The Canadian life sciences sector saw several notable developments in 2023. This article summarizes a number of the more remarkable court decisions, as well as other life sciences-related developments from 2023.
- Decisions under the PM(NOC) Regulations
- Ontario Court dismissed a claim for damages under section 8 of the PM(NOC) Regulations
- Continued development on the drafting and implementation of the PMPRB Guidelines
- New decisions pertaining to innovative drug data protection
- Applicants' press releases located by Patent Appeal Board lead to patent refusal
1. Decisions under the PM(NOC) Regulations
The Federal Court of Appeal and Federal Court issued several decisions in respect of patent infringement and invalidity actions, including in actions commenced under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations"). We highlight seven of these decisions below.
Janssen Inc. v. Apotex Inc., 2023 FCA 253: Serving serial NOAs raising different issues found to be an abuse of process
In Janssen v Apotex, Janssen successfully appealed the Federal Court's decision dismissing Janssen's motion for summary judgment. The Federal Court of Appeal found that Apotex litigating by instalments through serving multiple Notices of Allegations (NOA) amounted to an abuse of process.
Apotex served an NOA in 2021 alleging non-infringement of the CA2,655,335 Patent (335 Patent). Invalidity was not raised. Janssen was ultimately successful in that case, and Apotex's generic product was found to infringe the 335 Patent (2022 FC 107).
Apotex then served four new NOAs alleging invalidity. Janssen commenced actions against Apotex pursuant to section 6 of the PM(NOC) Regulations. Janssen then brought a motion for summary judgment on the basis of res judicata, abuse of process and the doctrine of election.
The Court of Appeal found that the lower court applied the wrong legal test in analyzing whether there was an abuse of process. In particular, with respect to its abuse of process reasoning, the Federal Court incorrectly focused on the distinction in the Regulations between non-infringement allegations and invalidity allegations, and the propriety of Apotex's service of multiple NOAs. Since the doctrine of abuse of process is about the inherent power of the Court to prevent the misuse of its procedure, the focus should instead have been on the proceedings before the Court.
Read the full decision here.
Sandoz Canada Inc v. Janssen Inc, 2023 FCA 221: Sound prediction threshold remains the same
The Federal Court of Appeal in Sandoz v Janssen provided a clarification and summary of the jurisprudence regarding the threshold required to establish a sound prediction of utility. The Court reaffirmed that the threshold required remains a "prima facie reasonable inference," a standard that remains unchanged from what was established by the Supreme Court's 2002 Wellcome/AZT decision (2002 SCC 77) and Eli Lilly v. Novopharm (2010 FCA 197).
The Court of Appeal, in alignment with the Federal Court's ruling in 2022 FC 715, upheld that the utility of Janssen's CA2,659,770 combination patent (macitentan and a PDE5 inhibitor to treat pulmonary arterial hypertension) could indeed be soundly predicted, and dismissed Sandoz's appeal.
Read the full decision here.
Apotex Inc v. Janssen Inc, 2023 FCA 220: A generic's adjusted product monograph can still induce infringement
In Apotex v Janssen, the Federal Court of Appeal calls into question the reliance on product monograph carve-outs to avoid infringement. The Court upheld the Federal Court's decision that the market and sale by Apotex of its Apo-Macitentan product would induce infringement of Janssen's CA2,659,770 combination patent (macitentan and a PDE5 inhibitor to treat pulmonary arterial hypertension), even though Apotex would only market its product for monotherapy.
The Court of Appeal affirmed that the legal test for inducing infringement, as first outlined in Corlac (2011 FCA 228), as follows:
- The acts of infringement must have been completed by the direct infringer;
- The completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
- The influence must be knowingly exercised by the inducer; in other words, the inducer knows that this influence will result in the completion of the acts of infringement.
Since the parties agreed that the first prong of the test was established, the Court focused on the second and third prongs. The Court of Appeal found that the Federal Court was correct in determining that the Apotex product monograph would influence physicians to prescribe combination treatment, even though it does not explicitly mention such a treatment. The absence of explicit instruction and of intention that direct infringement should result does not necessarily equal an absence of influence sufficient to satisfy the second prong of the test.
The Federal Court also correctly drew inferences pertaining to Apotex's knowledge of its influence; that Apotex knew or should have known that the Apo-Macitentan product monograph would influence physicians' prescribing decisions. Namely, Apotex was aware of the content of the product monograph, and the fact that it would be available to physicians treating pulmonary arterial hypertension.
