Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a
Paragraph IV Certification Notice Letter advising that Teva
Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to
the U.S. Food and Drug Administration (FDA) requesting permission to
manufacture and market a generic version of Viread®
(tenofovir disoproxil fumarate).
In the Notice Letter, Teva alleges that three patents associated with
tenofovir disoproxil – U.S. Patent Numbers 5,922,695; 5,977,089; and
6,043,230; and one patent associated with tenofovir disoproxil fumarate
– U.S. Patent Number 5,935,946 – owned by Gilead Sciences are invalid,
unenforceable and/or will not be infringed by Teva’s manufacture, use or
sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the
date of receipt to commence a patent infringement lawsuit against Teva.
Such a lawsuit would restrict the FDA from approving Teva’s ANDA for up
to 30 months or until a district court decision that is adverse to
Gilead, whichever occurs first.
Viread is currently protected by four patents, which are listed in the
FDA’s Approved Drug Products List, and all four patents would need to be
invalidated or expired before a generic version of Viread could be
marketed. The U.S. Patent & Trademark Office (PTO) confirmed the
patentability of these four Viread patents in 2008.
Gilead currently has a lawsuit pending against Teva in response to
Teva’s attempts to seek approval for generic versions of Truvada®
(emtricitabine and tenofovir disoproxil fumarate) and Atripla®
(efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300
mg) based on allegations that two emtricitabine patents are invalid,
unenforceable and/or will not be infringed by Teva’s manufacture, use or
sale of its generic product.
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