2017-12-05
The proposed Comprehensive Economic Trade Agreement between Canada and the European Union has been under review since 2013. Last year, in October 2016, Canada officially signed the agreement and passed Bill-C 30, which is intended to implement the CETA into Canadian Law.
The agreement has long been expected to alter the Canadian intellectual property landscape, including patents. The proposed amendments will have a major impact on pharmaceuticals or drug patents. The revisions affect the areas of pharmaceutical patent protection and patent procedural rights. Although they are not yet effective, it is best to consult a patent agent or lawyer if you have invented a drug and plan to patent it.
Today, we will take you through these amendments and how they will affect pharmaceutical patents.
Major Amendments to the Patent Law
Patent Term Restoration
Patent term restoration is available in many countries, but not Canada. CETA will help implement the first ever Canadian version of patent term restoration.
A patent provides you with an exclusive right to make, use, market and sell a patented product. Most inventors in the pharmaceutical field gain patent rights for their inventions. However, they are unable to market and sell this product for a particular period of time when the product is in the process of approval by the regulatory authority under the Food and Drug law. As a result, they are not able to enjoy their exclusive rights for a full patent term, i.e. 20 years.
Patent term restoration is a form of extending patent protection. It allows restoration of a portion of the patent term during which the patentee was unable to market or sell the product. Although the Patent Act does not moderate the lost patent protection, Bill C-30 offers a certificate of supplementary protection for up to 2 years.
Drug inventors and pharmaceutical companies, who have been struggling with the issue of a patent term, can breathe a sigh of relief.
Appeal Rights
At present, the innovator has no rights of appeal from unsuccessful Patented Medicines (Notice of Compliance) regulations applications. Patent Medicines (NOC) regulations applications grants generic drugs the official approval to sell a copy of the original drug in Canada. The right of appeal is not available to the innovator because the issuance of NOC to the generic pharmaceutical company renders any appeal moot. On the other hand, if the generic company loses a proceeding under the regulations, they have the right to appeal to the Federal Court and even the Supreme Court of Canada. CETA requires that both parties under the regulations are granted the right of appeal. It aims to bring about fairness and give an equal chance to innovators to appeal negative decisions.
Consult a Patents Lawyer or Agent in Edmonton
The amendments are not yet in effect, but are expected to come into force within the next two years. How the revisions will impact the pharmaceutical industry in Canada will only be known once they are implemented. For now, it is best to consult a patent agent or lawyer to reduce the chances of errors in your patent strategy.
