AbbVie Biotherapeutics Inc. & Anr. v. Assistant Controller of Patents and Designs,
Facts
Under the Patent Cooperation Treaty (PCT), AbbVie Biotherapeutics Inc. and AbbVie Inc., biopharmaceutical firms, filed a national phase patent application in India (No. 201817047767) for an invention named “Anti-cMet Antibody Drug Conjugates and Methods for Their Use.” The application was made to the Indian Patent Office on December 17, 2018, with a May 17, 2016, US priority date. The initial claims were on therapeutic methods, e.g., employing antibody-drug conjugates (ADCs) for the treatment of malignancies, such as non-small cell lung cancer (NSCLC), overexpressing the cMet protein. To the objections of lack of patentability under Sections 2(1)(j) and 3(i) of the Patents Act made by the Patent Office in its First Examination Report (FER), AbbVie responded through its amendments to transform method of treatment claims into product/composition claims. The amendments were, however, rejected by the Patent Office on the grounds of broadening the scope of the initial claims and contravening Section 59(1) of the Act. This refusal was contested in this appeal under Section 117A of the Patents Act, following rejection of a review petition as time-barred.
Issues
Whether the initial claims aimed at a method of treatment are patentable under Indian law in view of the exclusion under Section 3(i) of the Patents Act, 1970?
Whether the revised claims transforming the invention from the method of treatment to product/composition claims are allowed under Section 59(1) of the Patents Act, 1970?
Whether the suggested amendments broaden the scope of the claims originally filed and therefore are beyond the limits of permissible amendments according to Indian patent law?
Arguments
On AbbVie’s behalf, it was contended that the amendments were in scope of the initial disclosure and were permissible under Sections 57 and 59 of the Patents Act. The company pointed out that the structure of the anti-cMet antibody-drug conjugate (ADC) was already disclosed in the initial specification, and therefore reformulating the claims from a method to a product form did not add new matter. The appellants relied heavily on the Allergan judgment, where a similar conversion of method claims to product claims had been allowed. In contrast, the Patent Office argued that the original claims were explicitly directed to methods of treatment, which are non-patentable under Section 3(i), and that the attempted conversion to broad product claims was not a permissible amendment under Section 59(1). It was further argued that these new claims removed essential limitations (like dosage, disease specificity, and patient selection criteria), thereby broadening the scope beyond what was originally claimed.
Judgment
The Delhi High Court upheld the Patent Office’s refusal of the application, concluding that the original claims were method claims, falling squarely within the excluded category under Section 3(i). Moreover, the Court held that the amendments proposed by AbbVie were not in the nature of disclaimer, correction, or explanation as required under Section 59(1). Rather, they amounted to a complete transformation of the claim type—from method of treatment to broad product and composition claims. The Court found that the original specification focused entirely on therapeutic applications, and the attempt to introduce stand-alone product claims created new legal rights beyond what was originally sought. Such amendments, the Court said, undermined the statutory intent behind Section 59(1), which exists to prevent applicants from artificially broadening patent protection through post-filing claim manipulations. The Court also distinguished the Allergan case, noting that in Allergan the disease context remained intact, whereas in AbbVie’s amended claims, all references to disease and therapeutic context were removed. The Court ultimately dismissed the appeal, ruling that the Controller of Patents had rightly rejected both the original claims (as method claims) and the amended claims (as impermissibly broad product claims). The judgment reaffirms that Indian patent law does not allow backdoor patenting of excluded subject matter, and it strictly upholds the principle of claim scope limitation under Section 59(1) of the Act. The Registry was directed to share a copy of the judgment with the Controller General of Patents for compliance.