Trials@uspto.gov
`Tel: 571-272-7822
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`
`
`
` Paper 74
`Entered: September 6, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`DR. REDDY’S LABORATORIES, INC.,1
`Petitioner
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`_______________
`
`Case IPR2018-00272
`Patent 9,393,208 B2
`_______________
`
`Before MICHELLE N. ANKENBRAND, Acting Vice Chief Administrative Patent
`Judge, TONI R. SCHEINER, and DEBRA L. DENNETT, Administrative Patent
`Judges.
`
`DENNETT, Administrative Patent Judge.
`
`
`
`
`
`
`FINAL WRITTEN DECISION
`
`
`
`1 We terminated the proceeding between Petitioner Mylan Pharmaceuticals Inc.
`and Patent Owners by Order on August 12, 2019. Paper 73. Petitioner
`Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) from IPR2018-01341 was joined as
`Petitioner to this proceeding on April 1, 2019. Paper 36. Dr. Reddy’s remains as a
`Petitioner in this case.
`
`

`

`IPR2018-00272
`Patent 9,383,208 B2
`
`
`Finding Claims 1–7 Unpatentable
`35 U.S.C. § 318(a); 37 C.F.R. § 42.73
`
`Denying as Moot Petitioner’s Motion to Exclude
`and Dismissing-in-part as Moot and Denying-in-part
`Patent Owners’ Motion to Exclude
`37 C.F.R. § 42.64(c)
`
`
`I. INTRODUCTION
`
`This is a Final Written Decision in an inter partes review challenging the
`
`patentability of claims 1–7 (collectively, the “challenged claims”) of U.S. Patent
`
`No. 9,393,208 B2 (Ex. 1001, “the ’208 patent”). We have jurisdiction under
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`35 U.S.C. § 6. For the reasons that follow, we determine that Petitioner
`
`Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s” or “Petitioner”) demonstrates, by a
`
`preponderance of the evidence, that the challenged claims are unpatentable.
`
`A. Procedural History
`
`The procedural history of this proceeding is unusually complex, involving
`
`joinder; bankruptcy; change in ownership of the patent; settlement between the
`
`original Petitioner, Mylan Pharmaceuticals, Inc. (“Mylan”) and Patent Owners; and
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`a decision on the merits in the trial between the remaining Petitioner after joinder,
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`Dr. Reddy’s, and Patent Owners.
`
`Mylan filed a Petition (Paper 2, “Pet.”) requesting an inter partes review of
`
`claims 1–7 of the ’208 patent under 35 U.S.C. § 311. Mylan supported its Petition
`
`with the testimony of David C. Metz, M.D. (Ex. 1002) and Michael Mayersohn,
`
`Ph.D. (Ex. 1003). We instituted trial on June 14, 2018, to determine whether:
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`IPR2018-00272
`Patent 9,383,208 B2
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`1. Claims 1–7 of the ’208 patent are unpatentable under 35 U.S.C. § 102 as
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`anticipated by the ’285 patent2;
`
`2. Claims 1–7 of the ’208 patent are unpatentable under 35 U.S.C. § 103 as
`
`obvious over the ’285 patent; and
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`3. Claims 1–7 of the ’208 patent are unpatentable under 35 U.S.C. § 103 as
`
`obvious over the combination of the ’285 patent with the EC-Naprosyn label3 and
`
`Howden 2005.4
`
`Paper 9 (“Institution Decision” or “Inst. Dec.”), 24.
`
`On July 2, 2018, Dr. Reddy’s filed a Petition requesting an inter partes
`
`review of claims 1–7 of the ’208 patent in IPR2018-01341 (“1341 IPR”) and filed
`
`a Motion for Joinder to this proceeding. 1341 IPR, Papers 2, 3. In its motion
`
`requesting joinder, Dr. Reddy’s represented that it had filed substantively the same
`
`Petition as Mylan and agreed to take an “understudy” role to Mylan, accepting
`
`Mylan’s arguments and experts, and agreeing to take an active role only if Mylan
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`dropped out of the proceedings. 1341 IPR, Paper 3, 1, 7.
