UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`
`___________
`
`
`Case IPR2017-01995
`Patent 9,220,698
`
`___________
`
`
`PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`___________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`
`___________
`
`
`Case IPR2017-01995
`Patent 9,220,698
`
`___________
`
`
`PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`B.
`C.
`
`D.
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`PETITIONER’S PETITION IS BARRED UNDER § 315 ............................. 5
`A.
`Petitioner Brought the ’698 Patent Into the District Court Litigation
`More Than 19 Months Prior to Filing the Instant Petition .................... 5
`Legal Standard ....................................................................................... 7
`Petitioner’s Inter Partes Review Petition is Barred Under § 315(a) by
`Petitioner’s Civil Action Challenging Validity of the ’698 Patent ....... 8
`Petitioner’s Inter Partes Review Petition is Time-Barred Under
`§ 315(b) ...............................................................................................10
`PETITIONER HAS NOT ESTABLISHED THAT THE ’285 PATENT IS
`III.
`§ 102(e) PRIOR ART ..............................................................................................13
`A.
`Legal Standard .....................................................................................14
`B.
`Petitioner Has Not Met Its Burden to Show That the ’285 Patent Is §
`102(e) Prior Art ...................................................................................15
`IV. THE PTO HAS PREVIOUSLY REJECTED SUBSTANTIALLY THE
`SAME ARGUMENTS DURING PROSECUTION ...............................................16
`A.
`Institution of an Inter Partes Review Is Discretionary .......................16
`B.
`Petitioner Has Failed to Explain Why the Board Should Reconsider
`Obviousness Over a Plachetka Patent .................................................17
`CONCLUSION ..............................................................................................18
`
`I.
`II.
`
`V.
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`IPR2017-01995
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`Page i
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Apple Inc. v. Papst Licensing GmbH & Co. KG,
`IPR2016-01841, Paper 10 (P.T.A.B. Apr. 17, 2017) ......................................... 16
`Apple Inc. v. Rensselaer Polytechnic Inst.,
`IPR2014-00319, Paper 12 (P.T.A.B. June 12, 2014) ......................................... 12
`Applied Materials, Inc. v. Gemini Research Corp.,
`835 F.2d 279 (Fed. Cir. 1988) ...................................................................... 13, 14
`Ariosa Diagnostics, Inc. v. Illumina, Inc.,
`IPR2014-01093, Paper 69 (P.T.A.B. Jan. 7, 2016) ............................................ 15
`In re DeBaun,
`687 F.2d 459 (C.C.P.A. 1982) ............................................................................ 15
`Johnson Health Tech Co. v. Icon Health & Fitness, Inc.,
`IPR2014-01242, Paper 16 (P.T.A.B. Feb. 11, 2015) ............................................ 7
`Riverwood Int’l Corp. v. R.A. Jones & Co.,
`324 F.3d 1346 (Fed. Cir. 2003) .......................................................................... 14
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01750, Paper 15 (P.T.A.B. Apr. 3, 2017) ........................................... 14
`St. Jude Med., Cardiology Div., Inc. v. Volcano Corp.,
`IPR2013-00258, Paper 29 (P.T.A.B. Oct. 16, 2013 ..................................... 10, 11
`Tristar Prods., Inc. v. Choon’s Design, LLC,
`IPR2015-01883, Paper 6 (PTAB Mar. 9, 2016) ................................................... 8
`Unified Patents Inc. v. Berman,
`IPR2016-01571, Paper 10 (P.T.A.B. Dec. 14, 2016) ......................................... 17
`Statutes
`35 U.S.C. § 313 .......................................................................................................... 1
`35 U.S.C. § 314(a) ..................................................................................................... 5
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`Page ii
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`35 U.S.C. § 315 ...................................................................................................... 5, 7
`35 U.S.C. § 315(a) ................................................................................................. 1, 8
