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 IPR2018-00272
`Patent 9,393,208
`
`___________
`
`
`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 IPR2018-00272
`Patent 9,393,208
`
`___________
`
`
`PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.’S
`PATENT OWNER PRELIMINARY RESPONSE
`PURSUANT TO 37 C.F.R. § 42.120
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`I.
`II.
`
`INTRODUCTION .......................................................................................... 1
`PETITIONER HAS NOT ESTABLISHED THAT THE ’285
`PATENT IS § 102(e) PRIOR ART ................................................................ 5
`A.
`Legal Standard ...................................................................................... 6
`B.
`Petitioner Has Not Met Its Burden to Show That the ’285 Patent
`Is § 102(e) Prior Art ............................................................................. 7
`III. THE PTO HAS PREVIOUSLY REJECTED SUBSTANTIALLY
`THE SAME ARGUMENTS DURING PROSECUTION OF THE
`PARENT ’698 PATENT ................................................................................ 8
`A.
`Institution of an Inter Partes Review Is Discretionary ........................ 9
`B.
`Petitioner Has Failed to Explain Why the Board Should
`Reconsider Obviousness Over a Plachetka Patent ............................. 10
`IV. CONCLUSION ............................................................................................. 11
`
`IPR2018-00272
`
`
`
`Page i
`
`
`
`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) ........................................... 9
`Applied Materials, Inc. v. Gemini Research Corp.,
`835 F.2d 279 (Fed. Cir. 1988) .............................................................................. 6
`Ariosa Diagnostics, Inc. v. Illumina, Inc.,
`IPR2014-01093, Paper 69 (P.T.A.B. Jan. 7, 2016) .............................................. 8
`In re DeBaun,
`687 F.2d 459 (C.C.P.A. 1982) .............................................................................. 7
`Riverwood Int’l Corp. v. R.A. Jones & Co.,
`324 F.3d 1346 (Fed. Cir. 2003) ............................................................................ 7
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01750, Paper 15 (P.T.A.B. Apr. 3, 2017) ............................................. 6
`Unified Patents Inc. v. Berman,
`IPR2016-01571, Paper 10 (P.T.A.B. Dec. 14, 2016) ......................................... 10
`Statutes
`35 U.S.C. § 313 .......................................................................................................... 1
`35 U.S.C. § 314(a) ..................................................................................................... 5
`35 U.S.C. § 325(d) ..................................................................................... 5, 9, 10, 11
`Other Authorities
`37 C.F.R. § 42.108(a), (b) .......................................................................................... 9
`
`
`
`
`IPR2018-00272
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`
`
`Page ii
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`
`
`EXHIBIT LIST
`
`Exhibit No.
`2001
`
`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”)
`
`2002
`
`2003
`
`2004
`
`2005
`
`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”)
`
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Response
`to Final Office Action Mailed March 26, 2015 (Sept. 25, 2015)
`
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Advisory
`Action (Oct. 9, 2015)
`
`
`
`
`
`
`
`
`
`IPR2018-00272
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`Page iii
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`
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`Horizon Pharma USA, Inc. and Pozen Inc. (hereinafter, “Patent Owner”)
`
`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. 9,393,208 (“the ’208 patent”). Petitioner’s
`
`Petition fails to demonstrate a reasonable likelihood that claims 1-7 of the ’208
`
`patent are unpatentable. 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 ’208 patent. 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,
`
`such as ulcers and bleeding. (Id.) This is believed to be the case because NSAIDs
`
`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
`
`IPR2018-00272
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`
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`Page 1
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`
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`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 ’208 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
`
`release of the NSAID would be delayed until the pH of the environment was higher,
`
`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
`
`IPR2018-00272
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`Page 2
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`
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`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 his employee Everardus Orlemans, 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 related ’698 patent,1 the applicants successfully
`
`overcame the very challenge now raised by Petitioner, namely inherent anticipation
`
`by, or obviousness over, an earlier Plachetka patent.2 As explained during
`
`prosecution of the parent ’698 patent, 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
`
`
`1 The ’208 patent is a continuation of the ’698 patent. The ’208 patent is also
`
`terminally disclaimed over the ’698 patent.
