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Bolar exception

Definition : Bolar exception

The Bolar exemption allows certain acts needed to prepare an application for marketing authorisation (MA) while patent protection remains in force. Its scope depends on the applicable law. It covers neither all R&D activities nor, by itself, a commercial launch.

Principle

The exemption allows a third party to use a patented invention, without the proprietor’s consent, to prepare a regulatory application for marketing authorisation. It enables the necessary work to begin before patent expiry, so that the authorisation process need not delay market entry once the relevant rights have expired.

International and European context

  1. United States: The Drug Price Competition and Patent Term Restoration Act 1984, also known as the Hatch-Waxman Act, introduced a regulatory-use exemption allowing manufacturers to prepare the work required for FDA approval before patent expiry.
  2. European Union: Article 10(6) of Directive 2001/83/EC, as amended by Directive 2004/27/EC (French text), exempts the studies and trials necessary for the procedures referred to in paragraphs 1-4, and the resulting practical requirements, from patent and SPC rights. These procedures include generic and certain similar biological medicinal products. Regulation (EC) No 469/2009 concerns SPCs, it did not introduce this exemption.
  3. World Trade Organization: The TRIPS Agreement does not contain a specific Bolar provision. It allows limited exceptions to patent rights subject to its conditions. Domestic legislation determines the available exemption.

Conditions for applying the exemption

In France, Article L. 613-5(d) of the Intellectual Property Code (French text) covers the required regulatory studies and trials and acts needed to conduct them or obtain marketing authorisation.

  1. Regulatory purpose: identify the marketing-authorisation application and substantiate the connection between the acts and its preparation.
  2. Relevant acts: document the trials, quantities, recipients and uses. Classification depends on the actual operations.
  3. Applicable law: identify where each act occurs and the governing provision. National exemptions do not have identical scopes.
  4. Distinctions: do not confuse this exemption with the experimental-use exemption in Article L. 613-5(b), or with general permission to market a product.

Purpose and practical significance

The exemption seeks to facilitate access to generic medicines after patent expiry by allowing the regulatory work to take place earlier. Its application must balance that purpose with the patent proprietor’s rights. The acts relied on should therefore be tied to preparation of the authorisation application, rather than treated as permission for an early commercial launch.

Conclusion

The Bolar exemption separates regulatory preparation from commercial exploitation. Its availability depends on the acts, the applicable national law and the relevant rights. A marketing authorisation does not itself establish freedom to operate.



Further reading



When preparing a launch, consult Pharma Litigation Watch and the glossary entry on patent infringement.


This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. Where the question arises in a real case, the useful moment is almost always before proceedings are issued.

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