Summary
E.R. Squibb & Sons LLC and Ono Pharmaceuticals Co. Ltd. challenged a recommendation issued by the Patent Opposition Board recommending revocation of their granted patent for human monoclonal antibodies targeting Programmed Death 1 (PD-1), a breakthrough cancer immunotherapy. The petitioners contended that the Opposition Board had ignored key evidence filed by the patentee and violated principles of natural justice. The Madras High Court dismissed the writ petition as not maintainable, holding that a patent opposition board recommendation is an intermediate step and not a final order, and that the patentee retains a full opportunity to raise all objections before the Controller at the hearing stage, with a further right of appeal under Section 117A of the Patents Act. The ruling reinforces the statutory scheme of post-grant opposition proceedings and puts a firm brake on premature High Court intervention in patent administration.
Background
A cancer immunotherapy patent worth global significance and an opposition process spanning years formed the backdrop against which the Madras High Court was asked to step in before the Patent Controller had even delivered a final word.
Indian Patent No. IN340060, titled Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for Use in Cancer, was granted to E.R. Squibb & Sons LLC (“Squibb”), a leading pharmaceutical company incorporated in New Jersey, USA, and Ono Pharmaceuticals Co. Ltd. (“Ono”), a Japanese pharmaceutical company. The patent, which relates to a class of antibody-based cancer therapies now central to modern oncology, originated as a national phase entry of PCT Application No. PCT/JP2006/209606, filed in May 2006 and published as International Publication No. WO2006/121168 A1 in November 2006.
Zydus Healthcare Limited (“Zydus”), an Indian pharmaceutical manufacturer headquartered in Ahmedabad, filed a post-grant opposition under Section 25(2) of the Patents Act, 1970 on 1 July 2021, challenging the validity of Squibb’s patent 340060. In accordance with the statutory scheme, the Controller of Patents constituted an Opposition Board under Rule 56 of the Patent Rules, 2003 on 29 December 2021. Squibb and Ono filed their reply statement and supporting evidence on 1 October 2021, including affidavits from multiple expert witnesses addressing the scientific and commercial merits of the patented invention. Zydus filed evidence in reply under Rule 59 on 30 November 2021.
In August 2022, Squibb and Ono filed a Miscellaneous Petition before the Controller challenging the maintainability of Zydus’s rejoinder and the admissibility of its Rule 59 evidence, arguing that these documents had been filed without proper authority and that the Controller was obliged to rule on their admissibility before forwarding materials to the Opposition Board. Without deciding this Miscellaneous Petition, the Opposition Board issued its recommendation on 31 January 2023, finding the patent lacking in novelty, inventive step, sufficiency, and clarity. Squibb and Ono filed the present writ petition before the Madras High Court under Article 226 of the Constitution, seeking to quash the Opposition Board’s recommendation and direct the issuance of a fresh recommendation after the Miscellaneous Petition had been decided and all evidence on record considered.
Issues
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- Whether a writ petition under Article 226 of the Constitution is maintainable against a patent opposition board recommendation issued under Section 25(3) of the Patents Act, 1970, before the Controller has passed a final order under Section 25(4).
- Whether the Opposition Board’s failure to adjudicate the Miscellaneous Petition challenging the admissibility of the opponent’s Rule 59 rejoinder evidence amounted to a procedural irregularity vitiating the recommendation.
- Whether the Opposition Board’s alleged non-consideration of the patentee’s evidence, including expert affidavits addressing secondary considerations, constituted a violation of the principles of natural justice warranting High Court intervention at the recommendation stage.
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Squibb and Ono’s Arguments
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- The Opposition Board issued its recommendation without considering the evidence filed by the patentees under Rules 57 to 60 of the Patent Rules, 2003, including expert affidavits, which amounted to a procedural irregularity that vitiated the entire recommendation.
- The Board’s failure to decide the Miscellaneous Petition before forwarding documents to the Opposition Board was itself a violation of the statutory scheme, since the admissibility of Zydus’s Rule 59 rejoinder evidence was a threshold question that had to be resolved before the Board could properly examine the record.
