LYRICA use claim too broad and lacking utility
On February 4, 2013 Justice Hughes of the Federal Court of Canada released his Reasons for Judgment dismissing a prohibition application involving...Read More
Enantiomers are not innovative drugs – Federal Court of Appeal
On January 18, 2013, the Federal Court of Appeal, in a 2:1 decision, released its Reasons for Judgment holding that Takeda’s dexlansoprazole...Read More
Withdrawal of ALIMTA NOA renders prohibition application moot
On January 14, 2013, Justice Barnes of the Federal Court of Canada issued his Reasons for Judgment in respect of a prohibition...Read More
Opportunity for inspection enough for anticipatory prior use – Federal Court of Appeal
On December 20, 2012 the Federal Court of Appeal, clarified what constitutes anticipatory prior use under the “new” Parent Act in Wenzel...Read More
ACCUPRIL impeachment action allowed to continue notwithstanding patent expiry
In 2003, Pfizer commenced a prohibition application under the Patented Medicines (Notice of Compliance) Regulations in respect of Canadian Patent Nos. 1,341,...Read More
Wrongly issued COMBIGAN prohibition order upheld for different reasons
On November 23, 2012, the Federal Court of Appeal dismissed Apotex’s appeal of Justice Hughes’ Judgment granting a prohibition Order in respect...Read More
Third time’s a charm? Court of Appeal again remits Weatherford’s induced infringement claim
On October 17, 2012, the Federal Court of Appeal issues it’s Reason for Judgment in Corlac Inc. et al v. Weatherford Canada...Read More
4(2)(b) or not 4(2)(b) – Federal Court of Appeal answers the question in COMPLERA patent listing decision
On October 9, 2012, the Federal Court of Appeal released its Reasons for Judgment holding Canadian Patent No. 2,512,475 was not eligible...Read More
Janssen’s low dosage oral contraception regime patent valid
On September 11, 2012, The District Court for the District of New Jersey issued it opinion in an ANDA matter between Jansen...Read More
Would a biologic by any other (nonproprietary) name smell as sweet?
One of the many contentious issues in the evolving U.S. biosimilar regulatory landscape regards whether 351(k) biosimilar products will have the same...Read More
“Second best choice” does not teach away – ZEGERID
On September 4, 2012, the Court of Appeals for the Federal Circuit issued its per curiam opinion in Santarus v. Par Pharmaceutical....Read More
Supreme Court of Canada agrees to hear Ontario private label drug appeal
On August 30, 2012, the Supreme Court of Canada granted leave to appeal in Katz Group Canada Inc. v. Minister of Health and...Read More
CAFC divided over divided infringement
On August 31, 2012 the Court of Appeals for the Federal Circuit released its en banc decisions in Akamai Technologies, Inc. v....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
ANDA counterclaim of non-infringement not mooted by dedication of INTUNIV patent to public
On August 20, 2012, the United States District Court for the Northern District of California granted Watson and Impax’s motion for summary...Read More
Celltrion announces Korean approval of biosimilar monoclonal antibody
On July 23, 2012, Celltrion announced the approval by the Korean Food and Drug Administration of REMSIMA, its biosimilar anti-TNFα monoclonal antibody....Read More
Tobramycin patent listing – Federal Court confirms strict product specificity
On June 29, 2012, the Federal Court issued a decision upholding the Minister of Health‘s decision to refuse to list Canadian Patent...Read More
Supplementary Protection Certificates for new uses – ECJ clarifies “first authorization of the product”
On July 19, 20120 the European Court of Justice (ECJ) rendered it decision in Case C-130/11 dealing with the availability of Supplementary...Read More
LIPIDIL EZ – Absence of evidence of direct specific infringement sinks prohibition applications
On July 5, 2012, the Federal Court of Canada contemporaneously released public reasons in two matters (Court File Nos. T-991-10 and T-1184-10)...Read More
Sandoz’s LIPIDIL EZ non-infringement allegations justified
On June 15, 2012, Justice Zinn issued Judgments in two prohibition proceedings between Sandoz and Fournier in respect of fenofibrate tablets and...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
Court grants prohibition order despite obviousness finding; cites uncertainty in comity law as basis
On June 18, 2012, the Federal Court of Canada issued a Judgment and Reasons for Judgment in a prohibition proceeding between Allergan...Read More
Mometasone hydrate (NASONEX) patent valid but not infringed
On June 15, 2012, the District Court for the District of New Jersey released its redacted opinion in litigation between Schering and...Read More
Supreme Court of Canada denies leave to hear section 8 case
On June 14, 2012, the Supreme Court of Canada (“SCC”) denied leave to hear an appeal involving section 8 of the Patented...Read More