Warner Chilcott has announced to settle pending patent
lawsuits against Lupin Limited over Warner’s oral contraceptive drugs Loestrin 24 FE
and Femcon FE. Under the settlement agreement, Lupin agreed it will not sell
generic version of Loestrin 24 FE prior to July 22, 2014, unless another
company launches a generic version first.
Warner further agreed to grant Lupin a non-exclusive license covering Femcon FE which will permit Lupin to commence marketing either an
authorized generic product, which would be supplied by Warner Chilcott, or
generic equivalent of Femcon FE in the United States beginning on the earlier
of (1) 180 days after the FTF Teva Pharmaceutical Industries enters the market with
a generic Femcon FE product, or (2) January 01, 2013.
Earlier in September 2009, Warner Chilcott announced to have
filed two lawsuits against Lupin Limited in the District Court for the District
of Delaware for infringement of Warner’s US Patent Nos. 5,552,394 (the ‘394
patent) and 6,667,050 (the ‘050 patent) covering oral contraceptive drugs Loestrin
24 FE and Femcon FE respectively. The lawsuit was filed after Lupin’s submitted
abbreviated new drug applications (ANDAs) to the United States Food and Drug
Administration (USFDA) requesting approval to manufacture and sell generic
version of Loestrin 24 FE and Femcon 24 prior to the expiration of the ‘394 patent
in July 2014 and the ‘050 patent in April 2019.
Before announcing settlement with Lupin, Warner also settled
with FTF Applicant Watson for Loestrin 24 FE and according to the terms of
settlement, Watson may not enter the market until the earlier of January 22,
2014 or the date on which another generic product enters the market. Warner
also settled with FTF Applicant Teva for Femcon FE and as per terms of
settlement, Teva may not enter the market until the earlier of July 01, 2012 or
among other circumstances, the date that is two years following the date of the
filing of an ANDA with paragraph IV certification by a third-party.
Labels: 'Patent-Drug Regulatory' Linkage, 107A (b), Femcon FE, Loestrin 24 FE, Lupin, Teva, Warner, Watson
