The patent awarded to Gilead for hepatitis C drug Sofosbuvir, marketed by Gilead as Sovaldi in India, could leave 50 million patients outside of India without access to the medicine, Médecins Sans Frontières’ India old dna.The patent awarded to US pharmaceutical company Gilead by the Controller General of Patents, Designs and Trademark on May 9, contradicted the patent authority’s own prior order from January 2015, where Gilead’s application was rejected.<!– /11440465/Dna_Article_Middle_300x250_BTF –>The order dismissed five pre-grant oppositions from civil society and Indian pharma companies against the Gilead patent.Though India’s 12 million patients won’t face the brunt of this decision, it will damage India’s role as the provider of affordable generics to global South, and of raw materials or Active Pharmaceutical Ingredients (API). Leena Menghaney, South Asia head of Médecins Sans Frontières, told dna that because of voluntary licences signed by Indian generic companies with the originator company Gilead, the prices within the country will stay low.Treatment in India is priced at $350 for the course, as compared to the $84,000 in the US. Voluntary licences let the originator set the terms of the agreement in exchange for letting generic companies reproduce their drug, thus limiting the reach of the affordable drug.Countries such as Argentina, Egypt, Ukraine, Bangladesh, Iran, she said, will be affected as they depend on India for APIs.Argentina, Egypt and Ukraine had also rejected Gilead’s patent. Egypt ruled that the molecule is not novel but based on a prior existing structure, hence India’s sudden reversal of its own order has taken “groups across the world by surprise”.Two of the five oppositions filed with the authorities against Gilead’s patent were from Indian pharma companies BDR Pharma and the Optimus group that produce APIs and will no longer be able to supply them outside the country.Between last year’s order, the appeal by Gilead and the current order, Menghaney pointed out, there has been immense pressure by the US pharma lobby on India to grant patents and to “meddle” with India’s patent system.Menghaney and intellectual property lawyer Shamnad Basheer pointed out that the order was legally quite flawed. Basheer said that this judgement did not apply the standards laid down by the SC in 2013, when it decided against the patent sought by pharma company Novartis for its cancer drug Gleevec (compound name Imatinib).The apex court’s judgment clarified where the argument of ‘enhanced efficacy’ could be used, yet the decision taken by the Comptroller General is shaky on this very ground. “Enhanced efficacy over what?” asked Basheer saying that there was no clear comparative basis.He also said that the lack of legal training of officers in the patent office was worrying, as they played the role of judges in these cases.This lack of training, he said, showed in the Gilead judgement, as it was “not reasoned out well”.”This should not be allowed to set any precedent,” added Basheer, “it should be appealed immediately.”Lawyer Shwetasree Majumdar who represented the group Intellectual Property Initiative for Medicines, Access & Knowledge (I-MAK) in the case, said that no one would take this lying down, though she refrained from saying what the future steps would be, as the matter was still “sub-judice”.According to conventional practice, however, those in opposition have one more chance through a post grant opposition that can be filed even after a company has been awarded a patent.

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Gilead patent to hit millions of patients outside India