`35 U.S.C. § 315(b) ............................................................................................... 1, 10
`35 U.S.C. § 325(d) ............................................................................................... 5, 16
`Other Authorities
`37 C.F.R. § 42.104(a) ................................................................................................. 7
`37 C.F.R. § 42.108(a) ............................................................................................... 16
`37 C.F.R. § 42.108(b) .............................................................................................. 16
`157 Cong. Rec. S5429 (daily ed. Sept. 8, 2011) (stmt of Sen. Kyl) .......................... 8
`
`
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`IPR2017-01995
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`Page iii
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`Exhibit No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`EXHIBIT LIST
`Description of Document
`Gabriel, S.E., et al., “Risk for Serious Gastrointestinal
`Complications Related to Use of Nonsteroidal Anti-inflammatory
`Drugs,” Annals of Internal Medicine, Vol. 115, No. 10, pp. 787-
`796 (1991) (“Gabriel”)
`
`Cryer, B. and Feldman, M., “Effects of Nonsteroidal Anti-
`inflammatory Drugs on Endogenous Gastrointestinal
`Prostaglandins and Therapeutic Strategies for Prevention and
`Treatment of Nonsteroidal Anti-inflammatory Drug-Induced
`Damage,” Archives of Internal Medicine, Vol. 152, pp. 1145-
`1155 (1992) (“Cryer”)
`
`Fries, J.F., et al., “Nonsteroidal Anti-Inflammatory Drug-
`Associated Gastropathy: Incidence and Risk Factor Models,” The
`American Journal of Medicine, Vol. 91, pp. 213-222 (1991)
`(“Fries”)
`
`Second Amended Complaint for Patent Infringement, Horizon
`Pharma, Inc. v. Mylan Pharmaceuticals Inc., Civil Action No.
`2:15-cv-03327 (D.N.J. Feb. 10, 2016)
`
`Answer to Second Amended Complaint, Separate Defenses, And
`Counterclaims by Defendants Mylan Pharmaceuticals Inc., Mylan
`Laboratories Limited and Mylan Inc. , Horizon Pharma, Inc. v.
`Mylan Pharmaceuticals Inc., Civil Action No. 2:15-cv-03327
`(D.N.J. Feb. 19, 2016)
`
`Plaintiffs’ Answer to Defendants’ Counterclaims to Second
`Amended Complaint, Horizon Pharma, Inc. v. Mylan
`Pharmaceuticals Inc., Civil Action No. 2:15-cv-03327 (D.N.J.
`Mar. 7, 2016)
`
`2007
`
`157 Cong. Rec. S5429 (daily ed. Sept. 8, 2011) (statement of Sen.
`Kyl)
`
`
`
`
`
`
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`Horizon Pharma USA, Inc. and Pozen Inc. (hereinafter, “Patent Owner”)
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`respectfully submit this preliminary response under 35 U.S.C. § 313 to Mylan
`
`Pharmaceuticals Inc.’s (hereinafter, “Petitioner”) request for inter partes review
`
`(“IPR”) of claims 1-7 of U.S. Patent No. 9,220,698 (“the ’698 patent”). Petitioner’s
`
`Petition fails to demonstrate a reasonable likelihood that claims 1-7 of the ’698
`
`patent are unpatentable. First, Petitioner first asserted the ’698 patent in a
`
`counterclaim for declaratory judgment of invalidity and non-infringement 19 months
`
`before filing this IPR. Petitioner’s IPR Petition is thus barred under 35 U.S.C.
`
`§ 315(a) and (b). Second, each of the three proposed grounds includes U.S. Patent
`
`No. 8,557,285 (“the ’285 patent”) and Petitioner has not established that the ’285
`
`patent is § 102(e) prior art to the ’698 patent. Third, the Board has already
`
`considered—and rejected—similar arguments raised during prosecution. Petitioner
`
`therefore has not shown that there is a reasonable likelihood that it would prevail
`
`with respect to any of the challenged claims and institution should be denied.
`
`I.
`
`INTRODUCTION
`
`Non-steroidal anti-inflammatory drugs, or NSAIDs, have long been used for
`
`the management of inflammatory conditions including osteoarthritis, rheumatoid
`
`arthritis, and other musculoskeletal conditions. (Ex. 2001 at 787.) In fact, NSAIDs
`
`are one of the most widely used medicines in the world. (Id.) But NSAID use has
`
`long been known to increase the risk of serious damage to the gastrointestinal track,
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`such as ulcers and bleeding. (Id.) This is believed to be the case because NSAIDs
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`inhibit prostaglandin synthesis, which in turn, leads to toxic gastrointestinal effects.
