Judith Robinson

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Finality, finally:  Adir and Servier Canada Inc. confirm their perindopril win

Photo of Judith RobinsonPhoto of Joanne ChriquiBy Judith Robinson and Joanne Chriqui on Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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 … Continue reading

Federal Courts update guidance on COVID-19

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on Posted in Uncategorized
The Federal Court of Appeal (FCA) provided updated guidance for resuming hearings starting September 1, 2020 and clarified the effect of the federal Time Limits and Other Periods Act (COVID-19) on timelines for commencing and conducting litigation in the FCA. Both the FCA and the Federal Court confirmed that all Practice Directions, judgments, orders and … Continue reading

Federal Court lifts Suspension Period

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on Posted in Intellectual property
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 … Continue reading

Federal Courts begin to phase out the Suspension Period

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on Posted in Uncategorized
On June 11, 2020 the Federal Court (FC) and Federal Court of Appeal (FCA) published updated notices to gradually phase out the Suspension Period, which had previously been extended to June 15, 2020. Federal Court The FC’s June 11, 2020 Practice Direction and Order (Updated Order), amends its previous Practice Directions, which, subject to the … Continue reading

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

Photo of Fortunat Nadima NadimaPhoto of Christopher A. GuerreiroPhoto of Judith RobinsonBy Fortunat Nadima Nadima, Christopher A. Guerreiro and Judith Robinson on 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 … Continue reading

Suspension Periods extended at the FCA and CIPO

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on 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 … Continue reading

Federal Court extends Suspension Period and expands use of virtual hearings

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on 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 … Continue reading

“New NAFTA” to take effect July 1, 2020: USA completes domestic ratification of CUSMA

Photo of Kassandra ShorttPhoto of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Judith RobinsonBy Kassandra Shortt, Christopher A. Guerreiro, Kristin Wall and Judith Robinson on Posted in Uncategorized
Canada, the United States, and Mexico have each completed the domestic processes necessary to bring the Canada-United States-Mexico Agreement (CUSMA, also known as USMCA or New NAFTA) into effect. CUSMA will come into force on July 1, 2020, the first day of the third month after it was ratified by each member country. The United … Continue reading

FCA to select cases that are ready to progress during pandemic

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on 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 … Continue reading

Federal Courts Extend Suspension Period Until May 15

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on 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 … Continue reading

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

Photo of Bianca PietracupaPhoto of Joanne ChriquiPhoto of Judith RobinsonBy Bianca Pietracupa, Joanne Chriqui and Judith Robinson on 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 … Continue reading

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

Photo of John GreissPhoto of Randy SuttonPhoto of Judith RobinsonPhoto of Brian R. DaleyBy John Greiss, Randy Sutton, Judith Robinson and Brian R. Daley on 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 … Continue reading

COVID-19: Federal Courts Announce Special Measures

Photo of Allyson Whyte NowakPhoto of Judith RobinsonPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on 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 … Continue reading

Federal Court dismisses motion for determination of an issue of law under the new PM(NOC) Regulations

Photo of Colin HyslopPhoto of Judith RobinsonBy Colin Hyslop and Judith Robinson on Posted in Pharmaceuticals and life sciences
The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court … Continue reading

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

Photo of Kassandra ShorttPhoto of Judith RobinsonBy Kassandra Shortt and Judith Robinson on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole. Background As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to … Continue reading

Two generics, one hearing: Federal Court orders common trial on patent validity issues in section 6 actions

Photo of Chelsea NimmoPhoto of Christopher A. GuerreiroPhoto of Judith RobinsonBy Chelsea Nimmo, Christopher A. Guerreiro and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the … Continue reading

New protections for biologics and other pharmaceuticals under the United States-Mexico-Canada Agreement (USMCA)

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Judith RobinsonBy Christopher A. Guerreiro, Kristin Wall and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Canada has joined a new trilateral trade deal called the United States-Mexico-Canada Agreement (USMCA). The USMCA contains important new protections for biologic and other pharmaceutical innovation. Chief among them, Canada will introduce an extended ten-year period of data protection for biologics and patent-term restoration (PTR) for delays in the patent office. The … Continue reading

CETA Tracker: Update on section 6 actions under the Patented Medicines (Notice of Compliance) Regulations

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Judith RobinsonBy Christopher A. Guerreiro, Kristin Wall and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under the amended Regulations. New actions under the amended Regulations Nearly seven months after the amended Regulations came … Continue reading

Coulda, woulda, shoulda – Federal Court finds Apotex would not have used non-infringing alternatives in perindopril case

Photo of Brian John CapogrossoPhoto of Joanne ChriquiPhoto of Judith RobinsonBy Brian John Capogrosso, Joanne Chriqui and Judith Robinson on Posted in Intellectual property
On redetermination of an accounting of profits, the Federal Court (FC) rejected Apotex’s claim that the profits awarded to Servier due to Apotex’s manufacture and sale of infringing perindopril should be reduced based on alleged non-infringing alternatives (NIAs). Background In 2008, the FC found that Servier’s patent claiming perindopril was valid and infringed by Apotex, … Continue reading

FCA upholds damage award based on Teva’s infringing sales of levofloxacin

Photo of Paul JorgensenPhoto of Judith RobinsonPhoto of Allyson Whyte NowakBy Paul Jorgensen, Judith Robinson and Allyson Whyte Nowak on Posted in Uncategorized
The Federal Court of Appeal has upheld the Federal Court’s order that Teva Canada Limited pay Janssen Inc. (Janssen Canada) and Janssen Pharmaceuticals, Inc. (Janssen US) over $18 million for infringing sales of levofloxacin (reported here). The Court of Appeal’s decision addresses standing, mitigation, market reconstruction, and how freely a trial judge can swing the … Continue reading

CETA tracker: First CETA PM(NOC) action has been commenced in Federal Court

Photo of Kristin WallPhoto of Judith RobinsonBy Kristin Wall and Judith Robinson on Posted in Intellectual property, Pharmaceuticals and life sciences
The first court action under the newly amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) was commenced on December 11, 2017.  Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc. (T-1921-17) addresses allegations of infringement with respect to Canadian Patent Nos. 2,376,596; 2,596,133; 2,407,556 and 2,540,547 and a biosimilar new drug submission for … Continue reading

Federal Court confirms innovator must be named as respondent when PM(NOC) Regulations engaged

Photo of Judith RobinsonPhoto of Pharma in Brief teamBy Judith Robinson and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to another innovator company, confirming that the second innovator has a legal interest in the determination of … Continue reading

CETA tracker: CETA implemented September 21

Photo of Judith RobinsonPhoto of Allyson Whyte NowakPhoto of Kristin WallBy Judith Robinson, Allyson Whyte Nowak and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
Final CETA regulations impacting pharmaceuticals come into force Canadian and European Union leaders signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. As we reported, the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Act) and accompanying regulations provide key reforms to the Patent Act affecting the pharmaceutical industry, including … Continue reading
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