Multinationals Hit by Series of Indian Patent Office Rejections

In the first two weeks of 2011, the Indian Patent Office (IPO) announced the rejection/revocation of over five major patents covering antihypertensive, HIV/AIDS, contraception, and antibiotics treatments. These included: Novartis (Switzerland)'s antihypertensives Tekturna (aliskiren) and Valturna (aliskiren-valsartan), Bristol-Myers Squibb (BMS; U.S.)'s HIV/AIDS drug Reyataz (atazanavir); Bayer (Germany)'s oral contraceptive pills Yaz (drospirenone-ethinyl estradiol) and Yasmin (ethinylestradiol-drospirenone); and Theravance (U.S.)'s skin infection drug Vibativ (telavancin). The rejections and revocations continue to be made on the grounds of lack of inventive step, novelty, obviousness, and public access. Outlined below are the decisions pertaining to the rejected/revoked patents.

Novartis' Tekturna and Valturna

Novartis saw both patents of its anti-hypertensive drugs Tekturna and Valturna revoked following post-grant opposition from Indian generics major Sun Pharma. The IPO revoked the patent on the grounds that the Swiss major failed to defend the patents against Sun Pharma, which appealed the patent approvals stating that the Swiss firm's drugs lacked an inventive step, had insufficient disclosure/lack of best method. The Indian firm highlighted that Tekturna and Valturna were not inventions, and were non-patentable under the Act, an argument with which the IPO agreed. Tekturna is the first-in-class of orally effective direct renin inhibitors.

BMS Reyataz

BMS' patent application for HIV/AIDS drug Reyataz was rejected on the grounds that it lacked an inventive step and in the interest of public health. Atazanavir is recommended by the World Health Organization as a second-line AIDS therapy. Atazanvir was licensed to BMS by Novartis, which is also pursuing patent rights for the drug in India, although its original Indian patent application had lapsed. The patent rights to atazanavir are still being pursued by the Swiss major under a divisional patent application filed in 2007, and a "process of manufacture" patent application which was filed in 2008. Novartis, on the other hand, may not pursue its base-compound application for atazanavir as it did not respond to the IPO inquiries within the stipulated timeframe. BMS has the exclusive licence from Novartis to manufacture, distribute, and supply Reyataz worldwide.

Bayer's Yasmin and Yaz

The Chennai IPO rejected Bayer's patent applications for oral contraception pills Yasmin and Yaz after the German major failed to dismiss the pre-grant oppositions from Indian generics firms Cipla and Natco Pharma. Cipla and Natco argued that Bayer's claims were not inventive because use of micronization technique for improving bioavailability is obvious to a person skilled in the art. According to Patent Daily, the rejection was influenced by the U.S. Court of Appeals for the Federal Circuit and the U.S. District Court for the District of New Jersey decisions in the Bayer versus Barr (U.S. subsidiary of Israeli generics firm Teva) case (see Germany: 6August 2009: Bayer Schering Misses Out on Higher Royalties from Generic Yasmin as U.S. Court Upholds Patent Verdict), which both ruled in favour of Barr, invalidating the Yaz and Yasmin patents on the grounds of obviousness.

Theravance's Vibativ

The New Delhi IPO rejected the U.S. firm's Vibativ patent application on the grounds of lack of novelty and inventive step making the drug not patentable.

Outlook and Implications

The patent rejections and revocations highlight a patent system that looks to prevent "ever-greening", with a major focus on process rather than product for its patent approvals. Also highlighted is the fact that India's system allows both post- and pre-grant opposition from generic firms, and greatly favours generics with the aim of increasing patient access to and affordability of drugs. The decisions follow that relating to Abbott Laboratories (U.S.)'s HIV/AIDS treatment Kaletra (lopinavir-ritonavir), which was also rejected on the grounds of lack of innovation (see India - United States: 4 January 2011: Indian Patent Office Rejects Abbott's Kaletra Patent).

The rejections follow a trend where products that treat diseases with a high incidence in India and other emerging markets, such as HIV/AIDS, cancer, infectious, and cardiovascular diseases, which depend on India for cheap drug supplies, tend to be rejected. Generic drugs sold in India and developing nations tend to be up to 50% cheaper than the originator product. The above decisions will only promote Big Pharma's opposition and criticisms of the Indian patent system, alleging that it does not comply with the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) or the DOHA declaration. The decision on Bayer's Yaz and Yasmin could pave the way for more generic firms using obviousness and rulings from U.S. courts to oppose innovative pharma patents in India. It is highly unlikely that the above decisions will be appealed, as it takes years to progress through the Indian court system, with the deterrent being that most decisions are upheld, since most of the drugs would have lost their patents in developed markets. The rulings continue the trend of Indian courts taking a protectionist and public interest view in favour of generic firms: previously, the courts have rejected BMS's attempt to block Ranbaxy (India)'s Baraclude (entecavir) sales, as well as Bayer's Nexavar patent plea (see India - United States: 24 September 2010: New Delhi High Court Rejects BMS Bid to Block Ranbaxy's Baraclude Sales and Germany - India: 6 December 2010: India's Supreme Court Squashes Bayer's Nexavar Patent Plea). The patent rejections will pave the way for generic versions of the affected products, significantly eroding market shares for the products in question. India's patent system will continue to represent a very contentious are for innovative pharma looking to launch new products, and developed countries trying to negotiate free trade agreements with India, as both look to expand market reach and capitalise on India's growing population and rising middle class.