Canada: Pharmacapsules @ Gowlings: December 14, 2012 - Volume 11, Number 11

Last Updated: December 21 2012

Edited by Isabel Raasch and Jennifer L. Wilkie

Creation of a European Unitary Patent

By: Scott Foster

On December 11, 2012, the European Parliament approved a legislative package that is aimed at establishing a single unified European patent system. 

Under the current European system, an applicant files a single patent application at the European Patent Office.  If the application is granted, the single application becomes a bundle of national patent rights in each of the European countries selected by the applicant.  After grant, there are significant translation fees (to translate the single application into numerous languages) and each individual patent requires the payment of annual renewal fees to keep it in force.  It has long been recognized that the current system is expensive and may create a hurdle to small and medium-sized enterprises.  Also, under the current system, legal proceedings concerning the validity or infringement of any national patents are heard in the courts of that particular country.  For example, an infringement action for a GB patent will occur in the Patents Court or Patents County Court of England and Wales. 

Under the new system, an applicant can elect to receive a single unitary patent that covers all the contracting states, rather than a bundle of individual national patents.  This will reduce the amount of renewal fees payable.  Also, the rules will be changed to reduce the amount (and therefore cost) of translations required - machine translations will be permitted, in certain circumstances, rather than human translations.  Also, a new court (the "Unified Patent Court") will be set up with a first instance "Central Division" split between Paris, London and Munich.  A single Court of Appeal will be based in Luxembourg and appeals from that Court will go to the Court of Justice of the European Union.  There will also be rules in place to control where infringement proceedings can be commenced - generally speaking they will need to be brought where the defendant is domiciled or where the infringement is occurring.  These changes will reduce the forum shopping that is available under the current system. 

The new system will come into force either on January 1, 2014, or 4 months after thirteen states have ratified the agreement on the Unified Patent Court (provided that the UK, France and Germany are among them), whichever is the latest.  On February 18, 2013, the agreement on the Unified Patent Court will be open for signature.  There are a number of transitional provisions to ease applicants into the new system and to permit, for a period of time, applicants to continue with the current system rather than being forced to go with the new system. 

Impeachment Action Permitted to Continue for Expired Patent To Nourish Subsequent Damages Proceeding - Apotex Inc. v. Warner-Lambert Co., 2012 FCA 323, December 5, 2012 - quinapril)

By: Isabel Raasch

This was an appeal from an order dismissing part of an impeachment action. Justice Nadon writing for the Court of Appeal agreed with Apotex that Warner-Lambert's motion to dismiss part of an impeachment action commenced by Apotex was decided in error by the Federal Court judge.  Consequently, the appeal was allowed, the judgement of the Federal Court was set aside and the motion for the dismissal of part of the action was dismissed.

The Court of Appeal reasoned that Apotex should be allowed to continue with its impeachment action on two patents (the '330 and '615 patents) even though one of them expired in 2011 (the '615 patent) because, in light of the Statute of Monopolies and Gilbert Surgical Supply Co. Ltd v. Horner (1960) 34 CPR 17 (Ont. C.A.) a declaration of invalidity of the '615 patent is a necessary condition to proceedings Apotex intends to commence in Ontario under the Statute of Monopolies. In Gilbert Surgical Supply, the Court of Appeal of Ontario concluded that although being novel, an action where the invalidity of a patent was the basis upon which the action had been commenced under the Statute of Monopolies, could not be said to be bereft of success. 

The decision may be found at:

Court of Appeal Comment on Judicial Comity - Apotex Inc. v. Allergan Inc., 2012 FCA 308, November 23, 2012 - brimonidine-timop

By: Isabel Raasch

Justice Noël writing for the Court of Appeal disagreed with Apotex's appeal of Justice Hughes' decision to grant an order of prohibition with respect of the NOC for Apo-brimonidine-timop until expiry of the relevant patent.  Consequently, the appeal was dismissed.

Interestingly, the result of Justice Hughes' decision was upheld on appeal even though the Court of Appeal found that the order of prohibition was issued for the wrong reason.

Justice Hughes had found that Apotex's allegation of invalidity on grounds of obviousness was justified.  However, Justice Hughes issued the order of prohibition because, in a separate NOC proceeding involving the same patent (2011 FC 1316), the Court had come to the opposite conclusion and, as such, the issue of comity in the context of NOC proceedings was more properly left for the Court of Appeal to decide. 

Justice Noël concluded that "it was not open to the Federal Court judge to grant the prohibition in order to further his desire to clarify the jurisprudence", instead "it is up to the judges of the Federal Court to determine how [the doctrine of comity] is to be applied to their decisions".  Moreover, Justice Noël noted that the general view appears to be that the conclusions of law of a Federal Court judge will not be departed from by another judge unless he or she is convinced that the departure is necessary and can articulate cogent reasons for doing so and that on this test, "departures should be rare".

In addition and in any event, Justice Noël concluded that when the inventive concept is properly construed, the allegation of obviousness is not justified.   In this regard, Justice Noël found that the appropriate construction of the inventive concept should take the patent as a whole (as opposed to only the claims) into consideration.

Ironically, while criticizing the approach of the Court below, the Court of Appeal found the allegation of invalidity with respect to obviousness not justified, contrary to Justice Hughes. Had Justice Hughes not proceeded as he did, the Court of Appeal would not have had the opportunity to ensure the proper disposition of the proceeding.

The decision may be found at:

Invalidity Decisions Relating to Questions of Law from s. 55.2 Applications Binding on Lower Courts - Apotex Inc. v. Pfizer Ireland Pharmaceuticals, 2012 FC 1339

By: Alex Gloor

In this case, Justice Zinn granted an order for summary judgment in the Apotex impeachment action against Pfizer regarding Pfizer's '446 Patent that was at issue before the Supreme Court in Viagra (2012 SCC 60). Justice Zinn found that the impeachment action was moot given that the Supreme Court found the '446 Patent to be void (despite the proceeding before the Supreme Court being a s. 55.2 Application).

Pfizer had brought a motion before the Supreme Court to challenge the remedy granted. However, Justice Zinn held that even if the Supreme Court changes its decision with respect to the remedy, sufficiency is a question of law, and thus the Supreme Court's decision would be binding on lower courts. This is despite the fact that the proceeding before the Supreme Court was a s. 55.2 Application. As a result, even if the remedy from the Supreme Court decision is overturned, Pfizer's patent is now invalid as a result of Justice Zinn's decision, subject to appeal.

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