New Delhi, Aug. 16: Roche, the Swiss pharmaceutical giant, has decided to give up its patent in India on its breast cancer drug after an intense campaign by patients’ groups urging the Centre to take steps to make the medicine affordable.
Roche’s decision not to pursue its Indian patent on trastuzumab could open the doors to inexpensive generic versions of the product, which patients’ groups say has been used in India by less than 10 per cent of the women who have needed it.
“Roche has come to the conclusion not to pursue Indian patent (on trastuzumab),” a company spokesperson said in an email to The Telegraph.
“This decision takes into account the strength of the particular rights and the IP (intellectual property) environment in India in general.”
The company added: “While Roche may not have patent protection for trastuzumab in India, it is important to note that there are currently no approved bio-similars of trastuzumab in India.”
But patients’ interest groups have called on the Indian government to take necessary measures to speed up the development of bio-similars, or generic versions of the drug, through a fast-track approval process.
“We welcome the (Roche’s) decision — it removes the patent barrier that was blocking generic competition,” said Kalyani Menon-Sen, coordinator for the Campaign for Affordable Trastuzumab, a consortium of patients, women’s groups and health rights groups.
But Roche’s decision “should not be mistaken for altruism”, the Campaign said in a statement today.
“It is a face-saving gesture in response to the eroding legitimacy of both the patent and (the company’s) pricing policy in India. It is also a tactical move to avoid compulsory licensing, which would have more far-reaching implications for its plans in the Indian market.”
Indian patent laws allow the government to order compulsory licensing of a patented product that is viewed as necessary for public health. A compulsory license allows generic makers to produce a patent drug for a royalty fee to be paid to the patent holder.
Trastuzumab is used in treating an aggressive form of breast cancer typed as HER2+ which affects about one in five patients diagnosed with the disease.
The Campaign for Affordable Trastuzumab, relying on information from India’s National Cancer Registry, estimates that about 25,000 women across the country are diagnosed with HER2+ breast cancer each year, but less than 2,000 patients can afford the patented product.
When trastuzumab was introduced in India a few years ago, it was priced at about Rs 1.1 lakh per vial and typical therapy would involve 12 doses, Menon-Sen said.
She added that Roche cut the price to about Rs 92,000 in March 2012, soon after the Centre had granted a compulsory licence to an anti-kidney cancer drug called sorafenib, patented by a German drug-maker.
The Campaign for Affordable Trastuzumab had written to the Prime Minister in November 2012, urging the Centre to help make trastuzumab available free at public clinics and at an affordable price in the market.
Clinical studies have demonstrated that trastuzumab has a strong positive impact on HER2+ metastatic breast cancer and improves the chances of disease-free survival. In 2006, the US Food and Drug Administration approved trastuzumab for the treatment of all HER2+ breast cancers.
Roche said in its statement that it would support the Indian government’s efforts “to establish a pathway and guidelines for the introduction of bio-similars based on science and designed to ensure product quality and patient safety.”
The company said Roche had already introduced a local pricing and branding structure in India in partnership with a local company.
The Campaign for Affordable Trastuzumab said Roche had signed an agreement with a local company, Emcure, which offers a repacked and renamed version of trastuzumab to patients at Rs 72,000 per dose.