Section 107A explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Section 107A lists two acts that "shall not be considered as an infringement of patent rights". The first is making, constructing, using, selling or importing a patented invention solely for uses reasonably related to regulatory approval information. This limb is commonly called the Bolar exemption. The second is importation of patented products from a person who is duly authorised under the law to produce and sell or distribute the product, which is commonly called parallel import. If you are planning a generic launch or an import and want the position checked against the patent, our legal dispute resolution team can help.
Section 107A has two clauses and applies only "for the purposes of this Act". Clause (a) protects an act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to developing and submitting information required under any law that regulates the manufacture, construction, use, sale or import of a product, in India or abroad. Clause (b) protects importation of patented products from a person duly authorised under the law to produce and sell or distribute the product. Neither clause is a licence to sell the product commercially in India during the patent term.
Where section 107A sits and how it was changed
Section 107A was inserted by the Patents (Amendment) Act, 2002 with effect from 20 May 2003. The Patents (Amendment) Act, 2005, with effect from 1 January 2005, changed the text in four places. In clause (a) it replaced "using or selling" with "using, selling or importing" and "use or sale" with "use, sale or import". In clause (b) it replaced the words "who is duly authorised by the patentee to sell or distribute the product" with "who is duly authorised under the law to produce and sell or distribute the product". The Tribunals Reforms Act, 2021 and the Jan Vishwas (Amendment of Provisions) Act, 2023 did not touch this section. The previous section, section 107, deals with defences by way of revocation grounds and the section 47 conditions; section 107A is a separate list.
Clause (a): use for regulatory submissions
The text reads: any act of making, constructing, using, selling or importing a patented invention "solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product".
Break it into parts.
| Element | What the text says |
|---|---|
| Acts covered | Making, constructing, using, selling or importing the patented invention |
| Purpose test | "solely" for uses "reasonably related" to developing and submitting information |
| Which information | Information required under a law in force, in India or in another country |
| Which kind of law | A law that regulates the manufacture, construction, use, sale or import of any product |
| Result | The act "shall not be considered as an infringement of patent rights" |
Three points follow from the words.
- The word "solely" is the limit. If the same batch is also stocked for commercial sale, the act is not solely for regulatory use.
- The laws need not be Indian. A submission that a foreign regulator requires also qualifies, if the use is reasonably related to developing and submitting that information.
- The clause is not confined to medicines. The text says "any product" and "any law" that regulates the product. The Act does not use the words "drug" or "Bolar" here; the label is a convention. Check this plain reading against the facts of your product.
The text is silent on how much quantity is reasonable, on which regulators qualify and on whether the exemption covers a patent still in force or only the last years of its term. A reader should not add such rules.
Clause (b): importation from an authorised person
Clause (b) says "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" shall not be considered an infringement.
Points to note:
- "By any person": the importer need not be the patentee, a licensee or an agent.
- The source: the seller abroad must be "duly authorised under the law to produce and sell or distribute the product". The 2005 amendment moved the test from authority granted by the patentee to authority under the law. The text does not say which country's law or how authority is shown. Do not assume.
- The clause covers importation. It does not on its face cover what the importer does afterwards, such as selling in India; the text speaks only of importation. Take advice on the later steps.
The Act does not use the term "parallel import" in this section, and it does not define exhaustion of rights. The clause stands on its own words.
What the section does not say
- It does not mention any form, fee or notice to the patentee.
- It does not say that the act must be approved by a regulator before it is done.
- It does not tell the court how to test "reasonably related".
- It does not say what happens to products made under clause (a) after the submission is complete.
- It does not use the word "Bolar" or "parallel".
Illustration (invented)
Veda Pharmaceuticals Ltd. holds a patent on a tablet formulation for a blood pressure medicine. Arka Generics Pvt. Ltd. makes ten small batches of the same tablet to prepare the data needed for a regulator's approval of its own product, in India and in a second country. Arka sells none of them and keeps the stock for tests. These acts are made solely for uses reasonably related to developing and submitting the information, so clause (a) says they are not infringement. If Arka had also sold two of the batches to a hospital, the "solely" test would fail for those.
In a second case, Karan Instruments Pvt. Ltd. imports a patented diagnostic device from Delta Devices GmbH, a foreign manufacturer that is duly authorised under the law of its country to produce and sell the device. Under clause (b) the importation is not an infringement of the Indian patent. Whether Karan's later resale is covered is not answered by the clause.
How this fits with other sections
Section 107A speaks of acts "not considered as an infringement". It does not take away the patent. The patentee's rights in section 48 remain; section 107A removes two kinds of act from the scope of infringement. If a claim of infringement is made against you, relief in a suit is dealt with in section 108. The article on section 105 and 106 deals with a declaration that an act is not an infringement, which can be useful before a launch.
Need help checking an import or a regulatory trial?
Whether an act is "solely" for regulatory use, or whether an overseas seller is duly authorised under the law, depends on the documents. Our legal dispute resolution team can review them and advise before the batch is made or the shipment is ordered.
Key takeaways
- Section 107A has two clauses; both say the act "shall not be considered as an infringement of patent rights".
- Clause (a) turns on the word "solely": use reasonably related to developing and submitting information required under a law, in India or abroad.
- Clause (b) covers importation from a person duly authorised under the law to produce and sell or distribute the product; the 2005 amendment dropped the patentee's authorisation test.
- The text sets no quantity, no notice and no form.
- Commercial sale during the patent term is not made lawful by clause (a).
Read next
- Section 107: defences in a suit for infringement
- Section 108: reliefs in suits for infringement
- Defences in patent infringement suits
- Patent infringement: what constitutes and how to sue
Disclaimer: Based on the Patents Act, 1970 as amended up to the Jan Vishwas (Amendment of Provisions) Act, 2023, as consulted on 1 October 2026. Forms, fees and time limits under the Patents Rules, 2003 change from time to time and are not covered here. This article is general information, not legal advice; check the official text before acting.