`
`(Ex. 2002 at 1145.) The use of NSAIDs is recognized as causing the most prevalent
`
`serious drug toxicity in the United States, resulting in an estimated 2,600 deaths and
`
`24,000 hospitalizations annually in rheumatoid arthritis patients alone. (Ex. 2003 at
`
`213.) Over the years, pharmaceutical companies tried various approaches to develop
`
`safer NSAIDs, but were unsuccessful in reducing the risk of NSAID-associated GI
`
`injuries.
`
`In the early 2000s, Dr. Plachetka—the inventor of U.S. Patent Nos. 6,926,907
`
`(“the ’907 patent,” Ex. 1004) and 8,557,285 (“the ’285 patent,” Ex. 1005)
`
`(collectively, “the Plachetka patents”) and co-inventor of the ’698 patent—set out to
`
`create a better arthritis medicine with a lower risk of GI toxicity. While others in
`
`the field had tried to solve the GI toxicity problem by administering separate
`
`medicines to reduce gastric acidity or to replace gastroprotective prostaglandins, Dr.
`
`Plachetka approached the problem with an unorthodox solution: he combined a
`
`proton pump inhibitor (“PPI”) to inhibit the production of gastric acid with an
`
`NSAID to relieve pain and inflammation into a single dosage form. Significantly,
`
`Dr. Plachetka designed the dosage form to exhibit coordinated release of the active
`
`ingredients: the PPI would be released immediately into the stomach to elevate the
`
`gastric pH (i.e., lower the acidity) to reduce the toxic effects of the NSAID. The
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`release of the NSAID would be delayed until the pH of the environment was higher,
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`such as in the small intestine. Prior to Dr. Plachetka’s invention, no one had
`
`combined an immediate-release PPI with a delayed-release NSAID. This dosage
`
`form reduces the side effects previously associated with long-term, daily use of
`
`NSAIDs.
`
`Subsequent to the invention claimed in the ’907 and ’285 patents, Dr.
`
`Plachetka collaborated with Everardus Orlemans, a scientist from Pozen, and Brian
`
`Ault and Mark Sostek, scientists from AstraZeneca to improve upon the claimed
`
`inventions. They selected esomeprazole as the immediate-release PPI and naproxen
`
`as the delayed release NSAID. They also chose the specific dosages of
`
`esomeprazole and naproxen to include in the formulation, and determined that the
`
`formulation should be administered twice a day (in an AM unit dose form and, ten
`
`hours later, a PM unit dose form).
`
`During prosecution of the ’698 patent, the applicants successfully overcame
`
`the very challenge now raised by Petitioner, namely inherent anticipation by, or
`
`obviousness over, an earlier Plachetka patent.1 As explained during prosecution,
`
`applicants “unexpectedly discovered and demonstrated that, by practicing the recited
`
`method, they can achieve a [more beneficial] pharmacodynamic profile” in which
`
`the post-administration intragastric pH was higher than 4.0 for a longer period of
`
`
`1 In 2013, Horizon purchased these and the related patents from AstraZeneca AB.
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`time. (Ex. 1013, 1/30/2013 Applicant Arguments at 7-8.) Applicants argued that
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`the ’907 patent failed to teach the claimed unexpected pharmacokinetic parameters.
`
`(Ex. 1040, 9/25/2015 Applicant Arguments at 5-7.) The Examiner subsequently
`
`withdrew the obviousness rejections made over the ’907 patent and the ’698 patent
`
`issued on December 29, 2015. (Ex. 1041, 10/9/2015 Advisory Action at 2.)
