Background and Rejection of Patent Application
Fresenius Medical Care Deutschland GmbH filed a patent application in India (No. 7493/DELNP/2012) concerning pharmaceutical compositions involving microvesicles (MVs) derived from adult stem cells for treating tumor diseases. The application was initially rejected by the Controller of Patents in February 2020 on multiple grounds, including lack of novelty and inventive step, insufficient disclosure, and non-patentability under Sections 3(e) and 3(i) of the Patents Act, 1970.
Filing of Appeal and Proposed Amendments
The appellant challenged this decision before the IPAB, and the matter was later transferred to the Delhi High Court following IPAB's abolition. The appellant submitted amended claims during the appellate proceedings, clarifying the inventive elements, including specific dosage and use of cytotoxic agents like doxorubicin or vincristine. These amendments aimed to overcome the original objections.
Court’s Analysis and Ruling on Amendments
The Court held that such amendments were permissible under Section 59 of the Patents Act as they served as clarifications and did not expand the original claim’s scope. Drawing from precedents such as Nestlé SA and Opentv Inc., the Court confirmed that appellate bodies could direct or accept amendments provided they meet statutory requirements.
Remand to Patent Office
Finding the amended claims to be within legal limits, the Court allowed them to be taken on record and remanded the matter back to the Patent Office for re-examination. The earlier rejection order was set aside, and the Patent Office was directed to decide afresh within three months.
Case title: Fresenius Medical Care Deutschland GmbH Vs. Controller General of Patents, Designs and Trademarks & Anr.
Date of order: 16th April, 2025
Case No.: C.A.(COMM.IPD-PAT) 302/2022
Neutral Citation:2025:DHC:2778
Name of Court: High Court of Delhi
Name of Judge: Hon’ble Mr. Justice Amit Bansal
