IPR2018-00892
`
`
`Filed on behalf of Patent Owners Bristol-Myers Squibb Company and Pfizer Inc.
`
`By: Heather M. Petruzzi, Reg. No. 71,270 (Lead Counsel)
`
`Timothy A. Cook, Reg. No. 74,073 (Back-up Counsel)
`
`Amy K. Wigmore (Pro Hac Vice)
`
`Kevin S. Prussia (Pro Hac Vice)
` WILMER CUTLER PICKERING HALE AND DORR LLP
`
`1875 Pennsylvania Avenue NW
` Washington, DC 20006
`
`Tel: (202) 663-6028
`
`Email: Heather.Petruzzi@wilmerhale.com
`
`
`
`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.,
`Patent Owner.
`____________________________________________
`Case IPR2018-00892
`Patent 9,326,945 B2
`____________________________________________
`
`PATENT OWNERS’ OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
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`
`
`Filed on behalf of Patent Owners Bristol-Myers Squibb Company and Pfizer Inc.
`
`By: Heather M. Petruzzi, Reg. No. 71,270 (Lead Counsel)
`
`Timothy A. Cook, Reg. No. 74,073 (Back-up Counsel)
`
`Amy K. Wigmore (Pro Hac Vice)
`
`Kevin S. Prussia (Pro Hac Vice)
` WILMER CUTLER PICKERING HALE AND DORR LLP
`
`1875 Pennsylvania Avenue NW
` Washington, DC 20006
`
`Tel: (202) 663-6028
`
`Email: Heather.Petruzzi@wilmerhale.com
`
`
`
`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.,
`Patent Owner.
`____________________________________________
`Case IPR2018-00892
`Patent 9,326,945 B2
`____________________________________________
`
`PATENT OWNERS’ OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00892
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owners hereby object under the
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`Federal Rules of Evidence (“FRE”) and 37 C.F.R. § 42.62 to the admissibility of
`
`evidence that Petitioner submitted on April 5, 2018 in support of its Petition.
`
`Patent Owners’ objections apply equally to Petitioner’s reliance on these exhibits
`
`in any subsequently-filed documents. These objections are timely, having been
`
`filed within ten business days of the Institution Decision (October 15, 2018).
`
`Exhibit 1002
`
`Patent Owners object to Exhibit 1002, Declaration of Dr. Park. Patent
`
`Owner specifically objects to ¶¶ 36, 39, 41, 43, 44, 45, 49, 52, 53, 54, 113, 120,
`
`136, 146, 160, 163, 165, 166, 167, 169, 173, 175, 178, 190, 224 of Exhibit 1002,
`
`and all paragraphs that rely on those paragraphs. These paragraphs lack a
`
`disclosed basis of sufficient facts or data (FRE 705; 37 C.F.R. § 42.65), are not
`
`based on sufficient facts or data, are not the product of reliable principles and
`
`methods, and/or are not a reliable application of the principles and methods to the
`
`facts (FRE 702, 703). The paragraphs also do not have a probative value that is
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`substantially outweighed by the risk of prejudice to Patent Owners (FRE 703), are
`
`misleading and/or confusing (FRE 403), and are irrelevant (FRE 402).
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`
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`- 1 -
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`IPR2018-00892
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`Exhibit 1004
`
`Patent Owners object to Exhibit 1004, what purports to be a copy of Carreiro
`
`et al., “Apixaban, an oral direct Factor Xa inhibitor: awaiting the verdict,” Expert
`
`Opin. Investig. Drugs, 17(12):1937-1945 (2008).
`
`Patent Owners object to this document under Fed. R. Evid. 401, 402, and
`
`403 as lacking relevance and because its probative value is substantially
`
`outweighed by the danger of unfair prejudice, confusing the issues, misleading the
`
`fact finder, undue delay, wasting time, or needlessly presenting cumulative
`
`evidence. Patent Owners also object to this Exhibit as not properly authenticated
`
`under FRE 901 because Petitioner has not presented sufficient evidence that the
`
`document is authentic nor that the document is self-authenticating under FRE 902.
