If at first you don’t succeed, you may not be permitted to try again
Justice Barnes’ decision in Gilead Sciences, Inc. v. Minister of Health is a cautionary note to applicants in PM(NOC) Proceedings to think... Read More
Compound patent is not listable against fixed dose combination – Federal Court of Appeal
On April 15, 2015, the Federal Court of Appeal dismissed ViiV’s appeal of the Judgment of Justice Hughes that had held that Canadian... Read More
Multiple obvious paths still obvious – Federal Court
On February 26, 2015 Justice Barnes released his public reasons dismissing the second of Janssen’s prohibition applications in respect of Teva’s generic... Read More
Court rejects the notion of the person skilled in the art of the claim
On November 27, 2014, Justice Barnes dismissed the first of two of Janssen’s prohibition applications in respect of Teva’s generic version of... Read More
Seeking to Intervene? Proceed Quickly with Unique and Valuable Insights or Else
On February 2, 2015, Justice Stratas released his reasons for dismissing Canada’s Research Based Pharmaceutical Companies (“Rx&D”) motion for leave to intervene... Read More
Cross-referenced drug submissions must still address listed patents – Federal Court
On December 19, 2014 Justice Gleason released her Judgment and Reasons in a judicial review application brought by Pfizer seeking to quash... Read More
The Second Person’s Burdens (with apologies to Rudyard Kipling)
On January 9, 2015, the Federal Court of Appeal released Reasons for Judgment dismissing an appeal brought by Merck and BMS from... Read More
Back on Track: Federal Court of Appeal gives the green light to Teva’s section 8 claim for ratio-amlodipine
Pfizer brought a motion to strike Teva’s claim in T-1194-12, for damages under section 8 of the PM(NOC) Regulations in its entirety... Read More
Not defining skilled person in NOA insufficient to reverse order of evidence
On September 19, 2014, Prothonotary Milczynski dismissed Bristol-Myers Squibb’s motion for a partial reversal of the order of evidence in a prohibition... Read More
Abacavir Patent Not Listable Against Fixed Dose Combination Products
On September 18, 2014, Justice Hughes of the Federal Court of Canada dismissed three appeals of Orders of Prothonotary Milczynski that Canadian... Read More
Patent containing claim to single medicinal ingredient not eligible to be listed against combination product
On April 3, 2014, Prothonotary Milczynski granted Teva’s 6(5)(a) motion finding that Canadian Patent No. 2,289,753 is not eligible to be listed... Read More
Generics are not “patentees” subject to PMPRB oversight
On May 27, 2014, the Federal Court allowed two related judicial reviews from decisions of the Patented Medicines Prices Review Board that... Read More
Court of Appeal further clarifies section 8 damages framework
When a generic drug company is held off the market by an improper prohibition application, that generic is entitled to damages under... Read More
Lilly entitled to costs for moot ALIMTA prohibition application
On June 7, 2013, Justice Barnes of the Federal Court of Canada issued his Supplementary Reasons for Judgment dealing with the costs... Read More
VIAGRA patent not invalidated in prohibition application appeal
On June 4, 2013, the Supreme Court of Canada granted in part Pfizer’s application for a modification of its reasons of the... Read More
Date for assessing sufficiency of the specification is the publication date
On March 19, 2013, Justice Hughes of the Federal Court of Canada released his Reasons for Judgment in a prohibition application between... Read More
Lions and Tigers and Bears Oh My! SEROQUEL XR formulation patent obvious
On March 7, 2013, Justice Near of the Federal Court of Canada, dismissed AstraZeneca’s prohibition applications against Teva in respect quetiapine fumarate... Read More
FDA approves Teva’s tbo-filgrastim for severe neutropenia
On August 29, 2012, the U.S. FDA approved Sicor Biotech’s BLA for tbo-filgrastim (XMO2 filgrastim), to reduce the time certain patient receiving... Read More
Double patenting analysis must consider claim “as a whole” – CAFC
On August 24th, 2012 the Court of Appeals for the Federal Circuit affirmed a judgment of the United States District Court for... Read More
COPAXONE patents infringed, valid and enforceable – U.S. District Court
On June 22, 2012, the District Court for the Southern District of New York issued a decision that Sandoz/Momenta and Mylan/Natco infringed... Read More
On your mark, get set, go! Biosimilar litigation takes off in Canada
On May 18, 2012, Amgen Canada Inc. and Amgen Inc. (“Amgen”) commenced a proceeding (Court File No. T-989-12) under the Patented Medicines... Read More
Ramipril section 8 damages – distinct “but for” worlds for each generic
The Federal Court recently decided several cases dealing with section 8 of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”). The first... Read More
Teva can assert Ratiopharm’s EFFEXOR XR section 8 claim
On May 8, 2012, the Federal Court of Appeal allowed an appeal of a judgement of Justice Hughes (2011 FC 1169) that... Read More
ABILIFY compound patent attack a “poster child” for impermissible hindsight – CAFC
On May 7, 2012, the Court of Appeals for the Federal Circuit (CAFC) affirmed a judgment of the United States District Court... Read More
FDA’s biosimilar stakeholder submission roundup – Part IV
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More