|
Health Canada launches two initiatives related to recent Vanessa's Law amendments to the Food and Drugs Act
As previously reported, the Food and Drugs Act has recently been amended by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which received royal assent in November, 2014. Health Canada has now announced two new initiatives related to the Vanessa's Law amendments.
Read more »
AstraZeneca's LOSEC patent found valid and infringed by Apotex
As reported in our March Special Edition, Justice Barnes of the Federal Court, in a decision released March 16, 2015, found certain claims of Canadian Patent 1,292,693 ("'693 Patent") valid and infringed by Apotex. The '693 Patent pertains to a formulation for omeprazole having an "inert subcoating", which has been successfully marketed by AstraZeneca under the brand name LOSEC.
CIPO issues revised examination practice guidelines respecting medical uses
As reported in an IP Update, on March 18, 2015, the Canadian Intellectual Property Office (CIPO) issued revised practice guidelines for the examination of patent applications respecting medical use claims following the Federal Court's decision in AbbVie Biotechnology Ltd v The Attorney General of Canada, 2014 FC 1251.
Update on proposed amendments to the Patented Medicines (Notice of Compliance) Regulations
As reported previously, in late 2014 Industry Canada had proposed amendments to the PM(NOC) Regulations regarding the requirements for listing patents naming a single compound against fixed-dose combination products in view of the decisions Viiv Healthcare ULC v Canada, 2014 FC 893 (as reported previously), and Gilead Sciences Canada v Canada (Health), 2012 FCA 254. The Viiv appeal was heard on April 13, 2015, and a decision is expected to be released April 15, 2015.
Industry Canada published an update regarding these proposed amendments, indicating that pre-publication for comment is planned for 2015.
Patented Medicine Prices Review Board releases report on public drug plan expenditures
The Board released its inaugural edition of CompassRx, an annual report focusing on the 2012/2013 fiscal year and primarily using data from the National Prescription Drug Utilization Information System to identify "major drivers behind changes in prescription drug expenditures in public drug plans in Canada." The study analyzes, among other things, prescription drug expenditures, drug cost component, drug cost drivers, and Canadian pricing and reimbursement during the period studied.
PMPRB's announcement of release of CompassRx report on public drug plan expenditures; PMPRB's CompassRx report on 2012/2013 public drug plan expenditures.
Health Canada News
Release of draft and updated documents:
Announcement of pilot projects:
Federal Court rules that claimant for section 8 damages not required to particularize damages claim
In this action commenced by Apotex for damages pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") regarding eletriptan (Pfizer's RELPAX), Pfizer sought an order striking certain paragraphs of Apotex's claim, or in the alternative for particulars of those allegations pleaded (including as they relate to the scope of damages claimed). In dismissing Pfizer's motion, the Court was not persuaded that particulars of the damages claimed should be given, noting that "Section 8 Damages, as they are evolving in the case law, are their own unique form of damages as defined in the [Regulations]."
Apotex Inc v Pfizer Canada Inc, 2014 FC 1186.
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
|
Medicine:
|
naproxen/esomeprazole magnesium trihydrate (VIMOVO)
|
|
Applicants:
|
AstraZeneca Canada Inc and Pozen Inc
|
|
Respondents:
|
Mylan Pharmaceuticals ULC and Minister of Health
|
|
Date Commenced:
|
March 5, 2015
|
|
Court File No.:
|
T-336-15
|
|
Comment:
|
Application for Order of prohibition until expiry of Patent No. 2,449,098. Mylan alleges non-infringement and invalidity.
|
To check the status of Federal Court cases, please click here.
|
