The Supreme Court has rejected the appeal of Swiss drug major Novartis Pharma to get patent for its cancer drug Glivec. The verdict brings conclusion to the seven year old battle done by the MNC against section 3(d) of the Patent Act 2005, which allows patent authorities to reject patents on ‘marginal inventions.’
The real interest of the issue is that Pharma MNCs usually adopts a practice called ever greening under which they makes minute modifications to an existing drug and takes a new patent for that. Net impact of this practice is that the generic drug makers in countries like India are not able to produce and market that drug.
As a result of the fresh patent, affected patients are also compelled to buy drugs at exorbitant prices which is the usual case for a newly invented drug.
Now, the government in 2005, while modifying the original 1970 Patent Act has inserted a new clause under section 3(d) in the new Patent Act 2005, which instructs that patent will be granted only if the invention is substantial. Clearly, clause 3(d) is against ever greening.
A remarkable feature of the new clause is that it itself is a new invention, strengthening the country against the profit oriented maneuverability adopted by Pharma MNCs. It should be noted that the new Patent Act (2005) should be binding with the provisions of the TRIPs. Interestingly, the TRIPs doesn’t mention about the provision like section 3 (d).
Hence, the entire issue of anti ever greening clause of curious interest not just for India, but for other countries who are seeking protection from unhealthy practices adopted by Pharma MNCS. The successful establishment of section 3 (d) within India and in the global context becomes a vital issue.
On the other hand, for the big MNCs, the impact of the verdict is big, especially given the huge size of the Indian pharma market. The verdict and defense of the clause means business will be tough for them in the country. Now, the question is whether Novartis will go to the WTO’s Dispute Settlement Body to make a final battle against India’s 2005 Patent Act. If that happens, the final battle is yet to come of course, we may say.
But the worst story is yet to come for the MNCs; many poor countries may imitate the new clause in their domestic patent acts. Here, one should remember that India’s 1970 Patent Act was also imitated by many developing countries including China during that time. In this context, the Novartis verdict impact doesn’t remain within the boundaries of India.