Good morning. I am Gail Garland, CEO of the Ontario Bioscience Innovation Organization, a private sector, membership-based organization engaged in advocacy to enable development and commercialization in Ontario of life science technology through investment, strategic alliances, stakeholder engagement, thought leadership, and industry promotion.
As I prepared for today's session, I consulted with OBIO's membership—companies engaged in developing therapeutics, devices, and diagnostic technologies. Today I will use their lens in my comments about changes that can be made to Canada's patent regime that will help commercialize life sciences technology out of Canadian biotech companies and academia, and make Canada a better place to commercialize.
The first recommended change is on the subject of scope of patentable subject matter. In Canada, the recent proposed amendments to CIPO's examination guidelines have raised a number of concerns as to how the Canadian Intellectual Property Office, CIPO, will decide whether a claimed invention is considered patentable subject matter. This is particularly troubling for certain claims to diagnostic methods and medical uses, which under the new guidelines would not be considered patentable.
The view of legal experts working with biotechnology SMEs in Canada is that restricting what is considered an invention and therefore patentable subject matter is not an effective way of either increasing the quality of issued patents or encouraging innovation. There are approximately 40 diagnostic SMEs in Ontario advancing personalized medicine technology whose ability to patent their technologies could potentially be impacted by these amendments.
A second recommendation is to allow Canadian applicants to file a terminal disclaimer. In Canada, an applicant must claim all of the embodiments for a single invention in a single application. In the U.S., companies can file a terminal disclaimer as a way to overcome the objection to double patenting. For Canadian biotech start-ups, there are often compelling business reasons why a company may want to get a first patent issued quickly and then also have additional patents directed to other embodiments or aspects of the invention. This is possible in the United States but not in Canada, where the prohibition against double patenting requires that an applicant claim all of the embodiments for a single invention in a single application. This can delay the issuance of patents in Canada that would otherwise be valuable to companies, as they drag out prosecution to ensure they get claims to all the possible embodiments in a single patent. Bilateral agreements, such as the patent prosecution highway, are helpful for SMEs because they accelerate patent prosecution at no extra cost. Further moves towards a globally harmonized patent system will help Ontario bioscience companies compete in the global business environment.
Going against the spirit of global participation, there have been some judgments recently that could potentially damage Canada as a jurisdiction in which to file because of the amount of data required in an application to support the utility of a claim and measured as the “promise of the patent”. In some cases, it was determined that human chronic data that wouldn't normally be available until a product had been on the market needed to be included in a patent application at the time of filing.
The number of these cases is still small, but the impact is felt when companies decide not to file in Canada because they are worried they may not have enough data, or investors simply ignore commercializing in Canada. One way this issue can be addressed is by harmonizing with the U.S., where they use post-filing data to support a claim.
Here are some easy wins for patent reform. As it stands now, the Canadian IP system is unforgiving despite best intentions by applicants. Deadlines can be missed due to events such as correspondence lost in the mail and mistakes in fee payments. Since there is very little discretion to remedy these situations, an SME could lose its patent. If online patent information and file histories were accessible, someone could go online and see if something is missing or if there is a deadline approaching.
By comparison, both the U.S. Patent Office and the European Patent Office have online systems that allow the public to access file histories. Along the same lines, even though the current system allows companies to pay reduced fees by filing as an SME, the reality is that very few do because of the risk that at some point they could be challenged on their SME status and they could lose their patent.
Redrafting these rules so that they are more forgiving would allow SMEs to sleep better at night.
An issue that affects Ontario SMEs hoping to partner their technology is the lack of patent term extension in Canada. SMEs in the U.S. and the EU can have their patent term extended for up to five years to compensate for time lost in regulatory delays. Investors and MNEs valuing an Ontario SME's intellectual property adjust negatively for the lost commercial opportunity resulting from fewer years of market exclusivity. Less market exclusivity in Canada, already a small market for a multinational, may also negatively impact its willingness to market innovative technologies here.
For SMEs to realize their full economic potential, Canada must match global standards for intellectual property protection. To this end, we recommend the adoption of CETA, the comprehensive economic and trade agreement with the European Union. CETA is a unique opportunity for Canada to become the only country in the world with favoured trade status with both the U.S. and the EU. This is a competitive advantage that we need and should embrace.
In conclusion, Canadian patent reform should include global harmonization that is cost effective and speeds up granting of high-quality patents. Bioscience companies looking to make their way in the world need a competitive intellectual property regime that is predictable, stable, flexible, and consistent with trading partners.