`
`Shortly thereafter, on August 28, 2018, Patent Owner Pozen Inc. (“Pozen”)
`
`filed a Suggestion of Bankruptcy in this case, the effect of which automatically
`
`stayed this proceeding pursuant to 11 U.S.C. § 362. Paper 12. We suspended all
`
`deadlines in this proceeding on August 31, 2018. Paper 13.
`
`
`2 U.S. Patent 8,557,285 B2, filed Aug. 23, 2011, issued Oct. 15, 2013, to John R.
`Plachetka (Ex. 1005, “the ’285 patent”).
`
`3 Prescription Drug Label for EC-Naprosyn® and other Naprosyn® formulations
`(Ex. 1009, “EC-Naprosyn label”).
`
`4 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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`IPR2018-00272
`Patent 9,383,208 B2
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`On January 4, 2019, Mylan filed an order from the bankruptcy court
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`approving the sale of certain of Pozen’s assets, including the ’208 patent, to Nuvo
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`Pharmaceuticals (Ireland) Designated Activity Company (“Nuvo”), which lifted
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`the automatic stay of this proceeding. Ex. 1051, 1,19 (identifying Nuvo as the
`
`purchaser). On January 16, 2019, we received Mandatory Notices identifying
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`Nuvo as a real party-in-interest in this proceeding. Paper 16. On January 25,
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`2019, we issued an order modifying the schedule and the case caption to reflect the
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`change in ownership of the ’208 patent to Horizon Pharma USA, Inc. (“Horizon”)
`
`and Nuvo (collectively, “Patent Owners”). Paper 20.
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`Patent Owners filed a Response on March 1, 2019.5 Paper 32 (“PO Resp.”).
`
`We granted Dr. Reddy’s motion to join this proceeding on April 1, 2019. Paper
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`36. Mylan and Dr. Reddy’s filed a Reply on May 8, 2019 (Paper 49, “Pet.
`
`Reply”), and Patent Owners filed a Sur-reply on May 20, 2019 (Paper 52, “PO Sur-
`
`reply”). On June 3, 2019, pursuant to 37 C.F.R. § 42.100(c), we adjusted the one-
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`year pendency of this proceeding due to joinder. Paper 60.
`
`Patent Owners filed a motion to seal certain exhibits. Paper 31 (“PO Motion
`
`to Seal”). Both parties also filed motions to exclude, which have been fully
`
`briefed. See Papers 56, 57, 66 (briefing related to Petitioner’s Motion to Exclude);
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`Papers 55, 58, 65 (briefing related to Patent Owners’ Motion to Exclude).
`
`We held a hearing on June 14, 2019, and entered the transcript of the hearing
`
`into the record. Paper 70 (“Tr.”). On July 29, 2019, Mylan and Patent Owners
`
`filed a Joint Motion to Terminate Petitioner Mylan from the proceeding. Paper 71.
`
`
`5 Patent Owners’ rely on the expert testimony of Dr. David R. Taft (Ex. 2025) and
`Dr. David A. Johnson (Ex. 2026) to support the Response.
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`IPR2018-00272
`Patent 9,383,208 B2
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`We granted the motion and terminated Mylan from this proceeding on August 12,
`
`2019. Paper 73.
`
`B. Related Matters
`
`Mylan previously filed a petition requesting an inter partes review of U.S.
`
`Patent No. 9,220,698 (“the ’698 patent”), case IPR2017-01995 (“1995 IPR”).
`
`1995 IPR Petition 2. Mylan asserted that the ’698 patent and ’208 patent are
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`“related” (id.), and Patent Owners acknowledged that the ’208 patent “claims, or
`
`may claim, the benefit of priority” to the same application to which the ’698 patent
`
`claims priority (1995 IPR Paper 4, 2). On March 8, 2018, we instituted an inter
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`partes review of all claims challenged on all asserted grounds in the 1995 IPR. See
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`1995 IPR, Paper 18. On August 14, 2018, we joined Dr. Reddy’s to the 1995 IPR.
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`We terminated the 1995 IPR on March 27, 2019 (1995 IPR Paper 71), and denied
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`Dr. Reddy’s Request for Rehearing of our termination decision on August 12, 2019
`
`(1995 IPR Paper 77).
