Federal Court Recognizes Limits of Decisions under the Old PM(NOC) Regulations

02 November 2018

In a recent decision of the Federal Court, Amgen Inc v Pfizer Canada Inc, 2018 FC 1078, 2018 FC 1078, Prothonotary Milczynski dismissed Pfizer’s motion for summary dismissal of the proceedings under section 6.08 of the recently amended PM(NOC) Regulations. Prothonotary Milczynski’s decision is only the second such ruling under section 6.08, and the previous motion, which relates to a “skinny label” submission, was also dismissed.1



Background of the Proceeding

Pfizer, acting here as a second person, sought to market a biosimilar product to Amgen’s Neupogen and Neulasta products, containing filgrastim and pelfilgrastim respectively. In doing so, Pfizer served a Notice of Allegation regarding Amgen’s 1,341,537 patent (the “537 Patent”), listed on the Patent Register for both products. As this action is under the Amended Regulations, Amgen brought its claim for infringement of the patent, and Pfizer counterclaimed for invalidity.

In response to Amgen’s action, Pfizer brought a summary dismissal motion on the basis that the Court had previously dismissed an application by Amgen regarding the 537 Patent under the previous version of the PM(NOC) Regulations (the “Old Regulations”) on the grounds of obviousness, and therefore this proceeding was an abuse of process.

Previous Litigation Involving the 537 Patent

In T-2072-12, under the Old Regulations, Apotex sought to market a biosimilar for Neupogen, and served a Notice of Allegation regarding the 537 Patent on Amgen. In that proceeding, Justice Hughes found that Apotex’s allegation of obviousness regarding the 537 Patent was justified, and dismissed Amgen’s application to prohibit the Minster of Health from issuing a Notice of Compliance for Apotex’s biosimilar product. 2

Under the Old Regulations, where an allegation of obviousness is held to be justified by the Federal Court, resisting a subsequent allegation on the basis of the same prior art was held to be an abuse of process under section 6(5)(b). On this basis, the Court also dismissed Amgen’s application in T-1710-15, also brought under the Old Regulations in relation to the 537 Patent.

However, as these decisions were under the Old Regulations, which did not prohibit subsequent litigation, Amgen still had recourse to an action for patent infringement under the Patent Act. Amgen commenced an action against Apotex under the Patent Act, but this action was discontinued before a decision was rendered.

Court’s Dismissal of Pfizer’s Motion

With regards to Pfizer’s motion for summary dismissal, the question for the Court was whether section 6.08 of the Amended Regulations should be interpreted in a consistent manner with section 6(5)(b) of the Old Regulations, such that Amgen’s action should be dismissed in light of the Court’s previous decision that the allegations of obviousness were justified.

Prothonotary Milczynski noted that despite the previous determinations regarding the 537 Patent under the Old Regulations, there had been no final decision on the validity of the 537 Patent. As noted by the Court, an important factor was the fact that under the Old Regulations, decisions regarding the allegations in a Notice of Allegation do not result in a final decision on infringement or validity of a patent.

Despite the Court’s position that the language of section 6.08 of the Amended Regulations follows that found in section 6(5)(b) of the Old Regulations, Prothonotary Milczynski noted that there remained substantial differences in the manner in which the proceedings under the Old Regulations were carried out which must be considered.

Specifically, the fact that the Old Regulations: were not a final decision and subsequent litigation was permissible; did not provide for a guaranteed right of appeal to the patentee; and were performed on a paper record without full discovery and viva voce witness testimony, were all relevant facts to be considered. Ultimately, the Court held it would be improper for a previous, non-binding decision to be transformed into a binding decision through the amendments to the Amended Regulations.

In fact, if Amgen’s proceeding were dismissed, it would have no further recourse against Pfizer as it would be precluded from bringing a subsequent action for patent infringement pursuant to section 6.01 of the Amended Regulations. This would be the case despite the fact that Amgen had a valid and subsisting patent that had not been held by any court to be invalid. The Court noted that such an interpretation of the Amended Regulations would lead to an “absurd result”, and does not account for the substantial changes that were introduced by way of amendments, many of which sought to overcome this specific issue of non-binding invalidity determinations by way of Application.

Conclusions

As a result, the Court dismissed Pfizer’s motion, with costs payable to Amgen in any event of the cause. This decision of the Court follows the logical interpretation of the significant changes that came into force last year, treating actions under the Amended Regulations more in line with litigation under the Patent Act, and recognizing the significant limitations that were in place under the Old Regulations.

For patentees who have previously lost applications under the Old Regulations, but for which a patent has never been declared invalid, maintaining these patents on the Patent Register and commencing actions under the Amended Regulations in response to a Notice of Allegation remains a viable means for determining a final, in rem decision regarding infringement and validity of their patents.

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1.2018 FC 303

2. We have previously written on this earlier decision here https://gowlingwlg.com/en/insights-resources/articles/2015/federal-court-issues-first-biologics-decision-unde/


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