Research Exemptions to Patent Infringement
By Claire Palmer and Andrew Masson, January 6, 2025
Although many know there are research exemptions to patent infringement, the devil is in the details for successfully utilizing them. Each country has specific intricacies in how these exemptions operate, making careful planning vital. Here, we provide a general overview of Canada, the US, and the EU’s research/experimental use exemptions and highlight some important differences in how they operate.
A patent grants the patentee the right to stop others from making, using, or selling an invention for a period of time. There are however in most jurisdictions crucial “Research Exemptions” (also known as “Safe Harbours”, “Bolar Exemptions”, or “Experimental Exemptions”) for non-commercial research or experimentation. A Research Exemption insulates certain activities from claims of patent infringement and is supported by either statute (formal written laws) or common law (unwritten law based on previous court decisions).
Research Exemption in Canada:
In Canada, there are two exemptions:
1. A narrow statutory exemption for research and related activities mandated by the Government under regulatory laws;[1]
2. A broad common law “fair dealing” exemption for non-commercial research and experimentation.[2]
The statutory exemption has been interpreted by Canadian courts to capture activities that are both directly and indirectly required for regulatory reasons to sell products in Canada, for example, drug approval. Given the technicalities of this exemption, if you think your activities will fall under it, we recommend that you seek legal advice prior to initiating any potentially infringing activities.
The common law research exemption is intended to enable “users” (i.e. researchers) to “infringe” a patent in a “fair” way (for non-commercial/non-fraudulent purposes). “Fair” is fact-specific and judged holistically. There are five factors that courts will consider and are questions that you should ask yourself when considering the use of patented inventions:
1. Is the research and related experimentation bona fide (genuine) and being done in good faith? For example, someone working in a non-commercial research lab to confirm that a patented process works would be considered fair dealing.
2. Are you producing the patented product in small quantities commensurate with the research being done? If you need 10 g to do the research, it may be fair to produce 12 g of the patented product, but producing 1,000 g is unlikely to be considered fair.
3. Is the patented product remaining in the possession of the researcher or will it enter the commercial market? If a patented product produced by the researcher, directly or indirectly, enters a commercial market in any way, it is unlikely to be considered fair.
4. Will the researcher make profits from the activities? Obviously, it is not “fair” to sell products resulting from their infringing activities. However, getting paid to conduct bona fide research (as covered by the first factor) is likely to be considered fair.
5. Is the use of a patented invention causing a loss to the patentee? The patentee does not have the right to completely bar you from experimenting with a patented invention. Research and experimentation to develop a product that doesn’t infringe the patent is allowed and that product can be commercialized, but the commercialized final product must be completely independent of the use of the patented invention.
Research Exemptions in the US:
The US and Canada have nearly identical statutory research exemptions for legally mandated regulatory information (and the same regulatory advice applies).[3] However, the common law research exemption in the US is limited to conduct “solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.”[4] This means any entity making and selling products in the US will find it highly unlikely that any experimentation will fall within the common law research exemption. Meaning the US’s common law research exemption is highly restrictive.
Research Exemptions in the EU:
Research exemptions in the EU operate in a manner analogous to Canada. The EU philosophy provides sufficient room for research activities that promote innovation, but individual countries ultimately dictate the language and operation of the law within that principle. Therefore, when operating in the EU it is important to understand the nuances of research exemptions for the countries relevant to you.
Should you have any questions or would like more information on patent research exemptions, please contact:
Claire Palmer, Ph.D., Senior Patent Agent
T: 613.801.0450
E:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it.
This article is general information only and is not to be taken as legal or professional advice. This article does not create a solicitor-client relationship between you and MBM Intellectual Property Law LLP. If you would like more information about intellectual property, please feel free to reach out to MBM for a free consultation.
[1] Patent Act, RSC 1985, c P-4, s 55.2(1).
[2] See Teva Canada Limited v Novartis AG, 2013 FC 141, online (CanLII): https://canlii.ca/t/fw81j; Micro Chemicals Limited et al v Smith Kline & French Inter-American Corporation, [1972] SCC 506, online (CanLII): https://canlii.ca/t/1xd2k; Merck & Co Inc v Apotex Inc, 2006 FC 524, online (CanLII): https://canlii.ca/t/1n553.
[3] Hatch-Waxman Act, 35 USC §271(e)(1).
[4] See Madey v Duke, 307 F 3d 1351 (CA FC 2002).
