Paper No. ____
`Date Filed: July 15, 2014
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NOVEN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-00550
`
`U.S. Patent 6,335,031
`
`PRELIMINARY RESPONSE BY
`PATENT OWNERS PURSUANT TO 37 C.F.R. § 42.107
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`VI.
`
`35 U.S.C. § 315(a) Bars Noven’s Petition.......................................................1
`
`The Board Should Deny Institution Of Noven’s Petition In
`View Of Pending Delaware District Court Litigation.....................................6
`
`The Board Should Adopt The Delaware District Court’s
`Construction Of The Claim Term “Amount Of Antioxidant
`Effective To Stabilize Compound A From Degradation”...............................8
`
`The Board Also Should Adopt The Delaware District Court’s
`Construction Of The Claim Term “Stabilizing”............................................12
`
`The Board Should Reject Noven’s Proposed Construction Of
`The Claim Term “Comprising”.....................................................................13
`
`The Board Should Deny Institution Based On Ground 1
`Because Elmalem Does Not Anticipate Claim 15.........................................16
`
`VII. The Board Should Exclude Rosin, Elmalem And Ebert From
`Ground 3 Because They Are Redundant.......................................................21
`
`VIII. The Board Should Exclude Rosin And Ebert From Ground 4
`Because They Are Redundant .......................................................................24
`
`IX.
`
`The Board Should Deny Institution Based On Ground 5
`Because It Is Redundant Of Grounds 3 And 4 ..............................................25
`
`X.
`
`Conclusion .....................................................................................................27
`
`i
`
`

`

`TABLE OF AUTHORITIES
`
`Cases
`Abbott Labs v. Baxter Pharm. Prods., Inc.,
`334 F.3d 1274 (Fed. Cir. 2003) .....................................................................10
`
`Accord Healthcare, Inc. USA v. Eli Lilly & Co.,
`IPR2013-00356 (P.T.A.B. Oct. 1, 2013) (Paper 13).......................................5
`
`Eli Lilly and Co. v. Medtronic, Inc.,
`496 U.S. 661 (1990).........................................................................................2
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`721 F.3d 1330 (Fed. Cir. 2013) .......................................................................8
`
`Illumina, Inc. v. Trustees of Columbia Univ. in the City of New York,
`IPR2012-00006 (P.T.A.B. May 10, 2013) (Paper 43) ........................... 21, 24
`
`In re Ciprofloxacin Hydrochloride Antitrust Litig.,
`544 F.3d 1323 (Fed. Cir. 2008) .......................................................................3
`
`In re Rosuvastatin Calcium Patent Litig.,
`703 F.3d 511 (Fed. Cir. 2012) .....................................................................3, 4
`
`In re Rosuvastatin Calcium Patent Litig.,
`MDL No. 08-1949, 2008 WL 5046424 (D. Del. Nov. 24, 2008) ...................8
`
`In re Roth,
`No. 92-2941, 1993 WL 13725366 (B.P.A.I. Mar. 16, 1993)........................17
`
`In re Williams,
`171 F.2d 319 (C.C.P.A. 1948).......................................................................17
`
`Intelligent Bio-Sys, Inc. v. Illuminia Cambridge Ltd.,
`IPR2013-00324 (P.T.A.B. Nov. 21, 2013) (Paper 19)....................................7
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Inc. Co.,
`CBM2012-00003 (P.T.A.B. Oct. 25, 2012) (Paper 7) .......................... passim
`
`Motorola Mobility LLC v. Arnouse,
`IPR2013-00010 (P.T.A.B. Jan. 30, 2013) (Paper 20) .....................................5
`
`ii
`
`

