Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 18,
`Entered: March 8, 2018
`
`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 IPR20I7-0I995
`Patent 9,220,698 B2
`
`Before TONI R. SCHEINER, MICHELLE N. ANKENBRAND, and'
`Administrative Patent Judges.
`
`DENNETT, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. §42.108
`
`exhibit
`
`JkJLL
`_ S'Hne
`
`MYLAN PHARMS. INC. EXHIBIT 1087 PAGE 1
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`IPR2017-01995
`Patent 9,220,698 B2
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`I. INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”)
`on August 24, 2017, requesting an inter partes review of claims 1-7 of U.S. Patent
`No. 9,220,698 B2 (Ex. 1001, “the ’698 patent”). Pozen Inc. and Horizon Pharma
`USA, Inc. (“Patent Owners”) filed a Preliminary Response. Paper 10 (“Prelim.
`Resp.”). With permission. Petitioner filed a Reply. Paper 16.
`We have authority to determine whether to institute an inter partes review.
`35 U.S.C. § 314(b); 37 C.F.R. .§ 42.4(a). We may not institute an inter partes
`review “unless . . . there is a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314(a). Applying that standard, and Upon consideration of the information
`presented in each Petition and Preliminary Response, we institute an inter partes
`review as to claims 1-7 of the ’698 patent.
`
`II. BACKGROUND
`
`^
`
`^
`
`A. Related Matters
`Petitioner identifies the following pending litigation involving the ’698
`patent; Horizon Pharma, Inc. v. Mylan Pharms. Inc., No. 15-3327 (D.N.J.);
`Horizon Pharma, Inc. v. Mylan Pharms. 7«c. ,No. 16-4921 (D.N.J.); T/or/zow
`Pharma, Inc. v. Actavis Labs. FL, Inc., No, 16-4916 (D.N.J.), Pozen, Inc. v.
`Actavis Laboratories FL, Inc., Nos. 17-1615, 17-1616 (Fed. Cir.); Horizon
`Pharma, Inc. v. Dr. Reddy’s Labs., Inc., No. 16-4918 (D.N.J.); dead Horizon
`Pharma, Inc. v. Lupin Ltd.,Fio. 16-4920 (D.N.J.). Pet. 1-2.
`We remind the parties of their continuing obligation to file an updated
`mandatory notice “within 21 days of a change of the information” required in the
`notices. 37 C.F.R. § 42.8(a)(3).
`
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`B. The ’698 Patent (Ex. 1001)
`The ’698 patent, titled “Method for Delivering a Pharmaceutical
`Composition to Patient in Need Thereof,” issued December 29, 2015. Ex. 1001.
`The ’698 patent relates to methods for treating a patient with a pharmaceutical
`composition of naproxen and esomeprazole in a unit dose form. Id. col. 1,11. 13-
`18.
`
`Nonsteroidal anti-inflammatory drugs (NSAlDs) such as naproxen are used
`widely to treat pain and inflammation, but many NSAlDs are associated with
`gastrointestinal complications. Id. col. 1,11. 19-24. The presence of acid in the
`stomach and upper small intestine is a major factor in development of
`gastrointestinal disease in patients taking NSAlDs. Id. col. 1,11. 24-26. '
`Esomeprazole is a proton pump inhibitor (“PPl”). PPls inhibit gastric acid
`secretion, and thus raise the gastrointestinal tract pH. Id. col. 1,11. 30-33. PPls
`used in conjunction with NSAlDs reduce the risk of gastrointestinal injury. Id. col.
`1,11. 27-30.
`The specification explains that formulations providing dosages of PPls and
`naproxen may produce desired pharmacodynamic (“PD”) response and
`pharmacokinetic (“PK”) values, such as an intragastric pH of about 4 or greater,
`and a plasma level of naproxen that is efficacious. Id. col. 1,11. 34—37,11. 46-48.
