Its raining IPR’s from Lupin. Lupin recently filed an Inter partes review to a US patent 8,518,987 B2, which is an OB listed patent for Darunavir Ethanolate.
Darunavir Ethanolate is a protease inhibitor and used to treat HIV infection which is developed by G.D. Searle LLC and given exclusive market license to JANSSEN PRODS, received its first FDA approval (N021976) on Feb 25, 2008 for marketing Darunavir Ethanolate in the form of Tablet;Oral under the brand name PREZISTA, further it also received FDA approvals for Suspension;Oral form of Darunavir Ethanolate on Dec 16, 2011 and for the combination of Cobicistat;Darunavir Ethanolate on Jan 29, 2015. The following structure represents Darunavir Ethanolate.
US ‘987 contains 4 independent claims which claims:
Claim 1: A hydrated form of Darunavir which is restricted by the molar ratio of Darunavir to water is about 1:0.5 to about 1:3.
Claim 2. Darunavir Hydrate (No restrictions).
Claim 3: Composition comprising a hydrate of Darunavir which the ratio of compound to water is about 1:0.5 to about 1:3, and an inert carrier.
Claim 6: Composition comprising a hydrate of Darunavir and an inert carrier.
Lupin challenged the claims of US ‘987 under the grounds of
i) Unpatentable Under 35 U.S.C. § 102;
ii) Unpatentable Under 35 U.S.C. § 103 over the disclosed prior art.
Updates will be posted sooonn……….