Topic: Intellectual property

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

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

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

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

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

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

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

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

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

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

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

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

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

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
Continue Reading

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

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

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

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

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

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

The Federal Court of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal concluded that when viewed as a whole, there was no reviewable error in the judgment and dismissed the appeal.

Background

The underlying action concerned a claim by Teva Canada Limited (Teva) for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) concerning a generic version of VELCADE (bortezomib). The defendants, Janssen Inc. … Continue Reading

Federal Court rejects the concept of “first mover advantage” for generics in PM(NOC) infringement actions

The Federal Court has ordered that two additional generic defendants (Taro Pharmaceuticals Inc., Sandoz Canada Inc.) be added to a trial of common issues currently set for Bayer Inc.’s claims against Teva Canada Limited and Apotex Inc. concerning generic versions of XARELTO® (rivaroxaban) under the Patented Medicines (Notice of Compliance) Regulations (the Regulations).

All four proceedings are patent infringement actions brought by Bayer under the Regulations. The actions were launched in response to each defendant’s Notice of Allegation (NOA) for their respective generic versions of XARELTO® and one or more Bayer patents.

Earlier this … Continue Reading

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

The Federal Court has found that it is reasonably arguable that a claim for “a composition for use in the treatment of a disorder” may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished these claims from pure “use of a composition for a treatment” claims, which can only be infringed by a generic manufacturer through inducing infringement.

Background

The Court’s decision concerns a pleadings amendment motion by Eli Lilly Canada Inc. and its co-plaintiffs (collectively, Lilly) in patent infringement actions against: (1) Apotex Inc.; (2) Mylan Pharmaceuticals ULC; (3) Teva Canada Limited; … Continue Reading

Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations

On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect of patent validity issues were proper and dismissed the motion.

Background

This motion arose in the context of an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, relating to the drug INVEGA SUSTENNA (paliperidone). The plaintiffs, … Continue Reading

Federal Court relies on foreign prosecution history in first application of file wrapper estoppel

In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time. While CanMar is not a life sciences case, the application of Canada’s new file wrapper estoppel provision has implications for patentees generally.

In CanMar, the patentee contended that two elements of the claim at issue were non-essential. The Court reached the opposite conclusion by relying on prosecution history evidence admitted under section 53.1, and set out a test for … Continue Reading

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020.

Once the amendments come into force, the PMPRB will use a different basket of price comparator countries. Significantly, the new basket excludes the US. The PMPRB will also consider new pharmacoeconomic market size, and gross domestic product (GDP)-based … Continue Reading

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to … Continue Reading

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