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Mumbai: Roche Holding AG has lost patent protection in India for its breast cancer drug Herceptin because the Swiss drug maker missed a May deadline to renew it. Although Roche’s patent for Herceptin was valid till 2019, such patents have to be renewed every year within a stipulated time.

The Indian patent office has removed it from its register, an official of the Controller General of Patents, Designs and Trademarks at New Delhi said on Tuesday. He spoke on condition of anonymity.

If Roche does not restore the patent in six months through a separate process, copycat manufacturers can legally produce the medicine in the country.

An email query sent to Roche global spokesperson Silvia Dobry remained unanswered. Phone calls to her office were not returned.

A drug treatment for women with HER2-positive breast cancer, Herceptin works on the cancer molecule, targeting the HER2 receptors on the tumour, leaving healthy cells untouched. The patent for the medicine is owned by Genentech Inc, a group company of Roche. The drug contributed about 130 crore in sales to Roche India in fiscal year 2012, about 10% of its total sales. The company’s accounting year starts in January.

Roche in July chose not to follow up on three of its divisional patent applications for Herceptin with the Kolkata patent office.

Indian patent law allows a patent holder to seek an extension for the renewal but the holder has to apply in advance before the due date. The Swiss group can make a special request within six months to the patent office for restoration of the patent.

The procedure is cumbersome as it is a new grant and the law requires the patent office to publicly notify the company’s request and ensure there is no objection from any interested party.

“Assuming that the Rule 80 route (the law allowing extension of renewal date) fails, the patentee still has the option to file an application under Section 60 for restoration of a lapsed patent," said Prashant Reddy, a patent lawyer who first reported the lapse of Herceptin patent in a blog called SpicyIP, on Tuesday.

“But such restorations are long-drawn affairs since the patent office has to advertise the restoration application and any interested party can oppose the restoration of the application," Reddy said. “More importantly, the patentee has to be able to give the patent office a good enough reason to allow the restoration application."

The grant of patent in 2000 has already been opposed by a couple of generic companies.

Roche last year licensed Pune-based drug maker Emcure Pharmaceuticals Ltd to locally pack Hercepetin, which was till then imported from the Genentech’s biotech plant in the US.

The local arrangement, which has helped Roche to offer the drug at a 30-40% discount to consumers, also allows Emcure to sell the product in the local market.

“This local arrangement has not only helped the company to reduce prices significantly but also increase the patient access through supply by Emcure," a Roche India executive said, requesting anonymity.

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