Brain League IP Services and Origiin IP Solutions LLP have expressed that India needs to be taken seriously by global pharma majors when it comes to revoking of patents.

This goes by the developments in the last few months proving that process of getting patent is tough in India and those granted are extremely prone to revocation. These included the recent Roche’s Herceptin application. In 2012, India retracted patents granted to Roche's hepatitis C drug Pegasys, Pfizer Inc.'s cancer drug Sutent and Merck's asthma aerosol suspension formulation. While Roche’s Pegasys invention was seen to be not efficient compared to non-pegylated version, both Pfizer’s Sutent and Merck’s aerosol patents were annulled because of lack of inventive steps. A similar asthma treatment, Dulera, lost its Indian patent held by Novartis AG in 2010.

“These various decisions clearly indicate that the standard of innovation required to obtain a patent in India is higher when compared to other regions. Indian patent regime has become a thorn in the flesh of global drug makers,” Arun Narasani, CEO and co-founder, Brain League IP Services told Pharmabiz.

“Indeed, India will be taken seriously by multinational companies and would be extra careful when filing patent applications. Novartis’ Glivec case has clearly established that ‘evergreening’ will be difficult in India unless it is absolutely new. In this backdrop, there are two competing forces working against each other. On one hand, foreign MNCs will be reluctant to invest in  R&D to develop drugs aimed specifically for India because of uncertain IP protection. On the other hand, global companies  are witnessing reduced demand for their drugs from their traditional markets  or developed economies. But India cannot be ignored to driving their revenues, Narasani added.

But Bindu Sharma, Patent Attorney, Origiin IP Solutions LLP observes that the main reason for patents to be  revoked is the  section 3 (d), a provision of Indian Patent Act 1970, which  prohibits incremental innovation, especially if therapeutic efficacy is lacking. India being 14th largest pharmaceutical market globally  certainly needs to re-look into this provision to encourage patent filings in India and Foreign Direct Investment (FDI).

“Interestingly the key reason for the Roche’s patent revoke was  due to procedural noncompliance, failure of patentee to appear and submit documents to oppose post-grant challenge. Moreover, revocation was related only to the divisional application whereas the main application still continues to be in force,” said Sharma.

However, global pharma cannot ignore India to drive the much required revenues and would continue to protect their blockbuster drugs at least the primary versions through patents here. This would safeguard their interests going by the capability of Indian generic drug manufacturers who could make alternative drugs for the domestic market, and for other countries where there is no patent protection, said Narasani.