`The specification discloses the results of a clinical trial comparing PD responses
`and PK values resulting from twice daily orally-administered formulations of
`enteric coated naproxen 500 mg combined with non-enteric coated esomeprazole
`in dosages of 10, 20, and 30 mg, with twice daily orally-administered 500 mg non­
`enteric coated naproxen and once daily orally-administered enteric coated
`esomeprazole. Id. col. 24,1. 42-col. 45,1. 67.
`
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`The claims recite targeting naproxen and esomeprazole PK profile ranges for
`Cmax^ J- max^ and AUC.'
`The formulation may be used to. treat osteoarthritis, rheumatoid arthritis,
`ankylosing spondylitis, or a combination thereof Id. col. 2,11. 27-31.
`C. Illustrative Claim
`Petitioner challenges claims 1-7 of the ’698 patent. Claim 1, the sole
`independent claim, is illustrative of the claimed subject matter and recites:
`1. A method for treating osteoarthritis, rheumatoid arthritis, or
`ankylosing spondylitis comprising orally administering to a patient in
`need thereof an AM unit dose form and, 10 hours (±20%) later, a PM
`unit dose form, wherein:
`^
`the AM and PM unit dose forms each comprises:
`naproxen, or a pharmaceutically acceptable salt thereof,
`in an amount to provide 500 mg of naproxen, and
`esomeprazole, or a pharmaceutically acceptable salt
`thereof, in an amount to provide 20 mg of esomeprazole;
`said esomeprazole, or pharmaceutically acceptable salt thereof,
`is released from said AM and PM unit dose forms at a pH of 0
`or greater,
`the AM and PM unit dose forms target:
`i) a pharmacokinetic (pk) profile for naproxen where:
`a) for the AM dose of naproxen, the mean Cmax is
`86.2 pg/mL (±20%) and the median T„,a.v is 3.0
`hours (±20%); and
`
`' Cmax refers to the maximum plasma concentration of the drug administered, T,,,^;,
`(or tmax) refers to the time to the maximum plasma concentration of the drug
`administered, and AUC refers to the area under the plasma-concentration time
`curve from time zero to a specified time after drug administration. Ex. 1001, Table
`1.
`
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`b) for the PM dose of naproxen, the mean C^ax is
`76.8 pg/mL (±20%) and the median is 10
`hours (±20%); and
`ii) a pharmacokinetic (pk) profile for esomeprazole
`where:
`a) for the AM dose of esomeprazole, the mean
`area under the plasma concentration-time curve
`from when the AM dose is administered to 10
`hours (±20%) after the AM dose is
`administered (AUCo-io.a/77) is 1216 hr*ng/mL
`(±20%),
`b) for the PM dose of esomeprazole, the mean area
`under the plasma concentration-time curve
`from when the PM dose is administered to 14
`hours (±20%) after the PM dose is administered
`(AUCo-i4,pm) is 919 hr*ng/mL (±20%), and
`c) the total mean area under the plasma
`coneentration-time curve for esomeprazole
`from when the AM dose is administered to 24
`hours (±20%) after the AM dose is
`administered (AUCo-24) is 2000 hr*ng/mL
`(±20%); and
`the AM and PM unit dose forms further target a mean % time at
`which intragastric pH remains at about 4.0 or greater for about a
`24 hour period after reaching steady state that is at least about
`60%.
`Ex. 1001,52:26-67.-
`D. The Asserted Grounds of Unpatentability
`Petitioner asserts that the challenged claims of the ’698 patent are
`unpatentable based on the following grounds:
`
`^ Claim 1 includes the eorrections set forth in the Certificate of Correction issued
`on July 12, 2016.
`
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`Reference [s]
`’285 patenC
`
`’285 patent
`
`’285 patent, EC-Naprosyn
`label"^, and Howden 2005^
`
`Statutory Basis
`§ 102(e)
`
`Claims challenged
`1-7
`
`§103
`
`§ 103
`
`1-7
`
`1-7
`
`Petitioner supports the Petition with the testimony of David C. Metz, M.D.
