HC stops Natco Pharma from exporting generic of Bayers cancer drug

New Delhi: The Delhi High Court put on hold an order of its single judge allowing Indian generic drug makers to make, sell and export patented medicines for purposes of regulatory approval and clinical trials.

A bench of Acting Chief Justice Gita Mittal and Justice Anu Malhotra, however, said the stay would be presently applicable on state-run pharma company Natco only, which was allowed by the single judge to export two patented medicines of German drug major Bayer.

The bench said there was "a world of difference" between exporting for licence approvals, as claimed by Natco, and exporting for commercial purposes.

It directed that till September 21, the Indian company would not export generic version, Sorefenat, of the German companys patented product, Sorafenib marketed under the name of Nexavar.

The court said that export for commercial purposes was prohibited under the conditions of the compulsory licence given to Natco for selling the drug, meant for treating kidney and liver cancers, in India.

It said for exporting the drug for experimental purposes or for licence approvals, the Indian company will have to file a separate application and the court will restrict the exports to a limited quantity.

It also issued notice to Natco, the Centre and the Drug Controller General of India (DCGI) seeking their replies to Bayers plea challenging the single judges March 8 ruling.

The court also asked Natco what was the volume of its exports and said under the guise or shield of the March 8 order, the company cannot negotiate with third parties to sell the drug abroad.

"What you cannot do directly, you cannot do indirectly," the bench said.

In the March 8 ruling, the single judge had said that Indian generic drug makers have the fundamental right to make, sell and export patented medicines for purposes of regulatory approval and clinical trials.

The judge had said the sale by a non-patentee of a pharmaceutical product solely for the purposes prescribed in section 107A would "not be infringement and cannot be prevented".

Section 107A of the Patents Act explains what will not constitute infringement of a patent and includes selling of a patented invention for the purposes of development.

Bayer, however, in its appeal against the March 8 ruling has contended that Natco was exporting the finished product, instead of the active pharmaceutical ingredient (API), the salt.

The German companys patent for the drug in India expires in 2020.

Natco, opposed the foreign companys claim, saying it was only selling the drug in India.

It said it was exporting the finished product and API to countries like China where they want to conduct experiments on their own as well.

It also said that it has been exporting to such countries as licence approvals are granted only two to five years after applying for it.

The company said it will export for sale only after the patent of Bayer expires in 2020.

The high court had in March 2014 restrained the sale of Sorefenat overseas.

It had allowed Natco to export a small quantity, of less than 15 grams, for the purposes of clinical trials.

Later, in November 2014, the court had ruled that Natco could export one kilogram of the API Sorafenib for the purpose of clinical trials.