PharmAsia
August 14, 2013
Executive Summary
In a surprising move, Roche has decided to give up its patents for Herceptin in India, leaving the way open for generic drug makers eyeing the booming market. But do any local firms have the capabilities to develop and manufacture a biosimilar of trastuzumab?
In an interesting twist to the controversy over Herceptin patents in India, Swiss drug maker Roche told PharmAsia News it will “not pursue its Indian Patent 205534 and the related divisional applications” for its HER-2 positive breast cancer treatment Herceptin (trastuzumab).
Roche’s Herceptin India patent has been held to be valid until 2019, but the latest move by the world’s oncology drug leader means that trastuzumab can effectively be made by Indian generic companies six years sooner without a legal fight.
Importantly, the move could also head off a compulsory license for Herceptin, which has been rumored to be on the table by the Indian government.
Herceptin is Roche’s second-leading product, booking global sales of CHF 5.89 billion ($6.34 billion) in 2012.
The Patent Tangle
Last March, India granted its first compulsory license to Natco Pharma Ltd. on Bayer AG’s kidney cancer drug Nexavar (sorafenib), sending shock waves across the industry, with global pharmaceutical companies vehemently opposed to the decision saying it undermined intellectual property protection and research investments.
Recently, the Indian health ministry has also examined the possibility of revoking Herceptin patents by using Section 66 of the Indian Patent Act, a move that could help local companies make and market the drug.
Earlier, PharmAsia News was the first to report that the Kolkata Patent Office had deemed two of Roche’s divisional applications for Herceptin as abandoned following a submission made by Mylan Inc.
In response to an inquiry, Roche said it relies on patents to protect significant investments made in new pharmaceutical products and that regular reviews of its patent portfolio are a routine business practice.
"Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the "trastuzumab" patent) and the related divisional applications,” the company said. “This decision takes into account the strength of the particular rights and the IP environment in India in general."
The company said it would continue to enforce patents for other drugs in India, and that its decision would not impact the availability of Herceptin for Indian patients.
Roche Takes Another Track
In India, Roche has implemented a novel second-brand strategy for several drugs, including Herceptin and MabThera (rituximab), that allows local player Emcure Pharmaceuticals Ltd. to package and market lower-cost versions for the public market.
Roche said it is “currently reviewing the impact of this program.”
Although its patent may no longer be in force, the company noted 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,” Roche said.
Roche’s statement could suggest it will lobby to improve India’s biosimilars pathway, joining forces with some local stakeholders who have pressed for stricter requirements ("As New Biosimilars Roll Out, Indian Biotech Group Raises Quality Concerns" — PharmAsia News, May 15, 2013 5:57 PM GMT).
Notably, Roche has expressed reservations about the approval process for Dr. Reddy's Laboratories Ltd.’s Reditux, a biosimilar of MabThera approved in India in 2007 prior to the government’s release of biosimilars guidelines.
On devising better market-access strategies for Herceptin, Roche said it remains committed to working with the Indian government to address public health needs.
“Critically, 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 company said.
In response to an inquiry, Roche said it relies on patents to protect significant investments made in new pharmaceutical products and that regular reviews of its patent portfolio are a routine business practice.
"Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the "trastuzumab" patent) and the related divisional applications,” the company said. “This decision takes into account the strength of the particular rights and the IP environment in India in general."
The company said it would continue to enforce patents for other drugs in India, and that its decision would not impact the availability of Herceptin for Indian patients.
Roche Takes Another Track
In India, Roche has implemented a novel second-brand strategy for several drugs, including Herceptin and MabThera (rituximab), that allows local player Emcure Pharmaceuticals Ltd. to package and market lower-cost versions for the public market.
Roche said it is “currently reviewing the impact of this program.”
Although its patent may no longer be in force, the company noted 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,” Roche said.
Roche’s statement could suggest it will lobby to improve India’s biosimilars pathway, joining forces with some local stakeholders who have pressed for stricter requirements.
Notably, Roche has expressed reservations about the approval process for Dr. Reddy's Laboratories Ltd.’s Reditux, a biosimilar of MabThera approved in India in 2007 prior to the government’s release of biosimilars guidelines. On devising better market-access strategies for Herceptin, Roche said it remains committed to working with the Indian government to address public health needs.
“Critically, 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 company said.
SpicyIP, a well-known blog that covers developments on Indian patents, recently found that Roche had not paid its annuity fee to maintain the patent on Herceptin. The renewal fee was due May 5, but had lapsed, thereby inferring that the patent had ceased.
The blog post by patent expert Prashant Reddy however cited Section 53, Rule 80 of the Patents Act that allows patent holders to pay the fee over an extended period of six months. Data collated by the blog from submissions made by Roche lawyers showed that Roche earned roughly $24 million last year from the drug in India.
Industry experts suggest that even without the patent issue, India’s regulatory pathway will be tricky for trastuzumab biosimilars and could test the ability of the Indian government to approve complex biosimilars.
Among Indian companies, only Biocon has said it is in a fairly advanced stage to develop a biosimilar of trastuzumab with an expected approval by 2014. Biocon has teamed up with Mylan to develop biosimilars of several monoclonal antibodies and analog insulins.