Beware If You Compare: Data Protection May Stop Approval Of A New Drug Submission

January 25, 2016

Sanofi-Aventis’s ELOXATIN® had been sold in Canada since 1999 under the Special Access Program (SAP) of Health Canada, which allows for sale of a drug in exceptional cases prior to receiving regular marketing approval, i.e. prior to the issuance of a Notice of Compliance (NOC). The active ingredient is Oxaliplatin, an injectable medication for colorectal cancer chemotherapy and one of the best-selling cancer drugs in the world.

On October 27, 2006, Hospira filed a new drug submission (NDS) in Canada for Oxaliplatin. This was one month before Sanofi-Aventis filed their own NDS for ELOXATIN®.

Hospira’s NDS encountered difficulties and was not approved during the usual time-frame of one to two years. Meanwhile, Sanofi-Aventis leapfrogged Hospira’s application and was first to receive a NOC, in 2007. Because it was first to obtain marketing approval, it was granted Innovative Drug status and data protection, expiring on December 15, 2015. During that time, other applicants would not be allowed to refer to ELOXATIN®’s Innovative Drug data, including product monograph information or safety and efficacy data.

The data protection regime is established by the Food and Drug Regulations, more precisely section C.08.004.1. Usually, data protection cannot prevent issuance of a NOC to a sponsor that does not refer to a drug currently under data protection. Thus, in most cases where an independent NDS is filed, data protection cannot be invoked.

In this situation, Hospira corresponded with Health Canada for years before it finally qualified for a NOC in 2013. Hospira accomplished this by relying on new information related to Sanofi’s ELOXATIN®, including its Canadian product monograph. Unfortunately for Hospira, this attempt to move their application forward is ultimately what stopped it in its tracks.

In the fall of 2013, Health Canada refused to issue a NOC to Hospira because it had made a comparison to ELOXATIN®, which was still under data protection.

Hospira applied to the Federal Court to overturn the decision. On November 6, 2015, the Federal Court dismissed the case (Hospira Healthcare Corporation c. Canada (Health), 2015 FC 1205).

The Court concluded that Health Canada was correct in finding that data protection applied even if the comparison to ELOXATIN® occurred as a post-filing amendment to an independent NDS.

This decision demonstrates how cautious applicants must be when agreeing to make a direct or indirect comparison to a drug under data protection. Health Canada will not guide applicants through such aspects of the process, and so they may spend years breaking down a wooden door only to find a concrete wall on the other side.

Please contact Serge Shahinian for more details on these issues.

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James Duffy
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October 2, 2024

Proof of incapacity: analysis of CIUSSS de L’Ouest-de-L’île-de-Montréal (ST. Mary’s Hospital Center) c. R.C.

