Topic: Intellectual property

Subscribe to Intellectual property RSS feed

Federal Court supports virtual trials for intellectual property actions

By Bianca Pietracupa and Brian R. Daley on May 27, 2020 Posted in Intellectual property, Pharmaceuticals and life sciences

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

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

Suspension Periods extended at the FCA and CIPO

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on May 14, 2020 Posted in Intellectual property

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

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on April 30, 2020 Posted in Intellectual property

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

By Jordana Sanft, Chelsea Nimmo and Colin Hyslop on April 22, 2020 Posted in Intellectual property

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

By William Chalmers and Amy Grenon on April 22, 2020 Posted in Intellectual property

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

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

FCA to select cases that are ready to progress during pandemic

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on April 19, 2020 Posted in Intellectual property

On April 15, 2020, the Federal Court of Appeal (FCA) published an updated Notice to the Parties and the Profession (FCA Update). As we previously reported, the FCA suspended the running of time under the Federal Courts Rules (the Rules) to May 15, 2020 (the Suspension Period).

The FCA Update advises that circumstances permit the FCA to exempt some cases from its previous notices, allowing them to progress towards a determination on the merits. The FCA will review the list of cases and based on the nature, complexity, and the extent to which … 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

Federal Courts Extend Suspension Period Until May 15

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on April 5, 2020 Posted in Intellectual property

The Federal Court (FC) and the Federal Court of Appeal (FCA) have announced revised measures to facilitate limited court operations while providing relief to litigants and their counsel during the Covid-19 pandemic. As we reported, both courts introduced a first round of such measures in mid-March.

Federal Court

On April 4, 2020, the FC issued an Updated Practice Direction and Order (the FC Update), which supersedes the Court’s previous Practice Direction and Order of March 17, 2020 and the associated March 20, 2020 FAQ. The following are some of the highlights of the … 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

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: Federal Courts Announce Special Measures

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on March 19, 2020 Posted in Intellectual property

In light of the COVID-19 pandemic, the Federal Courts have issued statements on the temporary procedures they will follow to balance health and safety with the need to remain accessible to Canadians. The Federal Court (FC) and the Federal Court of Appeal (FCA) had earlier issued statements on March 13, 2020, which are superseded by this week’s updates.

Federal Court

On March 17, 2020, the FC announced it has suspended all General Sittings and hearings scheduled between now and April 17, 2020 (the Suspension Period) sine die. On March 20, 2020, the FC issued … 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

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

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

Amended CUSMA no longer extends data protection for biologics

By Kassandra Shortt, Christopher A. Guerreiro and Kristin Wall on December 11, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years currently provided under Canadian law.

Changes to the CUSMA

As we reported, the previous version of CUSMA required two notable changes to Canadian law concerning pharmaceuticals and biologics:

Extended data protection for biologics. CUSMA previously required Canada to provide a

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

By Christopher A. Guerreiro, Kristin Wall and Brian R. Daley on December 10, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020.

Background

As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and Procedures. The changes are intended to implement the recent amendments to the Patented Medicines Regulations, which come into force on July 1, 2020. The PMPRB released the Draft Guidelines on November 21, 2019.

Consultation update

According to a December 10, … Continue Reading

Federal Court refuses to allow fifth generic to join common trial on validity

By Colin Hyslop and Jordana Sanft on November 25, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has denied a motion by Dr. Reddy’s Laboratories’ (Dr. Reddy’s) seeking to participate in a common validity issues trial in actions concerning four other generic versions of the same drug under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations).

Background

As we reported, the Federal Court has made a number of orders concerning common validity trials in actions commenced by Bayer Inc. (Bayer) under the PM(NOC) Regulations in respect of generic versions of XARELTO (rivaroxaban). The common validity issues in these earlier actions against Apotex Inc., Teva Canada Limited, … Continue Reading

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

By Christopher A. Guerreiro, Kristin Wall and Brian R. Daley on November 21, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines.

Background

As we reported, the Government released final amendments to the Patented Medicines Regulations on August 9, 2019. These amendments are scheduled to come into force on July 1, 2020 and are intended to lower the prices of patented medicines in Canada. They include: (1) new factors for assessing excessive pricing, (2) new … Continue Reading

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

By Sarah Pennington and Kristin Wall on November 17, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s claims were non-obvious and possessed at least a scintilla of demonstrated utility. The Court also held that Apotex would induce infringement of Janssen’s patent with the product monograph for its proposed generic. This will likely be one of the last cases decided under the pre-September … Continue Reading