SC rejects Bayer plea against generic Cipla drug

In a boost for generic drug makers, the Supreme Court yesterday dismissed German pharmaceutical firm Bayer AG's attempt to block the Indian drug regulator from allowing Mumbai-based Cipla Ltd to launch a low-cost version of its patented cancer medicine.

Had Bayer won the case, it would have supported 'patent linkage', a provision that links marketing approval for introduction of a low-cost drug to the patent status of its original product.

Global drug makers have been demanding such a provision to strengthen protection for their patented medicines, but this has been opposed by local generic drug makers and health activists who fear such a move would lead to delay in launch of low-cost medicines and increase healthcare costs for the public.
In February this year, the Delhi High Court had quashed an appeal by Bayer to stop the drug controller general of India (DCGI) from giving marketing approval for its patented medicine Nexavar to Cipla (See: Delhi High Court allows Cipla to sell generic cancer drug). On Wednesday, the Supreme Court rejected the special leave petition filed by Bayer.

''The court said this matter should be decided in its patent infringement suit which is pending with the Delhi High Curt,'' said Prathibha Siva, who represented Cancer Patients Association of India, a party to the Bayer-Cipla case.

Cipla's lawyer said patent linkage goes beyond the provisions of international agreement for trade-related aspects of intellectual property rights or TRIPS, to which India is a signatory, and so the country need not implement such a linkage. The Bayer India spokesman did not reply to text messages and an email query.

Earlier, the Delhi High Court had noted the Indian patent system was distinct from the drug regulatory system with no linkage between them and so Bayer could not prevent DCGI from granting marketing approval to generic versions of patented drugs.

But the innovator company can sue the drug maker to enforce its patent under the Indian Patent Act. Bayer's patent infringement case against Cipla is pending before the Delhi HC. The Supreme Court in its ruling has also asked the Delhi High Court to decide Bayer's patent infringement suit within six months.

This comes as another setback for global drug makers whose proposals for key changes in the country's patent and drug laws, including implementation of patent linkage, was categorically rejected by three ministries last month.