`(Ex. 1002) and Michael Mayersohn, Ph.D. (Ex. 1003).
`
`111. ANALYSIS
`A. Discretionary Denial under 55 U.S.C. § 325(d)
`Patent Owners argue that we should exercise our discretion to deny all of the
`asserted grounds under 35 U.S.C. § 325(d) because they present substantially the
`same prior art and arguments the Office previously considered during prosecution
`of the ,’698 patent. Prelim Resp. 16. Patent Owners point to the Examiner’s
`rejection of the claims for obviousness-type double patenting and for obviousness
`over US 6,926,907 B2 (“the’907 patent”) (Ex. 1004), noting that the ’907 patent
`and the ’285 patent share a common specification and claim priority to the same
`provisional application. Id. Patent Owners contend that the Examiner agreed with
`arguments that the claimed PK parameters were unexpected and non-obvious over
`
`3 U.S. Patent 8,557,285 B2, filed Aug. 23, 2011, issued Oct. 15, 2013 to John R.
`Plachetka (Ex. 1005, “the ’285 patenf’).
`Prescription Drug Label for EC-Naprosyn® and other Naprosyn® formulations
`(Ex. 1009, “EC-Naprosyn label”).
`C.W. Howden, Review article: immediate-release proton-pump inhibitor
`therapy—potential advantages, 22 ALIMENT PHARMACOL. Ther. 25-30 (2005)
`(Ex. 1006, “Howden 2005”).
`
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`IPR2017-01995
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`the dosage forms disclosed in the ’907 patent. Id. According to Patent Owners,
`the same reasoning applies equally to the ’285 patent. Id.
`During prosecution of the application leading to the ’698 patent, the
`Examiner rejected the then-pending claims as obvious over the ’907 patent {see
`Exs. 1034, 6-7; 1035, 5-8), obvious over Hassan-Alin^ in view of the ’907 patent
`{see Ex. 1036, 3-6; Ex. 1037, 3-6), and unpatentable for obviousness-type double
`patenting over the ’907 patent {see Exs. 1034, 4; 1035, 4-6). Applicants argued
`that the ’907 patent did not disclose the PK/PD profile as claimed. Ex. 1038, 7-8.
`Applicants also argued that “while inherency may apply to anticipation rejections,
`it has only very limited application in the context of obviousness,” “the use of
`inherency in the instant [§ 103] rejection [over the ’907 patent alone] is wholly
`misplaced because the inherency is being used to characterize the unexpected
`results of the claimed method,” and “[i]nherency cannot be used, as it has here, to
`disregard the unexpected results of a novel combination of operative elements.”’
`Applicants thereafter filed a Request for Continued Examination. Ex. 1036, 3.
`In the subsequent Non-Final Office Action, the Examiner rejected the
`pending claims over Hassan-Alin in view of the ’907 patent, and did not reject the
`claims as obvious over the ’907 patent alone. Ex. 1036, 4. The Examiner found
`Hassan-Alin taught (1) esomeprazole provides more time with intragastric pH < 4
`than other proton pump inhibitors, and (2) there is no interaction between
`esomeprazole and naproxen. Id. at 6. The Examiner also found that one of
`
`^ Hassan-Alin et al.. Lack of Pharmacokinetic Interaction between Esomeprazole
`and the Nonsteriodal Anti-Inflammatory Drugs Naproxen and Rofecoxib in
`Healthy Subjects, 25 Clin. Drug Invest. 731 -740 (2205) (Ex. 1016).
`’ Applicants’ January 30, 2013 Response to Office Action (Ex. 3001), 8-9.
`
`7
`
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`IPR2017-01995
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`.
`
`ordinary skill in the art would have been motivated to look to art such as the ’907
`patent for teaching co-administration of naproxen and PPIs such as esomeprazole
`in effective amounts. Id. The Examiner concluded that “the fact that applicant has
`recognized another advantage which would flow naturally from following the
`suggestion of the prior art cannot be the basis for patentability when the differences
`would otherwise be obvious.” Id. at 7.
