Certificates of Supplementary Protection now also in Canada
Supplementary Protection Certificates (SPC) play a major role alongside patents for the pharmaceutical and biotech industries, as they can provide protection for approved medicines for up to a maximum of five more years after a basic patent expires in Europe. As a result of the CETA agreement between Canada and the European Union, it is now possible for patent applicants to apply for supplementary protection certificates in Canada as well.
As a consequence of the implementation of the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union, Canada has introduced a new and independent intellectual property right, i.e. the so-called Certificate of Supplementary Protection (CSP), which may extend the term of protection by a maximum of two years, whereas the maximum supplementary term of protection in Europe is five years.
CSPs are available for patents comprising a claim covering a medicinal ingredient or combination of medicinal ingredients, or the use of the approved medicinal ingredient or combination of ingredients, in a drug for which an Notice of Compliance (NOC) has issued.
CSPs may be granted on the basis of patents on pharmaceuticals, biologics and veterinary drugs, provided, of course, that said drug has been approved by the respective authorities in Canada (i.e. Health Canada).
The CSP application must be filed before the expiry of 120 days, which begins on the day of the grant of the NOC subsequent to the regulatory approval procedure for the drug or the day of the patent grant, if the patent is granted after NOC grant. This deadline cannot be extended.
It is mandatory that the medicinal ingredient or combination of ingredients has not been previously approved in Canada. The Canadian regulatory submission must have been filed within 12 months of a related regulatory filing in the in the European Union or any member countries thereof, the United States, Australia, Switzerland or Japan to be eligible for a CSP. The 12-month period may be extended to 24 months if the application for a CSP was submitted before 21 September 2018.
The option provided by the new intellectual property right is particularly important for pharmaceutical or biomedical innovators. It is generally estimated that the development of new drugs costs at least several hundred million US dollars. Marketed drugs protected by a patent tend to have an increasingly higher value by the end of the conventional patent term of 20 years. The possibility of obtaining an extension of protection of two years by the CSP may substantially increase the return of investment that was necessary for the development of a medicament.
Furthermore, in Canada, similar to the Orange Book in the United States of America, there is the possibility of having patents registered in a patent register free of charge. Such patents must have at least one claim to a medical ingredient, formulation, dosage form, or the use of a medicinal ingredient of a drug for which a Notice of Compliance has been issued or for which a NOC procedure is pending. A patent list (Form IV) must be submitted to Health Canada in order to list the corresponding patent in the Patent Register. The Form IV letter must be filed within a non-extendable period of only 30 days after the grant of the patent.
In particular, the information on the filed patents in the Patent Register represents a hurdle for generic manufacturers and may delay the market entry of competing products.
Given the very tight deadlines for applying for CSPs or the submission of granted patents for listing in the Patent Register, patent applicants in Canada who have been granted marketing authorization or have applied for a marketing authorization should be very careful to timely make such requests.
Dr. Lüder Behrens
European Patent and Trade Mark Attorney, Berlin