Rx IP Update - October 2018

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IN THIS ISSUE:

Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

Amgen not precluded from asserting patent under current PMNOC Regulations even though unsuccessful under old PMNOC Regulations

New court proceedings

Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

By Tierney GB Deluzio

This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition applications commenced by Abbott and Takeda.  Abbott and Takeda have pleaded patent infringement as a defence to the section 8 claim and have brought a counterclaim for patent infringement.  Apotex in turn has challenged the validity of Takeda’s patents.  As previously reported, the Ontario Superior Court of Justice (2017 ONSC 2348) dismissed a motion for summary judgment brought by Abbott and Takeda and ordered the matter to proceed to a damages trial, scheduled to commence in January 2019.

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Amgen not precluded from asserting patent under current PMNOC Regulations even though unsuccessful under old PMNOC Regulations

By Urszula Wojtyra

The Federal Court of Canada has refused Pfizer’s motion to dismiss an action under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) between Amgen and Pfizer in relation to Pfizer’s proposed biosimilar (NIVESTYM) of Amgen’s filgrastim (NEUPOGEN): 2018 FC 1078. Pfizer sought to dismiss the action under section 6.08 of the PMNOC Regulations, asserting that the action is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. Pfizer’s argument was based on a decision under the old PMNOC Regulations in which the Court found that Apotex’s allegation of invalidity was justified (as previously reported). Amgen’s second proceeding against Apotex under the old PMNOC Regulations was summarily dismissed as an abuse of process.  Pfizer argued on this motion that it is an abuse of the Court’s process for Amgen to invoke the PMNOC Regulations on that same patent. The Court disagreed, holding that the findings from the Apotex application cannot simply be grafted on to the present action as the Court in the Apotex application had not conclusively determined the validity of the patent. As actions commenced under the amended PMNOC Regulations determine different issues than in applications under the old PMNOC Regulations, the action was neither relitigation nor redundant. Pfizer would require leave from the Federal Court of Appeal to appeal the decision.

New Court Proceedings

For complete details about these proceedings, click here.

PMNOC Proceedings

sorafenib tosylate (NEXAVAR): Bayer v Apotex

dasatinib (SPRYCEL): Bristol-Myers Squibb v Teva

Other Proceedings

Undisclosed: Laboratoire Riva v Attorney General of Canada

Selected Rankings

Canadian IP Impact Case of the Year 
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences

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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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