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Nexavar: HC Rules In Favour Of Natco Pharma

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The Bombay High Court on Tuesday (15 July) refused to interfere with the order passed by an appellate board allowing drug maker Natco Pharma to manufacture and sell a generic copy of a patent-protected cancer drug made by German drug maker Bayer AG. The court was hearing a plea filed by Bayer challenging a March 2013 order passed by the Intellectual Property Applellate Board (IPAB) permitting Hyderabad-based Natco Pharma to manufacture and sell a generic copy of the patented drug Nexavar. “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.

In March 2012, the Controller General of Patents Design and Trademarks gave the first-ever compulsory licence to Hyderabad-based Natco Pharma to sell a generic version of Nexavar.

A compulsory licence allows the production of a generic version of a patented medicine and sell it at a cheaper price. Natco Pharma was asked to pay a royalty of 6 per cent on net sales of the drug to Bayer. India’s then controller general of patents P.H. Kurian granted the compulsory licence to Natco on two key grounds—affordability and availability of Bayer’s patented drug—that is required by the country’s intellectual property law.

While patient groups call the move the result  of their persistent demand for low-cost generic alternatives to patent-protected drugs, the Organisation of Pharmaceutical Producers of India (OPPI) fears it may affect the introduction of new medicines in the country.

OPPI director general Tapan Ray had said last year that such a move may “signal immense unpredictability in the environment of bringing new life-saving drugs to India”. He adds, “Grant of compulsory licence for Nexavar to Natco by the Indian Patent Office last year had already raised serious concerns across the world on the robustness of the IPR (intellectual property rights) ecosystem in India. Recent news reports on the same issue will vindicate the concerns.”

An appeal against the decision of the Controller General of Patents, Designs and Trademarks to grant a compulsory licence for Nexavar was filed with the Intellectual Property Appellate Board (IPAB) on May 4, 2012 by Bayer Pharma.

The order of the Indian patents office "damages the international patent system and endangers pharmaceutical research," the statement said.

"We will vigorously continue to defend our intellectual property rights, which are a prerequisite for bringing innovative medicines to patients."

The challenges faced by India's healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India's essential drugs list are not patented, Bayer had said at that time.

India is currently on the US government's Priority Watch List - countries whose practices on protecting intellectual property Washington believes should be monitored closely.
The US industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) believes Washington should take a tougher line by downgrading it to a Priority Foreign Country, a classification for the worst offenders, which may trigger possible actions, sources said.
"The multinational companies are exploring all options - from paring their investments in the country to forcing the US to take some actions," said a source in New Delhi, who is directly involved in the situation.

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