There had been some reported news in the past that Ahmedabad-based generic company Torrent Pharmaceuticals has made a pre-grant opposition against AstraZeneca blockbuster anti-cholesterol drug Rosuvastatin, but it is not clear against which Application the pre-grant opposition has been made. Globally marketed as Crestor, Rosuvastatin has three Orange Book listed patents –
- US RE37,314 (the ‘314 patent) claiming priority from Japanese patent application dated July 01, 1991, which exclude any possibility of equivalent Indian Application. The ‘314 patent broadly covers drug compound Rosuvastatin.
- US 6,316,460 (the ‘460 patent) claiming priority from British patent application dated January 26, 2000 and has equivalent Indian Application Nos. 1403/MUMNP/2005, IN/PCT/2002/00867/MUM and IN/PCT/2002/00112/MUM. The ‘460 patent covers marketed formulation of Rosuvastatin.
- US 6,858,618 (the ‘618 patent) claiming priority from British patent application dated November 22, 2000 and has no equivalent Indian Application. The ‘618 patent claims method for treating heterozygous familial hypercholesterolemia, which is likely not patentable in
under section 3(i) of the Patents Act, 1970. India
There are few other Applications filed by AstraZeneca for Rosuvastatin, which are pending with the Indian Patent Office (not including combination and process patent applications) –
- IN/PCT/2002/00922/MUM for crystalline salts of rosuvastatin, claiming priority from British patent application dated February 15, 2000 (equivalent US Patent No. 6,841,554).
- 1201/DELNP/2004 for method of preventing dementia in a patient by administering rosuvastatin, claiming priority from Swedish patent application dated October 19, 2001 (equivalent US Publication No. 20060229321).
- 112/MUM/2000 for use of particular oral dosage ranges of rosuvastatin to alter beneficially lipid levels or lipid ratios in a human patient, claiming priority from British patent applications earliest dated June 02, 1999 (equivalent WO Publication No. WO0045819).
In above listed patent applications, the Indian equivalent(s) of the ‘460 patent seems to be critical from the generic perspective to Torrent as it cover the PDR (Physician Desk Reference) formula of rosuvastatin, which likely reasoned to be possible Application opposed by Torrent. It would be appreciable if anyone can shed some light over this pre-grant opposition.