Canada: Pharmacapsules @ Gowlings - January 20, 2012 - Volume 11, Number 1

Edited by Jennifer L. Wilkie and Isabel Jaen Raasch.

Apotex Inc. v. sanofi et al., December 6, 2011, 2011 FC 1486, Plavix

On December 6, 2011, the Federal Court granted Apotex's impeachment action in respect of the '777 Patent, which relates to PLAVIX®. The Court declared the claims of the '777 Patent to be invalid.  As a consequence of the declaration of invalidity, the relief sought in sanofi's infringement action, heard at the same time, was dismissed. 

This was Apotex's second validity challenge to the '777 Patent.  In a previous PM(NOC) Proceeding,  Apotex' allegations of invalidity were found to be unjustified by all three levels of the Canadian courts. Of significance the validity of the '777 Patent had been upheld by the Supreme Court of Canada in 2006. The Court there had affirmed the decisions below that Apotex's allegations of anticipation, obviousness and double patenting were unjustified.  

In the impeachment proceeding, the Federal Court rejected Apotex' allegations that the '777 Patent was invalid for lack of novelty, insufficient disclosure, overbreadth and double patenting.  However, the Court held that the '777 Patent was invalid since it lacked utility. Further, in obiter, the Court stated that, if necessary, that it would have found that the patent was obvious – in direct contradiction to the Supreme Court decision on this issue in the previous litigation.

The finding in favour of impeachment was made on the allegation of inutility, and in particular lack of a sound prediction. The Court held that the '777 Patent "promised" that clopidogrel could be used in humans. 

The Court then held that although the patentee had an ample factual basis and sound line of reasoning for the utility, there was insufficient disclosure of these two elements in the patent specification. This finding was made despite the fact that the Court had held that sanofi had met its statutory disclosure requirement.

The Court also held that if the '777 Patent had been valid, it would have held that Apotex infringed it.

The full text of this decision can be accessed at:


Allergan Inc. v. Canada (Health), November 17, 2011, 2011 FC 1316, Combigan:

This proceeding under the NOC Regs dealt with two patents covering Allergan's COMBIGAN product. Crampton J. granted an order of prohibition with respect to the more recently issued of the two patents (the '764 Patent) , finding that it was not obvious. In obiter, he then denied Allergan's request for a prohibition order regarding the more recent of the two patents (the '626 Patent), holding that Sandoz's product monograph would not induce infringement of the patent.

Sandoz's only attack on the '764 Patent was that it was invalid as being obvious. While using the Sanofi framework in conducting his obviousness analysis, Crampton J. rejected Sandoz's argument that the inventive concept must be determined solely from the language in the claims.  A court may only look beyond the claims in determining the inventive concept when the claims are confined to a bare chemical formula or to a selection patent.  Crampton J. found that it is "both necessary and permissible" to look to the whole of the disclosure in determining the inventive concept in cases where the inventive concept is not readily discernible from the claims themselves.

Sandoz alleged that they would not infringe the '626 Patent.  The issue before the Court was whether Sandoz's product monograph would induce infringement.  The three-part test for inducement from AB Hassle v Canada ([2002] 3 FC 221) was followed.  It was found that infringement was likely to occur if the NOC was issued, however, Allergan failed to establish that Sandoz's product monograph would influence doctors and pharmacists to the point that the infringement would not take place without the monograph, and thus did not satisfy part two of the test.

Despite the above finding, Crampton J. addressed Sandoz's argument that the '626 Patent was invalid for lack of utility. Crampton J. quickly dismissed this allegation, finding that the '626 Patent exhibited both demonstrated and soundly predicted utility.

The full text of this decision can be accessed at:


Teva Canada Limited v. Wyeth LLC, December 9, 2011, 2011 FC 1442, venlafaxine

This was a successful motion by the defendants to dismiss the plaintiff's action for s.8 damages following a recent decision by Hughes J. (2011 FC 1169) in which he held that the plaintiff Teva was not permitted to continue ratiopharm's claim for s. 8 damages following their merger.

The motion was allowed despite the fact that the plaintiffs had filed an appeal. This was because Hughes J. was sceptical that there would be adequate time to prepare for the February 11, 2013 trial date once all appellate rights had been exhausted, and because the backlog in the courts has created a need to give consideration to other litigants seeking trial dates.

