Section 107A of the Patents Act, 1970
Certain acts not to be considered as infringement
Says regulatory and research use of a patented invention, and importation from a person lawfully authorised to sell it, are not infringement.
Official legal text
The verbatim statutory text of this provision is reproduced from the official source and checked by our legal reviewer before it is published here. Until that check is complete for this page, read the exact wording directly from the official source linked below — it is the only version that governs.
Nothing here replaces the statute. The official wording of the provision, together with any Gazette notification that applies to it, governs. This page only explains that material in ordinary language.
What this section says, in plain language
Section 107A carves out two acts that would otherwise be infringement. It was introduced by the Patents (Amendment) Act, 2002 and reshaped by the 2005 amendment, and it is central to how the Indian generic pharmaceutical industry operates.
The first exception is often called the Bolar provision or the regulatory use exception. Making, constructing, using, selling or importing a patented invention is not an infringement if it is done solely for uses reasonably related to the development and submission of information required under any law, in India or abroad, that regulates the manufacture, construction, use, sale or import of a product. In plain terms, a generic manufacturer may make batches of a patented drug while the patent is still in force, run the stability and bioequivalence studies, and file its regulatory dossier, so that it is ready to launch on the day the patent expires. Without this exception every generic entry would be delayed by years after expiry, which would give the patentee a period of extra monopoly the law never intended.
The exception is defined by purpose. The words 'solely for uses reasonably related' are the limit. Building commercial stock for sale, supplying the market, or exporting material for ordinary commercial purposes is not covered merely because a regulatory file exists somewhere. Anyone relying on this exception should keep documents showing which regulator the material is for, the quantities involved and how they relate to the studies required.
The second exception concerns importation. Importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product is not an infringement. This is India's limited form of exhaustion for imports. The 2005 amendment changed the earlier wording, which had required authorisation by the patentee, to authorisation under the law, and the change is significant: the authority to produce and sell may come from the legal regime of the exporting country rather than from the Indian patentee's consent.
The practical value of Section 107A is timing and access. It allows research and regulatory work to run in parallel with the patent term, and it allows lawfully produced goods to be sourced from abroad. It is not a general research exemption for academic work, which is dealt with by the conditions in Section 47, and it is not a licence to sell. Patentees should also note that it works both ways: an Indian innovator whose product is being studied abroad by a foreign generic company usually cannot stop that work either.
Why this section matters
Generic and biosimilar manufacturers, contract research and manufacturing organisations, importers and distributors, and innovator patentees planning life-cycle strategy.
During the last years of a patent term, when regulatory dossiers are prepared, and whenever goods are imported from a lawfully authorised source.
A defence that specified regulatory, research and importation activities do not amount to infringement.
A manufacturer that overshoots into commercial stockpiling loses the exception and faces an injunction and damages, while a patentee who assumes all pre-expiry activity is infringement may bring a suit that fails.
How it works in practice
Preparing a dossier while the patent is still alive
Prayag Pharmaceuticals Ltd of Ahmedabad wants to launch a generic version of a cardiovascular drug on the day the Indian patent held by Meridian Therapeutics expires, three years from now. It manufactures small batches of the active ingredient, runs dissolution and stability studies, conducts a bioequivalence study through a licensed clinical research site, and prepares filings for the Indian regulator as well as for two regulators abroad. Meridian sends a notice alleging infringement. Prayag replies under Section 107A, producing its study protocols, the regulatory correspondence and batch records showing that every kilogram made was allocated to the studies and retained samples. Because the acts are solely for uses reasonably related to the development and submission of information required by drug regulators, they are not infringement. Two years later Prayag's commercial team, keen to be first to market, wants to build launch stock in advance. Its counsel advises against it: manufacturing for commercial sale is not reasonably related to a regulatory submission, and stockpiling would take the activity outside Section 107A and expose the company to an injunction before expiry.
Simplified illustration only. Actual legal outcomes depend on the facts.
Key points to remember
- Acts done solely for uses reasonably related to development and submission of regulatory information are not infringement.
