SANJEEV NARULA
Bayer Pharm Aktiengesellschaft – Appellant
Versus
Controller General of Patents And Designs – Respondent
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
The refusal of a patent application for a therapeutic drug composition based on the grounds of it being a method of treatment is erroneous; claims must be recognized as product claims, distinguishing....
The court allowed the amendment of claims at the appellate stage and found that the invention satisfied the criteria of inventive step.
A pre-grant opposition is in the nature of an aid to examination and is not an adversarial proceeding and thus no right of the Petitioner can be said to be violated so as to invoke the extraordinary ....
The court has the authority to allow a change of name under Section 151 of the CPC.
The enhancement of known efficacy under Section 3(d) can include improvements in characteristics such as thermostability, and Section 3(e) requires that composition claims demonstrate properties beyo....
The Controller must provide a reasoned decision on pre-grant opposition addressing all raised grounds, particularly under Sections 3(d) and 3(e), to ensure compliance with natural justice standards.
A claimed patent must demonstrate novelty and an inventive step, which cannot be established by mere derivations that lack enhanced efficacy.
A patent rejection must be a reasoned order that explicitly analyzes prior art and demonstrates why a person skilled in the art would be motivated to combine teachings to arrive at the claimed invent....
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