`
`C. The ’208 Patent (Ex. 1001)
`
`The ’208 patent, titled “Method for Delivering a Pharmaceutical
`
`Composition to Patient in Need Thereof,” issued July 19, 2016. Ex. 1001. The
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`’208 patent relates to methods for delivering a pharmaceutical composition of
`
`naproxen and esomeprazole in a unit dose form. Id. at col. 1, ll. 13–18.
`
`Nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen are used
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`widely to treat pain and inflammation, but many NSAIDs are associated with
`
`gastrointestinal complications. Id. at col. 1, ll. 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 NSAIDs. Id. at col. 1, ll. 24–26.
`
`Esomeprazole is a proton pump inhibitor (“PPI”). PPIs inhibit gastric acid
`
`secretion, and thus raise the gastrointestinal tract pH. Id. at col. 1, ll. 30–33. PPIs
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`IPR2018-00272
`Patent 9,383,208 B2
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`used in conjunction with NSAIDs reduce the risk of gastrointestinal injury. Id. at
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`col. 1, ll. 27–30.
`
`The specification explains that administering formulations providing certain
`
`unit dosages of PPIs and naproxen may produce desired pharmacodynamic (“PD”)
`
`responses and pharmacokinetic (“PK”) values, such as an intragastric pH of about
`
`4 or greater, and a plasma level of naproxen that is efficacious. Id. at col. 1, ll. 34–
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`37, ll. 46–48. The specification discloses the results of a clinical trial comparing
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`PD responses and PK values resulting from twice daily orally-administered
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`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-
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`administered 500 mg non-enteric coated naproxen and once daily orally-
`
`administered enteric coated esomeprazole. Id. at col. 24, l. 5–col. 46, l. 30.
`
`The claims recite targeting naproxen and esomeprazole PK profile ranges for
`
`Cm ax, T m ax, and AUC.6
`
`D. Illustrative Claim
`
`Petitioner challenges claims 1–7 of the ’208 patent. Claim 1, the sole
`
`independent claim, is illustrative of the claimed subject matter and recites:
`
`A method for delivering a pharmaceutical composition to a
`1.
`patient in need thereof, comprising:
`
`orally administering to a patient 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:
`
`
`6 Cm ax refers to the maximum plasma concentration of the drug administered, T m ax
`(or tm ax) 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.
`
` 6
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`IPR2018-00272
`Patent 9,383,208 B2
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`i) naproxen, or a pharmaceutically acceptable salt
`thereof, in an amount to provide 500 mg of naproxen,
`and
`
`ii) 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 Cm ax is
`86.2 μg/mL (±20%) and the median Tm ax is 3.0
`hours (±20%); and
`
`b) for the PM dose of naproxen, the mean Cm ax is
`76.8 μg/mL (±20%) and the median Tm ax 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 (AUC0-10,am) 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
`(AUC0-14,pm) is 919 hr*ng/mL (±20%), and
`
`c) the total mean area under the plasma
`concentration-time curve for esomeprazole
`from when the AM dose is administered to 24
`hours (±20%) after the AM dose is
`
` 7
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`IPR2018-00272
`Patent 9,383,208 B2
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`administered (AUC0-24) 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, col. 46, l. 33–col. 47, l. 9.
`
`II. DISCUSSION
`
`Petitioner Dr. Reddy’s bears the burden of proving unpatentability of the
`
`challenged claims, and that burden of persuasion never shifts to Patent Owners.
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir.
`
`2015). To prevail, Petitioner must establish the facts supporting its challenge by a
`
`preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Below,
`
`we explain how Petitioner has met its burden with respect to the challenged claims.
`
`A. Principles of Law
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between
`
`the subject matter sought to be patented and the prior art are such that the subject
`
`matter as a whole would have been obvious at the time the invention was made to a
`
`person having ordinary skill in the art to which said subject matter pertains. KSR
`
`Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). Obviousness is a question of
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`law based on underlying determinations of fact. Graham v. John Deere Co., 383
`
`U.S. 1, 17 (1966); Richardson-Vicks, Inc. v. Upjohn Co., 122 F.3d 1476, 1479
`
`(Fed. Cir. 1997). The underlying factual determinations include: (1) the scope and
`
`content of the prior art; (2) any differences between the claimed subject matter and
`
`the prior art; (3) the level of skill in the art; and (4) objective evidence of
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`nonobviousness, i.e., secondary considerations. See Graham, 383 U.S. at 17–18.
