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`Filed on behalf of Patent Owners Bristol-Myers Squibb Company and Pfizer Inc.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and
`PFIZER INC.,
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`Patent Owners.
`
`IPR2018-00892
`
`Patent No. 9,326,945
`
`
`PATENT OWNERS’ OPPOSITION TO PETITIONER’S MOTION TO
`FILE SUPPLEMENTAL INFORMATION PURSUANT TO
`37 C.F.R. § 42.123(a)
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`TABLE OF CONTENTS
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`INTRODUCTION ................................................................................ 1
`
`
`I.
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`II. MATERIAL FACTS ............................................................................ 1
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`III. LEGAL AUTHORITY ......................................................................... 2
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`IV. PETITIONER SHOULD NOT BE ALLOWED TO REPLACE
`A PRIOR-ART REFERENCE AFTER INSTITUTION ..................... 3
`
`A.
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`B.
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`Petitioner’s Mistake Should Not Be Correctable via
`Supplemental Information and Allowing Correction
`Would Reduce the Efficiency of the Proceeding ....................... 3
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`Patent Owners Have Been Prejudiced by Petitioner’s
`Mistake ....................................................................................... 4
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`C.
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`Petitioner Could Have Discovered Its Mistake Sooner ............. 5
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`V.
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`CONCLUSION ..................................................................................... 5
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`
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`– ii –
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`
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`I.
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`INTRODUCTION
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`Petitioner’s Ex. 1010 is not a prior-art reference, but a compilation
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`consisting of the cover and publishing information of the fourth edition of Modern
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`Pharmaceutics (“Rudnic”) and pages from the third edition. Petitioner now seeks
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`to replace Ex. 1010 with Ex. 1042, which is an excerpt solely from the third
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`edition. Although Petitioner requests entry of a completely new reference, it still
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`has not carried its burden to show that any edition of Rudnic is a prior-art printed
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`publication. That behavior has prejudiced Patent Owners, who were forced to file
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`their Preliminary Response without knowing what Petitioner meant to rely on and
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`have been hampered in their ability to contest the public availability of Rudnic.
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`II. MATERIAL FACTS
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`Patent Owners were served with the Petition and the related exhibits on
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`April 5, 2018. Among the exhibits was Exhibit 1010, identified as “Rudnic et al.,
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`‘Tablet Dosage Forms,’ in Modern Pharmaceutics, 4th ed., G.S. Banker and C.T.
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`Rhodes, eds., Taylor & Francis Group, Boca Raton, FL, pp. 333-359 (2002).”
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`Paper 2 at App. B. When Patent Owners obtained a copy of the fourth edition of
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`Modern Pharmaceutics, it became clear that the pages referred to in the Petition
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`and the Park Declaration did not correspond to the cited chapter. Although it was
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`clear that something was wrong, Patent Owner had no way of knowing what. For
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`example, the Petition and the Park Declaration may have correctly cited the fourth
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`– 1 –
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`
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`edition but used the wrong page numbers, or they may have cited the proper page
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`numbers of an unknown reference.
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`In their July 18, 2018 Preliminary Response, Patent Owners questioned the
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`public availability and authenticity of Ex. 1010, pointing out that it appeared to be
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`“a compilation of multiple documents pieced together by Petitioner.” Paper 18 at
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`2-3, 13 & n.3, 26 n.10, 40-45; Ex. 2019. In the three months following that filing,
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`Petitioner did not seek to correct the Petition.
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`After the Board instituted review on October 15, 2018, Patent Owners
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`challenged the public availability of Rudnic in their Objections to Evidence.
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`Petitioner served Patent Owners with supplemental evidence on November 9,
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`2018. In those materials, for the first time, Petitioner claimed that the information
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`on which it was relying was actually from the third edition of Rudnic.
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`III. LEGAL AUTHORITY
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`37 C.F.R. § 42.123(a) provides that supplemental information may be filed
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`(1) if authorization to do so is requested within a month of institution and (2) if the
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`information is relevant to a claim for which trial has been instituted. The Board
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`may also consider whether allowing the supplemental information would comport
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`with its statutory mandate to consider “‘the efficient administration of the Office[]
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`and the ability of the Office to timely complete proceedings instituted under this
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`chapter.’” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 441-49
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`– 2 –
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`
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`(Fed. Cir. 2015) (alteration in original) (quoting 35 U.S.C. § 316(b)). In particular,
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`the Board can disallow submissions when the petitioner seeks to substantively
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`change the grounds laid out in the petition after the preliminary response or the
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`institution decision have pointed out weaknesses. Paper 22 at 7-9, Western Digital
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`Corp. v. Spex Techs., Inc., IPR2018-00082 (P.T.A.B. July 23, 2018).
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`IV. PETITIONER SHOULD NOT BE ALLOWED TO REPLACE A
`PRIOR-ART REFERENCE AFTER INSTITUTION
`A.
`
`Petitioner’s Mistake Should Not Be Correctable via Supplemental
`Information and Allowing Correction Would Reduce the
`Efficiency of the Proceeding
`
`“The provision for submitting supplemental information is not intended to
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`offer a petitioner a routine avenue for bolstering deficiencies in a petition raised by
`
`a patent owner in a preliminary response. Nor should the proposed supplemental
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`information change any grounds of unpatentability that were authorized in [a]
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`proceeding or change the type of evidence initially presented in the Petition to
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`support those grounds of unpatentability.” Paper 20 at 3, Merck Sharp & Dohme
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`Corp. v. Microspherix LLC, IPR2018-00402 (P.T.A.B. Sept. 10, 2018).