`
`Petitioner, having lost an infringement suit on the ’907 and ’285 patents in
`
`district court,2 now belatedly brings this petition for inter partes review of the ’698
`
`patent. Petitioner first asserted the invalidity of the ’698 patent in a counterclaim
`
`more than one year before filing its Petition. Prior to Petitioner’s assertion of the
`
`counterclaim, the ’698 patent was not involved in the litigation. Petitioner’s Petition
`
`is thus barred under § 315(a). Petitioner’s Petition is also time-barred under
`
`§ 315(b), as it was filed more than 12 months after Patent Owner answered
`
`Petitioner’s declaratory judgment count of noninfringement. Setting aside the fact
`
`that Petitioner’s petition is barred—each of the three combinations of art fail because
`
`they are all based on the ’285 patent and Petitioner has not established that the ’285
`
`patent is § 102(e) prior art to the ’698 patent. And the fact that the Patent Office
`
`
`2 See District Court Amended Memorandum Opinion, Public Version (Dkt. 497 in
`Case No. 3:11-cv-02317-MCL-DEA) (lead case); District Court Final Judgment
`(Dkt. 499 in Case No. 3:11-cv-02317-MLC-DEA); and District Court Final
`Judgment (Dkt. 87 in Case No. 3:13-cv-04022-MLC-DEA).
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`considered and rejected the very arguments that Petitioner now makes demonstrates
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`that Petitioner’s Petition does not support a conclusion of unpatentability.
`
`Under these circumstances, the Board should exercise its discretion to deny
`
`institution pursuant to 35 U.S.C. § 325(d). To institute IPR, “the information
`
`presented in the petition” must demonstrate a reasonable likelihood that the
`
`petitioner would prevail on invalidity. See 35 U.S.C. § 314(a) (IPR may not be
`
`instituted absent “a reasonable likelihood that the petitioner would prevail”). Even
`
`considering the merits, the petition does not demonstrate a likelihood of success on
`
`any of the three asserted grounds and should be denied.
`
`II.
`
`PETITIONER’S PETITION IS BARRED UNDER § 315
`
`A.
`
`Petitioner Brought the ’698 Patent Into the District Court
`Litigation More Than 19 Months Prior to Filing the Instant
`Petition
`It was Petitioner Mylan, not Patent Owner who first brought the ’698 into the
`
`related district court action. As shown below, Petitioner brought a counterclaim for
`
`declaratory judgment of invalidity and non-infringement of the ’698 patent in
`
`February 2016—19 months before filing this IPR. A brief history of the pleadings
`
`is set forth below.
`
`• May 13, 2015: Patent Owner and Plaintiffs Horizon Pharma, Inc. and Pozen
`
`Inc. filed an Original Complaint for patent infringement against Defendant
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`Petitioner in the District of New Jersey, alleging infringement of U.S. Patent
`
`Nos. 8,852,636 and 8,858,996. (2:15-cv-03327 Dkt. 1.)
`
`• June 18, 2015: Patent Owner filed a First Amended Complaint adding U.S.
`
`Patent No. 8,865,190. (2:15-cv-03327 Dkt. 6.)
`
`• August 18, 2015: Petitioner and Defendant Mylan Pharmaceuticals Inc. filed
`
`its Answer and Counterclaims to the First Amended Complaint. (2:15-cv-
`
`03327 Dkt. 9.)
`
`• August 31, 2015: Petitioner filed an Amended Answer and Counterclaims to
`
`the First Amended Complaint. (2:15-cv-03327 Dkt. 12.)
`
`• September 17, 2015: Patent Owner filed its Answer to Petitioner’s
`
`Counterclaims. (2:15-cv-03327 Dkt. 22.)
`
`• February 10, 2016: Patent Owner filed a Second Amended Complaint
`
`adding U.S. Patent Nos. 9,161,920 and 9,198,888. (2:15-cv-03327 Dkt. 32,
`
`Ex. 2004.)
`
`• February 19, 2016: Petitioner filed its Answer and Counterclaims to the
`
`Second Amended Complaint. (2:15-cv-03327 Dkt. 33, Ex. 2005.)
`
`Petitioner’s Counterclaim included a counterclaim for Declaratory Judgment
`
`of Non-Infringement and Invalidity for un-asserted and un-related ’698
`
`patent. (2:15-cv-03327 Dkt. 33, Counterclaims, ¶¶ 37-44, 75-80, Ex. 2005.)
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`• March 7, 2016: Patent Owner filed its Answer to Petitioner’s Answer and
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`Counterclaims, including answering Petitioner’s counterclaim of invalidity
`
`and noninfringement of the ’698 patent. (2:15-cv-03327 Dkt. 34, Ex. 2006.)
