution/dispersion and pH testing; and the
`
`importance of the claimed pH range from 6.8 to 7.8. The proper construction of the disputed
`
`claim term of the ‘477 Patent should capture these meanings found in the intrinsic record.
`
`I.
`
`Claim Construction Legal Standards.
`
`ARGUMENT
`
`Claim construction is part of the two-step process for assessing infringement “in which
`
`the court first determines, as a matter of law, the correct claim scope, and then compares the
`
`properly construed claim to the accused device to determine, as a matter of fact, whether all of
`
`the claim limitations are present in the accused device.” K-2 Corp. v. Salomon S.A., 191 F.3d
`
`1356, 1362 (Fed. Cir. 1999). It is not an exercise in rewriting claims but rather an opportunity to
`
`give effect to the terms chosen by the patentee. Id. at 1364. The Federal Circuit has held that
`
`claim terms should be given “their ordinary and customary meaning.” Phillips v. AWH Corp.,
`
`415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc). Such meaning “is the meaning that the term
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`would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as
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`of the effective filing date of the patent application.” Id. at 1313.
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`Intrinsic evidence—i.e., the claim language, the specification, and the prosecution
`
`history—“is the most significant source of the legally operative meaning of disputed claim
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`language.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). “The
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`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 16 of 31
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`starting point for any claim construction must be the claims themselves.” Pitney Bowes, Inc. v.
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`Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). “[T]he person of ordinary skill in
`
`the art is deemed to read the claim term not only in the context of the particular claim in which
`
`the disputed term appears, but in the context of the entire patent, including the specification.”
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`Phillips, 415 F.3d at 1313. While claim terms are understood in light of the specification, claim
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`construction cannot import specification limitations into the claims. Id. at 1323 (“For instance,
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`although the specification often describes very specific embodiments of the invention, we have
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`repeatedly warned against confining the claims to those embodiments.”). Also, “[l]ike the
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`specification, the prosecution history provides evidence of how the PTO and the inventor
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`understood the patent,” and can often inform the meaning of the claim language. Id. at 1317.
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`II.
`
`The Disputed Claim Term of the ‘336 Patent.
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`As noted above, the parties propose the following respective constructions of the disputed
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`Plaintiffs’ Proposed Construction
`No construction necessary, but to the
`extent the Court finds any construction
`necessary:
`
`“A compound having
`structure:
`
`the
`
`following
`
`term in claim 1 of the ‘336 Patent:
`
`Defendants’ Proposed Construction
`“A genus including each optical isomer of the
`formula
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.
`1/2Ca.
`and all mixtures thereof.”
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`
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`(See Joint Disputed Claim Terms Chart, ECF No. 76 at 4 (Civil Action No. 14-cv-2647-PAC)).
`
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―C
`OO.1/2Ca.
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`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 17 of 31
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`Defendants’ proposed construction is consistent with the understanding of the person of
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`ordinary skill in the art at the time of the invention, and supported by statements in the ‘336
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`Patent specification, as discussed herein and in the Declaration of David H. Sherman, Ph.D.
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`(“Sherman Decl.”) submitted contemporaneously herewith.
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`More specifically, claim 1 includes a drawing that depicts the types of molecules
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`encompassed within the claim’s scope. Defendants’ construction clarifies that the molecules the
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`drawing includes (all optical isomers and mixtures) to give full effect to the meaning of the term.
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`Construing the stereochemical limitation of this term will aid the Court and the parties in
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`conducting infringement and invalidity analyses concerning the ‘336 Patent.
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`Plaintiffs’ proposed construction (offered in the alternative to no construction at all) is at
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`best circular and ambiguous as to what molecules the drawing in claim 1 actually includes. To
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`this end, Plaintiffs’ construction essentially repeats the chemical structure of the claim without
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`further defining it, which provides no help to the trier of fact. See, e.g., TQP Dev., LLC v.
`
`Ticketmaster Entm’t, Inc., No. 2:09-cv-00279, 2011 WL 4458430, at *8 (E.D. Tex. Sept. 23,
`
`2011). Defendants are concerned Plaintiffs’ construction is designed to try to omit each optical
`
`isomer of the formula and all mixtures thereof. Such a construction is inconsistent with the plain
`
`and ordinary meaning of the term as it would have been understood by a person of ordinary skill
`
`in the art at the time of the invention, as well as the specification’s express statements including
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`isomers and mixtures. O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361
`
`(Fed. Cir. 2008) (“A determination that a claim term ‘needs no construction’ or has the ‘plain
`
`and ordinary meaning’ may be inadequate when . . . reliance on a term’s ‘ordinary’ meaning
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`does not resolve the parties’ dispute.”).
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`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 18 of 31
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`A.
`
`Person of Ordinary Skill in the Art.
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`The claim term is to be read as it would be understood by “a person of ordinary skill in
`
`the art in question at the time of the invention, i.e., as of the effective filing date of the patent
`
`application.” Phillips, 415 F.3d at 1313. “Importantly, the person of ordinary skill in the art is
`
`deemed to read the claim term not only in the context of the particular claim in which the
`
`disputed terms appears, but in the context of the entire patent, including the specification.” Id.
`
`The person of ordinary skill in the art is a hypothetical person who is presumed to be
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`aware of all pertinent art, follows conventional wisdom in the art and is a person of ordinary
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`creativity. In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); KSR Int’l Co. v. Teleflex Inc.,
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`550 U.S. 398, 421 (2007). With respect to the ‘336 Patent, the person of ordinary skill in the art
`
`would have held an advanced degree, such as an M.S. or a doctorate in one of the fields of
`
`medicinal or synthetic chemistry, pharmacology, pharmacy or medicine, with several years of
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`experience in one of the fields of medicinal or synthetic chemistry, pharmacology, pharmacy or
`
`medicine. (Sherman Decl. ¶ 23). In addition, the person of ordinary skill in the art would have
`
`either personally possessed, or had access to, knowledge and skills from medicinal and/or
`
`synthetic chemists, as well as biologists, pharmacists and/or clinicians, including possessing
`
`knowledge of statins, their mechanisms of action, and other cholesterol treatments. (Id.). Such
`
`person typically would have consulted with one or more members of a team of experienced
`
`professionals in the relevant field in order to solve a particular problem.8 (Id.).
`
`
`8 The parties have not identified a claim dispute that turns on resolving the specific level of
`ordinary skill, or whether a reference or information would be in the possession of such a person.
`Further, while Defendants do not concede that Plaintiffs can establish that the priority date of the
`‘336 Patent is August 20, 1987 (the date of the first foreign priority application listed on the face
`of the ‘336 Patent), the parties have not identified a claim dispute that turns on resolving the
`priority date. The interpretation of the disputed term of claim 1 by a person of ordinary skill in
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`Case 1:14-cv-02758-PAC Document 60 Filed 05/08/15 Page 19 of 31
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`B.
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`Stereochemistry – Generally.
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`At the time of the invention, the person of ordinary skill in the art would have understood
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`that two or more chemical structures may have the same molecular formula and the same atom-
`
`connectivity, yet they can be distinct chemical compounds if they are arranged differently in
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`three-dimensional space. Such compounds are called stereoisomers. See, e.g., Aventis Pharma
`
`Deutschland GmbH v. Lu