Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed
By Brandon Heard
On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for losses suffered while market entry of Teva’s bortezomib product was delayed by Janssen’s applications under the PMNOC Regulations relating to Patents Nos. 2,203,936 (936 Patent) and 2,435,146 (146 Patent). Teva had succeeded on allegations of obviousness in both proceedings: 2015 FC 247 and 2015 FC 184. Janssen markets its bortezomib product as VELCADE.
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Eli Lilly’s EFFIENT combination use patent found obvious
By Katie Lee
On July 13, 2018, the Federal Court dismissed Eli Lilly’s application for a prohibition order, finding that Apotex’s allegation of obviousness of Patent No. 2,432,644 (644 Patent) was justified: Eli Lilly Canada Inc v Apotex Inc, 2018 FC 736.
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Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations
By Urszula Wojtyra
In public reasons released on July 30, 2018, the Federal Court dismissed the first motion for summary dismissal brought under section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations: Genentech, Inc and Hoffmann-La Roche Limited v Amgen Canada Inc, 2018 FC 694. As previously reported here, the Court had previously dismissed the plaintiffs’ attempts to stop or delay this motion until after completion of examinations for discovery.
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Federal Court of Appeal dismisses Apotex’s appeal in judicial review of Health Canada decision seeking further information from facilities in India
By Katie Lee
As previously reported, the Federal Court dismissed Apotex’s application for judicial review of the decision of the Therapeutic Products Directorate (TPD), which continued to require Apotex to submit additional information with respect to products manufactured or tested in Apotex’s facilities in India. On August 2, 2018, the Federal Court of Appeal dismissed Apotex’s appeal: Apotex Inc v Canada (Health), 2018 FCA 147. The Federal Court of Appeal found that the application judge made no reviewable error in finding that the TPD’s decision was not improperly motivated, and dismissed the appeal.
Health Canada to implement further pre-market transparency initiatives for prescription drugs
By Abigail Smith
Health Canada announced it will move forward with Phase III of its prescription drug product transparency initiatives. Beginning October 1, 2018, the Health Products and Food Branch (HPFB) will implement five proposals discussed in its April 2018 “What We Heard” report which relate to Regulatory Decision Summaries (RDSs) and information in the Submissions Under Review (SUR) List. Specifically, HPFB will:
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Post RDSs for final positive decisions (issued on or after October 1, 2018) and final negative decisions (for submissions accepted into review on or after October 1, 2018) for abbreviated new drug submissions (ANDSs) and supplemental abbreviated new drug submissions (SANDSs) that may be of interest to stakeholders, including where HPFB deviates from guidance, for critical dose drugs, and for complex drug substances and/or products;
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Post RDSs for supplemental new drug submissions (SNDSs) for new routes of administration, dosage forms, and strengths (for final positive decisions issued a final positive decision on or after October 1, 2018);
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Add ANDSs to the SUR List (for ANDSs accepted into review on or after October 1, 2018);
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Add the company (sponsor) name to new entries on the SUR List for NDSs and SNDSs (accepted into review on or after October 1, 2018); and
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Add submission class entries to the SUR List (for NDSs and SNDSs accepted into review on or after October 1, 2018).
2017-2018 Statistical Report for PMNOC Regulations and Data Protection
By Andrew Mandlsohn
On July 11, 2018, Health Canada released the Therapeutic Products Directorate Statistical Report 2017/2018 providing an overview of its administration of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) and the data protection regime. The Report includes information regarding trends in listing on the Patent Register and the Register of Innovative Drugs, as well as related court activity. The Report shows a downward trend of new patents added to the Patent Register (606 in 2017/2018 compared to 769 in 2016/2017) along with an increase in the number of rejections (120 in 2017/2018 compared to 74 in 2016/2017), and an increase in new human drugs added to the Register of Innovative Drugs (37 in 2017/2018 compared to 31 in 2016/2017). The number of prohibition applications commenced as a result of notices of allegations served prior to amendments to the PMNOC Regulations coming into force on September 21, 2017, increased from 32 in 2016/2017 to 41 in 2017/2018, and there were 12 actions reported to have been commenced following the implementation of the amended PMNOC Regulations (as of March 31, 2018).
National Pharmacare Advisory Council seeks feedback from Canadians
By Andrew Mandlsohn
As previously reported (here and here), the Advisory Council on the Implementation of National Pharmacare (Council) was launched last month and has invited all Canadians to provide their feedback on national pharmacare to “help shape the Council’s independent report to the Federal Government, to be presented in spring 2019 … which will provide the Government with recommendations and a plan on how to move forward on national pharmacare.” Participants can provide their feedback online until September 28, 2018, (by questionnaire or through a discussion forum) or in writing to the Council.
Patented Medicine Prices Review Board releases August 2018 NEWSletter
By Andrew Mandlsohn
The Patented Medicine Prices Review Board (PMPRB) released the August 2018 issue of its NEWSletter which includes an update on the PMPRB’s Guideline Reform, including recent meetings held by the Steering Committee and the Technical Working Group.
CADTH launches the CADTH Pharmaceutical Reviews Update
By Urszula Wojtyra
The Canadian Agency for Drugs and Technologies in Health (CADTH) has launched the CADTH Pharmaceutical Reviews Update. This is a new consolidated publication that will communicate updates to CADTH’s drug review process. It replaces previous individual publications, including CDR Update, pCODR Update, Therapeutic Review Update, and Updates for Patient Groups. In this first issue of the CADTH Pharmaceutical Reviews Update, among other announcements, CADTH invites stakeholder comments on a number of proposals, and announces changes to the Pan-Canadian Oncology Drug Review.
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Proceedings
glatiramer acetate (COPAXONE): Teva v Sandoz
filgrastim (NEUPOGEN): Amgen v Sandoz
Other Proceeding
Medicine not identified: Abbott Laboratories v The Minister of Health
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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