SHIRE LLC, SHIRE DEVELOPMENT INC., SHIRE DEVELOPMENT, LLC, Plaintiffs-Appellees
Amneal PHARMACEUTICALS, LLC, ROXANE LABORATORIES INC., SANDOZ INC., MYLAN INC., MYLAN PHARMACEUTICALS INC., JOHNSON MATTHEY INC., JOHNSON MATTHEY PHARMACEUTICAL MATERIALS, ACTAVIS ELIZABETH LLC, ACTAVIS LLC, Defendants-Appellants
Appeals from the United States District Court for the District of New Jersey in No. 2:11-cv-03781-SRC-CLW, 2:11-cv-04053-SRC-MAS, 3:11-cv-03787-PGS-LHG, 2:11-cv-03886-SRC-MAS, 2:12-cv-03234-SRC-MAS, Judge Peter G. Sheridan, Judge Stanley R. Chesler.
ANGUS CHEN, Frommer Lawrence & Haug LLP, New York, NY, argued for plaintiffs-appellees. Also represented by EDGAR HAUG, PORTER F. FLEMING, SANDRA KUZMICH, RICHARD KURZ, ANDREW SCOTT ROPER.
MATTHEW R. REED, Wilson, Sonsini, Goodrich & Rosati, PC, Palo Alto, CA, argued for defendants-appellants Amneal Pharmaceuticals, LLC, Roxane Laboratories Inc., Sandoz, Inc., Mylan Inc., Mylan Pharmaceuticals Inc., Actavis Elizabeth LLC, Actavis LLC. Defendants-appellants Mylan Inc., Mylan Pharmaceuticals Inc. also represented by KATHERINE HASPER; WENDY L. DEVINE, San Diego, CA.
DANIEL E. YONAN, Blank Rome LLP, Washington, DC, for defendant-appellant Amneal Pharmaceuticals, LLC. Also represented by H. KEETO SABHARWAL, MARSHA ROSE GILLENTINE, JEREMIAH B. FRUEAUF, Sterne Kessler Goldstein & Fox, PLLC, Washington, DC.
ALAN B. CLEMENT, Locke, Lord, Bissell & Liddell, LLP, New York, NY, for defendant-appellant Roxane Laboratories Inc. Also represented by SCOTT B. FEDER, MYOKA KIM GOODIN, HUGH S. BALSAM, Chicago, IL.
DEANNE MAYNARD, Morrison & Foerster LLP, Washington, DC, for defendant-appellant Sandoz Inc. Also represented by BRIAN ROBERT MATSUI; DAVID CLARENCE DOYLE, MARK ANDREW WOODMANSEE, JAMES CEKOLA, San Diego, CA; ERIC C. PAI, Palo Alto, CA.
JONATHAN A. HARRIS, Axinn Veltrop Harkrider, LLP, Hartford, CT, for defendants-appellants Actavis Elizabeth LLC, Actavis LLC.
CONSTANTINE L. TRELA, JR., Sidley Austin LLP, Chicago, IL, argued for defendants-appellants Johnson Matthey Inc., Johnson Matthey Pharmaceutical Materials. Also represented by JOSHUA JOHN FOUGERE, Washington, DC; DOUGLAS R. NEMEC, RACHEL RENEE BLITZER, Skadden, Arps, Slate, Meagher & Flom LLP, New York, NY.
WILLIAM M. JAY, Goodwin Procter LLP, Washington, DC, for amicus curiae Generic Pharmaceutical Association. Also represented by DAVID ZIMMER, San Francisco, CA.
Before MOORE, MAYER, and LINN, Circuit Judges.
[116 U.S.P.Q.2d 1609] Linn, Circuit Judge.
In this consolidated Hatch-Waxman Act litigation, Amneal Pharmaceuticals, LLC, Actavis Elizabeth LLC, Actavis LLC, Mylan Inc., Mylan Pharmaceuticals Inc., Roxane Laboratories, Inc., Sandoz Inc. (collectively the " ANDA defendants" ) and Johnson Matthey Pharmaceutical Materials (" Johnson Matthey" ) (collectively, " defendants" ) appeal the district court's decision in Shire, LLC v. Amneal Pharmaceuticals, LLC, No. 11-3781, 2014 WL 2861430 (D.N.J. June 23, 2014) (" Op." ), granting Shire LLC, Shire Development Inc. and Shire Development, LLC's (collectively
" Shire's" ) motion for summary judgment that claim 4 of the U.S. Patent No. 7,105,486 (the " '486 patent" ); claims 1-4 of U.S. Patent No. 7,655,630 (the " '630 patent" ); claims 1-12 of U.S. Patent No. 7,659,253 (the " '253 patent" ); and claim 3 of U.S. Patent No. 7,662,787 (the " '787 patent" ) (collectively, the " asserted claims" ) are not invalid. Defendants also appeal the district court's decision in Shire, LLC v. Amneal Pharmaceuticals, LLC, No. 11-3781, (D.N.J. May 12, 2014), affirming the magistrate judge's decision denying defendants' motion to amend their invalidity contentions to include an on-sale bar claim, see Shire, LLC v. Amneal Pharms., LLC, No. 11-3781, 2013 WL 6858953 (D.N.J. Dec. 26, 2013) (" Magistrate Op." ). Johnson Matthey separately appeals the district court's decision that it induced infringement of the claims of the '630, '253 and '787 patents (the " compound claims" ) by providing the active pharmaceutical ingredient (" API" ) L-lysine-d-amphetamine (" LDX" ) dimesylate to the ANDA defendants. Because defendants have failed to raise a genuine issue of material fact that the asserted claims are obvious, we affirm the district court's judgment of nonobviousness. Because the district court did not abuse its discretion in denying defendants' motion to amend their invalidity contentions to include an on-sale bar claim, we affirm that ruling. Because in the circumstances of this case Johnson Matthey cannot be liable for induced infringement prior to the grant of FDA approval of the application filed by the ANDA defendants, we reverse the district court's judgment that Johnson Matthey has induced infringement of the asserted compound claims and remand the case for further proceedings consistent with this opinion.
A. The Patents-in-Suit
The '486, '630, '253 and '787 patents (collectively, the " patents-in-suit" ) share similar specifications and are all directed to derivatives of amphetamine. Amphetamines are a class of drugs that has long been used to treat a variety of disorders, including attention deficit hyperactivity disorder (" ADHD" ). See, e.g., '486 patent col.1 l.59--col.2 l.12; Physicians' Desk Reference 2992-93 (2000) (" PDR" ). A major drawback to the use of amphetamines is their potential for abuse. '486 patent col.2 l.13--col.3 l.12; PDR at 2992. The goal of the inventions is to " utilize covalent modification of amphetamine to decrease its potential for causing overdose or abuse." '486 patent col.9 ll.11-13. Specifically, the patents describe modifying amphetamine in such a way as to decrease its activity when administered in high doses--as happens when the drug is being abused--but to maintain activity similar to that of unmodified amphetamine when the modified amphetamine is delivered at lower doses. Id. at col.9 ll.13-21. One embodiment of the invention is LDX dimesylate. See id. at col.8 ll.43-67.
The claims of the '486 patent are directed to methods of using amphetamine derivatives, with asserted claim 4 directed to using a mesylate salt of LDX to treat ADHD. The asserted claims of the '630, '253 and '787 patents are compound claims directed to mesylate salts of LDX and crystalline forms thereof.
B. History of the Dispute
Shire is the assignee of the patents-in-suit and markets LDX dimesylate capsules. These capsules are approved by the Food and Drug ...