- Secondary considerations relevant to the inventive step inquiry, such as long-felt need, commercial success, regulatory approvals in 64 countries, and grants in other jurisdictions, were not addressed in the recommendation, despite having been placed on record.
- The recommendation was procedurally defective on its face, as it did not bear a date, constituting a serious formal lacuna.
- Relying on Ashok Leyland Limited v. The Controller of Patents & Designs, W.A. No. 1181 of 2024 (Madras High Court, Division Bench), the petitioners argued that a High Court retains constitutional jurisdiction to review the procedure adopted by an Opposition Board, and that the present case warranted a direction for a fresh de novo recommendation.
- Relying on Optimus Drugs Private Limited v. Union of India, W.P.(IPD) No. 24/2023, the petitioners submitted that procedural violations at the recommendation stage affect the patentee’s rights and vitiate the recommendation entirely, warranting reconstitution of the Board.
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Zydus Healthcare’s Arguments
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- The writ petition was not maintainable because the Opposition Board’s recommendation is not a final or binding order. It is an intermediate step in the post-grant opposition process. Under Section 25(4) of the Patents Act, the Controller is required to give both parties an opportunity of being heard before passing a final order, and the Controller is not bound by the recommendation.
- The Delhi High Court in Willowood Chemicals Private Limited v. Assistant Controller of Patents and Designs, W.P.(C) IPD 15/2023, had held that the legal framework of the Patents Act does not permit parties to challenge Opposition Board recommendations, since the Controller’s final decision is what gives rise to a right of appeal under Section 117A(2).
- The filing done by the Zydus witness was an affidavit under Rule 59 and not a “rejoinder” as characterised by the petitioners, and no improper document was filed.
- The Miscellaneous Petition filed by the petitioners on 3 August 2022 was filed with an unexplained delay of nearly a year after Zydus’s Rule 59 evidence was served, and no prejudice was caused to the petitioners since objections could be raised before the Controller at the hearing.
- Under Rule 62(1), the Controller may require members of the Opposition Board to be present at the hearing, providing a further safeguard against any procedural deficiency in the recommendation.
- The petitioners cannot rely on Ashok Leyland or Optimus Drugs, since in both those cases, specific unusual circumstances justified reconstitution. In Ashok Leyland, both parties consented; in Optimus Drugs, evidence had been admitted after the recommendation had already been issued, making the recommendation stale. Neither situation applies here.
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Court’s Observations and Analysis
The Statutory Architecture of Post-Grant Opposition
The Madras High Court began by mapping the legislative framework governing post-grant oppositions under the Patents Act, 1970. Under Section 25(3), on receiving a notice of opposition, the Controller constitutes the Opposition Board, which examines the notice along with all documents filed under Rules 57 to 60 and submits a report with reasons on each ground of opposition. Critically, Section 25(4) makes clear that after receiving the Board’s recommendation, the Controller must give the patentee and the opponent an opportunity of hearing before passing a final order to maintain, amend, or revoke the patent. Rule 62(1) implements this obligation, requiring the Controller to fix a hearing date and notify parties, and empowering the Controller to require Opposition Board members to attend the hearing itself.
The court’s reading of this scheme was decisive: the Opposition Board recommendation is a step in a process, not an end in itself. It is explicitly not binding on the Controller. The Controller retains full authority to accept, reject, or disregard the Board’s recommendation after conducting an independent hearing at which both parties may raise all arguments and objections.
Why the Petitioners’ Procedural Complaints Did Not Justify Writ Intervention
The court acknowledged that the petitioners’ core grievance, that the Board had failed to apply its mind to the evidence of the patentee and had not resolved the Miscellaneous Petition, was a procedural complaint and not a challenge to a final order. While such complaints may be legally relevant in appropriate circumstances, the court held that they do not make a writ petition against a recommendation maintainable, for a simple reason that those very complaints can be placed before the Controller at the hearing stage under Rule 62.