PROOF OF INCAPACITY: ANALYSIS OF CIUSSS DE L’OUEST-DE-L’ÎLE-DE-MONTRÉAL (ST. MARY’S HOSPITAL CENTER) c. R.C.1 Summary The authors comment on this decision rendered on September 20, 2024, in which the Court of Appeal ruled on the capacity to consent to care in the presence of a psychiatric disorder. The Court of Appeal overturned the first instance decision, which had found the respondent capable of refusing treatment with antipsychotic medications even though he had refuted his diagnosis, because he understood the benefits that antipsychotic medications could afford him and refused to take them because of their side effects. The Court of Appeal rather concluded that the trial judge had misapplied the five criteria to be used to assess whether a person is capable of consenting to care, particularly in the context where (i) the trial judge’s conclusion ran counter to the uncontradicted opinion of an expert; and (ii) there was much evidence supporting the fact that the respondent was incapable of making an informed decision. INTRODUCTION In this case, the Centre intégré universitaire de santé et de services sociaux de l’Ouest-de-l'Île-de-Montréal (the “CIUSSS”) appealed a decision rendered by the Superior Court on March 14, 2024, dismissing its application for an authorization to provide care to R.C., a 51-year-old man. The Superior Court had concluded that the CIUSSS had not proven that the respondent was incapable of consenting to care. The Court of Appeal was thus called upon to review the trial judge’s answer to the first question (incapacity to consent) in the analytical framework2 surrounding the test that has now been used for three decades.3 THE FACTS R.C. has a complex medical history. He was hospitalized several times between 2007 and 2019 for mental health issues, including suicidal ideation and personality disorders. In 2021, he was admitted to the CHUM for COVID-19-related complications having resulted in brain damage caused by hypoxia. From 2022 onwards, he made repeated visits to the emergency room, often to obtain benzodiazepines, leading him to become addicted. Even though he adhered to treatment with antipsychotic medication for a time, R.C. stopped taking his medication because of undesirable side effects. In January 2024, after an episode of confusion, he was taken to hospital where he was diagnosed with late-onset schizophrenia. However, R.C. refuted the diagnosis, claiming that his health problems were caused by an artificial intelligence device he believed had been implanted in his body. The psychiatrists who assessed him concluded that he was incapable of consenting to care. On February 16, 2024, the CIUSSS filed an application for authorization to re-hospitalize R.C. and administer antipsychotic medications, despite his categorical refusal. After analyzing the evidence, which essentially consisted of R.C.’s testimony and that of the CIUSSS psychiatrist, the Superior Court concluded that R.C. understood the nature of his condition and the benefits of the proposed treatment, despite his refusal to accept his diagnosis. The Court was of the opinion that the CIUSSS psychiatrists, in their analysis of R.C.’s capacity, had erroneously and repeatedly carried over his rejection of the diagnosis in a cascading fashion in their analysis of the five criteria from the decision in A.G.,4 thereby making the same error as the one that the Court of Appeal had identified in the M.H. decision.5 Despite the absence of a second opinion on R.C.’s capacity, the Superior Court had determined that he was able to consent to his care. According to the trial judge, in keeping with the teachings of the Court of Appeal in the F.D. decision,6 he therefore lacked jurisdiction to order care. For this reason, he dismissed the application for an authorization to provide care. THE COURT OF APPEAL’S DECISION The Court of Appeal began by reiterating the five criteria for assessing a person’s capacity, namely: Does the person understand the nature of the illness for which treatment is proposed? Does the person understand the nature and purpose of the treatment? Does the person understand the risks and benefits involved in undergoing the treatment? Does the person understand the risks involved in not undergoing the treatment? ls the capacity to consent to treatment affected by the patient's illness?7 It pointed out that the criteria are not cumulative and that it is incumbent upon the trier to assess them as a whole.8 Moreover, the mere fact that a person refuses care that would be in their best interest is not enough to conclude that the person is incapable,9 nor is their mere rejection of their diagnosis.10 In this case, the Court of Appeal considered that the Superior Court judge had committed a palpable and overriding error making its intervention warranted. It stated that the trial judge was obliged to express an opinion on whether the evidence proffered was sufficient, adding that the judge had a proactive role to play in protecting the interests of the person involved. If the trial judge felt that a point that had not been the subject in a genuine adversarial debate raised a problem in his view, it was up to him to ask questions.11 Subsequently, the court took extracts from the evidence consisting