Patents

On July 17, 2026, the Supreme Court of Canada (SCC) issued its decision in Pharmascience Inc. v. Janssen Inc., (2026 SCC 26), dismissing Pharmascience’s invalidity challenge to Janssen’s paliperidone palmitate dosing-regimen patent. While the majority of the SCC confirmed that a doctrine still exists in Canadian patent law under which a method of a medical treatment (MMT) is non-patentable subject matter, they affirmed the analysis and conclusions of the lower Courts that the claims of Janssen’s patent are not directed to a non-patentable MMT.  Background  Treatment of Schizophrenia entails lifelong management with antipsychotic medications, and the effectiveness of such treatment relies significantly on adherence to treatment regimens. A successful approach to improve treatment adherence has been the development of long-acting formulations, known as “depot formulations” or “long-acting injectables”, which gradually release the medication from the injection site and thus entail less frequent administration. Janssen developed such a long-acting injectable type of dosing regimen for the drug paliperidone palmitate for the treatment of Schizophrenia, marketed under INVEGA SUSTENNA.  Janssen’s Canadian Patent No. 2,665,335 (the ‘335 Patent) relates to such a dosing regimen, under which the drug is administered as follows:  Day 1: A first dose via deltoid injection;  Day 8 ± 2 days: A second dose via deltoid injection;  Monthly ± 7 days thereafter: Maintenance doses via deltoid or gluteal injection;  Two regimens are defined depending on renal impairment status, with specified mg-eq doses.  Pharmascience sought to invalidate the patent, arguing that the claims were invalid as impermissible methods of medical treatment.  Procedural History  Federal Court  Pharmascience sought to obtain marketing approval or a “Notice of Compliance” to market a generic version of INVEGA SUSTENNA. Under Canada’s pharmaceutical patent linkage regime, this led to proceedings before the Federal Court in which Pharmascience alleged invalidity of the patent. In its decision of August 23, 2022 (2022 FC 1218), the Federal Court (FC) upheld the validity of the ‘335 Patent.  Federal Court of Appeal  On February 1, 2024 (2024 FCA 23), the Federal Court of Appeal (FCA) affirmed the FC’s decision and again upheld the validity of the ‘335 Patent. In its analysis, the FCA established that in order to determine whether a claim is directed to an unpatentable MMT, the key inquiry is whether practising the invention calls for the exercise of professional skill and judgment. The FCA drew a distinction between:  skill and judgment applied in deciding how to use a treatment, which points to an unpatentable MMT; and  skill and judgment applied in deciding whether to use a treatment, which does not, on its own, indicate an unpatentable MMT.  Each case turns on its specific facts and the onus remains on the party attacking the patent to establish that the claim encompasses an unpatentable MMT.  Pharmascience then sought leave to appeal to the SCC, where the sole issue being assessed was patentable subject matter - whether the claims impermissibly claim a MMT and do not comply with section 2 (definition of “invention”) of the Patent Act.  Supreme Court The SCC maintained that a doctrine still exists in Canadian patent law under which MMTs are non-patentable subject matter. This doctrine is primarily attributable to the 1972 decision of the SCC in the Tennessee Eastman1 case, at which time it was only possible to patent a drug based on its method of manufacture, not as a pharmaceutical substance per se, as per former section 41(1) of the Patent Act. Following the repeal of former section 41(1), it has been argued that the rationale of Tennessee Eastman hinged on this repealed section and therefore the principles established in Tennessee Eastman should no longer apply. The majority of the SCC now confirms that the rule against patenting MMTs does not rest on former section 41(1) alone and continues to apply, grounded in the long-standing broader principle that “professional skills” are not patentable.  The SCC also affirmed that the ‘335 Patent’s dosing regimen claims do not monopolize professional medical skill and judgment in their implementation and thus do not relate to an unpatentable MMT. The appeal was therefore dismissed and the patent upheld on this ground.  The majority’s test: when does a claim cross the line into an MMT?  A patent impermissibly claims an MMT only if it seeks to monopolize professional medical skill and judgment - i.e., if it “fences in” an area of medical treatment. The analysis is purposive and substance-over-form; it turns on the claims and the evidentiary record.  The majority offered three non-exhaustive guideposts:  Focus on the claimed subject matter, not on the fact that doctors exercise judgment in choosing whether to use it for a particular patient. Clinical judgment in selecting/monitoring treatment generally does not make the invention unpatentable.  Individualization increases risk: the more the claim requires tailoring to individual patient characteristics, the more likely it is an MMT.  Ordinary-course professional development: the more the claimed subject matter is the kind of thing physicians would be expected to develop/improve as part of practice (without patent incentives), the more likely it is an MMT.  Fixed vs. variable dosage is not dispositive. While past Court decisions focused on fixed vs. variable dosages or timing of administration to be determinative factors, the SCC rejected such a categorical bright line; at most, variability may be an evidentiary proxy tied to the central “skill and judgment” question.  Application to Janssen’s dosing regimens  The majority affirmed the lower Courts’ key findings that:  Once the regimen is selected, no professional skill/judgment is required to implement it as claimed.  