“Delhi High Court Rejects Patent for Anti-cMet ADC: ‘Method-of-Treatment Claims Not Patentable’, Amendment Beyond Original Scope Not Allowed”
Safiya Malik
The Delhi High Court, Single Bench, of Justice Amit Bansal, dismissed an appeal filed under Section 117A of the Patents Act, 1970. The appeal contested the Assistant Controller of Patents and Designs' order dated July 31, 2023, which had rejected Indian Patent Application No. 201817047767 for impermissible claim amendments and non-patentability under Sections 2(1)(j), 3(i), and 59(1) of the Patents Act. The court upheld the Controller's decision, finding the amendments to broaden the claim scope unlawfully and stated that method of treatment claims was non-patentable under Indian law.
The appellants, AbbVie Biotherapeutics Inc. and AbbVie Inc., filed Indian Patent Application No. 201817047767 titled "ANTI-cMet ANTIBODY DRUG CONJUGATES AND METHODS FOR THEIR USE" on December 17, 2018, as a national phase application under the PCT. The application claimed priority from US patent application US 62/337,796 dated May 17, 2016. The subject matter focused on the therapeutic use of anti-cMet antibody-drug conjugates (ADCs) for treating cMet-overexpressing cancers.
A request for examination was submitted on May 15, 2020. The First Examination Report (FER) issued on November 5, 2020, raised objections under Sections 2(1)(j) and 3(i) of the Patents Act. In response, the appellants submitted amended claims on May 5, 2021. A hearing followed on December 6, 2022, after which the appellant filed written submissions on January 19, 2023.
Despite the submissions, the Controller refused the application, citing that the amendments introduced new product claims beyond the scope of originally filed method-of-treatment claims, thus violating Section 59(1). The Controller also held the original claims unpatentable under Sections 2(1)(j) and 3(i) due to lack of industrial applicability and statutory exclusions.
The appellants argued that the amendments were permissible under Sections 57(6) and 59, as they were based on disclosures in the specification and were necessary to address objections. They contended that international PCT provisions allow for such amendments and that a product claim for the anti-cMet ADC was inherently disclosed. Reliance was placed on Allergan Inc. v. Controller of Patents, where similar amendments had been allowed.
The respondent, represented by CGSC, countered that the original claims were exclusively method-based and that the proposed product claims had not been disclosed or claimed in the PCT or national phase entry. Citing Nippon A & L Inc. v. Controller of Patents, the respondent argued that amendments expanding the scope beyond originally filed claims are impermissible.
The Court noted that the original specification stated therapeutic methods using ADCs, dosage schedules, and efficacy results, confirming that the invention was directed at method-of-use, not standalone product protection. The Court stated: "The as-filed Specification, when read in its entirety, reflects that the original invention squarely resided in how to use these antibody-drug conjugates (ADCs) to achieve the therapeutic benefit."
The Court observed that the PCT application had 137 claims, all directed toward methods of treatment involving ADCs. None claimed the ADC as a product. The amended claims, however, sought to claim the ADC and compositions thereof, removing limitations on treatment protocols or patient categories. The Court remarked: "Claim 1... is a Product claim which has larger scope than the originally filed method of treatment claims."
It was held that the amendment failed to qualify as a disclaimer, correction, or explanation under Section 59. Instead, the amendment shifted the invention's core from a method to a product: "Changing an entire claim category from 'method' to 'product' can not be a mere correction of an error." The Court recorded that the introduction of new claims for compositions and pharmaceutical combinations, such as Claims 5 to 8, had no basis in the original filing.
Relying on its earlier decisions in Nippon A & L Inc. and Ovid Therapeutics v. Controller of Patents & Designs, the Court affirmed that amendments expanding claim scope are impermissible. In Ovid, it had stated: "While the amended Claim has disclaimed the earlier broadly claimed feature... overall, the amended Claim is not within the scope of the originally filed Claims."
The Court distinguished the Allergan case cited by the appellant, noting that in that matter, the disease context remained unchanged, and the product claim was within the original specification. By contrast, in the present case, "the unamended Claims and specification refer to a particular disease... however, the amended Claims do not refer to any disease."
The Court stated the principle laid down in Novartis AG v. Union of India (2013) 6 SCC 1, stating: "The patent system should not develop along lines 'where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims.'"
The Court upheld the Controller’s decision rejecting the patent application under Section 15 of the Patents Act. It stated: "There is no infirmity in the order of the Controller... The impugned order passed by the Controller refusing the subject patent application under Section 15 of the Act is upheld. There is no merit in the present appeal and the same is dismissed."
The Court also directed that: "The Registry is directed to supply a copy of the present order to the Office of the Controller General of Patents, Designs and Trade Marks on e-mail ID - llc-ipo@gov.in, for compliance."
Advocates Representing the Parties
For the Appellants: Ms. Archana Shankar and Mr. Pravin Anand, Advocates
For the Respondent: Ms. Manisha Agrawal Narain, CGSC, Mr. Abhishek Kumar and Mr. Nipun Jain, Advocates
Case Title: AbbVie Biotherapeutics Inc. & Anr. v. Assistant Controller of Patents and Designs
Neutral Citation: 2025: DHC:2594
Case Number: C.A.(COMM.IPD-PAT) 44/2023 & I.A. 23895/2023
Bench: Justice Amit Bansal
[Read/Download order]
