Time warp on the Patent Register: Amendments to Bayer’s aflibercept judicial review
In two judicial reviews considering when a first person’s patent is determined to be eligible for the Patent Register, and when a...Read More
Time warp on the patent register: Amendments to EMD Serono’s MAVENCLAD judicial review
This is one of two motions relating to judicial reviews that considered when a first person’s patent is eligible for listing on...Read More
Two-for-One Deal – A Successor Second Person Can Adopt the Original NOA
The Federal Court dismissed a judicial review by Bayer Inc. and Regeneron Pharmaceuticals, Inc. of the Minister of Health’s decision allowing Biosimilar...Read More
Long-Term Safety Data ≠ Longer Patent List for STELARA
The Federal Court upheld a decision of the Office of Submissions and Intellectual Property that Canadian Patent No. 3,113,837 was not eligible...Read More
To Market, To Market, or the Regulations Will Not Apply
The Federal Court dismissed two applications for judicial review by AbbVie Corporation, who challenged the Minister of Health’s decisions (1) finding JAMP...Read More
Appeal dismissed from motion to compel answers from examination for discovery
In Hospira Healthcare Corporation v. The Kennedy Institute of Rheumatology, Madam Justice Kane dismissed Hospira’s appeal from Prothonotary Milczynski’s Order arising from...Read More
Court dismisses first biologic prohibition application
Amgen brought this prohibition application to prevent the issuance of a Notice of Compliance to Apotex for its proposed filgrastim product. The...Read More
Don’t fence me in: specific treatment regimens are not methods of medical treatment
On December 22, 2014, Justice Kane of the Federal Court of Canada concluded that AbbVie’s Canadian Patent Application No. 2,385,745 was not...Read More
Relief or Relapse? Federal Court of Appeal orders re-trial of STELARA infringement case
The Federal Court of Appeal has remitted the infringement and validity action regarding AbbVie’s Canadian Patent No. 2,365,281 and Janssen’s drug STELARA...Read More
Janssen prima facie in contempt of STELARA injunction
After finding that Janssen’s STELARA products infringed AbbVie’s (formerly Abbott) Canadian Patent No. 2,365,281 (see here), Justice Hughes subsequently granted a permanent...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
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
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
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
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
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
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
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
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
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