A Preemptive Strike? Roche Relinquishes Its Herceptin Patent In India
In the latest twist involving Roche and its Herceptin breast cancer treatment in India, the drugmaker has decided to relinquish its patent rights, which opens the market to generic versions, but also precludes the possibility that the Indian government would proceed with plans to issue a compulsory license to another manufacturer.
"Roche has come to the conclusion not to pursue (the patent, which was set to expire in 2019) and the related divisional applications,” the drugmaker tells PharmAsia News, which first reported the decision. “This decision takes into account the strength of the particular rights and the intellectual property environment in India, in general."
The move comes after months of heated controversy over the price of the medication and an aggressive campaign by patient advocates to convince the government to issue a compulsory license. Herceptin, however, is just one of several recent examples in which the pharmaceutical industry has tussled with the Indian government over intellectual property rights.
Last year, the government awarded a compulsory license to a generic drugmaker to produce a lower-cost version of a Bayer cancer, a step that was regarded as a landmark decision at the time. And earlier this year, the Indian Supreme Court rejected a patent sought by Novartis for its Gleevec cancer medication.
Roche has, in fact, lowered the cost per dose of Herceptin to roughly $1,400 a month, but advocates complain the price is out of reach for many Indians (see this). The lowered pricing was part of a novel strategy to have Emcure Pharmaceutical repackage the drug for the local market. The effort was seen as a way to both lower prices and preempt a potential compulsory license, but ultimately failed, after the Indian health ministry recently moved to revoke the patents in the public interest, a highly unusual step that has been taken only twice in the past.
“We are well aware that the decision to relinquish the patent on Trastuzumab is a tactical move by Roche to avoid compulsory licensing, which would have much more serious and far-reaching implications for its plans in the Indian market,” says Kalyani Menon-Sen, a feminist activist who also coordinates the Campaign for Affordable Trastuzumab (the chemical name for Herceptin) in India.
Her comment reflects anticipation that Roche is expected to lobby the Indian government to strengthen guidelines for approving biosimilars. Although its patent may no longer be in force, Roche does not yet face competition for Herceptin, since there are currently no approved versions in India.
In fact, Roche is already questioning the approval process for the Indian government to Dr Reddy's Laboratories to make a biosimilar version of the MabThera, which is another Roche drug and used to treat rheumatoid arthritis and lymphoma. The tactic underscores what is expected to be a closely watched test of the Indian government to approve complex biosimilars, in general.
“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 drugmaker tells PharmAsia News.
STORY ENDS HERE
"Roche has come to the conclusion not to pursue (the patent, which was set to expire in 2019) and the related divisional applications,” the drugmaker tells PharmAsia News, which first reported the decision. “This decision takes into account the strength of the particular rights and the intellectual property environment in India, in general."
The move comes after months of heated controversy over the price of the medication and an aggressive campaign by patient advocates to convince the government to issue a compulsory license. Herceptin, however, is just one of several recent examples in which the pharmaceutical industry has tussled with the Indian government over intellectual property rights.
Last year, the government awarded a compulsory license to a generic drugmaker to produce a lower-cost version of a Bayer cancer, a step that was regarded as a landmark decision at the time. And earlier this year, the Indian Supreme Court rejected a patent sought by Novartis for its Gleevec cancer medication.
Roche has, in fact, lowered the cost per dose of Herceptin to roughly $1,400 a month, but advocates complain the price is out of reach for many Indians (see this). The lowered pricing was part of a novel strategy to have Emcure Pharmaceutical repackage the drug for the local market. The effort was seen as a way to both lower prices and preempt a potential compulsory license, but ultimately failed, after the Indian health ministry recently moved to revoke the patents in the public interest, a highly unusual step that has been taken only twice in the past.
“We are well aware that the decision to relinquish the patent on Trastuzumab is a tactical move by Roche to avoid compulsory licensing, which would have much more serious and far-reaching implications for its plans in the Indian market,” says Kalyani Menon-Sen, a feminist activist who also coordinates the Campaign for Affordable Trastuzumab (the chemical name for Herceptin) in India.
Her comment reflects anticipation that Roche is expected to lobby the Indian government to strengthen guidelines for approving biosimilars. Although its patent may no longer be in force, Roche does not yet face competition for Herceptin, since there are currently no approved versions in India.
In fact, Roche is already questioning the approval process for the Indian government to Dr Reddy's Laboratories to make a biosimilar version of the MabThera, which is another Roche drug and used to treat rheumatoid arthritis and lymphoma. The tactic underscores what is expected to be a closely watched test of the Indian government to approve complex biosimilars, in general.
“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 drugmaker tells PharmAsia News.
STORY ENDS HERE
.png)
No hay comentarios:
Publicar un comentario