In a move that could set the tone for future pharma patent battles, India’s intellectual property rights watchdog may decide tomorrow the fate of the country’s first compulsory licence (CL) application.
The office of the Controller general of patents, designs and trademarks is expected to give its verdict on an application filed by Hyderabad-based Natco Pharma for issue of a CL to manufacture a low-cost version of German drug multinational Bayer’s patent protected anti-cancer medicine, Nexavar (its generic or chemical name is Sorafenib).
The final hearing on the matter had concluded on February 29.
The Indian Patents Act allows such CL applications after three years of the grant of patent, if reasonable requirements of the public with respect to the patented invention have not been satisfied; the patented invention is not available to the public at a reasonably affordable price or if the patented invention has not worked in the territory of India. In this case, India had granted patent protection to Nexavar in 2008, enabling Natco to initiate CL proceedings three years later.
Natco plea for CL is that Bayer’s patent-protected and imported medicine is highly priced -- and is available only in limited quantities through pharmacies attached to a few big hospitals in major cities. That makes it a fit case for CL-triggered generic competition. As compared to Nexavar’s monthly price tag of Rs 2.8 lakh for a patient, Natco offers the generic version of the same drug at Rs 9,000.
Bayer had opposed the CL application, and justified its high price as the cost of innovation. The company also argued that it has the right to determine what constitutes a “reasonably affordable price”.
According to Natco’s submission, at least 100,000 people suffer from different types of renal cell carcinoma and hepatic cell carcinoma (the types of cancer for which Sorafenib is prescribed) in India. Further, every year, 30,000 new patients are diagnosed with both these diseases and nearly 24,000 patients die every year in the country.
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Bayer, however, argued that the total number of patients requiring Sorafenib treatment in India was as low as 8,000.
On the question of local working requirement in the territory of India, Bayer submitted that local working requirements in the Patents Act were directed towards ensuring that inventions were domestically worked -- that is, supplied to the Indian market. “An attempt to impose local working requirements — in the sense of local manufacturing — on patents granted in India would be beyond the scope of the Patents Act and against the intent of the legislature,” the MNC added.
Bayer has also slapped patent infringement suits against Natco and Cipla for producing low-cost versions of Nexavar.
India had introduced CL provisions in the Patent Act amendments made in 2005.
The government had never exercised the CL provisions, though it had discussed the possibilities of allowing local manufacturing of bird flu drug through CLs in the wake of bird flu epidemic threat nearly six years ago.