Cipla had submitted a post grant opposition to the patent IN209251 granted in 2007 to SUGEN INC., USA and Parmacia and Upjohn Co for Sunitinib (brand name: Sutent), a drug used in the treatment of Renal Cell Carcinoma (RCC). The post grant has been successful and the patent is revoked on grounds of lack of inventive step.
The order is available here.
Sunitinib is currently being marketed and sold by Pfizer at approximately for Rs. 1.96 lacs for a 45 days course i.e. Rs. 4357 per 25 mg capsule.
Due to the failure to apply patentability standards strictly, certain invalid/weak and poor quality patents on drugs have been granted in India which has resulted in blocking affordable generics for many life threatening diseases.
An example is the patent granted to Roche for Peg interferon alpha 2a used for treatment of Hepatitis C. Given the presumption of validity that patents enjoy – the burden of proving a patent invalid – falls on patient organisations or affected generic competitors. Sankalp Rehabilitation Trust, an organization working with vulnerable communities like Injecting drug users (IDUs) has challenged this patent granted to Roche through a post grant opposition as it affects access to treatment for patients living with Hepatitis C.
On rejection of post grant opposition in patent office, Sankalp appealed against it at Intellectual Property Appellate Board, Chennai. The final hearing of this case at IPAB concluded on 21 September and now civil society and patient groups are anxiously waiting for the judgment order.
See here a recent press release issued by patient groups and civil society in this context.