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Supreme Court of Canada to hear appeal on patent utility regarding AstraZeneca’s NEXIUM
As reported in our IP Update, on March 10, 2016, the Supreme Court of Canada granted AstraZeneca leave to appeal a Federal Court of Appeal decision, affirming a trial decision invalidating its patent relating to esomeprazole (NEXIUM) for lack of utility.
Legal review of CETA completed by Canada and European Union; likely in force in 2017
by Kevin Siu »
On February 29, 2016, Canada’s Minister of International Trade (Chrystia Freeland) and the European Commissioner for Trade (Cecilia Malmström) announced that the legal review of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) has been completed. As part of the review, modifications were made to the investment chapter of CETA relating to provisions on governments’ right to regulate and the structure and process relating to the dispute-settlement tribunal.
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Supreme Court leave sought in consumer class action regarding VIAGRA patent litigation
As previously reported, the Court of Appeal for British Columbia dismissed a certification application for a proposed class action in which the plaintiff alleged that purchasers of sildenafil (Pfizer’s VIAGRA) had been overcharged as a result of Pfizer’s unsuccessful litigation under the Patented Medicines (Notice of Compliance) Regulations. The Court of Appeal found, inter alia, that the completeness of the patent regulatory regime forecloses parallel civil actions by consumers that are rooted in a breach of the Patent Act. On February 8, 2016, the plaintiff filed for leave to appeal to the Supreme Court of Canada.
Low v Pfizer Canada Inc (SCC Case No. 36848)
British Columbia Court of Appeal decision — 2015 BCCA 506
British Columbia Supreme Court decision — 2014 BCSC 1469
Children's Hospital of Eastern Ontario litigation regarding Long QT syndrome gene patents settled
On March 9, 2016, the Children’s Hospital of Eastern Ontario (CHEO) announced that it had reached a settlement with Transgenomic, Inc. (Public Health Access Agreement in Respect of Long QT Gene Patents, effective March 8, 2016), that allows “CHEO and all other Canadian public sector hospitals and laboratories the right to test Canadians for Long QT syndrome on a not-for-profit basis … without legal roadblocks from [the] gene patents.” As previously reported, on November 3, 2014, CHEO sought a declaration of invalidity and non-infringement of five Canadian patents relating to nucleotide and amino acid sequences of genes and proteins implicated in Long QT syndrome, an inherited cardiac disorder. The patents at issue were owned by one or more of the defendants, University of Utah Research Foundation, Genzyme Genetics, and Yale University, but were during the course of the litigation assigned to Transgenomic who became the sole defendant in the proceeding. In accordance with the parties’ settlement, CHEO discontinued the proceeding.
CHEO Announcement
Public Health Access Agreement
Health Canada News
Revisions made to Post-NOC Changes: Quality Guidance document. On February 19, 2016, Health Canada announced the release of the revised guidance document entitled Post-Notice of Compliance (NOC) Changes – Quality Guidance, originally published in September 2009, regarding the conditions for the categorization of any post authorization change and recommendations for supporting documentation. The revisions to the Quality Guidance are effective immediately, and include various changes to Appendices 1, 2, 3, 5 and 8, relating to, among other things, additions or modifications to the categorization, the conditions and supporting data required. Consequently, modifications have also been made to Section B of the Post-NOC Changes: Level III Form.
Notice, Post-Notice of Compliance (NOC) Changes - Quality Guidance, Notice - Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form
Revisions made to Post-NOC Changes: Safety and Efficacy Document. On February 8, 2016, Health Canada posted revisions to the Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document that had been made on February 2, 2016. The revisions reflect that Level II and Level III changes no longer require the submission of mock-ups under the Plain Language Labelling requirements.
Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document
Draft Guidance for Industry relating to Pharmacovigilance Open for Consultation. On February 17, 2016, Health Canada announced the release for consultation of the Draft Guidance Document for Industry: Preparation and Submission of Summary Reports for Marketed Health Products, Annual Summary Reports and Issue-Related Summary Reports. According to Health Canada, the guidance “will replace Section 5 of the current Guidance Document for Industry: Reporting Adverse Reactions to Marketed Health Products”, and “is to provide market authorization holders with information on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to the preparation and submission of annual summary reports and issue-related summary reports for marketed health products”. The deadline for comments is April 18, 2016.
Consultation: Draft Guidance for Industry - Preparation and Submission of Summary Reports for Marketed Health Products - Annual Summary Reports and Issue-Related Summary Reports
CADTH will no longer accept confidential submitted drug prices after April 1
On February 25, 2016, CADTH (Canadian Agency for Drugs and Technologies in Health) published pCODR Communication 52, which states that for all drug applications filed for review through the Common Drug Review (CDR) or pan-Canadian Oncology Drug Review (pCODR) process on or after April 1, 2016, CADTH will no longer accept prices that are submitted confidentially. The submitted price will be disclosed in all applicable CDR and pCODR review reports, as well as Canadian Drug Expert Committee (CDEC) and pCODR Expert Review Committee (pERC) recommendation documents posted on the CADTH website.
PMPRB News
PMPRB will hear allegations of breach of reporting requirements for acne drugs. On February 25, 2016, the Patented Medicine Prices Review Board (PMPRB) announced that it will hold a public hearing with respect to allegations that Galderma Canada Inc. failed to report pricing and sales information in relation to four acne drugs: Differin, Differin XP, TactuPump, and TactuPump Forte. Those who wish to participate in this proceeding must apply to the PMPRB for leave to intervene by April 4, 2016. The time, date, and location of the hearing have not yet been determined.
Press Release
PMPRB releases report analyzing generic drug pricing in Canada. On February 9, 2016, the PMPRB published the most recent edition of its series of reports on generic drug pricing. The report, entitled Generics 360, compares generic drug prices in Canada with those of France, Germany, Italy, Sweden, Switzerland, the United Kingdom, the United States, the Netherlands, Spain, Australia and New Zealand. It examines the prices of 554 leading generic drugs.
The report indicates that average generic drug prices in Canada declined from 63% to 36% of their brand-name counterparts between 2010 and 2014. The report further indicates that Canada has narrowed the gap between its generic drug prices and those of foreign markets, although prices of generic drugs remain higher in Canada than internationally.
Press Release
Generics 360: Generic Drugs in Canada, 2014
New Court proceedings
Patented Medicines (Notice of Compliance) Regulations
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Medicine:
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vitamin D
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Applicants:
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The D Drops Company Inc., Reinhold Vieth, Elaine Vieth and DDROPS Company
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Respondents:
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Atrium Innovations Inc.
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Date Commenced:
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February 16, 2016
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Court File No.:
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T-284-16
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Comment:
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Action for infringement of Patent No. 2,578,881 and trademark infringement regarding “Walgreens Baby Vitamin D3 Drops”.
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To check the status of Federal Court cases, please click here. |