`,
`.
`Applicants argued that, without a known PK/PD relationship for the claimed
`drug formulation, skilled artisans could not predict whether any particular PK
`profile would produce a therapeutically effective formulation. Ex. 1040, 7.
`Applicants further argued that Hassan-Alin used extended release (enteric coated)
`esomeprazole, while the claimed invention used immediate release esomeprazole,
`and the two formulations have very different PK/PD profiles. Id. at 10. Finally,
`I
`Applicants argued that, “in the context of obviousness, inherency is a very, very
`limited doctrine,” that “inherency is a doctrine that primarily focuses on
`anticipation,''" and “it is quite illogical to rely on inherency in the context of
`obviousness.” W at 11, 13.
`j
`■ -
`Without further analysis, the Examiner subsequently found that Applicants’
`arguments overcame the obviousness rejection over Hassan-Alin in view of the
`’907 patent. Ex. 1041,2.
`We have considered Patent Owners’ arguments, but decline to exercise our
`discretion under 35 U.S.C. § 325(d). First, we note that Petitioner’s asserted
`grounds based on the ’285 patent alone rely on inherency, which neither
`Applicants nor the Examiner addressed fully during prosecution. Specifically,
`Petitioner contends that the ’285 patent inherently discloses the PK/PD elements of
`the challenged claims. Pet. 36-38. Inherency may be used to support
`unpatentability based on either anticipation or obviousness. See In re Montgomery,
`
`.
`
`8
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`677 F.3d 1375, 1379-80 (Fed. Cir. 2012) (“A reference may anticipate inherently
`if a claim limitation that is not expressly disclosed ‘is necessarily present, or
`inherent, in the single anticipating reference.’” (quoting Verizon Servs. Corp. v.
`Cox Fibernet Va., Inc., 602 F.3d 1325, 1336-37 (Fed. Cir. 2010)); PAR Pharm.,
`Inc. V. TWi Pharms., Inc., 773 F.3d 1187, 1195-96 (Fed. Cir. 2014) (“A party must
`... meet a high standard in order to rely on, inherency to establish the existence of
`a claim limitation in the prior art in an obviousness analysis—the limitation at
`issue necessarily must be present, or the natural result of the combination of
`elements explicitly disclosed by the prior art.”); Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344, 1354 (Fed. Cir. 2012) (“[A]n obvious formulation cannot become
`nonobvious simply by administering it to a patient and claiming the resulting
`serum concentrations.”). During prosecution. Applicants argued that inherency is
`more applicable to anticipation than to obviousness. See, e.g., Ex. 3001, 8
`(“[W]hile inherency may apply to anticipation rejections, it has only very limited
`application in the context of obviousness.”); Ex. 1040, 11. Here, Petitioner asserts
`V
`anticipation as a ground of unpatentability, whereas the prosecution history of the
`’698 patent indicates that the Examiner’s rejections were based on obviousness.
`Compare Pet. 34^3, with Ex. 1034, 4, 6-7; Ex. 1035, 4-8; Ex. 1036, 3-6; Ex.
`1037,3-6.
`)
`■
`Second, in Ground 3, Petitioner relies on art that allegedly directly discloses
`PK and PD information on immediate-release PPIs and delayed-release naproxen.
`See Exs. 1006 and 1008. Similar art was not before the Examiner during
`prosecution.
`For these reasons, we decline to exereise our diseretion to deny institution
`under § 325(d).
`
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`B. Level of Ordinary Skill in the Art
`We consider each asserted ground of unpatentability in view of the
`understanding of a person of ordinary skill, in the art. Petitioner contends that a
`person of ordinary skill in the art at the time of the invention is a collaboration
`between a pharmacologist or pharmacokineticist having a Ph.D. degree or
`equivalent training, or a M.S. degree with at least two years of some experience in
`dosage form design and in in vitro and in vivo evaluation of dosage form
`performance, and a medical doctor having at least two years of practical experience
`treating patients in the gastroenterology field. Pet. 7-8 (citing Ex. 1002
`23-24;
`Ex. 1003 ^119-20).