The renal-impairment split reflects an objective distinction and does not meaningfully constrain professional judgment.  The ± dosing windows and alternate injection sites were supported by evidence as clinically interchangeable / operational flexibility without clinical implications.  Result: the claims were not framed (in substance) as fencing in physicians’ clinical decision-making; they were treated as patentable subject matter.  Concurring reasons  While all of the Justices agreed on the result, two of the Justices disagreed on the doctrine and would have gone further. They:  Disagreed that MMTs are inherently non-patentable subject matter;  Would re-examine/overrule Tennessee Eastman and assess MMT claims like any other invention as defined in the Patent Act, with many failing instead under utility/operability/reproducibility/control concepts (rather than under a subject-matter exclusion).  Despite that doctrinal divergence, they agreed that the ‘335 Patent is valid.  Practical Takeaways  MMT exclusion remains the majority rule: claims that effectively fence in clinical decision-making remain vulnerable on subject-matter grounds.  Dosing regimen patents remain viable: evidentiary record and claim substance will be critical - particularly around whether implementation requires individualized clinical judgment.  No bright-line “fixed vs. range” rule: Rather, the actual role of medical skill/judgment in practicing the claimed regimen is key.  Overall, the SCC’s decision appears to fall in a middle ground between the positions advanced by the parties: confirming a doctrine of non-patentability of MMTs while at the same time confirming the patentability of dosing-regimen-based inventions depending on the facts of a given case, and as a result upholding the validity of the ‘335 Patent.  Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] SCR 111.

The theme for this year’s World Intellectual Property Day is “IP and Sports: Ready, Set, Innovate”, celebrating IP’s contributions to the world of athletics, athletes, and fans alike. It may seem surprising, but the world of IP has always been strongly linked to sports, whether it be cutting-edge equipment and gear, or the latest trends and brands in apparel. In honour of this year’s theme, we at Lavery thought it would be fun to highlight various sports-related inventions that have been patented over the years. From the serious to the downright silly, we have chosen several patents that show IP’s important, and sometimes bizarre, contributions to sports and athletics. US 2642679A: Ice rink resurfacing machine Starting with a classic, Frank J. Zamboni’s 1949 patent for an “Ice rink resurfacing machine” is recognizable to anyone who’s ever attended a hockey game. Fun fact: between 1928 and 1978, Frank Zamboni was awarded a total of 15 patents related to ice resurfacing machines as well as other technologies.1 US 267799A: Cork swimming-suit Before there were swimsuits made of space-age materials featuring ultra-hydrodynamic designs, we apparently had swimsuits made of… cork? Patented by Paschal Plant in 1882, this suit was intended to be sufficiently buoyant so as to “enable a person to float with perfect security” and aid in coming up to the surface after a dive. Water safety has never been so fashionable! US6446264B2: Articles of clothing Fast forward 120 years to see how far swimwear innovation has advanced. The use of such “tech suits” correlated with the breaking of numerous swimming world records when introduced, emphasizing the real impact of innovation. US2662587A: Chair for aerial skilifts While modern ski lift technology has existed since the 1930s, Mcilvaine Alexander’s 1949 patent was the first to feature a retractable footrest that could be brought by the passenger into operating position during loading, thereby no longer requiring as much help from attendants.2 US642544A: Bicycle Patented by Louis S. Burbank in 1898, this “innovative” bicycle design is intended to “provide means whereby one may enjoy with a bicycle or similar vehicle exercise like that of rowing” and is “adapted to develop the muscles of the arms and body as well as those of the legs”. Looking at the image above, many questions arise, for example relating to starting, staying upright, and stopping. US638920A: Golf-tee According to the National Golf Foundation, at least 22,000 patents related in some way to golf were filed with the U.S. Patent and Trademark Office (USPTO) between 1976 and 2018, the most of any sport by far.3 For comparison, baseball, the second most patented sport, saw 1,508 patents filed in the same period. An early example of a golf-related patent is this one for a “wooden” golf tee, patented by George F. Grant in 1899. According to the patent, the wooden golf tee was intended to replace “the usual conical mounds of sand or similar material formed by the fingers of the player on which the ball is supported when driving off”. US12011645B2: Golf tee Some 135 years later and golf tee innovation continues, in this case with a two-part design in which the upper portion can move and/or detach from the lower portion when the ball is struck, minimizing any resistance from the tee. US5356330A: Apparatus for simulating a "high five" When looking at technical achievements in sports, one can’t overlook the crowds of adoring fans. With that said, this invention relates to a self-righting hand-arm configuration, which is adapted to pivot when struck by a user, thereby simulating a "high five". According to the patent, solitary fans are, tragically, “unable to perform a ‘high five’ to express excitement during a televised sporting event”, making this invention nothing short of miraculous for such individuals. Other features of this invention include a “miniaturized, battery operated sound generator and speaker, for outputting a