`
`Subsumed within the Graham factors are the requirements that all claim limitations
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`IPR2018-00272
`Patent 9,383,208 B2
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`be found in the prior art references and that the skilled artisan would have had a
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`reasonable expectation of success in combining the prior art references to achieve
`
`the claimed invention. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir.
`
`2007). “Obviousness does not require absolute predictability of success . . . all that
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`is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894,
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`903–4 (Fed. Cir. 1988).
`
`Moreover, “[t]he combination of familiar elements according to known
`
`methods is likely to be obvious when it does no more than yield predictable
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`results.” KSR, 550 U.S. at 416. “If a person of ordinary skill can implement a
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`predictable variation, § 103 likely bars its patentability.” Id. at 417.
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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’s declarants,
`
`Dr. Metz and Dr. Mayersohn, testify that a person of ordinary skill in the art would
`
`have had the knowledge of a collaboration of a pharmacologist or
`
`pharmacokineticist having a Ph.D. degree or equivalent training, or a M.S. degree
`
`with at least 2 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 2 years of practical experience treating patients in the gastroenterology field.
`
`Ex. 1002 (Metz Decl.) ¶ 24, and Ex. 1003 (Mayersohn Decl.) ¶ 19. Dr. Metz offers
`
`his opinion from the perspective of a medical doctor in the field of
`
`gastroenterology with at least 2 years of experience treating patients as of
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`September 9, 2008. Ex. 1002 ¶ 24. Dr. Mayersohn offers his opinion from the
`
`perspective of a pharmacologist with the training described above. Ex. 1003
`
` 9
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`¶¶ 19–20.
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`IPR2018-00272
`Patent 9,383,208 B2
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`We adopted Petitioner’s definition of the person of ordinary skill in the art in
`
`our Institution Decision, and Patent Owners’ experts apply that definition. See
`
`Ex. 2025 ¶ 34; Ex. 2026 ¶ 53.
`
`Patent Owners contend that Petitioner’s declarants do not meet Petitioner’s
`
`hypothetical construct of a person of ordinary skill in the art because they did not
`
`consult with each other in providing their opinions on the patentability of the ’208
`
`patent. Paper 32 ¶¶ 20–21. Dr. Metz, a medical doctor, testifies that he
`
`collaborated with Dr. Mayersohn, a pharmacologist, by providing an opinion
`
`which, when combined with that of Dr. Mayersohn, concludes that the challenged
`
`claims are unpatentable. Ex. 1059 (Metz Reply Decl.) ¶ 8. Dr. Mayersohn testifies
`
`that Patent Owners take an overly formalistic reading of the proposed definition of
`
`a person of ordinary skill in the art, and that the definition simply means that both a
`
`medical doctor and a pharmacologist or pharmacokineticist “have a contribution to
`
`make in understanding the claimed subject matter.” Ex. 1074 (Mayersohn Reply
`
`Dec. ¶ 9.
`
`We adopt the following as the level of ordinary skill in the art: person(s)
`
`having the knowledge of a collaboration of a pharmacologist or pharmacokineticist
`
`having a Ph.D. degree or equivalent training, or a M.S. degree with at least 2 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 2 years of practical
`
`experience treating patients in the gastroenterology field. We do not find that one
`
`individual would be required to satisfy all of the above requirements or necessarily
`
`would have to consult with a counterpart before forming an opinion, as the art
`
`involved represents two different areas of study, yet reflects the skill in the art. See
`
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`
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`Based on their stated qualifications, we find: (1) Dr. Mayersohn is qualified
`
`to opine from the perspective of the pharmacologist or pharmacokineticist at the
`
`time of the 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 at least two years of 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)); (3) Dr. Taft is qualified to opine from the
`
`perspective of the pharmacologist or pharmacokineticist at the time of the
`
`invention (see Ex. 2025 ¶¶ 2–12 (Dr. Taft’s statement of qualifications) and
`
`Exhibit 1 (curriculum vitae)); and (4) Dr. Johnson is qualified to opine from the
`
`perspective of a medical doctor with at least two years of practical experience
`
`treating patients in the gastroenterology field at the time of the invention (see
`
`Ex. 2026 ¶¶ 1–15 (Dr. Johnson’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) (2016)7; Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
`
`
`7 The Office recently changed the claim construction standard applicable to an
`inter partes review. See Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board,
`83 Fed. Reg. 51,340 (Oct. 11, 2018). The rule changing the claim construction
`standard, however, does not apply to this proceeding because Petitioner filed its
`Petition before the effective date of the final rule, i.e., November 13, 2018. Id. at
`51,340 (rule effective date and applicability date), 51,344 (explaining how the
`Office will implement the rule).
