1 Jul
2017

Pharmaceutical brands in the Americas: practical strategies for a fast-moving sector

Experts from Canada, the United States and Venezuela discuss cutting-edge strategies for the creation, protection and exploitation of brands in the pharmaceutical industry

Pharmaceutical companies operate in a highly regulated sector, in which industry-specific rules need to be navigated alongside trademark regulations as brands are developed, launched and protected. With this in mind, World Trademark Review has assembled a panel of experts from across the globe – Sebastián González Yanes from Citemark International in Venezuela; Keith Barritt and Robert O’Connell from Fish & Richardson in the United States; and Canadian firm Smart & Biggar/Fetherstonhaugh’s Timothy O Stevenson – to discuss how best to navigate the complex regulatory environment, enhance protection and ensure that obstacles to commercialisation are overcome.

Let us start at the beginning of brand creation. At what stage should the naming process begin and when should the legal team get involved?

Sebastián González Yanes (SGY): The complex process of name creation and selection requires that lists of tentative names first be reviewed from a regulatory point of view in key markets, with close attention paid to regional differences and any linguistic and cultural negative connotations. It is then possible to proceed with clearance and availability searches in markets of interest before covering other regions and secondary markets. My recommendation is to have the legal team work together with the naming agencies to draw up an initial brief and then to get more involved once the first tentative lists are available, so that they can exclude any names which do not meet regulatory requirements, as well as any that are likely to fall within absolute grounds for refusal. The legal team can then prepare a search strategy, review opinion reports and narrow down the list to a small number of candidates, along with some back-ups. In certain jurisdictions, such as Venezuela, the use of large numbers of back-up trademarks must be carefully considered due to the high final registration fees. However, recent changes include the substantive examination of applications, together with a formalities check. This means that if a trademark is going to be refused for formal reasons, this decision will issue at an early stage, allowing the applicant to abandon the application without incurring further expenses.

Timothy O Stevenson (TOS): As with any new brand development, I would say that it is advisable to include trademark counsel in the process as early as possible – particularly in the form of registrability and freedom to use searches for marks that are of serious interest. This helps to avoid resources being expended on trademarks which are obviously problematic or high risk. In many jurisdictions, including Canada, brand owners in the pharmaceutical industry must consider possible trademark confusion with other brands, as well as compliance with health regulatory regimes designed to prevent patient confusion over the names of medications. This often involves searching (and sometimes applying) for several different marks for a single product, and then abandoning those candidates for which obstacles arise. Experienced trademark counsel can help to speed up this process by highlighting the relative risks of various options, as well as coordinating the timing of the various trademark application steps with the regulatory approval timeline for the pharmaceutical product.

Robert O’Connell (ROC): I would answer both questions the same: as early as possible. Name selection and clearance can take a long time, particularly if input from a lot of stakeholders must be factored in. You want ample time to develop and vet lists of potential names, narrow them down to smaller lists of finalists and get those finalists moving towards approval at both the US Patent and Trademark Office (USPTO) and applicable regulators. This can take many months. Regarding when to get trademark counsel involved, I would say right at the beginning, together with regulatory counsel. I always preach to my clients that having trademark counsel involved early on actually saves money and time. Experienced counsel can suggest time-tested processes for the efficient clearance of proposed marks and steer a client away from names which will be non-starters before too much time and resources (and emotion) are invested in them.

How realistic an option are non-traditional marks, such as colour and shape marks, for pharmaceutical trademarks in your jurisdiction?

Keith Barritt (KB): In the United States, the colour or shape of a pharmaceutical product can be protected as a trademark if the applicant can show that it has acquired distinctiveness over time such that consumers have come to associate it with a single source. This can be particularly difficult for colour, as consumers may associate the colour as a feature of the drug itself, regardless of the manufacturer. Some courts are reluctant to grant protection to colours for pharmaceuticals out of fear of patient confusion and anxiety. Some courts have even deemed colour functional for pharmaceuticals. To establish protection, the manufacturer should embark on an aggressive marketing campaign to associate the colour or shape with a single source. Consumers need not be able to name the source, provided that they think of the colour or shape as designating a single source. A few pharmaceutical manufacturers have tried to establish protection for smells and flavours. These efforts have generally failed, as such features are not deemed to serve a trademark function or to be functional and are thus not protectable with respect to pharmaceuticals.

