Delhi High Court Revives Patent Bid For Improved Process To Make Drug Used To Reverse Muscle Relaxation

The Delhi High Court has set aside the Patent Office's decision refusing a patent application for an improved process to prepare sugammadex, a drug used to reverse the effects of certain muscle relaxants administered during surgery.

The court found that the applicant was denied a mandatory opportunity of hearing before the refusal.

Justice Jyoti Singh observed that hearings held during the pre-grant opposition proceedings could not replace the separate hearing required before the application was refused. The failure deprived the applicant of an opportunity to respond to the objections. It was also denied the chance to seek amendments, if necessary, to overcome them.

The matter has been sent back to the Patent Office for fresh consideration. A new decision must be taken within six months. Both the applicant and the party opposing the patent must be given an opportunity of hearing. The fresh decision must not be influenced by the earlier refusal order.

The application was filed by Fresenius Kabi Ipsum SRL in March 2016. It concerned an improved process for preparing sugammadex using an isolated salt of 3-mercaptopropionic acid.

Fresenius Kabi distinguished its process from earlier methods that generated the salt during the reaction. Its application instead involved using an isolated salt. The company argued that this improved the reproducibility, yield, and purity of the reaction. It also relied on the process's suitability for industrial-scale manufacturing.

The company further claimed that its process produced fewer impurities. It also contended that it reduced the overall reaction time compared with earlier methods.

Two pre-grant oppositions were filed against the application. The first came in 2020. Another followed in October 2021.

The oppositions raised objections that the invention had already been disclosed in earlier material. They also challenged whether it involved an inventive step and was eligible for patent protection.

Three rounds of oral hearings were held in the opposition proceedings. The Patent Office subsequently refused the application in November 2024.

The refusal order held that the claimed process lacked novelty and inventive step in light of four earlier documents. It also found the process non-patentable because it did not involve a new reactant or result in a new product.

Justice Jyoti Singh held that the separate hearing requirement under Section 14 of the Patents Act still applied. In the circumstances covered by that provision, an applicant must be given an opportunity to address objections before a patent application is refused. The earlier hearings during the pre-grant opposition could not take its place.

The judge observed that the Patent Office “was thus under a statutory mandate to grant opportunity of hearing to the Appellant under Section 14 before taking a decision to refuse the application solely on the grounds taken by Respondent No. 2 in the pre-grant opposition.”

The court further held that this was “not merely a procedural violation, but violation of a substantive right” and went to the root of the matter.

Although it did not rule on whether the invention deserved a patent, the court flagged issues in the refusal order. These included whether the earlier material explicitly or implicitly disclosed the invention. It also noted that the order did not identify which document was the closest prior art.

The court further noted that the refusal order did not adequately explain why the features relied upon by the applicant did not make the process new or inventive. It also observed that four earlier documents had been combined to conclude that the invention was obvious. The order did not explain why a skilled person would combine those documents in that manner.

The court observed that this reflected a hindsight approach, “which has been condemned by Courts in several judgments.”

The court set aside the refusal order and directed fresh consideration of the application. A decision must now be taken within six months after hearing both sides. The earlier refusal order must not influence the fresh decision.