Topic: Life sciences and healthcare

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Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on the date that the IO expires.

These amendments are intended as a successor to the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (IO), which is scheduled to expire on September … Continue Reading

Two new interim orders update previous orders on medical devices and foreign products during pandemic

The Minister of Health has issued two new interim orders (IOs) regarding authorizations for COVID-19-related products. The first new order extends interim authorizations for COVID-19 medical devices until transition regulations can be passed. The second new order extends and updates the Minister’s authority to permit the import and sale of foreign drugs, medical devices, and foods for a special dietary purpose to alleviate domestic shortages of those products.

The new IOs will expire on March 1, 2022, unless they are repealed or superseded by regulations.

A complete list of the interim orders issued pursuant to s. 30.1(1) of … Continue Reading

Federal Court of Appeal provides guidance on the “inventive concept”

The Federal Court of Appeal (FCA) has held that the “inventive concept” can go beyond the essential elements of the claim and may include advantageous properties stated in the patent’s description. The FCA confirmed that the inventive concept is the end-point in the obviousness analysis: for a claimed invention to be obvious, the gap between the inventive concept and the state of the art must have been obvious to the notional uninventive person of skill in the art.

Background

The patent at issue was Canadian Patent No 2,527,646 (the 646 Patent), which claims the chemical compound lisdexamfetamine … Continue Reading

Ontario Superior Court summarily dismisses Apotex’s novel monetary claims under Statutes of Monopolies, Trademarks Act, and at common law

On March 8, 2021, the Ontario Superior Court granted summary judgment dismissing novel claims by Apotex under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law. It is the first decision on the merits of Apotex’s novel claims and arises in the context of litigation relating to Eli Lilly’s patented olanzapine product (marketed as Zyprexa®). The decision stands to impact numerous actions brought by generics on similar grounds against various innovator companies.

Procedural Background  

Apotex Inc. and Apotex Pharmachem Inc. (collectively, Apotex) brought an action in the Ontario Superior Court seeking damages … Continue Reading

Health Canada consults on proposed guidelines for the use of electronic media in prescription drug labelling

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label.

Consultation on the draft guidance document is open until May 7, 2021.

Background and scope

The draft guidance would apply to prescription drugs for human use with labels that are linked (e.g.Continue Reading

Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the same patent was invalid.

Background

ZYTIGA® (abiraterone acetate or AA) is a drug marketed in Canada by Janssen Inc., Janssen Oncology, Inc., and BTG International Ltd. (collectively, Janssen) for the treatment of prostate cancer. Canadian Patent No. 2,662,422 (the 422 Patent) … Continue Reading

Federal Court finds 45-day limitation period does not apply to s 8.2 PM(NOC) related rights of action for unlisted patents

Summary

The Federal Court has held that the “related right of action” for infringement of unlisted patents under section 8.2 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) is not subject to the 45-day limitation period familiar to patentees asserting infringement of listed patents under subsection 6(1).

Background

Merck Canada Inc. and Merck Sharp & Dohme Corp. (the Plaintiffs) are involved in litigation under the Regulations against Sandoz Canada Inc. and Pharmascience Inc. (the Defendants) regarding proposed generic versions of the drug JANUVIA (sitagliptin).

The Plaintiffs initially brought infringement actions under subsection 6(1) in respect … Continue Reading

Bill C-213, An Act to enact the Canada Pharmacare Act: rejected by Parliament

On February 24, 2021, Parliament voted down Bill C-213, which would have enacted the Canada Pharmacare Act. The Private Member’s Bill was first introduced a year ago, re-introduced in September 2020 after Parliament’s prorogation, and defeated at Second Reading.

The Canada Pharmacare Act set out a series of criteria and conditions that would have been required before a federal cash contribution could be provided to a province for its public drug insurance plan: public administration; comprehensiveness; universality; portability; and accessibility.

These criteria were intended to align with principles of pharmacare identified in the June 2019 Final Report of … Continue Reading

Federal Court upholds patent validity and issues declarations of infringement against two generic apixaban tablets

In one of its first patent decisions of 2021, the Federal Court tackled arguments regarding the relevant date for insufficiency allegations and the level of disclosure required for demonstrated utility. The Court resolved these and other issues in the patentees’ favour, granting declarations of infringement against two proposed apixaban generics.

Background

ELIQUISTM (an blood thinner) is marketed in Canada by Bristol-Myers Squibb Canada Co. Pharmascience Inc. and Sandoz Canada Inc. (the Defendants) sought approval to market generic versions of ELIQUISTM in Canada.

The Court’s decision concerned the claims of two patents asserted against each of the … Continue Reading

PM(NOC) Regulations do not preclude defendants from amending the statement of defence

A defendant in a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations was allowed to amend its defence to include invalidity allegations not found in the Notice of Allegation.

Background

In an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) concerning three patents, the defendant sought to amend its statement of defence to add new prior art references and invalidity allegations. These allegations had been raised against the plaintiffs by a different generic in another subsection 6(1) proceeding, but were not in the defendant’s notice of allegation … Continue Reading

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

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

Health Canada finalizes regulations relating to sale of unapproved drugs for emergency treatment under the Special Access Program

Regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were published in Canada Gazette (Part II) on October 14, 2020. We previously reported on these changes, which seek to reduce the administrative burden associated with the Special Access Program (SAP) (for human drugs) and the Emergency Drug Release (EDR) (for drugs for veterinary use).

To recap, previously a practitioner requesting a drug under the SAP was required to submit supporting data concerning the use, safety, and efficacy of the drug with each request. This supporting … Continue Reading

PMPRB Update: Final Guidelines Released

On Friday, October 23, the Patented Medicine Prices Review Board (PMPRB) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments).

According to the PMPRB:

The Guidelines provide information on the PMPRB’s general approach to the price review process and investigations. They supersede all previous guidance documents, policy communiqués and written or verbal statements of any kind by the PMPRB regarding the administration of the price review process and investigations, including all previous versions of the PMPRB’s Compendium of Guidelines,

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New Interim Order to address COVID-19-related drug shortages in Canada

On October 16, 2020, the Minister of Health (the Minister) signed the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 (the IO), which introduces new tools for the Minister to address actual or potential drug shortages caused, or exacerbated, by COVID-19.  The scope of the IO excludes shortages of veterinary or natural health products.

This IO is the fifth IO to be issued by Health Canada in the context of COVID-19.  The other COVID-19-related IOs are:

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Overview of IP Law In Canada – The Intellectual Property Review, 9th Edition

The recently published Ninth Edition of the Intellectual Property Review (the Review) includes a chapter detailing the various forms of IP protection available in Canada, and highlights important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team.

The chapter also provides an overview of patent law, protection of IP in respect of pharmaceuticals including under the PM(NOC) Regulations, data protection and patent term restoration. Canada is one of 16 countries featured in the Review, with chapters also available on the US and UK.

Links:

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National Pharmacare Update

On September 23, 2020, the government identified national pharmacare, a national program to fund prescription drugs in Canada, as a continued priority in the Speech from the Throne (the Speech) to open the Second Session of the 43rd Parliament of Canada.

As we reported, the federal government previously announced funding for the implementation of certain recommendations from the Advisory Council on the Implementation of National Pharmacare, including the creation of: (1) the Canadian Drug Agency; (2) a national formulary; and (3) a national strategy for high-cost drugs for rare diseases.

The Speech reaffirms that national pharmacare remains an … Continue Reading

New Interim Order to expedite the approval of COVID-19 drugs and vaccines

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada. It also allows for addition of new indications related to COVID-19 that are not included in a currently-marketed product’s authorization.

Expedited Approval

The Interim Order establishes alternative pathways to the standard regulatory review process which helps expedite the authorization of eligible products.

  • Manufacturers will be permitted
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