of a psychiatric report and the testimony of its author and went on to note that the evidence did not allow the trial judge to conclude that R.C. was capable of consenting or refusing the proposed treatment plan, on the contrary. Based on the same evidence, the Court declared R.C. incapable of consenting to care and sent the case back to the Superior Court so that it could determine whether there was indeed categorical refusal and assess the terms of the treatment plan sought. AUTHORS’ COMMENTS This decision of the Court of Appeal follows approximately 20 other decisions12 respecting orders authorizing care handed down by this same court, which have all further established and clarified the guiding principles surrounding such orders since the F.D. decision of 2015.13 These successive decisions have not only added to case law, they have refined the assessment criteria and legal requirements pertaining to applications for authorization to provide care. Such a development in case law shows that the courts are committed to circumscribing complex healthcare situations. Doing so involves striking a balance between the rights to freedom and self-determination and the protection of those who are vulnerable or otherwise unable to consent. On July 6, 2015, the Court of Appeal of Quebec marked a decisive turning point where orders authorizing care are involved by rendering a decision that sent a clear message to the Superior Court, namely F.D. c. Centre universitaire de santé McGill (Hôpital Royal-Victoria).14 In that decision, an analytical framework was established to ensure compliance both with the provisions of the law and the spirit of the law. Since then, the Court has handed down some 20 other significant decisions, each shedding additional light. The guiding principles derived from these decisions can be summarized under the following themes: Rights relating to the judicial process Every person has the fundamental right to contest an application for a order authorizing care, to be heard and to be represented.15 The judge must proactively protect the user’s interests and ensure that they are represented by a lawyer.16 Scope of the care plan Requiring a definite care plan does not mean dictating which medication should be administered in a limitative way.17 A judge may remove certain substances from a treatment plan if they deem that to be in the patient’s best interest.18 It is crucial to draw a distinction between preventive care and a treatment plan that includes various alternatives as the situation evolves.19 For a future hospitalization clause to be valid, there must be a reasonable foreseeability of hospitalization.20 When a patient is to be placed, the application for authorization must indicate where they are to be placed.21 Physical restraint may only be used if it is necessary to avoid serious harm, and must be limited to the minimum.22 A parent’s refusal to consent to a treatment plan may not be warranted if the plan is in the child’s best interests.23 Duration of the authorization When the person concerned is not cooperating and access to their previous medical records is not available, the judge must be especially careful in assessing whether the proposed care plan is legal, in particular in terms of its duration and scope.24 The duration of the care order should be as short as reasonably possible, without compromising the effectiveness of the treatment.25 When a future hospitalization is contemplated, the judge must take into account the time required to stabilize the patient.26 The 30-day period for a future hospitalization should not be considered an absolute limit, as a longer period may be deemed necessary after a thorough analysis.27 The evidence The mere fact that a relationship exists between an expert and a party does not make the expert’s testimony inadmissible: The circumstances surrounding the expert’s role must be reviewed.28 An expert who does not know a patient’s reasons for refusing treatment is not deemed to have breached their duty to inform.29 An expert may testify to reported facts without the possibility of anyone opposing them; however, this does not mean that reported facts are proven, as the rules of evidence remain stringent in this context.30 An expert report may suffice as testimony; the judge need not require the patient’s testimony if the patient cannot understand the issues at hand.31 Applications for safeguard orders may be unsuccessful where there is no expert report and it is not demonstrated that the matter is urgent.32 This review highlights the significant advances that the courts have made in overseeing applications for orders authorizing care and protecting vulnerable people. The analytical framework established in the F.D. decision remains relevant, and subsequent decisions have further refined its questions. The decision that the Court of Appeal handed down in Centre intégré universitaire de santé et de services sociaux de l’Ouest-de-l'Île-de-Montréal c. R.C. is milestone in the jurisprudence on court orders authorizing care. By overturning the lower court’s judgment, the Court of Appeal reaffirmed the need for a thorough assessment of the capacity to consent, emphasizing that the work of medical teams and applications made by