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
Federal Court of Appeal affirms data protection for Sanofi’s ELOXATIN (oxaliplatin)
On April 10, 2012, the Federal Court of Appeal (“FCA”) dismissed Teva’s appeal of a data protection decision of Justice Campbell (2011...Read More
CAFC affirms obviousness and unenforceability of Sanofi’s docetaxel (TAXOTERE) formulation patents
The Court of Appeals for the Federal Circuit recently affirmed a District Court’s finding that claim 5 of U.S. patent No. 5,750,561...Read More
AstraZeneca and Amgen team up to develop five human monoclonal antibodies
AstraZeneca and Amgen have announced an agreement to jointly develop a portfolio of Amgen’s clinical stage human monoclonal antibodies. The antibodies subject...Read More
Trospium (SANCTURA XR) patents obvious – US District Court
On March 31, 2012 Judge Sleet of the District Court for the District of Delaware concluded that the claims of four...Read More
Federal Court of Appeal dismisses Mylan’s appeal of donepezil decision (ARICEPT)
On March 29, 2012, the Federal Court of Appeal (“FCA”) dismissed Mylan’s appeal of a decision of Justice Hughes (2011 FC 547)...Read More
Roche announces positive phase III results for trastuzumab conjugate
On March 30, 2012, Roche announced results of a phase III trial of its antibody conjugate, trastuzumab emtansine (T-DM1), in the treatment...Read More
US Court upholds validity of quetiapine formulation patent (SEROQUEL XR)
On March 28, 2012, the U.S. District Court for the District of New Jersey, in a 100 page opinion, held that AstraZeneca’s...Read More
Supreme Court of Canada Denies Leave to Appeal Patent Decision on Good Faith
Today the Supreme Court of Canada denied leave to appeal the decision in Corlac Inc. et.al. v Weatherford et.al. (2011 FCA 228). On July...Read More
Fujifilm / Kyowa Kirin joint venture to make biosimilar adalimumab
On March 27, Fujifilm Corporation and Kyowa Hakko Kirin Co. Ltd. announced the commencement of business operations for their joint venture, Fujifilm Kyowa...Read More
GSK and Genentech settle Cabilly patent lawsuit
GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech’s Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents. In...Read More
RITUXAN and AVASTIN do not infringe Sanofi’s CMV enhancer patents
The Court of Appeals for the Federal Circuit recently upheld a summary judgement decision that neither rituximab nor trastuzumab infringes two Sanofi...Read More
Quetiapine Formulation Patent Obvious – U.K. High Court
On March 22, 2012, the U.K. High Court of Justice, Chancery Division held that AstraZeneca’s patent covering an sustained release formulation of...Read More
Federal Court of Appeal confirms infringement of Merck’s patent on lovastatin and also holds Merck liable for section 8 damages in respect of the same patent
In two decisions rendered in December 2011, the Federal Court of Appeal highlighted the unique dynamic presented by the Patented Medicines (Notice...Read More
Prometheus’ Patent Claims Directed to Patent-Ineligible Natural Laws – U.S. Supreme Court
On March 20, 2012 the U.S. Supreme Court clarified the scope of patentable subject matter, holding that Prometheus’ patent claims directed to...Read More
Apotex sues FDA over import alert
On February 29, 2012, Apotex brought a request for arbitration at the International Center for Settlement of Investment Disputes seeking damages under...Read More
India Grants First Patent Compulsory License
On March 9, 2012, the Indian Controller of Patents granted Natco Pharma’s application for a compulsory license thereby permitting it to market...Read More
Centocor’s ustekinumab infringes Abbott’s human IL-2 antibody patents – US District Judge
On March 9, 2012, the District Court of Massachusetts found, within a series of competing summary judgement motions, that Centocor’s ustekinumab (STELARA)...Read More
Pfizer scraps alliance with Biocon for biosimilar insulin and insulin analog products
In October 2010, Pfizer and Biocon announced an alliance to develop biosimilar insulin products. On March 12, 2012, the partnership ended, with...Read More
Roche teams up with Emcure for Indian oncology mAbs
According to the Ecomonic Times, Roche has teames up with Indian manufacturer Emcure Pharmaceuticals to produce rituximab and trastuzumab for the Indian...Read More
Federal Court of Canada rules thalidomide is innovative drug
Justice DeMontigny determined that thalidomide is an innovative drug entitled to data protection notwithstanding prior approval in the 1960s. Full decision may...Read More