Topic: Pharmaceuticals and life sciences

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

By Shantelle LaFayette, Colin Hyslop and Brian R. Daley on May 27, 2020 Posted in Intellectual property, Pharmaceuticals and life sciences

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

By Fortunat Nadima Nadima, Christopher A. Guerreiro, Judith Robinson and Jordana Sanft on May 25, 2020 Posted in Intellectual property, Pharmaceuticals and life sciences

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

Health Canada amends regulations to permit distribution of OTC and NHP samples to general public

By John Greiss and Randy Sutton on May 5, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences, Uncategorized

Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of these products was limited to physicians, dentists, veterinary surgeons and pharmacists. The regulatory amendments were made as part of Canada’s obligations under the Canada–United States–Mexico Agreement (CUSMA) and the passing of the CUSMA … Continue Reading

Update: Expanded Federal Funding for Research and Innovation

By David Yi and Jordana Sanft on April 26, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

As we reported in March, the Federal Government pledged $275 million to research relating to COVID-19. On April 23, 2020, an additional $1.1 billion in funding was announced and includes funding for:

Research and Data:
- $114.9 million for research to accelerate the development, testing, and implementation of medical and social countermeasures to COVID-19. This will be provided through the Canadian Institutes of Health Research.
- $40 million for the Canadian COVID-19 Genomics Network for COVID-19 viral and host genome sequencing research.
- $10 million to improve data monitoring coordination of pandemic-related data across the country.
Vaccine Development:
- $600 million to support

First trial judgment under new PMNOC Regulations declares claims to biologic drug invalid

By Orestes Pasparakis, Paul Jorgensen, Kassandra Shortt, Daniel Daniele and Mark Davis on April 21, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has released its first trial judgment in an action brought under the new Patented Medicines (Notice of Compliance) Regulations. In Amgen Inc v Pfizer Canada ULC, 2020 FC 522, the Court dismissed Amgen’s action and declared certain claims in Canadian Patent No. 1,341,537 (537 Patent) invalid for obviousness. The action related to Pfizer’s filgrastim biosimilar.

Under the new Regulations, which came into force in September 2017, a full action determines the question of whether the marketing of a generic or biosimilar drug would infringe any valid claims of any patents listed … Continue Reading

Health Canada releases Guidance Document addressing the Plain Language Labelling Regulations requirements for non-prescription drug products

By Sarah Pennington, John Greiss and Randy Sutton on April 15, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (colloquially known as the Plain Language Labelling Regulations or PLL Regulations) for non-prescription (i.e. over-the-counter or OTC) drug products.

The Guidance Document, entitled Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (the Guidance Document), is effective as of April 1, 2020. It identifies information that will support requirements mandated under the PLL Regulations, and points to other FAQs, … Continue Reading

Health Canada issues Interim Order to address shortages of health products

By John Greiss, Randy Sutton and Brian R. Daley on April 13, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister on March 30, 2020.

The Interim Order allows the Minister to permit the exceptional importation and sale of: (1) drugs, including biocide drugs (such as hand sanitizers and disinfectants) but not natural health products (NHPs); (2) medical devices; and (3) foods for … Continue Reading

Quebec maintains drug evaluation activities for listing purposes and launches clinical trials

By Fortunat Nadima Nadima, Veronique Barry and Olga Farman on April 13, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

In this post, the Pharma in Brief team reports on two recent developments in the Quebec regulatory landscape related to the COVID-19 crisis.

Adjustments to submission procedure for applications for listing of innovative drugs and blood products on formulary

On April 6, 2020, Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) issued a notice to drug manufacturers and blood system product manufacturers describing temporary measures implemented recently to avoid processing backlogs for applications for listing on Quebec’s formulary during the COVID-19 crisis. As of March 30, 2020, manufacturers of innovative drugs or blood products can … Continue Reading

Federal Court issues first decision on patent term restoration – Minister’s decision denying certificate of supplementary protection (CSP) is unreasonable

By Morgan Westgate, David Yi and Kristin Wall on April 8, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On April 7, 2020, the Federal Court issued a decision in Canada’s first judicial review under the Patent Act and new Certificate of Supplementary Protection Regulations (CSP Regulations). It is the first decision issued under this regime, and also one of the first decisions to apply the Supreme Court of Canada’s new standard of review framework set out in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 (Vavilov).

