IN THE HIGH COURT OF DELHI AT NEW DELHI
Amit Bansal, J.
Societe Des Produits Nestle Sa – Appellant
Versus
The Controller of Patents And Design & Anr. – Respondents
C.A.(COMM.IPD-PAT) 22 of 2022, I.A. 5588 of 2022 (stay), I.A. 5589 of 2022 (O-XI R-1(4) of CPC) and I.A. 16487 of 2022 (of waiver of costs)
Decided On : 03-02-2023
The appellant filed a patent application for a composition for use in the prophylaxis of allergic disease. The Patent Office refused the application, citing non-patentability under Section 3(i) of the Act and objections to the amended claims under Section 59. The appellant appealed, arguing that the claims were directed towards a composition, not a method of treatment, and that the amendments were made to overcome objections. The court found that the claims were not directed towards a method of treatment and allowed the amendment of claims at the appellate stage. The court also found that the appellant provided sufficient data to demonstrate synergy, and the invention satisfied the criteria of inventive step.
JUDGMENT
Amit Bansal, J.
Background
1. The present appeal under Section 117A of the Patents Act, 1970 (hereinafter referred as "Act") impugns the order dated 29th December, 2021 passed by the Assistant Controller of Patents and Designs, Patent Office, Delhi (Patent Office) refusing the application for grant of patent application No.201817040811 for an invention title "Composition for use in the Prophylaxis of Allergic Disease".
2. Oral submissions in the matter were heard on 29th November, 2022 and 30th November, 2022. Vide order dated 30th November, 2022, the judgment was reserved in the appeal, giving liberty to the parties to file written submissions. Written submissions were filed on behalf of the appellant as well as the respondent.
Brief Facts
3. Brief facts necessary for deciding the present appeal are set out below:
I. On 10th March, 2017, the appellant filed PCT international application No.PCT/EP2017/055680 claiming priority from a European Patent Application, i.e., EP16172431.5 dated 1st June, 2016.
II. On 29th October, 2018, the appellant filed the National Phase Application in India as Indian Patent Application No.201817040811 titled as "Composition for use in the Prophylaxis of Allergic Disease".
III. On 22nd February, 2019, the patent application was published in the official Journal of Patent Office and subsequently, the appellant filed a Request for Examination of the Patent Application on 20th May, 2020.
IV. On 29th January, 2021, the first examination report (FER) containing objections to the grant of the patent was issued by the respondent no.2.
V. On 28th July, 2021, the appellant filed response to the first examination report.
VI. On 23rd August, 2021 and 23rd September, 2021, hearing notice were issued by the respondent no.2. Hearing notice dated 25th October, 2021 was issued by the respondent no.2, fixing the date of hearing on 23rd November, 2021.
VII. On 23rd November, 2021, arguments were advanced on behalf of the appellant.
VIII. On 7th December, 2021, the appellant filed written note of submissions in support of the arguments advanced during the hearing.
IX. On 29th December, 2021, the impugned order was passed by the Assistant Controller of Patents and Designs refusing the application for grant of patent filed on behalf of the appellant under Section 15 of the Act.
4. The impugned order passed by the Patent Office held that:
(i) Claims of the patent application of the appellant defined a method for `treatment of human body' and were therefore, not patentable as the scope of the Claims fell under Section 3(i) of the Act.
(ii) The amended Claims filed by the appellant were not permissible in terms of Section 59 of the Act, as the amended Claims sought to confer greater scope of protection, in comparison to the originally filed Claims, which Section 59 of the Act prohibits.
(iii) The data given by the appellant for the claimed composition was not demonstrating stabilized synergism and the appellant failed to provide data comparing individual effects of each drugs/active ingredients with combination of them so as to prove synergy. Therefore, the patent application did not meet the requirements of Section 2(1)(ja) and Section 3(e) of the Act.
5. The appellants being aggrieved by the decision of the Assistant Controller of Patents and Designs have filed the present appeal.
Submissions
6. Counsel appearing on behalf of the appellant assails the impugned order on the following grounds:
(i) The original set of Claims, specifically Claim 4, was directed towards a `composition' and not towards a `method of treatment..Therefore, the amendment did not enlarge the scope of Claims and description.
(ii) In any event, the amendments were carried out to overcome the objections raised by the Patent Office in the FER dated 29th January, 2021 and the hearing notices dated 23rd August, 2021 and 25th October, 2021. Therefore, the same were within the scope of the originally filed Claims and therefore, permissible under Section 59 o
The court allowed the amendment of claims at the appellate stage and found that the invention satisfied the criteria of inventive step.
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....
Procedural fairness and proper interpretation of claim scope are essential in patent application refusals.
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....
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 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 established that adherence to statutory procedures in patent examination is crucial for ensuring fair assessment of novelty and inventive steps.
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