`

`Nissan N. Am., Inc. v. Bd. Of Regents, Univ. of Tx. Sys.,
`IPR2012-00037 (P.T.A.B. Mar. 19, 2013) (Paper 24) ........................... 10, 12
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`267 F. Supp. 2d 533 (N.D. W. Va. 2003)......................................................15
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .....................................................................10
`
`Power Mosfet Techs., L.L.C. v. Siemens AG,
`378 F.3d 1396 (Fed. Cir. 2004) .....................................................................15
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`550 F.3d 1075 (Fed. Cir. 2008) .....................................................................17
`
`Spectrum Int'l, Inc. v. Sterlite Corp.,
`164 F.3d 1372 (Fed. Cir. 1998) .....................................................................15
`
`St. Jude Med. v. Volcano Corp.,
`IPR2013-00258, (P.T.A.B. Oct. 16, 2013) (Paper 29)....................................4
`
`Teva Neuroscience, Inc. v. Watson Labs., Inc.,
`No. 2:10-cv-05078, 2013 WL 1595585 (D.N.J. April 12, 2013)..................15
`
`Texas Instruments Inc. v. U.S. Int'l Trade Comm'n,
`988 F.2d 1165 (Fed. Cir. 1993) .............................................................. 12, 15
`
`Statutes
`
`21 U.S.C. § 355(j) ......................................................................................................1
`
`21 U.S.C. § 355(j)(2)(A)(vii)(IV)..........................................................................2, 3
`
`21 U.S.C. § 355(j)(2)(B)(iv)(II).................................................................................2
`
`21 U.S.C. § 355(j)(5)(C)(i) ........................................................................................3
`
`35 U.S.C. § 271(e)(2).................................................................................................2
`
`35 U.S.C. § 314..........................................................................................................7
`
`35 U.S.C. § 314(d) .....................................................................................................7
`
`35 U.S.C. § 315......................................................................................................4, 6
`
`iii
`
`

`

`35 U.S.C. § 315(a) ...................................................................................... 1, 4, 6, 27
`35 U.S.C. § 315(a) ...................................................................................... 1, 4, 6, 27
`
`35 U.S.C. § 315(b) .................................................................................................4, 5
`35 U.S.C. § 315(b) .................................................................................................4, 5
`
`Regulations
`Regulations
`
`37 C.F.R. § 42.100(b) ............................................................................. 9, 10, 11, 12
`37 CPR. § 42.100(b) ............................................................................. 9, 10, 11, 12
`
`37 C.F.R. § 42.107(c).............................................................................................6, 9
`37 CPR. § 42.107(c) ............................................................................................. 6, 9
`
`37 C.F.R. § 42.108(a)........................................................................................ 16, 21
`37 CPR. § 42.108(a) ........................................................................................ 16, 21
`
`iv
`
`iV
`
`

`

`Novartis AG and LTS Lohmann Therapie-Systeme AG (“Patent
`
`Owners”) respectfully submit this Preliminary Response to the Petition of
`
`Noven Pharmaceuticals Inc. (“Noven”) seeking inter partes review (“IPR”)
`
`of U.S. Patent No. 6,335,031 (“‘031 patent”).
`
`I.
`
`35 U.S.C. § 315(a) Bars Noven’s Petition
`
`35 U.S.C. § 315(a) provides that “[a]n inter partes review may not be
`
`instituted if, before the date on which the petition for such a review is filed,
`
`the petitioner . . . filed a civil action challenging the validity of a claim of the
`
`patent.” Noven effectively filed a civil action challenging the validity of a
`
`claim of the ‘031 patent before the date of its petition. Its petition thus is
`
`barred by 35 U.S.C. § 315(a).
`
`Noven is seeking approval from the United States Food and Drug
`
`Administration (“FDA”) under 21 U.S.C. § 355(j) of the Hatch-Waxman Act
`
`to market a generic copy of Novartis’s Exelon® Patch rivastigmine
`
`transdermal device, which is indicated for the treatment of mild to moderate
`
`dementia associated with Alzheimer’s disease and Parkinson’s disease. On
`
`April 2, 2014, Noven filed the instant petition challenging the validity of
`
`claims 1-3, 7, 15, 16 and 18 of the ‘031 patent. More than one year before,
`
`and prior to February 18, 2013, Noven filed with the FDA a certification
`
`1
`
`

