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Patent Rights and Their Impact on Pharmaceutical Markets

Introduction

The recent decision of the National Company Law Appellate Tribunal (NCLAT) in “Swapan Dey v Competition Commission of India & Anr.[1]” brings back the focus on the interplay between patent rights, competition law, and public health in the pharmaceutical sector. While the case has largely been viewed as a jurisdictional determination concerning the respective roles of patent and competition authorities, it also raises broader questions regarding how issues of pricing, licensing, and market access associated with patented pharmaceutical products are to be addressed within the existing legal framework.

Pharmaceutical markets present distinctive challenges for regulation. Structural features such as inelastic demand, information asymmetries between suppliers and consumers, and significant regulatory barriers to entry can amplify the effects of exclusivity. Against this backdrop, the interaction between patent protection and competition oversight assumes particular importance, especially where access to essential medicines is implicated.

The Dispute and the NCLAT’s Decision

The dispute arose when Swapan Dey, associated with a hospital operating a dialysis facility, filed information under Section 19 (1) (a) of the Competition Act, 2002 before the Competition Commission of India (CCI). The information was filed against Vifor International AG, the patentee and supplier of ferric carboxymaltose (FCM), an injectable drug used for the treatment of iron deficiency anaemia.

It was alleged that Vifor’s pricing practices, limited availability of FCM, and patent exclusivity resulted in denial of access to the drug. The informant further contended that Vifor had abused its dominant position by entering into exclusive licensing arrangements with only two Indian companies, Emcure and Lupin, thereby restricting supply, in violation of Sections 3 (4) and 4 (2) (b) (i) of the Competition Act.

Patent rights and their pharmactual marketAfter defining the relevant market and examining the allegations, the CCI[2] held that no prima facie case of anti-competitive agreement or abuse of dominance was made out and closed the matter under Section 26 (2) of the Act. On appeal, the NCLAT upheld the CCI’s decision. In doing so, the Tribunal emphasised that conduct arising from the exercise of patent rights must be examined within the framework of the Patents Act, 1970, which it characterised as the special statute governing patent licensing, working, and public-interest safeguards. The Tribunal’s reasoning effectively treated the dispute as patent-centric and outside the scope of competition law scrutiny.

Pharmaceutical Patents and Competition Law: Past Practice

The approach adopted in Swapan Dey may be contrasted with earlier instances where the existence of patent rights did not preclude an examination of market effects under competition law. In Macleods Pharmaceuticals Ltd. v Boehringer Ingelheim,[3] the CCI examined allegations relating to aggressive patent enforcement strategies and conduct aimed at delaying the entry of generic medicines. While the matter was ultimately closed at the prima facie stage, the Commission considered issues such as licensing behaviour, supply restrictions, and communications with medical professionals.

Similarly, in Biocon Ltd. & Mylan Pharmaceuticals Pvt. Ltd. v F. Hoffmann-La Roche AG,[4] the CCI declined to accept the contention that pending patent and regulatory proceedings before civil courts ousted its jurisdiction. The Commission held that allegations concerning pricing, market access, regulatory interference, and exclusionary conduct could be examined independently under the Competition Act. These decisions reflect an approach that recognises the potential market implications of pharmaceutical patent rights while assessing conduct on a case-specific basis. This approach is also reflected in Manoj Hirasingh Pardeshi v Gilead Sciences Inc.[5], where the CCI analysed the competitive implications of voluntary licensing arrangements for antiretroviral drugs, notwithstanding the eventual closure of the matter on the ground of lack of dominance.

Judicial Engagement with Market Effects under Patent Law

Indian courts adjudicating pharmaceutical patent disputes under the Patents Act have also engaged with considerations that overlap with competition-related concerns. In Natco Pharma Ltd. v Bayer Corporation[6], patent authorities and courts examined not only the validity of patent rights but also the effects of pricing and supply on access to medicines, treating affordability and availability as relevant factors in the grant of a compulsory licence.

In F. Hoffmann-La Roche Ltd. v Cipla Ltd.[7], the Delhi High Court, while considering interim injunctive relief, weighed patent exclusivity against public interest, taking into account the availability of lower-priced alternatives. A similar sensitivity to market consequences is evident in BDR Pharmaceuticals v Bristol-Myers Squibb[8], where licensing behaviour and supply practices were scrutinised to assess whether public demand was being met.

Judicial attention to market foreclosure has also been visible in Bayer Corporation v Union of India[9], where attempts to delay generic entry through regulatory mechanisms were rejected. More recently, in the Risdiplam litigation (F. Hoffmann-La Roche AG v Natco Pharma Ltd.[10]), courts did not ignore the practical implications of patent exclusivity on pricing, availability, and patient access, even while focusing on patent validity and interim relief.

Read together, these decisions indicate that the regulatory approach to patent-related conduct in the pharmaceutical sector has not been confined to a single statutory framework. While competition authorities have examined such conduct through the lens of market effects under the Competition Act, parallel consideration of access, pricing, and supply has also emerged in judicial proceedings under the Patents Act. This overlap becomes more evident when one turns to decisions of Indian courts adjudicating pharmaceutical patent disputes, where questions of exclusivity have been assessed alongside public interest and market-related considerations.

