Rx IP Update — April 2014 | Smart & Biggar/Fetherstonhaugh

IN THIS ISSUE:

Recent developments in section 8 jurisprudence »

Recent developments in section 8 jurisprudence

The Federal Court of Appeal recently released several decisions regarding the scope and application of section 8 of the Regulations. In its simplest terms, section 8 makes an innovator liable to a generic manufacturer for the generic manufacturer's damages if an application for a prohibition Order is unsuccessful.

Federal Court news

The Federal Court has released a strategic plan for the next five years. The plan identifies access to justice and modernizing practices and procedures as the two main challenges facing the Court. Steps to address these challenges include greater use of technology, simplifying the Court's Rules and processes and embracing increased flexibility and responsiveness.

Health Canada news

As reported in the March 2013 edition of Rx IP Update, in early 2013, Health Canada consulted with stakeholders regarding a draft revised guidance document updating the 2006 guidance document "Guidance for Industry — Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names." Health Canada recently held a Webinar regarding the revised draft Guidance Document for Industry: Review of Drug Brand Names.

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

Medicine:	gliclazide MR (DIAMICRON)
Applicant:	Les Laboratoires Servier and Servier Canada Inc
Respondents:	Ranbaxy Pharmaceuticals Canada Inc and the Minister of Health
Date Commenced:	February 19, 2014
Court File No.:	T-444-14
Comment:	Application for Order of prohibition until expiry of Patent No. 2,629,670. Ranbaxy alleges non-infringement and invalidity.

Medicine:	Unidentified
Applicant:	Hospira Healthcare Corporation
Respondents:	The Minister of Health and Attorney General of Canada
Date Commenced:	February 27, 2014
Court File No.:	T-501-14
Comment:	Application for Order quashing the Minister's decision which found Hospira to be a "second person" for the purposes of section 5(2) of the PMNOC Regulations. Hospira pleads that section 5(2) only applies to a Supplemental New Drug Submission linked to a submission that engages section 5(1) and its New Drug Submission did not engage section 5(1).

Medicine:	abacavir sulfate — lamivudine (KIVEXA)
Applicant:	ViiV Healthcare ULC and ViiV Healthcare UK Limited
Respondents:	Apotex Inc and the Minister of Health
Date Commenced:	March 14, 2014
Court File No.:	T-668-14
Comment:	Application for Order of prohibition until expiry of Patent No. 2,216,634. Apotex alleges non-infringement and invalidity.

Other proceedings

Medicine:	latanoprost (XALATAN, Apo-latanoprost)
Plaintiff:	Apotex Inc
Defendants:	Pfizer Inc, Pharmacia Aktiebolag and Pfizer Canada Inc
Date Commenced:	February 11, 2014
Court File No.:	T-393-14
Comment:	Action for declaration of invalidity and non-infringement regarding Patent No. 1,339,132; and damages or an accounting of profits pursuant to section 53.2 of the Trademarks Act, based on its Apotex's assertion of invalidity of the '132 Patent.

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

RANKINGS AND RECOGNITIONS

Smart & Biggar/Fetherstonhaugh is once again recognized as 'the biggest and deepest IP shop in Canada' by Benchmark Canada 2014
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Smart & Biggar/Fetherstonhaugh recognized in Who's Who Legal: Canada 2013
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Smart & Biggar honoured with two prestigious awards at the inaugural LMG Life Sciences Awards
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Smart & Biggar/ Fetherstonhaugh tops the Canadian rankings in the LMG Life Sciences 2013
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Smart & Biggar/ Fetherstonhaugh achieves dominant results in iam Patent 1000 — The World's Leading Patent Practitioners
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Smart & Biggar/Fetherstonhaugh chosen by Managing Intellectual Property as both the "Canadian Specialty IP Firm of the Year" and the "Canadian Trademark Contentious Firm of the Year"
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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 2014 Edition of Chambers Global — The World's Leading Lawyers for Business
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Smart & Biggar honoured in the 2013 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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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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Firm recognized in The International Who's Who of Life Sciences Lawyers 2013
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Smart & Biggar/ Fetherstonhaugh recognized in Euromoney's Guide to the World's Leading Patent Law Practitioners
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Smart & Biggar achieves top ranking in Canadian IP law in The 2014 Lexpert®/American Lawyer Guide to the Leading 500 Lawyers in Canada
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Congratulations to our 20 lawyers recognized in the 2014 edition of The Best Lawyers in Canada®
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Gunars A. Gaikis, J. Christopher Robinson and Steven B. Garland named "Lawyers of the Year" by Best Lawyers
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For more information or to request a copy of any decision, pleading or legislation, please contact:

Nancy P. Pei (Editor)
CASE-LAW BRIEFS BY: Junyi Chen	Urszula Wojtyra	Tracey L. Stott	Kyle A. Ferguson
LITIGATION CONTACTS Gunars A. Gaikis Nancy P. Pei	Steven B. Garland Jeremy E. Want	J. Sheldon Hamilton Colin B. Ingram	Yoon Kang
PROSECUTION CONTACTS J. Christopher Robinson Thuy Nguyen	Yoon Kang	David E. Schwartz	Daphne C. Lainson
REGULATORY CONTACTS Nancy P. Pei	Daphne C. Lainson

DISCLAIMER

The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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