`

`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV certification”)
`
`challenging the validity of the ‘031 patent. On February 18, 2013, Noven
`
`sent a letter pursuant to 21 U.S.C. § 355(j)(2)(B)(iv)(II) (“Paragraph IV
`
`notice letter”) informing Patent Owners of Noven’s Paragraph IV
`
`certification and challenging the validity of claims 1-3, 7-13, 15-16, 18 and
`
`20 of the ‘031 patent, thereby forcing Patent Owners to bring a civil action
`
`to defend their ‘031 patent against Noven’s challenge.
`
`The filing of a Paragraph IV certification under the Hatch-Waxman
`
`Act constitutes a “highly artificial” act of patent infringement under 35
`
`U.S.C. § 271(e)(2). Eli Lilly and Co. v. Medtronic, Inc., 496 U.S. 661, 678
`
`(1990). This “highly artificial” act of infringement was intended by
`
`Congress to create an artificial basis for subject matter jurisdiction and to
`
`provoke the patent owner to file a civil action—despite the absence of any
`
`infringing manufacture, sale or use—so that issues of patent validity and
`
`infringement could be adjudicated by a district court in advance of FDA
`
`approval of the Paragraph IV filer’s potentially infringing drug product. Id.
`
`Consistent with this policy, the Hatch-Waxman Act further provides that if a
`
`patent owner fails to bring suit against the Paragraph IV filer for this “highly
`
`artificial” act of infringement, the Paragraph IV filer may pursue the patent
`
`2
`
`

`

`owner for a declaratory judgment of patent invalidity—again, despite the
`
`absence of any infringing manufacture, sale or use. 21 U.S.C. §
`
`355(j)(5)(C)(i).
`
`By these provisions of the Hatch-Waxman Act, the traditional roles of
`
`patent infringement litigants are deliberately reversed: the Paragraph IV filer
`
`becomes a de facto declaratory judgment plaintiff, and the patent owner
`
`becomes a de facto declaratory judgment defendant. For this reason, the
`
`Federal Circuit on several occasions has characterized the Paragraph IV
`
`filer, rather than the patent owner, as the party who initiates the challenge to
`
`patent validity. E.g., In re Rosuvastatin Calcium Patent Litig., 703 F.3d
`
`511, 515 (Fed. Cir. 2012) (“Several generic producers initiated a challenge
`
`to the [patent-in-suit] by filing an Abbreviated New Drug Application
`
`(ANDA) accompanied by a Paragraph IV certification, 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV).” (emphasis added)); In re Ciprofloxacin
`
`Hydrochloride Antitrust Litig., 544 F.3d 1323, 1334 (Fed. Cir. 2008)
`
`(“[G]eneric manufacturers … filed Paragraph IV ANDAs and initiated
`
`challenges of the validity of the patent.” (emphasis added)) (reversed on
`
`other grounds).
`
`3
`
`

`

`Thus, although Patent Owners here undertook the formality of filing a
`
`complaint against Noven, Noven alone had the power and the discretion to
`
`initiate civil action by filing a Paragraph IV certification challenging the
`
`validity of the ‘031 patent. Noven’s April 2, 2014 petition accordingly
`
`should be barred by 35 U.S.C. § 315(a), because the filing of Noven’s
`
`Paragraph IV certification more than a year before April 2, 2014 effectively
`
`constituted the filing of a civil action.
`
`The legislative history behind 35 U.S.C. § 315 further confirms that
`
`Noven’s petition should be barred. Congress has stated that the IPR process
`
`was not intended to be used as a “tool[] for harassment” by “repeated
`
`litigation and administrative attacks,” which “would frustrate the purpose of
`
`the section as providing quick and cost effective alternatives to litigation.”
`
`Ex 2001 (H.R. Rep. No. 112-98), 48. Consistent with Congress’s intent, the
`
`Board has construed 35 U.S.C. § 315 broadly to prevent petitioners from
`
`harassing patent owners with repeated and dilatory attacks in both district
`
`courts and at the USPTO. St. Jude Med. v. Volcano Corp., IPR2013-00258,
`
`(P.T.A.B. Oct. 16, 2013) (Paper 29 at 3) (construing § 315(b) to bar an IPR
`
`petition filed more than one year after a counterclaim); Accord Healthcare,
`
`Inc. USA v. Eli Lilly & Co., IPR2013-00356 (P.T.A.B. Oct. 1, 2013) (Paper
`
`4
`
`

