Novartis AG v. Biogen Inc.

Novartis AG v. Biogen Inc.
Court (s) Database
Federal Court Decisions
Date
2024-01-24
Neutral citation
2024 FC 52
File numbers
T-1664-22
Decision Content
Date: 20240124
Docket: T-1664-22
Citation: 2024 FC 52
Ottawa, Ontario, January 24, 2024
PRESENT: Madam Justice Pallotta
BETWEEN:
NOVARTIS AG AND NOVARTIS PHARMACEUTICALS CANADA INC.
Applicants
and
BIOGEN, INC., BIOGEN MA INC., BIOGEN CANADA INC. AND SAMSUNG BIOEPIS CO., LTD.
Respondents
PUBLIC JUDGMENT AND REASONS
(Identical to the Confidential Judgment and Reasons
issued on January 12, 2024)
I. Introduction [1] In this application, Novartis AG and Novartis Pharmaceuticals Canada Inc (Novartis Canada) (collectively, Novartis) allege that the respondents’ unauthorized use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in the registered trademark BEOVU, contrary to sections 7(b), 19, 20, and 22 of the Trademarks Act, RSC 1985, c T-13 [TMA].
[2] For the reasons that follow, I find Novartis has established that the respondents’ use of BYOOVIZ violates Novartis’ rights in the BEOVU mark.
II. Background [3] Novartis owns Canadian trademark registration TMA1072372 for BEOVU, registered February 11, 2020 in association with pharmaceutical preparations for use in ophthalmology and pharmaceutical preparations for prevention and treatment of ocular disorders and diseases. Novartis uses the BEOVU trademark in association with an anti-vascular endothelial growth factor (anti-VEGF) biologic drug. The BEOVU drug is approved in Canada for treating neovascular age-related macular degeneration, commonly referred to as wet AMD.
[4] Anti-VEGF drugs are prescription drugs that must be administered by an ophthalmologist. The drugs are liquid formulations that are injected into the vitreous body of the eye using a syringe.
[5] On March 8, 2022, Health Canada issued a notice of compliance authorizing the respondents to market an anti-VEGF drug for treating wet AMD and other ophthalmic indications, under the name BYOOVIZ.
[6] Samsung Bioepis Co, Ltd (Samsung) manufactures the BYOOVIZ drug in Canada.
[7] Biogen, Inc is the parent company of Biogen MA Inc, and Biogen MA Inc is the parent company of Biogen Canada Inc (collectively, Biogen). Biogen MA Inc is responsible for commercializing the BYOOVIZ drug and has a pending Canadian trademark application, filed August 6, 2020 (application no. 2044395), to register BYOOVIZ for use in association with pharmaceutical preparations. Biogen Canada Inc is Biogen MA Inc’s primary Canadian operating subsidiary and a licensee of the BYOOVIZ trademark.
[8] The BYOOVIZ drug is a biosimilar drug. It was approved as a biosimilar equivalent to another Novartis drug, marketed under the brand name LUCENTIS. While Novartis’ BEOVU and LUCENTIS drugs are both anti-VEGF medications used to treat wet AMD, they contain different active pharmaceutical ingredients (API). The API in BEOVU is brolucizumab. The respondents’ biosimilar drug contains ranibizumab, the same API that is in LUCENTIS.
[9] Novartis commenced this application before the respondents had started selling the BYOOVIZ drug in Canada, and the evidence in the record was obtained before the BYOOVIZ drug was on the market. However, the parties confirmed that, by the time of the hearing, the respondents were promoting and selling the BYOOVIZ drug in Canada. The parties also confirmed they were not treating this proceeding as an application for quia timet relief, and there are no issues that arise due to the timing of the notice of application relative to the start of the respondents’ activities.
[10] While Biogen and Samsung each filed written submissions and made oral submissions, their positions are substantially aligned. For convenience, I will generally refer to the respondents’ evidence and submissions without distinguishing between Biogen and Samsung. Where I refer to Biogen or Samsung submissions separately, it does not mean their positions diverged on the point.
III. Issues [11] The issues on this application are:
Does the respondents’ use of the BYOOVIZ trademark infringe Novartis’ rights in the BEOVU trademark, contrary to sections 19 or 20 of the TMA?
Do the respondents’ actions constitute passing off contrary to subsection 7(b) of the TMA?
