Allyson Whyte Nowak

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Thirty years of the Patented Medicines (Notice of Compliance) Regulations

Photo of Gunars GaikisPhoto of Orestes PasparakisPhoto of Brian R. DaleyPhoto of Allyson Whyte NowakPhoto of Kristin WallBy Gunars Gaikis, Orestes Pasparakis, Brian R. Daley, Allyson Whyte Nowak and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.  Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation … Continue reading

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

Photo of William ChalmersPhoto of David YiPhoto of Allyson Whyte NowakBy William Chalmers, David Yi and Allyson Whyte Nowak on Posted in Damages, Intellectual property, Life sciences and healthcare
The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine product. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements … Continue reading

ONCA Confirms Generics Limited to Section 8 Damages in the Face of an Innovator’s Legitimate Exercise of Rights under the PM(NOC) Regulations

Photo of Allyson Whyte NowakPhoto of David YiPhoto of Christopher A. GuerreiroBy Allyson Whyte Nowak, David Yi and Christopher A. Guerreiro on Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On August 16, 2022, the Ontario Court of Appeal (ONCA) released its decision in Apotex Inc. v. Eli Lilly Canada Inc., 2022 ONCA 587.  The ONCA denied Apotex’s appeal of a lower court summary judgement decision that dismissed Apotex’s novel claims under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law (see … Continue reading

Federal Court of Appeal Gradually Phases Out Suspension Period

Photo of Allyson Whyte NowakPhoto of Kristin WallPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on Posted in Intellectual property
The Federal Court of Appeal (FCA) has begun to gradually restore filing deadlines in appeals before the Court that were subject to the Court’s Suspension Period. Under the Suspension Period system, the progress of individual appeals has been managed by “selecting” and “deselecting” them from a Selected Files list. As we previously reported, the FCA … Continue reading

Federal Court of Appeal Restores Suspension Period

Photo of Allyson Whyte NowakPhoto of Kristin WallPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on Posted in Uncategorized
On April 21, 2021, the Federal Court of Appeal (FCA) announced that it will restore the Suspension Period by default for all new matters and begin reinstating the Suspension Period on existing matters by removing them from its Selected Files List. Selected Files As previously reported in June 2020 (June 2020 Update), the FCA began … Continue reading

Ontario Superior Court summarily dismisses Apotex’s novel monetary claims under Statutes of Monopolies, Trademarks Act, and at common law

Photo of David YiPhoto of Allyson Whyte NowakBy David Yi and Allyson Whyte Nowak on Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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 … Continue reading

Federal Courts update guidance on COVID-19

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak 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 Courts begin to phase out the Suspension Period

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak 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

Federal Court extends Suspension Period and expands use of virtual hearings

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak 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

FCA to select cases that are ready to progress during pandemic

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak 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 Brian R. DaleyBy Allyson Whyte Nowak 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

Federal Court reinstates damages decision concerning prejudgment interest

Photo of David YiPhoto of Allyson Whyte NowakPhoto of Pharma in Brief teamBy David Yi, Allyson Whyte Nowak and Pharma in Brief team on Posted in Damages
The Federal Court has vindicated Lilly, reinstating a patent infringement damages decision that awarded Lilly prejudgment interest equal to its average annual rate of return during the interest earning period, on a compound basis. It found that Lilly’s real-world rate of return was convincing evidence of both what could have and what would have occurred … Continue reading

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

Photo of William ChalmersPhoto of Randy SuttonPhoto of Allyson Whyte NowakBy William Chalmers, Randy Sutton and Allyson Whyte Nowak on 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 … Continue reading

FCA Confirms Entirety of Inventors’ Conduct is Relevant in Obviousness Analysis and Upholds Inventiveness of Crystal Form Patent

Photo of David YiPhoto of Allyson Whyte NowakBy David Yi and Allyson Whyte Nowak on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive. Obviousness The FCA began be reiterating key points of the … Continue reading

FCA Confirms that Non-Infringing Alternative Must be Legal and Objectively Economically Viable

Photo of David YiPhoto of Allyson Whyte NowakPhoto of Pharma in Brief teamBy David Yi, Allyson Whyte Nowak and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue … Continue reading

ONCA Permits Pleading Amendments Asserting Validity of Previously Invalidated Patent following Nexium Decision

Photo of David YiPhoto of Allyson Whyte NowakPhoto of Pharma in Brief teamBy David Yi, Allyson Whyte Nowak and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug. Apotex’s claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 … Continue reading

Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations

Photo of David YiPhoto of Allyson Whyte NowakPhoto of Pharma in Brief teamBy David Yi, Allyson Whyte Nowak and Pharma in Brief team on Posted in Uncategorized
The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious. Background … Continue reading

ONCA upholds dismissal of summary judgment in lansoprazole s. 8 case

Photo of David YiPhoto of Allyson Whyte NowakPhoto of Randy SuttonBy David Yi, Allyson Whyte Nowak and Randy Sutton on Posted in Intellectual property, Pharmaceuticals and life sciences
As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA) affirmed the lower court’s finding that a real-world notice of non-compliance – withdrawal (NON-W) issued by Health … Continue reading

Change in utility law not a factor in s. 8 damages

Photo of David YiPhoto of Louisa PontrelliPhoto of Allyson Whyte NowakBy David Yi, Louisa Pontrelli and Allyson Whyte Nowak on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Appeal (FCA) has refused to apply the “special circumstances” exception to issue estoppel in view of a change in law arising from the rejection of the “promise doctrine” in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (NEXIUM, reported here). Noting any injustice to Lilly is “entirely commercial in nature” … Continue reading
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