`

`13 at 3-4) (construing § 315(b) to bar a petition filed more than one year
`
`after a complaint was filed, even though the patent owner had filed a
`
`complaint alleging patent infringement of the same patent less than one year
`
`earlier).1 Allowing a Paragraph IV filer such as Noven to provoke civil
`
`1
`
`The one-year grace period afforded by 35 U.S.C. § 315(b) was
`
`intended to give patent infringement defendants time to decide whether to
`
`initiate IPR against patents being asserted against them in litigation.
`
`Motorola Mobility LLC v. Arnouse, IPR2013-00010 (P.T.A.B. Jan. 30,
`
`2013) (Paper 20 at 4-5). By contrast, a Paragraph IV filer already will have
`
`analyzed the relevant patents before its Paragraph IV filing and notice letter,
`
`and thus will not need any additional time to decide whether to initiate IPR
`
`once litigation begins. This distinction further serves to illustrate the extent
`
`to which a Paragraph IV filer such as Noven constitutes a de facto plaintiff.
`
`Here, Noven could have initiated IPR against the ‘031 patent as of the date
`
`of its Paragraph IV filing. And Noven knew that its Paragraph IV filing
`
`would provoke Patent Owners to sue on the ‘031 patent, particularly in view
`
`of the fact that Patent Owners previously sued several other Paragraph IV
`
`filers on the same patent. (Petition at 1.)
`
`5
`
`

`

`action, and then to file an IPR petition well after civil action is underway,
`
`clearly would subvert the stated intent of 35 U.S.C. § 315.
`
`For these reasons, Patent Owners respectfully submit that Noven’s
`
`petition is barred by 35 U.S.C. § 315(a).
`
`II.
`
`The Board Should Deny Institution Of Noven’s Petition
`In View Of Pending Delaware District Court Litigation
`
`Currently before Judge Richard G. Andrews of the United States
`
`District Court for the District of Delaware is the matter of Novartis Pharm.
`
`Corp. v. Noven Pharm. Inc., 1:13-cv-00527-RGA (D. Del.) (“Noven suit”).
`
`The Noven suit has been pending since April 3, 2013, and involves the same
`
`parties, experts and patent validity issues as this petition. Judge Andrews is
`
`scheduled to try those issues on December 1-3, 2014, well before this Board
`
`will be able to decide them. Moreover, Judge Andrews already has upheld
`
`the validity of the ‘031 patent over many of the same references raised in
`
`Noven’s petition—namely Enz, the Handbook, Rosin and Elmalem—in the
`
`matter of Novartis Pharm. Corp. v. Watson Labs. Inc., 1:11-cv-01112-RGA
`
`(D. Del.) (“Watson suit”). Because district court decisions from pending
`
`litigation do not constitute “new testimony evidence” under 37 C.F.R. §
`
`42.107(c) (see, e.g., Anova Food, LLC. v. Leo Sandau, IPR2013-00114
`
`(P.T.A.B. June 25, 2013) (Paper 11 at 2-3)), Patent Owners submit herewith
`
`6
`
`

`

`as Ex 2002 a copy of Judge Andrews’s June 18, 2014 decision from the
`
`Watson suit upholding the validity of the ‘031 patent.
`
`In view of these facts, Patent Owners respectfully request that the
`
`Board exercise its discretion to deny institution of Noven’s petition.2
`
`Denying institution of the petition will serve three goals. First, it will
`
`prevent waste of this Board’s resources adjudicating issues and references
`
`2
`
`While 35 U.S.C. § 314 sets forth standards by which the Board must
`
`deny IPR, there is no corresponding statute that sets forth standards by
`
`which the Board must institute IPR. The absence of any such statute gives
`
`the Board the discretion not to institute IPR. See Intelligent Bio-Sys, Inc. v.
`
`Illuminia Cambridge Ltd., IPR2013-00324 (P.T.A.B. Nov. 21, 2013) (Paper
`
`19 at 4) (“Congress did not mandate that an inter partes review must be
`
`instituted under certain conditions. Rather, by stating that the Director—and
`
`by extension, the Board—may not institute review unless certain conditions
`
`are met, Congress made institution discretionary.” (emphasis in original)).
`
`The non-appealable nature of the Board’s institution decisions under 35
`
`U.S.C. § 314(d) further confirms the existence of this discretionary
`
`authority.
`
`7
`
`

