Increased challenges in patenting diagnostic methods for companies in Canada could stifle innovation and investment in the sector.
Diagnostic methods are used to determine whether a patient has a particular condition, to provide a prognosis or to assess a treatment’s effectiveness .
Recent U.S. court decisions have made it more difficult to patent diagnostic methods in that country. The Canadian Intellectual Property Office (CIPO) last year released a practice notice concerning the examination of patent applications containing diagnostic method claims. The administrative notice does not have the force of law, but early office actions applying the guidance suggest that, with no basis in Canadian law, CIPO is adopting a much stricter test to determine the patentability of medical diagnostic methods.
The new practice notice contemplates that diagnostic methods that rely on a new technique or a new molecule to detect a condition remain patentable. For example, a diagnostic method that relates to a new technique used to detect the presence of a known biomarker or a method that describes a conventional technique used to detect the presence of a new biomarker are likely to be patentable under new CIPO guidelines.
However, diagnostic methods where the novelty lies in evaluating a correlation between acquired data and a disease state will likely be difficult to protect in Canada under the new administrative guidelines.
This is a significant issue for companies in the diagnostic space because many new diagnostic methods might be a newly discovered correlation between a medical condition and a known biomarker, in which the biomarker can be assayed by existing techniques.
The difficulty in securing patent protection for such methods creates a potential disincentive to innovate and invest in this area, because there is no period of exclusivity granted to recoup the costs of developing a new diagnostic method. Investors therefore cannot be assured of a return on their money.
In addition, the lack of readily available patent protection might increase secrecy in this area, as companies rely more on trade secret protection to give them a competitive advantage in the marketplace.
The full implications of CIPO’s revised position on the patentability of diagnostic methods remain unclear, and there remains considerable uncertainty as to the scope of available patent protection for diagnostic methods that don’t match CIPO’s criteria for patentability. As a result, the patenting strategy for some new diagnostic methods may need to be re-evaluated.
While certain diagnostic methods will continue to be readily protectable by patents, in other cases applicants might need to either reconsider use of the patent system altogether and rely on trade secret protection or be prepared for appeals to the Patent Appeal Board and, ultimately, the Federal Court of Canada. •
Jennifer Marles is a partner and Christina Kwok is an associate at Oyen Wiggs Green & Mutala LLP. Both are intellectual property lawyers. The article’s contents are not intended to be legal advice. Readers should contact a registered patent agent for advice on their specific circumstances.
