SC rejects Bayer’s plea, boost for generic Drugs industry

Mumbai: In encouraging news for generic drug industry and public health, the Supreme Court on Wednesday dismissed multinational Bayer’s appeal against the Delhi High Court’s decision, on its plea for ‘patent linkage,’ which was turned down. Essentially, Bayer in its petition had sought the drug regulator to link marketing approval (of generic drugs) to their patent status, which was rejected in February this year. Thereafter, Bayer filed a special leave petition before the Supreme Court against the high court order.

Bayer’s petition in the Delhi High Court had sought the drug regulator to stop registering a generic version of a patented cancer drug, and hence block generic competition. This was also perhaps the only ever case filed in the high court, where a drug MNC had taken the government to court.
While dismissing the appeal on Wednesday, 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, which had rejected Bayer’s petition in February this year.
The Supreme Court is also
believed to have said that 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 company, 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.
Experts pointed out there is no procedure in the country under which its drug regulator can link marketing approval (registration) to a drug with its patent status. “The drug regulator cannot become the patent police in the country”, they added.
Advertisement