E.R.Squibb & Sons LLC and Ono Pharmaceuticals Co. Ltd., holders of Indian Patent IN340060 granted on 31.01.2023 for human monoclonal antibodies to Programmed Death 1 (PD-1) for cancer treatment originating from PCT application filed 02.05.2006, faced post-grant opposition under Section 25(2) of Patents Act 1970 by Zydus Healthcare Limited alleging lack of novelty, inventive step, sufficiency and clarity, leading to Opposition Board's recommendation dated 31.01.2023 favoring revocation without considering patentees' evidence like affidavits from experts Dr. Fife, Sarah Roques, Dr. Feltquate and Dr. Mark or deciding maintainability of opponent's rejoinder under Rules 57-60 of Patents Rules 2003.
Patentees filed writ petition under Article 226 seeking certiorarified mandamus to quash the recommendation and direct reissuance after proper consideration.
The court reasoned that the Board's recommendation is merely advisory and not final as per Cipla v. Union of India, patentees can raise all objections including non-consideration of evidence during hearing before Controller under Rule 62 where Controller may accept, reject or reconstitute Board, no prejudice is caused since appeal lies under Section 117A against final order, and thus premature interference is unwarranted rendering the petition not maintainable. The writ petition was dismissed without costs.
Law Point:
Recommendation of Opposition Board under Section 25(3) of Patents Act 1970 is advisory in nature and not a final decision amenable to direct writ challenge, as parties can raise objections during hearing before Controller under Rule 62 of Patents Rules 2003: Cipla Ltd. v. Union of India, (2012) 13 SCC 641, Para 6; Para 30.
Controller must consider all evidence and documents under Rules 57-60 before final decision, but non-consideration by Board does not vitiate process if addressed in hearing, with appeal available under Section 117A: Para 28, Para 30.
Writ petition challenging Opposition Board's recommendation prematurely is not maintainable when statutory remedies like hearing and appeal exist: Para 31.
Case Title:E.R.Squibb & Sons LLC Vs. Union of India:05.01.2026:W.P. No.8451 of 2023: High Court of Judicature at Madras, Name of Judge: Hon'ble Mr. Justice N. Senthilkumar.
[Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation]
[Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi]
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