`
`Thus, it was Petitioner, not Patent Owner, who brought the ’698 patent into
`
`the district court case on February 19, 2016. Prior to Petitioner’s counterclaim, the
`
`’698 patent was not implicated in the district court litigation.
`
`Legal Standard
`B.
`“In a Preliminary Proceeding, the petitioner bears the burden of showing
`
`compliance with the threshold requirement of § 315(b). Specifically, in order to
`
`show ‘standing’ to file a petition, the petitioner ‘must certify . . . that the petitioner
`
`is not barred or estopped from requesting an inter partes review . . . .’ 37 C.F.R.
`
`§ 42.104(a) (first emphasis added).” Johnson Health Tech Co. v. Icon Health &
`
`Fitness, Inc., IPR2014-01242, Paper 16 at 4 (P.T.A.B. Feb. 11, 2015).
`
`35 U.S.C. § 315 addresses the relationship of inter partes review to other
`
`proceedings or actions. It states, in relevant part:
`
`(a) Infringer’s civil action.—
`
`
`(1) Inter partes review barred by civil action.—An inter partes
`review may not be instituted if, before the date on which the
`petition for such a review is filed, the petitioner or real party in
`interest filed a civil action challenging the validity of a claim of
`the patent.
`****
`(3) Treatment of counterclaim.—A counterclaim challenging the
`validity of a claim of a patent does not constitute a civil action
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`challenging the validity of a claim of a patent for purposes of this
`subsection.
`
`
`(b) Patent Owner’s Action.—An inter partes review may not be
`instituted if the petition requesting the proceeding is filed more than 1
`year after the date on which the petitioner, real party in interest, or privy
`of the petitioner is served with a complaint alleging infringement of the
`patent. The time limitation set forth in the preceding sentence shall not
`apply to a request for joinder under subsection (c).
`Petitioner’s Inter Partes Review Petition is Barred Under § 315(a)
`C.
`by Petitioner’s Civil Action Challenging Validity of the ’698
`Patent
`It is black letter law that, pursuant to 35 U.S.C. § 315(a)(1), a Petitioner who
`
`files a declaratory judgment for invalidity is barred from subsequently seeking an
`
`inter partes review. Tristar Prods., Inc. v. Choon’s Design, LLC, IPR2015-01883,
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`Paper 6 at 9 (PTAB Mar. 9, 2016) (“the filing of a declaratory judgment action
`
`challenging the validity of the patent bars a Petitioner from later seeking review of
`
`the patent in an inter partes review proceeding.”); see also Ex. 2007, 157 Cong. Rec.
`
`S5429 (daily ed. Sept. 8, 2011) (statement of Sen. Kyl) (“The Senate bill, at proposed
`
`sections 315(a) and 325(a), would have barred a party or his real party in interest
`
`from seeking or maintaining an inter partes or post grant review after he has filed a
`
`declaratory judgment action challenging the validity of the patent. The final bill will
`
`still bar seeking IPR or PGR after a declaratory-judgment action has been filed, but
`
`will allow a declaratory-judgment action to be filed on the same day or after the
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`petition for IPR or PGR was filed.”) (emphasis added).
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`Here, Petitioner filed a declaratory judgment for invalidity of the ’698 patent
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`prior to filing its Petition. That Petitioner filed its declaratory judgment for invalidity
`
`in the form of a counterclaim is of no distinction because the ’698 patent had not
`
`been asserted against Petitioner at the time it filed its counterclaim. (Exs. 2004,
`
`2005.) This is not a situation in which Petitioner merely filed a “counterclaim” for
`
`invalidity in response to a Complaint alleging infringement of the same patent as
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`contemplated by 35 U.S.C. § 315(a)(3). Instead, and inapposite to the intent of the
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`statute, Petitioner initiated a civil action challenging the validity of the ’698 patent
`
`by filing its declaratory judgment counterclaim introducing the ’698 patent, a patent
`
`never previously asserted by Patent Owner. Petitioner could and should have filed a
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`separate and independent declaratory judgment for invalidity on the ’698 patent, a
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`patent unrelated to the patents previously asserted by Patent Owner. Instead,
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`Petitioner consciously chose to file its declaratory judgment action as a counterclaim
`
`to an unrelated case.