`At this stage of the proceeding. Patent Owners do not dispute Petitioner’s
`proposed level of ordinary skill, which we adopt for purposes of this decision.
`Further, based on their statements of qualifications and curricula vitae, for
`the purposes of this decision, we findtl) Dr. Mayersohn is qualified to opine from
`the perspective of the pharmacologist or pharrhacokineticist the time of the
`V
`invention (see Ex. 1003
`2-9 (Dr. Mayersohn’s statement of qualifications) and
`Exhibit A (curriculum vitae)), and (2) Dr. Metz is qualified to opine from the
`perspective of a medical doctor with practical experience treating patients in the
`gastroenterology field at the time of the invention (see Ex. 1002
`2-10
`(Dr. Metz’s statement of qualifications) and Exhibit A (curriculum vitae)).
`C. Claim Construction
`.
`The Board interprets claims in an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLCv. Lee, 136 S. Ct. 2131; 2144-46 (2016).
`Under that standard, claim terms are given their ordinary and customary meaning
`in view of the specification, as would be understood by one of ordinary skill in the
`
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`art at the time of the invention. /« re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475,
`1480 (Fed. Cir. 1994).
`Petitioner proposes that we construe a single claim limitation: “target.” Pet.
`15. Petitioner proposes that the broadest reasonable construction of “target” is
`“with the goal of obtaining,” which follows from the term’s plain meaning. Id. at
`16. According to Petitioner, the intrinsic evidence does not expressly ascribe any
`particular meaning to “target,” and the prosecution history does not mention the
`term or its meaning. Id. (citing Ex. 1003
`71-72, 79-80). Petitioner relies on
`several dictionaries as extrinsic evidence in support of the proposed construction.
`Id. at 17 (citing Exs. 1031-1033^).
`Patent Owner does not address Petitioner’s proposed construction. See
`generally Prelim. Resp.
`We are persuaded, for purposes of this decision, that Petitioner’s proposed
`construction reflects the broadest reasonable construction consistent with the
`specification of the ’698 patent and its file history. However, the claims use the
`term “target” as follows: “the AM and PM unit dose forms targef" or “further
`target” specified parameters. We accept Petitioner’s construction generally, but
`
`^ The dictionaries on which Petitioner relies provide the following definitions for
`the word “target”: “an objective, goal” (Webster’s New World College
`Dictionary 1485 (Wily Pub. 4th ed. 2005) (Ex. 1031); “to establish as a target or
`goal” (American Heritage Dictionary 1770 (Houghton Mifflin Co. 4th ed.
`2006) (Ex. 1032); “establish as a goal” (Merriam-Webster’s Concise
`Dictionary Large Print Edition 650 (Merriam-Webster, Inc. 2006) (Ex. 1033).
`
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`alter the meaning for grammatical reasons such that “target” means “have or set the
`goal of obtaining.”
`On this record, no other claim terms require express construction.
`D. Procedural Arguments
`Patent Owners argue that the petition is barred under 35 U.S.C. § 315(a) and
`(b), and that the ’285 patent is not 35.U.S.C. § 102(e) prior art. Prelim. Resp. 1.
`Because each of these assertions would defeat the Petition on procedural grounds,
`we address them before considering Petitioner’s asserted grounds of
`unpatentability.
`1. Whether the Petition is Barred Under 35 U.S.C § 315(a)
`Section 315(a) provides that an inter partes review may not be instituted if a
`petitioner or real party in interest files a civil action challenging the validity of a
`claim of the patent before the date on which the petition is filed. 35 U.S.C.
`§ 315(a). Section 315(a)(3) further clarifies that “[a] counterclaim challenging the
`validity of a claim of a patent does not constitute a civil action challenging the
`validity of a claim of a patent for purposes of this subsection.” 7r/.