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`Rather, § 42.123(a) is typically used to submit additional information to
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`show that a reference relied on in the petition is a printed publication. See, e.g.,
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`Paper 28 at 3-7, Blue Coat Sys., Inc. v. Finjan, Inc., IPR2016-01444 (P.T.A.B. Oct.
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`23, 2017); Paper 37 at 2-3, Palo Alto Networks, Inc. v. Juniper Networks, Inc.,
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`IPR2013-00369 (Feb. 5, 2014). The Board itself suggested that Petitioner use a
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`– 3 –
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`
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`supplemental information submission to establish Rudnic’s publication date. Paper
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`24 at 33.
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`Instead, Petitioner seeks to replace an alleged prior-art reference relied on in
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`two instituted grounds but still has not filed information with the Board to establish
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`its public availability, despite Patent Owners’ challenge and the Board’s
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`encouragement to do so. It is Petitioner’s burden to establish that the reference is a
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`printed publication. However, nothing in its motion or the Carroll Declaration (Ex.
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`1045) addresses that issue. Petitioner has waited for Patent Owners (and the
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`Board, see Paper 24 at 33) to point out a significant flaw—that one of its alleged
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`prior-art references was not a reference at all, but a combination of unrelated
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`materials—and then sought to correct it without addressing the heart of the
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`problem, i.e., its status as prior art. The prior-art references are arguably the most
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`important part of a petition, and it is especially important for the Board to ensure
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`that supplemental information is not used to edit them after the fact.
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`B.
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`Patent Owners Have Been Prejudiced by Petitioner’s Mistake
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`As discussed in response to Petitioner’s Motion to Correct, Petitioner has not
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`made a simple clerical mistake. At the time it submitted its Petition, Petitioner
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`essentially did not know what prior-art reference it was relying on. And so neither
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`could Patent Owners or the Board. Patent Owners prepared their Preliminary
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`Response without knowing what reference Petitioner meant to refer to.
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`– 4 –
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`
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`Petitioner, citing Palo Alto Networks, contends that there is no prejudice
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`because the textual material contained in Ex. 1010 was the material on which it
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`intended to rely all along, and so none of its substantive arguments regarding that
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`material have changed. But the petitioner in Palo Alto Networks sought to submit
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`supplemental information to support the public availability of two references—not
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`to change the references themselves. Paper 37 at 2-3, Palo Alto Networks,
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`IPR2013-00369. Furthermore, Patent Owners could not have known, looking at
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`hybrid Ex. 1010 (or the citations in the Petition and Park Declaration), that the
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`textual material provided was the material Petitioner meant to rely on. Patent
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`Owners cannot effectively contest the public availability or substance of a
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`reference that Petitioner has not adequately identified.
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`C.
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`Petitioner Could Have Discovered Its Mistake Sooner
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`Petitioner contends that it “could not have anticipated” its mistake until
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`Patent Owners pointed it out. Paper 32 at 3. But it was Petitioner’s responsibility
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`to check its alleged prior-art references; a simple check of the fourth edition’s table
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`of contents would have revealed a substantial mismatch in page numbers. Further,
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`even after Patent Owner pointed out the problem, Petitioner waited until after
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`institution to explain it away.
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`V. CONCLUSION
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`Petitioner’s Motion to File Supplemental Information should be denied.
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`– 5 –
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`
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`Dated: December 3, 2018
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`
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`Customer Number: 24395
`Tel: (202) 663-6028
`Fax: (202) 663-6363
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`
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`Respectfully submitted,
`
`By: /Heather M. Petruzzi/
`Heather M. Petruzzi
`Reg. No. 71,270
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Avenue, NW
`Washington, DC 20006
`
`Counsel for Patent Owners Bristol-
`Myers Squibb Co. & Pfizer Inc.
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`– 6 –
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`
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on December 3, 2018, I caused a true and correct copy
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`of Patent Owners’ Opposition to Petitioner’s Motion to File Supplemental
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`Information Pursuant to 37 C.F.R. § 42.123(a) to be served via electronic mail on
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`the following attorneys of record and crystalregan@parkerpoe.com:
`
`Micheal L. Binns
`PARKER POE ADAMS & BERNSTEIN LLP
`1180 Peachtree Street, N.E., Suite 3300
`Atlanta, GA 30309
`michealbinns@parkerpoe.com
`
`Robert L. Florence
`PARKER POE ADAMS & BERNSTEIN LLP
`1180 Peachtree Street, N.E., Suite 3300
`Atlanta, GA 30309
`robertflorence@parkerpoe.com
`
`Karen L. Carroll
`PARKER POE ADAMS & BERNSTEIN LLP
`1180 Peachtree Street, N.E., Suite 3300
`Atlanta, GA 30309
`karencarroll@parkerpoe.com
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`
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`Sharad K. Bijanki
`PARKER POE ADAMS & BERNSTEIN LLP
`1180 Peachtree Street, N.E., Suite 3300
`Atlanta, GA 30309
`sharadbijanki@parkerpoe.com
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`
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`_/Michael E. Nelson/____________
`Michael E. Nelson
`Reg. No. 64,115
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`
`
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