healthcare institutions are important to ensure appropriate care. This decision not only underscores the fact that it is important to protect the rights of users, but also that the work of the court is crucial, for it must ensure that the criteria are met without substituting its opinion for that of the experts heard. CONCLUSION The decision discussed in this paper is part of a series of decisions that have clarified and enhanced the guiding principles established since the F.D. decision was handed down in 2015.33 The Court of Appeal has provided valuable guidelines for judges, institutions and healthcare professionals to use in their assessment of applications for authorization to provide care. Through a careful review of the circumstances of each case, the courts have shown that they are committed to effectively circumscribing complex health situations by ensuring that institutions have the tools they need to respond appropriately. Lastly, we must recognize that while progress has been made, there are still unresolved issues that need to be addressed. Recent court decisions, including the one that led to the R.C. decision,34 illustrate the importance of constant dialogue between those involved in the legal aspect of cases and those dealing with clinical realities. As jurisprudence continues to develop, paying close attention to future developments will be key to ensuring that healthcare institutions can act effectively in consideration of patients’ needs. 2024 QCCA 1231. F.D.c. Centre universitaire de santé McGill (Hôpital Royal-Victoria), 2015 QCCA 1139. See the landmark decision, Institut Philippe Pinel de Montréal c. A.G., 1994 CanLII 6105 (QC CA). Institut Philippe Pinel de Montréal c. A.G., 1994 CanLII 6105 (QC CA). M.H. c. Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, 2018 QCCA 1948, para. 57. F.D. c. Centre universitaire de santé McGill (Hôpital Royal-Victoria), 2015 QCCA 1139. This decision, para. 13; with reference to Institut Philippe Pinel de Montréal c. A.G., 1994 CanLII 6105 (QC CA), pp. 28 to 33. This decision, para. 14; with reference to M. B. c. Centre hospitalier Pierre-le-Gardeur, 2004 CanLII 29017 (QC CA), para. 45; M.C. c. Service professionnel du Centre de santé et de services sociaux d’Arthabaska-et-de-L’Érable, 2010 QCCA 1114, para. 13. This decision, para. 14; with reference to M. B. c. Centre hospitalier Pierre-le-Gardeur, 2004 CanLII 29017 (QC CA), para. 46. This decision, para. 14, with reference to Starson v. Swayze, 2003 SCC 32, para. 79 and M.H. c. Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, 2018 QCCA 1948, paras. 61–62. This decision, para. 18. We have excluded the following decisions from our analysis: Bédard c. Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal, 2023 QCCA 508; M.G. c. Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, 2019 QCCA 203; S.F. c. CIUSSS de Centre-Ouest-de-l’île-de-Montréal – Hôpital général juif – Sir Mortimer B. Davis, 2021 QCCA 1531; P.L. c. Centre intégré de santé et de services sociaux de la Montérégie-Centre, 2018 QCCA 318; N.G. c. Sir Mortimer B. Davis Jewish General Hospital, 2021 QCCA 1892; F.D. c. Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, 2017 QCCA 1206. F.D.c. Centre universitaire de santé McGill (Hôpital Royal-Victoria), 2015 QCCA 1139. Ibid. M.H.c. Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, 2018 QCCA 1948, paras. 68 and 69. A.N. c. Centre intégré universitaire de santé et de services sociaux du Nord-de-l’île-de-Montréal, 2022 QCCA 1167 , para. 30. Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale c. D.M., 2017 QCCA 1333, para. 25. Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean c. O.G., 2018 QCCA 345, paras. 15 and 16. C.R.c. Centre intégré de santé et de services sociaux du Bas-St-Laurent, 2017 QCCA 328, para. 28. G.J. c. Centre intégré de santé et de services sociaux de Laval, 2021 QCCA 1944, paras. 24 to 26. Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ) c. J.B., 2017 QCCA 1638,, paras. 30 to 35. X.Y.c. Hôpital général du Lakeshore, 2017 QCCA 1465, para. 20. A.P. c. Centre hospitalier universitaire Sainte-Justine, 2023 QCCA 58, para. 19. L.C. c. Centre hospitalier de l’Université de Montréal (CHUM), 2015 QCCA 1139, paras. 4 and 5. D.A. c. Centre intégré de santé et de services sociaux des Laurentides, 2016 QCCA 1734, para. 31. T.F. c. CIUSSS de l’Est-de-l’île-de-Montréal , 2022 QCCA 1306, para. 25. N.M. c. Centre intégré de santé et de services sociaux de la Montérégie-Centre, 2022 QCCA1567, para. 17. M.G. c. Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de-l’Île-de-Montréal , 2021 QCCA 1326, para. 11. Centre intégré universitaire de santé et de services sociaux de l’Ouest-de-l’île-de-Montréal (Douglas Mental Health University Institute) c. I.A., 2023 QCCA 1100, para. 30. Institut universitaire en santé mentale Douglas c. W.M., 2016 QCCA 1081, para. 5 A.D. c. Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de-l’île-de-Montréal, 2023 QCCA 1240, paras. 50, 56–57. A.F. c. Centre intégré de santé et de services sociaux des Laurentides, 2021 QCCA 928, para. 50. F.D. c. Centre universitaire de santé McGill (Hôpital Royal-Victoria), 2015 QCCA 1139. CIUSSS de l'Ouest-de-l'Île-de-Montréal (St. Mary’s Hospital Center) c. R.C.,2024 QCCA 1231.