`.
`PatenCOwners contend that the Petition is barred because “Petitioner [first]
`brought a counterclaim for declaratory judgment of invalidity and non-
`infringement of the ’698 patent.” Prelim. Resp. 5. Although Patent Owners
`acknowledge that a counterclaim challenging validity is not a civil action for
`purposes of § 315(a), Patent Owners assert:
`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 contemplated by 35 U.S.C.
`§ 315(a)(3). Instead, and inapposite to the intent of the 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.
`
`12
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`Petitioner could and should have filed a separate and independent
`declaratory judgment for invalidity on the ’698 patent, a patent
`unrelated to the patents previously asserted by Patent Owner. Instead,
`Petitioner consciously chose to file its declaratory judgment action as
`a counterclaim to an unrelated case.
`Id. at 9.
`Thus, Patent Owners argue that Petitioner’s counterclaim amounts to a civil
`action challenging the validity of the ’698 patent and that Petitioner is barred from
`subsequently seeking an inter partes review. Id. at 8-9 (citing Tristar Prods., Inc.
`V. Choon’s Design, LLC, Case 1PR2015-01883, slip op. at 9 (PTAB Mar. 9, 2016)
`(Paper 6); 157 Con. Rec. S5429 (Ex. 2007)). In reply. Petitioner argues that
`“§ 315(a)(3) clarifies that ‘[a] counterclaim challenging the validity of a claim of a
`patent does not constitute a civil action challenging the validity of a claim of a
`patent.’” Reply 1. Patent Owner does not direct us to any persuasive authority to
`support the proposition that § 315(a) was intended to apply to a counterclaim
`challenging the validity of patent claims where the patent is not the subject of the
`complaint. In any event, we need not reach this issue because Petitioner also
`replies that the counterclaim was dismissed without prejudice before filing the
`Petition. Id. at 3 (citing Ex. 1047^).
`Dismissal without prejudice places the parties in a position as if the action
`was never filed. See, e.g., Bonneville Assocs., Ltd. P’ship v. Barram, 165 F.3d
`1360, 1364 (Fed. Cir. 1999) (“The rule in the federal courts is that ‘[t]he effect of a
`voluntary dismissal without prejudice pursuant to Rule 41(a) is to render the
`proceedings a nullity and leave the parties as if the action had never been
`
`^ Stipulation and Order to Dismiss Certain Counterclaims in Horizon Pharma, Inc.
`V. Mylan Pharms. Inc., Civil Action No. 315-cv-03327-MLC-DEA.
`
`13
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`brought.’”) (citations omitted); Graves v. Principi, 294 F.3d 1350, 1356-57 (Fed.
`Cir. 2002) (“The dismissal of an action without prejudice leaves the parties as
`though the action had never been brought.”); Oracle Corp. v. Click-to-Call Techs.
`LP, IPR2013-00312, slip op. at 12-13 (PTAB Oct. 28, 2014) (Paper 52) (“[Bjoth
`the Federal Rules of Civil Procedure and Federal Circuit precedent treat a
`dismissal without prejudice as something that, de jure, never existed.”); accord,
`Wright, Miller, Kane, 8c Marcus, 9 Federal Prac. & Proc. Civ. § 2367 (3d ed.)
`(“[A]s numerous federal courts have made clear, a voluntary dismissal without
`prejudice under Rule 41(a) leaves the situation as if the action never had been
`filed.”) (footnote omitted).
`On these facts, we find that §315(a) does not bar Petitioner’s Petition for an
`inter partes review.
`2. Whether the Petitioner is Barred Under 35 U.S.C. § 315(b)
`Sectibn 315(b) bars institution of anreview if the petition
`requesting the proceeding is filed more than one year after the date on which the
`petitioner is served with a complaint alleging infringement of the patent. 35 U.S.C.
`§ 315(b).
