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2024 Supreme(Mad) 1200
IN THE HIGH COURT OF JUDICATURE AT MADRAS
SENTHILKUMAR RAMAMOORTHY, J.
M/s.Guangzhou Ocusun Ophthalmic Biotechnology Company Limited – Appellant
Versus
Joint Controller of Patents & Designs – Respondent
CMA(PT)/23 of 2024
Decided on : 08-08-2024
Advocate Appeared
For the Appellant : Mr.Tarun Khurana for Khurana and Khurana
For Respondent: Mr.S.Janarthanam, SPCGSC
IMPORTANT POINT
The court established that proper identification of prior art and substantial evidence of therapeutic efficacy are crucial for patent eligibility under Section 3(d) of the Patents Act.
Headnote:
Patent - Patent Application - Patents Act Section 3(d) - The court discussed the applicability of Section 3(d) regarding patent eligibility and inventive step, emphasizing the need for substantial therapeutic efficacy and proper identification of prior art.
Fact of the Case:
The appellant's patent application for a crystal form of a lanosterol prodrug was rejected by the Patent Office, citing lack of patent eligibility under Section 3(d) and inventive step based on prior art.
Finding of the Court:
The court found that the rejection was flawed as the prior art was misidentified and the appellant provided sufficient evidence of therapeutic efficacy, necessitating reconsideration of the application.
Issues: Whether the patent application was correctly rejected under Section 3(d) of the Patents Act and whether the claimed invention demonstrated an inventive step.
Ratio Decidendi: The court held that the prior art was not properly identified and that the appellant's evidence of therapeutic efficacy was not adequately considered, warranting a remand for reconsideration.
Result: The impugned order is set aside and the matter is remanded for reconsideration.
ORDER :
PRAYER: Transfer Civil Miscellaneous Appeal (Patent) filed under Section 117-A (2) of the Patents Act, 1970, pleased to pass an order setting aside the impugned order dated 15.02.2024 passed by the Respondent in respect to the Application No.202147005676 and allow Patent Application No.202147005676.
This appeal is directed against the order dated 15.02.2024 by which Patent Application No.202147005676 was rejected.
2. The appellant filed the above mentioned patent application titled “CRYSTAL FORM OF LANOSTEROL PRODRUG COMPOUND AND APPLICATION THEREOF” before the Patent Office, Chennai, on 10.02.2021. The said application was filed as a national phase application, which was derived from PCT application No.PCT/CN2019/097773. The appellant claimed priority from 25.07.2018. Pursuant to a request for examination, the First Examination Report(FER) was issued on 21.06.2022. By such FER, objections were raised inter alia on the ground that the claimed invention is patent ineligible under Section 3(d) of the Patents Act, 1970 and that it lacks an inventive step in view of prior art documents D1 and D2. The appellant replied to the FER on 21.12.2022 and also amended the claims by filing amended claims 1 to 5. After a hearing on 23.01.2024, the application was rejected by the order impugned herein.
3. Learned counsel for the appellant submits that the application was in respect of a crystal form of lanosterol prodrug compound and not in respect of a crystal form of lanosterol. He points out that a prodrug exhibits pharmacological activity only upon being metabolized in the body after the drug is administered. He submits that the appellant applied for and obtained a patent in respect of the lanosterol pro-drug compound from the Indian Patent Office. He also submits the crystal form of the pro-drug was granted patent in multiple jurisdictions, including China, United States of America, Europe and Japan.
4. With regard to the rejection under Section 3(d) of the Patents Act, learned counsel contends that the Joint Controller failed to identify the known substance. He submits that the lanosterol pro-drug compound for which the appellant was granted a patent was published after the priority date in respect of the current application. Consequently, he contends that D1 is not really a prior art document. For this principle, he relies upon the judgments in Mr.Tony Mon George, Constituted Attorney of AbbVie Inc. v. Deputy Controller of Patents and Designs, judgment dated 20.12.2023 in (T)CMA(PT)No.150 of 23 and Pfizer Products Inc. v. Controller of Patents & Designs, 2020 SCC OnLine IPAB 19.
5. Without prejudice to this contention, and assuming without admitting that Section 3(d) of the Patents Act applies, he submits that the appellant demonstrated therapeutic efficacy by including experimental results in the complete specification. Consequently, he contends that the claimed invention passes through the exemption filter in Section 3(d). He relies upon experimental examples 2 and 3 at internal pages 16 to 21 of the complete specification, in this regard, and points out that it is categorically stated therein that the cataract symptoms were significantly reduced after lanosterol pro-drug 026 eye drops were administered for 42 days compared to the symptoms before administration, and that the cataract symptom showed no evident change before and after administration of Kary Uni eye drops and lanosterol eye drops.
6. As regards the inventive step analysis, learned counsel submits that D2 discloses a Markush structure with hundreds of prophetic compounds. Without the benefit of hindsight, learned counsel submits that it would not be obvious to PSITA to even arrive at lanosterol on such basis. As regards the pro-drug of lanosterol, he contends that it would not be obvious from D2 by any stretch of the imagination.
7. Mr.Janarthanan, learned special panel counsel, appears on behalf of the respondent. By relying upon the counter affidavit of the Deputy Cont
