As the shockwaves continue to roll through various US industries (primarily pharma, but computer technology and telecom, as well), Reuters is reporting that the United States Trade office indicated that while dialog will continue, it may ultimately lodge a formal complaint with the World Trade Organization, over Monday’s India Supreme Court “no patent” decision, on the incremental chemical process change, related to Novartis’ Gleevec® leukemia drug.
. . . . Section 3 (d) of the [India] Patents Act, 1970, [was enacted as] a public heath safeguard. . . [by the Indian] Parliament in 2005 to prevent evergreening or patenting of new forms of already known molecules. Putting an end to the controversy over the provision, the Supreme Court recognised the impact of patents on access to medicines and called for a strict interpretation of this section. . . .
Among other things, Section 3 (d) disallows patenting of new forms of already known molecules, unless the patent applicant shows significant enhancement in efficacy of its product. . . .
We will — of course, keep a close eye on this, as it has the potential to completely reshape the dynamics of drug delivery revenue models in India — one of the world’s largest emerging economies, and one with an immensely accelerating appetite for, and ability to afford, 21st Century Western style medicines.