The judicial review application was brought by GlaxoSmithKline Biologicals S.A. (GSK) in respect of an August 3, 2018 decision (Decision) … Continue Reading

Canada completes domestic ratification of CUSMA

By Kassandra Shortt, Christopher A. Guerreiro and Kristin Wall on April 5, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Canada has completed domestic ratification of the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA or new NAFTA). As we reported, Canada introduced Bill C-4 to implement CUSMA on January 29, 2020 and it received royal assent as the Canada-United States-Mexico Agreement Implementation Act (CUSMA Implementation Act) on March 13, 2020.

No coming-into-force date for CUSMA has been set. Deputy Prime Minister Chrystia Freeland stated: “The Canadian government will continue to work with the United States and Mexican governments to determine an ‘entry into force’ date that is mutually beneficial” and that she … Continue Reading

Ontario introduces formulary changes for generic drugs to mitigate risk of drug shortages

By John Greiss, Christopher A. Guerreiro and Kristin Wall on March 31, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On March 30, 2020, the Ontario government launched two one-day consultations on changes to regulations concerning the listing of generic drug products under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These consultations end March 31, 2020.

Both changes are said to be needed to help mitigate the risk of drug shortages in Ontario during the COVID-19 pandemic.

Private-label generics eligible for listing

As we previously reported, the Ontario government took steps late last year to permit the listing of private-label generic drugs on the provincial drug … Continue Reading

Coulda, Shoulda, but Not Likely Woulda: Federal Court of Appeal affirms finding that generic would not have used a non-infringing alternative

By Bianca Pietracupa, Joanne Chriqui and Judith Robinson on March 29, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal has affirmed the Federal Court’s decision awarding an accounting of profits to ADIR and Servier Canada Inc. (Servier), concluding that Apotex Inc. and Apotex Pharmachem Inc. (Apotex) would not have used a non-infringing alternative (NIA).

Background

In 2008, the Federal Court found that Servier’s patent for the drug perindopril was valid and infringed by Apotex. Apotex’s liability was affirmed on appeal. A trial on an accounting of profits ensued and Apotex was ordered to remit the aggregate amount of C$61 million plus interest. In a first appeal by Apotex, … Continue Reading

New Federal initiatives to combat pandemic: Patent Act amended to allow limited government use of patented inventions for public health emergencies

By Chelsea Nimmo, Anna Wilkinson and Kristin Wall on March 25, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On March 25, 2020, the Canadian Government passed into law Bill C-13, An Act respecting certain measures in response to COVID-19, following emergency sittings of Parliament and the Senate. Bill C-13 amends both the Patent Act and the Food and Drugs Act and may have implications for the pharmaceutical industry.

Patent Act – Limited government use of patented inventions for public health emergencies (s. 19.4)

A new stand-alone provision has been added to the Patent Act: section 19.4. This section allows the Minister of Health to apply for government authorization to make, construct, use, and sell a … Continue Reading

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

By John Greiss, Randy Sutton, Judith Robinson and Brian R. Daley on March 25, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Changes Affecting Ontario

The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees:

The dispensing of medication is limited to no more than a 30-days’ supply. Dispensers may use professional judgment to provide a longer supply in exceptional cases, but should not exceed the patient’s usual supply
Prescriptions should not be refilled more than 10 days in advance of a patient depleting

PM(NOC) Statutory Deadlines Still Applicable

By Caroline Henrie, Amy Grenon and Jordana Sanft on March 24, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

As we reported, the Federal Court (FC) has suspended its hearings scheduled between March 16, 2020 and April 17, 2020 (the Suspension Period) sine die. Proceedings brought in accordance with the Patented Medicines (Notice of Compliance) Regulations (Regulations) fall under the FC’s jurisdiction. However, certain deadlines related to these proceedings are set by the Regulations themselves. Such ‘statutory’ deadlines are not subject to the FC’s Suspension Period.