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June 27, 2024

Misuse of the complaints mechanism on an e-commerce platform

At a time when Canada and many other countries are taking steps to protect users from harm online,1 a decision was handed down by the Supreme Court of British Columbia (the “Court”) on January 15, 2024, regarding the conduct of a competitor with respect to complaints about intellectual property infringement made on Amazon’s e-commerce website. Amazon’s platform is similar to many other e-commerce platforms that have a complaint mechanism for third-party use of intellectual property in violation of the rights of the real owners thereof. The complaint mechanism makes it possible for a complainant to submit an intellectual property infringement claim regarding content to which it has a good faith right in order to partially or fully remove the content in question from the pages of the alleged infringing party published on Amazon’s platform. Such a mechanism has its purpose, as it is an effective way of tracking down counterfeiters. As we will see in Keezio Group, LLC v. The Shrunks' Family Toy Company Inc.,2 the mechanism can also be used maliciously. The facts and the plaintiff’s allegations In this case, complaints were lodged by a competitor of the company that was the subject of the complaints, with both entities operating in the inflatable bed industry. Keezio Group, LLC (“Keezio”) markets the “Hiccapop Inflatable Toddler Travel Bed” (the “Hiccapop Bed”), while The Shrunks’ Family Toy Company Inc. (“The Shrunks”) offers inflatable beds consisting of a mattress placed in an inflatable bed frame. Both companies primarily sell their products on the Amazon retail platform. In February 2017, Amazon informed Keezio that it had received a report of trademark infringement regarding the Hiccapop Bed, the complainant being identified as Mr. Cirjak of The Shrunks. Subsequently, in accordance with the applicable process, Amazon removed the product from Keezio’s product-listing pages on its website. It is worth noting that assessing the substantive validity of a complaint is not part of Amazon’s complaints handling process. On or about April 17, 2017, Keezio received another notice. The complaints of 2017 were eventually withdrawn and the page featuring the Hiccapop Bed was restored. In November 2019, Keezio received two more notices of complaints from Amazon regarding violations similar to those received about two years prior. The first of these two notices, sent on November 22, 2019, referred to trademark infringement. Amazon thus removed the page in question, which contained a chart comparing Keezio’s products with The Shrunks’ products. Keezio asked for clarification of this alleged infringement but received no response from The Shrunks. Having received no details about the infringement from The Shrunks, Keezio ultimately changed its webpage to remove all mentions of “The Shrunks”, replacing them with “Rhymes with Skunks”. Although Amazon informed Keezio in a message in November 2019 that it would restore its content, the evidence does not clearly establish whether this was done. The second notice of infringement, dated November 28, 2019, concerned an allegation of copyright infringement on six webpages for the Hiccapop Bed. The pages were delisted on or about November 28, 2019, and eventually reinstated on December 2, 2019. The Shrunks denied having filed the complaints of 2019. However, the Court did not hesitate to conclude that The Shrunks was also behind these complaints. Issues at bar about the complaints There were many issues in this case, and some claims were eventually withdrawn. We will focus on the two complaints made in 2019. Specifically, Keezio argued that the complaints that The Shrunks had lodged with Amazon were unfounded, resulting in a loss of business for Keezio. In particular, the Court analyzed section 7 of the Trademarks Act.3 To succeed in such a claim, the plaintiff must prove (i) that a false or misleading statement was made (ii) that tends to discredit the business, goods or services of a competitor, (iii) resulting in damages. The Court held that the person making the statements need not know of their falsity in order to satisfy these criteria. Findings of the Court (i) The allegation of trademark infringement in the comparative chart The trademark infringement complaint concerned a comparative chart featuring both Hiccapop Bed and The Shrunks products, with comparative data on the features of both products. The data itself was not challenged. The complaint related to the unauthorized use of The Shrunks’ registered trademark in the chart. Basing itself on the landmark decision in Clairol International Corp. et al v. Thomas Supply and Equipment Co.,4 the Court concluded that Keezio’s comparative chart did not amount to “use” of The Shrunks trademark pursuant to s. 4(1) of the Trademarks Act, and that therefore said chart did not constitute trademark infringement. Accordingly, the Court determined that The Shrunks’ complaint that Keezio infringed its trademark was unfounded. The Court further concluded that the comparative chart was not contrary to section 22 of the Trademarks Act:5 The mere depiction of a competitor’s trademark in comparative advertising does not in itself depreciate the value of the goodwill attached to a product. (ii) The allegation of copyright infringement The copyright infringement notice contained six Amazon Standard Internal Catalog Identification Numbers (ASINs), which identified six webpages that were sales pages for the Hiccapop Bed. The Court ruled that the allegation of copyright infringement in question was unfounded, as it related to a bed, which is a useful article sold in a quantity of more than 50. The reproduction of the bed design was therefore not covered by subsection 64(2)6 of the Copyright Act. The Court found The Shrunks liable for the two complaints made in November 2019, which