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`(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 art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d
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`1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set
`
`forth in the specification with reasonable clarity, deliberateness, and precision. In
`
`re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`Petitioner proposes construction of the claim limitation “target,” contending
`
`that the broadest reasonable construction of “target” is “with the goal of
`
`obtaining,” which follows from the term’s plain meaning. Pet. 13–14. According
`
`to Petitioner, the intrinsic evidence does not expressly ascribe any particular
`
`meaning to “target,” and the term is not a term of art in the patent’s field. Id. at 15
`
`(citing Ex. 1003 ¶¶ 66, 74–78).
`
`In the Institution Decision, we generally adopted Petitioner’s proposed
`
`construction of the “target,” limitation, but altered the meaning for grammatical
`
`purposes, determining that “target” means to “have or set the goal of obtaining.”
`
`Inst. Dec. 9–10.
`
`Patent Owners do not offer a construction of “target.” See generally PO
`
`Resp. Rather, Patent Owners argue that in the related district court litigation, the
`
`court granted Petitioner’s motion for summary judgment that the ’208 patent is
`
`invalid as indefinite in its use of the term “target.” Id. at 16. Patent Owners argue
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`that the Board, therefore, should not consider the prior art challenges made here.
`
`Id. at 19.
`
`We do not agree. Indeed, we previously addressed Patent Owners’ argument
`
`in this regard in a decision denying a motion to terminate that we permitted Patent
`
`Owners to file after the district court’s grant of summary judgment. See Paper 35.
`
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`As we explained in that decision, indefiniteness under 35 U.S.C. § 112 is outside
`
`our statutory authority in an inter partes review. Id. at 5.8
`
`We remain persuaded that our construction in the Institution Decision is the
`
`broadest reasonable construction of the term “target” consistent with the
`
`specification of the ’208 patent and its file history. Thus, we determine that the
`
`term “target” means to “have or set the goal of obtaining.”
`
`No other claim term requires express construction. See Vivid Techs., Inc. v.
`
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need
`
`be construed that are in controversy, and only to the extent necessary to resolve the
`
`controversy”).
`
`D. Obviousness of the Challenged Claims Over the ’285 Patent
`
`Petitioner asserts that the subject matter of claims 1–7 of the ’285 patent
`
`would have been obvious over the ’285 patent. Pet. 43–48. Patent Owners
`
`disagree. Resp. 34–40. Before turning to Petitioner’s challenge, we provide a
`
`brief background of the ’285 patent and address several preliminary issues that the
`
`parties raise, including whether the ’285 patent qualifies as prior art.
`
`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. Ex. 1005, col. 3, ll. 27–
`
`29. The ’285 patent refers to a “unit dosage form” as a single entity for drug
`
`administration, such as a tablet or capsule combing both an acid inhibitor and an
`
`NSAID. Id. at col. 4, ll. 42–45. The composition contains an acid inhibitor in an
`
`
`8 Patent Owners did not request rehearing of that decision. Tr. 19:21–20:7.
`Having already decided the issue, we do not further address Patent Owners’
`argument here.
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`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. at col. 3, ll. 29–32. The ’285 patent
`
`identifies esomeprazole and omeprazole as among the preferred PPIs that may be
`
`used effectively as acid inhibitors. Id. at col. 3, ll. 44–50. The ’285 patent also
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`identifies naproxen and naproxen sodium as long-acting NSAIDs useful in the
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`invention, having half-lives of about 12 to 15 hours. Id. at col. 6, ll. 29–33.
