Intellectual property law grants patent holders a period of market exclusivity, typically 20 years, during which no one else can manufacture, use, or sell the patented invention. But this exclusivity isn’t absolute. Several narrow exceptions exist, and one of the most consequential for the pharmaceutical industry is the Bolar provision.
Concisely, the Bolar provision (also called the Bolar exemption or Bolar exception) allows generic and biosimilar manufacturers to conduct research, development, and regulatory testing on a patented drug before its patent expires. Most importantly, without that activity being counted as patent infringement. This helps generic versions reach the market almost immediately after patent expiry, rather than years later.
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Where the Bolar Provision Comes From
The exemption traces back to Roche Products, Inc. v. Bolar Pharmaceutical Co. (1984), a US case in which a generic manufacturer began testing a patented drug ahead of patent expiry to prepare its regulatory submission. The court initially ruled this as infringement, a decision that would have effectively extended the innovator’s monopoly well beyond the patent term, since generics couldn’t even start the testing and approval process until the patent lapsed.
Congress responded by codifying a research exemption in the Hatch-Waxman Act of 1984, which established that it is not an act of infringement to make, use, or import a patented invention solely for purposes reasonably related to generating the data needed for FDA submission. This is often referred to as the “safe harbor” provision in US patent law, and it’s the direct ancestor of what the rest of the world now calls the Bolar exemption.
Internationally, the concept is explicitly recognized under TRIPS Article 30, which permits WTO member countries to carve out limited exceptions to patent rights, the Bolar exemption being the most widely adopted example.
Bolar Exemption vs. Bolar Exception
Functionally, no. “Bolar provision,” “Bolar exemption,” and “Bolar exception” all refer to the same legal mechanism: a carve-out that permits pre-patent-expiry research and regulatory filings for generic or biosimilar products.
The terminology simply varies by region and by author. US commentary tends to use ‘exemption’ or ’safe harbor,’ while Indian and international IP literature more often uses ‘exception’ or ‘provision.’ When you see any of these terms in a regulatory or patent context, they’re pointing to the same principle.
The Bolar Provision Around the World
| Jurisdiction | Legal Basis | Key Detail |
| United States | 35 U.S.C. § 271(e)(1), via Hatch-Waxman Act | Permits pre-expiry testing and ANDA (Abbreviated New Drug Application) preparation without infringement liability |
| India | Section 107A, Indian Patents Act, 1970 | Defines specific acts, including sale, manufacture, and construction, for regulatory submission that are not considered infringement |
| European Union | Directive 2004/27/EC (the “Bolar clause”) | Allows studies, trials, and regulatory filings needed for generic/biosimilar marketing authorization before patent expiry |
Most major pharmaceutical markets have adopted some form of this exception precisely because, without it, generic entry would be delayed by years after every patent expiry — undermining the very purpose of a fixed patent term.
Why the Bolar Provision Matters for Generic and Biosimilar Developers
For generic and biosimilar companies, the Bolar exemption is what makes “day-one launch” strategies possible. It allows manufacturers to:
- Source reference listed drugs (RLDs) and comparator products for bioequivalence and bioavailability studies while the innovator’s patent is still active
- Conduct the clinical and analytical work required to support an ANDA or biosimilar application
- File for regulatory approval so that market entry can happen immediately or very close to patent expiry, rather than years afterward
This is also why comparator drug sourcing has become such a specialized function in clinical trial supply chains: developers need compliant, well-documented access to innovator products during the patent window, precisely because the Bolar exemption protects that research activity. Getting comparator sourcing and regulatory documentation right during this window can directly affect how quickly a generic or biosimilar reaches patients after exclusivity ends.
The Bottom Line
The Bolar provision, whether you call it an exemption or an exception, is one of the most practically important concepts in generic and biosimilar drug development. It doesn’t shorten a patent term, but it removes the artificial delay that would otherwise follow patent expiry, letting affordable generic alternatives reach patients faster.
Spring Bio Solution specializes in sourcing and supplying Reference Listed Drugs (RLDs), comparators, and innovator products for clinical trials, bioequivalence (BE) studies, and research programs worldwide.
Looking for a reliable sourcing partner? Contact us today to discuss your RLD and comparator sourcing requirements.
Frequently Asked Questions
What is the Bolar exemption?
The Bolar exemption is a patent law provision that allows generic or biosimilar manufacturers to research, test, and prepare regulatory submissions for a patented drug before the patent expires, without this being treated as patent infringement.
Is “Bolar exception” the same as “Bolar provision”?
Yes. “Bolar provision,” “Bolar exemption,” and “Bolar exception” all describe the same legal concept. They’re used somewhat interchangeably depending on the jurisdiction and source.
What is Section 107A of the Indian Patent Act?
Section 107A is India’s codification of the Bolar exemption. It specifies acts such as manufacture, sale, or import for the purpose of developing and submitting regulatory information that are not considered patent infringement.
Does the Bolar provision apply to biosimilars?
Yes. Most jurisdictions, including the US and the EU, extend Bolar-type protections to biosimilar development, allowing pre-expiry research and regulatory filing similar to those for small-molecule generics.
Can generic companies file an ANDA before patent expiry?
Yes. Under the Bolar exemption, generic companies can conduct the necessary studies and file an Abbreviated New Drug Application (ANDA) with the FDA before the innovator’s patent expires, so approval can be finalized close to or at patent expiration.
