IMPORTANT POINT
Procedural fairness and proper interpretation of claim scope are essential in patent application refusals.

JUDGMENT

Sanjeev Narula, J. (Oral)

1. Appellant's patent application No. 5818/DELNP/2006 [hereinafter `subject application'] has been refused through order dated 16th May, 2012 [hereinafter, `impugned order'] under Section 15 of the Patents Act, 1970 [hereinafter `Act'] on the ground that the claims recited in the subject application do not fulfil the criteria laid down under Section 3(e) and Section 3(i) of the Act.

2. Before taking note of the controversy, it would be appropriate to take note of the claim 1 of the subject application, which reads as follows:

"We Claim:

1. A composition comprising;

i) two units containing 3 mg estradiol valerate,

ii) 5 units containing 2 mg estradiol valerate and 2 mg dienogest,

iii) 17 units containing 2 mg estradiol valerate and 3 mg dienogest,

iv) 2 units containing 1 mg estradiol valerate, and

v) 2 units containing placebo."

3. The ground for refusal, as delineated in the impugned order, reads as follows:

"FINDING AND CONCLUSION:

The issue before me was to decide whether the finally amended claims falls within the scope of section 3(e) & section 3(i) of the patents Act 1970.

Section 3(e) & 3(i)

"A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substances"

Any process for the medicinal, surgical, curative, prophylactic [diagnostic, therapeutic] or other treatment of human beings or

any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.

As we understand that the composition should have a synergistic effect over the combination of the components. The invention claims composition comprising (i) two units containing 3 mg estradiol vale rate,

ii) 5 units containing 2 mg estradiol valerate and 2 mg dienogest,

iii) 17 units containing 2 mg estradiol valerate and 3 mg dienogest,

iv) 2 units containing 1 mg estradiol valerate, and (v) 2 units containing placebo.

The Agents for applicant has stated that the "composition of the invention comprises a synergistic admixture with improved efficacy and other enhanced and new properties which are disclosed or taught in any of the prior art" and also provide the Studies with previous tested pharmaceutical compositions (2B versus 2C).

but they have failed to substantiate these arguments to prove the synergistic effect of the composition over the prior art cited documents, and also failed to prove that the invention is not a method of treatment the used ingredients does not have any % ratio it has shown only doses form of the ingredients and therefore claimed composition is a method of treatments in the form of daily doses units as indicated in page 4 of the complete specification. Therefore the claimed invention cannot patentable u/s 3(e) & 3(i) of the patent Act 1970.

In view of all the circumstances, submissions made by the agent for applicant during the hearing including all the documents on the record and in view of my above findings, I hereby refuse to grant of Patent for application no. 5818/DELNP/2006. U/S 3(e) and 3(i) of the Patent Act 1970."

APPELLANT'S CONTENTIONS:

4. Mr. Debashish Banerjee, counsel for the Appellant, contends as follows:

4.1. The Appellant was deprived of a fair opportunity to address the objection under Section 3(e) of the Act, as this specific ground was not mentioned in the notice preceding the hearing. This omission undermines the procedural fairness owed to the Appellant, preventing them from preparing a defence against a contention that was never formally raised.

4.2. Respondent's decision is flawed due to a critical misinterpretation of Section 3(i) of the Act. The crux of this argument is the Respondent's failure to distinguish between a composition and a method of treatment. The claim, as delineated, underscores that the patent application was directed towards a product - a composition - rather than a process or method of treatment. This distinction is critical, a