The company said in a statement emailed to Managing IP that it has decided not to pursue Indian patent 205534 (the secondary patent covering trastuzumab, marketed as Herceptin) and its related divisional applications.
“This decision takes into account the strength of the particular rights and the IP environment in India in general,” said a spokesman for the company.
Roche’s move comes just months after the IP Appellate Board of the country’s IP office upheld a compulsory licence issued to domestic generics company Natco over a Bayer drug, Nexavar. The Committee on Price Negotiation for Patented Drugs later issued a report recommending India issue more such licences.
Last month, however, the Times of India reported that the Department of Industrial Policy and Promotion had refused to issue a compulsory licence for trastuzumab.
Roche’s spokesman added: “While Roche may not have patent protection for Trastuzumab in India, it is important to note that there are currently no approved biosimilars of Trastuzumab in India. 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.”
