Delhi HC Allows Alembic, Natco Pharma To Export Sorafenib

New Delhi, 22 April 2019: The Delhi High Court on Monday allowed Alembic Pharmaceuticals and Natco Pharma to export sorafenib, an active ingredient in Bayer’s cancer drug Nexavar, and rivaroxaban, the active ingredient in its blood thinner medicine Xarelto for research and development (R&D) purpose.

A divison Bench of Justice S Ravindra Bhat and Justice Sanjeev Sachdeva, agreeing with majority of the findings of a single judge bench allowing the exports, said the question of whether those samples were being sent only for research and development or not will have to be heard afresh by the court.

Alembic refused to comments on the issue as they said they had not seen a copy of the judgment, while Bayer and Natco Pharma remained unavailable for comments.

On March 8, 2017, a single-judge Bench of the high court had allowed Alembic Pharmaceuticals and Natco Pharma to export the two drugs manufactured by Bayer for research purposes. The patent of the said drugs, Nexavar and Xarelto, which garnered about $4.2 billion in revenue in 2016 for Bayer, is scheduled to end by 2020, according to reports.

In their pleadings before the top court, Natco had said it wanted to sell sorafenib to a Chinese company while Alembic had targeted rivaroxaban for Brazil and the West Asia. The two companies had, however, told the court that they would not export patented invention other than for research, even in the future.

After the judgment, Bayer had moved a division bench of the high court, which had granted an interim stay on exports for some time. Source in Alembic, however, said that the stay was only for a short period of time and that they had been able to start exports for research purposes again.

In his 2017 judgment, Justice Rajiv Sahai Endlaw had said that since Natco and Alembic both were a grantee of Compulsory Licence of Bayer, they could not be deprived of their right to export the drugs for research purposes. The court had then, however, said that if Bayer could make out a case that the exports being done by Alembic and Natco was being done for purposes other than research, they could approach the high court again.Business Standard