Have the respondents used the BEOVU trademark in a manner that is likely to have the effect of depreciating the value of the goodwill attaching to it, contrary to section 22 of the TMA?
What is the appropriate remedy, if any?
IV. Overview of the Evidence [12] The parties rely on the affidavit evidence of nine witnesses, and the transcripts of their cross-examinations conducted out of court. Novartis’ affiants are two company witnesses (Eve-Lyne Begin and Angela Hamed) and an ophthalmologist (Arif Samad). The respondents’ affiants are a Biogen company witness (Blake Leitch), three ophthalmologists (Robert Devenyi, Farzin Forooghian, and Frank Stockl), a linguistics professor (Anne-José Villeneuve), and Joseph Connolly of Sentrex Health Solutions Inc (Sentrex), which is described as a “fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients, and is more commonly referred to as a specialty pharmacy”. Drs. Samad, Devenyi, Forooghian, and Stockl are proposed as experts in ophthalmology with experience prescribing and administering anti-VEGF medications. Dr. Villeneuve is proposed as an expert witness in linguistics and phonology in French and English. I am satisfied that the proposed experts are qualified to give opinion evidence in their respective fields.
[13] The following is a non-comprehensive overview of the witnesses’ evidence, beginning with Novartis’ affiants.
Eve-Lyne Begin:Ms. Begin is the Brand Director of Ophthalmology at Novartis Canada.Her affidavit explains some of Novartis Canada’s marketing efforts for the BEOVU drug, which were primarily directed to health care professionals.
Angela Hamed:Ms. Hamed is a Regional Director of Portfolio Management at Novartis Canada.Her affidavit provides information about Novartis, the BEOVU trademark, and Novartis’ use of the BEOVU trademark in Canada.
Arif Samad: Dr. Samad is an ophthalmologist and associate professor in the Ophthalmology and Visual Sciences department at Dalhousie University.Dr. Samad’s affidavit explains wet AMD and its treatment, including the drugs that are used and how they are administered.He states: the ophthalmologist, who is familiar with the available products and their respective trademarks, selects the specific anti-VEGF drug to be administered; staff at ophthalmology clinics routinely identify anti-VEGF drugs by their brand names; the BEOVU drug, and other anti-VEGF drugs such as LUCENTIS, EYLEA, and VABYSMO, are received from the pharmacy in a similar sized box or, in the case of a syringe filled at a hospital pharmacy, a sealable plastic bag; and patients may request medicines based on their own research.The respondents argue Dr. Samad’s affidavit (but not his cross-examination testimony) should be given no weight, including because he did not disclose financial ties to Novartis, and his cross-examination revealed a number of substantial changes to his affidavit evidence.
Blake Leitch: Mr. Leitch is the head of Marketing and Communications in the Global Biosimilars unit of Biogen MA Inc.His affidavit provides information on Biogen’s corporate structure, the BYOOVIZ name selection process, and the regulatory approval process for the BYOOVIZ drug, including Health Canada’s approval of the name.It attaches mock-up packaging for the BYOOVIZ drug, explains the marketing efforts that have been undertaken, and states the drug is intended to capitalize on the LUCENTIS market share, not the much smaller BEOVU market share.He states the reputation of the BEOVU drug has suffered due to safety warnings, and his affidavit attaches articles about the BEOVU drug that are accessible in Canada, as evidence of negative publicity. Mr. Leitch states the BYOOVIZ and BEOVU drugs have been sold concurrently in the United States since July 2022 and he is unaware of any confusion.
Anne-José Villeneuve:Dr. Villeneuve is an Associate Professor at the University of Alberta’s Campus Saint-Jean, and an Adjunct Professor in the Department of Linguistics.She provides an opinion as to how BEOVU and BYOOVIZ would be pronounced by a majority of Canadians, depending on their predominant language.In Dr. Villeneuve’s view, the two terms differ phonetically, do not resemble each other in appearance, and do not have meaning in English or French or share any conceptual similarity.However, if an average French-speaking Canadian “spent some time analyzing and dissecting” BEOVU, they may come to understand the “vu” portion to signify “to see” and therefore allude to eyes.In “analyzing and dissecting” BYOOVIZ, an average Canadian may come to understand “viz” to indicate “vision”, however this interpretation is less obvious given that the final consonant “Z” is absent from the French and English spelling of “vision”.Novartis submits Dr. Villeneuve’s evidence is not necessary to assist the Court, including because she did not put herself in the position of the average consumer as required by the confusion analysis, she has no experience with pharmaceuticals, and she does not know how ophthalmologists would pronounce the trademarks at issue.
