Expressing concern over the recent order by Indian Supreme Court on the patent of a cancer drug,the US has said the access to medicine and innovation are not mutually exclusive.
“On the Indian Supreme Court decision regarding pharmaceutical patents,I think it’s fair to say that the governments of India and the US share the goal of providing safe,affordable medicines. The US believes that access and innovation are not mutually exclusive,” a senior official from the US Trade Representative (USTR) said.
Speaking on condition of anonymity,the USTR official was briefing reporters after the release of a Congressional-mandated report on violations of intellectual property rights by countries across the globe.
“We can increase access to medicines and at the same time support innovation through development of new and improved drugs. We’re very interested in working within it to achieve right policy mix to maximise both innovation and access. And supporting innovation is,in our view,an important part of that policy mix,” the official said.
Putting India along with China and Russia and seven other countries in its “Priority Watch List” on the issue of violation of the intellectual priority watch,the USTR report urged India to reconsider how it can meet legitimate domestic policy objectives by fostering,rather than undermining that innovation climate.
The USTR,in its report,designated Ukraine a priority foreign country (PFC) under the ‘Special 301’ statute due to severe deterioration of enforcement in the areas of
government,use of pirated software and piracy over Internet,as well as denial of fair and equitable market access through authorisation and operation of copyright collecting societies.
USTR,in its report expressed,concerns about misappropriation of trade secrets in China,and incremental progress on a few of China’s many other significant IPR and market access challenges.
It also added Barbados,Bulgaria,Paraguay,and Trinidad and Tobago to the ‘Watch List’ due to specific problems identified in the report.
On India,the USTR said that the recent actions by the Indian Government have raised serious questions about the innovation climate in the country and risk hindering the country’s progress towards an innovation-focused economy.
Noting that in pharmaceutical sector,some innovators are facing serious challenges in securing and enforcing patents in India,the report urged New Delhi to adopt policies that support both cutting-edge innovation to address important health challenges and promote a robust generic market.
“The US is concerned that the recent decision by India’s Supreme Court with respect to prohibition on patents for certain chemical forms absent a showing of ‘enhanced efficacy’ may have the effect of limiting the patentability of potentially beneficial innovations,” the report said. Such innovations will include drugs with fewer side effects,decreased toxicity,or improved delivery systems,it added.
“Moreover,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,” USTR said. Stating that the US will also continue to monitor closely developments concerning compulsory licensing of patents in India,the report said New Delhi’s decision to restrict patent rights 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,” it said.