`
`This Court should not reward Petitioner’s gamesmanship of challenging the
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`validity of un-related and un-asserted patents in District Court litigation while
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`simultaneously avoiding
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`the statutory estoppel barring a petitioner from
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`retroactively re-challenging the patent’s validity before the PTAB.
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`Allowing Petitioner to maintain its Petition would run counter to the purpose
`
`of post grant reviews, that is, to avoid harassment and to provide a cost-effective
`
`alternative to district court patent validity litigation.
`
`D.
`
`Petitioner’s Inter Partes Review Petition is Time-Barred Under
`§ 315(b)
`35 U.S.C. § 315(b) states that “[a]n inter partes review may not be instituted
`
`if the petition requesting the proceeding is filed more than 1 year after the date on
`
`which the petitioner, real party in interest, or privy of the petitioner is served with a
`
`complaint alleging infringement of the patent.” Here, Petitioner served a
`
`Counterclaim of non-infringement, was served Patent Owner’s Answer asserting
`
`infringement, and exchanged infringement contentions with Patent Owner all well
`
`before the 12-month time bar contemplated by § 315(b).
`
`The PTAB has previously held that a counterclaim of infringement is a
`
`“complaint alleging infringement” for purposes of 35 U.S.C. § 315(b). St. Jude
`
`Med., Cardiology Div., Inc. v. Volcano Corp., IPR2013-00258, Paper 29 at 3
`
`(P.T.A.B. Oct. 16, 2013) (“We must decide whether a counterclaim alleging
`
`infringement of a patent is “a complaint alleging infringement of the patent” within
`
`the meaning of 35 U.S.C. § 315(b). We determine that it is.”) (denying petition
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`because it was not filed within the time limit imposed by 35 U.S.C. § 315(b)). The
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`Board also noted, “The legislative history indicates also that 35 U.S.C. § 315(b) was
`
`intended to set a deadline for allowing an accused infringer to seek inter partes
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`review after he has been sued for infringement.” Id. (internal quotations and citation
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`omitted).
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`Here, Petitioner asserted the counterclaim for declaratory judgment of non-
`
`infringement on February 19, 2016, more than 1 year before the filing of its Petition.
`
`In its counterclaim, Petitioner specifically stated: “A definite and concrete, real and
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`substantial, justiciable controversy exists between Mylan and Horizon and Pozen
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`concerning Mylan’s noninfringement of the ’698 patent, which is of sufficient
`
`immediacy and reality to warrant the issuance of a declaratory judgment.” (2:15-cv-
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`03327 Dkt. 33, Counterclaims, ¶ 43, Ex. 2005.) Petitioner’s filing of its
`
`counterclaim, injecting the issue of infringement of the ’698 patent into the district
`
`court action, thus triggered the countdown on Petitioner’s deadline to file an inter
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`partes review petition.
`
`Even assuming Petitioner’s counterclaim for declaratory judgment of non-
`
`infringement does not constitute being “served with a complaint alleging
`
`infringement of the patent,” Patent Owner’s Answer to Petitioner’s Counterclaims,
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`filed and served March 7, 2016, more than 1 year before the filing of the Petition,
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`constitutes serving Petitioner “with a complaint alleging infringement of the patent.”
`
`In responding to Petitioner’s counterclaim for declaratory judgment of non-
`
`infringement, Patent Owner specifically stated: “Plaintiffs do not contest that there
`
`is a case or controversy between Plaintiffs and Mylan as to Mylan’s infringement of
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`the patents-in-suit and deny the remaining allegation in Paragraph 43.” (2:15-cv-
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`03327 Dkt. 34, ¶ 43, Ex. 2006) (emphasis added).3
`
`Finally, the parties’ actions in the district court action leave no doubt as to
`
`whether Petitioner was “served with a complaint alleging infringement of the
`
`patent.” On April 15, 2016, as required by the district court’s scheduling order,
`
`Petitioner served its non-infringement contentions for the ’698 patent on Patent
`
`Owner. Subsequently, on April 25, 2016, as required by the scheduling order, Patent
`
`Owner served its infringement contentions for the ’698 patent on Petitioner.