`Patent Owners advance two arguments that the Petition is time-barred under
`§ 315(b): (1) Petitioner’s counterclaim alleging non-infringement of the ’698
`j^atent constitutes “service of a complaint alleging infringement of the patent”; and
`(2) even if Petitioner’s non-infringement counterclaim does not constitute service.
`Patent Owners’ answer to that counterclaim (not contesting that a case or
`controversy exists as to the ’698 patent) constitutes service. Prelim. Resp. 10-12..
`In this case, it is not necessary to determine whether either event that Patent
`Owners identify triggered the one-year bar for filing a Petition because the
`counterclaims to which Patent Owners refer were dismissed without prejudice. See
`
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`Ex. 1047. As we explain in lll.D.l., supra, a dismissal without prejudice places
`the parties in a position as if the action was never filed. See Macuato U.S.A. v.
`BOS GmbH & KG, 1PR2012-00004, slip op. at 15-16 (PTAB Jan. 24, 2013) (Paper
`18) (voluntary dismissal without prejudice of an infringement action against a
`petitioner “nullifies the effect of the alleged service of the complaint on [that]
`[pjetitioner”). In such circumstances, we view the litigation landscape as if no
`claims related to the ’698 patent arose in the district court litigation in February
`2016. Consequently, § 315(b) does not give rise to a bar of Petitioner’s petition.
`3. Whether the ’285 Patent is Prior Art
`Petitioner contends that the ’285 patent is prior art to the ’698 patent under
`35U.S.C. § 102(e). Pet. 21.
`The ’285 patent, filed as application No. 13/215,855 on August 3, 2011, is a
`divisional of application No. 12/553,804 (now abandoned), which is a divisional of
`application No. 11/129,320, filed May 16, 2005, and issued as U.S. Patent
`8,206,741, which is a continuation-in-part of the ’907 patent. Ex. 1005, 1. The
`’285 patent claims priority to Provisional Application No. 60/294,588, filed on
`June 1, 2001. Id.
`In the Preliminary Response, Patent Owners argue that Petitioner fails to
`/
`establish that the ’285 patent is prior art to the ’698 patent. Prelim. Resp. 13. The
`argument is based on Petitioner’s contention that the ’285 patent is § 102(e) prior
`art to the ’698 patent because the patents identify different inventive entities. Id.
`Patent Owners argue that Petitioner has not met its burden to establish that the
`portions of the ’285 patent on which it relies as prior art and the subject matter of
`the ’698 patent claims represent the work of different inventive entities. Id.
`“In an inter partes review, the burden of persuasion is on the petitioner to
`prove ‘unpatentability by a preponderance of the evidence’ ” and “that burden
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`never shifts to the patentee.” Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). Petitioner also has the initial burden of
`production to show that an asserted reference is prior art to the challenged claims
`under a relevant subsection of 35 U.S.C. § 102. M at 1379. A threshold issue,
`then, is whether Petitioner has met its initial burden of showing that the ’285 patent
`qualifies as § 102(e) prior art to the ’698 patent.
`Section 102(e)(2) prohibits patenting an invention described in a patent
`granted on an application for patent by another filed in the United States before the
`invention by the applicant for patent. 35 U.S.G. § 102(e)(2).
`Petitioner contends that “by another” refers to a different inventive entity,
`which exists if not all inventors are the same. Pet. 21-22 n. 4 (citing Ex parte
`DesOrmeaux, 25 USPQ2d 2040 (BPAl 1992) and explaining Plachetka is listed as
`the inventor on the ’285 patent, while Plachetka and three other inventors are listed
`as inventors on the ’698 patent). In counterpoint. Patent Owners argue that one
`patent naming an inventive entity that differs from the inventive entity named by
`another, patent does not necessarily make the first patent prior art. Prelim. Resp. 13
`(citing, Applied Materials, Inc. v. Gemini Research Carp., 835 F.2d 279, 281 (Fed.
`Cir. 1988)).