it determined to be false or misleading as the allegations of trademark and copyright infringement were unfounded. The Court stated that the complaints tended to discredit Keezio’s business because they misled Amazon into removing Keezio’s product listing pages. On this point, the Court referred to a passage from the Federal Court decision Yiwu Thousand Shores E-Commerce Co. Ltd. v. Lin.7 With regard to damages, the Court determined that Keezio’s evidence regarding the calculation of damages was inadequate on several counts, but nonetheless awarded damages based on a decrease in Keezio’s sales on the dates of delisting. The Court did not hold The Shrunks’ principal personally liable and did not grant a permanent injunction or punitive damages. It also dismissed The Shrunks’ counterclaim for copyright infringement, and ordered The Shrunks to pay Keezio costs, excluding taxes and disbursements. Comments This decision highlights how crucial it is for complainants to be serious when filing complaints. The complaints mechanism on platforms such as Amazon is an extremely useful and effective tool for reporting rights violations, provided that use of such mechanisms is made in good faith and based on solid legal foundations. Although such a mechanism is easy to use, the rights involved must absolutely be analyzed in advance, as an ill-founded complaint can result in harm—which can be considerable—especially when the platform has a global reach. In such a case, the removal of a webpage can result in significant damages. It is therefore essential to exercise due diligence, as a country-by-country analysis of rights can reveal different legal situations and rights holders from one country to another. Not only must competitors carefully consider and weigh their actions, but e commerce website operators must also be vigilant and respond promptly to requests for removal and geographic restrictions. Amazon recently experienced a situation like this when a UK court ruled against it.8 The decision dealt with a targeting operation on Amazon’s website, where sales offers or advertisements were intentionally directed at consumers in the UK where the trademarks were not owned in that country by the same company offering the products for sale. A word to the wise! See Bill C-63, the Online Harms Act, which establishes a regime to address such harm. Keezio Group, LLC v. The Shrunks' Family Toy Company Inc., 2024 BCSC 64. Section 7 of the Trademarks Act: Prohibitions 7. No person shall - make a false or misleading statement tending to discredit the business, goods or services of a competitor; - direct public attention to his goods, services or business in such a way as to cause or be likely to cause confusion in Canada, at the time he commenced so to direct attention to them, between his goods, services or business and the goods, services or business of another; - pass off other goods or services as and for those ordered or requested; or - make use, in association with goods or services, of any description that is false in a material respect and likely to mislead the public as to (i) the character, quality, quantity or composition, (ii) the geographical origin, or (iii) the mode of the manufacture, production or performance of the goods or services. Clairol International Corp. v. Thomas Supply & Equipment Co. 55 C.P.R. 176, 1968 CanLII 1280. Section 22 of the Trademarks Act: 22.Depreciation of goodwill - 22 (1) No person shall use a trademark registered by another person in a manner that is likely to have the effect of depreciating the value of the goodwill attaching thereto. Subsection 64 (2) of the Copyright Act: 64 (2) Non-infringement re certain designs Where copyright subsists in a design applied to a useful article or in an artistic work from which the design is derived and, by or under the authority of any person who owns the copyright in Canada or who owns the copyright elsewhere, - the article is reproduced in a quantity of more than fifty, or - where the article is a plate, engraving or cast, the article is used for producing more than fifty useful articles, it shall not thereafter be an infringement of the copyright or the moral rights for anyone, - to reproduce the design of the article or a design not differing substantially from the design of the article by (i) making the article, or (ii) making a drawing or other reproduction in any material form of the article, or - to do with an article, drawing or reproduction that is made as described in paragraph (c) anything that the owner of the copyright has the sole right to do with the design or artistic work in which the copyright subsists. Yiwu Thousand Shores E-Commerce Co. Ltd. v. Lin, 2021 CF 1040. See paragraph 58 of this decision: [58] I agree with ThousandShores that the Respondent made false allegations and misstatements to Amazon.ca in the Takedown Requests, at least one of which was made after the Respondent’s receipt of the October 2020 Letter. ThousandShores had no ability to respond directly to his allegations. The absence of any evidence of use of the OHUHU trademark by the Respondent and the likelihood of confusion between the parties’ marks means the Impugned Registration is invalid. Accordingly, the Respondent’s statements regarding the Impugned Registration, the inauthenticity of ThousandShores’ OHUHU Goods and its infringement of the Respondent’s rights were false. The statements clearly tended to discredit ThousandShores’ business, the OHUHU Storefront, and the OHUHU Goods. They misled Amazon.ca, causing it to remove ThousandShores’ listings for the OHUHU Goods with a resulting loss of profits. ThousandShores’ only recourse was to provide evidence of authorization or license by the Respondent, or to challenge the validity of the Impugned Registration. Lifestyle Equities CV and another v Amazon UK Services Ltd and others [2022] EWCA Civ 552, upheld by the Supreme Court on March 6, 2024 ([2024] UKSC 8).

