Patent Opposition Board Recommendations Are Advisory, Not Binding Decision: Madras High Court

The Madras High Court has refused to step in midway in a patent dispute over a cancer drug, holding that a recommendation made by the Opposition Board during post-grant opposition proceedings is only advisory and does not create anu valid binding rights.

Dismissing the writ petition filed by two foreign pharma firms, Justice N. Senthilkumar said the patent holders must place all their objections before the Controller of Patents, who alone takes the final call.

The court was hearing a challenge by US-based E.R. Squibb & Sons LLC and Japan's Ono Pharmaceutical Co. Ltd.*to a recommendation issued by the Opposition Board in post-grant opposition proceedings initiated by Zydus Healthcare Limited.

In an order pronounced on January 5, 2026, the court made it clear that the recommendation does not decide anyone's rights.

“When such being the case, there is no impediment for the petitioner in taking part in the final decision making process conducted by the patent authority and raise these objections,” the court said.

The dispute centers on a patent titled Human Monoclonal Antibodies to Programmed Death-1 (PD-1) for use in Cancer, granted in favour of Squibb and Ono. Zydus later filed a post-grant opposition.

The Opposition Board examined the material placed before it and, in January 2023, submitted its recommendation to the Controller of Patents. Instead of waiting for the Controller's final decision, the patent holders moved the High Court, asking it to quash the recommendation itself.

Before the court, the companies argued that the Board had ignored substantial evidence, including expert material, and had failed to deal with their objections to certain documents filed by Zydus. They also pointed to what they described as procedural lapses under the Patents Rules, 2003, and said the recommendation was flawed because these issues were never addressed.

The Union of India and Zydus countered this by saying the challenge was premature. They stressed that the controller is not bound by the Board's views, must independently assess the entire record after hearing both sides, and that any grievance against the final decision can be carried in appeal.

Agreeing with the the patent office, the court noted that the Opposition Board's role is limited.

The Controller, it said, may “concur with the recommendations or may reject the recommendations and even call for a fresh constitution of the Board.”

The court also noted that the patent holders would get a full hearing before the Controller and could raise every objection there, including complaints about evidence not being considered or alleged procedural irregularities.

The court found no prejudice at this stage and concluded that the writ petition was not maintainable, leaving the companies to pursue their remedies before the patent authority and, if needed, in appeal under the Act.