TOS: Under current Canadian law, it is possible to register a trademark consisting of colour as applied to the visible surface of a particular object, provided that the shape of that object is depicted in the trademark application. It is also possible to obtain a registered mark for a shape alone, which is referred to as a ‘distinguishing guise’, provided that the applicant can demonstrate that the shape has become distinctive in Canada as of the filing date. Numerous trademarks of these types have been registered for non-pharmaceutical products. However, due to the specifics of the Canadian health system and the way that Canadian courts have applied the law, registering colour and shape trademarks for drugs has proven extremely difficult. A significant hurdle is the nature of the Canadian pharmaceutical market, in which patients are closely guided by physicians and pharmacists when selecting drug treatments. This has led the Canadian courts to hold that patients generally do not perceive the colour and shape of pharmaceuticals as an indicator of a particular trade source. By way of example, in Pfizer Products Inc v Canadian Generic Pharmaceutical Assoc (2015 FC 493), the Canadian Federal Court held that the blue diamond configuration of Pfizer’s Viagra product was not distinctive in the minds of a significant proportion of physicians, pharmacists and patients.

SGY: By contrast, Venezuela’s current legislation – based on a revived law which dates back to 1956 – does not allow for the registration of non-traditional trademarks such as colours, shapes, smells, textures and sounds. This has been confirmed by local case law. However, before September 2008, Decision 486 of the Cartagena Agreement was in place; several registrations issued under this decision for non-traditional trademarks (specifically, shape and colour combinations applied to pills and shape marks involving dosage delivery devices and product containers) should remain live and enforceable. Any revision of the law – which is becoming increasingly urgent in order to adapt to modern legislation and business dynamics – will surely address the regulation of non-traditional trademarks. However, in most cases it is extremely difficult to meet evidentiary standards for distinctiveness and consumer recognition of features such as colours or shapes. Therefore, most applications will either be rejected or be vulnerable to invalidation. Packaging features of drugs involving colours and graphical configurations, when properly claimed, can be registered in Venezuela, which can be a useful way to prevent counterfeiting.

In terms of name selection and clearance, what role do regulatory authorities play in approving pharmaceutical marks?

ROC: In the United States, the primary regulator is the Food and Drug Administration (FDA), which plays a critical role. No pharmaceutical product can be sold in the United States until the name has been approved by the FDA’s Division of Medication Error Prevention and Analysis. Thus, pharmaceutical name clearance must factor in both trademark availability and FDA approval. The FDA’s approval criteria bear some similarity to the trademark standard of likelihood of confusion, but FDA review is more robust and takes into consideration factors such as whether the name falsely suggests the presence of an ingredient or makes an implicit (or explicit) claim as to efficacy. The FDA also assesses how a name sounds when spoken and how it appears when handwritten.

The FDA’s standards are not public, but it is more difficult to obtain approval at the FDA than at the USPTO. For its part, the USPTO applies heightened scrutiny to pharmaceutical trademarks, given the risks associated with accidental administration of the wrong drug. The FDA’s three-phase name approval process is entirely separate from the trademark examination process at the USPTO and works on its own timetable. The different standards employed by the agencies can sometimes result in a name being approved by the USPTO, but subsequently rejected by the FDA. While every application for a new drug name to the FDA must include a second choice, savvy brand owners will typically clear and apply for multiple options, to maximise the chances that at least one will survive both the USPTO and FDA review processes.

TOS: Health Canada similarly plays a significant role in approving drug brand names, with the policy objective of averting medication errors by ensuring that proposed names are neither misleading nor likely to be confused with other products already authorised for use in Canada. The applicant must conduct an initial brand name review, followed by a look-alike, sound-alike (LASA) brand name assessment, the results of which will be reviewed by Health Canada. The initial review assesses, among other things, whether the new name implies or suggests unsubstantiated attributes regarding efficacy, superiority, composition, route of administration or dosage form, and whether the name is identical to that of another product authorised in Canada which contains different ingredients.

