UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
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`v.
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`ASTRAZENECA AB,
`Patent Owner.
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
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`PATENT OWNER’S MOTION FOR OBSERVATIONS REGARDING THE
`CROSS-EXAMINATION OF ROBERT J. TANENBERG
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`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
`
`v.
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`ASTRAZENECA AB,
`Patent Owner.
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
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`PATENT OWNER’S MOTION FOR OBSERVATIONS REGARDING THE
`CROSS-EXAMINATION OF ROBERT J. TANENBERG
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`
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`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
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`Patent Owner AstraZeneca AB submits this Patent Owner’s Motion for
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`Observations Regarding Cross-Examination of Petitioners’ Reply Witness, Robert
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`J. Tanenberg, pursuant to the Scheduling Order (Paper No. 17) and the Joint Notice
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`of Stipulation (Paper No. 57).
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`Observation #1 - In Ex. 2222 at 22:13-23:16, Dr. Tanenberg testified that he
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`did not focus on claims 25 and 26 of the RE’186 patent for the purpose of his
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`analysis of secondary considerations, despite also testifying that he understood
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`claims 25 and 26 to saxagliptin include the chemical and biological properties that
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`are associated with the compound saxagliptin. This testimony is relevant to
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`statements and conclusions in Dr. Tanenberg’s declaration and Petitioner’s Reply
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`brief regarding failure of others, long-felt need, and unexpected results (Ex. 1041
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`at ¶34, 43, 51-53; Reply at 18-24), specifically, to whether Dr. Tanenberg failed to
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`consider the full scope of properties associated with the chemical compound
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`saxagliptin for the purpose of his analysis of secondary considerations, and raises
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`concerns that his opinions are non-responsive to Dr. Lenhard. Ex. 2057 at ¶16 (Dr.
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`Lenhard stating that: “[m]y consideration of the objective evidence of non-
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`obviousness is in connection with the chemical compound saxagliptin.”).
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`Observation #2 - In Ex. 2222 at 25:1-16, Dr. Tanenberg testified that he did
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`not dispute that a nexus exists between the evidence of secondary considerations
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`and claims 25 and 26 of the RE’186 patent. This testimony is relevant to
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`1
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`statements and conclusions in Dr. Tanenberg’s declaration and Petitioner’s Reply
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`brief regarding failure of others, long-felt need, and unexpected results (Ex. 1041
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`at ¶¶30, 43, 53; Reply at 18-24), specifically, to whether Dr. Lenhard’s opinion
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`that the properties and advantages of saxagliptin are directly tied to the active
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`pharmaceutical ingredient saxagliptin is undisputed. Ex. 2057 at ¶ 54.
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`Observation #3 - In Ex. 2222 at 27:22-28:6, Dr. Tanenberg testified that the
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`majority of drugs that go into clinical testing will not succeed in becoming an
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`FDA-approved drug, and that many fail for safety or efficacy reasons. This
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`testimony is relevant to statements and conclusions in Dr. Tanenberg’s declaration
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`and Petitioner’s Reply brief regarding unpredictability, failure of others, long-felt
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`need, and unexpected results (Ex. 1041 at ¶¶31-33, 36-41, 52, 55; Reply at 18-24),
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`specifically, to the weight given to Petitioner’s argument that a gliptin investigator
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`may forgo FDA approval for non-clinical reasons and to Patent Owner’s argument
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`that achieving a DPP-4 inhibitor compound with the necessary drug-like properties
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`for FDA-approval was unpredictable.
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`Observation #4 - In Ex. 2222 at 35:16-21, Dr. Tanenberg testified that he did
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`not look at the invention dates of any of the class of FDA-approved DPP-4
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`inhibitors, rather he only looked at the dates those drugs were approved by the
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`FDA. This testimony is relevant to statements and conclusions in Dr. Tanenberg’s
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`declaration and Petitioner’s Reply brief regarding long-felt need (Ex. 1041 at ¶¶32-
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`2
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`37; Reply at 22-24), specifically, to whether Dr. Tanenberg failed to apply the
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`legal standard of evaluating long-felt need as of the patent’s filing date and not
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`when the patented product first entered the market.
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`Observation #5 - In Ex. 2222 at 35:22-24, Dr. Tanenberg testified that he did
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`not consider evidence of failure of others after the 2001 timeframe. This testimony
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`is relevant to statements and conclusions in Dr. Tanenberg’s declaration and
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`Petitioner’s Reply brief regarding failure of others (Ex. 1041 at ¶¶38-50; Reply at
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`18-20), specifically, to whether Dr. Tanenberg failed to consider Dr. Lenhard’s
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`evidence that many other companies attempted to develop a safe and effective
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`DPP-4 inhibitor and failed to do so even after the invention of saxagliptin. Ex.
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`2057 at ¶66 and Table 4.
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`Observation #6 - In Ex. 2222 at 37:2-5, Dr. Tanenberg testified that
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`vildagliptin is not approved by the FDA for the treatment of type 2 diabetes. This
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`testimony is relevant to statements and conclusions in Dr. Tanenberg’s declaration
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`and Petitioner’s Reply brief regarding failure of others (Ex. 1041 at ¶¶39-41; Reply
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`at 18-20), specifically, to whether vildagliptin is a failure.
