New hepatitis C treatment, sofosbuvir in India: People Before Profit or Smart Strategic Decision?
New hepatitis C treatment is novel and creative, but not novel and creative enough
On 13 January 2015 India has rejected Gilead’s patent application for the new hepatitis C treatment, sofosbuvir. HCV advocates all over the world applauded to this brave decision, but little do we know about the reasons behind it.
India’s patent system: a reason for thriving pharmaceutical industry
India’s patent system is quite controversial, and particularly in what concerns pharmaceutical industry. Until 2005, only “process patents” existed according to India’s Patents Act. This basically meant that pharmaceutical companies could recreate another company’s product by simply making changes to production process. Process patent system was the reason why Indian pharmaceutical industry prospered and became one of the world’s largest.
India has made it to the list of the countries that “present the most significant concerns regarding insufficient [intellectual property rights] protection or enforcement”, according to United States Trade Representative.
The current India’s patent system was put in place in 2005 and allows the companies patenting the substance and not just the process of producing it. However, to avoid all the cheating when the companies make minor changes in order to refresh their patent, a provision was put in place (so-called section 3(d)):
“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant [are not inventions within the meaning of this act].”
Section 3(d) and the therapeutic efficacy requirement was cited in the patent office’s decision to reject Gilead’s patent application.
New hepatitis C treatment is novel and creative, but creativity is not the point
The decision agrees that the changes described in the application make sofosbuvir “novel and inventive.” However, “a molecule with minor changes in addition to the novelty must show significantly enhanced therapeutic efficacy as compared to the nearest prior art molecule which is structurally and functionally close,” decision says. This “closest prior art,” in case of sofosbuvir, is a compound D1 (patent WO2001/92282).
According to the Patent’s Office Decision, the application does not have sufficient data to prove this required therapeutic efficacy improvement. Attention though, it might only mean that Gilead needs to acquire more data before filing another patent application, and that the battle over the patent for the miraculously effective new hepatitis C treatment isn’t final yet.