Global Insight Perspective | |
Significance | This is the first post-patent challenge and the first product to be patented under the newly amended Indian Patent Act. |
Implications | The challenge will be viewed as a test case for providing clarity on the provision, and will encourage Indian firms triggering further opposition and potential litigation. |
Outlook | The already cautious multinationals may go on the backfoot, curbing new patent product launches, particularly if the challenge ends in favour of the Indian firm. |
Post-Grant Patent Opposition
Sketchy details emerged from India over the patent challenge initiated by India's Wockhardt on Roche's hepatitis C drug Pegasys, which is also regarded as the first product to be patented under new patent norms. The Hindu Business Line splashed reports of the development, confirming Wockhardt's filing that noted that the case will be examined by the Regional Patent Office in Chennai. Pegasys (peginterferon alfa-2a)—alone or in combination with Copegus (ribavirin monotherapy)—is indicated for the treatment of adults with chronic hepatitis C virus infection with liver disease who have not been previously treated with interferon alpha, as well as patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.
The timing of the challenge coincides with the provision requirement obliging any post-patent grant opposition to be filed before the end of the first year of the product patent. In this case, Roche's Indian subsidiary, Hoffman la Roche, gained patent recognition in March 2006. The report adds that the pricing strategy adopted by Roche India for Pegasys is 225, 000 rupees (US$51,136) for six-month therapy and would also include the price of Copegus. Roche's Pegasys patent is valid in India until 16 May 2017.
Outlook and Implications
The post-grant patent opposition comes in the backdrop of half a dozen pre-grant oppositions being faced by Big Pharma in India. The lack of details over the exact nature of the opposition notwithstanding, the development raises the stakes in the battle for product patent recognition in India for drug-makers. The opposition itself does not halt marketing or production of the specific drug, but casts a shadow over its long-term future. Roche India was able to successfully beat off any opposition in the earlier stages and gain a product patent last year, but it was mindful of the fact that there are generic copies of the drug already marketed in India from Wockhardt, Shantha Biotechnics and Bharat Biotech. This is the case because of provision under the new patent rules that allow companies that had introduced the drug prior to January 2005 to produce and market it, even if the patent is granted. Still, the company was able to stick to its pre-grant prices despite competition from Indian companies.
Wockhardt's challenge poses new problems, not only for Roche India, but given the high possibility that it will be followed closely by other multinationals seeking to introduce their patented molecules in the Indian pharma market. The ongoing court battle between Novartis and the Indian government over the former's patent rejection of cancer drug Glivec/Gleevec (imatinib myselate), coupled with the pre-grant oppositions with majority of patent applications, has already made multinational pharma firms cautious over introducing new drugs. This new development could very well influence GlaxoSmithKline (GSK) and Merck to hold back key introductions planned for the next three years. Significantly, the opposition will further examine the patent application and grant process. The concept of pre- and post-grant opposition was included in the new Indian Patent Act, as a provision to appease the domestic powerful generic drug-makers and still go ahead with the country's World Trade Organization (WTO) and Trade-Related Intellectual Property Rights (TRIPS) obligations. In effect, Indian companies have been encouraged to take up the provisions, subsequently sparking patent battles.
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India: 18 August 2006: Novartis Challenges Indian Authorities' Refusal to Grant Patent for Glivec
India 12 April 2006: Roche Expands Patented Portfolio in India, with Launch of Cancer Drug Tarceva
India: 8 March 2006: Pre-Grant Patent Litigation Surges, as Multinationals and Indian Drug-Makers Battle it Out
India: 6 March 2006: Hepatitis Drug Secures Roche's First Product Patent in India