Delhi High Court Sets Aside Rejection Of South Korean Pharma's Patent Application, Orders Fresh Review

The Delhi High Court has set aside a Controller of Patents order refusing South Korean pharmaceutical company Hanmi Pharm Co. Ltd.'s patent application for a pharmaceutical compound and its manufacturing process, finding that the Controller had entirely failed to consider the process claims submitted by the applicant.

Justice Tushar Rao Gedela, in an order dated May 11, 2026, remanded the matter to the Patent Office for fresh consideration. The Court directed that Hanmi Pharm be given a fresh hearing before any decision is taken on the application.

The case arose from Hanmi Pharm's Indian Patent Application filed in July 2014 as a National Phase Application under a PCT filing from December 2012. The application claimed priority from a Korean filing made in December 2011.

The patent application concerned a thieno[3,2-d]pyrimidine derivative compound, its pharmaceutically acceptable salts, and a method for preparing the compound.

The Controller of Patents had refused the application on April 25, 2022. The refusal cited lack of inventive step under Section 2(1)(ja) and non-patentability under Section 3(d) of the Patents Act, 1970.

Hanmi Pharm challenged the refusal before the High Court under Section 117A of the Act.

The amended set of claims filed by Hanmi Pharm included 22 claims. Claim 1 related to the compound, while Claims 14 to 22 related to the process for preparing it.

The Court found that the impugned order analysed only Claims 1 to 13 while examining prior art documents D1 and D2. It drew its conclusions without addressing the process claims at all.

The Court noted that it had specifically queried the government counsel on this issue. "A query was put to the learned CGSC for the respondent as to whether the Process Claims were dealt with in the impugned order or not," the Court recorded.

During the hearing on May 4, 2026, the Central Government Standing Counsel admitted that the process claims had not been addressed in the refusal order.

The Court held that this omission made the order unsustainable. "It would be difficult to uphold the impugned order as it was incumbent upon the learned Controller to consider the Process Claims as well," Justice Gedela observed.

The Controller has now been directed to decide the application afresh on merits, in accordance with law, within six months.

The Court also directed that a copy of the order be brought to the notice of the Controller General of Patents, Designs and Trademarks for necessary administrative action.