The court reasoned that the hearing before the Controller is not a mere formality. The Controller can examine whether the Board considered all evidence, can require Board members to clarify their reasoning, and can independently evaluate whether the recommendation is sound. The petitioners had a full opportunity to raise every objection, including non-consideration of their expert evidence, the alleged procedural defect in admitting the Rule 59 rejoinder, and the absence of a date on the recommendation, before the Controller. Permitting a writ petition to short-circuit this process would disrupt the legislative design.
Distinguishing Ashok Leyland and Optimus Drugs
The court carefully examined the two Madras High Court precedents on which the petitioners principally relied.
In Ashok Leyland Limited v. The Controller of Patents & Designs, W.A. No. 1181 of 2024, the Division Bench had permitted reconstitution of the Opposition Board, but crucially, both parties in that case had consented to reconstitution. The court also confirmed that it retained constitutional jurisdiction to review the procedure adopted by an Opposition Board, but the operative relief was based on consent, not on a contested finding that the writ petition was maintainable in the abstract.
In Optimus Drugs Private Limited v. Union of India, W.P.(IPD) No. 24/2023, the court had directed reconstitution of the Board because, after the Board’s initial recommendation, the Controller had permitted both parties to file further evidence. The Board’s recommendation had therefore become stale on its face since it was issued before the additional evidence existed, making it meaningless for the Controller to decide the opposition on the basis of an outdated recommendation. To guard against confirmation bias, the Board was reconstituted.
Neither of these exceptional circumstances was present in the current case. The Opposition Board in the Squibb case issued its recommendation after examining the record as it stood at the time. The petitioners had not been permitted to file further evidence after the recommendation was issued; the evidence they relied upon had already been before the Board. The court held that the petitioners could not transplant the remedy fashioned in cases of genuine procedural breakdown onto a situation where the statutory process remained intact, and the Controller had yet to act on the recommendation.
No Prejudice; No Basis for Quashing
The court further addressed the question of prejudice directly to ascertain if any irreversible harm was caused to Squibb and Ono by allowing the recommendation to stand. The answer, on the court’s analysis, was no. The recommendation does not determine any right; it feeds into a hearing at which the patentee stands on equal footing with the opponent. The absence of a date on the recommendation, the alleged non-consideration of expert affidavits, and the unanswered Miscellaneous Petition are all matters that remain open before the Controller. Section 117A of the Patents Act further provides a statutory right of appeal against the Controller’s final order, ensuring that any error in the post-grant opposition process is ultimately capable of correction.
The court was also not blind to the broader concern flagged by Zydus that challenges to intermediate steps in opposition proceedings, filed at premature stages, have the effect of prolonging patent disputes and entrenching uncertainty. The court declined to permit the writ petition to operate as a procedural tool for delay.
Findings
In view of the observations and the arguments presented by both the parties, the Madras High Court held that:
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- A writ petition under Article 226 of the Constitution challenging a patent opposition board recommendation issued under Section 25(3) of the Patents Act is not maintainable, where the Controller has not yet passed a final order under Section 25(4).
- The Opposition Board’s recommendation is not a final or binding order; it is an intermediate step, and the Controller retains full authority to accept or reject it after conducting an independent hearing at which both parties may raise all objections, including contentions about procedural irregularity and non-consideration of evidence.
- The petitioners’ reliance on Ashok Leyland was misplaced, as that case proceeded on the consent of both parties; and their reliance on Optimus Drugs was misplaced, as that case turned on evidence filed after the recommendation had already been issued; circumstances absent in the present case.
- The petitioners may raise all objections, including the non-consideration of their expert evidence, the undecided Miscellaneous Petition, and any other procedural complaints, before the Controller at the hearing stage under Rule 62, and may thereafter exercise the statutory right of appeal under Section 117A of the Patents Act if aggrieved by the final order.
- The writ petition was dismissed as not maintainable, with no order as to costs; connected Writ Miscellaneous Petitions were closed.
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Case Citation: E.R. Squibb & Sons LLC & Anr. v. Union of India & Ors., W.P. No. 8451 of 2023, High Court of Judicature at Madras, decided on 5 January 2026. Available at https://indiankanoon.org/doc/44964329/
Authored by Gaurav Mishra, IP Attorney, BananaIP Counsels