Patent export for regulatory approval falls within Section 107A and is not infringement when confined to bona fide development use.

Section 107A of the Patents Act permits making, using, selling, importing and exporting a patented product when the activity is undertaken solely for development and submission of information required for regulatory approval in India or abroad, and such conduct is not infringement merely because it crosses territorial borders. The provision is a distinct special enactment reflecting a separate legislative policy, not a mere proviso subordinated to Section 48. Whether a particular export is genuinely for regulatory use depends on facts and evidence, so such disputes should ordinarily be pursued in civil proceedings rather than writ jurisdiction.

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Issues: (i) Whether sale and export of a patented product for development and submission of information required for foreign regulatory approval fall within Section 107A of the Patents Act, 1970. (ii) Whether Section 107A is merely an exception or proviso to Section 48, or an independent special provision. (iii) Whether disputes on whether an export is genuinely for Section 107A purposes should ordinarily be decided in writ proceedings.

Issue (i): Whether sale and export of a patented product for development and submission of information required for foreign regulatory approval fall within Section 107A of the Patents Act, 1970.

Analysis: The statutory language of Section 107A was read in its plain and contextual sense. The words "making, constructing, using, selling or importing" were held to cover activity undertaken solely for uses reasonably related to development and submission of information required under Indian law or the law of a country other than India. The Court held that the word "selling" is not territorially confined to India and that export of the patented product can be part of such sale where the end use is regulatory and not commercial. The Court also relied on the legislative history of the Bolar-style exemption and on comparative materials, including the TRIPS framework and foreign regulatory-exception jurisprudence, to hold that the quantity exported is not by itself decisive.

Conclusion: Yes. Sale and export for genuinely regulatory purposes fall within Section 107A and do not constitute infringement.

Issue (ii): Whether Section 107A is merely an exception or proviso to Section 48, or an independent special provision.

Analysis: Section 48 confers the patentee's exclusive rights subject to the other provisions of the Act, whereas Section 107A was enacted as a distinct special provision reflecting a separate legislative policy. The Court rejected the contention that Section 107A must be narrowly treated as a proviso to Section 48. It held that the provision is not to be subordinated to Section 48 in the manner of a classical proviso, but must be given full effect in accordance with its text and purpose.

Conclusion: Section 107A is an independent special provision and not a mere proviso or exception subordinated to Section 48.

Issue (iii): Whether disputes on whether an export is genuinely for Section 107A purposes should ordinarily be decided in writ proceedings.

Analysis: The Court held that whether a particular export is truly connected to regulatory development and submission of information depends on facts, quantities, end use, destination, and regulatory requirements. Such matters call for factual inquiry and, where necessary, evidence and expert evaluation. The Court therefore held that blanket public law reliefs such as seizure directions or broad prohibitory orders are not appropriate for such controversies, and the dispute is better addressed in civil proceedings.

Conclusion: Such disputes should ordinarily be tried in civil proceedings and not in writ jurisdiction.

Final Conclusion: The Court upheld the legality of sale and export of patented products when confined to bona fide regulatory-use purposes under Section 107A, rejected the restrictive territorial reading urged by the patentee, and directed that factual disputes of this kind be resolved in civil suits rather than by public law remedies.

Ratio Decidendi: Section 107A permits making, constructing, using, selling, or importing a patented invention, including for export, when the act is solely for reasonably related regulatory development and submission of information, and such conduct is not to be treated as infringement merely because it crosses territorial borders.

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