Robert Devenyi: Dr. Devenyi is a vitreoretinal surgeon with the University Health Network (UHN) in Toronto, and was previously the UHN Ophthalmologist in Chief.The Devenyi affidavit describes the use of anti-VEGF drugs to treat wet AMD, and provides a list of drugs currently on the market in Canada.Dr. Devenyi describes his personal approach to the prescription of anti-VEGF drugs and his clinical practice.He does not prescribe BEOVU because it has been shown to cause inflammation that can lead to vision loss.Dr. Devenyi states the anti-VEGF drugs EYLEA and LUCENTIS, which he uses regularly, come from the manufacturer in the original manufacturer packaging.Sometimes Dr. Devenyi will prescribe AVASTIN “off label”.AVASTIN is approved and indicated to treat certain cancers, but it is effective for treating wet AMD and can be prescribed even though it is not specifically indicated for that treatment.A specialty pharmacy will repackage AVASTIN under sterile conditions, supplying syringes bearing a label with the brand name of the drug.According to Dr. Devenyi, patients almost never ask for a specific anti-VEGF drug.When a patient attends his clinic for treatment of wet AMD or diabetic retinopathy, clinic staff will place a syringe containing the proper drug in the patient treatment room.Before administering the drug, Dr. Devenyi performs a crosscheck to ensure the drug is correct.When he first treats the patient or switches to a different medication, Dr. Devenyi tells his patients what drug he is administering.
Joseph Connolly: As noted above, Mr. Connolly founded Sentrex, a specialty pharmacy.His affidavit states the majority of ophthalmology clinics source their drugs from specialty pharmacies like Sentrex.Sentrex supplies more than 35% of ophthalmology clinics across Canada, with a dominant market share in Ontario, Quebec, New Brunswick, Newfoundland, and Nova Scotia.Mr. Connolly explains the checks and balances Sentrex has in place to ensure patients receive the correct drug, and describes the information Sentrex places on medication labels.In Mr. Connolly’s experience, the average age of patients who are prescribed anti-VEGF drugs is 81, and while it is possible for patients to pick up their own prescriptions from a pharmacy, anti-VEGF medications are in almost every case sent directly to the clinic where the patient’s retinal specialist will administer the drug.
Farzin Forooghian: Dr. Forooghian is an ophthalmologist and Clinical Associate Professor of Ophthalmology at the University of British Columbia.His affidavit provides an overview of available anti-VEGF drugs and the drugs he commonly prescribes, taking cost and British Columbia’s funding model into account.Dr. Forooghian states he would not raise BEOVU as a treatment option at an initial consultation and would only offer it as a final option if other anti-VEGF drugs were ineffective, which has not yet happened in his practice.Dr. Forooghian states his patients almost never ask for a specific drug, and if a patient asked for a particular anti-VEGF drug out of the sequence he follows, he would explain his duty to use drugs authorized by the Provincial Retinal Diseases Treatment Program and most cost-effective to treat their specific condition.Dr. Forooghian states all anti-VEGF drugs in the province of British Columbia are provided by compounding pharmacies.The compounding pharmacy he uses orders the drugs from a drug manufacturer or distributor, removes them from the original packaging, repackages them in new syringes under sterile conditions, places the syringes in colour-coded bags, and delivers them to his clinic where the drugs are refrigerated until used.The bags and syringes bear the name of the drug.Dr. Forooghian states he does not see the original manufacturer packaging when he administers anti-VEGF drugs to patients.When Dr. Forooghian enters the room to administer the drug, the drug will already be there in its colour-coded bag.Dr. Forooghian verbally confirms the patient’s name and date of birth, cross-references the anti-VEGF drug indicated in the patient’s chart with the colour of the bag, and visually verifies it is the correct drug.Dr. Forooghian states he always tells the patient the name of the drug they are about to receive, and always tells the patient if he has switched them to a different drug.
