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Bayer Petition Rejected

Bayer Petition Rejected - 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.

Bayer Petition Rejected


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