The LASA assessment involves:

  • searching the proposed name against databases of existing medications, identifying names with a similarity scores of 50% or over and examining the literature to find error reports;
  • simulating medication-use scenarios (including prescription, dispensing, administration and monitoring) to evaluate the probability of errors being committed; and
  • documenting results and preparing a final report.

In addition to reviewing the evidence submitted, Health Canada will search its own drug submission tracking system to identify any names currently in the approval process which might potentially be confused with the proposed name.

SGY: In Venezuela, the Pharmaceutical Products Review Board of the National Institute of Hygiene is responsible for issuing marketing authorisation for the commercialisation, manufacture, production, distribution, import and export of pharmaceuticals. While marketing authorisation and trademark prosecution can be initiated in parallel, the board will focus mainly on consumer safety, labelling and packaging requirements, rather than on acceptance of the proposed trademark for the product to be marketed. The board has established standard and guidelines which prohibit marks that:

  • are suggestive of the therapeutic indication;
  • include the word ‘doctor’ or other academic titles;
  • are based on the product’s excipients;
  • may result in phonetic confusion with trademarks for other products;
  • contain the names or surnames of individuals, unless they are recognised in scientific literature;
  • are formed solely of initials or numbers;
  • include the names of saints or religious expressions;
  • may cause confusion about the product’s composition;
  • contain only an international non-propietary name (INN); or
  • contain a number referring to one of the active principals, where the product contains more than one active principal.

Additionally, the manufacturer or laboratory’s house mark may not be used jointly with the INN, unless it is affixed, for labelling purposes, in smaller letters below the trademark. Despite these guidelines, conflicts and refusals are rarely issued. Early involvement of legal counsel is recommended – especially when reviewing packaging, labelling and proposed trademarks and building a back-up list of other cleared trademarks.

What are the major differences in the way that trademarks are handled for prescription and over-the-counter (OTC) drugs in your jurisdiction?

TOS: From a purely trademark law perspective, in Canada, trademarks for prescription and OTC medications are generally treated in the same way in terms of the application process, registration, renewal and enforcement. The LASA brand name assessment process described opposite applies to prescription drugs and in some cases can also apply to non-prescription products regulated by Health Canada.

SGY: The Venezuela Patent and Trademark Office will examine every application in the same way. However, when evaluating the likelihood of confusion between two trademarks, the examiner will take account of consumer safety where the application contains an explicit treatment description for the product and there is a risk that confusion or error may arise in a consumer seeking to acquire a prescription-only product.

KB: Both types of trademark can be registered at the USPTO, which does not even ask about the prescription or OTC status of the drug. As Bob mentioned earlier, the FDA plays a major role in the regulation of trademarks for prescription drugs. Although it has the authority to review a proposed trademark for an OTC drug which will be marketed pursuant to a new drug application or abbreviated new drug application, because prescription drugs are generally more powerful – and potentially more harmful if taken incorrectly or if the wrong medicine is chosen – than OTC drugs, it is unsurprising that the FDA focuses on them.

When a product goes from prescription to OTC, use of the same trademark may be acceptable to the FDA if there is no change in indications, dosing or strength. However, if the OTC and prescription versions are not identical, the FDA believes that it “might be appropriate” to market the OTC product under a different or modified trademark. Many OTC drugs are marketed pursuant to prescribed ingredients and permissible indications under an FDA monograph and are not individually scrutinised by the FDA. For these, the FDA still recommends that the trademarks be evaluated by the sponsor for safety considerations.

Does your jurisdiction allow generic substitution (and are any options open to trademark owners to mitigate its impact)?

SGY: Generic substitution is encouraged when patent protection for a particular product has expired. While pharmacists must offer the generic product, prescribing physicians may explicitly instruct pharmacists that the drug cannot be substituted unless for reasons of non-availability. Health professionals must indicate the INNs or active ingredients in every prescription and the form may not include trademarks, slogans or any other distinctive elements associated with product manufacturers or distributors.