`
`Patent Owners further object as not being an original document under FRE 1002,
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`an authentic duplicate under FRE 1003, nor a document that falls under any
`
`exceptions to the original-document requirement, including those of FRE 1004.
`
`Petitioner has not established that the document is a “printed publication” under 35
`
`U.S.C. §102(b) with a copyright date of 2008. 35 U.S.C. § 311(b).
`
`Exhibit 1010
`
`Patent Owners object to Exhibit 1010, what purports to be a copy of Rudnic
`
`et al., “Tablet Dosage Forms,” in Modern Pharmaceutics, 4th ed., G.S. Banker and
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`C.T. Rhodes, eds., Taylor & Francis Group, Boca Raton, FL, pp. 333-359 (2002).
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`- 2 -
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`IPR2018-00892
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`Patent Owners object to this document under Fed. R. Evid. 401, 402, and
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`403 as lacking relevance and because its probative value is substantially
`
`outweighed by the danger of unfair prejudice, confusing the issues, misleading the
`
`fact finder, undue delay, wasting time, or needlessly presenting cumulative
`
`evidence. Patent Owners also object to this Exhibit as not properly authenticated
`
`under FRE 901 because Petitioner has not presented sufficient evidence that the
`
`document is authentic nor that the document is self-authenticating under FRE 902.
`
`Patent Owners further object as not being an original document under FRE 1002,
`
`an authentic duplicate under FRE 1003, nor a document that falls under any
`
`exceptions to the original-document requirement, including those of FRE 1004.
`
`Petitioner has not established that Rudnic is a “printed publication” under 35
`
`U.S.C. §102(b) that was published in 2002 at least because the Exhibit bears no
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`library stamp, the cover page of the Exhibit does not appear to be a photocopy of a
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`hardcopy textbook, nothing in the Exhibit associates the Rudnic chapter to the
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`specific version of the textbook, and inconsistent markings within the Exhibit
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`suggest that it is a compilation of multiple documents pieced together by
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`Petitioner.
`
`Exhibit 1015
`
`Patent Owners object to Exhibit 1015, what purports to be a copy of
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`Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral
`
`- 3 -
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`IPR2018-00892
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`Dosage Forms, U.S. Department of Health and Human Services, Food and Drug
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`Administration, Center for Drug Evaluation and Research (CDER) (Aug. 1997)
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`Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral
`
`Dosage Forms, U.S. Department of Health and Human Services, Food and Drug
`
`Administration, Center for Drug Evaluation and Research (CDER) (Aug. 1997).
`
`Patent Owners object to this document under Fed. R. Evid. 401, 402, and
`
`403 as lacking relevance and because its probative value is substantially
`
`outweighed by the danger of unfair prejudice, confusing the issues, misleading the
`
`fact finder, undue delay, wasting time, or needlessly presenting cumulative
`
`evidence. Petitioner has not established that the FDA Dissolution Guidance is a
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`“printed publication” under 35 U.S.C. §102(b) by establishing that it was printed
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`and/or publicly accessible as of a certain date.
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`
`
`Date: October 29, 2018
`
`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
`
`
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`- 4 -
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`IPR2018-00892
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`CERTIFICATE OF SERVICE
`I hereby certify that, on October 29, 2018, I caused a true and correct copy
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`of the following materials:
`
`•
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`PATENT OWNERS’ OBJECTIONS TO EVIDENCE PURSUANT
`
`TO 37 C.F.R. § 42.64
`
`to be served via electronic mail on the following attorneys of record and
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`crystalregan@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
`
`Micheal L. Binns
`PARKER POE ADAMS & BERNSTEIN LLP
`1180 Peachtree Street, N.E., Suite 3300
`Atlanta, GA 30309
`michealbinns@parkerpoe.com
`
`Sharad K. Bijanki
`PARKER POE ADAMS & BERNSTEIN LLP
`1180 Peachtree Street, N.E., Suite 3300
`Atlanta, GA 30309
`sharadbijanki@parkerpoe.com
`
`
`
`_/Michael E. Nelson/____________
`Michael E. Nelson, Ph.D.
`Reg. No. 64,115
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`
`
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`- 5 -
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