Global Insight Perspective | |
Significance | This is the second product patent approved by the Indian Patent Office following the 2006 approval of Roche's (Switzerland) Pegasys, and the first for an AIDS treatment. |
Implications | The announcement will bring cheer to the 9,000 product patent applicants currently under review, particularly to the five AIDS drugs applications set for review next year. The positive effects of the approval may be dampened by potential post-grant opposition from consumer patient groups in India. |
Outlook | In terms of revenue enhancement, the approval may not amount to much since the Indian government is expected to negotiate price structure. However, in general terms it will work to bolster industry sentiments and provide some clarity to the controversial amendments to the Indian Patent Act. |
Pfizer Receives First Approval
Pharma major Pfizer has scored its first product patent approval in India after the Indian Patent Office granted product exclusivity for its AIDS drug Maraviroc (Selzentry/Celsentri). The drug received its first global regulatory approval from the U.S. FDA earlier this year and is indicated as a first-in-class drug for treatment of experienced adult patients infected with only CCR5-tropic HIV-1 detectable who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral (ARV) agents. Furthermore, the product is currently being evaluated by the European Commission for patent exclusivity after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive recommendation. The Business Standard highlights the response of non-governmental organisation (NGO) Medicines Sans Frontiers (MSF) to the approval, which has unsurprisingly expressed opposition to the Patent Office's decision, with other consumer patient groups known to be evaluating the finer points of the decision, noting the significance of the drug's pricing and accessibility. Meanwhile, the share price of Pfizer at the Bombay Stock Exchange was up more than 7%, reflecting positive sentiment in the industry.
Outlook and Implications
The approval is significant in the backdrop of a slew of rejections for Big Pharma products at the Indian Patent Office. This includes AstraZeneca's (U.K.) Iressa, Novartis's (Switzerland) Glivec/Gleevec (currently under litigation), Wockhardt's (India) Nadoxin, and Eli Lilly's (U.S.) Forteo. In the AIDS treatment segment, the scenario is not much different. So far, multinational firms have either resolved to withdraw patent applications or are facing pre-grant oppositions from Indian generic firms and consumer patient groups. The threat of compulsory licensing of AIDS drugs is also not being ruled out, as was observed in Thailand. U.K. firm GlaxoSmithKline (GSK; Combivir and Trizivir) and U.S.-based Abbott Laboratories (Kaletra/Aluvia) have withdrawn their patent applications, while Gilead Sciences (U.S.) has gone a step further and issued licences to generic firms in order to mitigate some of the risks involved.
Pfizer's approval will boost industry sentiments but is unlikely to shake the cautious approach of Big Pharma firms as far as the Indian patent system is concerned. The U.S. firm will go ahead with registering the product in India and will most certainly negotiate with the government for a pricing structure in the domestic market. Furthermore, it will provide a fillip to five more AIDS drugs applications from Merck & Co. (U.S.; raltegavir), GSK (amprenavir), Roche (saquinavir), Boehringer (Germany; BILR-355BS), and Johnson & Johnson (J&J; U.S.; rilpivirine), respectively, which will be reviewed next year. Consumer groups are reportedly already on the case and are expected to launch a post-patent grant opposition with the regulatory body, but it is unclear whether it will affect the marketing practices of Maraviroc in the Indian retail market. India is home to 2.2 million AIDS sufferers, and the government is due to initiate an expansion of the ARV drugs programme, including second-line therapy.
Related Articles
- United States: 7 August 2007: Pfizer Gains Maraviroc Approval, Provides Pipeline Update
- United States - European Union: 20 July 2007: CHMP Recommends Approval of Pfizer's Celsentri