See the full decision here.
Teva Canada Limited v. Janssen Inc, 2023 FCA 68: FCA clarified "but-for" element of the test for inducing infringement of pharmaceutical "use" patents
In Teva v Janssen, the Court of Appeal overturned the trial judge's ruling that Teva did not induce infringement of Janssen's Canadian Patent No. 2,655,335 (335 Patent), thus granting Janssen's cross-appeal. In particular, the Court of Appeal determined that the Federal Court had applied an "an unduly onerous requirement" to the second prong of the test for inducing infringement outlined in Corlac.
In its decision, the Court of Appeal provided guidance on this second prong of the Corlac test, which necessitates demonstrating that direct infringement would not have taken place but for the influence of the alleged inducer.
In this instance, the Teva product included the alleged infringing use as one of the recommended uses within its product monograph. The Court of Appeal disagreed with the Federal Court's narrow interpretation. The Federal Court had reasoned that the "but for" element was not fulfilled because physicians would use their own skill and judgment in prescribing the Teva product regardless of what is included in the product monograph. However, the Court of Appeal determined that since the Teva product incorporated all the dosing and administration elements of the product claims, it inevitably led to the conclusion that Teva would induce infringement of the "use" claims of the 335 Patent.
The Court of Appeal also dismissed Teva's appeal of the Federal Court's finding of non-obviousness and direct infringement of the 335 Patent's product claims.
See the full decision here.
Janssen Inc v. Canada (Health), 2023 FC 870: Judicial review of patent register eligibility: Is there a role for the "concurrent jurisdiction" category of correctness?
In this case, the Federal Court determined that Health Canada's refusal to list one of Janssen's patents on the Patent Register was reasonable. The Court also dismissed an ultra vires argument brought by Janssen relating to language of the Regulations.
Janssen had filed Supplemental New Drug Submissions seeking approval of a new use for its product STELARA. Although Health Canada approved the new use, it refused to list Canadian Patent No. 3,113,837 on the Patent Register. After setting out the procedural history, the Court stated that "The parties agree and I concur that the [refusal to list the patent] is reviewable on a standard of reasonableness." The Court then proceeded to discuss the approach to a reasonableness review as outlined by the SCC in Vavilov.
In upholding the decision, the Court applied the test from Abbott Laboratories Limited v. Canada (Attorney General), 2008 FC 700, confirmed in 2008 FCA 354: (1) What does the patent claim; (2) what is the changed approved in the SNDS; and (3) does the patent claim the very change in the SNDS?
Find a full summary of Janssen Inc v Canada (Health) here and further commentary here.
Allergan v Juno, 2023 FC 1686: Allergan's 691 Patent stands up to obviousness and insufficiency allegations
Allergan brought this action under section 6(1) the PM(NOC) Regulations, alleging that Juno's generic product would infringe Allergan's CA2,585,691 Patent (691 Patent) for its LUMIGAN RC (bimatoprost) product. Juno conceded infringement, and failed in its counterclaim allegation that the 691 Patent was invalid due to obviousness and insufficiency.
Identifying or construing the inventive concept of claim 16 of the 691 Patent was a key dispute between the parties. The Court agreed with Allergan, and considered the Patent's specification to assist in building the inventive concept of the claim. In particular, when read with the specification, the inventive concept of claim 16 included comparable efficacy in reducing inter-ocular pressure when compared to LUMIGAN while using less of bimatoprost.
The Court also rejected Juno's argument that the 691 Patent was insufficient. The 691 Patent discloses sufficient information to enable the skilled person to make the same successful use of the invention as the inventor could. The components found in claim 16 were all well known and would not be difficult to prepare or administer to patients. Further, the examples in the patent would lead the skilled person to expect equal or superior effects compared with the old LUMIGAN. The Court also rejected several of Juno's specific insufficiency arguments relating to safety, efficacy, permeability, and rabbit studies data.
Find a full summary of Allergan v Juno here.
AbbVie Corporation and Abbvie Biotechnology Ltd v JAMP Pharma Corporation, 2023 FC 1520
In a lengthy decision, the Federal Court invalidated AbbVie's CA2,504,868 (868 patent) and CA2,801,917 (917 Patent) patents for obviousness, but declared its CA2,904,458 patent (458 Patent) to be valid.
