Topic: Intellectual property

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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

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

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

Federal Court issues new consolidated guidelines on complex proceedings

On October 22, 2020, the Federal Court (FC) issued new Case and Trial Management Guidelines for Complex Proceedings (the FC Guidelines). These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession:

  1. Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015);
  2. Trial Management Guidelines (April 2017);
  3. Intellectual Property (experimental testing) (May 12, 2016); and
  4. Guidelines for Actions under the Amended PMNOC Regulations (September 21, 2017).

The FC Guidelines are divided in two sections: the first is a general section … 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,

Continue Reading

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:

Continue Reading

Federal Court finds Minister’s CSP decision unreasonable on patent eligibility for fixed-dose combination drug product

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) and the drug JULUCA® (Decision).

The Federal Court determined that the Decision was unreasonable, including for failing to interpret the CSP regime in a manner consistent with the Canada-European Union Comprehensive Economic and Trade … Continue Reading

PMPRB takes jurisdiction over medicine (again) following Federal Court of Appeal remand

The Patented Medicine Prices Review Board (PMPRB or Board) has found that a patent can pertain to a medicine based on clinical similarities to the invention—even if the patent does not actually encompass the medicine.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders. The patentee, Galderma Canada Inc. (Galderma), markets two adapalene products in Canada:

  • Differin®, which contains 0.1% adapalene (DIFFERIN).
  • Differin XPTM, which contains a higher concentration of adapalene: 0.3% (DIFFERIN XP).
Continue Reading

Federal Court lifts Suspension Period

On June 25, 2020, the Federal Court (FC) issued its latest Practice Direction and Order (FC Update) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations

Background

The FC Update is the fifth Practice Direction and Order issued by the FC in response to the Covid-19 pandemic. For ease of reference, the FC has published a consolidated version of these five notices, including those provisions of each … Continue Reading

PMPRB launches consultation on revised Draft Guidelines

On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public comment until July 20, 2020.

Background

Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. These amendments are intended to lower the prices of patented medicines in Canada. They include: (1) new factors for … Continue Reading

Federal Court determines that infringement action under PM(NOC) Regulations is not moot where trial proceeds after patent expiry

On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent.

Background

Sandoz served a Notice of Allegation on AstraZeneca alleging non-infringement, invalidity and ineligibility for listing of AstraZeneca’s patent for saxagliptin tablets (marketed as ONGLYZA), being Canadian Patent No. 2,402,894 (894 Patent). AstraZeneca commenced an action against Sandoz seeking a declaration that … Continue Reading

PMPRB update: Amendments delayed, new Guidelines consultation announced, and judicial review heard

This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review of those amendments.

Amendments to the Patented Medicines Regulations delayed

The federal government has delayed the implementation of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), which are now scheduled to come into force on January 1, Continue Reading

Two PM(NOC) Actions Dismissed After Common Trial on Validity of Treatment Regimen Patent

The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were obvious and that some were anticipated. This is the third decision on the merits of an action under the Regulations since they were amended in September 2017. We previously reported on the first and second trial judgments.

The actions. Continue Reading

Federal Court supports virtual trials for intellectual property actions

The Federal Court of Canada has embraced virtual hearings as the best solution to the prolonged Covid-19 shutdown. While acknowledging some litigants’ concerns pertaining to procedural fairness and information security in recent rulings, the Court is more concerned that justice delayed can become justice denied.

Videoconferencing will not impede the Court’s ability to assess the credibility of witnesses

The unprecedented suspensions following Covid-19 saw some litigants facing lengthy suspensions mid-way through trial. In Rovi Guides, Inc. v Videotron Ltd., one party argued that it would be unfair to require some witnesses to testify remotely after other witnesses had testified … Continue Reading

Dosing regimen patent found valid and infringed in the second decision under the new PM(NOC) Regulations

In the second trial judgment under the new Patented Medicine (Notice of Compliance) Regulations, the Federal Court (FC) found for the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V., and enjoined Teva Canada Limited (Teva) from making, constructing, using or selling paliperidone palmitate (paliperidone) in accordance with its abbreviated new drug submission. The Court rejected Teva’s argument that the claimed dosing regimens were obvious, as well as its arguments against direct infringement of certain of the claims.

Background

Paliperidone is marketed in Canada as INVEGA SUSTENNA and is used to treat schizophrenia and related … Continue Reading

FCA gives guidance for common PM(NOC) trials involving multiple actions

The Federal Court of Appeal has reversed the Federal Court’s decision to add two additional generic defendants (Taro Pharmaceuticals Inc. and Sandoz Canada Inc.) to an upcoming common trial under the Patented Medicines (Notice of Compliance) Regulations. The common trial will determine patent validity issues in Bayer Inc.’s actions against Teva Canada limited and Apotex Inc. concerning generic versions of XARELTO® (rivaroxaban).

Background

This is an appeal by Teva and Apotex from a decision of the Federal Court allowing Taro and Sandoz to join Teva and Apotex in a trial of common validity issues. As we reported, the … Continue Reading

Suspension Periods extended at the FCA and CIPO

This week, the Federal Court of Appeal (FCA) extended its Suspension Period and the Canadian Intellectual Property Office (CIPO) extended its deadlines, both until the end of May.

Federal Court of Appeal

As we reported, the FCA has issued a number of Notices to the Parties and the Profession concerning the conduct of litigation during the pandemic, including a Suspension Period and various exceptions under which cases may proceed.

On May 12, 2020, the FCA published its most recent Notice to the Parties and Profession (FCA Update). The FCA Update announces that the … Continue Reading

Federal Court extends Suspension Period and expands use of virtual hearings

On April 29, 2020, the Federal Court (FC) published a Practice Direction and Order (FC Update) extending its Suspension Period until May 29, 2020 and adjourning hearings until June 29, 2020—subject to certain exceptions. During this time, the Court has made provisions to hold certain hearings by phone or Zoom videoconference.

The FC Update is an amendment to its previous Updated Practice Direction and Order dated April 4, 2020, which we discuss here and otherwise remains in force.

Extension of Suspension Period & other measures

The FC Update introduces three main changes to procedural timelines:… Continue Reading

Governmental Use of Patented Inventions during a Pandemic: A Global Survey

Key Contacts: Jordana Sanft (Toronto), Jeffrey Lewis (New York), Jenny Shum (New York), Clemens Rubel (Munich), Seiko Hidaka (London), Justin Davidson (Hong Kong SAR), Jackie O’Brien (Sydney)

Around the globe, pharmaceutical and medical device companies are helping in the fight of the COVID-19 pandemic. Many of these companies may have patents pertaining to technology that could be used for the benefit of the broader public during this time of crisis, such as patents on ventilators, diagnostic tests, pharmaceuticals or personal protective equipment. Governments around the globe have mechanisms in place that can mandate the use of patented inventions during a … Continue Reading

No leave required for experimental testing conducted prior to litigation

The Federal Court of Appeal (FCA) has decided that the Federal Court’s Notice to the Profession regarding experimental testing (the Notice) does not apply to testing conducted in advance of litigation. As a result, parties wishing to lead evidence of pre-litigation testing at trial are not required to obtain leave of the Court.

Background

This decision was rendered in the context of actions for patent infringement under the Patented Medicines (Notice of Compliance) Regulations. Bayer Inc. and Bayer Intellectual Property GMBH (Bayer) initiated actions against Apotex Inc. (Apotex) and Teva Canada Limited (… Continue Reading

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