Anita Gogia is an IPilogue Writer and a 2L JD Candidate at Osgoode Hall Law School.

On November 2, 2022, in the case of (“Bhagwani”), the Ontario Superior Court of Justice upheld trademark principles which state that an enforceable right does not exist on the mere filing of a trademark application absent use of the mark.

In Bhagwani, the divisional court an injunction prohibiting Bhagwani from using “Bombay Frankie” in any restaurant they operate. The motion judge had to 2788610 Ontario Inc. because it was the first to file a trademark application for “Bombay Frankies” despite not having yet used the mark. The divisional court reversed this decision and held that an applicant cannot sue for trademark infringement until the . If they are to sue for passing off when registration is pending, they cannot do so successfully unless the mark has developed goodwill.

2788610 Ontario Inc. applied to register the mark in October 2020 but that application had yet to be examined, approved, or advertised. It was in the process of developing a franchise system of restaurants but had not opened or advertised any restaurant or obtained any reputation associated with the mark. In contrast, Bhagwani had on various menu items and to register “Bombay Frankie” in 2021. They also opened two restaurants with the “Bombay Frankie” name.

In granting the injunction, the motion judge applied the :

• First, a serious issue to be tried is present. The issue is whether 2788610 Ontario Inc.’s entitlement to the trademark manifests on the application date or registration date. The judge accepted that this is a novel claim and to establish a “serious issue to be tried”.
• Second, the judge held that 2788610 Ontario Inc. would suffer irreparable harm that is not compensable without the injunction. The judge concluded that Bhagwani would have a significant advantage if they continued operation with the marks in issue on their restaurants.
• Third, the balance of convenience favoured the granting of an injunction.

The divisional court reviewed the motion judge's decision on a standard of correctness because it is an error in principle attributable to the application of an . The divisional court applied the test in accordance with established trademark principles:

• First, in finding a serious issue to be tried, the motion judge incorrectly concluded that 2788610 Ontario Inc. had a right to the marks by virtue of the trademark application or that its trademark would be registered (both errors of law). Per , a trademark must be registered to give rise to a cause of action. There is no certainty that 2788610 Ontario Inc.’s application will be granted. In considering a possibility of a passing off claim, the court upheld that to establish passing-off per , 2788610 Ontario Inc. must have shown existing goodwill. While 2788610 Ontario Inc. was engaged in start-up activities, those per the jurisprudence. In this analysis, the court notably recognized that goodwill could exist from the perspective of potential franchisees (but was not established on the facts of this case).
• Second, the court held that the motion judge made a by ruling that 2788610 Ontario Inc. would suffer irreparable harm without an injunction because the loss of goodwill , only established by clear evidence. The cause of action protects existing, not potential goodwill. The court cited , noting that confusion does not per se result in “irreparable harm not compensable in damages.” Irreparable harm is a high bar.
• Third, although the divisional court did not consider the balance of convenience, the court did note that such consideration may favour Bhagwani, who had to remove signs, website content, and social media accounts bearing the “Bombay Frankie” name.

The post The “Bombay Frankie” Confirms That First Mover’s Advantage Remains Without Enforceable Trademark Rights appeared first on IPOsgoode.

Telmisartan is a pharmaceutical used in the management of hypertension. It is marketed under the trade name Micardis, but several generic versions are also available. In an effort to obtain a Notice of Compliance and market its generic version of Micardis, Apo-Telmisartan, Apotex submitted an Abbreviated New Drug Submission (ANDS) on December 16, 2010. The main requirement of an ANDS is that the manufacturer of the drug demonstrate that the new drug is the "pharmaceutical equivalent" of a Canadian Reference Product (CRP) which is usually a brand-name drug, in this case Micardis (). "Pharmaceutical equivalent" is defined as a new drug that, in comparison with another drug, contains identical amounts of the "identical medicinal ingredients", in comparable dosage forms, but does not necessarily contain the same non-medicinal ingredients ().

However, over a series of correspondences and meetings between Apotex and the TPD, a decision to reject the ANDS was finalized on April 12, 2012. The reasoning of the TPD was that Micardis and Apo-Telmisartan did not contain "identical medicinal ingredients" and were therefore not "pharmaceutically equivalent".

The only medical input ingredient in Micardis is telmisartan, a carboxylic acid. However, Micardis also contains the non-medical ingredient sodium hydroxide. During the wet granulation process employed during manufacturing, an acid-base reaction occurs between telmisartan and sodium hydroxide. As a result, the form found in the final drug product is, in fact, the salt telmisartan-sodium.

Similar to Micardis, Apo-Telmisartan contains telmisartan as the sole medical input ingredient and makes use of a wet granulation process during manufacturing. However, Apo-Telmisartan employs potassium hydroxide as an excipient (non-medical ingredient). Apotex claimed that no acid-base reaction occurs between telmisartan and potassium hydroxide and the form found in the final drug product is telmisartan and not the salt telmisartan-potassium. The TPD concluded it was unclear from the data whether the final product contained the free acid form of telmisartan or a mixture of the potassium salt and the free carboxylic acid.

Although the Health Canada Policy on "" clearly provides that different complexes, esters, or salts of the same active moiety are considered non-identical, it does not indicate at what time (input or final product) the issue of identicalness should be addressed.

The TPD took the position that "identical medicinal ingredient" refers to the active substances as they appear in the final product and not the input ingredients. Therefore, the finished product in Apo-Telmisartan is either telmisartan or telmisartan-potassium, neither of which is identical to the CRP Micardis (telmisartan-sodium).

Apotex asserted that "identical medicinal ingredient" should assess whether the input ingredients were the same. Under this interpretation, as the input ingredient is telmisartan in both cases, Micardis and Apo-Telmisartan would be "pharmaceutically equivalent".

Ruling in favour of Apotex's position, Justice Kane relied on several fundamental principles of statutory interpretation to resolve the issue. Looking at the ordinary interpretation of the word "ingredients", the original ingredients remain ingredients and are not referred to as the possible mixtures they might become. The judge uses a baking analogy where egg whites and sugar are used to create a meringue for a pie. If someone was asked what the ingredients were in the pie, the answer would not be meringue, but would be sugar and egg whites. In addition, of the FDR requires the manufacturer to provide samples of the ingredients of the new drug and samples of the new drug in dosage form. This suggests that "ingredients" refers to something other than the final dosage form as they are listed separately.

Although I agree that there is a lack of clarity in the definition of the term "identical medicinal ingredients", I was at first concerned that interpreting "identical medicinal ingredient" as the input ingredient and not the final dosage form could lead to some safety issues. As the neutral form and salt form of a compound can often have different properties, finding an input ingredient "pharmaceutically equivalent" to a CRP only to have that ingredient converted to a different compound during manufacturing could lead to a compound for which the safety and efficacy has not yet been verified. However, in this case Apotex supplied evidence that there was no safety concern involving the use of potassium hydroxide as an excipient and furthermore, the Director General of the TPD could assess the safety and effectiveness of the final product during the next stages of approval. After Justice Kane's judicial review of the matter, it appears as though "identical medicinal ingredient" refers to the input ingredient and not the final product. For now, that's how this cookie has crumbled.

Corey McClary is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

The post "Meringue" is not an Ingredient in Lemon Meringue Pie: Defining "Identical Medicinal Ingredient" appeared first on IPOsgoode.