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Indian Drug Regulator Withdraws Patent Linkage Proposal; Patent Filings Drop 41% in FY2007/08
10 Jul 08
The Indian patent office has reported a 41% drop in patent filings from Indian firms in FY2007/08, while the Drug Controller General of India (DCGI) has withdrawn plans to grant generic marketing approvals based on patent status.
Global Insight Perspective | | Significance | India's Controller General of Patents, Designs and Trademarks (CGPDM) has reported a 41% drop in patent filings from Indian firms to 449 patent applications. Meanwhile, the DCGI has unofficially announced the withdrawal of its "patent linkage" proposals, acknowledging that the function is outside its purview. | Implications | Although the reasons behind the drop in product patent applications are unclear, a recently closed door for generics revenue generation in India has been reopened with the Drug Controller General of India's (DCGI) decision. | Outlook | The reported announcements prove that generic drugs continue to be major revenue generators for Indian firms, especially domestically. Indian drug companies may well be choosing to file patents of their drugs in other parts of the world, while increasingly using the ruling government's pro-poor stance and stating the public health clause to file pre- and post-patent grant opposition for multinationals' drugs. Meanwhile, Indian pharma firms will applaud the DCGI's decision, with ligation continuing to be the primary means for settling patent infringement claims in the country. |
India's Controller General of Patents, Designs and Trademarks (CGDPM) has reported a 41% year-on-year (y/y) drop in filings by Indian patent companies from 765 in FY2006/07 to 449 in FY2007/08, reports the Economic Times. Product patent applications from Indian firms have consistently increased since 2004, with 278 and 542 applications filed in FY2004/05 and FY2005/06, respectively. Meanwhile, The Drug Controller General of India (DCGI) has withdrawn its recent proposals to create a patented drug database and use the database as a reference for all marketing approvals (see India: 29 April 2008: Indian Government to Create Designated Pharmaceuticals Department), reports Mint. It had also withdrawn its rejection of all marketing approvals of generics for drugs protected by the Indian patent law (see India: 30 April 2008: Indian Drug Price Controller to Deny Applications for Generics of Patented Products). The DCGI, Suringer Singh, observed that the activities stated in the proposal were outside the department's purview, requiring the office to track the current status of all Indian patents issued. The DCGI's office is concerned only with registration of drugs based on the quality, safety, and efficacy of the drug. The decision, however, is yet to be confirmed, with Singh considering posting a formal regulatory announcement on the DCGI Web site. Outlook and Implications The reasons behind the drop in patent filings are uncertain, but could well be down to the government's pro-poor stance, which has resulted in stricter price control regulations in the country. India pharma firms have used this to their advantage, with even small home-grown companies filing patent opposition grants against global pharma majors' patents in India. Okasa's (India) pre-patent opposition to Swiss pharma major Novartis's patent for an alfa crystal form of cancer drug Glivec/Gleevec (imatinib) in India is a prime example of this (see India: 10 January 2008: Pre-Grant Patent Opposition to Novartis's Glivec Alfa Crystal Form Emerges). Concurrently, the number of patents filed in other countries has increased, with mid-cap companies like Suven Life Sciences (India) having sealed product patents in several major regions around the world. Therefore, pharma firms are likely to be using a "generic" strategy to operate in India while trying to build their innovative pipeline globally. Indian generic major Cipla has used the Patent Cooperation Treaty (PCT) method to obtain patents for blockbuster drugs such as Glivec (imitab), Fosamax (alendoronate), and Nexium (osemaprazole). Meanwhile, Indian firms' "generic" strategy will continue to drive revenues in the domestic market with the DCGI having withdrawn its patent linkage proposal. The proposal received much opposition from Indian firms, with patent linkages regarded as one of the key barriers for generics entry into the European Union (EU; see European Union: 10 June 2008: EGA Highlights Barriers to Generics Market Entry in Europe). Although the withdrawal reiterates the Indian government's priority to provide affordable medicines to its citizens with cheap generic drugs, foreign firms—constituting the majority of the patent holders in the country—will have continue to resort to ligation proceedings against generic manufacturers.
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