Frank Stockl:Dr. Stockl is an ophthalmologist, vitreoretinal surgeon, and Assistant Professor in the Department of Ophthalmology at the University of Manitoba in Winnipeg.He practices in Manitoba and northwestern Ontario.Dr. Stockl’s affidavit provides an overview of the anti-VEGF drugs available to ophthalmologists in Canada.In Manitoba, anti-VEGF drugs are available through the Winnipeg Regional Health Authority (WRHA) pharmacy.Manitoba mandates stepwise therapy—ophthalmologists must administer the first-line drug and only move to the next drug if certain criteria are met. AVASTIN is the first-line drug in Manitoba for wet AMD (as noted above, this is an “off-label” use) and the WRHA plan does not currently cover the cost of BEOVU.AVASTIN is less commonly prescribed in Ontario as the costs of approved anti-VEGF drugs are covered under Ontario’s health plan.In Manitoba, anti-VEGF drugs are delivered to a compounding pharmacy in vials in their original manufacturer packaging.The compounding pharmacy transfers the drugs from their original packaging into syringes, then the syringes are labelled with the name of the drug, placed in a colour-coded plastic cassette, and sent to the receiving clinic via a refrigerated courier service.In northwestern Ontario, anti-VEGF drugs are procured from private pharmaceutical distributors and may be delivered to the clinic in the manufacturers’ packaging, with a label applied by the pharmacy.The drug name is also etched into the syringe.For drugs that are supplied in a vial, they are repackaged into syringes under sterile conditions.A syringe label indicates the drug name.In Dr. Stockl’s clinic, a clinical assistant will pull the correct drug from the refrigerator, remove it from its package, and place the syringe in the treatment room.A technician verifies the patient’s name and date of birth, confirms the eye to be treated, and crosschecks the drug.When Dr. Stockl enters the room, he verifies the drug by inspecting the label, and confirms the drug name and the eye to be treated with the patient prior to administration.At a hospital, a nurse will confirm the patient’s name, date of birth, the drug to be administered, and which eye or eyes are to be treated in Dr. Stockl’s presence. Dr. Stockl crosschecks the drug name on the syringe with the drug named by the nurse before proceeding with the injection.Dr. Stockl states the vast majority of patients will not ask for a specific anti-VEGF drug.If a patient asks about a certain drug, Dr. Stockl states he will usually tell them that the decision is constrained by algorithms provided by the government as to what can be used, and explains the related rules.Dr. Stockl states he informs patients that if the specific drug is still what they want, they would have the option to purchase the drug out-of-pocket or through third party insurance if covered.
V. Analysis A. Does the respondents’ use of the BYOOVIZ trademark infringe Novartis’ rights in the BEOVU trademark, contrary to sections 19 or 20 of the TMA? [14] Novartis submits the respondents have contravened sections 19 and 20 of the TMA.
[15] Novartis argues the BEOVU registration gives it the exclusive right to use the BEOVU trademark with the registered goods—pharmaceutical preparations for use in ophthalmology and pharmaceutical preparations for prevention and treatment of ocular disorders and diseases—throughout Canada. By virtue of section 20 of the TMA, the exclusive right granted by section 19 is deemed to be infringed when another person sells, distributes, or advertises goods or services in association with a confusing trademark or trade name.
[16] The respondents submit the causes of action for infringement under sections 19 and 20 are distinct. The respondents submit Novartis has no cause of action under section 19 of the TMA, which is limited to infringement by use of an identical trademark in association with registered goods or services.
[17] The respondents’ position on this point is consistent with the jurisprudence. The Federal Court of Appeal stated in Sandhu Singh Hamdard Trust v Navsun Holdings Ltd, 2019 FCA 295 (at paragraph 20) that section 19 is concerned with use of a trademark that is identical to a registered trademark, while section 20 is broader in scope and captures use of a trademark that is confusing in light of, but not necessarily identical to, a registered mark (see also Ratiopharm Inc v Laboratoire Riva Inc, 2006 FC 889 at paragraph 7 [Ratiopharm] and A & W Food Services of Canada Inc v McDonald's Restaurants of Canada Ltd, 2005 FC 406 at paragraphs 9-13 [A&W]).
[18] The BEOVU and BYOOVIZ marks are not identical. The infringement analysis will therefore proceed under section 20 of the TMA.
[19] Turning to the test for confusion, subsection 6(2) of the TMA provides that use of a trademark causes confusion with another trademark if the use of both trademarks in the same area would be likely to lead to the inference that the goods or services associated with the trademarks are manufactured, sold, leased, hired, or performed by the same person, whether or not the goods or services are of the same general class.