ROC: In the United States, generic substitution is not only permitted, but also strongly encouraged and sometimes required by insurers seeking to keep costs down. The FDA’s Orange Book guides doctors and pharmacists in identifying therapeutically equivalent drugs. In addition, under the federal system, the 50 states have their own laws and regulations covering how much discretion a pharmacist has in dispensing a generic drug as opposed to a branded product. Generic names of new drug compounds (also called non-proprietary names) are also subject to regulatory approval, according to analogous standards (eg, the generic name must convey the pharmacological nature of the compound, cannot misleadingly suggest the presence of an ingredient and cannot suggest efficacy). Brand names must be easily distinguishable from the generic name of the compound, in large part to make it easier for all parties to discern whether the branded or generic product is being prescribed and dispensed.

TOS: Generic substitution is similarly allowed in Canada and provincial governments have adopted policies to encourage this practice – notably through provincial reimbursement drug plans, which often refund only the price of the generic drug or the lowest-cost alternative. The Public Service Health Care Plan – a private insurance plan sponsored by the government – also practises generic substitution. When the brand name drug is the least expensive, this will usually be dispensed. Otherwise, the patient can either accept the generic alternative or request the brand name drug and pay the difference. However, if the clinician believes that a patient requires the brand name drug and specifies “no substitution” on the prescription, the plan will pay the full cost of the brand name product.

What is the current situation with regard to parallel imports as they affect the pharmaceutical industry in your jurisdiction?

TOS: While trademark infringement can be a difficult cause of action to assert in the context of grey-market goods which are in fact genuine, other causes of action can potentially be relied upon to prevent the sale of grey-market pharmaceuticals – namely, actions for copyright infringement and passing off.

Copyright may be asserted in any aspects of the pharmaceutical product packaging which constitute artistic or literary works under the Copyright Act, including the overall design of the package, the specific artwork or logos and the content of the product monograph. Due to the specific wording of the provision in the Copyright Act which addresses parallel imports, in most cases ownership of the copyright must be assigned to the brand owner’s Canadian subsidiary in order for an action for copyright infringement to succeed. An action for passing off could also be an effective approach. In such cases the plaintiff must prove three elements:

  • goodwill in the trademark;
  • misrepresentation by the defendant; and
  • damages suffered by the plaintiff resulting from the misrepresentation.

While there is no Canadian jurisprudence specific to the pharmaceutical context, the crucial misrepresentation element could be satisfied by material differences between the grey-market goods and those sold via authorised channels, such as product composition or possibly product labelling which does not comply with Canadian requirements.

SGY: Current regulations do not allow for the unauthorised parallel import of pharmaceutical products. This is because the Pharmaceutical Products Examination Board grants marketing authorisation to commercialise a pharmaceutical product only to a specific company or distributor. Thus, an additional marketing authorisation to allow the import of the same product granted in parallel to a third party will not succeed without the rights holder’s authorisation.

KB: Section 381(d) of the Food, Drug and Cosmetic Act states that prescription drugs (or drugs composed wholly or partly of insulin) made in the United States and exported to a foreign country can be re-imported by the original manufacturer only. Even when original manufacturers re-import drugs, the drugs must be real, properly handled and re-labelled for sale in the United States if necessary.

The Medicine Equity and Drug Safety Act, enacted in 2000, theoretically allows prescription drugs manufactured in the United States and exported to certain foreign countries to be re-imported from those countries for sale to US consumers. However, before the law can take effect, the secretary of health and human services must determine whether adequate safety could be maintained and whether costs could be reduced significantly – which thus far has not happened. The Food, Drug and Cosmetic Act also prohibits the import of unapproved new drugs. Unapproved new drugs include any drugs – including foreign-made versions of US approved drugs – which have not been manufactured in accordance with FDA approval. The FDA may refuse admission to any drug which appears to be unapproved, placing the burden on the importer to prove that the drug in question is in fact approved.

Turning to brand protection, what are the key enforcement challenges in your jurisdiction?

ROC: What I would broadly call ‘unauthorised products’ undoubtedly constitute the most serious challenge facing pharmaceutical companies in the US market. They may be loosely categorised as:

  • counterfeit drugs, which purport to be the genuine branded product but are not;
  • knock-off products, which purport to be cheap generic equivalents of branded products; and
  • genuine grey-market products.