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`Example 6 discloses a multi-layer tablet dosage form comprising 500 mg
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`naproxen sodium, an enteric film coat that dissolves only when the local pH is
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`above 4, and 5 mg immediate-release omeprazole. Id. at col. 16, ll. 1–54, col. 17,
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`l. 36. Examples 7 and 8 disclose coordinated delivery dosage forms containing,
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`respectively, 20 mg immediate release omeprazole and 250 mg delayed release
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`naproxen, and 10 mg immediate release omeprazole and 250 mg delayed release
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`naproxen. Id. at col. 17, l. 49–col. 20, l. 36. Example 9 discloses a clinical study
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`in which one group of participants received twice daily 20 mg omeprazole
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`followed by 550 mg naproxen sodium. Id. at col. 20, ll. 45–50.
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`In addition, the ’285 patent claims pharmaceutical compositions in unit
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`dosage form comprising therapeutically effective amounts of esomeprazole,
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`wherein at least a portion of the esomeprazole is not surrounded by an enteric
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`coating, and enteric coated naproxen. Id. at col. 22, ll. 8–29.
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`2. The ’285 Patent as § 102(e)9 Prior Art
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`Before turning to the merits of Petitioner’s obviousness challenge, we
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`address whether the ’285 patent is prior art to the ’208 patent. Petitioner has the
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`9 Because the application for the ’208 patent was filed before the March 16, 2013,
`effective date of the Leahy-Smith America Invents Act (“AIA”), we refer to the
`pre-AIA version of the statute.
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`initial burden of production to show that the ’285 patent is prior art to the
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`challenged claims under § 102(e). See Dynamic Drinkware, 800 F.3d at 1378–79
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`(burden of production regarding availability of a reference as prior art placed
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`initially on a petitioner). If Petitioner meets its burden of production, then the
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`burden of production shifts to Patent Owners to come forward with evidence that
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`the ’285 patent is not prior art. See id. at 1379.
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`Petitioner contends that the ’285 patent is prior art to the ’208 patent under
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`35 U.S.C. § 102(e) because it is a “patent granted on an application for patent by
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`another filed in the United States before the invention by the applicant for patent.”
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`Pet. 20; Pet. Reply 3 (quoting 35 U.S.C. § 102(e) (emphasis added)). Petitioner
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`points to the ’285 patent’s identification of John R. Plachetka as the sole inventor,
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`and the ’208 patent’s identification of Brian Ault, Everardus Orlemans, John R.
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`Plachetka, and Mark Sostek as inventors as evidence that the two patents have
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`different inventive entities. Pet. Reply. 3–4; see also Ex. 1001, [72] (’208 patent);
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`Ex. 1005, [72] (’285 patent). Petitioner also supports its argument with citations to
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`the trial and deposition transcripts of Drs. Orlemans and Sostek. Pet. Reply 4
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`(citing Ex. 2018, 21:6–14, 22:7–7 (Dr. Orlemans’ testimony describing his
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`contributions to the ’208 patent); Ex. 2019, 130:14–24 (Dr. Sostek’s testimony
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`describing his contributions to the ’208 patent)).
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`Patent Owners argue that Petitioner has not met its burden to establish by a
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`preponderance of the evidence that the ’285 patent qualifies as § 102(e) prior art.
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`PO Resp. 21–22; PO Sur-reply 5–8. Specifically, Patent Owners counter that what
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`is significant in comparing inventive entities “is not merely the differences in the
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`listed inventors, but whether the portions of the references relied on as prior art,
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`and the subject matter of the claims in question represent the work of a common
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`inventive entity.” PO Resp. 23 (citing Riverwood Int’l Corp. v. R.A. Jones & Co.,
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`324 F.3d 1346, 1356 (Fed. Cir. 2003)).
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`Patent Owners also rely on Duncan Parking Technology, Inc. v. IPS Group,
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`914 F.3d 1347 (Fed. Cir. 2019), to suggest that Petitioner failed to establish that
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`the ’285 patent is work “by another.” PO Sur-reply 6.
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`In Duncan Parking the Federal Circuit explained, in deciding whether a
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`reference patent is “by another” for the purposes of § 102(e):
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`[T]he Board must (1) determine what portions of the reference patent
`were relied on as prior art to anticipate the claim limitations at issue,
`(2) evaluate the degree to which those portions were conceived “by
`another,” and (3) decide whether that other person’s contribution is
`significant enough, when measured against the full anticipating
`disclosure, to render him a joint inventor of the applied portions of the
`reference patent.
