Monday, September 24, 2012

Novartis Supreme Court Update: Purpose and Interpretation of Section 3(d)

In an earlier post, I had blogged  on the update in the Novartis hearings before the Supreme Court.

A well-wisher of the blog has brought to my attention an update of the hearings held on September 13, 2012. It appears that on behalf of the patent applicant, Novartis, Mr.Gopal Subramanium submitted to the Supreme Court that the purpose of Section 3(d) is not to facilitate access to medicines. Its purpose, according to Novartis, is to prevent grant of patents to trivial modifications to existing products.

The submissions appear to have been made in connection with a clarification sought by Justice Aftab Alam. It was further submitted that the Doha Declaration, and consequently the issue of access to medicines has been incorporated in the Indian Act in its compulsory licensing provisions. A good part of the arguments seem to have revolved around the issue of compulsory licensing provisions of the Act.

With respect to Section 3(d), it appears that according to Mr. Subramanium, Section 3(d) applies only to discoveries which do not have an inventive step. Consequently, according to Mr.Subramanium, if something is covered by Section 2(1)(j) and 2(1)(ja), Section 3(d) is not attracted in such an instance. 

It was also submitted that Section 3(d) must be read as an aid to Section 2(1)(ja), and that 3(d) does not limit 2(1)(ja). Therefore, according to Mr. Subramanium, the IPAB had erred in rejecting the patent application of Novartis citing Section 3(d) despite holding that Gleevec was novel and non-obvious.

In my opinion, this is precisely the kind of mess that is created when the IPAB or the Patent Office examine for novelty and non-obviousness instead of first using Section 3 of the Act as a filter. A similar unnecessary analysis was undertaken by the IPAB in the Yahoo order where a patent application of Yahoo was rejected. In my opinion, if Section 3 is used as a filter to weed out what are not inventions under the Act, unnecessary analysis on novelty and non-obviousness can be avoided.

Coming back to the Novartis case, it was submitted on behalf of Novartis that the IPAB erred in applying the test of anticipation under Section 3(d), besides applying it under Section 2(1)(j).

What surprised me are the reported submissions by Mr.Subramanium on the distinction between obviousness and anticipation. It has been reported that the following is what was submitted to the Court by Mr. Subramanium:

“Responding to a clarification sought about the difference between obviousness and anticipation, Mr Subramaniam said that, in the analysis of obviousness, the existing knowledge is complete and enabling and therefore it is obvious to reach the claimed product. He said that, in the analysis of anticipation, full details are not given in the existing knowledge

Further hearing in the matter was scheduled for September 18, 2012.

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