Pharma in Brief: The 2020 Year in Review

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2020.

Introduction

The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. The industry was among the heroes of 2020, developing, commercializing and distributing drugs, vaccines, and personal protective equipment to deal with COVID-19 at remarkable speeds.

In addition to evolving public health measures related to the pandemic, governments also advanced major policy initiatives, such as reforms to the Patented Medicines Price Regulation Board (PMPRB) … Continue Reading

Federal Court updates guidance on COVID-19

On January 18, 2021, the Federal Court (FC) issued its latest COVID-19 Practice Direction, which supersedes all its prior COVID-19 practice directions. The FC’s facilities in Ontario and Quebec have been closed in light of the recent public health measures to combat the pandemic. The FC will continue its operations remotely in these two provinces until further notice. These measures in Ontario and Quebec are largely the same as were in place during earlier stages of the COVID-19 pandemic.

Also on January 18, 2021, the FC issued a new Practice Direction outlining its Document Retention Schedule, including … Continue Reading

Canada amends CSP Regulations, adding UK to list of “timely submission requirement” countries

Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection (CSP). The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021.

Impact on “timely submission requirement”

CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.

The “timely submission requirement” in paragraph 106(1)(f) of the Patent Act stipulates that the Canadian application for market authorization for the approved … Continue Reading

Divided success in PM(NOC) actions regarding glatiramer acetate

The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon “speculative” prior art and rejected an argument that there was insufficient disclosure to satisfy the test for sound prediction. However, the Court found one of the two patents in issue was invalid for obviousness. Injunctive relief was granted in respect of the other patent.

Background

Teva Canada Innovation and Teva Canada Limited (together, Teva) and Pharmascience Inc. (Pharmascience) market glatiramer acetate products in Canada for indications … Continue Reading

Prosecution history cannot be invoked against patent licensees

The Federal Court has found that prosecution history evidence is inadmissible to rebut representations made by a patent licensee (as opposed to the patentee) on claims construction. The Court also considered the issues of “essential elements”, infringement, and obviousness in the context of a formulation patent.

Background

The Court’s decision concerns Canadian Patent No. 2,507,002 (002 Patent), which is listed on the patent register against Allergan Inc.’s (Allergan) silodosin capsules (marketed as RAPAFLO®) under an exclusive license in Canada granted by Kissei Pharmaceutical Co., Ltd. (Kissei). Allergan brought an action against Sandoz … Continue Reading

Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 (Interim Order for Medical Devices) on March 18, 2020. 

Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister. Any authorization for drugs, vaccines, and medical devices issued … Continue Reading

Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

On November 27, 2020, the Minister of Health (the Minister) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), pursuant to s. 30.1(1) of the Food and Drugs Act.

Summary

The current Interim Order is a response to international frameworks which allow for bulk importation of drugs from Canada, which the Minister believes could cause Canadian drug shortages. For example, the US Food and Drug Administration (FDA) published a rule entitled Importation of Prescription Drugs (the US Importation Rule) which permits US pharmacists or wholesalers to bulk import certain … Continue Reading

Federal Court of Appeal Upholds First Trial Judgment under New PM(NOC) Regulations

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FCA 188, the Court dismissed Amgen’s appeal from the Federal Court’s decision declaring certain claims in Amgen’s Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to Pfizer’s filgrastim biosimilar drug.

Appeal decision

The Court of Appeal found that the Trial Judge applied the correct approach to obviousness, noting that it requires a flexible approach and must be applied in context to the facts … Continue Reading

NOC issued after Federal Court overturns Minister’s decision on effective date of consent letter under the PM(NOC) Regulations

On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to issue the NOC given the nature of the consent provided.

Background

Fresenius Kabi Canada Ltd. (Fresenius Kabi) seeks to market its adalimumab product, IDACIO, in Canada. IDACIO is a biosimilar of AbbVie Biotechnology Ltd.’s (AbbVie) HUMIRA. AbbVie owns … Continue Reading

Finality, finally:  Adir and Servier Canada Inc. confirm their perindopril win

The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “Servier”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “Apotex”). The end was marked by the Supreme Court of Canada’s dismissal of Apotex’s application for leave to appeal a decision requiring it to disgorge its profits associated with infringement of Servier’s patent.

Judith Robinson and Joanne Chriqui of Norton Rose Fulbright Canada are proud to have successfully represented Servier at all levels of this hotly contested litigation.

The first chapter was a 2008 trial judgment upholding the validity … Continue Reading

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