Roche lost Herceptin patent due to procedural problems

New Delhi: Swiss pharma company Roche Holding AG has lost an Indian patent for breast cancer drug Herceptin due to procedural problems with the patent application.

The decision on Sunday does not affect the main patent granted to the compound trastuzumab, which is currently being considered by department of industrial policy and promotion (DIPP) for compulsory licensing that allows local companies to make and sell copies of patented drugs in special circumstances.

add_main_imageThe company said it’s considering its next course of action.

Roche had filed for a patent on Herceptin on 11 October 2000, and this had been granted on 6 April 2007, but faced a post-grant challenge. NextMAds

“It was totally the fault of the patent holder in not appearing and submitting documents to oppose post-grant challenge even though opportunity was given to it. Hence on purely technical grounds the patent on transtuzumab (Herceptin) has been cancelled,” said C.M. Gulati, expert on rational use of drugs and editor of the Monthly Index of Medical Specialities.

“Under Indian law, even when a patent is granted, it can be challenged. It is the duty of patent holder to make submissions to defend the patent. If the patent holder does not do so, the patent is liable to be revoked,” he said.

The health ministry rejected reports that the Indian government had revoked the patent and said it had lapsed due to procedural delays on the part of the Swiss company.

“Before the controllers issued their decisions, the applicants were given due opportunity of being heard but the applicants have chosen not to attend,” it said in a press release. “It is submitted that in the instant cases, the Patent Office has followed the due course of principle of natural justice, gave the applicant the opportunity of being heard and then only finally disposed of the matter.”

The Swiss drug maker confirmed this in a statement on Monday.

“I can confirm that the assistant controller of patents at the Kolkata Patent Office has revoked divisional patents of Herceptin and that we are now considering the further course of action,” Roche said.sixthMAds

Leena Mehanganey, legal adviser to the Campaign for Access to Affordable Trastuzumab, welcomed the decision.

“We were concerned to see that Roche has filed a series of divisional patent applications—that is patent applications that contain matter from a previously filed application—with the Kolkata Patent Office,” she said.

The decision comes days after India revoked a patent granted to GlaxoSmithKline Plc for breast cancer drug Tykerb.

The decision is the latest in a series of rulings on intellectual property and pricing in India that have frustrated attempts by Western drugmakers to sell their medicines in India’s fast-growing drugs market.

On Friday, India revoked a patent granted to GlaxoSmithKline’s for breast cancer drug Tykerb, following on from a landmark court ruling in April disallowing patents for incremental innovations.

Roche has already adapted its business model in India to increase affordable access to drugs and try to stave off trouble from India’s patent authorities.

In August 2012, it introduced cut-price versions of Herceptin and another cancer drug MabThera, under an alliance with Indian generics firm Emcure Pharmaceutics.

Last year, India revoked patents granted to Roche’s hepatitis C drug Pegasys, Pfizer Inc’s cancer drug Sutent, and Merck & Co’s asthma treatment aerosol suspension formulation. All were revoked on grounds that included lack of innovation.

PTI and Reuters contributed to this story.