Federal and state laws make it impossible to sell these products in brick-and-mortar stores, but counterfeits and knock-offs from both domestic and offshore sources are ubiquitous online. Even in the best-case scenario, where the unauthorised product is genuine or a true therapeutic equivalent, such goods rob brand owners of sales. However, a far greater danger is posed by the fact that these products are usually not genuine, are not manufactured to professional standards and may often be unsafe. They thus pose a serious public health risk and can do great harm to a brand’s reputation and goodwill.

Another challenge is that the limited duration of US patents and the significant costs of developing new drugs place tremendous pressure on branded pharma companies to maximise returns for products during the term of the patent – and beyond. Brand owners spend vast sums on developing comprehensive branding programmes for their major products (involving not just the drug name, but often a logo and the colour and shape of the pill or dispenser). Those branding elements are then aggressively enforced – not only during the patent term, but also thereafter to raise additional barriers to generic competitors.

SGY: In Venezuela, the most important issues in enforcement relate to delays in responses from the authorities and courts in processing certain actions and issuing preliminary injunctions, especially when these involve risks to public safety. Customs authorities and the police require more education and encouragement so that they can work together with rights holders to detect pharmaceutical counterfeiting at the borders or during transit.

TOS: Historically, the most significant enforcement challenge in Canada for brand owners seeking to assert their IP rights has been the reluctance of Canadian courts to grant interlocutory injunctions (ie, to enjoin the defendant from selling the infringing product before trial). However, jurisprudence in the Canadian Federal Court from the past two years suggests that willingness to grant interlocutory injunctions in trademark infringement actions may be increasing. The three-part test to obtain an interlocutory injunction in Canada is as follows:

  • There is a serious question to be tried;
  • The plaintiff will suffer irreparable harm if an injunction is not granted; and
  • The balance of convenience favours the grant of an injunction.

The irreparable harm criterion – which requires the plaintiff to demonstrate that the harm caused cannot be satisfied by a damages award – has historically been difficult to meet. However, two recent Canadian Federal Court decisions in which interlocutory injunctions were granted in trademark cases – Reckitt Benckiser LLC v Jamieson Laboratories Ltd (2015 FC 215) and Sleep Country Canada Inc v Sears Canada Inc (2017 FC 148) – suggest that the courts may be relaxing this standard somewhat and that interlocutory injunctions may once again be available in appropriate circumstances.

Are there restrictions on pharmaceutical-related advertising in your jurisdiction?

TOS: The Canadian Food and Drugs Act contains a general prohibition against advertising “any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety”. In advertising materials for prescription drugs aimed at the general public, no representations can be made “other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug”.

In addition, the act prohibits the advertisement of “any food, drug, cosmetic or device to the general public as a treatment, preventive or cure for any diseases, disorders or abnormal physical states referred to in Schedule A”, which includes a wide range of conditions, from asthma and diabetes to depression, hepatitis and cancer. However, consumer-directed ads for OTC drugs and natural health products which treat conditions not listed in Schedule A and which are truthful and accurate may be permitted, provided that they comply with Health Canada’s Consumer Advertising Guidelines for Marketed Health Products and are reviewed and pre-cleared by independent agencies. Finally, advertising materials directed to health professionals must be reviewed and pre-cleared by the Pharmaceutical Advertising Advisory Board.

KB: The FDA’s Office of Prescription Drug Promotion oversees prescription drug advertising by looking for and taking action against ads which violate the law, educating industry and others about the specifics of the law and encouraging better communication of promotional information provided both to healthcare professionals and to consumers. Ads for prescription drugs must be accurate and not misleading. Following recent losses in court over how much information a manufacturer may provide regarding unapproved so-called ‘off-label’ uses of its drug products, in early 2017 the FDA released multiple draft guidance documents seeking public input on how to regulate appropriately in this area while still respecting manufacturers’ free speech rights. Thus, this area of law is in flux, with cracks appearing in the FDA’s traditional role as the sole gatekeeper of what information can be disseminated about use of a particular drug.

The United States allows direct-to-consumer advertising on television and radio for prescription pharmaceuticals. Such ads must include information about the risks of the drug and where more information can be obtained. The Federal Trade Commission (FTC) has authority over advertising of OTC drugs. Under FTC regulations, claims for OTC drugs must be truthful and non-deceptive. Depending on the claim, advertisers may be required to back up their representations with competent and reliable scientific evidence, including tests, studies or other objective data.