The full text of this decision can be accessed at:


Janssen Inc. v. Teva Canada Limited, December 15, 2011, 2011 FC 1480, levofloxacin:

This was a motion to add four parties as plaintiffs to the action. By way of history, Janssen Inc. and Daiichi Limited were successful in a 2006 infringement action against Novopharm (now Teva). Prior to this decision, a bifurcation order had been issued that separated the issues of patent invalidity and infringement from that of monetary remedies. The parties who sought to be joined to the remedies action were related to the plaintiff Janssen Inc. and were involved in either the manufacture, sale or distribution of levofloxacin. Their motive for joining the action as plaintiffs was the potential for recovery of damages under s. 55(1) of the Patent Act as "persons claiming under the patentee".

Hughes J. found that a determination of whether these parties were in fact "persons claiming under the patentee" could only be determined following a trial, and that this trial might require discovery, further evidence, expert evidence and submissions from the parties regarding this new evidence. He distinguished prior case law (2004 FCA 57) where such a motion was allowed on the basis that in the prior case law the proceedings were still at an early stage, and thus the additional evidence and discovery required could more easily be accommodated.

Hughes J. noted that, if he were to join any of the new parties, their claim(s) for damages would be limited to six years from the filing of the present motion, which took place on August 30, 2011. Given that Teva's infringement was found to have taken place between November 29, 2004 to November 17, 2006, the effect of the limitation period would have been to preclude the new plaintiffs from approximately nine months of damages.

Hughes J. also made it clear that any or all the four parties seeking joinder were free to start a new action for damages at this time.

The full text of this decision can be accessed at:

Merck Frosst Canada & Co. v. Apotex Inc., November 25, 2011, 2011 FCA 329, norfloxacin:

This appeal dealt with a number of issues relating to s. 8 of the PM(NOC) Regulations. First at issue was the interpretation of the word "pending" in a transitional provision of the 1998 Regulations. The question was whether the 1993 or the 1998 version of the Regulations applied in determining s. 8 damages. The second issue was whether the 1998 Regulations were invalid because they cause retroactive or retrospective effects, or interfere with vested rights, without authorization in the Patent Act. The final question was whether the Federal Court erred in concluding that Apotex suffered a loss as a result of Merck's prohibition application.

The FCA confirmed O'Reilly J.'s trial decision that the prohibition application was pending as of the relevant date for the transitional provision, and thus the 1998 Regulations applied. At this date, the prohibition application had been heard by the Supreme Court but a decision had not yet been released. It was held that an application is "pending" if it "remains alive either at first instance, or on appeal". In this case, it would have been pending until the release date of the Supreme Court's judgment.

The FCA rejected Merck's argument that the 1998 Regulations were invalid because they retrospectively imposed a set of rules that were fundamentally different from those that applied when Merck applied for the prohibition. It was held that the new s. 8 did not revolutionize the substantive law, that the legislative amendment did not deprive Merck of any rights that it previously held, that there is no right to the continuance of the substantive standards in laws and that any change in the law was such that Merck would not have been prejudiced by reliance that Merck may have placed on any part of the 1993 Regulations that was affected by the 2008 amendments.

Merck's submission that the FC erred in concluding that Apotex suffered a loss as a result of the prohibition application was also rejected. The FCA found that there was a sufficient factual basis for the FC to make the factual findings that it did. One of Merck's arguments under this heading was that Apotex could not have acquired norfloxacin from Novopharm under its supply agreement as to do so would have been an contrary to the terms of Novopharm's compulsory licence. This argument was rejected as res judicata and subject to issue estoppel, having been considered by the Supreme Court in its previous consideration of this case ([1998] 2 S.C.R. 193).

The full text of this decision can be accessed at: 

Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) and GlaxoSmithKline Inc., December 15, 2011, 2011 FCA 329, fluticasone furoate:

This appeal affirmed two lower decisions (2011 FC 465 and 2010 FC 1211) where it was held that the CGPA lacked standing to bring the application to dispute the listing of fluticasone furoate on the Patent Register on the basis that it was not directly affected. The FCA affirmed that the FC and the prothonotary both applied the correct legal principles in denying standing.

The CGPA was also denied public interest standing on the basis that it failed to establish that generic manufacturers do not have a reasonable and effective means at their disposal to challenge the listing of a drug on the Register.

For a summary of the decision at the Federal Court, see:

Pharmacapsules @ Gowlings, June 1, 2011 - Volume 10, Number 3 at:

The full text of the FCA decision can be found at:

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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