Can Manufacturing for Export Constitute Patent Infringement? – A Detailed Analysis Under Indian Law

Intellectual property laws, particularly patent protection, play an essential role in promoting innovation by granting inventors exclusive rights over their inventions. One recurring question that arises in patent-intensive industries—especially pharmaceuticals, biotechnology, chemicals, and engineering—is whether manufacturing a patented product within India exclusively for the purpose of export amounts to infringement of the patentee’s rights in India. This issue is crucial for companies that rely heavily on exports and need clarity to avoid potential litigation.

Indian law provides a clear framework on the rights of a patentee, the scope of infringement, and the statutory exceptions that may apply. The jurisprudence that has evolved over the last decade, particularly through the Delhi High Court, has further clarified the answer. This article examines whether exporting patented products manufactured in India constitutes infringement under the Patents Act, 1970, and discusses the relevant case law and statutory provisions.

Exclusive Rights of a Patentee Under Indian Law

Section 48 of the Patents Act, 1970 gives the patent-holder the exclusive right to:

The important point is that the restriction applies to acts done within India. Therefore, even if the final product is never sold or used in India and is completely exported, the act of manufacturing itself violates the patentee’s exclusive rights unless the law specifically allows it.

The Patents Act does not give any general exemption for “manufacture for export.” Unlike customs or trade laws that treat domestic and export markets differently, patent law protects the patent-holder’s monopoly against any unauthorised making of the invention in India. Manufacturing for export includes several acts—making, storing, and often selling—that fall within Section 48. As a result, manufacturing for export is treated the same as manufacturing for the domestic market. So, export is not treated as a separate or neutral act; it is only the result of the earlier act of manufacture that already amounts to infringement.

In Raj Parkash v. Mangat Ram Chowdhry (Delhi High Court), the Court held that manufacturing a patented invention without consent is a complete infringement by itself, even if the product is not ultimately sold. This basic principle has been relied upon in many later decisions. Indian patent law therefore focuses on where the infringing act takes place, not on the market where the product is finally sold.
Accordingly, when a product is manufactured in India, the patent-holder’s rights are violated at the moment of manufacture. The fact that the product is meant for export does not remove the infringement, because the infringing act happens within India’s borders.

Statutory Exceptions Under Section 107A: Narrow Safe Harbours

The only situations in which manufacturing linked to export may be lawful are those specifically mentioned in Section 107A of the Patents Act. These provisions create narrow exceptions and courts have always interpreted them strictly, without allowing any broad or implied exemption.

Sections 107A(a) and 107A(b) provide limited exceptions only for genuine research or regulatory purposes. Under Section 107A(a), acts done for experimental or research use must be genuine and cannot be used as a cover for commercial activity. This was explained by the Delhi High Court in Roche v. Cipla (2009), where large-scale manufacturing in the name of experimentation was clearly rejected.
Section 107A(b), often called the Bolar exemption, allows the making, using, or exporting of a patented invention only to the extent reasonably necessary for generating and submitting information to regulatory authorities in India or abroad. In Bayer Corporation v. Union of India (2019), the Delhi High Court firmly held that exports are allowed only when they are directly connected to regulatory approval, the quantities manufactured or exported match that purpose, and there is no element of commercial supply. The Court clearly rejected the idea of a general export exemption.

Similarly, in NATCO Pharma Ltd. v. Bayer Corporation, and again in Merck Sharp & Dohme Corp. v. Sanjeev Gupta, the Court placed the responsibility on the manufacturer to show:

Any sign of commercial intention, or large-scale exports suggesting commercial purpose, was held to completely defeat a defence under Section 107A.

Recent Judicial Clarification

The issue of whether manufacturing a patented invention in India for export constitutes infringement was addressed directly by the Delhi High Court in Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd., CS (COMM) 565/2025. This decision is significant as it brings conceptual clarity to the relationship between Section 48 (exclusive rights) and Section 107A(b) (the regulatory or Bolar exception), treating them as complementary rather than competing provisions.

The Delhi High Court expressly rejected the argument that export-oriented manufacture enjoys any inherent immunity. Instead, it held that only a specific legislative exemption can override Section 48, and such exemption must be strictly proven.

This reasoning is consistent with earlier authorities such as Bayer Corporation v. Union of India, but Novo Nordisk goes further by clearly stating that export is not neutralised merely because the goods leave India. Judicial restraint in expanding export exceptions is guided by broader policy considerations. As noted in Bayer v. Union of India, diluting patent rights through unchecked export manufacturing would:

The courts have therefore ensured that statutory exceptions are applied only in genuine cases and not as a route for commercial circumvention

Conclusion

Indian patent law adopts a clear and consistent position: manufacturing a patented product in India for export constitutes patent infringement, irrespective of whether the product is sold domestically. Export is not a general defence, and the act of manufacturing itself violates the patentee’s exclusive rights under Section 48.

Only narrowly tailored exceptions—particularly under Section 107A(b)—permit limited manufacturing or export, and only when such acts are strictly confined to regulatory purposes, non-commercial in nature, and proportionate in scope. Courts place a heavy evidentiary burden on manufacturers seeking the benefit of these exceptions.

In light of robust enforcement and evolving jurisprudence, businesses engaged in export-oriented manufacturing must exercise caution, undertake thorough patent due diligence, and obtain appropriate licences or legal advice to mitigate infringement risks.

Manan Doshi

Manan is an Associate in the Litigation Team, focusing on court proceedings, drafting pleadings, conducting in-depth legal research, and analysing judicial outcomes across a broad spectrum of intellectual property disputes. He has a keen interest in legal research and is particularly passionate about the international intellectual property landscape.