Innovative Medicines in Canada: Important Patent Questions to Ask

By Kay Palmer and Claire Palmer, May ^2nd, 2017

THE INTERPLAY OF DATA PROTECTION, PATENT REGISTER & PMPRB IN PATENT PROSECUTION & MAINTENANCE DECISIONS IN CANADA

Patents directed to medicines, and in particular, innovative drugs are impacted by a number of legislative regimes in Canada. The impact of these regimes should be fully considered when decisions are made with respect to obtaining and maintaining patent rights in Canada.

A number of key questions need to be fully considered prior to obtaining or maintaining patent protection relating to innovative drugs in Canada are discussed below. These questions relate to the Canadian patent regime, data protection provided under Canada’s Food and Drug Regulations, Canada’s Patented Medicines Notice of Compliance Regulations and the Health Canada’s Patent Register and the Patented Medicines Price Review Board. Only after answering the questions below should decisions regarding Canadian patent rights covering medicines be made.

FIRST QUESTION: Does the drug in question fall under the definition of an “innovative drug”?

Under the Food and Drug Regulations, an innovative drug is "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, or polymorph". Innovative drugs are provided eight years of data protection from the issuance of the first drug approval (i.e. Notice of Compliance issued by the Minister of Health) with a pediatric extension for qualifying drugs. This data protection prevents a subsequent manufacturer from relying upon the data in the innovator’s drug submission for the first six years of the eight-year period.

If the answer to the first question is yes, the following question should be answered:

When would data protection for the innovative drug expire? i.e. Does the data protection outlast any patent protection for the drug?

SECOND QUESTION: What are all of the Canadian patents and applications (including PCT applications anticipated to enter Canada) that relate to the innovative drug and how do they relate?

For example, do the claims of the patents or applications directly cover the drug or linked to the drug by the merest slenderest thread.

THIRD QUESTION: When would each of these patents or patents resulting from these applications expire? i.e. Do the patents expire before or after the anticipated end of data protection?

FOURTH QUESTION: Does the patent term end before or after the term of data protection?

As patent applications related to innovative drugs are often filed well before drug approval, the effective patent term can be significantly reduced – some studies suggest that the post-Health Canada approval patent term is ten years or less in Canada. Accordingly, for some innovative drugs the patent term ends prior to data protection.

If the answer is no, the following question should be answered:

Does the patent whose term ends after the end of the term of data protection impact a competitor from entering the Canadian market either in terms of the Patent Register (see below) or Infringement proceedings?

FIFTH QUESTION: Is the patent eligible for listing on Health Canada’s Patent Register?

The PM (NOC) Regulations allow innovative drug manufacturers that have patents listed on Health Canada’s Patent Register to seek an order prohibiting the Minister of Health from issuing a Notice of Compliance (the regulatory safety approval issued by Health Canada) to a second-entry wishing to rely on the innovator’s drug product for regulatory approval, until after the expiration of the patents in question. 

Not all patents that relate to a drug are eligible for listing on Health Canada’s Patent Register. There are specific requirements to list a drug. Accordingly, it is important to determine if each patent related to the drug is eligible for listing on the Health Canada Patent Register.

 SIXTH QUESTION: Does the PMPRB have jurisdiction?

The PMPRB regulates the “factory gate” price for all patented drug products in Canada including those sold by Special Access Programs. The PMPRB does not have jurisdiction if there are no issued patents or the patents have expired. The PMPRB has jurisdictions if the patent has a nexus to the drug by the merest slenderest thread. This is in contrast to Patent Register listing eligibility requirements.

If PMPRB does have jurisdiction, the price at which the drug can be sold will be impacted.

CONCLUDING COMMENTS:

The above questions are simply a sampling of the questions which must be answered when determining the best strategy to protect your innovative drug. Other considerations include for example whether the drug is a biologic. Given the complexity, it is critical to obtain the advice of Canadian council.

For more information please contact:

Kay Palmer, Senior Patent Agent

T: 613.801.0452

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Claire Palmer, Senior Patent Agent

T: 613.801.0450

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The Supreme Court of Canada Knocked Down the "Promise Doctrine” for Determining Utility

By Suzanne Hof and Poonam Tauh, ^{June 30th}, 2017

Today, the Supreme Court of Canada, in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, has determined that the Promise Doctrine is not the correct method of determining whether the utility requirement under s. 2 of the Patent Act is met, and upheld the utility of the appelants’ 2,139,653 patent.

The Promise Doctrine holds that if a patentee’s patent application promises a specific utility, only if that promise is fulfilled, can the invention have the requisite utility, but where no specific utility is promised, a mere scintilla of utility will suffice.

The Court has found that the Promise Doctrine is excessively onerous in two ways: (1) it determines the standard of utility that is required of a patent by reference to the promises expressed in the patent; and (2) where there are multiple expressed promises of utility, it requires that all be fulfilled for a patent to be valid.