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April 15, 2024

Can artificial intelligence be designated as an inventor in a patent application?

Artificial intelligence (“AI”) is becoming increasingly sophisticated, and the fact that this human invention can now generate its own inventions opens the door to new ways of conceptualizing the notion of “inventor” in patent law. In a recent ruling, the Supreme Court of the United Kingdom (“UK Supreme Court”) however found that an artificial intelligence system cannot be the author of an invention within the meaning of the applicable regulations under which patents are granted. This position is consistent with that of several courts around the world that have already ruled on the issue. But what of Canada, where the courts have yet to address the matter? In this bulletin, we will take a look at the decisions handed down by the UK Supreme Court and its counterparts in other countries before considering Canada’s position on the issue. In Thaler (Appellant) v Comptroller-General of Patents, Designs and Trade Mark,1 the UK Supreme Court ruled that “an inventor must be a person”. Summary of the decision In 2018, Dr. Stephen Thaler filed patent applications for two inventions described as having been generated by an autonomous AI system. The machine in question, DABUS, was therefore designated as the inventor in the applications. Dr. Thaler claimed that, as the owner of DABUS, he was entitled to file patent applications for inventions generated by his machine. That being so, he alleged that he was not required to name a natural person as the inventor. Both the High Court of Justice and the Court of Appeal dismissed Dr. Thaler’s appeal from the decision of the Intellectual Property Office of the United Kingdom not to proceed with the patent applications, in particular because the designated inventor was not valid under the Patents Act 1977. The UK Supreme Court, the country’s final court of appeal, also dismissed Dr. Thaler’s appeal. In a unanimous decision, it concluded that the law is clear in that “an inventor within the meaning of the 1977 Act must be a natural person, and DABUS is not a person at all, let alone a natural person: it is a machine”.2 Although there was no doubt that DABUS had created the inventions in question, that did not mean that the courts could extend the notion of inventor, as defined by law, to include machines. An ongoing trend The UK Supreme Court is not the first to reject Dr. Thaler’s arguments. The United States,3 the European Union4 and Australia5 have adopted similar positions, concluding that only a natural person can qualify as an inventor within the meaning of the legislation applicable in their respective jurisdictions. The UK ruling is part of the Artificial Inventor Project’s cross-border attempt to ensure that the DABUS machine—and AI in general—is recognized as a generative tool capable of generating patent rights for the benefit of AI system owners. To date, only South Africa has issued a patent to Dr. Thaler, naming DABUS as the inventor.6 This country is the exception that proves the rule. It should however be noted that the Companies and Intellectual Property Commission of South Africa does not review applications on their merits. As such, no reason was given for considering AI as the inventor. More recently, in February of this year, the United States Patent and Trademark Office issued a guidance on AI-assisted inventions. The guidance confirms the judicial position and states in particular that “a natural person must have significantly contributed to each claim in a patent application or patent”.7 What about Canada? In 2020, Dr. Thaler also filed a Canadian patent application for inventions generated by DABUS.8 The Canadian Intellectual Property Office (“CIPO”) issued a notice of non-compliance in 2021, establishing its initial position as follows: Because for this application the inventor is a machine and it does not appear possible for a machine to have rights under Canadian law or to transfer those rights to a human, it does not appear this application is compliant with the Patent Act and Rules.9 However, CIPO specified that it was open to receiving the applicant’s arguments on the issue, as follows: Responsive to the compliance notice, the applicant may attempt to comply by submitting a statement on behalf of the Artificial Intelligence (AI) machine and identify, in said statement, himself as the legal representative of the machine.10 To date, CIPO has issued no notice of abandonment and the application remains active. Its status in Canada is therefore unclear. It will be interesting to see whether Dr. Thaler will try to sway the Canadian courts to rule in his favour after many failed attempts in other jurisdictions around the world, and most recently in the UK Supreme Court. At first glance, the Patent Act11 (the “Act”) does not prevent an AI system from being recognized as the inventor of a patentable invention. In fact, the term “inventor” is not defined in the Act. Furthermore, nowhere is it stated that an applicant must be a “person,” nor is there any indication to that effect in the provisions governing the granting of patents. The Patent Rules12 offer no clarification in that regard either. The requirement implied by the clear use of the term “person” in the wording of the relevant sections of the law is important: It was a key consideration that the UK Supreme Court analyzed in Thaler. Case law on the subject is still ambiguous. According to the Supreme Court of Canada, given that the inventor is the person who took part in conceiving the invention, the question to ask is “[W]ho is responsible for the inventive concept?”13 That said, however, we note that the conclusion reached was that a legal person—as opposed to a natural person—cannot be considered an inventor.14 The fact is that the Canadian courts have never had to rule on the specific issue of recognizing AI as an inventor, and until such time as the courts render a decision or the government takes a stance on the matter, the issue will remain unresolved. Conclusion Given that Canadian law is not clear on whether AI can be recognized as an inventor, now would be a good time for Canadian authorities to clarify the issue. As the UK Supreme Court has suggested, the place of AI in patent law is a current societal issue, one that the legislator will ultimately have to settle.15 As such, it is only a matter of time before the Act is amended or CIPO issues a directive. Moreover, in addition to having to decide whether AI legally qualifies as an inventor, Canadian authorities will have to determine whether a person can be granted rights to an invention that was actually created by AI. The question as to whether an AI system owner can hold a patent on an invention generated by their machine was raised in Thaler. Once again, unlike the UK’s patent act,16 our Patent Act does not close the door to such a possibility. Canadian legislation contains no comprehensive list of the categories of persons to whom a patent may be granted, for instance. If we were to rewrite the laws governing intellectual property, given that the main purpose such laws is to encourage innovation and creativity, perhaps a better approach would be to allow AI system owners to hold patent rights rather than recognizing the AI as an inventor. Patent rights are granted on the basis of an implicit understanding: A high level of protection is provided in exchange for sufficient disclosure to enable a person skilled in the art to reproduce an invention. This ensures that society benefits from such inventions and that inventors are rewarded. Needless to say, arguing that machines need such an incentive is difficult. Designating AI as an inventor and granting it rights in that respect is therefore at odds with the very purpose of patent protection. That said, an AI system owner who has invested time and energy in designing their system could be justified in claiming such protection for the inventions that it generates. In such a case and given the current state of the law, the legislator would likely have to intervene. Would this proposed change spur innovation in the field of generative AI? We are collectively investing a huge amount of “human” resources in developing increasingly powerful AI systems. Will there come a time when we can no longer consider that human resources were involved in making AI-generated technologies? Should it come to that, giving preference to AI system owners could become counterproductive. In any event, for the time being, a sensible approach would be to emphasize the role that humans play in AI-assisted inventions, making persons the inventors rather than AI. As concerns inventions conceived entirely by an AI system, trade secret protection may be a more suitable solution. The professionals on our intellectual property team are at your disposal to assist you with patent registration and provide you with a clearer understanding of the issues involved. [2023] UKSC 49 [Thaler]. Ibid., para. 56. See the decision of the United States Court of Appeals for the Federal Circuit in Thaler v Vidal, 43 F. 4th 1207 (2022), application for appeal to the Supreme Court of the United States dismissed. See the decision of the Boards of Appeal of the European Patent Office in J 0008/20 (Designation of inventor/DABUS) (2021), request to refer questions to the Enlarged Board of Appeal denied. See the decision of the Full Court of the Federal Court of Australia in Commissioner of Patents v Thaler, [2022] FCAFC 62, application for special leave to appeal to the High Court of Australia denied. ZA 2021/03242. Federal Register: Inventorship Guidance for AI-Assisted Inventions. CA 3137161. Notice from CIPO dated February 11, 2022, in Canadian patent application 3137161. Ibid. R.S.C., 1985, c. P-4. SOR/2019-251. Apotex Inc.v. Wellcome Foundation Ltd., 2002 SCC 77 at paras. 96–97. Sarnoff Corp. v. Canada (Attorney General), 2008 FC 712, para. 9. Thaler, paras. 48–49, 79. Ibid., para. 79.

