Life Sciences and Pharma IP 2026

INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali Mittal and Gursimran Singh Narula, Anand and Anand

The Competition Commission does not have power to investigate disputes concerning abuse of patents In the landmark decision in Swapan Dey v Competition Commission of India and Another , the National Com ‑ pany Law Appellate Tribunal put to rest the complaints alleging that Vifor International abused its dominant position, by enforcing patent rights related to ferric carboxymaltose injections for treatment of iron-defi ‑ ciency anaemia. The tribunal clarified the legal position on the Com ‑ petition Commission’s jurisdiction on such matters, holding that the Patents Act prevails over the Com ‑ petition Act in cases involving patent enforcement. It further noted that the Competition Act itself extends specific protection to patentees; therefore, initiating infringement proceedings cannot be construed as Parliament enacted the Jan Vishwas (Amendment of Provisions) Act, 2023, which came into force in August 2023, with the objective of decriminalising and ration ‑ alising offences while promoting a trust-based gov ‑ ernance framework. The legislation had amended the Patents Act by curtailing several penalties and fines and by simplifying the adjudication of offences and related appeals. Continuing this reform, the Patents (Amendment) Rules, 2025 operationalise this shift towards a structured framework. The amended rules have brought the following changes: • administrative adjudication framework – a new Chapter XIV-A has been introduced to govern con ‑ traventions that earlier attracted criminal penalties under Sections 120, 122 and 123 of the Patents Act; • electronic filing of complaints – complaints con ‑ cerning contraventions must now be filed electroni ‑ cally under Form 32; anti-competitive or abuse of dominance. Decriminalisation of the Patents Law • time-bound enquiry – the amended rules mandate digital show-cause notices and provide a struc ‑ tured, time-bound opportunity for response, hear ‑ ing, consideration of evidence and final decision by the authority; and

not apply if the later process results in a new product or employs at least one new reactant. The subject invention concerned a multi-step chemical process for treating industrial effluents and recovering useful by-products. The Patent Office had rejected the application by holding that the steps involved were standard chemical operations and that the claimed process was merely the use of a known process. The Division Bench set aside the findings of the Assistant Controller, noting that the comparison performed was insufficient and lacked a feature-by-feature compari ‑ son with the cited prior arts. The Court also held that the “person skilled in the art” test was irrelevant in determining the applicability of Section 3 (d). Letters rogatory for a parallel US litigation In Pfizer Inc and Others v Softgel Healthcare Pvt Ltd , the Madras High Court addressed Pfizer’s request to enforce letters rogatory issued by the US District Court, Delaware. The petition sought appointment of a commissioner to obtain documents and record tes ‑ timony from Softgel, which was not a party to the US litigation but allegedly possessed information relating to the ANDA product at issue. Softgel opposed the petition, citing it as a “fishing expedition”. The Madras High Court, however, emphasised India’s obligation under the Hague Evidence Convention and interna ‑ tional comity, noting that execution of letters rogatory is permissible unless it conflicts with Indian law. Writ jurisdiction against pre-grant opposition In Adiuvo Diagnostics Pvt Ltd v Union of India , the petitioner had challenged the rejection of its pre-grant opposition and the granting of a patent to a foreign applicant. The petitioner argued that the order was perverse as it failed to consider critical evidence, including expert affidavits relied upon in the oppo ‑ sition. The respondents objected to maintainability of the petition. However, the Court reaffirmed that, although the petitioner had other statutory remedies open, its jurisdiction under Article 226 cannot be oust ‑ ed where there is failure to consider material evidence or where the decision-making process is perverse. It reviewed the impugned order and observed that the Patent Office had failed to consider the affidavits of three experts. The Court remanded the matter for re- hearing and decision in a time-bound manner.

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