First, the Court found that the Promise Doctrine conflates s. 2 of the Act (which requires that an invention be “useful”) and s. 27(3) (which requires disclosure of an invention’s “operation or use”), by inappropriately requiring that to satisfy the utility requirement in s. 2, any disclosed use (by virtue of s. 27(3)) be demonstrated or soundly predicted at the time of filing. If that is not done successfully, the entire patent is invalid, as the pre-condition for patentability — an invention under s. 2 of the Act — has not been fulfilled.

Second, the Court found that the Promise Doctrine runs counter to the words of the Act by requiring that where multiple promised uses are expressed, they all must be satisfied for the patent to meet the utility requirement in s. 2.

The Court established the correct approach to utility as follows:

• [54] To determine whether a patent discloses an invention with sufficient utility under s. 2, courts should undertake the following analysis. First, courts must identify the subject-matter of the invention as claimed in the patent. Second, courts must ask whether that subject-matter is useful — is it capable of a practical purpose (i.e. an actual result)?
• [55] The Act does not prescribe the degree or quantum of usefulness required, or that every potential use be realized — a scintilla of utility will do. A single use related to the nature of the subject-matter is sufficient, and the utility must be established by either demonstration or sound prediction as of the filing date.

With respect to the ‘653 patent, the Court stated that the utility of the optically pure salts of the enantiomer of omeprazole as a proton pump inhibitor to reduce production of gastric acid (the subject matter of the ‘653 patent) was soundly predicted. The ‘653 patent is therefore not invalid for want of utility."

Today’s long-awaited decision places Canada back in-line with international standards, and provides greater certainty to patentees and to patent prosecutors and litigators.

For more information please contact:

Suzanne Hof, Senior Patent Agent

T: 613.801.0510

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Poonam Tauh, Senior Patent Agent

T: 403.800.9018

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A Ticket to Success: Ontario Launches its Scale-Up Vouchers Program for Innovative Technology Companies

By Stephanie White and Yang Wang, May 9th, 2017

Last November, the province of Ontario committed to help small businesses become more globally competitive. In doing so, the Ontario government promised a Scale-Up Vouchers program that would provide high potential SME’s (small and medium-sized enterprises) with access to additional resources to support critical business activities. Ontario has now made good on that promise.

On April 28, 2017, Ontario’s Ministry of Research, Innovation & Science (MRIS) and Ministry of Economic Development and Growth (MEDG) launched the Ontario Scale-Up Vouchers Program, a four-year, $32.4 million initiative. Details of the program can be found at http://www.ontarioscaleupprogram.ca/.

The program is intended to foster the growth of SMEs in Ontario to become sustainable Canadian companies. Although Canada generates world class research, and there are many start-ups based on this research, we continue to lag behind other industrialized nations in successful technology commercialization. Canada spends a lot of public money on R&D, however, to date, resources directed at supporting commercialization of the resulting innovative technologies have been largely ineffective.

In order to address this shortfall, while at the same time maximizing the likelihood of meaningful return on investment, the Ontario government has decided to target the Scale-Up Vouchers program to a subset of Ontario SMEs identified as “high-growth”. More specifically, the program is directed to companies in the high value fields of Information and Communications Technology, Advanced Materials and Manufacturing, Clean Technology, and Life Sciences. In order to be considered “high growth”, and consequently eligible to apply to the program, a company must:

• have an annual revenue of between $1 and 50 million; and
• should already be experiencing a 20% annual growth rate in revenue, sales or employment over the most recent fiscal year; and/or
• have secured private investment of at least $2 million in the previous two years

The program will be delivered by three Ontario Regional Innovation Centres; MaRS, Invest Ottawa and Communitech. Each application will be reviewed and scored by a selection committee to identify those companies considered to have a high potential for exponential growth in Canada and globally.

Companies successful in the application process will be provided access to growth coaches, who are senior executives and professionals with proven expertise in talent management, sales and revenue growth, IP protection and innovation, and/or financing. Successful applicants will also be eligible to work with their coaches to apply for a voucher to offset eligible expenses for supporting growth by:

• increasing sales
• securing and nurturing talent
• developing and protecting intellectual property and/or
• accessing capital

Voucher values correlate to the size of company revenue, as follows:

• $150,000 voucher value – for companies with revenues between $1 million and $5 million (with an expectation for the company to match 33% of the voucher value)
• Up to $250,000 voucher value – for companies with revenues over $5 million (with an expectation for the company to match 50% of the voucher value)

It is important to highlight the value of this program in championing Ontario’s innovative technology companies and, importantly, in recognizing the value of encouraging intellectual property protection of Canadian technologies. Strong intellectual property protection is inextricably linked to access to capital and ongoing commercial success, particularly for early stage companies. We are hopeful that similar programs will become available for pre-revenue, start-up companies with valuable technologies, so that we will continue to see fresh cohorts of applicants over the four year lifetime of this Scale-Up Vouchers Program.

For more information please contact:

Stephanie White, Partner

T: 613.801.1067

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Yang Wang, Summer Law Student

T: 613.801.1082

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