The Supreme Court today dismissed an appeal from German pharmaceutical major Bayer for stopping the Drugs Controller General of India (DCGI) from giving marketing approval to low-cost versions of medicines that are under patent protection in the country.
The appeal was against an earlier judgment of the high court here, which did not find merit in Bayer’s argument in favour of a system that links the patent status and marketing approval process of a drug in India.
While patent protection comes under the domain of the patent office and is governed by intellectual property laws, drug approval is the responsibility of the DCGI, which enforces the Drugs and Cosmetics Act.
Dismissing Bayer’s petition, the HC had in February held that the patent system was distinct from the drug regulatory system and Indian law did not prevent DCGI from granting marketing approval to generic versions of patented drugs.
Welcoming the verdict, civil society groups said a decision to allow patent linkage would have undermined the registration of affordable generic medicines and public health safeguards contained in India’s patent legislation.
Bayer had wanted the DCGI to be restrained from granting marketing approval to generic versions of sorafenib tosylate, a cancer drug, as it holds patent rights for the drug in India. The court refusal had seen generic drug manufacturer Cipla getting marketing approval for the product.
An SC bench of judges A Alam and R M Lodha refused to entertain the petition filed by Bayer. They took into account the fact that the DCGI had already granted marketing approval to Cipla and that Bayer’s suit for infringement, filed simultaneously with the stop-marketing lea, was pending before the HC.
During the proceedings, the judges observed that it could not be said that the DCGI did not have the authority to grant marketing approval to generic versions of patented drugs.
They also observed that the ultimate relief sought by Bayer was to prevent Cipla from marketing its generic version of Bayer’s patented drug. They noted this issue of injunction ought to be decided in the suit for infringement under the Patents Act. Dismissing the petition, the SC hoped the Delhi HC would decide Bayer’s infringement suit in six months.
Patent linkage is a major demands of foreign drug multinational firms, along with exclusivity for clinical trial data, which they feel are needed to protect their business interests as they expand their presence in the country.
