IN THIS ISSUE:
Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal
Health Canada publishes updated guidance document on classification of products at the device-drug interface
PMPRB releases report analyzing generic drug pricing in Canada
CADTH update outlines revisions to biosimilar and pharmaceutical review programs
Government of Canada announces suspension of IP provisions under the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP)
Pleading amendments relating to SCC decision striking down promise doctrine denied by Ontario Superior Court of Justice
Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
New court proceedings
Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal
by Abigail Smith
On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs awarded against it for its infringement of Janssen’s patent for levofloxacin (LEVAQUIN): Teva Canada Ltd v Janssen Inc, 2018 FCA 33. As previously reported, the Federal Court awarded close to $19 million in damages and pre-judgment interest to the plaintiffs: Janssen Inc v Teva Canada Ltd, 2016 FC 593 and subsequently granted $1 million in costs: 2016 FC 727 .
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Health Canada publishes updated guidance document on classification of products at the device-drug interface
by Andrew Mandlsohn
On February 7, 2018, Health Canada published an update to the guidance document Classification of Products at the (Medical) Device-Drug Interface. According to Health Canada’s notice, the update is “intended to reflect the changes to the definition of (medical) device made to the Food and Drugs Act (the Act) following the enactment of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) on November 6, 2014, and to bring greater clarity to the description of how Health Canada classifies health products at the device-drug interface.”
PMPRB releases report analyzing generic drug pricing in Canada
by Andrew Mandlsohn
On February 6, 2018, the Patented Medicine Prices Review Board (PMPRB) announced the publication of 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 prices in other countries, with a particular focus on the PMPRB comparator countries (i.e., the PMPRB7; namely, France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States). The report examines the prices of 605 leading generic drugs and indicates that average generic drug prices in Canada declined from 63% to 33% of their brand-name counterparts between Q1-2010 and Q4-2016. The report further indicates that Canada has narrowed the gap between its generic drug prices and those of foreign markets, although the average prices of generic drugs remain higher in Canada than internationally. In addition, although not factored into the results published, the report also describes a joint initiative announced on January 29, 2018 on behalf of participating federal, provincial, and territorial drug plans, the pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association. As part of this five-year initiative, price discounts of 25-40% on some of the most commonly prescribed drugs in Canada (resulting in total discounts up to 90% of their brand-name counterparts) will take effect on April 1, 2018 (a list of the generic drugs is published here) and tendering will not be pursued by participating drug plans.
CADTH update outlines revisions to biosimilar and pharmaceutical review programs
by Katie Lee
In its Common Drug Review (CDR) Update – Issue 133 (with further details in Revisions to CADTH’s Biosimilar and Resubmission Processes, Other Administrative Changes and New Fee Guidance for Applications to CADTH’s Pharmaceutical Review Programs) published on February 13, 2018, CADTH announced revisions to its biosimilar and administrative review process. This update includes the following:
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Revisions to CADTH’s biosimilar process which creates a streamlined approach for biosimilar reviews through shorter timelines, fewer submission requirements and abbreviated biosimilar summary dossier templates;
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The announcement that application fees now apply to all CDR submissions and resubmissions irrespective of the notice of compliance / notice of compliance with conditions issuance date;
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A new fee guidance for pharmaceutical review programs which includes a new, reduced fee for the new biosimilar review process and an annual fee adjustment based on the Consumer Price Index; and
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New patient input templates for biosimilars, which offers specific prompts for biosimilar review.
Other updates include the issuance of new administrative forms, such as a revised pre-submission information requirements form for advanced notice, a revised application overview template and updated contact information.
Government of Canada announces suspension of IP provisions under the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP)
by Katie Lee
On January 30, 2018, the Government of Canada posted the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP) - Backgrounder. According to the Backgrounder, Canada and other signatories agreed to suspend certain obligations under the Trans-Pacific Partnership (TPP) with respect to intellectual property, patents and pharmaceuticals, including on patent term adjustments to compensate for unreasonable patent office delays and marketing authorization delays. Canada already provides for patent term extension for marketing authorization delays under the Patent Act and Certificate of Supplementary Protection Regulations which came into force September 21, 2017 (as previously reported). On February 20, 2018, Global Affairs Canada subsequently issued a news release announcing the release of the full text of the CPTPP and projected economic impacts of the CPTPP on Canada.
Pleading amendments relating to SCC decision striking down promise doctrine denied by Ontario Superior Court of Justice
by Brandon R. Heard
The Federal Court previously found certain claims of Canadian Patent No. 1,341,206 (“206 patent”), relating to ramipril (ALTACE) invalid. In the present action, Apotex seeks relief in the Ontario Superior Court of Justice pursuant to the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-Marks Act. On February 6, 2018, Dunphy J. dismissed motions by the Defendants Sanofi and Schering for leave to amend their statements of defence following the recent decision by the Supreme Court of Canada in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (AstraZeneca): Apotex v Schering Corporation, 2018 ONSC 903.
The Defendants sought to plead that they should not be estopped or otherwise precluded from taking the position that Apotex cannot rely on the earlier Federal Court decision invalidating the patent at issue, which was arguably wrong in view of AstraZeneca. In AstraZeneca, as previously reported, the Supreme Court of Canada struck down the promise doctrine as “incongruent with both the words and the scheme of the Patent Act”.
Dunphy J. relied on the doctrines of issue estoppel and collateral attack in denying Sanofi and Schering leave to amend. He distinguished jurisprudence indicating that an exception to these doctrines is available in special circumstances; i.e. in the event of a change in the law. In his view, AstraZeneca did not result in a change in the law, but merely a change in an “aspect of the interpretation of a statutory provision that was not amended.” In view of AstraZeneca, it was arguable, but not certain, that the Federal Court’s earlier decision was in error. Moreover, allowing the proposed amendments would effectively require re-litigation of the entire issue previously decided at trial (i.e. the validity of the 206 patent). Dunphy J. also dismissed the motions on the alternative basis of sections 62 and 63 of the Patent Act. In his view, the appeal available under section 63 is the only avenue “by which a patent that has been declared to be void can be treated otherwise”.
Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
by Urszula Wojtyra
The Federal Court previously found that Apotex and Cobalt infringed Bayer’s valid patent for an oral contraceptive composition combining drospirenone and ethinyl estradiol (Bayer’s YAZ and YASMIN) (2016 FC 1013, as reported here). The Federal Court subsequently held that Bayer was entitled to elect between damages and an accounting of Apotex’s profits (2016 FC 1192, as reported here). In so holding, the Federal Court disagreed with Apotex’s argument that it, rather than Bayer, should be entitled to elect whether Bayer should be limited to recovering Apotex’s profits. The Federal Court of Appeal dismissed Apotex’s appeal of the latter decision, holding that “the proposition that the infringer of a patent can determine the remedy to which the patentee is entitled is an astounding proposition” (Apotex Inc v Bayer Inc, 2018 FCA 32). The Federal Court of Appeal affirmed that, under the Patent Act, a successful patentee always has a right to its damages, and only it has the right to elect an accounting of profits, subject to the court’s discretion.
New Court Proceedings
For complete details about these pharmaceutical proceedings, click here.
apixaban (ELIQUIS): Bristol-Myers Squibb v Apotex
paliperidone palmitate suspension (INVEGA SUSTENNA): Janssen v Teva
bictegravir/emtricitabine/tenofovir alafenamide hemifumarate (BIKTARVY): Viiv; Shionogi; Viiv Healthcare v Gilead
Selected Rankings
Canadian IP Impact Case of the Year
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences
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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada
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