Delhi High Court: Roche asked to explain stand on Avastin copy

The Delhi High Court has questioned the swiss drug maker Roche for suing the Drug Controller General of India (DCGI), and Hyderabad-based Hetero Drugs, over the approval process for a bio similar of biotech cancer drug- bevacizumab.

Roche is the original inventor of the drug, which is a cancer drug, sold under the name of Avastin. The company has argued that Hetero’s drug is not a bio similar to bevacizumab and therefore, claims of this nature cannot be made by the company to promote their drug in India.

Justice Valmiki Mehta not quite convinced about the authenticity of the case, has asked Roche’s counsel to submit documents in justification of the company’s civil suit move. The issues that the hon'ble judge has outlined to be replied to are:

• Roche’s right to file a civil suit in the face of the fact that the drug maker does not have a patent for the drug in India;


• The company also has to prove that it has a personal interest at stake, and that Hetero’s new drug being granted government approval would have an impact on Roche.

Justice Mehta has also asked Hetero’s Counsel Abhishek Singhvi to submit arguments in his company’s defence on June 2, 2016, the date of the next hearing reports Economic Times.

"Bevacizumab is a descriptive term which describes that particular drug," Mehta said. "Since you're not an owner of a registered patent in India, (Hetero) can in fact (copy the drug)," he told Roche's counsel, Kapil Sibal.

Hetero Drugs wrongly obtained statutory permission for the drug and would mislead the public by calling its drug a bevacizumab biosimilar, affecting Roche's reputation in the process as the Swiss firm was the inventor of the drug, argued Sibal.

Sibal also argued that despite clinical trials of the drug having been skipped the government's Subject Expert Committee (SEC) recommended Hetero's drug as a bevacizumab biosimilar for use in metastatic colorectal cancer.

Roche’s Avastin has earned $7 billion through sale globally. The drug treats debilitating ailments like colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer. Hetero Drugs and Intas Pharmaceuticals are the two companies that have been granted an SEC recommendation for approval for a bevacizumab bio similar.

However a technical committee along with an apex committee have to be gone through with, by the companies, before the DCGI can grant their drugs a bio similar status.