Gennova moves application to dismiss Boehringer’s case on stroke medicine

NEW DELHI: Pune-based Gennova Biopharmaceuticals has filed an application alleging that German drug maker Boehringer Ingelheim had concealed important information when it approached the Delhi High Court late last month to stop the Indian company from launching its stroke medicine.

Gennova alleges that Boehringer did not disclose a public interest litigation (PIL) still pending with another bench at the court on the same objections when it filed its own writ petition on August 26. Not only this, the documents that the PIL was based on came from the office of Boehringer’s head of regulatory affairs in India, claimed Gennova's counsel, Rajiv Nayar.

Gennova’s stroke medicine—tenecteplase—was approved by an expert committee of the Central Drugs Standard Control Organisation (CDSCO) in July and launched on August 29. Tenecteplase is prescribed globally to treat only heart attacks.

The affidavit in support of the PIL and the original affidavit filed by Boehringer were identical, said Nayar. According to Gennova’s counsel, the PIL was filed at the behest of Boehringer and the German company approached the high court when it couldn’t yield an interim order.

“We had (earlier) shown that the two petitions are inspired from the same head,” said Nayar.

The PIL was initiated by Kolkata-based neurologist Deep Das and is to be heard next by a division bench of Chief Justice G Rohini and Justice Sangita Dhingra on September 20.

Boehringer’s counsel has strongly objected to the statements, arguing that there is no connection between the company and PIL petitioner Das.

Das’ petition focuses on the health risks of using tenecteplase for stroke treatment while Boehringer’s petition is on the process followed by the Indian drug regulator to grant Gennova approvals for the drug, stated Boehringer counsel Amarjit Singh Chandhiok.

“There’s a procedure established by law. That procedure needs to be followed. There has to be an innovative drug with which you have to compare it,” Chandhiok said.

Justice Sanjeev Sachdeva, who was hearing the case, has directed that Boehringer’s petition also be moved to the court hearing Das’ PIL. The case is expected to be heard next by Chief Justice G Rohini and Justice Sangita Dhingra on September 20.