Back to glossary

Bolar exception

Definition : Bolar exception

The Bolar exception is an exception to the exclusive right conferred by a pharmaceutical patent that allows a third party to carry out certain research and development (R&D) activities without fear of being sued for infringement, even if these activities involve the use of a third party's patent. This exception is mainly used in the pharmaceutical field and concerns the manufacture of and experimentation with medicines before the end of the patent protection period.

Principle

The Bolar exception authorizes a third party, without the consent of the patent holder, to use a patented invention for the purpose of preparing a regulatory file to obtain a marketing authorization (MA) for a product, generally a medicine. This exception aims to encourage competition by allowing companies to begin the work necessary to bring generic drugs to market as soon as possible, without waiting for the patent to expire, which can sometimes take several years.

The Bolar exception in the international and European context:

  1. United States: The Bolar exception was recognized in the United States under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This legislation allows generic drug manufacturers to begin producing and testing their products before patents expire, in order to prepare the MAA application to the Food and Drug Administration (FDA). This law is a perfect example of the application of the Bolar exception in American law, as it facilitates rapid access to generic medicines and therefore competition in the pharmaceutical market.
  2. European Union: In Europe, the Bolar exception was introduced into European Union law by Regulation (EC) No. 469/2009 concerning the drug patent. Article 10 of this regulation stipulates that it is possible to conduct the preclinical and clinical studies necessary to obtain a marketing authorization for a generic drug without violating the rights of the patent holder. This exception is limited to acts that do not infringe the effective implementation of the patent and that are carried out for the sole purpose of submitting an application for marketing authorization.
  3. The World Trade Organization (WTO): The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated within the framework of the WTO, does not contain a specific provision on the Bolar exception, but allows exceptions to the exclusive right to patents in certain cases, in particular for the manufacture of generic medicines for the purpose of submission to health authorities.

Conditions for application of the Bolar exception

For the Bolar exception to apply, several criteria must be met:

  1. Objective of the activity: The activities must be carried out for the sole purpose of obtaining a marketing authorization (MA) for a product, and not for marketing before the patent expires.
  2. Nature of use: The use of the patented invention must be limited to research and development purposes. Any activity for commercial purposes (such as the sale of generic products before the expiry of the patent) is not covered.
  3. Restriction géographique : L’exception Bolar s’applique généralement dans le cadre de la législation nationale ou communautaire, et son application peut varier d’un pays à l’autre. Dans l’UE, elle est spécifiquement appliquée pour les médicaments génériques.
  4. Geographical restriction: The Bolar exception generally applies under national or Community legislation, and its application may vary from one country to another. In the EU, it is specifically applied to generic medicines. Use for experimental purposes: The acts must be strictly related to the experimentation or research necessary to obtain a marketing authorization. They must not encroach on the commercial use of the protected product.

Objectives and issues of the Bolar exception

The Bolar exception primarily addresses a public health objective by facilitating access to generic medicines as soon as a patent expires, by reducing the time needed to bring generic versions of a medicine to market. It therefore promotes increased competition in the pharmaceutical industry, which can contribute to lower medicine prices.

However, it also raises questions of fair competition and protection of the rights of patent holders, particularly with regard to the balance between the incentive for innovation and access to health products. The application of the exception must therefore be carefully supervised to avoid abuse and to guarantee that the activities carried out under this exception are strictly linked to the preparation of a marketing authorization application and not for anticipated commercial purposes.

Conclusion

The Bolar exception is a mechanism aimed at establishing healthy competition in the pharmaceutical industry and promoting rapid access to generic drugs after the expiration of patents. By allowing research and development before the expiration of the patent, it balances the interests of patent holders and generic drug manufacturers, while serving the public interest of health. It is now a recognized principle in many jurisdictions, with specific adaptations according to local legislation and market needs.