`
`Petitioner failed to meet its statutory deadline. Petitioner’s Petition was filed
`
`more than 18 months after its complaint alleging non-infringement. Petitioner’s
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`Petition was also filed more than 17 months after Patent Owner’s Answer to
`
`Petitioner’s declaratory judgment for non-infringement, in which Patent Owner
`
`alleged infringement. The parties’ actions in the district court litigation is clear
`
`evidence that Petitioner was served with a complaint alleging infringement of the
`
`’698 patent. This Court should deny institution of this Petition.
`
`
`3 To promote judicial efficiency, the case in which Petitioner first asserted invalidity
`and noninfringement of the ’698 patent was subsequently dismissed without
`prejudice and consolidated with a later-filed case in which Patent Owner asserted
`the ’698 patent (2:16-cv-04921 Dkt. 1.) This, however, does not reset the clock, as
`Petitioner was still the first party to introduce the ’698 into the earlier case. Apple
`Inc. v. Rensselaer Polytechnic Inst., IPR2014-00319, Paper 12 at 6-7 (P.T.A.B. June
`12, 2014).
`
`IPR2017-01995
`
`
`
`Page 12
`
`
`
`III. PETITIONER HAS NOT ESTABLISHED THAT THE ’285 PATENT
`IS § 102(e) PRIOR ART
`Petitioner raises three potential grounds of unpatentability, all based on a
`
`Plachetka patent: anticipation by the ’285 patent, obviousness in light of the ’285
`
`patent, and obviousness in light of the combination of the ’285 patent, the EC-
`
`Naprosyn label, and Howden. (Paper 1 at 3.) Petitioner’s arguments, however,
`
`incorrectly assume that the ’285 patent is prior art under § 102(e).
`
`The ’285 patent was filed on August 23, 2011 with Plachetka as the sole
`
`inventor. The ’285 patent claims priority to Provisional Application No. 60/294,588,
`
`which was filed on June 1, 2001. The ’698 patent was filed on September 3, 2009—
`
`two years before the ’285 patent—with Plachetka, Ault, Sostek, and Orlemans as co-
`
`inventors.
`
`Petitioner asserts that the ’285 patent is § 102(e)(2) prior art simply because
`
`the named inventors on the ’285 and ’698 patents overlap but are not identical.
`
`(Paper 1 at 21-22 n.4.) Petitioner sets forth no further support or analysis as to why
`
`the ’285 patent should be treated as prior art under § 102(e)(2). The fact that one
`
`patent has named a different inventive entity on its face than another does not
`
`necessarily make the first patent prior art. Applied Materials, Inc. v. Gemini
`
`Research Corp., 835 F.2d 279, 281 (Fed. Cir. 1988). It is Petitioner’s burden to
`
`establish that the portions of the ’285 patent on which it relies as prior art and the
`
`IPR2017-01995
`
`
`
`Page 13
`
`
`
`subject matter of the ’698 claims in question represent the work of different inventive
`
`entities. Petitioner has made no such showing here.
`
` Legal Standard
`A.
`“The question of whether the asserted prior art is “by another” is not . . .
`
`dependent on the inventors listed on the face page of a patent, but dependent on who
`
`the inventor of the underlying subject matter asserted as prior art is, as compared to
`
`the claimed subject matter at issue.” Robert Bosch Tool Corp. v. SD3, LLC,
`
`IPR2016-01750, Paper 15 at 20 (P.T.A.B. Apr. 3, 2017) (quoting Applied Materials,
`
`Inc. v. Gemini Research Corp., 835 F.2d 279, 281 (Fed. Cir. 1987) (“the fact that an
`
`application has named a different inventive entity than a patent does not necessarily
`
`make that patent prior art.”)); see also Riverwood Int’l Corp. v. R.A. Jones & Co.,
`
`324 F.3d 1346, 1356 (Fed. Cir. 2003) (“To fully answer the question before us—
`
`whether the ’806 patent is prior art as to the ’789 and ’361 patents—the district court
`
`must look beyond the superficial fact that the references were issued to different
`
`inventive entities.”). “What is significant is not merely the differences in the listed
`
`inventors, but whether the portions of the reference relied on as prior art, and the
`
`subject matter of the claims in question, represent the work of a common inventive
`
`entity.” Riverwood Int’l, 324 F.3d 1356 (emphasis added). If the subject matter
`
`relied on as prior art and the subject matter of the claims at issue have the same
`
`inventor, then the prior art cannot be used to invalidate the claims absent a statutory
`
`IPR2017-01995
`
`
`
`Page 14
`
`
`
`bar. In re DeBaun, 687 F.2d 459, 462 (C.C.P.A. 1982) (“[W]e have reaffirmed that
`
`an applicant’s own work, even though publicly disclosed prior to his application,
`
`may not be used against him as a reference, absent the existence of a time bar . . .