`
`2 In 2013, Horizon purchased these and the related patents from AstraZeneca AB.
`
`IPR2018-00272
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`Page 3
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`
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`pH was higher than 4.0 for a longer period of time. (Ex. 1013, 1/30/2013 Applicant
`
`Arguments at 7-8.)
`
`Applicants argued that the ’907 patent failed to teach the claimed unexpected
`
`pharmacokinetic parameters.3 (Ex. 2004, 9/25/2015 Applicant Arguments at 5-7.)
`
`The Examiner subsequently withdrew the obviousness rejections made over the ’907
`
`patent and the ’208 patent issued on July 19, 2016. (Ex. 2005, 10/9/2015 Advisory
`
`Action at 2.)
`
`Petitioner, having lost an infringement suit on the ’907 and ’285 patents in
`
`district court,4 now brings this petition for inter partes review of the ’208 patent.
`
`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
`
`
`3 Although Petitioner failed to include relevant portions of the ’698 prosecution
`
`history with this Petition, those materials were included in Petitioner’s Petition
`
`targeting the ’698 patent, IPR2017-01995. For ease of reference, they are included
`
`in Patent Owner’s exhibits.
`
`4 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).
`
`IPR2018-00272
`
`
`
`Page 4
`
`
`
`the ’208 patent. And the fact that, during prosecution of the parent ’698 patent, the
`
`Patent Office considered and rejected the very arguments that Petitioner now makes
`
`demonstrates that the 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 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 2 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 ’208 patent was filed on December 28, 2015
`
`and claims priority to Provisional Application No. 61/095,584 (filed on September
`
`IPR2018-00272
`
`
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`Page 5
`
`
`
`9, 2008) and Application No. 12/553,107 (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 ’208 patents overlap but are not identical.
`
`(Paper 2 at 20-21 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 not Patent Owner’s burden
`
`to prove that the ’285 patent is not § 102(e)(2) art. It is Petitioner’s burden to
`
`establish that the portions of the ’285 patent on which it relies as prior art and the
`
`subject matter of the ’208 claims in question represent the work of different inventive
`
`entities. Petitioner has made no such showing here.
`
`A.
` Legal Standard
`“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
`
`IPR2018-00272
`
`
`
`Page 6
`
`
`
`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
`
`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 ’208 patents list John Plachetka as an inventor, the ’285
`
`IPR2018-00272
`
`
`
`Page 7
`
`
`
`has a different inventive entity because the ’208 lists three other inventors in addition
`
`to John Plachetka.” (Paper 2 at 20-21 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. Petitioner also failed to provide any shred of
`
`evidence to support its argument.
`
`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.
`
`III. THE PTO HAS PREVIOUSLY REJECTED SUBSTANTIALLY THE
`SAME ARGUMENTS DURING PROSECUTION OF THE PARENT
`’698 PATENT
`As described above, during prosecution,
`
`the Examiner entered an
`
`obviousness-type double patenting rejections to the pending claims based on the
`
`parent ’698 patent. In turn, during examination of the ’698 patent, the Examiner
`
`made obviousness and obviousness-type double patenting rejections over the ’907
`
`Plachetka patent, which is a grandparent to the ’285 patent. As applicants
`
`IPR2018-00272
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`
`
`Page 8
`
`
`
`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.
`
`A.
`Institution of an Inter Partes Review Is Discretionary
`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.
`
`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).
