Federal Court reaffirms and reissues section 8 venlafaxine judgments overturned by the Court of Appeal for hearsay

by Abigail Smith »

As previously reported, in 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to $125 million in damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations for its venlafaxine hydrochloride product (Pfizer’s EFFEXOR XR): Teva Canada Limited v Pfizer Canada Inc, 2014 FC 248, further reasons 2014 FC 634.

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Supreme Court of Canada News

SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court of Appeal’s decision (reported here) affirming the validity of AstraZeneca’s Patent No. 1,292,693. The Federal Court of Appeal rejected Apotex’s arguments on construction and invalidity (sufficiency, overbreadth, ambiguity and utility).

Apotex seeks leave in trazodone drug submission dispute with Health Canada. As previously reported, the Federal Court of Appeal (FCA) overturned the Federal Court’s conclusion that Apotex failed to mitigate the loss it incurred as a result of Health Canada’s tortious conduct in considering Apotex’s Apo-Trazodone drug submission. The FCA otherwise dismissed the parties’ appeals relating to Apotex’s claims in negligence, misfeasance in a public office, and contract: Apotex Inc v Canada, 2017 FCA 73. On June 5, 2017, Apotex applied to the Supreme Court for leave to appeal (docket no. 37593).

Health Canada News

Health Canada releases Good Label and Package Practices Guide for Non-prescription drugs and Natural Health Products.On May 31, 2017, Health Canada released its Good Label and Package Practices Guide for Non-prescription drugs and Natural Health Products (“Guide”) (Guide). The Guide’s objective is to assist sponsors, manufacturers, and licence holders in designing safe and clear labels and packages for non-prescription drugs, natural health products, and contact lens disinfectants. As of June 13, 2017, any new Drug Identification Number applications or (Supplemental) New Drug Submissions for non-prescription drugs must comply with Health Canada’s Plain Language Labelling Regulations which include a requirement to include a Canadian Drug Facts Table on the product labels. Health Canada will require all non-prescription drug products to comply at the retail level by June 30, 2021.

Health Canada seeks to improve the Licensing of Production of Cannabis for Medical Purposes. In May 2017, Health Canada implemented certain measures to streamline the licensing approach for medical cannabis producers and to allow for increased production of cannabis (Announcement). Among the measures are an increase in resources to streamline application processing, permitting licensed producers to increase production based on vault capacity, and authorizing longer validity periods for newly issued licenses and existing licenses that are renewed for licensed producers with good compliance records.

Competition Bureau approves Rx Drug Mart Inc.’s acquisition of 27 Rexall pharmacies previously acquired by McKesson

On June 9, 2017, the Competition Bureau (Bureau) approved Rx Drug Mart’s purchase of 27 retail pharmacies from Rexall Pharmacy Group in 26 Canadian communities. In December of 2016, the Bureau found that the proposed merger of McKesson and Rexall Health would likely result in a substantial lessening or prevention of competition in the wholesale and retail sale of certain pharmacy products and services, including prescription and over-the-counter pharmaceuticals. The Bureau reached a consent agreement with McKesson whereby the latter was required to sell Rexall pharmacies across 26 communities. The Bureau has now approved McKesson’s sale of those pharmacies to Rx Drug Mart, an independent operator of retail pharmacies, finding that it has the capacity to compete effectively in the relevant communities.

RXDM to acquire 27 former Rexall pharmacies across Canada

Consent Agreement reached in sale of Rexall Health to McKesson

Competition Bureau statement regarding McKesson’s acquisition of Katz Group’s healthcare business

Patented Medicine Prices Review Board releases May 2017 NEWSletter

The Patented Medicine Prices Review Board (PMPRB) released the May 2017 issue of its NEWSletter. Highlights include:

• The consultation on the potential changes to the Patented Medicines Regulations (“Regulations”), which ends on June 28, 2017, and that the PMPRB's consultations on guideline modernization will await the outcome of the amendments to the Regulations.

• Update on the work of the National Prescription Drug Utilization Information System, including the recent release of Meds Entry Watch and CompassRx;

• The approval of a Voluntary Compliance Undertaking from GlaxoSmithKline Inc. for multiple patented products for $31 million.

Court Decisions

Court denies proposed defence that Teva Hungary is second person in section 8 action. In an action brought by Teva Canada (“Teva”) for section 8 damages relating to its bortezomib product (Janssen's VELCADE), the Court denied the defendants’ motion to amend their defence to claim that Teva was not a 'second person' as defined in the Patented Medicines (Notice of Compliance) Regulations: Teva Canada Limited v Janssen Inc, 2017 FC 434. The defendants sought to claim that as a result of an agreement between Teva parties, Teva Hungary had beneficial ownership of Teva's assets. The Court found that the defendants had no reasonable prospect of success as Teva was clearly a second person: it filed the submission for the Notice of Compliance (NOC), sent the Notice of Allegation, was the respondent in the two unsuccessful prohibition applications commenced by the defendants, and ultimately received the NOC. The Court also analogized liability under section 8 to an undertaking given by a party to secure an interlocutory injunction that it will make good any losses suffered by the second person if the application should fail in the end.

Apotex's claims for damages against individual defendants, including former Minister of Health Rosa Ambrose, allowed to stand. Apotex Inc. and two of its Indian affiliates sued the former federal Minister of Health, the former federal Deputy Minister of Health, and other individuals ("Individual Defendants"), as well as the Crown, in connection with Health Canada's import ban placed on products from the Indian affiliates. As previously reported here and here, the Federal Court held that the import ban against the Indian companies was unlawful. The Individual Defendants moved to strike the action against them, on the basis that the Federal Court did not have jurisdiction over the claims made against them, arguing that personal claims had to be brought in the provincial court. The Court dismissed the motion: Apotex Inc et al v Rona Ambrose et al, 2017 FC 487. The Court held that it was not plain and obvious that the various causes of action alleged by Apotex - misfeasance in public office, negligence, conspiracy, defamation, and the novel cause of action called "monetary relief in public law"- and defences thereto are not essentially dependent upon and nourished by the federal statutory framework.

PMNOC proceedings

Other Proceedings

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