predetermined or user selectable sound in response to the striking of the simulated hand”. These sounds can include the “the cheer of a crowd or the voice of a specific player”. US1718305A: Basket ball Patented by George L. Pierce in 1928, this invention changed the look of basketballs to something more closely resembling their modern-day counterparts. According to the patent, basketballs had previously been made with panels tapering down to narrow points. This invention ensured a properly balanced basketball in which the best portions of the hide were saved and used in the pole portions of the ball. It is worth noting that basketballs were actually a dark brown until the late 1950s. The iconic orange colour we recognize today was initially selected by basketball coach Tony Hinkle, who thought it would be easier for fans to see.4 And there you have it, several sports-related patents, which—while not all game-changers—hopefully illustrated IP’s longstanding and far-reaching relationship with the world of athletics. It remains to be seen what wondrous (and wacky) inventions the future holds.   https://zamboni.com/about/zamboni-archives/patents/ https://gizmodo.com/17-historic-patents-that-make-winter-olympic-sports-pos-1520995330 https://www.dennemeyer.com/ip-blog/news/everyday-ip-the-notable-ip-of-golf-basketball-and-other-sports/ https://suiter.com/basketball-patents/

As we reported previously, changes were introduced into Canadian patent practice in October 2022 to further streamline Canadian patent examination, to pave the way for a patent term adjustment (PTA) system in Canada as per the Canada-United States-Mexico Agreement (CUSMA). The PTA system is set forth in the recent amendments to the Patent Rules published on December 18, 2024, which came into force on January 1, 2025. The purpose of the PTA system is to compensate patentees for unreasonable delays in the processing and grant of applications by the Canadian Intellectual Property Office (CIPO). PTA requirements To qualify for a PTA, a patent must meet the following criteria: Have a filing date (which is the PCT filing date for a Canadian national phase case) on or after December 1, 2020; Have an issue date on or after December 2, 2025; Issue after the later of 5 years from filing or 3 years from requesting examination (passing the “5/3 threshold” - see below). Furthermore, to obtain a PTA for a patent meeting the above-noted criteria, a request must be filed together with a fee (currently C$2,500) within three months of patent issuance Any PTA will be added on to the base “20-year from filing” calculation of patent term, and will also require the payment of annual maintenance fees during any additional patent term as a result of the PTA. PTA calculation - the “5/3 threshold” The starting point for the calculation of PTA is any additional days to patent issuance beyond the later of: 5 years from the Canadian national phase entry date for a PCT-based case, the Canadian filing date for a non-PCT case, or the presentation date (i.e., the date that the actual divisional filing documents are submitted) for a divisional application; or 3 years from date of requesting examination. The next step of the calculation will be to subtract from the above additional days any days in which the processing of the application was in the Applicant’s hands (any overlapping days in this regard are only counted once), such as delays in paying fees or attending to filing formalities, time to respond to CIPO notices, extensions, periods of abandonment, the period after the filing of a first request for continued examination (RCE), etc. As such, the PTA is only focused on any delays attributable to CIPO. Practical considerations One strategy to maximize the potential of obtaining a PTA is to request examination closer to the deadline, which is 4 years from the PCT filing date for a Canadian national phase case, or 4 years from the Canadian filing date for a non-PCT case. The basis of this strategy is to try to shift the balance towards period (2) noted above being applied to the PTA calculation. In doing so, any delays attributable to the Applicant before requesting examination are no longer relevant to the calculation. This strategy is less relevant for divisional applications, as the deadline for requesting examination is often only 3 months after the presentation date (when the divisional filing documents are submitted). A further strategic consideration relates to cases in which a third Examiner's report is issued or an RCE is filed. The filing of an RCE applies in the following scenarios: Following the issuance of a third Examiner’s report in cases in which examination was requested on or after October 3, 2022; Re-opening examination after allowance, for all cases. Since the issuance of a third Examiner's report (even in cases where examination was requested prior to October 3, 2022) or the filing of an RCE will have a significant negative impact on the PTA calculation, Applicants should try to streamline prosecution, to file amendments and address any issues early on during examination, to avoid the issuance of a third Examiner's report and/or the filing of an RCE. Similarly, Applicants should avoid re-opening examination after allowance, which requires the filing of an RCE (even in cases where examination was requested prior to October 3, 2022). While it is predicted1 that few patents will qualify for a PTA in view of the issues noted above and CIPO’s efforts to reduce pendency, the calculation will in most cases be relatively straightforward, allowing Applicants to assess whether requesting PTA is worthwhile before proceeding. The Regulatory Impact Analysis Statement published with the final version of the new Patent Rules predicts about 113 PTA applications per year over the next 10 years.

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).