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`Duncan Parking, 914 F.3d at 1358. The facts before us here, however, differ from
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`those in Duncan Parking. In Duncan Parking, the Federal Circuit determined
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`whether a certain person (Schwarz), who was a named inventor on the asserted
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`prior art but not on the challenged patent, had made significant contributions to the
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`relied-upon disclosures of the asserted prior art, thereby making him an inventor of
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`the relied-upon disclosures of that patent, and, in turn, making the relied-upon
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`disclosures work “by another” and hence prior art to the challenged patent. Id. at
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`1357–59.
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`Here, in contrast, there is no dispute that the work in the ’285 patent asserted
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`as prior art is Dr. Plachetka’s alone. See, e.g., PO Sur-reply 6; Ex. 2082, 46:21–24.
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`We need to determine instead whether Drs. Ault, Sostek, and Orlemans made
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`significant contributions to the challenged claims of the ’208 patent. If so, then the
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`’285 patent is work “by another” and prior art under § 102(e).
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`As we note above, Petitioner points to the different inventors listed on the
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`’285 patent and the ’208 patent and cites to certain testimony regarding
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`Drs. Orlemans’, Sostek’s, and Ault’s contributions to the ’208 patent. Patent
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`Owners do not disagree that all four named inventors contributed to the ’208
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`patent. Indeed, Patent Owners cite to the testimony of Dr. Plachetka in the related
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`district court litigation as evidence that he was responsible for the design and
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`dosage form that exhibits coordinated release of the two active ingredients. PO
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`Resp. 24 (citing Ex. 2015 (Plachetka trial testimony) at 25:5–15). Patent Owners
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`further acknowledge that Dr. Plachetka collaborated with “AstraZeneca” to further
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`refine the dosage form and relied on Dr. Orlemans and AstraZeneca scientists,
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`Drs. Ault and Sostek, to design and implement a series of clinical trials, including
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`PN400–104, the clinical trial that provided the PK/PD data included in the claims
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`of the ’208 patent. Id.
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`Comparing “not merely the differences in the listed inventors, but whether
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`the portions of the references relied on as prior art, and the subject matter of the
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`claims in question represent the work of a common inventive entity,” Riverwood,
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`324 F.3d at 1356, we find that the evidence demonstrates that Dr. Plachetka did not
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`invent the subject matter of the ’208 patent challenged claims alone. Rather, the
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`evidence supports that Drs. Plachetka, Orlemans, Ault, and Sostek are co-inventors
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`of the subject matter of the challenged claims of the ’208 patent and, thus, a
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`different inventive entity than solely Dr. Plachetka, invented the relied-upon
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`subject matter of the ’285 patent.
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`Patent Owners urge that Petitioner’s argument that the ’285 patent and the
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`’208 patent “describe the work of different inventive entities is incompatible with
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`[Petitioner’s] position that the ’285 and ’208 patents claim the same invention,”
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`and that Petitioner states that the ’208 patent claims the precise formulation and
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`precise method of administration disclosed in the ’285 patent. PO Resp. 24, 25.
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`However, Patent Owners misstate Petitioner’s position. Specifically,
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`Petitioner contends:
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`Drs. Orlemans, Ault, and Sostek—named inventors of the ’208
`patent—designed and implemented the trials that led to recognizing the
`PK properties of the formulation claimed in the ’208 patent.
`Dr. Orlemans testified that he “helped with the design of the study,”
`which was “one of the first studies that was done actually to find out
`what the effect is of the tablet on intragastric pH . . . .” Ex. 2018, 21:6-
`14, 22:7-8. Dr. Sostek testified that several people, including he and
`Dr. Orlemans, “contributed . . . as a team in designing the study.” Ex.
`2019, 130:14-24. Dr. Sostek further testified that Drs. Orlemans and
`Ault contributed to “the clinical trials and the data generated from their
`end . . . .” Id. at 132:19-133:6. Drs. Orlemans, Ault, and Sostek
`identified the ’208 patent’s PK/PD limitations.
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`Pet. Reply 4. Petitioner argues that the ’285 patent discloses the formulation
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`claimed in the ’208 patent. Id. at 6. Petitioner further argues that the PK/PD
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`values in the ’208 patent’s claims ar