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`Observation #7 - In Ex. 2222 at 38:16-39:20, Dr. Tanenberg testified that the
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`approved dosing for vildagliptin in Europe is twice daily when used as a
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`monotherapy or with metformin and is administered once daily only when used in
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`combination with a sulfonylurea. This testimony is relevant to statements and
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`3
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`conclusions in Dr. Tanenberg’s declaration and Petitioner’s Reply brief regarding
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`unexpected results (Ex. 1041 at ¶53; Reply at 22), specifically, to whether
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`saxagliptin’s property of once-daily dosing is unexpected as compared to
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`vildagliptin.
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`Observation #8 - In Ex. 2222 at 40:22-41:12, Dr. Tanenberg testified that
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`each of the available oral treatments for type 2 diabetes in the prior art had
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`“shortcomings” and that each patient with type 2 diabetes will eventually need two
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`or more oral agents and/or insulin to maintain good control. This testimony is
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`relevant to statements and conclusions in Dr. Tanenberg’s declaration and
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`Petitioner’s Reply brief regarding long-felt need (Ex. 1041 at ¶¶18-21, 31-37;
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`Reply at 22-24), specifically, to whether there was a long-felt need in the prior art
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`for a new alternative treatment option for treating type 2 diabetes.
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`Observation #9 - In Ex. 2222 at 44:1-5, Dr. Tanenberg testified that for the
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`purpose of his analysis of unexpected results, he only compared the properties of
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`saxagliptin to the later-invented FDA-approved DPP-4 inhibitors: sitagliptin,
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`linagliptin, and alogliptin. This testimony is relevant to statements and conclusions
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`in Dr. Tanenberg’s declaration and Petitioner’s Reply brief regarding unexpected
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`results (Ex. 1041 at ¶¶28-30, 51-55; Reply at 20-22), specifically, to whether Dr.
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`Tanenberg failed to apply the legal standard of comparing the unexpected
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`4
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`properties of the claimed invention to the closest prior art in reaching his opinions
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`regarding unexpected results.
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`Observation #10 - In Ex. 2222 at 44:21-45:6 and 46:23-47:4, Dr. Tanenberg
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`testified that the cardiac hospitalization warning on saxagliptin’s label does not
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`match and is different from the warning on vildagliptin’s label concerning liver
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`toxicity. This testimony is relevant to statements and conclusions in Petitioner’s
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`Reply brief regarding unexpected results (Reply at 22), specifically, to Petitioner’s
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`contrary assertion in its Reply brief that “[s]axagliptin’s cardiac hospitalization
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`warning matches vildagliptin’s toxicity warning.” Reply at 22.
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`Observation #11 - In Ex. 2222 at 11:1-12:14, Dr. Tanenberg testified that he
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`was not sure he knew there was a parallel district court litigation involving the
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`RE’186 patent, and that he did not review materials generated in that litigation,
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`including the testimony of Dr. James Lenhard and Mylan’s clinical expert, Dr.
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`Garry Tobin. This testimony is relevant to statements and conclusions in Dr.
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`Tanenberg’s declaration and Petitioner’s Reply brief regarding failure of others,
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`long-felt need, and unexpected results (Ex. 1041 at ¶¶31-55; Reply at 4, 8-9, 18-
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`24), specifically, to the weight given to Dr. Tanenberg’s statements and
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`conclusions because it raises concerns that he has not considered all relevant
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`information on these issues.
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`5
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`Respectfully submitted,
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`Dated: December 12, 2016
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`By: /Anthony A. Hartmann /
`Anthony A. Hartmann, Reg. No. 43,662
`Finnegan, Henderson, Farabow,
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`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington DC 20001
`Counsel for Patent Owner
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`6
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that copies of the foregoing PATENT OWNER’S
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`MOTION FOR OBSERVATIONS REGARDING THE CROSS-
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`EXAMINATION OF ROBERT J. TANENBERG was served electronically via
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`e-mail on December 12, 2016, in its entirety to the following:
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`Counsel for Petitioner Mylan Pharmaceuticals Inc.:
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`Steven W. Parmelee
`sparmelee@wsgr.com
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`Richard Torczon
`rtorczon@wsgr.com
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`Jad A. Mills
`jmills@wsgr.com
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`Douglas H. Carsten
`dcarsten@wsgr.com
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`Counsel for Petitioner Wockhardt BIO AG.:
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`Patrick Gallagher
`PCGallagher@duanemorris.com
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`Gary Speier
`gspeier@carlsoncaspers.com
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`Iain McIntyre
`imcintyre@carlsoncaspers.com
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`7
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`Counsel for Petitioner Teva Pharmaceuticals U.S.A., Inc..:
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`Counsel for Petitioner Aurobindo Pharma U.S.A., Inc..:
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`Sailesh K. Patel
`SPatel@schiffhardin.com
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`George Yu
`GYu@schiffhardin.com
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`Samuel Park
`SPark@winston.com
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`Andrew Sommer
`ASommer@winston.com
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`By: /Lauren K. Young/
`Lauren K. Young
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`8
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`Dated: December 12, 2016
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`Counsel for Petitioners Sun/Amneal:
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