Shire LLC v. Watson Pharmaceuticals, Inc.

January 07, 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Shire LLC v. Watson Pharmaceuticals, Inc., Case No. 11 Civ. 2340 (JPO), 2012 U.S. Dist. LEXIS 141850 (S.D.N.Y. Sept. 25, 2012) (Oetken, J.)

Drug Product and Patent(s)-in-Suit: Adderall XR®; U.S. Pat. Nos. 6,913,768 (“the ’768 patent”), RE 41,148 (“the ’148 patent”), and RE 42,096 (“the ’096 patent”)

Nature of the Case and Issue(s) Presented: Watson filed an ANDA in December 2010 and a paragraph IV certification against Shire’s patent for Adderall XR. On April 5, 2011, Shire filed suit alleging that Watson’s proposed ANDA infringes three patents owned by Shire. The filing of the complaint triggered a thirty-month stay of the approval of Watson’s ANDA by the FDA. The thirty-month stay is not set to expire until August 2013. In October 2005, Shire filed a Citizen’s Petition requesting that the FDA adopt more stringent bioequivalence standards, which it supplemented in January 2006 and March 2012. On or around June 22, 2012, the FDA issued a ruling adopting new bioequivalence standards for ANDAs referencing Adderall XR, although it did not adopt all of the bioequivalence standards that Shire proposed. On July 30, 2012, Shire moved to stay the instant litigation for a period of ninety days. Watson eventually negotiated terms to which it and Shire jointly consented to the stay. On August 6, 2012, the Court granted the parties’ joint proposed order to stay this action for ninety days. The ninety-day stay in this litigation did not toll the thirty-month stay of FDA approval.

On August 17, 2012, Shire moved to extend the thirty-month stay of FDA approval. Shire argued that it was entitled to an extension because Watson had failed to disclose to the district court that the agreed-upon ninety day stay in the action did not toll the thirty month stay of FDA approval. Watson argued that an extension is unwarranted because it has not delayed the litigation. The district court denied Shire’s motion.

Why Watson Prevailed: The court’s denial of Shire’s motion was based on three reasons. First, Watson had not acted in a manner that slowed or delayed the litigation. Indeed, Watson had sought a shorter discovery period to streamline the litigation. Second, Shire’s motion was premature as the thirty month stay was not set to expire until August 2013. Third, Shire sought an open-ended extension that was only tied to resolution of the case. The court found that when extensions were given, the extension was for a specific amount of time that was related to the delay caused by a party. Here, Watson had not acted to delay the action.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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