Delhi High Court Upholds Refusal Of AbbVie's Patent Application For Anti-cMet Antibody-Drug Conjugate

Delhi High Court Upholds Refusal Of AbbVie's Patent Application For Anti-cMet Antibody-Drug Conjugate

Introduction

The Delhi High Court has upheld the refusal of AbbVie Biotherapeutics Inc. and AbbVie Inc.'s patent application for an anti-cMet antibody-drug conjugate (ADC) for cancer treatment. The Court's decision was based on the grounds that the original claims were method-of-treatment based, which are non-patentable under Section 3(i) of the Patents Act, 1970, and the amended product claims constituted an impermissible broadening of scope under Section 59(1) of the Act.

Factual Background

AbbVie filed a national phase PCT application in India for their anti-cMet ADC, which focused on therapeutic methods using the conjugate to treat cancers overexpressing cMet. The original application included 137 claims directed solely toward methods of treatment.

Procedural Background

The Patent Office issued a First Examination Report (FER) raising objections regarding lack of industrial applicability and non-patentability. AbbVie responded with amended claims, but the Assistant Controller ultimately rejected the application on July 31, 2023, maintaining the same grounds for refusal.

Issues Involved

1. Patentability of Method-of-Treatment Claims: Whether the original claims, being method-of-treatment based, were patentable under the Indian Patents Act.

2. Permissible Scope of Claim Amendments: Whether the amended product claims exceeded the permissible scope under Section 59(1) of the Patents Act.

Contentions of the Parties

Appellant's Contentions: AbbVie argued that the amended claims were disclosed in the patent specification and the as-filed claims, making them permissible under Section 59(1). They relied on the decision in Allergan Inc. v. Controller of Patents.

Respondent's Contentions: The Controller contended that the amended claims proposed by AbbVie violated Section 59(1) by broadening the scope of the original claims.

Reasoning and Analysis

The Court analyzed the original claims and proposed amendments, noting that:

• The original claims were limited to specific methods of treatment, while the amended claims sought to cover the ADC as a standalone product.
• The transition from method-of-treatment claims to general product claims constituted an impermissible broadening of claim scope.

Final Decision

The bench of Justice Amit Bansal dismissed AbbVie's appeal, finding 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 also agreed that the original claims lacked industrial applicability under Section 2(1)(j) and were excluded under Section 3(i).

Implications

This decision depicts the importance of carefully drafting patent claims to ensure compliance with the Indian Patents Act. It also underscores the need for patent applicants to understand the permissible scope of claim amendments during the prosecution process.

In this case the appellant was represented by team Anand & Anand led by Mr. Pravin Anand and Ms. Archana Shanker, Advocates.