- This covers regulatory requirements under Indian law and under the law of other countries.
- The exception is limited by purpose; commercial stockpiling and market supply are outside it.
- Importation from a person duly authorised under the law to produce and sell or distribute the product is not infringement.
- The 2005 amendment replaced authorisation by the patentee with authorisation under the law.
- Keep batch records, study protocols and regulatory correspondence to prove the exception applies.
Common mistakes and misunderstandings
- Treating the provision as a general research exemption. Academic and experimental use is addressed by the conditions under Section 47.
- Assuming that any quantity may be made so long as some regulatory filing exists. Volumes must be consistent with the studies.
- Believing the importation exception permits imports from any source. The supplier must be duly authorised under the law to produce and sell or distribute.
- Confusing this exception with a compulsory licence. Section 107A does not permit commercial sale in India during the patent term.
Connected provisions
This page explains a section of the Patents Act, 1970. The working detail that goes with it lives in the Patents Rules, 2003. The connected rules appear in their own block so that the statutory duty and the procedural steps stay clearly distinguishable when you cite either one.
Forms, deadlines and fees
Any official fee connected with this provision is fixed by the First Schedule to the Patents Rules, not by the provision itself. The amount depends on who the applicant is and on whether the filing is made online or on paper, so no figures are reproduced here. How Indian patent fees work.
Amendment history
What changed in this provision, newest first. Read the footnotes in the official consolidated text for the full record.
- 2005The Patents (Amendment) Act, 2005The importation limb was widened. Importing from a person duly authorised under the law to produce, sell or distribute the product is not infringement.
- 2002The Patents (Amendment) Act, 2002The section was inserted, creating two safe harbours: acts done to develop and supply information required by a law regulating the manufacture or sale of a product, and importation by a person authorised by the patentee.
Compiled from official consolidated texts and Gazette notifications. See the site-wide change log.
Related judgments
You will not find case summaries under this heading today. Each one must pass a legal review before it appears, and that work has not been completed for this provision. If you are researching decided cases, use a law report or a court database in the meantime. How case notes are prepared.
Questions people ask about Section 107A
What is the Bolar exemption in Indian patent law?
It is the first limb of Section 107A. Making, constructing, using, selling or importing a patented invention is not infringement when it is done solely for uses reasonably related to the development and submission of information required under a law regulating the manufacture, use, sale or import of a product. The law may be Indian or foreign. It lets a generic manufacturer complete its development and regulatory work during the patent term so that it can enter the market promptly once the patent expires.
Can I stockpile product before the patent expires?
No. Section 107A protects acts done solely for uses reasonably related to regulatory development and submission. Manufacturing commercial quantities for sale after expiry is a commercial purpose, not a regulatory one, and it falls outside the exception. Courts look at volumes, batch documentation and internal plans. If the quantity made greatly exceeds what the studies and retained samples require, the exception is likely to fail and the patentee can seek an injunction and damages for the excess.
Does Section 107A allow parallel imports into India?
It allows importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product. The 2005 amendment changed the test from authorisation by the patentee to authorisation under the law, which widens the position considerably. What still matters is the status of your supplier: you need to be able to show that the supplier was lawfully entitled to produce and sell or distribute the product. Keep supply chain documents proving that entitlement.
Can I export material made under Section 107A?
Export is possible where it is genuinely part of the regulatory purpose, for example sending samples to a foreign regulator or to a partner conducting studies required for a foreign submission. Indian courts have examined export cases closely, looking at quantity, the identity of the recipient and the regulatory need. Bulk commercial export dressed up as regulatory supply is unlikely to succeed. Document the foreign regulatory requirement, the recipient's role and the quantity justification before any consignment leaves.
Planning regulatory work before a patent expires?
MYCrave helps generic manufacturers and importers document activity so that it stays inside the Section 107A exception.
You will be speaking with MYCrave Consultancy & Services, the firm that operates this platform. General questions are answered free; matter‑specific work is quoted before anything is done.