Bristol-Myers Squibb, Natco Pharma settle patent dispute

The dispute was over the patent of Hepatitis B drug entecavir

The patent disupte between US-based pharma major Bristol-Myers Squibb (BMS) and Indian pharma company Natco Pharma Ltd over entecavir, a pharmaceutical combination for treating Hepatitis B has been settled amicably, both the companies informed Intellectual Property Appellate Board (IPAB).

The counsels appearing for the two companies informed the Board about the settlement during the hearing on the rectification application filed by Natco held today in Chennai. S Majumdar of S Majumdar and Company, the counsel for Natco and M S Bharat, of Anand and Anand, the counsel for BMS, submitted that as on date the matter has amicably been settled between the parties on certain terms and conditions.

While the terms of settlement were incorporated in the miscellaneous petition, which sought the IPAB to withdraw the rectification application, the parties requested the court that the registry should not allow any third party to see the terms of settlement.

"As per the request made by both the parties through their respective counsels, the registry shall not furnish any certified copy of the terms of compromise and the copy of the miscellaneous petition, to any third parties as well as no one should be allowed to inspect the same from the registry," said the Coram comprising IPAB Chairman Justice K N Basha and Technical Member (Patent) D P S Parmar.

"The registry is directed to make an endorsement on the top of the records as confidential and not permitted for any inspection or for furnishing certified copies to any parties in respect of the above mentioned topics," said Justice K N Basha. The rectification application filed by Natco was dismissed withdrawn as not pressed. The MP filed for withdrawal of the rectification application is allowed and all the MPs dismissed, he said.

According to information available the rectification application was filed to revoke a patent of entecavir, owned by BMS. The patent, filed on July 2, 2002 was published on January 25, 2008.

According to earlier reports, a US Court has invalidated a patent of the drug, marketed as Baraclude, as obvious and an appeal by BMS was denied by the US Court of Appeals for the Federal Circuit, last year. The US patent 5,206,244 was challenged by Isreal-based generics major Teva Pharmaceutical Industries. In 2014, the US pharma major said that it is reviewing the decision of the Court of Appeals and considering legal options.

In 2010, Zydus Cadila and Natco Pharma launched their generic versions of Baraclude. Zydus Cadila launched its product under the brand Entehep and Natco Pharma started marketing it as X-vir. Ranbaxy has also launched a generic product of the drug earlier in the market, say reports.

The patent which was disputed by Natco Pharma and settled in IPAB is for a pharmaceutical composition effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient comprising up to one per cent of entecavir, among other ingredients.