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
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
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
Illegality doctrine does not preclude Apotex from recovering on perindopril undertaking – U.K. Court of Appeal
On May 3, 2012, the United Kingdom Court of Appeal allowed Apotex’s appeal form a decision of Norris J. that had precluded...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
Statements in Clinical Pharmacology section do not induce YASMIN patent infringement – CAFC
On April 16, 2011, the Court of Appeals for the Federal Circuit affirmed that Sandoz, Watson and Lupin do not infringe U.S....Read More
U.S. Appeals Court overturns District Court’s finding of obviousness (AMRIX/cyclobenzaprine hydrochloride)
On April 16, 2012, the U.S. Court of Appeals for the Federal Circuit (Cephalon et.al. v Mylan Pharmaceuticals et.al.) overturned a Delaware...Read More
PM(NOC) guidance document updated to address cross-referenced drug submissions
On April 2, 2012, Health Canada issued an updated guidance document on the Patented Medicines (Notice of Compliance) Regulations. In particular, section...Read More
Regeneron’s VEGF-TRAP-EYE infringes Genentech’s UK Patent
On March 22, 2012, Justice Floyd of the Chancery Division of the High Court of Justice held that Regneron’s VEGF-TRAP-EYE infringes European...Read More
EMA publishes new procedural advice document for biosimilar applicants
The European Medicines Agency (EMA) has published a new document providing procedural advice for users of the centralised procedure for biosimilar product...Read More