IN THIS ISSUE:

Health Canada launches two initiatives related to recent Vanessa's Law amendments to the Food and Drugs Act »

AstraZeneca's LOSEC patent found valid and infringed by Apotex »

CIPO issues revised examination practice guidelines respecting medical uses »

Update on proposed amendments to the Patented Medicines (Notice of Compliance) Regulations »

Patented Medicine Prices Review Board releases report on 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 »

New Court proceedings »

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.

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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

• An updated Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024) was released and implemented on April 1, 2015.
• Draft Good Label and Package Practices Guide: As explained by Health Canada, the objective of the guide is to provide direction to sponsors in designing safe and clear labels and packages for prescription and non-prescription pharmaceuticals, biologics, and natural health products (NHP). The consultation on the draft document is open until May 4, 2015; this template should be used for any comments.
• An updated Special Access Programme Fact Sheet.

• Advance Notice of Importation Process Pilot for Cosmetics and Drugs. The one-year pilot, March 13, 2015 to March 11, 2016, applies to commercial importations of cosmetics and drugs imported into Canada that will be modified or relabelled prior to being sold in order for their sale to be lawful in Canada. During the pilot phase, parties may use the Advance Notice of Importation Form to provide Health Canada with advance notice of multiple products imported within a 3 month period.
• Notice — Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Centralised Procedure (CP) of the European Union: the International Generic Drug Regulators Pilot (IGDRP), formed in 2012, has now been expanded to include applications filed under the European Medicines Agency's Centralised Procedure.

Apotex Inc v Pfizer Canada Inc, 2014 FC 1186.

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

To check the status of Federal Court cases, please click here.

RANKINGS AND RECOGNITIONS

Smart & Biggar repeats as Managing Intellectual Property's 2015 Canadian Trademark Contentious Firm of the Year, and wins Canadian Trademark Milestone Case of the Year Award
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Gunars Gaikis recognized as one of the top thirty patent attorneys in the world by Expert Guides
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Smart & Biggar/Fetherstonhaugh is once again recognized as 'the biggest and deepest IP shop in Canada' by Benchmark Canada 2015
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Smart & Biggar's Yoon Kang named 2014 Canadian Patent Non-Contentious Attorney of the Year by LMG Life Sciences
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Smart & Biggar/Fetherstonhaugh tops the Canadian rankings for the second year in a row in the LMG Life Sciences 2014
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Smart & Biggar/Fetherstonhaugh lauded as the "touchstone for IP law in Canada" in the 2014 edition of IAM Patent 1000 — The World's Leading Patent Practitioners
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Smart & Biggar honoured as one of only two Canadian firms selected as a 'Band One' firm in Canadian intellectual property law in the 2015 Edition of Chambers Global — The World's Leading Lawyers for Business
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Smart & Biggar's François Guay, Gunars Gaikis and Steven Garland featured in the Globe and Mail's Report on Business for excellence in IP Litigation
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Smart & Biggar/Fetherstonhaugh recognized in Who's Who Legal: Life Sciences 2015
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Yoon Kang, Keltie Sim Luft and Ekaterina Tsimberis recognized as top female legal practitioners by Expert Guides
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Smart & Biggar achieves top ranking in Canadian IP law in The 2015 Lexpert®/American Lawyer Guide to the Leading 500 Lawyers in Canada
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Smart & Biggar/Fetherstonhaugh tops the charts with 26 lawyers listed as Leading IP Lawyers in the 2015 edition of The Best Lawyers in Canada
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Christopher Robinson named "2015 Vancouver Biotechnology Law Lawyer of the Year" by Best Lawyers
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Smart & Biggar/Fetherstonhaugh repeats Top Tier ranking in Managing Intellectual Property's World IP Survey
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Smart & Biggar/Fetherstonhaugh leads all Canadian firms in Who's Who Legal: Patents 2014
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Smart & Biggar/Fetherstonhaugh chosen for the second year in a row as the Best Canadian IP Firm at The International Legal Alliance Summit & Awards
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Smart & Biggar Selected in Canadian Lawyer's Top 10 Intellectual Property Boutiques
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Smart & Biggar honoured in the 2014 Lexpert® Guide to the Leading US/Canada Cross-border Litigation Lawyers in Canada with the most litigators selected in the field of cross-border IP litigation in Canada
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