UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT. ALLERGAN, INC. and SAINT REGIS MOHAWK TRIBE, Plaintiffs/Appellants,

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1 Case: Document: 45 Page: 1 Filed: 01/16/ UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT ALLERGAN, INC. and SAINT REGIS MOHAWK TRIBE, Plaintiffs/Appellants, v. TEVA PHARMACEUTICALS USA, INC., AKORN, INC., MYLAN PHARMAECUTICALS INC., and MYLAN, INC., Defendants/Appellees. APPEAL FROM THE U.S. DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS IN CASE NO. 2:15-CV-1455, JUDGE WILLIAM BRYSON UNOPPOSED MOTION OF PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA FOR LEAVE TO FILE A BRIEF OF AMICUS CURIAE IN SUPPORT OF ALLERGAN, INC. AND THE SAINT REGIS MOHAWK TRIBE AND REVERSAL Counsel for Amicus Curiae Pharmaceutical Research and Manufacturers of America

2 Case: Document: 45 Page: 2 Filed: 01/16/2018 CERTIFICATE OF INTEREST Counsel for Amicus Curiae Pharmaceutical Research and Manufacturers of America certifies the following: 1. The full name of every party or amicus represented by me is: Pharmaceutical Research and Manufacturers of America 2. The name of the real party in interest (please only include any real party in interest NOT identified in Question 3) represented by me is: None 3. Parent corporations and publicly held companies that own 10 percent or more of the stock in the party: PhRMA has no parent corporation and no publicly traded company owns 10% or more of its stock. However, its membership includes companies that have issued stock or debt securities to the public. A list of PhRMA s members is available at: 4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court (and who have not or will not enter an appearance in this case) are : None 5. The title and number of any case known to counsel to be pending in this or in any other court or agency that will directly affect or be directly affected by this court s decision in the pending appeal. See Fed. Cir. R. 47.4(a)(5) and 47.5(b). (The parties should attach continuation pages as necessary): The patents-in-suit are also the subject of pending IPR proceedings, captioned Mylan Pharmaceuticals Inc., et al. v. Saint Regis Mohawk Tribe, IPR , IPR , IPR , IPR There is an additional case involving the same patents pending in the Eastern District of Texas, captioned Allergan, Inc. v. Deva Holding A.S., No. 2:16-cv WCB. i

3 Case: Document: 45 Page: 3 Filed: 01/16/2018 Dated: January 16, 2018 By: /s/ Aaron Stiefel Aaron Stiefel ARNOLD & PORTER KAYE SCHOLER LLP 250 W. 55th Street New York, NY (212) ii

4 Case: Document: 45 Page: 4 Filed: 01/16/2018 Pursuant to Federal Rule of Appellate Procedure 29, the Pharmaceutical Research and Manufacturers of America ( PhRMA ) moves this Court for leave to file an amicus brief in support of plaintiffs/appellants and reversal of the decision below. PhRMA represents the country s leading researchbased pharmaceutical and biotechnology companies. 1 PhRMA s members are devoted to discovering and developing innovative medicines, treatments, and vaccines that save, prolong, and improve the quality of the lives of countless individuals worldwide. PhRMA works to protect its members investments in research and development by supporting public policies that promote innovation in the biopharmaceutical industry, including a robust system of patent protection. To that end, PhRMA frequently participates as an amicus in cases, such as this one, that involve significant issues impacting patent rights. PhRMA s proposed amicus brief, submitted herewith, addresses the issue of whether the district court, in deciding that the patents-in-suit were invalid as obvious, was correct in dismissing the significance of its own finding that Allergan, Inc. s Restasis product was a commercial success and satisfied a long- 1 A complete list of PhRMA members is available at Members include Allergan plc and Teva US Specialty Medicines. Plaintiff-appellant Allergan, Inc. is an indirect subsidiary of the former; defendant-appellee Teva Pharmaceuticals, USA, Inc. is a corporate affiliate of the latter.

5 Case: Document: 45 Page: 5 Filed: 01/16/2018 felt need. The district court attributed the product s success to earlier blocking patents. The district court s approach effectively eliminates commercial success and long-felt need as objective indicia available as evidence of the nonobviousness of improvement patents. That, in turn, will weaken patent rights protecting pharmaceuticals and diminish the incentive for pharmaceutical companies to invest in research and development, particularly that directed to improving existing products. In reviewing the district court s decision it will be useful for the Court to have the benefit of the perspective of the industry responsible for innovative pharmaceutical development which will be affected by this Court s ruling. Based on the foregoing PhRMA asks that the Court grant it leave to file its amicus curiae brief. Plaintiffs/appellants Allergan, Inc. and The Saint Regis Mohawk Tribe have consented to PhRMA s filing of its amicus curiae brief. Defendants/appellees Teva Pharmaceutical USA, Inc., Akorn, Inc., Mylan Pharmaceuticals Inc. and Mylan, Inc. take no position on PhRMA filing its amicus curiae brief. 2

6 Case: Document: 45 Page: 6 Filed: 01/16/2018 Respectfully submitted, /s/ Aaron Stiefel Aaron Stiefel ARNOLD & PORTER KAYE SCHOLER LLP 250 W. 55th Street New York, NY (212) DAVID E. KORN PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA 950 F Street, NW, Suite 300 Washington, DC (202)

7 Case: Document: 45 Page: 7 Filed: 01/16/2018 CERTIFICATE OF COMPLIANCE following: Pursuant to Federal Rules of Appellate Procedure 27 and 32, I certify the The motion complies with the type-volume limitations of Federal Rule of Appellate Procedure 27(d)(2)(A). This motion contains 412 words, excluding the parts of the motion exempt by Federal Rule of Appellate Procedure 27 and Federal Circuit Rule 27(d). /s/ Aaron Stiefel Aaron Stiefel ARNOLD & PORTER KAYE SCHOLER LLP 250 W. 55th Street New York, NY (212)

8 Case: Document: 45 Page: 8 Filed: 01/16/2018 CERTIFICATE OF SERVICE I, Aaron Stiefel, hereby certify that, on January 16, 2018, the foregoing document was filed and served on all counsel of record via through the Court s CM/ECF system. /s/ Aaron Stiefel Aaron Stiefel ARNOLD & PORTER KAYE SCHOLER LLP 250 W. 55th Street New York, NY (212)