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Withdrawal of ALIMTA NOA renders prohibition application moot

pemetrexed

On January 14, 2013, Justice Barnes of the Federal Court of Canada issued his Reasons for Judgment in respect of a prohibition application on under the Patented Medicines (Notice of Compliance) Regulations involving Teva, Takeda, and Lilly’s pemetrexed product, ALIMTA.

Background

On April 24, 2011, Lilly commences started a prohibition application against Teva in response to a Notice of Allegation (“NOA”) in respect of Canadian Patents No. 1,340,794 and 2,400,155. In the NOA Teva had alleged non-infringement of the155 Patent and invalidity of the 794 Patent. Teva ultimately satisfied Lilly that its proposed pemetrexed product would not infringe the 155 Patent, but failed to file any evidence in respect of its allegations of invalidity. On March 4, 2012, Teva advised Lilly that it has withdrawn its NOA.

The only question before the Court was the proper s disposition of Lilly’s prohibition application. Lilly, relying on the statutory presumption of validity accorded by subsection 43(2) of the Patent Act, submitted that the Court ought to grant the prohibition Order preventing the Minister from issuing a NOC to Teva until the expiry of Takeda’s 794 Patent in October 2016. Teva, on the other hand, submitted that the proper disposition was to dismiss the application as moot.

Analysis

Justice Barnes accepted that Regulations provide a complete code of procedure and that Teva has a right to withdraw its NOA. Justice Barnes characterized Lilly concerns that Teva was seeking to manipulate the Regulations as speculative and untenable.

 [10] Lilly argues that it would be improper and unjust to permit a second person to withdraw its NOA and Detailed Statement solely to overcome its failure to file evidence. That, of course, is the kind of abuse of process concern that has been identified in a number of previous cases including Schering Canada Inc. v Nu-Pharm Inc., [1994] FJC no 1396 at para 22, 58 CPR (3d) 14. In this case, however, there is no clear evidence as to what motivated Teva’s decision and there has been no attempt by Teva to file a second NOA. At this stage it is speculative to infer any improper or ulterior motive on the part of Teva, or to assume that it will in the future attempt to file a second NOA. Suffice it to say that any attempt by Teva to circumvent the unmet disclosure obligations in this proceeding is likely to be met with some judicial scepticism.

[11] Lilly’s concern about its potential exposure to section 8 damages by virtue of Teva’s so-called “manipulation” of the system is equally untenable. That risk is based on an assumption that Teva will improperly file a second NOA that will withstand an abuse of process challenge and that the Court will be unmindful of its obligations under subsection 8(4) and 8(5) of the Regulations. This is the type of concern that was rejected by the Federal Court of Appeal in Sanofi-Aventis v Apotex, 2006 FCA 328, [2006] FCJ no 1493, as being too remote and speculative to justify a hearing. The same reasoning applies in this case. 

In finding no live issue between the parties, Justice Barnes concluded:

[13] Although I do not doubt that this Court could issue an Order of prohibition in circumstances similar to these, the weight of authority indicates that it is generally undesirable to do so and that it is preferable to deal with abuse of process concerns as and when they arise: see for example Justice Marc Nadon’s decision in AB Hassle v Canada, [1997] FCJ no 280, (1997) 72 CPR (3d) 318, and the cases cited therein, and the Federal Court of Appeal decision in AB Hassle v Canada, [1999] FCJ no 1464, 3 CPR (4th) 73.

[14] In short, there is no live issue between the parties and the present application is therefore moot. There is no reason to depart from the usual disposition of moot cases, which is to dismiss the proceeding on that ground.

A copy of Justice Barnes’ Reasons of Judgment may be found here.

Postscript

For details of the costs of the moot prohibition application, see our post here.