JAMP's SIMLANDI biosimilar relates to AbbVie's HUMIRA biologic, the monoclonal antibody ("mAb") adalimumab, for treating autoimmune diseases. The 868 and 917 Patents disclose multi-variable dosing methods for treating TNF-α disorders, including IBD, Crohn's disease, ulcerative colitis (868 Patent), and HS (917 Patent). The 458 Patent discloses protein formulation, protein stability, and the shelf life of proteins.
The law of anticipation, with respect to the 917 Patent, was "central to this dispute." The Court specifically addressed whether prior art that discloses a dosing range can anticipate a specific point within a range or embodiment or a narrower range. In particular, with respect to selection patents the Court stated that "ranges do not necessarily anticipate points. But they may." With respect to the 917 Patent, the Court found that there is no teaching in the prior art that would direct the skilled person to arrive at the specific dosing regimen, as the adalimumab concentration range (20-150 mg/mL) in the prior art did not "plant a flag at the specific concentration of 100 mg/mL, especially where specific examples of formulations given do not include the relevant protein."
Further, the Court affirmed that subsection 38.2(2) is not to be narrowly interpreted and can serve as an independent ground of invalidity, even if it is considered a procedural requirement under the Patent Act. The Court also recognized the fundamental unfairness in expanding an applicant's monopoly that originally filed by allowing "an applicant to successfully broaden or enlarge the patent through amendment to specifications or drawings." With respect to the 917 Patent, even though AbbVie added a claim term to Claim 1, "AbbVie has not gained anything more than it originally had."
Notably, the Court did not grant AbbVie a permanent injunction against JAMP, despite JAMP conceding to infringement of the 458 Patent.
Find a full summary of AbbVie v JAMP here.
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2. Ontario Court dismissed a claim for damages under section 8 of the PM(NOC) Regulations
In Apotex v Eli Lilly, 2023 ONSC 1968, the Ontario Superior Court of Justice has dismissed a claim for damages brought by Apotex under section 8 of the PM(NOC) Regulations. The Ontario Court held that Apotex was not entitled to claim section 8 damages in the circumstances before it and that, in any event, Apotex had not sustained any loss.
In particular, Apotex failed in the underlying prohibition application. Although the Federal Court had dismissed the underlying prohibition application on the ground of mootness, the Federal Court found that Apotex's allegations were not justified (see 2010 FC 1065). The Federal Court commented that it would have issued a prohibition order but for this mootness. The Ontario Court therefore determined that Apotex was not entitled to section 8 damages.
Even had it been entitled to section 8 damages, the Ontario Court determined, based on the evidence at trial, that Apotex did not suffer any damages during the period for which it made its section 8 claim. Apotex would not have launched its generic product in the hypothetical "but-for" section 8 world until the same time as it did in the real world.
See the full detailed summary of Apotex v Eli Lilly, 2023 ONSC 1968 here.
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3. Continued development on the drafting and implementation of the PMPRB Guidelines
In 2023, there have been continued development on the drafting and implementation of the Patented Medicines Prices Review Board (PMPRB) Pricing Guidelines.
In 2022, the PMPRB had released Draft Guidelines for stakeholder comments by Dec. 5, 2022, and for implementation on Jan. 1, 2023. However, as with other prior draft Guidelines, this version was also shelved. Consequently, the Interim Guidance issued on Aug. 18, 2022, remains in place, with the release date of the final Guidelines now pushed to 2024.
On June 20, 2023, the PMPRB invited stakeholders to comment on its proposed amendment for conducting interim price reviews on New Medicines per the Interim Guidance. Part of the Interim Guidance established a process where existing medicines are reviewed based on the relevant Non-Excessive Average Price (NEAP) projected in the 2021 compliance letters sent to applicable patentees by the PMPRB in March 2022.
Most recently, in November 2023, the PMPRB invited stakeholders to comment on the new draft PMPRB Guidelines. In this first phase of consultation, the PMPRB is seeking feedback over the six themes found in its "Scoping paper for the consultations on the Board's Guidelines." Following the themes outlined in the Scoping Paper is intended to serve "as a catalyst for a more informed, focused, and productive consultation process in developing new Guidelines."
For commentary on the PMPRB Guidelines development, read this article.
Find commentary of the proposed amendment for conducting interim price reviews (as per the PMPRB Interim Guidance) here.