[20] In determining whether trademarks are confusing, the court shall have regard to all the surrounding circumstances, including: (a) the inherent distinctiveness of the trademarks and the extent to which they have become known; (b) the length of time the trademarks have been in use; (c) the nature of the goods, services, or business; (d) the nature of the trade; and (e) the degree of resemblance between the trademarks in appearance, sound, or the ideas suggested by them: TMA, s 6(5).
[21] The test to be applied is a matter of first impression in the mind of a casual consumer somewhat in a hurry who, in this case, sees the BYOOVIZ mark at a time when he or she has no more than an imperfect recollection of the BEOVU mark, and does not pause to give the matter any detailed consideration or scrutiny, nor to examine closely the similarities and differences between the marks: Veuve Clicquot Ponsardin v Boutiques Cliquot Ltée, 2006 SCC 23 at paras 19-20 [Veuve Clicquot]; Masterpiece Inc v Alavida Lifestyles Inc, 2011 SCC 27 at paras 40-41 [Masterpiece]. The factors to be considered when making a determination as to whether or not a mark is confusing to a somewhat-hurried consumer in all the circumstances include, but are not limited to, those enumerated in subsection 6(5) of the TMA: Veuve Clicquot at para 21; Masterpiece at para 44. The list of circumstances is not exhaustive, and different circumstances will be given different weight in a context-specific assessment: Veuve Clicquot at para 21, citing Mattel, Inc v 3894207 Canada Inc, 2006 SCC 22 [Mattel].
[22] Reverse confusion is also actionable under the TMA and assessed according to the same criteria: A&W at para 32.
[23] The parties agree that the outcome of this proceeding hinges on whether there is a likelihood of confusion between the BEOVU and BYOOVIZ trademarks.
[24] The parties disagree on the identity and attitude of the relevant consumer for the likelihood of confusion analysis. The parties also disagree on the relevant point in time for assessing whether a consumer is likely to be confused, which I address in the subsection on consumer attitude.
(1) Relevant consumers [25] Novartis argues that physicians, pharmacists, and patients—who are the end recipients of the drug and who generally encounter the trademark when their ophthalmologist tells them the name of drug that they will be given—are all relevant consumers. Novartis relies on Ciba-Geigy Canada Ltd v Apotex Inc, [1992] 3 SCR 120 [Ciba-Geigy] and Ratiopharm for the principle that patients using prescription drugs are considered to be relevant consumers for the purposes of a confusion analysis.
[26] Novartis argues that, since patients have no direct access to the BEOVU or BYOOVIZ drugs, it is all the more necessary that they be able to exercise some kind of control over what they are given: Ciba-Geigy at 147. The fact that the patient has a choice is sufficient for patients to be considered relevant consumers, regardless of whether the choice is great or small, easily exercised or not: Ciba-Geigy at 150. Novartis states patients receiving anti-VEGF treatments have, at the very least, a choice to refuse treatment, and it would be wrong to exclude them on the basis that they have no choice regarding the brand of drug to be taken: Ciba-Geigy at 150.
[27] The respondents argue that patients are not relevant consumers. The respondents submit that trademark use in the context of highly specialized anti-VEGF medications does not transcend to the patient level, and the only relevant consumers are doctors and pharmacists.
[28] Biogen submits it is the persons who are likely to buy the goods that must be considered in a confusion analysis: Baylor University v Hudson’s Bay Co (2000), 184 FTR 316 at para 27, 8 CPR (4th) 64 (FCA). While patients are the ultimate recipients of the drug, they never encounter the names of anti-VEGF drugs as consumers and do not rely on a trademark associated with an anti-VEGF medication to guide their purchasing decisions. In the anti-VEGF medication market context, Biogen states patients do not interact with the brand names of anti-VEGF medications as consumers because they rely entirely on their doctors to select, purchase, and administer the correct medication. Patients do not see the packaging for anti-VEGF medications or have any contact with the medication before it is administered. To the extent a patient is exposed to a trademark associated with anti-VEGF medication, it is when their ophthalmologist tells them the single name of the drug they will be getting—no other drug name is presented to the patient. Biogen argues it does not make sense to consider the perception of a patient solely because they are the beneficiary of the product, when they do not in fact “use the trademark as a consumer”.
