CETA AND PHARMACEUTICAL PATENTS: SUPPLEMENTARY PROTECTION CERTIFICATES NOW ESTABLISHED IN CANADASeptember 27th, 2017
PATENT TERM EXTENSIONS
For the first time, CETA will provide for patent term extensions in Canada to recoup time for the clinical trials and regulatory reviews that are required to obtain marketing authorizations for medicinal products. This is a major development as Canada has lagged behind other industrialized countries in the protection of pharmaceutical and veterinary patents, since no extension of patent term was previously available.
Under the rules coming into force on September 21, 2017, owners of a patent covering a drug for human or veterinary use will be able to apply for a Certificate of Supplementary Protection if the following requirements are met:
(1) the patent covers a medicinal ingredient (or combination of medicinal ingredients) for which marketing authorization is granted on or after September 21, 2017;
(2) the authorization for sale is the first authorization for sale that has been issued with respect to the medicinal ingredient (or combination of medicinal ingredients); and
(3) no other certificate of supplementary protection has been issued with respect to the medicinal ingredient (or combination of medicinal ingredients).
Only one supplementary protection certificate may be issued per medicinal ingredient. This means that where a medicinal ingredient is protected in more than one patent, only one of the patents may have its term extended.
Patent term will be extended for a maximum of two years. The term of extension is based on the time elapsed from filing application for patent and receiving marketing authorization and may thus be shorter in cases where the pharmaceutical development is exceptionally fast.
COORDINATION BETWEEN REGULATORY AND PATENT STRATEGY IS ESSENTIAL
Companies developing new products in the pharmaceutical field will want to follow the new rules closely to make sure that the opportunities for extending patent term are maximized.
Coordination between regulatory and intellectual property strategies will be crucial to ensure that the deadlines for applying for a certificate of supplementary protection are met.
Applications for a certificate must be filed on:
(a) the day on which the authorization for sale of the patented medicinal ingredient is issued, if the patent is granted on or before that day; or
(b) the day on which the patent is granted, if the patent is granted after the day on which the authorization for sale of the medicinal ingredient is issued. These deadlines are strictly enforced and there are no provisions to accept late applications.
EXCEPTION FOR EXPORT
The issuance of a certificate of supplementary protection will give the holder the same rights that are granted by the patent set out in the certificate with respect to the medicinal ingredient in question for the duration of its term. That is, the certificate holder will have exclusive rights to making, constructing, using and selling of any drug that contains the medicinal ingredient during the certificate’s term. One exception for export applies: a third party may make, construct, use or sell the medicinal ingredient for the purpose of export from Canada without infringing the certificate.
Our specialists at BCF will be pleased to advise you concerning the opportunities offered by the public procurement markets made available with the implementation of CETA. Notably at BCF we can assist you prepare for this opportunity as you prepare entry in the European market with your intellectual property plan, your tax plan, your commercial business implementation plan, your rules of origin plan or your labour mobility plan.