Brian Daley

Feb 29, 2024 | lexblog.com | Pardeep Heir |Christopher A. Guerreiro |Brian Daley

The Federal Court of Appeal (FCA) has held that in order to determine whether a patent claims an unpatentable method of medical treatment (MMT), it is necessary to determine whether the use of the invention requires the exercise of professional skill and judgment. In the case of pharmaceutical dosing claims, the determination cannot be based solely on whether the claimed dosing and schedule is fixed or not.

Feb 5, 2024 | lexblog.com | Pardeep Heir |Christopher A. Guerreiro |Brian Daley

The Federal Court of Appeal (FCA) has held that the sale of single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is possible to infringe a dosing regimen patent by combining a first dose sourced from the patentee with other doses sourced from an unlicensed third party.

Jan 18, 2024 | lexblog.com | Pardeep Heir |Christopher A. Guerreiro |Brian Daley

The Federal Court of Appeal (FCA) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation (NOAs) under the Patented Medicines (Notice of Compliance) Regulations (Regulations). Reversing the Federal Court (FC), the FCA found that the generic or biosimilar manufacturer should raise all of its allegations in its NOA, and it should not keep some in reserve in the event that it is not initially successful.

Dec 17, 2023 | lexblog.com | Paul Jorgensen |Christopher A. Guerreiro |Brian Daley

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not in the public interest to force patients to switch to another biosimilar product.

Dec 3, 2023 | lexblog.com | Orestes Pasparakis |Brian Daley |Allyson Whyte Nowak |Gunars Gaikis

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation in Canada. We have had the privilege of arguing many of the landmark cases on behalf of our clients.