[29] In terms of patient choice, Biogen submits Ciba-Geigy and Ratiopharm are distinguishable from the circumstances of this case. In Ciba-Geigy, the asserted trademark rights related to the appearance of prescription blood pressure pills purchased from a pharmacist and self-administered by the patient. The drugs at issue were designated interchangeable pharmaceutical products pursuant to the Prescription Drug Cost Regulation Act, 1986, SO 1986, c 28, which allows patients a choice to refuse to be sold a drug other than the one indicated by the doctor’s prescription. In Ratiopharm, patients could purchase the cough drug at issue over the counter, with a pharmacist as the intermediary.
[30] In this case, Biogen submits Novartis’ argument of patient choice with respect to their anti-VEGF medication is contrary to the evidence. Anti-VEGF medications must be administered by a highly qualified ophthalmologist and patient preference plays no role in drug selection. Biogen submits ophthalmologists alone select which drug will be administered—often, it is the price of an anti-VEGF medication that will dictate the selection. Furthermore, there are government regulations and policies that dictate which drugs will be covered and may mandate biosimilars, eliminating any choice by the patient. Biogen argues that while a patient may have a choice to refuse treatment, such a choice is highly unlikely to be the result of brand preference.
[31] Biogen argues it is justifiable to exclude patients receiving a drug from the category of relevant consumers in appropriate circumstances. Biogen states the facts of this case are similar to NeoRx Corp v Cytogen Corp, [1995] TMOB No 79, 61 CPR (3d) 559 [NeoRx], where the Trademarks Opposition Board (TMOB) distinguished Ciba-Geigy and found that the end user of the product at issue, a radiolabelled injectable solution used for tumour imaging, were highly trained, skilled persons such as pharmacists, physicians, radiologists, and technicians working in the specialized field of nuclear medicine. Patients were not relevant consumers, despite being injected with the product at issue in NeoRx.
[32] Samsung supports Biogen’s position and argues that patients are removed from the decision-making process for anti-VEGF drugs. Patients never handle the drugs themselves, do not request specific drugs, do not see the packaging, and have no agency to select the drug that will be administered. Patients accept the treatment recommended by their ophthalmologist or mandated by provincial funding regimes, and generally rely on their highly trained ophthalmologist to make the right selection of an anti-VEGF drug on their behalf.
[33] I agree with Novartis that patients are relevant consumers in a likelihood of confusion analysis. I am not persuaded by the respondents’ arguments that patients lack the requisite control over the anti-VEGF medication given to them so as to exclude their perception as a relevant consumer. While Ciba-Geigy involved a different factual context, the principles the Supreme Court of Canada set down in that decision support Novartis’ position. In my view, patients exercise the requisite control over the anti-VEGF medications they will receive, and the principles in Ciba-Geigy support Novartis’ position that the patient is a relevant consumer.
[34] The fact that the BYOOVIZ and BEOVU drugs are not interchangeable in the same way as the goods at issue in Ciba-Geigy is not a basis for distinguishing the principles set down in Ciba-Geigy. The Supreme Court of Canada stated that what is significant is that the patient has a choice, regardless of whether the choice is great or small, easily exercised or not: Ciba-Geigy at 150. The ophthalmologists’ evidence in this case is that patients are told the brand name of the drug that will be administered to them. Patients also sign a consent form agreeing to be injected with the anti-VEGF drug. While the patient typically does not see product packaging, the drug name is on the syringe that will be used to inject the drug and the patient may see the name on the syringe before the drug is administered. A patient, upon hearing the trademark, and possibly also upon seeing the trademark on the syringe, can exercise at least the choice to refuse administration. In my opinion, this choice is sufficient to make patients relevant consumers for the purpose of assessing the likelihood that trademarks may be confusing.
[35] Furthermore, the evidence shows that at least in some circumstances in some clinics, patients can choose between anti-VEGF medications. For example, Dr. Stockl’s evidence was that if a patient asks about a certain drug, he would tell them that the decision is constrained by algorithms provided by the government and he would explain the related rules; however, if the specific drug is still what patient wants, they would have the option to purchase the drug out-of-pocket or through third party insurance, if covered.