`

`that are already before a district court judge who is familiar with them.
`
`Second, it will eliminate the risk of inconsistent decisions between the Board
`
`and the Delaware District Court concerning the validity of the challenged
`
`claims of the ‘031 patent, such as occurred in Fresenius USA, Inc. v. Baxter
`
`Int’l, Inc., 721 F.3d 1330, reh’g denied, 733 F.3d 1369 (Fed. Cir. 2013).
`
`Third, given that trial in the Noven suit is scheduled to occur on December
`
`1-3, 2014, Patent Owners believe that the Delaware District Court will be
`
`able to render its decision on both the validity and infringement of the ‘031
`
`patent ahead of the Board’s decision on validity, thereby promoting the
`
`expeditious disposition of all patent disputes between Patent Owners and
`
`Noven, as intended by the Hatch-Waxman Act. In re Rosuvastatin Calcium
`
`Patent Litig., MDL No. 08–1949, 2008 WL 5046424, at *5 (D. Del. Nov.
`
`24, 2008).
`
`III. The Board Should Adopt The Delaware District Court’s
`Construction Of The Claim Term “Amount Of Antioxidant
`Effective To Stabilize Compound A From Degradation”
`
`The term “amount of antioxidant effective to stabilize Compound A
`
`from degradation” appears in challenged claims 15, 16 and 18. In the Noven
`
`and Watson suits, the Delaware District Court construed that term to mean
`
`“an amount of antioxidant that will significantly reduce degradation of
`
`8
`
`

`

`Compound A over a prolonged period of time.”3 Because district court
`
`orders from pending litigation do not constitute “new testimony evidence”
`
`under 37 C.F.R. § 42.107(c) (see, e.g., Anova Food, LLC. v. Leo Sandau,
`
`IPR2013-00114 (P.T.A.B. June 25, 2013) (Paper 11 at 2-3)), Patent Owners
`
`submit herewith as Exs 2003 and 2004 copies of the Delaware District
`
`Court’s claim construction orders from the Noven and Watson suits.
`
`For the following reasons, Patent Owners respectfully request that the
`
`Board adopt the Delaware District Court’s construction as the broadest
`
`reasonable construction consistent with the specification of the ‘031 patent,
`
`in accordance with 37 C.F.R. § 42.100(b).
`
`First, the Delaware District Court’s construction accords with the
`
`plain and ordinary meaning of the language “amount . . . effective.” The
`
`Board recognizes that claim terms typically are given their ordinary and
`
`accustomed meaning. E.g., Nissan N. Am., Inc. v. Bd. Of Regents, Univ. of
`
`3
`
`The alternate construction that Noven proposes in its petition (“an
`
`amount of antioxidant that reduces the oxidative degradation of Compound
`
`A”) is the same construction that Patent Owners advocated and lost in the
`
`Noven and Watson suits.
`
`9
`
`

`

`Tx. Sys., IPR2012-00037 (P.T.A.B. Mar. 19, 2013) (Paper 24 at 5) (citing
`
`Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc)).
`
`The term “effective amount” ordinarily means an amount that will achieve
`
`the claimed effect. See Abbott Labs v. Baxter Pharm. Prods., Inc., 334 F.3d
`
`1274, 1277-78 (Fed. Cir. 2003).
`
`Second, 37 C.F.R. § 42.100(b) requires the Board to interpret a claim
`
`“in light of the specification of the patent in which it appears.” The
`
`specification of the ‘031 patent is clear that the claimed effect that the
`
`claimed amount of antioxidant is intended to achieve is “to stabilize
`
`Compound A from degradation.” The specification states that “[t]he present
`
`applicant has found that stable pharmaceutical compositions comprising
`
`compound A can now be obtained, which show insignificant degradation of
`
`compound A over a prolonged time period, e.g. 2 years, as indicated by
`
`standard tests, e.g. stress tests.” (Ex. 1001, col. 1, ll. 29-33, emphases
`
`added.) The specification also provides examples 1-3, which uniformly
`
`describe compositions showing “insignificant degradation” after storage of
`
`at least four months, with Example 1 explaining that “[t]he compositions and
`
`devices of this invention provide storage stable systems.” (Ex. 1001, col. 7,
`
`ll. 17-52, emphases added.) The specification further describes as one
`
`10
`
`

