Boehringer Ingelheim Pharmaceuticals filed a patent application titled "Pharmaceutical composition". The invention relates to a paediatric suspension of nevirapine hemihydrate. The application was filed with a total of six claims and upon its examination, the examiner raised objections on the grounds of non-patentability and definitiveness of the claims. The applicant, in compliance with the objections, then amended the claims.

A pre-grant opposition by way of representation was filed by the Indian Network for People Living with HIV/AIDS and Positive Women Network in response to the publication of the application. The grounds of opposition which were relied upon were: lack of novelty, lack of inventive step, non-patentability of Claims under Section 25(1)(f), Patent Act, 1970, under Section 3(d), Patent Act, 1970 and under Section 3(e), Patent Act, 1970.

The opponents submitted three prior art documents to support the ground of anticipation. However, according to the Assistant Controller, since no single document submitted taught all the features of the claim of the invention, none of the documents challenged the novelty of the invention. Consequently the composition claimed was held novel.

In terms of inventive steps, the opponents challenged the inventiveness of the invention and submitted documents to substantiate their argument. The Assistant Controller took into consideration the feature of the invention, as mentioned by the applicant, to be the use of suspension of nevirapine hemihydrates between one and 150 microns in the composition to test the inventive step. However, the absence of any disclosure about the specific advantage of the particle size in the specification negated the claim of the applicant that the particular particle size was advantageous to maintain stability of the solution and that the particular size would result in a stable suspension for pediatric consumption.

Thus the opponents' position and careful examination of their submitted documents led the Assistant Controller to say that a skilled person in the art should be able to arrive at the invention disclosed in the challenged patent application and thus be obvious to him.

The objection under Section 3(d), by the opponents, hinged on the fact that the claim was devoid of enhanced efficacy as required under the provision. The Assistant Controller concluded on the same on finding that there was no data to compare the therapeutic effect of the known substance and claimed substance. The composition claims also failed the requirements under Section 3(e) in disclosing any synergy between the ingredients thus adding on to the refusal for grant of patent on the above-mentioned grounds.

This legal action is of great importance. This is because of the way that it points towards submission of data relating to therapeutic effect; thereby showing enhanced efficacy in the claimed substance from known substance, in order to overcome the bar given under Section 3(d). This decision also comes after the denial of a patent to Novartis' Glivec caused controversy.

Gladys Mirandah

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