Canada Edges Toward Patent Term Extension, CETA: Comes with New hope

Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union—is moving Canada closer toward a patent term extension. On October 31, 2016 a amended bill was introduced in  Canada parliament. 

• Foreign ownership and investments, 

• Access to public procurement contracts, 

• Automobiles, 

• Food (e.g. beef and dairy products) 

• Agriculture.

• Pharmaceuticals were also a part of the discussion.

Key Facts:

• The supplementary protection certificate (SPC) is a right that extends the legal duration of a pharmaceutical patent for the period corresponding to that necessary to obtain marketing authorisation, requiring a long and complex administrative procedure to protect human health.

• Eligibility for extension: To be eligible for patent term extension, a patent must claim:

• the medicinal ingredient or combination of all the medicinal ingredients contained in the drug (i.e., a "product" claim);

• the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process and contained in the drug (i.e., a"product-by-process" claim); or

• a use of the medicinal ingredient or combination of all the medicinal ingredients contained in the drug (i.e., a "use" claim).

• Eligible patents: Not all patents will be eligible for a certificate of supplementary protection (CSP). To be eligible, a patent specified in a CSP application must:

• Length of extension: The extension will be up to a maximum of two years, which will take effect on expiry of the original term of the patent set out in the certificate.

• NOC must be the first authorization for sale with respect to the medicinal ingredient or combination of medicinal ingredients.

 

CETA was the product of several years of negotiations. It is a wide-ranging trade agreement covering diverse topics such as:

• • Thus, by definition, patents directed to solely to processes and formulations are excluded.
  • the same medicinal ingredient (or combination) as produced by a defined process; or any use of the same medicinal ingredient (or combination).
  • be in force at the time of the application for a CSP and at the time of grant of the CSP; and include at least one claim that pertains to
  • the same medicinal ingredient (or combination) contained in the drug for which regulatory approval is being sought;

Term of a CSP

A CSP will take effect on the expiry of the original 20-year term of the corresponding patent.

The term of a CSP is the difference between 1) the date of the filing of the application for the patent and 2) the date of issuance of the authorization for sale (Notice of Compliance or “NOC”), reduced by five years, and capped at two years. In other words:

However, the Minister of Health may reduce the term of a CSP, if he or she considers that the patentee’s failure to act resulted in “unjustified” delays in the regulatory approval process.

Eligible drugs and excluded variations

Not all drugs will be eligible for a CSP. The objective of the CSP Regulations is to provide additional protection for drugs containing new medicinal ingredients and new combinations of medicinal ingredients “as such”.