Bombay HC upholds IPAB order on Nexavar’s generic copy
Bayer, which makes Nexavar, says it is disappointed with the ruling and will appeal against the decision
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Mumbai: The Bombay high court on Tuesday dismissed a challenge by Bayer AG against a decision to allow drug maker Natco Pharma Ltd to manufacture and sell a generic copy of a patent-protected cancer drug made by the German company.
“We don’t see a reason to interfere with the order passed by IPAB and, therefore, the case is dismissed,” said justice M.S. Sanklecha.
The court was hearing a plea filed by Bayer challenging a March 2013 order passed by the Intellectual Property Appellate Board (IPAB) permitting Hyderabad-based Natco Pharma to manufacture and sell a generic copy of the patented drug Nexavar.
Bayer has the option to move the Supreme Court against the order.
“We are disappointed by the decision of the High Court. We will continue to defend our intellectual property rights and appeal this decision,” Bayer said in a statement.
In March 2012, the controller general of patents gave the first-ever compulsory licence to Natco Pharma to sell a generic version of Nexavar. A compulsory licence allows a company to produce a generic version of a patented medicine and sell it at a cheaper price.
India’s then controller general of patents P.H. Kurian granted the compulsory licence to Natco on two key grounds, affordability and availability, specified by the country’s intellectual property law.
Natco Pharma’s generic anti-cancer drug is priced at Rs.8,800 for a month’s dosage—a fraction of the Rs.2.8 lakh Nexavar costs.
“Natco is pleased to inform that the Bombay High Court upheld the compulsory license (CL) granted to the Company on Nexavar (sorafenib tosylate) of German drug Major Bayer’s patented kidney cancer drug,” the company said in a stock exchange filing.
India’s existing patent law permits any interested party to seek a compulsory licence for a patented drug if the patent holder cannot meet the demand for the product in terms of affordability and availability within three years of the patent’s grant.
Bayer initially challenged the ruling at the IPAB, which refused to stay the compulsory licence granted to Natco Pharma. Subsequently, Bayer moved the high court seeking relief.
“This judgement, though, the detailed order is awaited, dismissing the petition, is historic as the court, for the first time, upholds the order of the controller general of patents and the IPAB in giving considerable weightage to the aspect of availability of a life saving drug at a reasonably affordable price, as provided under the Patent Act,” said Advait M. Sethna, senior counsel representing the Controller General of Patents Design and Trademarks.
Currently, there are three brands of the cancer drug available in the domestic market—Nexavar, Natco’s Sorafenat and Cipla Ltd’s Soranib. Cipla had launched its generic version of this drug challenging the patentability of the Bayer’s molecule in India.
“If the stay is granted, it will definitely jeopardize the interest of the public who need the drug at the later stage of the disease, since it is admitted that this drug improves the quality of life,” IPAB said in its March 2013 order.
“Therefore, the right of access to affordable medicine is as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them...”
Although Bayer had questioned Cipla’s launch by filing a patent infringement case in the Delhi high court, the court did not grant an injunction.
“The grant of compulsory license in this case and subsequent decisions at the IPAB and now the Bombay high court were in compliance with the law of the land. But it will ultimately discourage foreign companies to enter local market with research-based products,” said Anoop Narayanan, a senior intellectual property lawyer and founder of AN and Associates, a Mumbai-based law firm.
The government should instead promote insurance and other healthcare schemes to enable patients to afford newer medicines, he said.
Shares of Natco Pharma rose 5% following the high court decision to close at Rs.1,071.90 on the BSE on a day the benchmark Sensex closed at 25,201 points, up 0.8%.