`-
`Although Patent Owners correctly state the holding in Applied Materials, the
`\
`case is distinguishable from the facts presented here. In Applied Materials; both
`the alleged prior art patent (the ’712 patent) and the patent-in-suit (the ’313 patent)
`grew from the same original application. Applied Materials, 835 F.2d at 281
`(emphasis added). The court held that if the invention claimed in the ’313 patent
`was fully disclosed in the’712 patent,the disclosed invention had to have been
`invented before the filing date of the ’712 patent. Id. (“When the 102(e) reference
`patentee [’712] . . . had knowledge of the joint applicants’ invention [’313] by
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`being one of them, and thereafter describes it, he necessarily files the application
`[’712] after the [’313] applicant’s invention date......”). Unlike Applied
`Materials, in the instant case the ’285 patent and the ’698 patent did not arise out
`of the same original application, but they have an inventor in common—
`Dr. Plachetka.
`In addition. Patent Owners characterize events leading to filing the
`application for the ’698 patent in a way that suggests the invention is work “by
`another”:
`Subsequent to the invention claimed in the ’907 and ’285 patents.
`Dr. Plachetka collaborated with [others] to improve upon the claimed
`inventions. They selected esomeprazole as the immediate-release PPl
`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).
`
`Prelim. Resp. 3. Patent Owners also urge that what is significant is 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. Id. at 14.
`The issue thus raised is an evidentiary one. At this stage of the proceeding,
`however, the record is devoid of evidence regarding the events leading to the filing
`of the application that matured into the ’698 patent. For instance, although Patent
`Owners refer to collaboration between Dr. Plachetka and others. Patent Owners do
`not direct us to any evidence in the record supporting such collaboration.
`\
`For the purposes of this decision. Petitioner provides adequate evidence to
`make a threshold showing that the ’285 patent is a patent “by another” such that it
`qualifies as prior art under § 102(e).
`
`17
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`E. Asserted References
`Before turning to Petitioner’s asserted grounds, we provide a brief summary
`of the asserted references.
`1. The ’285 Patent (Ex. 1005)
`The ’285 patent is directed generally to a pharmaceutical composition in unit
`dosage form suitable for oral administration to a patient. Id. col. 3,11. 27-29. The
`composition contains an acid inhibitor in an amount effective to raise the gastric
`pH of a patient to at least 3.5, preferably to at least 4, and more preferably to at
`least 5. Id. col. 3,11. 29-32. The ’285 patent identifies esomeprazole and
`omeprazole as among the preferred PPls that may be used effectively as acid
`inhibitors. Id. col. 3,11. 44-50. The ’285 patent also identifies naproxen and
`naproxen sodium as long-acting NSAlDs useful in the invention. Id. cot. 6,11. 29-
`33. Example 6 discloses a multi-layer tablet dosage form comprising 500 mg
`naproxen sodium, an enteric film coat that dissolves only when the local pH is
`above 4, and 5 mg immediate-release omeprazole. Id. col. 16,11. 1-54, col. 17,1.
`36. Examples 7 and 8 disclose coordinated delivery dosage forms containing,
`respectively, 20 mg irhmediate release omeprazole and 250 mg delayed release
`naproxen, and 10 mg immediate release omeprazole and 250 mg delayed release
`naproxen. Id. co\. 17,1. 49-col. 20,1. 36. Example 9 discloses a clinical study in.
`which one group of participants received twice daily 20 mg omeprazole followed
`by 550 mg naproxen sodiurn. 7(7. col. 20,11. 45-50.
`In addition, the ’285 patent claims pharmaceutical compositions in unit
`dosage form comprising therapeutically effective amounts of esomeprazole,
`wherein at least a portion of the esomeprazole is not surrounded by an enteric
`coating, and enteric coated naproxen. Id. col. 22,11. 8-29.
`
`18
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`2. How den 2005 (Ex. 1006)
`Howden 2005 is a 2005 review article on potential advantages of immediate-
`release PPIs. Ex. 1006, 1. The article provides an overview of the PK and PD of
`an immediate-release omeprazole for oral suspen