[Ip-health] The Hindu Business Line: Roche not to pursue patent on breast cancer drug Herceptin

Thiru Balasubramaniam thiru at keionline.org
Fri Aug 16 06:49:46 PDT 2013

Roche not to pursue patent on breast cancer drug Herceptin

In a development that will bring some relief to breast cancer patients,
Swiss drug-maker Roche has said that it will not pursue the patent on
Trastuzumab, used to treat women with HER2-positive breast cancer.

Marketed as Herceptin, the drug has been in the spotlight as pro-health
campaigners urged the Government to issue a compulsory licence on the drug,
so that other companies would be able to make less-expensive versions.


A Roche spokesperson said, “Regular reviews of our patent portfolio are a
routine business practice. In this connection, Roche has come to the
conclusion not to pursue Indian Patent No. 205534 (the "Trastuzumab"
patent) and the related divisional applications. This decision takes into
account the strength of the particular rights and the IP (intellectual
property) environment in India.” The development comes against the backdrop
of Roche reportedly losing its patent on Herceptin since it had missed the
annual renewal date. In fact, Roche’s divisional patents on the drug too
were treated as withdrawn by the Kolkata patent office due to non-adherence
to procedure or incorrect filing.

The Herceptin imbroglio notwithstanding, Roche said it would “continue to
enforce other patents covering our drugs in India”. The Herceptin patent
expires in 2019 and media reports peg local sales from Herceptin at Rs 130

On a more ominous note, Roche pointed out, “While the patent for
Trastuzumab may no longer be in force, it is important to note that there
are currently no approved biosimilars of Trastuzumab in India.”

An estimated 25,000 new cases of HER2-positive breast cancer are added
every year, according to health campaigners.

Women with breast cancer are put through the HER2 test and if they are
positive, the drug is given to them, both as a first line or advanced form
of treatment depending on the spread of the cancer, explains Kumar
Prabhash, a medical oncologist with Mumbai’s Tata Memorial Hospital for

Herceptin costs about Rs 6 lakh for a course of 12 injections.

The company has a tie-up with Pune’s Emcure to sell the drug at a lesser

Roche further pointed out that Trastuzumab's patent status had no effect on
the availability of the product in India.

“We have already introduced a local pricing and branding structure, in
partnership with the local company, for a number of our drugs, including
Trastuzumab, and are reviewing the impact of this programme,” it added.

*jyothi.datta at thehindu.co.in*

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