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Patent Travails

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Multinational drug majors’ concern against India’s patent rules now has another example to highlight.
On September 14, the Intellectual Property Appellate Board (IPAB) in Chennai dismissed German drug maker Bayer's appeal to stay the Compulsory License (CL) issued to Hyderabad based Natco to manufacture kidney cancer drug sorafenib - branded as Nexavar.

In a landmark decision in March, the patent controller had issued India’s first Compulsory License allowing Natco to sell its generic drug at Rs 8,800 or less for a month's treatment and pay 6 per cent royalty to Bayer on the total sales. The patent office had observed the German firm was selling the drug at Rs 2.8 lakh a month. The CL was granted on grounds of affordability to the patients.
As per Section 85 of the Indian Patent Act, a CL can be issued if the patented invention is not available ‘at an affordable price to the public’. The CL was granted considering factors like the ‘drug was not reasonably priced’, ‘was not adequately available’, and was ‘not manufactured in the country’.

It is estimated that over 30,000 patients in India are suffering from advanced kidney and renal cancer.

"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 and further, it would in effect amount to deciding the main petition itself. Though this is not a reason why we are not granting stay, yet this is an additional factor,” the IPAB said in its 17- page order.

The IPAB is yet to take a decision on Bayer’s appeal against the CL granted by the patent office.

Sorafenib product patent was granted in India in 2007. This patent was opposed by Cipla at post grant level and launched its generic sorafenib. The patent infringement case filed by Bayer against Cipla is pending at the Delhi High court. Bayer had earlier tried to prevent generic launches of the drug by filing a separate litigation demanding patent-product approval linkage, which was rejected by Delhi high court and by the apex cout in appeal. Earlier, Bayer’s writ petition challenging controller decision on Natco’s CL is disposed of by Bombay high court and asked Bayer to file in Delhi high court.

Market sources say Cipla, which is fighting a case against Bayer for launching its generic version of Nexaver, also sells the drug at less than Rs 7,000 for a month’s treatment. Natco is also selling the drug at a discounted price to tap the Rs 22-25 crore market for kidney cancer. Bayer had also offered to sell the drug at about Rs 30,000 per month.

“Now the option left before Bayer is to approach the Supreme Court to revoke the decision of IPAB and get a stay”, said a patent attorney, who had represented domestic companies in some of the earlier patent cases. 

Recently, the Delhi High Court had ruled in favour of Cipla against Swiss drugmaker Roche, over its cancer drug Tarceva. In another high-profile legal battle, Novartis is challenging the Indian Government against the decision of the Indian patent office not to grant patent for its cancer drug Glivec. Novartis is also questioning Section 3(d) of the Indian Patent Act which says ‘frivolous" inventions as non patentable. The case is now before the Supreme Court.

With innovator companies beginning to taste domestic industry-friendly decisions by India’s patent office, it is likely that more patent litigations will take place in the future.