Topic: Pharmaceuticals and life sciences

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Health Canada reports on a national strategy for rare disease drugs

Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada’s commitment to create a national strategy for drugs for rare diseases based on recommendations made by the Advisory Council on the Implementation of National Pharmacare.

The “What We Heard Report” is organized around four major themes that were identified in Health Canada’s discussion paper and addressed in the consultation feedback. Health Canada’s report observes, inter alia:

  1. Ensure consistent access. Provincial and territorial formularies can have different criteria
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PMPRB excessive price decision quashed by Federal Court of Appeal

The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination.

Procedural background

The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive price in Canada and ordering Alexion to remit excess revenues earned between 2009 and 2017. Alexion’s application was dismissed by the Federal Court in 2019. The Federal Court of Appeal has reversed this finding and granted Alexion’s application on the basis that the … Continue Reading

CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the Panel’s non-binding recommendations in April 2022.

Mandate and membership of the Panel

According to CADTH, the Panel’s recommendations are intended to contribute to discussions on a potential pan-Canadian prescription drug list. The mandate of the Panel is to:

  • Recommend principles and a framework for
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PMPRB Guidelines update: consultation on changes re delayed implementation

The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines.

The PMPRB has indicated that these changes are intended to account for delays in the coming-into-force date of amendments of the Patented Medicines Regulations (the Regulations). As we reported, the New Guidelines have already been updated once to account for earlier delays to these amendments. Following a further delay, most of … Continue Reading

PMPRB Update: delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which are scheduled to come into force at the same time as the amendments.

The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the Board, such as pharmacoeconomic value; a requirement to include “adjustments” when computing average transaction prices reported to the Board; and a revised … Continue Reading

Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation

The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the “second person” (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation (NOA). While new allegations may not be appropriate in every case, nor without consequence for the second person in a subsequent section 8 claim, they are not categorically prohibited.

Background 

The underlying Federal Court (FC) decision concerned a motion by a section 6 … Continue Reading

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees.

Regulations amending the Regulations, which will come into force on June 30, 2021, were recently published in the Canada Gazette, Part II. The corresponding amendments to the Patent Act are also set to come into force on this date.

Certificates of Supplementary Protection

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Federal Court quashes NOC in dispute over Data Protection Provisions

The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product.

The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process did not allow the Court to determine how the Minister interpreted section C.08.004.1 of the Food and Drug Regulations (the Data Protection Provisions).  The Court found that the decision was therefore unreasonable and remanded the matter back to … Continue Reading

Quebec Prohibits Financial Assistance by Drug Manufacturer for Patients’ Drug Costs

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme.[1]

Among the new prohibitions was one that would prohibit a manufacturer from offering any financial assistance to patients to help cover the cost of a drug on the provincial List of Medications (Quebec’s formulary). The aim was to end the practice of brand name drug manufacturers covering the patients’ portion of the cost of brand name drugs … Continue Reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP.

Proposed FDR Amendments Create Imbalance in Linkage Regime

As previously reported, the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug … Continue Reading

PMPRB Update: New periods for compliance with the new Guidelines

The PMPRB has confirmed that patentees of “Grandfathered” and “Gap” medicines will have two reporting periods to comply with new price ceilings to be set under its new Guidelines, replacing previous guidance that only one reporting period would be permitted.

Updates to the Guidelines

As we reported, the Guidelines were released by the PMPRB on October 23, 2020 and are intended to implement amendments to the Patented Medicines Regulations that were passed in August 2019.

At the time they were released, the Guidelines were scheduled to take effect together with the amendments to the Regulations on January 1, … Continue Reading

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

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