rajdeep kumar 1 year ago

rajdeep

On April 16, 2025, the Delhi High Court delivered a significant judgment in AbbVie Biotherapeutics Inc. & Anr. v. Assistant Controller of Patent Designs (C.A.(COMM.IPD-PAT) 44/2023), dismissing the appeal filed by AbbVie Biotherapeutics Inc. and AbbVie Inc. The court upheld the Assistant Controller of Patents and Designs’ refusal of Indian Patent Application No. 201817047767, titled “ANTI-cMet ANTIBODY DRUG CONJUGATES AND METHODS FOR THEIR USE.” This ruling underscores the stringent requirements for patent amendments under Indian law and the non-patentability of method-of-treatment claims. This blog explores the case details, the court’s reasoning, and its implications for the pharmaceutical and biotechnology sectors.

Case Background

AbbVie Biotherapeutics Inc. and AbbVie Inc., biopharmaceutical companies, filed a national phase patent application in India on December 17, 2018, under the Patent Cooperation Treaty (PCT) for an invention related to anti-cMet antibody-drug conjugates (ADCs) used in treating cMet-overexpressing cancers, particularly non-small cell lung cancer (NSCLC). The application, stemming from PCT/US2017/033176 and claiming priority from a 2016 US filing, initially comprised 137 claims, all focused on methods of treatment involving the administration of anti-cMet ADCs.

The First Examination Report (FER), issued on November 5, 2020, raised objections under:

• Section 2(1)(j): Lack of industrial applicability, as the claims were directed to a method of treatment.
• Section 3(i): Non-patentability, as methods of treatment of human beings are excluded subject matter.

In response, AbbVie submitted amended claims on May 5, 2021, shifting from method-of-treatment claims to product claims covering the anti-cMet ADC itself and related compositions. A hearing was held on December 6, 2022, followed by written submissions. On July 31, 2023, the Assistant Controller rejected the application, citing violations of Section 59(1) (impermissible amendments), Section 2(1)(j), and Section 3(i). A subsequent review petition was dismissed as time-barred on March 6, 2024, leading AbbVie to appeal to the Delhi High Court under Section 117A of the Patents Act, 1970.

Key Arguments

Appellants’ Submissions

AbbVie, represented by Ms. Archana Shankar and Mr. Pravin Anand, argued that the amended claims were permissible and the refusal was erroneous. Key points included:

1. Right to Amend: Under Sections 57 and 59, amendments to claims can be made at any time during the patent application’s lifecycle. The appellants were not barred from amending claims at the national phase, even if no amendments were made during the PCT stage.
2. 
   
3. Compliance with Section 59(1): The amended claims, focusing on the anti-cMet ADC product, were disclosed in the original specification and as-filed claims, thus falling within the scope of the original disclosure. The amendments addressed the Section 3(i) objection by removing method-of-treatment elements.
4. Precedent Support: The appellants relied on Allergan Inc. v. Controller of Patents (2023), where a similar amendment from method to product claims was allowed, arguing that their case warranted similar treatment.

Respondent’s Submissions

The Assistant Controller, represented by Ms. Manisha Agrawal Narain, defended the refusal, arguing:

1. PCT Consistency: Under Section 138(4), national phase applications must align with the PCT filing. AbbVie’s failure to amend claims to product claims during the PCT stage meant the national phase entry retained method-of-treatment claims, limiting permissible amendments.
2. 
   
3. Section 59(1) Violation: The proposed amendments broadened the scope from specific method-of-treatment claims (tied to NSCLC treatment) to general product claims, exceeding the original disclosure’s intent and violating Section 59(1).
4. Non-Patentable Subject Matter: The original claims, being method-of-treatment claims, were non-patentable under Section 3(i) and lacked industrial applicability under Section 2(1)(j).
5. Well-Reasoned Order: The Controller’s decision was thorough and aligned with precedents like Nippon A & L Inc. v. Controller of Patents (2022), which clarified the restrictive scope of amendments.

