Biosimilars, otherwise known as subsequent entry biologics or “SEBs” in Canada, are a rapidly emerging trend in healthcare. There is a common Needle-and-Threadmisconception that biosimilars are “generic” biologic medications. In reality, biosimilars and traditional generic pharmaceuticals are significantly different, principally due to the distinct nature and complexity of the molecular structure of biologics. Biosimilars present novel and intriguing legal issues that are quickly rising to the forefront of legal commentary.
The emergence of biosimilars has come with improvements in technology, economics, and the prominent role that biologics now play in the healthcare setting. The complex technology used in the production of biologics is becoming less costly and early patents on the technology are now expiring. Biologics have also been accepted as a crucial treatment option for many indications that should occupy a standard care role, but the cost is often prohibitive. Biosimilars provide a more cost-effective option for patients to access valuable biologic treatments. Of course, not all biologic treatments will necessarily become available as biosimilars. Various business factors must be considered by potential biosimilar manufacturers, including the market size, the relevant science and technology, and the high cost of development and production.
In Cobalt Pharmaceuticals v Bayer, 2015 FCA 116, Justice David Stratas called for a full consideration by the Court of Appeal or SCC of the policy and logic arguments against the current law in Canada that methods of medical treatment are not patentable. Justice Stratas acknowledged that the issue would have to be squarely raised on the facts, but this should nonetheless provide incentive for litigants who have had patent claims defeated by this doctrine to seek appeal to these higher Courts for further consideration.
With the increasing number of biosimilar manufacturers seeking approval in markets around the world, including Canada, and the importance of dosage regimens for the administration of these extremely valuable and life-saving medicines, the issue of the patentability of methods of medical treatment may again be before the SCC in the coming years.
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A version of this article was published by LexisNexis in The Lawyers Weekly, 12 February 2016
Source: Lexology, Dimock Stratton LLPGeoffrey D. Mowatt and Nikolas S. Purcell