`
`.”).
`
`B.
`
`Petitioner Has Not Met Its Burden to Show That the ’285 Patent
`Is § 102(e) Prior Art
`Petitioner’s sole analysis of how the ’285 patent allegedly qualifies as
`
`§ 102(e) prior art is contained in a footnote. The Petition states: “Therefore, even
`
`though both the ’285 and ’698 patents list John Plachetka as an inventor, the ’285
`
`has a different inventive entity because the ’698 lists three other inventors in addition
`
`to John Plachetka.” (Paper 1 at 21-22 n.4.)
`
`It is Petitioner’s burden, however, to establish by a preponderance of the
`
`evidence, that the ’285 patent qualifies as § 102(e) prior art. Ariosa Diagnostics,
`
`Inc. v. Illumina, Inc., IPR2014-01093, Paper 69 at 9 (P.T.A.B. Jan. 7, 2016).
`
`Petitioner has utterly failed to meet its burden here—it has provided no analysis
`
`comparing the subject matter of the two sets of claims to determine whether the
`
`inventive entities are truly different.
`
`Because Petitioner has failed to meet its burden to establish that the ’285
`
`patent is § 102(e) prior art, it cannot demonstrate there is a reasonable likelihood of
`
`success with respect to any of the challenged claims. The Board should therefore
`
`decline to institute this inter partes review.
`
`IPR2017-01995
`
`
`
`Page 15
`
`
`
`IV. THE PTO HAS PREVIOUSLY REJECTED SUBSTANTIALLY THE
`SAME ARGUMENTS DURING PROSECUTION
`As described above, during prosecution, the Examiner made obviousness and
`
`obviousness-type double patenting rejections to the pending claims based on the
`
`’907 Plachetka patent. The ’907 patent is a grandparent to the ’285 patent. As
`
`applicants successfully argued during prosecution of the ’698 patent, the claimed
`
`pharmacokinetic parameters were unexpected and non-obvious over the dosage
`
`forms disclosed in the ’907 patent. This reasoning, which the Examiner ultimately
`
`agreed with, applies equally to the ’285 patent.
`
`Petitioner, however, provided no explanation how its arguments made in the
`
`Petition are any different than what was presented during prosecution. Since the
`
`Patent Office has already considered such argumentation, it would be appropriate to
`
`exercise its discretion and deny institution.
`
`Institution of an Inter Partes Review Is Discretionary
`A.
`The Board has discretionary power to authorize an IPR to proceed, or to deny
`
`some or all of the grounds. 37 C.F.R. § 42.108(a), (b). This discretionary power to
`
`determine whether or not to institute trial is guided, in part, by 35 U.S.C. § 325(d).
`
`Under 35 U.S.C. § 325(d), the Board may deny institution if “the same or
`
`substantially the same prior art or arguments previously were presented to the
`
`Office.” See id. (denying institution where petition raised the “same or substantially
`
`the same prior art or arguments previously were presented to the Office”); Apple Inc.
`
`IPR2017-01995
`
`
`
`Page 16
`
`
`
`v. Papst Licensing GmbH & Co. KG, IPR2016-01841, Paper 10 at 20-22 (P.T.A.B.
`
`Apr. 17, 2017) (denying institution of petition that presented “substantially the same
`
`arguments regarding the unpatentability of the claimed subject matter over [the prior
`
`art]” that were considered during prosecution).
`
`In Unified Patents Inc. v. Berman, IPR2016-01571, Paper 10 at 12 (P.T.A.B.
`
`Dec. 14, 2016), the PTAB denied institution, in part, because the prior reference
`
`cited i
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