[36] Trademarks serve a public interest in assuring consumers that they are buying from the source from whom they think they are buying and receiving the quality which they associate with that particular trademark: Mattel at para 21. Confusion must be avoided in the minds of all customers, and is not limited to the direct customers: Ciba-Geigy at 140. The Supreme Court of Canada stated it is “all the more necessary” for patients to be able to exercise some kind of control over what they are being given if they have no direct access to a drug: Ciba-Geigy at 147. In light of these principles, patients are a relevant consumer for anti-VEGF drugs. Even in circumstances where patients do not request a specific anti-VEGF medication, which the evidence suggests occurs the majority of the time, they are informed of the ophthalmologists’ choice of drug and they consent to being injected with a drug that is identified by its trademark.
[37] The facts of NeoRx are distinguishable, at least because the decision does not mention any evidence that patients were told the name of the imaging medium that would be injected. In any event, I do not find the TMOB’s limited discussion of how the circumstances of NeoRx were found distinguishable from Ciba-Geigy to be helpful in deciding whether patients are a relevant consumer in the case before me. If the TMOB’s finding that the reference consumer would not include the patient was based on its statement (at paragraph 11) that the patient would not “purchase or self-administer” the goods that were at issue, I respectfully disagree that the principles in Ciba-Geigy are distinguishable on that basis.
[38] Patients are clearly affected by the ophthalmologist’s choice of anti-VEGF medication, and while the funding models vary from province to province, the drug is purchased for the patient’s benefit and use, injected into the patient’s body at regular intervals according to the treatment plan, and the patient can be switched to a different drug. Patients know what medication they are on by its brand name. In my view, a patient who is told the name of the anti-VEGF drug they will receive is a relevant consumer, and entitled to protection from confusion.
[39] In summary, on the facts of this case, the patient as the ultimate end-user of the drug is a relevant consumer for the likelihood of confusion analysis.
(2) Consumer attitude [40] The casual consumer somewhat in a hurry will differ, depending on the context, and an analysis of the likelihood of confusion accounts for the relevant consumer’s “attitude”. The care or attention of the consumer may reflect the context and importance of the purchase and the surrounding circumstances: Masterpiece at para 67. This care or attention must relate to the attitude of the consumer approaching an important or costly purchase when he or she encounters the trademark, not the research, inquiries, or care that may subsequently be taken: Masterpiece at paras 68-69.
[41] Novartis submits that consumer attitude or mindset increases the likelihood of confusion for the relevant universe of consumers.
[42] For ophthalmologists, Novartis argues that the high-throughput, busy, stressful, and demanding nature of their practices should be accounted for in assessing likelihood of confusion. For patients, Novartis’ position is that the attributes of the average patient consumer and the circumstances in which they would encounter the trademarks at issue increase the likelihood of confusion. Novartis submits patients are a sensitive population. The average patient receiving the BEOVU or BYOOVIZ drug: is generally over the age of 70 (with the average age over 80); is concerned because they are experiencing vision loss and have received a diagnosis that could lead to blindness; is feeling stressed, anxious, overwhelmed, or frightened; is potentially difficult to communicate with; may have issues understanding and difficulty hearing; and presents with a multitude of challenges including comprehension and dementia. Novartis states it is this elderly, anxious, and sensitive population of patients suffering from wet AMD who encounter a relevant trademark when they hear it spoken by their ophthalmologist that must be taken into account in assessing whether there is a likelihood of confusion between the trademarks at issue.
[43] The respondents argue that doctors and pharmacists are consumers who will exercise more attention and caution when encountering trademarks. Doctors and pharmacists are highly skilled professionals who exercise the utmost care, and are “less likely to be in the same hurry” as the purchaser of a mid-priced meal or dress: Ratiopharm at para 59. The respondents note that in Pierre Fabre Médicament v Smithkline Beecham Corp, 2004 FC 811 [Pierre Fabre], the Court described the pharmacist as a health professional who is used to prescriptions, and will consult with the doctor if there is a problem, which reduces the risk of confusion: Pierre Fabre at para 15. Also, the respondents submit doctors and pharmacists are closer in the chain to manufacturers, and are unlikely to be confused as to the source. In support of this proposition, the respondents contend that Novartis representative Ms. Begin admitted that health care practitioners are not confused as to the source of anti-VEGF drugs because they know who the provider is.
[44] The respondents state that if patients are relevant consumers, then they are informed consumers, decreasing the likelihood of confusion. If a patient were to request a particular anti-VEGF drug, an ophthalmologist would be required to explain the distinction between the anti-VEGF drug proposed to be used and the anti-VEGF drug requested by the patient, prior to the time of transfer. As such, in the rare instances where the patient is involved in the selection of an anti-VEGF medication, the patient is an informed one since health care professionals intervene before the patient has any contact with either medication.
