After hashing out Bayer and winning battel, NATCO Pharmaceutical is again comes in illumination by a move to block patent application of one of the very known Pharma giant "Gilead's Sovaldi (sofosbuvir)- hepatitis C drug." in India. Natco has filed a pre-grant opposition on the ground of lack of inventive step. It has been an earlier note that Indian Pharmaceutical Alliance (IPA) and Initiative for Medicine and Access to Knowledge (I-MAK) had also filed pre-grant opposition on similar grounds. Section 25 of the Indian Patents Act, any person can in writing oppose the grant of a patent by filing a representation to the Controller of Patents. The grant of a patent can be opposed under mainly on grounds that invention lacks novelty, inventive step, insufficient disclosure of the invention etc.
Natco Pharmaceuticals said it had filed the opposition about few days ago on the grounds that the patent would not be valid as the pro-drug and compound, sofosbuvir, was a known product and 'not inventive' enough.
Hepatitis C has been identified as a public health issue especially due to the lack of affordable treatment. Every year Hepatitis C kills nearly 5,00,000 people. If untreated, Hepatitis C can cause liver cirrhosis or liver cancer. Because of which treatment of hepatitis C has been a very sensitive issue since past several years. Sovaldi, already famous as its 'wonder drug', that claims cure rate of 90% for Hepatitis C and a short duration of therapy with comparatively high price of US $84,000 for a 12-week course, i.e. relevantly amounting to $1,000 a day. This smoking drug has been in constant talk in US because of its astronomical price.
It has always been a war between the high priced medicines and patent protection where ultimately the public who has to suffer. As the Natco is the talk of the town being a compulsory license holder of Bayer's Nexavar, again if Natco through its way in the pre-grant opposition, that will create shiny conflict between the country and the giant pharma industry looking forward for there coin to be placed in the country.
Over to the step taken by the Natco, generic companies have started keeping an eye on even the slightest movement made in this case to gain the seafull opportunity for generics.
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