Generic Tamiflu: What if Patent is granted?

Indian pharmaceutical companies has already commenced to manufacture and market generic versions of Tamiflu (Oseltamivir Phosphate), the patent application for which is still pending for grant with Delhi Patent Office. Indian Patent Application No. 396/DEL/96 (“396 patent application”) covering avian flu drug Tamiflu was filed under section 5 (2) (“mail-box” application) for which examination has to be initiated after 1.1.2005. Currently 396 patent application is subject to pre-grant opposition under section 25 (1) of the Patents Act, 1970 which is likely to be taken up by Patent Office in near future. But the important question that arises here is what will be the fate of pharmaceutical companies that are manufacturing and marketing generic version of Tamiflu if patent is granted? According to section 11A of the Patents Act, 1970 all patent applications will be publish after completion of 18 months, after which application will be open for pre-grant opposition. Further section 11A (7) states that an applicant, on and from the date of publication of the application for patent and until the date of grant of a patent in respect of such application, will have the like privileges and rights as if a patent for the invention had been granted on the date of publication of the application with a proviso that the applicant will not be entitled to institute any proceedings for infringement until the patent has been granted with a further proviso that the rights of a patentee in respect of applications made under section 5 (2) before the 1st day of January, 2005 shall accrue from the date of grant of the patent with yet another proviso that after a patent is granted in respect of applications made under 5 (2), the patent-holder will only be entitled to receive reasonable royalty from such enterprises which have made significant investment and were producing and marketing the concerned product prior to the 1.1.2005 and which continue to manufacture the product covered by the patent on the date of grant of the patent and no infringement proceedings will be instituted against such enterprises. Prior to January 01, 2005 Proviso of section 11A (7) of the Patents Act, 1970 clearly states that a patent-holder cannot a bring an infringement suit against generic manufactures which have made significant investment and were producing and marketing the concerned product prior to the 1.1.2005 and will continue to manufacture the product covered by the patent on the date of grant of the patent by paying reasonable royalty to the patentee. Is this section provides Tamiflu generics a shield against infringement action? Answer is No. Proviso clearly emphasizes that generic manufactures should be producing and marketing the patented product prior to 1.1.2005, the requirement which is not met in the case of Tamiflu. Generic manufactures, however, got market approval from Drug Controller General of India (DCGI) in 2006 and started marketing their generic versions from February 2006. This clearly shows that in case of patent issuance, Roche/Gilead is not bond by the proviso of section 11A (7) and can institute patent infringement lawsuit against generic manufactures. Generic Dilemma Generic Tamiflu is already having presence in the Indian market which has recently witness the introduction of product patent in pharmaceutical sector. Considering that Gilead/Roche has successfully procured Tamiflu patent worldwide, the likelihood of obtaining patent in India cannot be ruled out. Tamiflu, however, do not fall under the scope of proviso of section 11 A (7). It is the generics that will be in dilemma if patent is issued. Two critical issues that will certainly cause problem to generics: 1) timely vacating their generic version from market, and 2) Stockpiling.