As the FC states in its recent FAQ on its COVID-19 Practice Direction and Order, the deadline for commencing a proceeding pursuant to section 6 of the … Continue Reading

COVID-19: Health Canada simplifies regulatory requirements for COVID-19-related products

By John Greiss, Randy Sutton and Kristin Wall on March 22, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19.

Expedited review of Health Product Submissions and Applications

Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications. Until a vaccine or therapeutic product is available on the Canadian market, the Special Access Program will continue to be available for COVID-19 related treatments.

Submissions or applications to Health Canada should be directed to the appropriate bureau using the contact information found on this page.

Diagnostic … Continue Reading

COVID-19: Sharing information for licensed health products during a pandemic

By John Greiss, Kristin Wall and Randy Sutton on March 17, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to help “flatten the curve”, many interactions between HCPs and companies are moving to the virtual world. At the same time, HCPs will look to the industry to provide timely and accurate information through their medical teams or patient support programs (PSPs) about how to manage … Continue Reading

Bill C-4: New CUSMA Implementation Act Received Royal Assent

By Christopher A. Guerreiro and Kristin Wall on March 15, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On March 13, 2020, the Government passed Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). Canada will be the third and final party to ratify the treaty.

The Bill, sponsored by Deputy Prime Minister Freeland, was introduced on January 29, 2020. The Bill was recently expedited in order to ensure that it passed before both Houses adjourned at the end of the week over concerns regarding the spread of COVID-19.

As we reported, Bill C-4 does not contain any amendments to the Patent Act. Canada is still expected to amend the Patent Act to include … Continue Reading

COVID-19: Health Canada Issues Bulletin Confirming Obligations of DEL Holders

By John Greiss and Randy Sutton on March 5, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and efficacy of products.

The bulletin reminded DEL holders of their obligations to notify or report to Health Canada any events that could have an impact on pharmaceutical operations. Specifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could … Continue Reading

Federal Court invalidates Health Canada’s decision to disclose records in response to ATI request

By Caroline Henrie and Christopher A. Guerreiro on January 30, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has invalidated Health Canada’s decision to disclose records pertaining to a veterinary pharmaceutical product, Fortekor Flavour Tabs (Fortekor), pursuant to the Access to Information Act (the Act). Health Canada defended its decision on the basis that the information contained in the records was “part of public domain information”. On judicial review, the Court agreed with the applicant, Elanco Canada Limited (Elanco), that Health Canada’s argument was based on unsubstantiated information, relating to different medications, with different compounds, in different jurisdictions.

Background

Through the veterinary drug submission process, Elanco provided Health Canada with … Continue Reading

Patent owner files its own pleading in a PM(NOC) action

By Colin Hyslop, Daniel Daniele and Brian R. Daley on January 29, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, including by making new and different allegations than those made by the plaintiff.

Background

This decision arose in the context of Allergan Inc.’s (Allergan) action against Apotex under s 6(1) of the PM(NOC) Regulations concerning ulipristal acetate. Allergan licenses … Continue Reading

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

By Caroline Henrie, David Yi and Jordana Sanft on January 21, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD.

What Constitutes SaMD

Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations of what constitutes a “device” or “medical device” in the Act and Regulations (including by reference to the definition … Continue Reading

Pharma in Brief: The 2019 Year in Review

By Kristin Wall, Jordana Sanft, Christopher A. Guerreiro and Colin Hyslop on January 19, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

In this article, the Pharma in Brief team curated the most significant topics we covered during 2019.

The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national pharmacare, replacing the North American Free Trade Agreement (NAFTA), and changes to drug approval pathways.

There were few pharmaceutical patent decisions released in 2019 but plenty of activity in the Courts, as the first actions under the new Patented Medicines (Notice of Compliance) … Continue Reading

Ontario reduces restrictions on ordinary commercial term benefits and private label products

By William Chalmers, Randy Sutton and Allyson Whyte Nowak on December 17, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow private label products to be listed as benefits or be designated as “interchangeable”. The amendments to the Regulations come into force on January 1, 2020.

Removal of OCT benefit financial cap

OCT benefits are payments made between … Continue Reading