Case 1:18-cv-01288-LPS Document 20 Filed 08/29/18 Page 1 of 25 PageID #: 275 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE VALEANT PHARMACEUTICALS ) INTERNATIONAL, SALIX ) PHARMACEUTICALS LTD. and COSMO ) TECHNOLOGIES LIMITED, ) ) Plaintiffs, ) ) v. ) C.A. No: 18-1288 (UNA) ) ACTAVIS LABORATORIES FL., INC., ) JURY TRIAL DEMANDED ACTAVIS PHARMA, INC., TEVA ) PHARMACEUTICALS USA, INC. and ) REDACTED - PUBLIC VERSION TEVA PHARMACEUTICAL INDUSTRIES ) LTD., ) ) Defendants. ) OPENING BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR TEMPORARY RESTRAINING ORDER AND PRELIMINARY INJUNCTION OF COUNSEL: Jack B. Blumenfeld (#1014) Michael Flynn (#5333) Thomas P. Steindler MORRIS,NICHOLS,ARSHT &TUNNELL LLP Paul M. Schoenhard 1201 North Market Street David Mlaver P.O. Box 1347 MCDERMOTT WILL &EMERY LLP Wilmington, DE 19899 500 N. Capitol St. N.W. (302) 658-9200 Washington, D.C. 20001 [email protected] (202) 756-8000 [email protected] [email protected] [email protected] Attorneys for Plaintiffs [email protected] Gary Frischling Sami Sedghani Yite John Lu MCDERMOTT WILL &EMERY LLP IRELL &MANELLA LLP 275 Middlefield Road, Suite 100 1800 Avenue of the Stars, Suite 900 Menlo Park, CA 94025 Los Angeles, CA 90067 (650) 815-7406 (310) 277-1010 [email protected] Attorneys for Plaintiff Attorneys for Plaintiffs Cosmo Technologies Limited Valeant Pharmaceuticals International and Salix Pharmaceuticals Ltd. Original Filng Date: August 22, 2018 Redacted Filing Date: August 29, 2018 Case 1:18-cv-01288-LPS Document 20 Filed 08/29/18 Page 2 of 25 PageID #: 276 TABLE OF CONTENTS Page I. NATURE AND STAGE OF PROCEEDINGS ...................................................................1 II. SUMMARY OF ARGUMENT ...........................................................................................1 III. STATEMENT OF FACTS ..................................................................................................4 A. Technology Background ..........................................................................................4 B. Cosmo’s Patented Invention ....................................................................................5 C. Uceris® ....................................................................................................................6 D. Defendants’ Accused Product ..................................................................................6 IV. ARGUMENT .......................................................................................................................7 A. Legal Standard .........................................................................................................7 B. Plaintiffs Are Likely To Succeed on the Merits ......................................................8 1. Infringement .................................................................................................8 a. Claim Construction ..........................................................................8 b. Infringement of Claims 6 and 16 .....................................................9 2. Validity ......................................................................................................10 C. Plaintiffs Will Suffer Irreparable Harm in the Absence of Injunctive Relief ........11 1. Irrevocable Loss of Market Share and Permanent Price Erosion ..............12 2. Goodwill.............................................................15 3. Lost Research and Development and Lost Market Opportunities .............16 D. The Balance of the Hardships Favors the Issuance of Injunctive Relief ...............17 E. The Public Interest Favors Injunctive Relief .........................................................19 V. CONCLUSION ..................................................................................................................20 i Case 1:18-cv-01288-LPS Document 20 Filed 08/29/18 Page 3 of 25 PageID #: 277 TABLE OF AUTHORITIES Page(s) Cases Abbott Labs. v. Sandoz, Inc., 500 F. Supp. 2d 807 (N.D. Ill. 2007) .......................................................................................13 Abbott Labs v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008)................................................................................................19 ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312 (Fed. Cir. 2012)................................................................................................19 Ariosa Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296 (Fed. Cir. 2013)................................................................................................10 Astrazeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010)..................................................................................................8 Bio-Tech. Gen. Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir. 1996)..................................................................................................12 Broadcom Corp. v. Qualcomm Inc., 543 F.3d 683 (Fed. Cir. 2008)..................................................................................................19 Canon Computer Sys., Inc. v. Nu-Kote Int’l, Inc., 134 F.3d 1085 (Fed. Cir. 1998)................................................................................................10 Cosmo Technologies Ltd. v. Actavis Laboratories FL, Inc., No. 15-164-LPS (D. Del.)................................................................................................1, 2, 18 Cosmo Technologies Ltd. v. Actavis Laboratories FL, Inc., No. 18-1006-LPS (D. Del.)........................................................................................................2 In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 2011 WL 1980610 (D. Del. May 20, 2010)...............................................................7, 8, 10, 18 Hybridtech, Inc. v. Abbott Labs, 849 F.2d 1446 (Fed. Cir. 1988)..........................................................................................17, 19 M/A-Com Tech. Solutions Holdings, Inc. v. Laird Techs., Inc., 2014 U.S. Dist. LEXIS 86661 (June 16, 2014) .........................................................................7 Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91 (2011)...................................................................................................................10 ii Case 1:18-cv-01288-LPS Document 20 Filed 08/29/18 Page 4 of 25 PageID #: 278 NutriSweet Co. v. Vit-Mar Enterprises, Inc., 112 F.3d 689 (3d Cir. 1997).......................................................................................................7 PPG Indus. Inc. v. Guardian Indus. Corp., 75 F.3d 1558 (Fed. Cir. 1996)..................................................................................................18 Payless Shoesource, Inc.v. Reebok Int’l, Ltd., 998 F.2d 985 (Fed. Cir. 1993)..................................................................................................19 Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)..................................................................................................8 Polymer Techs., Inc. v. Bridwell, 103 F.3d 970 (Fed. Cir. 1996)............................................................................................13, 15 Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359 (Fed. Cir. 2001)............................................................................................8, 15 Research Found. Of State Univ. of N.Y. v. Mylan Pharms., Inc., 723 F. Supp. 2d 638 (D. Del. 2010)...........................................................................................7 Sanofi-Synthelabo v. Apotex Inc., 488 F. Supp. 2d 317 (S.D.N.Y. 2006), aff’d 470 F.3d 1368 (Fed. Cir. 2006)................. passim Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372 (Fed. Cir. 2009)............................................................................................7, 10 Statutes Hatch-Waxman Act, 21 U.S.C. § 355(j)..........................................................................................1 Other Authorities 429 F.3d at 1382 ......................................................................................................................18, 20 Fed.R.Civ.P. 65................................................................................................................................1 iii Case 1:18-cv-01288-LPS Document 20 Filed 08/29/18 Page 5 of 25 PageID #: 279 I. NATURE AND STAGE OF PROCEEDINGS Pursuant to Fed. R. Civ. P. 65, Plaintiffs Valeant Pharmaceuticals International, Salix Pharmaceuticals Ltd., and Cosmo Technologies Limited, by and through their counsel, respectfully submit this brief in support of their motion for a temporary restraining order (“TRO”) and preliminary injunction (“PI”) to prevent Defendants Actavis Laboratories FL, Inc., Actavis Pharma Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Limited (collectively, “Actavis” or “Defendants”) from manufacturing, offering to sell, or selling their generic version of budesonide extended-release tablets, for oral use, that is the subject of ANDA No. 205457 (the “Accused Product”), which infringes Cosmo’s U.S. Patent No. 10,052,286 (the “’286 patent” or “Asserted Patent”).1 II. SUMMARY OF ARGUMENT Plaintiffs bring this motion to temporarily and preliminarily enjoin Actavis’ recent at-risk ODXQFK RI D JHQHULF YHUVLRQ RI 3ODLQWLIIV¶ 8FHULV SURGXFW EDVHG RQ WKH ތ SDWHQW ZKLFK issued on August 21, 2018 and reads verbatim on Actavis’ generic product as