Canada: Innovative Medicines In Canada: Important Patent Questions To Ask

Last Updated: May 18 2017
Article by Kay Palmer and Claire Palmer

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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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