Court’s Analysis and Decision

Justice Amit Bansal dismissed the appeal, upholding the Controller’s refusal. The court’s reasoning focused on the following key points:

1. Nature of Original Claims: The original 137 claims in the PCT application were exclusively method-of-treatment claims, detailing therapeutic regimens (e.g., dosing schedules, patient populations, and IHC scores) for cMet-overexpressing cancers, particularly NSCLC. No standalone product claims for the anti-cMet ADC were included, indicating the invention’s focus on therapeutic use.
2. 
   
3. Scope of Amendments: The amended claims (1–8) shifted to product claims, covering the anti-cMet ADC and compositions without treatment limitations. This transformation:

• Eliminated references to specific diseases, dosing, or patient criteria.
• Introduced new composition claims (Claims 5–8) not present in the original filing.
• Broadened the scope to cover the ADC in all uses, beyond the original method-of-treatment context.

1. Section 59(1) Violation: The court applied the framework from Nippon A & L Inc., which requires amendments to be disclaimers, corrections, or explanations that:

• Incorporate actual facts.
• Do not claim matter not disclosed in the original specification.
• Fall within the scope of original claims.

1. The amendments were neither disclaimers (as they expanded rather than narrowed scope), explanations (as they transformed the claim category), nor corrections (as they were not fixing clerical errors). By removing disease-specific limitations and introducing new composition claims, the amendments exceeded the original disclosure’s intent, violating Section 59(1).
2. Comparison with Ovid Therapeutics: The court found the case analogous to Ovid Therapeutics v. Controller of Patents & Designs (2024), where amendments broadening method claims to composition claims without disease limitations were rejected. Similarly, AbbVie’s amendments expanded protection to the ADC itself, beyond the original therapeutic context.
3. Distinction from Allergan: The court distinguished Allergan Inc., noting that the amended claims in that case pertained to the same disease as the original claims, whereas AbbVie’s amendments removed all disease-specific limitations, significantly broadening the scope.
4. Non-Patentability of Original Claims: The original method-of-treatment claims were correctly deemed non-patentable under Section 3(i) and lacking industrial applicability under Section 2(1)(j), as they did not fit the definition of a product or process.
5. Artful Drafting Concerns: Citing Novartis AG v. Union of India (2013), the court cautioned against amendments that artificially broaden claims through “artful drafting,” emphasizing that patent scope must reflect the invention’s intrinsic worth.

Implications of the Judgment

This ruling has far-reaching implications for patent applicants, particularly in the pharmaceutical and biotechnology sectors:

1. Strict Interpretation of Section 59(1): The decision reinforces the restrictive scope of amendments under Indian patent law. Applicants cannot transform method-of-treatment claims into product claims to circumvent Section 3(i) exclusions unless the product claims were explicitly disclosed and claimed originally.
2. 
   
3. Importance of Original Claim Drafting: The case highlights the critical need to include diverse claim types (e.g., product and method claims) in the initial PCT filing, as national phase amendments are limited by the original disclosure. Failure to claim products early can preclude later amendments.
4. Non-Patentability of Method Claims: The reaffirmation of Section 3(i)’s bar on method-of-treatment claims underscores India’s policy against patenting therapeutic methods, pushing applicants to focus on novel products or processes.
5. Consistency with Precedents: By aligning with Nippon and Ovid and distinguishing Allergan, the court provides clarity on when amendments are permissible, emphasizing disease-specific limitations and original intent.
6. Caution Against Artful Drafting: The reference to Novartis signals judicial scrutiny of strategic claim amendments, urging applicants to ensure amendments align with the original invention’s scope.

Conclusion

The Delhi High Court’s decision in AbbVie Biotherapeutics Inc. & Anr. v. Assistant Controller of Patent Designs is a pivotal ruling that clarifies the boundaries of patent amendments in India. By upholding the Controller’s refusal, the court emphasized that amendments must remain within the original specification’s scope and cannot broaden protection beyond the disclosed invention. This judgment serves as a cautionary tale for pharmaceutical and biotech companies, underscoring the need for strategic claim drafting at the PCT stage and alignment with India’s stringent patentability criteria.

For patent practitioners, the ruling offers a robust framework to navigate amendment challenges, particularly in the context of method-of-treatment exclusions. For innovators, it highlights the importance of anticipating India’s legal landscape when seeking patent protection. As India continues to balance innovation with public interest, such decisions shape a rigorous yet fair patent regime.