Summary
In a recent ruling, the Delhi High Court upheld the refusal of AbbVie’s patent application for an anti-cMet antibody-drug conjugate for cancer treatment. The Court found that the original claims, being method-of-treatment based, were non-patentable under Section 3(i), and that the amended product claims constituted an impermissible broadening of scope, in violation of Section 59(1) of the Patents Act, 1970.
The Delhi High Court, in a recent judgment, addressed a pivotal issue concerning the scope of permissible claim amendments under the Indian Patents Act, 1970. Abbvie Biotherapeutics Inc & Anr. filed an appeal challenging the rejection of their patent application (No. 201817047767) by the Assistant Controller of Patents on grounds of non-compliance with sections 2(1)(j), 3(i), and 59(1) of the Act. The invention pertained to an anti-cMet antibody-drug conjugate (ADC) designed for the treatment of cancer.
In its decision, the Court upheld the Controller’s decision, stating that the original claims related to a method of treatment, which is excluded from patentability under Section 3(i) of the Patents Act, and they failed to meet the requirement of industrial applicability under Section 2(1)(j). The Court further found that the proposed amendments exceeded the permissible scope under Section 59(1) of the Act.
Background
AbbVie Biotherapeutics Inc. and AbbVie Inc. (“Abbvie”), filed a national phase PCT application in India on December 17, 2018, titled “Anti-cMet antibody drug conjugates and methods for their use”.
The patent application focused extensively on therapeutic methods using anti‐cMet antibody-drug conjugates in treating cancers overexpressing cMet, such as non-small cell lung cancer (NSCLC). The original PCT application included 137 claims, all of which were directed solely toward methods of treatment.
A First Examination Report (FER) was issued by the Controller on November 5, 2020, raising objections including lack of industrial applicability under Section 2(1)(j) and non-patentability under Section 3(i) of the Act. In response, AbbVie submitted a revised set of eight claims, including an independent product claim for the anti-cMet ADC conjugated with monomethyl auristatin E, along with claims for pharmaceutical compositions.
Subsequently, a hearing was scheduled for December 6, 2022, where objections under Sections 2(1)(j), 3(i), and 59(1) were discussed. Following the hearing, AbbVie submitted written submissions on January 19, 2023. However, the Patent Office ultimately rejected the application on July 31, 2023, maintaining the same grounds for refusal.
AbbVie challenged the patent refusal, contending that the amended product claims were based on disclosures already present in the original specification and claims, making them permissible under Section 59(1). AbbVie also cited Allergan Inc. v. Controller of Patents, where similar amendments had been accepted.
The Controller’s counsel contended that the amended claims proposed by AbbVie violated Section 59(1), by broadening the scope of the original claims, as neither the PCT application nor the national phase filing included any standalone product claims.
Court’s analysis
After extensive analysis of the original claims and the proposed amendments, the Court noted that the originally filed claims were entirely focused on therapeutic methods using anti-cMet ADCs, covering detailed dosages, administration schedules, patient selection criteria, and treatment efficacy. The Court further observed that there was no claim to the anti-cMet antibody-drug conjugate as a standalone product or a pharmaceutical composition, and the complete specification was directed solely toward methods of use to achieve the therapeutic benefit rather than product protection.
Furthermore, the Court observed that the original specification and claims covered methods of treatment, which are not patentable under the Indian Patents Act. The Court also noted that AbbVie’s amendments, submitted in response to the FER, marked a clear shift from the original method of treatment claims to product/composition claims, intended to overcome the statutory patentability requirements under Section 3(i) of the Act.
Additionally, the Court agreed with the Controller’s decision for disallowing the amended claims under Section 59(1) of the Patents Act, 1970. It noted that the original claims were directed to a method of treatment for non-small cell lung cancer, involving specific therapeutic parameters such as dosing schedules and patient selection based on IHC scores. In contrast, the amended claims sought broad protection for an anti-cMet antibody-drug conjugate as a product, without any reference to therapeutic use, patient criteria, or disease specificity. The Court observed that this transition from a method of treatment to a general product claim did not qualify as a correction or explanation or disclaimer under Section 59(1). Rather, it constituted an impermissible broadening of claim scope that introduced new subject matter not originally claimed. The amended claims also introduced entirely new claims covering pharmaceutical compositions, which were not disclosed or covered in the originally filed claims.
Citing Novartis AG v. Union of India, (2013), the Court reiterated that Indian Patents Act does not permit artificially broadening claims, and that the scope of a patent should be determined by the intrinsic worth of the invention rather than by artful claim drafting.
Regarding the citation of Allergan Inc. v. Controller of Patents by AbbVie, the Court noted that the judgment did not examine whether the amendment fell within the restrictive categories of correction, explanation, or disclaimer under Section 59(1). The Court further distinguished the two cases by highlighting that the amended claims in Allergan continued to relate to the same disease as the original claims, whereas in the present case, the amended claims omitted the disease-specific limitation, thereby broadening the scope beyond what was originally disclosed.
Conclusion
In conclusion, the Court found no infirmity in the Controller’s decision that the proposed amendments exceeded the permissible scope under Section 59(1) of the Patents Act. The Court, further agreed that the original claims, being directed to methods of treatment, were excluded under Section 3(i) and lacked industrial applicability under Section 2(1)(j). Consequently, the appeal was found to be without merit and was dismissed.
Citation: Abbvie Biotherapeutics Inc & Anr vs The Controller General Of Patents (C.A.(COMM.IPD-PAT) 44/2023) (H.C. Delhi April 16, 2025). Available at: https://indiankanoon.org/doc/26511870/
Author: Dr. Vasundhara Paliwal
Article Review: Neetha Mohan
Accessibility Review: Rakesh Krishnan