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28 September 2020
Patented Medicines (Notice of Compliance) Regulations
Certificates of supplementary protection
Patented Medicine Prices Review Board
Deposits of biological material
Methods of medical treatment
Spanning 5,525 miles, the US-Canada border is the longest border between any two countries. US goods and services trade with Canada totalled an estimated US$718.5 billion in 2018, possibly the largest bilateral trade volume between two individual countries. Given the extensive integration of the Canadian and US economies, US life sciences companies can expect to have Canadian business interests. This article highlights eight life sciences IP issues of importance for innovators doing business in Canada.
The Patented Medicines (Notice of Compliance) (PMNOC) Regulations establish a patent linkage system similar in some respects to the US system under the Hatch-Waxman Act. Pursuant to the PMNOC Regulations, the minister of health maintains a Patent Register, similar to the US Orange Book. The minister is prohibited from granting regulatory approval to the manufacturer of a small molecule or biologic drug seeking marketing authorisation based on a comparison or reference to a drug that is listed on the Patent Register unless and until the manufacturer addresses the patents listed in relation to that drug.
A patent is eligible to be listed on the Patent Register only if it includes a claim for a medicinal ingredient, formulation, dosage form medicinal ingredient or use of a medicinal ingredient for which regulatory approval for sale in Canada has been granted or will be pending when the patent issues. To add a patent to the Patent Register, the applicant must submit a patent list to Health Canada. This must be done within 30 days of the patent's issuance if a related regulatory submission has been filed. If a related regulatory submission has not been filed when the patent issues, the patent list must be filed together with the regulatory submission.
Certificates of supplementary protection (CSPs) compensate for drug regulatory approval delays before Health Canada. CSPs are available for both small molecules and biologics and have a maximum term of two years.
To be eligible for a CSP, a patent must claim a medicinal ingredient (MI), a combination of MIs or a use of an MI or combination thereof contained in a drug for which marketing authorisation has been granted by way of a notice of compliance (NOC) issued by Health Canada on or after 21 September 2017. The MI or combination thereof must not have been previously approved and a prior CSP must not have been granted for the MI or combination thereof.
Importantly, the new drug submission (NDS) on which the NOC is issued must have been filed in Canada within 12 months of the first related regulatory filing in the European Union or any country thereof, the United States, Australia, Switzerland or Japan.
The unextendible deadline for filing a CSP application may be as early as 120 days after the patent's issuance.
There is a priority scheme based on patent grant date to determine entitlement where there are conflicting CSP applications.
Data protection is available under the Food and Drugs Act for 'innovative drugs' containing a medicinal ingredient not previously approved in a drug by Health Canada. The data protection period is eight years from the date of issuance of the first NOC for the innovative drug, with a possible six-month paediatric extension. A manufacturer seeking an NOC on the basis of a direct or indirect comparison with an innovative drug will be prevented from filing its drug submission for the first six years of the eight-year (or eight-and-a-half-year) period. The same data protection term applies to both small molecules and biologics.
The Patented Medicine Prices Review Board (PMPRB) reviews prices of patented medicines sold in Canada compared with prices in other markets. If a price is found to be excessive, the board can order the patentee to do one or more of the following to offset excess revenues:
PMPRB jurisdiction is expansive, with the Canadian courts having held that a patent need have only the "merest slender thread" of a connection to the medicine.
Deposits of biological material may be taken into account in determining whether a Canadian patent specification complies with the description and enablement requirements, as Canada is a party to the Budapest Treaty. Notably, Canadian law requires the deposit to have been made on or before the Canadian (Patent Cooperation Treaty) filing date and details of the deposit to be provided before 18-month publication.
The Canadian courts have found methods of medical treatment to be unpatentable despite the lack of a specific exception to patentability in the Patent Act. Nevertheless, claims directed to the use of a medicine in therapy are patentable. The principal practical limitation relates to claims directed to dosage regimens, which may be found unpatentable irrespective of claim form.
Diagnostic methods have not received judicial consideration in Canada. The Patent Office guidelines can result in a complex examination of applications claiming diagnostic methods. As a practical matter, if a non-physical step or element of a claim must be relied on in order to distinguish over the prior art, an objection for lack of subject-matter eligibility is likely.
Double patenting can be a uniquely problematic issue in Canada. The courts have found patents invalid where they fail to claim an invention patentably distinct from another patent held by the same patentee. In the absence of a statutory continuation or terminal disclaimer procedure, double patenting can pose an insurmountable problem.
For further information on this topic please contact David Schwartz at Smart & Biggar by telephone (+1 613 232 2486) or email (email@example.com). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
An earlier version of this article was published by MassBio.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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