SHP6 Apr 2011 10:10
Full details
Shire files lawsuit against Watson Pharmaceuticals
Shire files lawsuit against Watson Pharmaceuticals, Inc. for infringement of
ADDERALL XR® patents and for breach of contract.
Dublin, Ireland and Philadelphia, US - April 6, 2011 - Shire plc (LSE: SHP,
NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that
its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the
Southern District of New York against Watson Pharmaceuticals, Inc. and its
subsidiaries Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., Andrx
Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of Shire's U.S.
Reissue Patent No. RE 41,148, U.S. Reissue Patent No. RE 42,096 and U.S. Patent
No. 6,913,768 and also for breach of contract.
The lawsuit results from an Abbreviated New Drug Application (ANDA) recently
filed by Watson for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30
mg ADDERALL XR, pursuant to which Watson provided notice that it would seek to
market its generic products before the expiration of Shire's patents. The
lawsuit alleges that all of Watson's generic strengths infringe the
patents-in-suit. Pursuant to Hatch-Waxman legislation, there will be up to a
30-month stay with respect to Watson's proposed generic products. The lawsuit
also alleges that Watson has violated existing settlement and license
agreements between Shire and Watson, signed in November 2007, arising from an
ANDA that Watson filed in 2006, which also sought approval to market generic
versions of ADDERALL XR.
Shire submitted a Citizen Petition (CP) to the FDA in October 2005 requesting
that the FDA impose stricter bioequivalence standards before approving any ANDA
for ADDERALL XR. The FDA responded that the CP raised "complex issues" and has
not resolved the matter. The FDA has not approved any ANDA for ADDERALL XR.