`
`IPR2018-00272
`
`
`
`Page 9
`
`
`
`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 in the Petition had been previously considered during prosecution. Noting that
`
`the Petitioner failed to “present any argument distinguishing the Examiner’s prior
`
`consideration of [the reference] or . . . provide a compelling reason why [the Panel]
`
`should readjudicate substantially the same prior art and arguments as those presented
`
`during prosecution and considered by the Examiner.” Id. The PTAB noted that it
`
`was the Petitioner’s burden to either explain why the prior art was being applied in
`
`a different manner in the petition or to provide another compelling reason as to why
`
`the Panel should reconsider the art and arguments. Because the petitioner had failed
`
`to do so, the Panel exercised its discretion under § 325(d) to deny institution. That
`
`same outcome is appropriate here.
`
`B.
`
`Petitioner Has Failed to Explain Why the Board Should
`Reconsider Obviousness Over a Plachetka Patent
`The purpose of these inter partes review proceedings is to allow parties to
`
`present novel issues and art not considered during prosecution. It would be a waste
`
`of administrative resources to institute this petition in order to address an issue that
`
`was already considered and decided during prosecution. Further, the Petition is
`
`glaringly silent as to why the Board should revisit the Examiner’s non-obviousness
`
`determination over a Plachetka patent.
`
`IPR2018-00272
`
`
`
`Page 10
`
`
`
`As described above, during prosecution, the Examiner raised the same
`
`arguments with respect to the ’907 patent that Petitioner now raises with respect to
`
`the ’285 patent. The ’907 patent and ’285 patent share a common specification and
`
`claim priority to the same provisional application. The Petition fails to present a
`
`complete picture of the prosecution history of the parent ’698 patent, omitting a
`
`discussion of the relationship between the ’907 and ’285 Plachetka patents, and
`
`ignoring critical arguments that were made during prosecution to overcome the ’907
`
`patent.
`
`The Petition fails to identify any new issue or evidence that would merit
`
`revisiting the Examiner’s non-obviousness determination. Accordingly, the Board
`
`in its discretion should deny institution pursuant to 35 U.S.C. § 325(d).
`
`IV. CONCLUSION
`
`For the reasons discussed above, Patent Owner respectfully requests that the
`
`Board deny institution for Petitioner’s Petition. In the event that this inter partes
`
`review is instituted, however, Patent Owner reserves the right to challenge
`
`Petitioner’s Grounds for other reasons.
`
`
`
`
`
`
`
`
`
`
`IPR2018-00272
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`
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`Page 11
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`
`
`DATED: March 20, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: _/Thomas A. Blinka/____
`Thomas A. Blinka, Ph.D.
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., N.W. Suite
`700
`Washington, DC 20004-2400
`Tel: (202) 842-7800
`Fax: (202) 842-7899
`tblinka@cooley.com
`
`USPTO Reg. No. 44,541
`
`IPR2018-00272
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`
`
`Page 12
`
`
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`
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`CERTIFICATE OF COMPLIANCE WITH WORD COUNT LIMITS
`
`Pursuant to 37 C.F.R. § 42.24(d), I certify that this Petition complies with the
`
`type-volume limits of 37 C.F.R. § 42.24(a)(1)(i). According to the word processing
`
`system used to prepare it, this Response contains 2497 words, excluding parts that
`
`are exempted by 37 C.F.R. § 42.24(a).
`
`Date: March 20, 2018
`
`
`
`
`
`
`
`
`BY:
`
`
`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`IPR2018-00272
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`
`
`Page 13
`
`
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`
`
`
`I, Thomas A. Blinka, hereby certify that on this 20th day of March 2018, the
`
`foregoing PATENT OWNER’S PRELIMINARY RESPONSE PURSUANT TO
`
`37 C.F.R. § 42.120 was served electronically via email on the following:
`
`Brandon M. White
`bmwhite@perkinscoie.com
`700 13th St., NW Suite 600
`Washington, DC 20005
`
`Emily Greb
`egreb@perkinscoie.com
`One East Main St., Suite 201
`Madison, WI 53703
`
`Date: March 20, 2018
`
`
`
`
`
`
`BY:
`
`
`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
`
`IPR2018-00272
`
`
`
`Page 14
`
`
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