Double patenting issue must be considered at time of Hearing of Application under the PM(NOC) Regulations

July 8, 2010

Sandoz Canada Inc. v. Abbott Laboratories, 2010 FCA 168

The Federal Court of Appeal rendered a decision that will have important implications on the litigation strategy of pharmaceutical companies.

Although the Federal Court issued an order under the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”) prohibiting the Minister of Health from issuing a notice of compliance (“NOC”) to Sandoz for its clarithromycin extended release 500 mg tablets until after expiry of the 266 patent (a decision appealed by Sandoz), Abbott also cross-appealed from this decision.  The court found that Abbott had failed to adequately respond to Sandoz’ allegation of invalidity with respect to double patenting of claim 22 of the 395 patent over the 541 patent.  Accordingly, Abbott sought that the court’s decision dismissing an order of prohibition in relation to the 395 patent be set aside.

In particular, Abbott argued that the application judge erred in law by assessing the allegations in the notice of allegations (“NOA”) as of the wrong date (i.e. the date the NOA was served) instead of the date of the hearing of the application.  Because of this alleged error, Abbott argued the application judge did not give effect to the dedication of the 541 patent to the public subsequent to service of the NOA and just prior to the hearing.  Had the application judge given effect to this dedication, which Abbott argued had the effect of re-writing the patent as if the dedicated claims had never issued, there was no basis for Sandoz’ argument of double patenting.

The Federal Court of Appeal agreed with Abbott and overturned the application judge’s decision in this respect:

In my view, the purpose of the Regulations is not served in the present case by considering the allegation of double patenting as at the date the NOA was served.  To do so ignores the fact and the effect of the dedication of the ‘541 patent.  The result is that the Minister of Health may issue a NOC to Sandoz, yet at the time of such issuance its allegation of double patenting is unjustified.

The purpose of the Regulations is served in the present case by considering the effect of the dedication as of the date of the hearing.  This result is consistent with the language of subsection 6(2) of the Regulations which allows the issuance of an order of prohibition if the Court finds that none of the allegations made by a generic “is justified”.  It is also consistent with decisions such as Glaxo Wellcome which was cited with approval by the Supreme Court of Canada in Merck.  It follows that, in my respectful view, the Judge erred by considering the status of the ‘541 patent as of the date of the NOA was issued.  The status of the ‘541 and ‘395 patents should have been considered as of the date of the hearing.

As noted above, the Judge accepted that had the dedication taken place prior to the service of the NOA, the effect of the dedication would have been to remove the evidentiary basis for the allegation of double patenting.  Had she taken cognizance of the dedication by considering the ‘541 patent as of the date of the hearing she would have concluded that the allegation of double patenting was not justified.  In my view, that is the correct result.

The court ultimately dismissed Sandoz’ appeal with respect to the 266 patent, and allowed Abbott’s cross-appeal for an order of prohibition in respect of the 395 patent.  It is unknown at this time whether Sandoz has or will seek leave to appeal to the Supreme Court of Canada.

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