Smart & Biggar/Fetherstonhaugh updates

New regulations governing post-market oversight of opioids
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 18 2018

As part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids) recently came into force, adding post-market oversight of prescription opioids. The minister of health can now impose terms and conditions on the market authorisation for listed opioids. The amendments also introduce a mandatory warning sticker and patient information handout for 'Class A' opioids (as set out in Part A of the List of Opioids).

PMPRB forming working group on guideline reform
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 18 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced that the next step in its guideline reform will be the inception of a multi-stakeholder working group intended to gather stakeholder input on key technical aspects of the new regime. The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation.

Update on Vanessa's Law
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 11 2018

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), approved in 2014, amended the Food and Drugs Act and granted new powers to the minister of health directed at post-marketing oversight of therapeutic products (ie, drugs, medical devices and drug-device combinations). There have been many developments since 2014, including the passage of certain associated regulations and the release of Health Canada guidance.

New regulations governing powers to require assessments, tests and studies
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 11 2018

The sections of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) that grant the minister of health powers to require assessments, tests and studies and create appropriate regulations recently came into force. Among other things, the amendments support post-market safety by imposing notification requirements for foreign incidents and eliminate the requirement for filing clinical case reports in a filed submission or supplement.

Eli Lilly seeks leave in olanzapine Section 8 damages action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • July 09 2018

In early 2018 the Federal Court of Appeal dismissed Eli Lilly Canada's appeal of a trial decision awarding more than $70 million to Teva Canada under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Federal Court of Appeal recently granted Teva's cross-appeal seeking to add to its recovery lost pipe fill sales and an adjustment to account for underreporting of sales in the data relied on by both parties' experts. Eli Lilly has since applied to the Supreme Court for leave to appeal.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 04 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 04 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

Supreme Court denies Idenix leave to appeal in SOVALDI dispute
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • July 02 2018

The Supreme Court recently dismissed Idenix's application for leave to appeal the decision of the Federal Court of Appeal affirming the trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). The Federal Court of Appeal upheld the validity of Gilead's patent and declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility.

PMPRB forming working group on guideline reform
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • July 02 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced that the next step in its guideline reform will be the inception of a multi-stakeholder working group intended to gather stakeholder input on key technical aspects of the new regime. The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation.

Health Canada to propose post-market amendments to Medical Devices Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 27 2018

Health Canada recently issued a notice of intent to "propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada". Among other things, the amendments will provide the minister of health with the authority to request analytical issue reports from a manufacturer when there is a suspicion of a safety concern and require manufacturers to notify Health Canada of any significant change in the safety of a medical device.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 27 2018

Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.

Top five reasons to consider patent litigation in Canada
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 25 2018

Canada has historically been a much less active jurisdiction for patent litigation compared to the United States, which can be explained in part by the simple fact that the US market is almost 10 times the size of the Canadian market. However, there are a few notable differences in the procedure and substantive law applied in both jurisdictions that have resulted in Canada becoming an increasingly attractive option for high-stakes patent litigation in recent years.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 25 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

First CSPs issued and application fee increased
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 20 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Release of information contained in drug submissions and medical device applications
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 20 2018

In December 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications. Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 18 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • June 18 2018

Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.

Supreme Court denies leave regarding natural health product licence
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 13 2018

The Supreme Court recently dismissed The Winning Combination's leave to appeal. The Federal Court of Appeal had previously set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination for its natural health product, Resolve.

Teva seeks leave in levofloxacin damages assessment
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 13 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 06 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

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