Rx IP Update

IN THIS ISSUE:

B.C. Supreme Court finds class action claim based on invalidation of Pfizer's VIAGRA (sildenafil) patent discloses causes of action »

Health Canada news »

Teva seeks leave to appeal re: availability of punitive and exemplary damages under section 8 of the NOC Regulations »

Recent Court decisions »

Federal Court dismisses Alcon's application for Order of prohibition for Apotex's generic version of TRAVATAN Z »

New Court proceedings »

B.C. Supreme Court finds class action claim based on invalidation of Pfizer's VIAGRA (sildenafil) patent discloses causes of action

Immediately following the Supreme Court of Canada's November 2012 decision finding that Pfizer's VIAGRA use patent was invalid for failing to satisfy the disclosure requirements of the Patent Act in Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 (reported in the November 8, 2012 IP Update), the individual plaintiff, a purchaser of VIAGRA, filed a class action suit against Pfizer in British Columbia. The plaintiff claimed that Pfizer wrongfully obtained and relied on the VIAGRA patent, which inflated the price of the drug by delaying the introduction of competing generic versions. The plaintiff sought disgorgement of the difference between the revenue collected by Pfizer based on the actual price for VIAGRA and the price had generic sildenafil been available between January 1, 2006 and November 30, 2012. This alleged damages period approximates the period from the approvable date of Teva's generic version to the date when Teva was successful before the Supreme Court of Canada. The members of the proposed class are all British Columbia residents who purchased VIAGRA in that time period.

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Health Canada news

Pilot project to target patient input in reviews of orphan drugs. As reported in the October 2012 edition of Rx IP Update, Health Canada is developing a framework for the designation, authorization and monitoring of orphan drugs in Canada. On August 6, 2014, the Minister of Health announced a pilot project regarding input from Canadians with rare diseases to help inform future reviews of orphan drugs. The project, involving the reviews of Hoffmann-La Roche's obinutuzumab for chronic lymphocytic leukemia and Hyperion Therapeutics' RAVICTI Oral Liquid for the treatment of urea cycle disorders, will simulate how input from patients will be gathered and incorporated into the drug submission review process once the Orphan Drug Framework is in effect.

Press release.


Teva seeks leave to appeal re: availability of punitive and exemplary damages under section 8 of the NOC Regulations

Teva commenced an action against Pfizer under section 8 of the NOC Regulations seeking compensation for losses suffered as a result of alleged delayed market entry of its generic version of sildenafil (Pfizer's VIAGRA). In addition, Teva sought punitive and exemplary damages and a quantification of Pfizer's profits (on the basis of its assertion that the governing rule for establishing the quantum of punitive damages is proportionality). Pfizer was successful before the Prothonotary and the Federal Court in striking those portions of Teva's Statement of Claim relating to punitive and exemplary damages and the quantification of profits. The Federal Court of Appeal affirmed that punitive and exemplary damages were not available under section 8, including as the NOC Regulations explicitly or implicitly preclude them. Teva has sought leave to appeal.

Teva Canada Limited v Pfizer Canada Inc, SCC Case No. 36019.
Federal Court decision — 2014 FC 69.
Federal Court of Appeal decision — 2014 FCA 138.


Recent Court decisions

Patented Medicines (Notice of Compliance) Regulations

Federal Court dismisses Alcon's application for Order of prohibition for Apotex's generic version of TRAVATAN Z. On July 15, 2014, the Federal Court dismissed Alcon's application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex for its generic travoprost product, which was compared to Alcon's TRAVATAN Z. The Federal Court held that Apotex's allegations of anticipation and obviousness relating to Alcon’s use patent were justified, and the allegation of lack of utility was not.

Alcon Canada Inc v Apotex Inc, August 8, 2014.
Federal Court decision — 2014 FC 699.


New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

Medicine:

emtricitabine and tenofovir disoproxil fumarate (TRUVADA)

Applicant:

Gilead Sciences, Inc and Gilead Sciences Canada, Inc

Respondents:

The Minister of Health and Apotex Inc.

Date Commenced:

August 5, 2014

Court File No.:

T-1693-14

Comment:

Application for Order of prohibition until expiry of Patents Nos. 2,261,619, 2,298,059 and 2,512,475. Apotex alleges improper listing, non-infringement and invalidity.

Medicine:

tenofovir disoproxil fumarate (VIREAD)

Applicant:

Gilead Sciences, Inc and Gilead Sciences Canada, Inc

Respondents:

The Minister of Health and Apotex Inc

Date Commenced:

August 5, 2014

Court File No.:

T-1694-14

Comment:

Application for Order of prohibition until expiry of Patents Nos. 2,261,619 and 2,298,059. Apotex alleges improper listing, non-infringement and invalidity.

Other proceedings

Medicine:

Applicant:

Novabiotics Limited

Respondents:

Johnson & Johnson

Date Commenced:

July 28, 2014

Court File No.:

T-1673-14

Comment:

Appeal from a decision of the Trade-marks Opposition Board refusing Novabiotics' application to register the trade-mark LUMINADERM based on a finding of a likelihood of confusion with certain of Johnson & Johnson LUBRIDERM trade-marks.

Medicine:

Applicant:

Eli Lilly Canada Inc.

Respondents:

The Minister of Health

Date Commenced:

August 5, 2014

Court File No.:

T-1712-14

Comment:

Application for judicial review of a decision of the Minister of Health, dated July 22, 2014, to disclose third party information belonging to the applicant pursuant to a request under the Access Information Act.

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

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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

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

 
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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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