Is India Undermining Intellectual Property Rights
Is India Undermining Intellectual Property Rights The revocation of Pfizer Inc’s local patent, for its cancer drug Sutent, by the Indian patent office caused yet another furore over the contentious issue of Intellectual Property infringement in India?
According to media reports, in any order, the assistant controller of patents and designs at the Patent Office, Delhi, Nilanjana Mukherjee stated that “the invention that is claimed in the patent (No. 209251 granted on application No. IN/PCT/2002/00785/DEL) does not involve any inventive step…and hence not patentable under section 2 (1) j of the Patents Act, 1970 (Indian Patent Act).”
The post-grant enquiry board headed by Ms Mukherjee, re-examined the claim filed by generic drug manufacturer Cipla Ltd, challenging the local patent for Sutent, a drug for the cancer of the liver and kidney that Pfizer sells throughout the world.
Sutent, known generically as Sunitinib Malate, was developed by American drug companies Sugen Inc and Pharmacia and Upjohn Co. They licensed it to Pfizer for worldwide marketing. In 2007, it was granted the patent in India but Cipla opposed it the next year. Other drug manufacturers in India, including Natco Pharma Ltd, also opposed the grant of patent.
Sunitinib, a copy of the drug manufactured by Cipla, has been priced at almost one-tenth the price of Sutent. Patent revocation eliminated the threat of a patent infringement case against Cipla. It would also facilitate other local drug companies to come up with their own generic versions of the drug. In response, Pfizer alleged that India was undermining intellectual property rights by misusing the compulsory licence provisions.
According to media reports, the chief intellectual property counsel of Pfizer Inc. told US lawmakers during a Congressional hearing, “We believe that India is undermining IP by misuse of its compulsory license provisions. Compulsory licenses are intended to be used in extraordinary situations of extreme urgency or another national emergency.” Pfizer further alleged that India has created a protectionist regime that adversely affects jobs in the US. Accordingly, Pfizer decided to appeal against the revocation before the Intellectual Property Appellate Board. FDI
Jazz Tobaccowalla, managing director of Pfizer India, in a statement released to the media, said, “We believe the decision undermines intellectual property rights in India and we will vigorously defend our basic Sutent patent.”
Subsequent to the appeal, the Intellectual Property Appellate Board set aside the revocation of the patent of Pfizer’s anti-cancer drug Sutent and asked the patent office to consider the entire matter afresh.
“The impugned order is set aside and the matter is sent back to the Controller General with directions to constitute a fresh Opposition Board and to nominate a Controller other than the Controller who has passed the impugned order to decide the matter within a time-bound frame,” Board chairman Justice Prabha Sridevan and technical member DPS Parmar said, according to media reports.
It must be kept in mind that the Controller in question had revoked the patent twice, once in 2012 and the second time in 2013, after being directed by the Supreme Court to dispose of the matter afresh, after Pfizer challenged the first revocation. Pfizer moved the Board after its claims were rejected the second time.
These tussles between major Western drug manufacturers and India have been ongoing. Patent office had earlier taken away the exclusive right of Germany’s Bayer AG to sell another cancer drug in India called Nexavar. Bayer too challenged this decision.
In addition, in a patent infringement case filed by Switzerland’s Roche Holding AG over Cipla’s Erlocip, yet another cancer drug, the Delhi High Court ruled in favour of Cipla.
Multinational pharmaceutical companies view India’s $ 12 billion drug market as a big opportunity but remain apprehensive of the level of protection available for intellectual property in a market-driven by generic drugs, which account for 90 per cent of the sales.