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 a 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 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 medication.

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.

Summary

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 make such requests in a timely manner.

Dr. Lüder Behrens
European Patent and Trade Mark Attorney, Berlin

Dr. Markus Engelhard and Dr. Dennis Kretschmann offer their thoughts on the subject of “IP: Brexit and patents” in an article for online English-language magazine ‘European Biotechnology. Life Science and Industry Magazine’.

Is the unitary European patent on its way? How will Brexit affect the European patent system? The two experts explore this and other interesting questions in their article.

The article is available to view here.

According to a recent study by the European Patent Office, patents in the field of the Fourth Industrial Revolution and the Internet of Things are becoming increasingly important for applicants. In the last three years the number of patent filings has grown by more than 50%. At the top are applicants from Asia.

In December 2017, the European Patent Office (EPO), together with the Handelsblatt Research Institute, published a large-scale study on European patent applications in the field of the Fourth Industrial Revolution (4IR) and the Internet of Things. 

The analysis of the European patent applications filed up to and including 2016 shows that the number of applications has increased rapidly since the mid-1990s. In 2016 alone, more than 5000 patent application were filed with the EPO. 4IR applications have increased by 54% over the last three years – a multiple of the total 7.65% growth in applications to the EPO for all technologies in the same period.

The study presents the most important technology trends and also looks at their implementation in a variety of new applications in practice, including some case studies. New applications (e. g. personal applications, companies, vehicles) and core technologies (connectivity, hardware and software) account for the majority of the inventions applied for. However, the highest growth rates can be observed in enabling technologies such as 3D systems, artificial intelligence and energy supply.

In terms of numbers, Europe (29%) and the USA (25%) are in the lead for 2011-2016, followed by Japan (18%). Germany is the leading European country with 8%, followed by France with 6%. In terms of individual filers, however, companies from Asia are far ahead, led by Samsung. The number of Korean and Chinese registrations is growing particularly rapidly.