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March 5, 2024

Labour shortage: Revised ratios of qualified staff members in child care centres

At a time when the pandemic is continuing to have repercussions and we are experiencing a severe labour shortage, the educational childcare sector is facing unprecedented challenges. These circumstances have led to a reassessment of the standards relating to the presence of qualified childcare staff with children. The purpose of this bulletin is to shed light on the regulatory amendments that have been made to the Educational Childcare Regulation1 (the “ECR”), and more specifically to the required ratio of qualified staff members. Enacted by Order in Council 102-2024,2 these amendments came into force on March 1, 2024. Childcare providers should imperatively take cognizance of these regulatory amendments, as they will help them optimize their operations and improve their ability to respond to the challenges they are facing in attracting and retaining qualified childcare staff. Background On July 22, 2021, in response to the impact of the pandemic on educational childcare services, amendments were made to the requirements respecting the ratio of qualified staff members provided for in the ECR. During the first 9 months that followed the end of the public health emergency, the ratio was reduced to one qualified staff member out of three. During the 12 months after that, it was increased to one in two. The ratio applicable to childcare services was expected to return to pre-pandemic levels, or a ratio of two qualified staff members out of three, on March 1, 2024.3 However, faced with the labour shortage,4 which is particularly affecting the childcare sector, the government estimated that many childcare providers would not be able to comply with a qualified childcare staff ratio of two out of three, as was initially required for that date. As a result, the legislator amended the ECR once again so as to address ongoing problems and prevent service closures or disruptions. These amendments are summarized below. New ratio requirements for childcare services Section 23 of the ECR has been amended to reaffirm the general standard stipulating that the ratio of qualified childcare staff must be two out of three. However, section 23.1 of the ECR now provides for certain exceptions to the previously established rule on the ratio of qualified childcare staff. The notable exceptions are as follows: A ratio of one qualified childcare staff member out of two may be maintained during the provision of childcare until March 31, 2027. A ratio of one qualified childcare staff member out of three will be authorized while childcare is being provided during the first and last business hour of the permit holder’s core hours. A ratio of one qualified childcare staff member out of three will also be authorized during the first five years following: the initial issuance of a day care centre permit; the modification of a day care centre permit to increase, by 8 or more, the maximum number of children that may be provided with childcare in the permit holder’s facility; or the conclusion of a first subsidy agreement between the Ministère de la Famille and the holder of a day care centre permit, provided that the agreement was entered into after October 31, 2023. Conclusion The changes described above, came into force on March 1, 2024, are intended to address the current shortage of qualified staff in the childcare sector in Quebec. Although the temporary flexibility and the exceptions to the qualified staff ratio will help childcare providers guarantee the continuity and accessibility of their services, compliance with prescribed ratios is still mandatory. Note that failure to comply with these requirements may lead to administrative penalties or penal sanctions, as well as a decision by the Ministère de la Famille suspending, revoking or not renewing a permit. The members of the Lavery team are available to answer your questions. The information and comments contained herein do not constitute legal advice. They are intended solely to enable readers, who assume full responsibility, to use them for their own purposes. Chapter S-4.1.1, r. 2. Regulation to amend the Educational Childcare Regulation, O.C. 102-2024 (G.O. II) Regulation to amend the Educational Childcare Regulation, O.C. 879-2021 (G.O. II). Ministère de la Famille, Mémoire au conseil des ministres : Projet de règlement modifiant le Règlement sur les services de garde éducatifs à l’enfance, tabled on September 20, 2023; Ministère de la Famille, Portrait de la main-d’œuvre du réseau des services de garde éducatifs à l’enfance, 2022–2023, October 2023.

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