Roche has decided not to pursue a patent extension until 2019 in India for its blockbuster cancer drug, Herceptin, clearing the way for generic drug makers to manufacture the drug.
The patent for breast cancer drug Herceptin, also known as Trastuzumab, lapsed in May; however, the company had until November to claim its patent.
"Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent for Trastuzumab) and the related divisional applications. This decision takes into account the strength of the particular rights and the Intellectual Property environment in India in general," a spokesperson from Roche was quoted as saying by Indian publication The Economic Times.
The company added that it will continue to enforce other patents in the country and remains committed to working with the Indian government.
"We believe ensuring access to innovative medicines such as Herceptin is a complex issue and that significant progress will only be made through ongoing close collaboration between the government, industry and care providers without compromising intellectual property rights or biosimilar approval requirements," the spokesperson added.
According to industry analysts, Heceptin, which is Roche’s second best selling drug, contributes close to Rs 127 crore to Roche’s annual turnover. It is thought that even though the patent has expired, Swiss Roche will remain the only drug company still manufacturing the drug due to the complex science involved in making it.
Previously the health ministry had considered revoking Herceptin’s patent, which can be done under Section 92 of the Indian Patent Act, which allows the government to revoke a patent during an emergency situation. However, as the government didn’t know if there were any other Indian pharmaceutical firms ready to make the drug it refrained.
The company told The Economic Times: "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. 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."
In recent months multinational drug companies have come under increasing pressure to reduce the price of key cancer drugs in order to make them available to more people.
Biocon-Mylan, Reliance Life Sciences and BDR Pharma are among the companies said to be working on a copy of Herceptin.
Caption: The patent for breast cancer drug Herceptin, also know as Trastuzumab, lapsed in May. Photo courtesy of RedAndr.