Pardeep Heir

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.

Jan 10, 2024 | lexblog.com | Pardeep Heir |Paul Jorgensen |Christopher A. Guerreiro |Kristin Wall

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024. The most significant legal development in 2023 was the introduction of a system of patent term adjustment (PTA). On the regulatory front, seemingly all of Canada’s agencies – the PMPRB, pCPA, CADTH, Health Canada – had important developments in 2023, including that CADTH is being expanded into a new agency: the CDA.

Oct 22, 2023 | lexblog.com | Pardeep Heir |Paul Jorgensen |Kristin Wall

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor. Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations).