IN THE HIGH COURT OF JUDICATURE AT MADRAS
N. SENTHILKUMAR, J.
E.R.Squibb & Sons Llc - Petitioner
Versus
Union Of India Through The Ministry Of Commerce Department Of Industrial Policy & Promotion – Respondent
W.P. No.8451 of 2023, W.M.P. Nos.8647, 8649, 8650 of 2023
Decided On : 05-01-2026
| Table of Content |
|---|
| 1. challenge of opposition board recommendation. (Para 1 , 2 , 10) |
| 2. petitioners argue evidence not considered. (Para 3 , 4 , 5 , 6 , 8 , 9) |
| 3. analysis of procedural irregularities. (Para 7 , 13 , 14 , 22 , 28) |
| 4. final authority not bound by recommendations. (Para 25 , 26 , 30) |
| 5. writ petition dismissed as not maintainable. (Para 31) |
ORDER :
N. SENTHILKUMAR, J.
The present writ petition is filed challenging the recommendation of the Opposition Board in Patent No.IN340060 (Patent Application No.5057/CHENP/2007) dated 31.01.2023 made by the second respondent in Patent No.IN340060 with regard to post grant opposition proceedings, as per Section 25 (2) of the Patents Act, 1970 , which was initiated by the third respondent herein. Aggrieved by the same, the present writ petition has been filed.
2. The Indian Patent No.340060 was granted in respect of an invention titled as 'Human Monocolonal Antibodies to Programmed Death I (PD-1) for use in Cancer', which is used for treating cancer. An application was made in A. No.5057/CHEMP/2007, which is a national phase entry of International (PCT) Application No.PCT/JP2006/209606, which was filed on 02.05.2006 and came to be published as International Publication No.WO2006/121168 A1 dated 16.11.2006. The third respondent herein has given a post grant opposition under Section 25 (2) of the Patents Act, 1970 as against the grant of patent. Based on which, the opposition Board has made the impugned recommendation.
3. After filing of the reply evidence, the opponent/third Respondent has filed a rejoinder. Thereafter, the petitioners herein filed a Miscellaneous Petition, which questions the maintainability of the rejoinder filed by the Respondent No.3 and also the evidence under Rule, 59. According to the Petitioners, as the Opposition Board has to consider all documents under Rule 57 to 60 which are on record, the Respondent No.2 was duty bound to decide the maintainability of the rejoinder filed by the Respondent No.3 and also the evidence under Rule, 59. Only after the maintainability of the rejoinder was decided, the competent authority could decide whether or not to supply such documents to the opposition Board, after which the recommendations of the Board can be formed.
4. It is the case of the petitioners that the opposition board has made the recommendation without considering the evidence submitted by the patentee, namely the writ petitioner. The petitioners have filed 7 evidence of Dr.Fife, an evidence of Sarah Roques, an evidence of Dr.Feltquate, an evidence of Dr.Mark. Many of such evidence and various documents, issues addressed in such evidence; details and data provided have not been considered, and appreciated by the opposition Board while making the recommendation.
5. Mr.P.S.Raman, the learned senior counsel appearing for the petitioner pointed out that in the recommendation of the opposition board, there is no date, therefore, it is a serious lacuna. The recommendations hold that the patent lacks novelty, inventive step, sufficiency and clarity. The learned senior counsel further pointed out that the said drug has been used in 64 countries and the drug has been legally protected. In support of his contention, the learned senior counsel relied on Rule 57 to 60 of the Patents Rules, 2003 .
"57. Filing of written statement of opposition and evidence.- The opponent shall send a written statement in duplicate setting out the nature of the opponent's interest, the facts upon which he bases his case and relief which he seeks and evidence, if any, along with notice of opposition and shall deliver to the patentee a copy of the statement and the evidence, if any.
58. Filing of reply statement and evidence. - (1) If the patentee desires to contest the opposition, he shall leave at the appropriate office a reply statement setting out fully the grounds upon which the opposition is contested and evidence if any, in support of his case within a period of two months from the date of rec
The recommendation of the Opposition Board is not binding, and a writ petition challenging it is not maintainable; objections can be raised during hearings before the Controller.
Patents Act requires adherence to procedures in post-grant oppositions, emphasizing natural justice and timely resolutions to prevent delays in patent adjudication.
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 need for a systematic manner in conducting pre-grant oppositions and the right to file affidavits of own experts in rebuttal.
The court highlighted the importance of timely adjudication in patent opposition proceedings and mandated adherence to procedural timelines.
Quasi-judicial orders under Patents Act dismissing post-grant oppositions must provide cogent reasons and technical analysis under Section 25(2)(c); unreasoned orders are set aside and remanded.
The introduction of a dichotomy in patent law between pre-grant and post-grant opposition necessitates adherence to legislative intent, despite procedural delays in enactment.
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