[45] The respondents further state that Novartis’ arguments about patient anxiety or sensitivity are mischaracterized and taken out of context. Patients are not a particularly sensitive population, and ophthalmologists actively mitigate patient anxiety and carefully provide the patient with detailed information and explanations, walking them through each step of the procedure. Where health care practitioners intervene before the patient comes into contact with the medication, the patient is deemed to be informed because they must consult with their doctor before they are given the medication, and there will be less risk of confusion than in the case of impulse buying: Pierre Fabre at paras 14, 16. The respondents submit that, given the importance of the decision in selecting anti-VEGF medications, patients will be more attentive, alert, and less susceptible to being confused, and the Court should not undermine patients’ attention and alertness simply because of their age.
[46] Related to these points, the parties disagree on the relevant “point in time” for assessing whether a consumer is likely to be confused.
[47] Novartis argues the question has been definitively settled by the Supreme Court of Canada in Masterpiece. Likelihood of confusion is a test of first impression, and what matters is the consumer’s impression when they encounter the marks in question: Masterpiece at paras 70–74. Novartis states that for patients, at least one scenario relevant to the confusion analysis is the patient’s first impression when they encounter the trademark by hearing it spoken by an ophthalmologist. The respondents’ reliance on factors such as checks and balances for avoiding medication errors are irrelevant to a confusion analysis based on first impression, because they occur after the trademark is encountered.
[48] The respondents’ position is that confusion under the TMA is tied to use. Section 2 of the TMA defines “confusing” with reference to “use” and section 4 of the TMA distinguishes between trademark use with services, which generally requires advertising of a service that is available to be performed in Canada, and trademark use with goods, which generally requires a purchase. The respondents argue that the reference to “encounter” in Masterpiece stems from a factual matrix that dealt with the likelihood of confusion between trademarks that were used in association with services. The respondents state the trademarks at issue in this case are not “sound marks”, but rather word marks that must be visually represented or displayed: Playboy Enterprises Inc v Germain, [1988] 1 FC 163, 16 CPR (3d) 517 at 522-523; Philip Morris Products SA v Marlboro Canada Limited, 2010 FC 1099 at paras 237-238, rev’d on other grounds in 2012 FCA 201. An ophthalmologist saying the name of the anti-VEGF drug aloud to a patient is not trademark use.
[49] Furthermore, the respondents state that patients would rarely, if ever, “encounter” the BEOVU trademark. Patients are only told the single name of the anti-VEGF drug that will be administered to them—no other drug name is presented. The respondents state the BEOVU drug is a drug of last resort, a failed drug that is only used for a small percentage of patients who do not improve on other drugs. According to the respondents, the real reason Novartis commenced this action is because the BYOOVIZ biosimilar drug will effectively replace Novartis’ LUCENTIS drug, which is a first line treatment with about 30% of the anti-VEGF drug market.
[50] I am not persuaded by the respondents’ arguments. I agree with Novartis that in Masterpiece, the Supreme Court of Canada did not distinguish between the first impression test as applied to goods versus services, and specifically used the term “encounter” with reference to goods (or wares) as well as services. For example, see the Supreme Court of Canada’s statements at paragraphs 67, 70, and 72:
[67] …[C]onsumers in the market for expensive goods may be less likely to be confused when they encounter a trade-mark, but the test is still one of “first impression”…
[…]
[70] … Properly framed, consideration of the nature of wares, services or business should take into account that there may be a lesser likelihood of trade-mark confusion where consumers are in the market for expensive or important wares or services. The reduced likelihood of confusion is still premised on the first impression of consumers when they encounter the marks in question…[emphasis in original]
[…]
[72]…Careful research and deliberation may dispel any trade-mark confusion that may have arisen. However, that cannot mean that consumers of expensive goods, through their own caution and wariness, should lose the benefit of trade-mark protection. It is confusion when they encounter the trade-marks that is relevant…
[51] I agree with Novartis that while “use” of a confusingly similar trademark is required under section 20 of the TMA, the timing of the respondents’ “use” and the timing of a consumer’s confusion upon encountering a trademark need not be aligned. It is the likelihood of confusion at the time of encounter that matters, even if that confusion is remedied by the time a consumer pays for the purchase. In Ma