`

`aspect of the invention a surprising “stabilising [sic] effect” achieving
`
`significant reductions in the oxidative degradation of Compound A during
`
`stress tests conducted over two or three months in length. (Ex. 1001, col. 4,
`
`ll. 10-30, emphasis added.) The specification thus describes the claimed
`
`effect to be achieved by the claimed amount of antioxidant as a significant
`
`reduction in the degradation of Compound A over a prolonged period of
`
`time.
`
`Third, 37 C.F.R. § 42.100(b) requires the Board to give a claim its
`
`broadest reasonable construction. There is no reasonable construction of the
`
`term that is broader than “an amount of antioxidant that will significantly
`
`reduce degradation of Compound A over a prolonged period of time.” To
`
`construe that term without any limits as to the extent or time of the reduction
`
`in degradation—as Noven suggests—not only would be inconsistent with
`
`the specification of the ‘031 patent, which consistently imposes such limits,
`
`but would also allow claims 15, 16 and 18 to encompass an amount of
`
`antioxidant that is effective to reduce the degradation, for example, of just
`
`one molecule of Compound A for just one picosecond. Clearly, such a
`
`construction is not reasonable, as it reads “stabilize” out of the claim term.
`
`See Texas Instruments Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1171
`
`11
`
`

`

`(Fed. Cir. 1993) (rejecting construction that would “read an express
`
`limitation out of the claims”).
`
`In view of these considerations, Patent Owners respectfully request
`
`that the Board adopt the Delaware District Court’s construction as the
`
`broadest reasonable construction in view of the specification of the ‘031
`
`patent, in accordance with 37 C.F.R. § 42.100(b). See Nissan N. Am., Inc.,
`
`IPR2012-00037 (P.T.A.B. Mar. 19, 2013) (Paper 24 at 5-7) (finding that a
`
`district court’s constructions of certain claim terms were consistent with the
`
`patent specification and were the broadest reasonable constructions in
`
`accordance with 37 C.F.R. § 42.100(b)).
`
`IV. The Board Also Should Adopt The Delaware District
`Court’s Construction Of The Claim Term “Stabilizing”
`
`The term “stabilizing” appears in challenged claims 15, 16 and 18. In
`
`the Noven and Watson suits, the Delaware District Court construed the term
`
`to mean “significantly reducing degradation of Compound A over a
`
`prolonged period of time.”4 For the same reasons in Section III above,
`
`4
`
`The alternate construction that Noven proposes in its petition
`
`(“reducing degradation”) is the same construction that Patent Owners
`
`advocated and lost in the Noven and Watson suits.
`
`12
`
`

`

`Patent Owners respectfully request that the Board adopt the Delaware
`
`District Court’s construction of “stabilizing” as the broadest reasonable
`
`construction consistent with the specification of the ‘031 patent.
`
`V.
`
`The Board Should Reject Noven’s Proposed
`Construction Of The Claim Term “Comprising”
`
`Noven asserts that, because each of the challenged claims contains the
`
`transition “comprising” and “do not recite a degree of optical purity,” the
`
`challenged claims “do not exclude other components from the claimed
`
`composition, including ent-rivastigmine” and thus “embrace compositions
`
`containing both rivastigmine and its enantiomer, including compositions
`
`concerning racemic RA7.” (Petition at 9.) For the following reasons,
`
`Plaintiffs respectfully submit that Noven construction of “comprising” is
`
`wrong and should be rejected.
`
`First, Noven’s characterization of the compounds known as
`
`“rivastigmine” and “RA7” is misleading and incorrect. To clarify matters:
`
`(i)
`
`“RA7” is the racemate: i.e., N-ethyl-3-{(1-dimethylamino)
`
`ethyl}-N-methyl-phenyl-carbamate HCl. (Ex. 1009 at 2.)
`
`(ii)
`
`“Rivastigmine” is the (S)-enantiomer: i.e., (S)-N-ethyl-3-{(1-
`
`dimethylamino)ethyl}-N-methyl-phenyl-carbamate.
`
`13
`
`