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4. New decisions pertaining to innovative drug data protection
In 2023, there were two decisions relating to data protection for innovative drugs under section C.08.004.1 of the Food and Drugs Regulations.
Canada (Attorney General) v. Catalyst Pharmaceuticals, Inc., 2023 FCA 3: Federal Court of Appeal upholds inapplicability of data protection
In January, the Federal Court of Appeal upheld the Minister of Health's decision that data protection applies only where a manufacturer seeks a Notice of Compliance (NOC) by relying on data from an innovative drug.
This is the newest judgment in a series of decisions involving Catalyst's FIRDAPSE and Médunik's RUZURGI, which both contain amifampridine. Even though NDS' for both drugs were pending at the same time, an NOC first issued for Catalyst's FIRDAPSE, thereby designating it as an innovative drug under subsection C.08.004.1(1) of the Food and Drugs Regulations.
An NOC was then issued for Médunik's RUZURGI shortly after, sparking two judicial reviews by Catalyst (2021 FC 505 and 2022 FC 292 under appeal in this decision) against the issuance of an NOC for RUZURGI. Catalyst argued that RUZURGI's reference to studies found in the US submission for FIRDAPSE was a comparison with an innovative drug, such that data protection applied.
The Court of Appeal concluded that the Federal Court should not have interfered with the Minister's decision to issue an NOC to Médunik, restoring Médunik's NOC for RUZURGI. Since Health Canada "did not find the FIRDAPSE studies necessary to assess the safety and efficacy of RUZURGI, it was reasonable to conclude that Médunik was not relying on them to obtain its NOC".
Find a full summary of Canada (Attorney General) v. Catalyst here.
Janssen Inc. v. Canada (Attorney General), 2023 FC 7: The definition of an "innovative drug" under the Food and Drugs Regulations is not changed by CUSMA
Janssen unsuccessfully sought judicial review of the Minister of Health's refusal to reassess its decision that Janssen's SPRAVATO product was not an innovative drug under subsection C.08.004.1(1) of the Food and Drugs Regulations.
Janssen's main argument pertained to the introduction of the new Canada-United States-Mexico Agreement (CUSMA) implemented in Canada following the approval of SPRAVATO. In particular, Janssen argued that the Minister erred by not interpreting subsection C.08.004.1(1) of the Food and Drug Regulations consistently with the new CUSMA agreement. Namely, an "innovative drug" as defined by subsection C.08.004.1(1) excludes a variation of a previously approved enantiomer (such as SPRAVATO); however, the related CUSMA article did not include such an exclusion. The Court noted that the domestic Regulations ultimately governs over international treaties in Canada.
Additionally, the Court found the Minister correctly concluded that it was inappropriate for Janssen to seek a reassessment of SPRAVATO's eligibility as an innovative drug since section C.08.004.1 contemplates that the SPRAVATO's data protection eligibility is to be determined at the time it was approved. Janssen submitted that the Minister was unreasonable in not granting a reassessment because the Minister conflated the timing of assessing data protection with the date on which data protection commences. Since the Regulations only provide that data protection commences on the data an NOC is issued, Janssen argued that the Minister is required to assess data protection each time a generic seeks an NOC based on a comparison with an existing approved drug. However, the Court disagreed with Janssen and found that the Minister did not read into the Regulations a pre-NOC timing requirement for assessing data protection eligibility.
Find the full decision here.
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5. Applicants' press releases located by Patent Appeal Board lead to patent refusal
The Patent Appeal Board (PAB) released two decisions relating to patent applications claiming compositions comprising the insomnia drug doxepin and uses thereof; CD #1632 – Patent Application No. 2,687,118 and CD #1633 – Patent Application No. 2,687,124. The PAB held that both applications should be refused by the Commissioner of Patents.
Of particular note, in reaching such decisions, the PAB did not rely on the prior art cited by each respective Examiner during prosecution. Rather, the PAB conducted its own prior art search, and found the claims to be anticipated and/or obvious in view of the original applicant's SOMAXON Pharmaceuticals LLC's (Somaxon's) own press releases, published shortly before the earliest priority date of each application. The Somaxon press releases related to the results of Phase 2 and Phase 3 clinical trials published on the now defunct Somaxon webpage, which the PAB accessed through the Wayback Machine Internet Archive. These decisions should serve as a reminder to applicants to properly manage and monitor the disclosure of any results prior to the filing of patent applications.
Find a detailed description of each decision in the full article.
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