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
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
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
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