PHARMACEUTICAL PATENTS

November 27th, 2014

THREE THINGS THAT WILL CHANGE WITH THE CANADA-EUROPEAN UNION FREE TRADE AGREEMENT

DIDIER CULAT | Quebec City
EMMA SAFFMAN | Montreal

Do you conduct research and development in the pharmaceutical field? Do you find that the protection under the Patent Act in Canada is sufficient particularly when you compare this protection with that of other countries?

Know that the Canada-European Union Free Trade Agreement is making several changes in the field of patents.

Firstly, the Agreement provides that Canada must accede to the Patent Law Treaty signed in Geneva on June 1st, 2000 by 59 countries. On October 23rd, 2014, the Government of Canada tabled in the House of Commons Bill C-43 regarding the implementation of the Patent Law Treaty in order to join the 36 other countries in the world that have already acceded to the Treaty. As such, with the implementation of the Treaty, Canada:

  • will notably harmonize the requirements for obtaining a filing date for a patent application;

  • require that an applicant be notified of a missed due date before an application is deemed to be abandoned;

  • standardize mechanisms to help unintentional loss of patent rights.

Secondly, the Agreement provides for patent term extensions in Canada for a maximum of 2 to 5 years to recoup time for clinical trials and regulatory reviews that are required to obtain marketing authorizations for pharmaceutical patents. This is a major development as Canada is lagging behind other industrialized countries in the protection of pharmaceutical patents as no extension of patent term is currently available.

Certain people feel that Canada will only agree to a patent extension of 2 years, which is modest compared to the international standard of 5 years but one can easily imagine the contradictory pressure to protect research and development versus a limitation of price protection on patented medication.

Thirdly, the Agreement also provides that the Patented Medicines (Notice of Compliance) Regulation shall be amended in order to add a right of appeal for all parties in situation of legal proceedings concerning the validity of pharmaceutical patents. Before, the right of appeal existed only for the party who was contesting the validity of the patent. This will help holders of patents in situations where the validity of their patent is contested by manufacturers of generic products.

Note that the Free Trade Agreement was signed on September 26, 2014 and requires the approval of the European Council and the European Parliament. Implementation legislation must also be passed by the Parliament of Canada and each Canadian province. At this stage, it is uncertain whether approval of the Member States of the European Union is required and the issue will likely be debated when the Agreement comes before the European Council for approval.

Our specialists at BCF will be pleased to advise you concerning the changes to the protection afforded by patents in the pharmaceutical fields as provided in the implementation of the Agreement.

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