Washington: Raising questions over innovation climate in India, the US has said the recent decision by India's Supreme Court to prohibit patent of Novartis' cancer drug Glivec could "preclude issuance of a patent" in the country.
In its '2013 Special 301 Report', the United States Trade Representative (USTR) also said action by India like allowing of compulsory licensing "establishes a troubling precedent" and "raised serious questions about the innovation climate in India"
The USTR report further said India remains on the Priority Watch List in 2013, as "it made limited progress in improving its weak IPR legal framework and enforcement system" in 2012.
"The United States is concerned that the recent decision by India's Supreme Court with respect to India's prohibition on patents for certain chemical forms absent for showing of "enhanced efficacy" may have the effect of limiting the patentability of potentially beneficial innovations," the report said.
The USTR was referring to the April 1 verdict by the Supreme Court that rejected Swiss drug maker Novartis AG's plea for patent protection for its cancer drug Glivec. The apex court had ruled that there was no new invention and no new substance used in the drug prescribed for treating blood, skin and other types of cancer.
"...The decision appears to confirm that India's law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application," the report added.
On the decision by the Indian Intellectual Property Appellate Board (IPAB) to allow Hyderabad-based Natco Pharma to manufacture and sell Bayer's patented cancer drug Nexavar under compulsory license, USTR said: "India's decision in this case to restrict patent rights of an innovator based, in part, on the innovator's decision to import its products, rather than manufacture them in India, establishes a troubling precedent.
"Unless overturned, the decision could potentially compel innovators outside India ? including those in sectors well beyond pharmaceuticals, such as green technology and information and communications technology ? to manufacture in India in order to avoid being forced to license an invention to third parties."
Indian patent office had allowed Natco Pharma to manufacture and sell generic Nexavar to cancer patients at a price of Rs 8,800 for a monthly dose of 120 tablets as compared to Rs 2,80,000 charged by Bayer.