`

`Rivastigmine, being an (S)-enantiomer, cannot be an (R)-enantiomer. And
`
`rivastigmine, being an (S)-enantiomer, cannot be a racemate. Thus, contrary
`
`to Noven’s assertions, there is no such thing as “racemic rivastigmine.”
`
`Second, it is a scientific fact that a racemate and its enantiomers are
`
`chemically distinct compounds, and that the way in which they rotate light is
`
`the signature feature that distinguishes them. An (S)-enantiomer rotates
`
`light counter-clockwise, an (R)-enantiomer rotates light clockwise, and a
`
`racemate does not rotate light at all. Each of the challenged claims of the
`
`‘031 patent is directed expressly to “(S)-N-ethyl-3-{(1-dimethylamino)
`
`ethyl}-N-methyl-phenyl-carbamate in free base or acid addition salt form”
`
`(emphasis added). The “(S)-” prefix specifically refers to an (S)-enantiomer.
`
`Thus, while the challenged claims can encompass some amount of (R)-
`
`enantiomer, that amount cannot be equal to or greater than the amount of
`
`(S)-enantiomer; otherwise, the claimed (S)-enantiomer will be read out of
`
`the claim.
`
`Third, a claim that is directed expressly to a specific enantiomer, such
`
`as an (S)-enantiomer, by law cannot be construed to encompass a racemate,
`
`regardless of whether the claim recites a degree of optical purity. E.g.,
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`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 267 F. Supp. 2d 533, 542-
`
`14
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`

`

`43 (N.D. W. Va. 2003) (denying defendant’s summary judgment motion that
`
`patent claim reciting (S)-enantiomer was anticipated by prior art racemate
`
`despite lack of optical purity claim limitation); Teva Neuroscience, Inc. v.
`
`Watson Labs., Inc., No. 2:10-cv-05078, 2013 WL 1595585, at *5-6 (D.N.J.
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`April 12, 2013) (rejecting proposed construction of claim expressly
`
`requiring “R(+)” enantiomer to cover compound resembling racemic
`
`mixture).
`
`Fourth, contrary to Noven’s assertions, the transition “comprising”
`
`cannot be used to add any and all unrecited elements to a claim, and also
`
`cannot be used to read out an express limitation of the claim, such as “(S)-.”
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`E.g., Spectrum Int’l, Inc. v. Sterlite Corp., 164 F.3d 1372, 1379-80 (Fed. Cir.
`
`1998) (rejecting argument that “comprising” permits the addition of
`
`elements from the prior art to the elements set forth in the claim to abrogate
`
`claim limitations); Power Mosfet Techs., L.L.C. v. Siemens AG, 378 F.3d
`
`1396, 1409 (Fed. Cir. 2004) (“‘Comprising,’ while permitting additional
`
`elements not required by a claim, does not remove the limitations that are
`
`present.”). See also Texas Instruments Inc. v. U.S. Int’l Trade Comm’n, 988
`
`F.2d 1165, 1171 (Fed. Cir. 1993) (rejecting construction that would “read an
`
`express limitation out of the claims”).
`
`15
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`

`

`Fifth, Rosin, which issued on August 14, 1990, discloses the racemate
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`RA7. (Ex. 1008, col. 10, l. 23.) Rosin was cited to the USPTO during the
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`prosecution of the application that issued as the ‘031 patent. Consistent with
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`the above scientific and legal principles, at no time during the prosecution of
`
`that application did the USPTO examiner assert—as Noven does now—that
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`any claim was invalid because it “encompassed” the prior art racemate RA7.
`
`For these reasons, Patent Owners respectfully request that the Board
`
`reject Noven’s proposed construction of “comprising” as including
`
`compositions containing an equal or greater amount of “ent-rivastigmine.”
`
`VI. The Board Should Deny Institution Based On
`Ground 1 Because Elmalem Does Not Anticipate Claim 15
`
`37 C.F.R. § 42.108(a) grants the Board the discretion to “authorize the
`
`review to proceed on all or some of the challenged claims and on all or some
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`of the grounds of unpatentability asserted for each claim.” Ground 1 of
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`Noven’s petition alleges that Elmalem anticipates claim 15. For the
`
`following reasons, Noven is wrong that Elmalem anticipates claim 15.
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`Patent Owners thus respectfully request that the Board deny institution based
`
`on Ground 1.
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`First, Elmalem discloses only the racemate “RA7,” which is “N-ethyl,
`
`N-methyl-3-[1-(dimethylamino)ethyl] phenyl carbamate HCl.” (Ex. 1009 at
`
`16
`
`