Statutory Context and the Interface Between Patent and Competition Law

Indian statutory law reflects a calibrated balance between patent exclusivity and public interest considerations. The Patents Act, 1970 incorporates safeguards such as Section 83, which emphasises the working of patents in India and their availability at reasonably affordable prices, and Section 84, which provides for compulsory licensing where public requirements are not met or access is restricted due to pricing. Section 140 further prohibits unfair or restrictive licensing conditions.

At the same time, the Competition Act, 2002 permits intellectual property holders to impose reasonable restrictions necessary for protecting their rights under Section 3(5), while continuing to regulate abuse of dominant position under Section 4 without providing blanket immunity for IP-related conduct. Read together, these provisions demonstrate a legislative intent to accommodate both innovation incentives and market-related concerns, particularly in sectors such as pharmaceuticals.

Practical Implications for Patent-Intensive Markets

Viewed in this light, the decision in Swapan Dey carries practical implications for stakeholders operating in patent-intensive markets. By emphasising the Patents Act as the primary forum for disputes arising from the exercise of patent rights, the ruling clarifies the regulatory pathway for addressing issues relating to licensing, pricing, and access. At the same time, it underscores the importance of understanding the scope and limitations of remedies available under patent law, particularly in sectors such as pharmaceuticals where market effects may be immediate.

From an advisory and compliance perspective, the ruling is also likely to influence how disputes are framed and pursued by affected parties. Patentees, licensees, healthcare providers, and procurement agencies may need to engage more closely with patent law mechanisms when raising concerns linked to supply, affordability, or licensing conditions. The decision further highlights the relevance of strategic forum selection, evidentiary preparation, and timing of relief in matters situated at the intersection of intellectual property and competition law.

Conclusion

The decision in Swapan Dey v Competition Commission of India is significant not merely for its jurisdictional holding but for the clarity it provides regarding the regulatory framework applicable to disputes arising from the exercise of patent rights. By reaffirming the central role of the Patents Act in governing licensing and access-related issues, the ruling is likely to shape future enforcement strategies and dispute resolution approaches in patent-intensive sectors. As pharmaceutical markets continue to raise complex questions concerning innovation, access, and competition, the interaction between patent and competition law will remain a critical area of legal and policy engagement.

Author: Aditi Yadav, in case of any queries please contact/write back to us via email to [email protected] or at IIPRD. 

References

  1. The Patents Act, 1997
  2. The Competition Act, 2002
  3. Gitanjali Shankar & Nitika Gupta, Intellectual Property and Competition Law: Divergence, Convergence and Independence (2011) 4 NUJS Law Review 113.
  4. Smruthy N. Pradeep, Anti-Competitive Behaviour in the Patented Pharmaceutical Industry: A Study of the Cases before the Competition Commission of India, IP Bulletin Vol. III, Issue I (2022) 132–144.
  5. Swapan Dey v Competition Commission of India & Anr., Competition Appeal (AT) No. 5 of 2023, NCLAT (decided 30 October 2025), arising out of CCI Case No. 05 of 2022.
  6. In Re: Swapan Dey, Case No. 05 of 2022, Competition Commission of India, order dated 25 October 2022 (order under section 26(2), Competition Act, 2002).
  7. Macleods Pharmaceuticals Ltd. v Boehringer Ingelheim, Case No. 59 of 2019, Competition Commission of India.
  8. Biocon Ltd. & Mylan Pharmaceuticals Pvt. Ltd. v F. Hoffmann-La Roche AG, Case No. 68 of 2016, Competition Commission of India.
  9. Manoj Hirasingh Pardeshi v Gilead Sciences Inc., Case No. 03 of 2012, Competition Commission of India.
  10. Natco Pharma Ltd. v Bayer Corporation, Compulsory Licence Application No. 1 of 2011, Controller of Patents (9 March 2012).
  11. Bayer Corporation v Union of India, (2014) 60 PTC 277 (Bom).
  12. F. Hoffmann-La Roche Ltd. v Cipla Ltd., (2009) 40 PTC 125 (Del).
  13. BDR Pharmaceuticals International Pvt. Ltd. v Bristol-Myers Squibb Company, Compulsory Licence Application No. 2 of 2013, Controller of Patents.
  14. Bayer Corporation v Union of India, W.P. No. 1323 of 2013, Bombay High Court.
  15. F Hoffmann-La Roche AG v Natco Pharma Ltd. (Risdiplam litigation), FAO(OS)(COMM) 43/2025, Delhi High Court.

[1] Swapan Dey v Competition Commission of India & Anr., Competition Appeal (AT) No. 5 of 2023, NCLAT (decided 30 October 2025), arising out of CCI Case No. 05 of 2022.

[2] In Re: Swapan Dey, Case No. 05 of 2022, Competition Commission of India, order dated 25 October 2022 (order under section 26(2), Competition Act, 2002).

[3] Case No. 59 of 2019, Competition Commission of India

[4] Case No. 68 of 2016, Competition Commission of India

[5] Case No. 03 of 2012, Competition Commission of India

[6] Compulsory Licence Application No. 1 of 2011, Controller of Patents (9 March 2012)

[7] (2009) 40 PTC 125 (Del)

[8] Compulsory Licence Application No. 2 of 2013, Controller of Patents

[9] (2014) 60 PTC 277 (Bom)

[10] FAO(OS)(COMM) 43/2025, Delhi High Court

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