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
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
Genentech and U Penn settle HERCEPTIN patent suit
On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product... Read More
Merck Serono partners with Dr. Reddy’s on cancer biosimilars
On June 6, 2012, Germany’s Merck Serono, a division of Merck, announced a partnership with India’s Dr. Reddy’s Laboratories Inc. to develop... Read More
Apotex partly denied section 8 claim on basis of ex turpi causa principle
On May 23, 2012, Justice Snider released her decision in Apotex v Merck involving Apotex’s section 8 claim regarding the drug lovastatin. ... Read More
Motivation to resolve enantiomers – eszoplicone (LUNESTA)
eszoplicone On May 31, 2012, Judge Dennis M. Cavanaugh denied two competing summary judgment motions in a Hatch-Waxman proceeding involving Sunovian and... 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
Court denies all summary judgment motions in Genentech & U Penn HERCEPTIN suit
On May 14, 2012 the United States District Court for the Northern District of California dismissed a number of competing summary judgment... Read More
Supreme Court of Canada denies leave to hear section 8 cases
On May 17, 2012, the Supreme Court of Canada announced its decisions not to hear appeals in three section 8 cases: Apotex... Read More
BONIVA dosing regimen patent held obvious in summary judgment motion
On May 7, 2012, the United States District Court for the District of New Jersey granted a summary judgment motion holding that... Read More
PRECEDEX: enantiomer patent valid and enforceable; method of use patent obvious
On May 4, 2012, the District Court of New Jersey issued an amended memorandum opinion in relation to Sandoz’ paragraph IV challenge... 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
Mylan’s obviousness challenge of erlotinib compound patent fails – US District Judge
On May 1, 2012, the United States District Court for the District of Delaware held that two erlotinib patents, RE 41065 and... 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
FDA’s biosimilar stakeholder submission roundup – Part III
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
Ontario budget passes – includes cut to some generic drug prices
On April 24, 2012, the Ontario Legislature passed a budget which includes a reduction in the cost of the top 10 generic... Read More
FDA’s biosimilar stakeholder submission roundup – Part II
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
FDA’s biosimilar stakeholder submission roundup – Part I
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
Generics can challenge overly broad use codes – U.S. Supreme Court
On April 17, 2012, the U.S. Supreme Court released its decision in Caraco Pharmaceutical Laboratories Ltd. et al v. Novo Nordisk A/S... Read More
Federal Court of Appeal issues another decision dealing with “promise of the patent” [ARIMIDEX/anastrozole]
On April 11, 2012, the Federal Court of Appeal dismissed Mylan’s appeal of a decision of Justice Rennie (2011 FC 1023) which... Read More