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//The Indian Supreme Court yesterday dismissed an appeal by German drug maker Bayer AG to link new product approvals to patents which would undermine the registration of affordable generic medicines under India’s patent regime. Last year health groups demanded in a joint appeal that Bayer cancel the suit, see: Defend affordable drug treatment in India!//

India: Supreme Court rejects Bayer's appeal for patent linkage

December 02, Pharmabiz.com - The Supreme Court has rejected the Special Leave Petition (SLP) filed by multinational drug company Bayer Corporation against the Delhi High Court's February 9, 2010 decision in which the High Court had rejected Bayer's petition seeking patent linkage in India.

A Division Bench of the Supreme Court comprising Justice A. Alam and Justice RM Lodha rejected the appeal filed by Bayer Corporation against the Delhi High Court's February 2010 decision.

The patent linkage case of the Bayer Corporation dates back to 2008 when Bayer Corporation filed a Writ Petition before the Delhi High Court against Union of India, the DCGI and Cipla Ltd seeking an order that the DCGI should consider the patent status of its drug, Sorefenib tosylate, before granting a marketing approval to any generic versions of the drug and refuse marketing approval to any generic version. Sorefenib tosylate is used to treat renal cancer and is sold by Bayer at Rs. 2, 85,000 for 120 tablets for a month dosage.

The appeal in the Delhi High Court was filed against a judgement delivered by Justice Ravindra Bhat on 18 August 2009, rejecting Bayer's attempt to introduce the patent linkage system in India through a court direction. But, in a landmark judgment on February 9 this year, a division bench of the Delhi High Court comprising chief justice AP Shah and justice Muralidhar had dismissed the appeal by Bayer Corporation, seeking the introduction of patent linkage system in India. Then, the multinational drug major moved Supreme Court against the Delhi High Court order.

Patent linkage is a system in which the Drug Controller refuses to grant or delays a marketing approval to a generic drug manufacturer to manufacture and sell a drug, if the drug is already patented. Patent linkage is known to be against public health interests as it will delay the entry of cheap, generic medicines into the market and keep medicines out of reach of those who need them.

Experts are of the view that if introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market. Such early entry of generic drugs is possible either through mechanisms such as compulsory licensing within the Patents Act itself, or where there is a bona fide belief that a patent has been wrongly granted. This is especially important as India is now witnessing an increase in the number of patents being granted to drugs by the Indian patent office.

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Times of India, Dec 2, 2010

Boost for generic biz : SC rejects Bayer’s petition

MUMBAI: In encouraging news for generic drug industry and public health, the Supreme Court on Wednesday dismissed German MNC Bayer Corporation's appeal against the Delhi high court's decision on its plea for "patent linkage" .

In February, the Delhi high court had dismissed an appeal by Bayer, which sought to link regulatory approval of generic medicines with their patent status . Bayer filed a special leave petition before the Supreme Court against the high court order . Patent linkage is a system in which a drug controller refuses to grant or delays a marketing approval to a generic company to manufacture and sell a drug, if the drug is already patented. Bayer had sought the drug regulator to stop registering a generic version of a patented cancer drug, and hence block generic competition.

This was perhaps the only case filed in the high court, where a drug MNC had taken the government to court. While dismissing the appeal, the Supreme Court bench, consisting of Justice Alam and Justice Lodha, said that it did not want to differ from the Delhi high court order. Sources said the Patents Act gives right to drug companies to seek recourse in the courts, in case there is an infringement of their patent.

In this case, it was pointed out that Bayer is fighting another case against generic company Cipla, for infringement of patent in the Delhi high court. If Bayer's plea for "patent linkage" had been accepted by the court, it would have undermined public health safeguards contained in India's patent legislation, experts pointed out. Bayer had filed a writ petition before the Delhi high court against the Indian government, the Drug Controller General of India (DGCI) and Cipla seeking an order that the DCGI should consider the patent status of its drug, "Sorafenib Tosylate" , before granting marketing approval to any generic pharma firm, and refuse marketing approval to it. "Sorafenib Tosylate" is used to treat kidney cancer, and is sold by Bayer at around Rs 2.85 lakh for 120 tablets—a month's dosage, while Cipla's generic version is priced substantially cheaper. Rupali Mukherjee