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Bolar Exemptions in North America

Bolar Exemptions in the U.S.

Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated products. Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act") which created the Section 271(e)(1), which is often referred to as the "Safe Harbor" or "Bolar" exemption. The Bolar exemption insulates certain activities from patent infringement. Specifically, Section 271(e)(1) reads:

          It shall not be an act of infringement to make, use, offer to sell, or sell within the United
          States or import into the United States a patented invention (other than a new animal drug
          or veterinary biological product (as those terms are used in the Federal Food, Drug, and
          Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using
          recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving
          site specific genetic manipulation techniques) solely for uses reasonably related to the
          development and submission of information under a Federal law which regulates the
          manufacture, use, or sale of drugs or veterinary biological products.

Importantly, the Bolar exemption is equally applicable to generic and branded pharmaceuticals, medical devices, biologics, and biosimiliars and exempts a wide variety of activities reasonably related to gaining information relevant to gaining FDA approval. While both pre- and post-approval activity can be exempt, only limited types of post-approval conduct is exempt.[1]

Bolar exemptions in Canada

Canada provides both a statutory and common law exemption to patent infringement for regulated drug products. The statutory exemption to patent infringement is found in Section 55.2(1) of the Canadian Patent Act which states that:

         It is not an infringement of a patent for any person to make, construct, use or sell the
          patented invention solely for uses reasonably related to the development and submission
          of information required under any law of Canada, a province or a country other than
          Canada that regulates the manufacture, construction, use or sale of any product.

It is worth noting that this provision relates to regulatory approval for inventions in any technology area. Like the United States, the Canadian exemption extends to materials that are not submitted to a regulatory authority.

Bolar exemptions in Mexico

Mexican law similarly provides for a Bolar-like exemption, although such protection is available only when a patent is within eight years of expiration for a biologic product, or within three years for a small molecule. Unfortunately, neither the Mexican Institute of Industrial Property (IMPI) nor the Medicines Regulatory Agency (COFEPRIS) have provided any guidance on whether small quantities of active pharmaceutical ingredients can be imported for conducting tests and trials necessary for applying for a marketing authorization in Mexico.

[1] See, Momenta Pharms., Inc. v. Teva Pharms. USA Inc., 809 F.3d 610 (Fed. Cir. 2015), cert. denied sub nom. Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 137 S. Ct. 68 (2016).

© 2023 Sterne KesslerNational Law Review, Volume VII, Number 352

About this Author

Paul Calvo, Intellectual Property Attorney, Sterne Kessler Law Firm
Ph.D. Director

Dr. Calvo, a director in the Biotechnology/Chemical Group, represents a diverse group of U.S. and international companies innovating in the biotechnology and pharmaceuticals industries.  He provides counsel with regard to global patent portfolio strategy, licensing, patent validity, infringement, and design around strategies.  Dr. Calvo is experienced in U.S. and international patent procurement and enforcement matters (particularly patent prosecution and oppositions), FDA/ANDA practice, technology transfer, invalidity, noninfringement, freedom-to-operate and patentability opinions, and...