`

`2.) By contrast, claim 15 is directed to the (S)-enantiomer “Compound A,”
`
`which is “(S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-methyl-phenyl-
`
`carbamate in free base or acid addition salt form.”
`
`(Ex. 1001, col. 9.)
`
`Elmalem does not disclose (S)-N-ethyl-3-{(1-dimethylamino)ethyl}-N-
`
`methyl-phenyl-carbamate. It is well settled that a prior art reference that
`
`discloses a racemate does not disclose, and thus does not anticipate, a claim
`
`directed to a specific enantiomer of that racemate. 5 E.g., In re Williams, 171
`
`F.2d 319, 320 (C.C.P.A. 1948); Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d
`
`1075, 1084 (Fed. Cir. 2008); see also In re Roth, No. 92-2941, 1993 WL
`
`13725366, at *2 (B.P.A.I. Mar. 16, 1993) (prior art reference disclosing
`
`racemate containing R-trans and S-trans enantiomers in admixture did not
`
`anticipate claims to R-trans enantiomer). Because Elmalem’s disclosure of
`
`the racemate RA7 does not constitute a disclosure of the (S)-enantiomer
`
`Compound A, Elmalem does not anticipate claim 15.
`
`5
`
`As explained in Section V above, a claim directed to a specific
`
`enantiomer cannot be construed to encompass a racemate, even if it lacks a
`
`specific purity limitation and uses the transition “comprising.”
`
`17
`
`

`

`Second, both the Delaware District Court’s construction and Noven’s
`
`proposed construction of the term “amount of anti-oxidant effective to
`
`stabilize Compound A from degradation” in claim 15 require an amount of
`
`antioxidant that reduces the oxidative degradation of Compound A. To
`
`reduce the oxidative degradation of Compound A, there must be oxidative
`
`degradation of Compound A to begin with. Elmalem, however, does not
`
`disclose that RA7 or Compound A undergoes oxidative degradation. The
`
`purpose of the study in Elmalem was not to assess the oxidative degradation
`
`of RA7, but rather to assess the ability of aqueous injectable formulations of
`
`RA7 and other drugs to antagonize the respiratory depressant effect of
`
`morphine in rabbits. (Ex. 1009 at 1.)
`
`Third, both the Delaware District Court’s construction and Noven’s
`
`proposed construction of the term “amount of anti-oxidant effective to
`
`stabilize Compound A from degradation” in claim 15 require an amount of
`
`antioxidant that reduces the oxidative degradation of Compound A. Because
`
`Elmalem was not a stability study, there is no disclosure in Elmalem that the
`
`amount of sodium metabisulphite included in the aqueous injectable
`
`formulation of Elmalem reduced the oxidative degradation of RA7 or
`
`Compound A.
`
`18
`
`

`

`Fourth, as explained in Section III above, the Delaware District
`
`Court’s construction of the term “amount of anti-oxidant effective to
`
`stabilize Compound A from degradation” in claim 15 requires an amount of
`
`antioxidant effective to significantly reduce the oxidative degradation of
`
`Compound A. Because there is no disclosure in Elmalem that the amount of
`
`sodium metabisulphite included in the aqueous injectable formulation of
`
`Elmalem reduced the oxidative degradation of RA7 or Compound A, there is
`
`of course no disclosure in Elmalem that such an amount significantly
`
`reduced the oxidative degradation of RA7 or Compound A.
`
`Fifth, as explained in Section III above, the Delaware District Court’s
`
`construction of the term “amount of anti-oxidant effective to stabilize
`
`Compound A from degradation” in claim 15 requires an amount of
`
`antioxidant effective to significantly reduce the oxidative degradation of
`
`Compound A over a prolonged period of time. Elmalem states that an
`
`aqueous injectable formulation of RA7 was “made up freshly in sterile
`
`saline” (Ex. 1009 at 2 (emphasis added)), thereby disclosing that it was
`
`administered shortly after it was “made up.” This disclosure forecloses the
`
`possibility that there could have been any reduction in the oxidative
`
`degradation of RA7 or Compound A over a prolonged period of time.
`
`19
`
`

`

`In sum, Elmalem does not anticipate claim 15 because it does not
`
`disclose:
`
`(i)
`
`(ii)
`
`Compound A, as required by claim 15;
`
`that there is oxidative degradation of Compound A, as required
`
`by both the Delaware District Court’s construction and Noven’s
`
`proposed construction of claim 15;
`
`(iii)
`
`that the amount of sodium metabisulphite in the aqueous
`
`injectab