Roche won't pursue Herceptin patents in India

Roche ($RHHBY) is throwing in the towel on its IP protection for Herceptin in India. As PharmAsia News reports, the company will give up its patents for Herceptin there, a move that opens it up to biosimilar competition and potentially heads off compulsory licensing in the process. And as Roche points out, giving up these patents doesn't necessarily mean biosimilar versions will spring to market anytime soon.

"While the patent for trastuzumab in India may no longer be in force, it is important to note that there are currently no approved biosimilars of trastuzumab in India," Roche spokesman Daniel Grotzky told FiercePharma in an emailed statement.

The drug for HER2-positive breast cancer is the second-leading product for the Swiss drug giant, with $6.34 billion in 2012 revenue. Herceptin's IP protection was struck down earlier this month by the Kolkata Patent Office, which said the patents hadn't been properly submitted. Now, PharmAsia News says, Herceptin can effectively be made by Indian generic pharma companies 6 years ahead of its scheduled 2019 patent expiration.

But there may not be any coming in the near term. Cipla, an Indian leader in generic cancer drugs, formed a biosimilars partnership in 2010 with its eye on a Herceptin knockoff. But as of February, the World Health Organization (WHO) expressed the belief that Cipla and its Indian counterparts weren't ready to make biosimilar copies. "We support the Indian Government's leadership in establishing a pathway and guidelines for the introduction of biosimilars onto the market that is based on science and is designed to ensure product quality and patient safety," Grotzky said.

Roche's decision may also eliminate the possibility of India granting a compulsory license on the drug now that Herceptin is already open to competition. India last March granted the first compulsory license to local company Natco Pharma on Bayer's kidney drug Nexavar, and one for Herceptin was rumored to have been on the table, PharmAsia News notes.

Roche, like many of its peers, had already seen one of its patents yanked before Herceptin was called into question. Last year, the Swiss drug giant lost a patent fight over its hepatitis C drug, Pegasys. But the Herceptin move was a bit surprising; Roche had teamed up with domestic drugmaker Emcure Pharmaceuticals to produce the drug in India, and a year ago the pair said it would roll out less costly versions of Herceptin as well as MabThera, also known as Rituxan. Recently, Roche said it would be cutting Herceptin prices in India by 31% to $1,366 per month.

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