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KRISHNA RAO
Enterabio Ltd. – Appellant
Versus
Controller General of Patents & Designs, Mumbai – Respondent
JUDGMENT :
Krishna Rao, J.
1. This is an appeal under Section 117A of the Patents Act, 1970 against the order passed by the Assistant Controller of Patents and Designs dated 29th September, 2020, rejecting the appellant’s Patent Application No.1150/KOLNP/2011.
2. The subject invention pertains to composition for oral administration of proteins (insulin). Invention provides a single solid oral pharmaceutical composition comprising insulin, a protease inhibitor and a compound selected from the group consisting of a monosodium and a disodium salt of N-8-[2-hydroxybenzoyl]amino)caprylate (SNAC). The protease inhibitor is selected from aprotinin and soy bean trypsin inhibitor (SBTI) in a range of from 10 to 200 mg, and said compound is in a range of from 50 % to 70 % by weight of the composition and a method of administering them.
The absorption enhancer increases absorption of insulin in the blood stream.
A protease inhibitor prevents activity of protease which degrades a protein, insulin in the present case.
3. Learned Counsel for the appellant has contended that the Assistant Controller of Patents and Designs has not provided adequate reasons by selective reading and misrepresentation of p
The court allowed the amendment of claims at the appellate stage and found that the invention satisfied the criteria of inventive step.
A new form of a known substance can only be considered patentable provided the same demonstrates enhanced efficacy.
The Controller must provide proper reasoning for rejecting a patent application and consider the applicant's submissions, failing which violates the principles of natural justice.
A claimed patent must demonstrate novelty and an inventive step, which cannot be established by mere derivations that lack enhanced efficacy.
The court found deficiencies in the respondent's reasoning regarding patent application rejection, stressing the need for a proper evaluation of inventive step and adherence to principles of natural ....
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