This article was originally published by MassBio on March 25, 2020. It has been republished with permission.
Spanning 5525 miles, the United States-Canada border is the longest border between any two countries. U.S. goods and services trade with Canada totaled an estimated $718.5 billion in 2018, possibly the largest bilateral trade volume between two individual countries. Given the extensive integration of the Canadian and U.S. economies, U.S. life sciences companies can expect to have Canadian business interests. This blog highlights eight life sciences intellectual property issues of importance to innovators doing business in Canada.
1. The Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) establish a patent linkage system similar in some respects to the United States’ system under the Hatch-Waxman Act. Pursuant to the PMNOC Regulations, the Minister of Health maintains a “Patent Register” similar to the U.S. Orange Book. The Minister is prohibited from granting regulatory approval to a manufacturer of a small molecule or biologic drug seeking marketing authorization based on a comparison or reference to a drug that is listed on the Patent Register unless and until the manufacturer addresses the patent(s) 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 after issuance of the patent, if a related regulatory submission has been filed. If a related regulatory submission has not yet been filed when the patent issues, the patent list must be filed together with the regulatory submission.
2. Certificates of Supplementary Protection (CSPs) compensate for drug regulatory approval delays before Health Canada. The maximum term of a CSP is two years, and CSPs are available for both small molecules and biologics.
To be eligible for a CSP, a patent must claim a medicinal ingredient (MI), combination of MIs, or a use of an MI or combination thereof contained in a drug for which marketing authorization has been granted by way of a Notice of Compliance (NOC) issued by Health Canada on or after September 21, 2017. The MI or combination thereof must not have been previously approved and there must not be a prior CSP granted for the MI or combination thereof.
Importantly, the new drug submission (NDS) on which the NOC issued must have been filed in Canada within 12 months after first related regulatory filing in the EU or any country thereof, the US, Australia, Switzerland, or Japan.
The unextendible deadline for filing a CSP application may be as early as 120 days after the issuance of the patent.
There is a priority scheme based on patent grant date to determine entitlement as between conflicting CSP applications.
3. Data protection is available under the Food and Drugs Act for an “innovative drug” 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 pediatric extension. A manufacturer seeking a NOC on the basis of a direct or indirect comparison to an innovative drug will be prevented from filing its drug submission for the first six years of the eight-year (or 8.5-year) period. The same data protection term applies to both small molecules and biologics.
4. The Patented Medicine Prices Review Board (PMPRB) reviews prices of patented medicines sold in Canada based on comparison to prices in other markets. If a price is found to be excessive, the Board can order patentee to do one or more of the following to offset excess revenues: (1) reduce the price of the medicine sold in Canada; (2) reduce the price of another medicine sold in Canada; or (3) pay to Her Majesty in right of Canada a sum specified in the order.
PMPRB jurisdiction is expansive, the Canadian courts having held that a patent need only have the “merest slender thread” of a connection to the medicine.
5. 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 (PCT) filing date and details of the deposit provided before 18-month publication.
6. Methods of medical treatment have been found unpatentable by the Canadian courts despite the lack of a specific exception to patentability in the Canadian Patent Act. Nevertheless, claims directed to “use” of a medicine in therapy are patentable. The principal practical limitation at present relates to claims directed to dosage regimens, which may be found unpatentable irrespective of claim form.
7. 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.
8. 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.