SGY: Statutory regulations for advertisement are set out in Ministry of Health Resolution 252/2004. OTC products can be openly advertised and promoted in any medium upon approval from the Pharmaceuticals Review Board, provided that all advertising complies with the data inclusion requirements and proper statements required by regulations. Ad reviews are conducted after the marketing authorisation has been validly issued. In the case of prescription drugs, promotion is restricted to ‘health professionals’, as defined by law. Ads and promotions presented for approval may be rejected if:

  • they constitute or result in an act of unfair competition;
  • they contain statements which may be considered misleading;
  • they make use of the term ‘quality’ with regard to the product’s characteristics and properties;
  • they use the term ‘innocuous’ in relation to the product’s use; or
  • they promote self-medication.

Turning to the online world, do pharmaceutical brand owners face particular online challenges and how should these be overcome?

SGY: E-pharmacies are not currently permitted in Venezuela, but the open exchange of pharmaceutical products through online marketplaces is of major concern – especially since many of the products sold in this way blatantly lack marketing protection. This is a growing trend, although it is closely monitored by the authorities, which are willing to collaborate in investigations and takedown proceedings. Another ever-present threat is cybersquatting. Domain name availability assessments, including defensive registrations, should thus be included as a high priority at the early stages of name evaluation.

ROC: As mentioned earlier, counterfeit and knock-off products are widely available on the Internet. The fly-by-night nature of these operations makes enforcement a frustrating and expensive endeavour. Brand owners must have comprehensive and sophisticated online monitoring programmes, and must also work closely with law enforcement and customs authorities in the ongoing effort to stem the tide of unsafe and fake products.

TOS: Due to the price control on drugs (with the Patented Medicines Prices Review Board setting a maximum price for patented drugs in Canada), pharmaceuticals often cost less in Canada than in the United States. This has led to a boom in online pharmacies – specifically, Canadian businesses which sell pharmaceuticals online primarily to US customers, usually at a price somewhere between the Canadian and US prices. Pharmaceutical companies may consider taking legal action against internet pharmacies where unauthorised or illegal versions of their products are sold online. For example, internet pharmacies may engage in the parallel import of pharmaceuticals, for which the strategies discussed above may be appropriate.

Are there any other issues which you would like to raise with respect the creation and protection of pharmaceutical brands in your jurisdiction?

KB: Some countries have shown hostility to pharmaceutical trademarks – for example, by requiring use of generic names only when prescribing, viewing the trademark as something which allows a manufacturer to artificially inflate the price of a drug once it is off-patent and subject to generic competition. Some states allow (or even require) generic drugs to bear the pioneer drug trademark. However, in general, the United States still has a robust system in place for protecting the integrity of pharmaceutical trademarks. While generic names play a role in providing consistent terminology for certain compounds, trademarks enhance public health by assisting health professionals, reducing medication errors and enabling consumers to better recall what medication they took in the event of an adverse reaction. Generic names may be unique, but that does not necessarily mean that they are distinctive. Indeed, because drugs in the same class share the same stem, there is a degree of built-in similarity between generic names for pharmaceuticals in the same class. Such similarities can be useful to healthcare practitioners when it comes to identifying the pharmacological properties of a particular drug. However, requiring prescriptions to bear generic names only would create its own type of potential confusion, as many healthcare practitioners might encounter difficulty remembering or properly spelling such names, and would more likely be confused by the close similarity of many generic names, resulting in more errors.

TOS: From a Canadian perspective, the well-established test for whether two trademarks are confusing is one of a likelihood of confusion that the products bearing the respective parties’ marks come from the same source. The test is not a mere possibility of confusion, but focuses on confusion in a trademark sense – in other words, that the two marks would indicate the same source. During the examination of trademark applications relating to pharmaceuticals, examiners at the Canadian Trademarks Office occasionally appear to apply a different confusion test, seemingly in the interest of preventing “any possibility of confusion” in the realm of pharmaceuticals because of the health and safety issues relating to medicines. However, as discussed above, Canada already has an extensive regulatory regime dedicated to preventing patient confusion from a health and safety perspective, and the Canadian Trademarks Office’s role is to analyse confusion from a trademark (ie, indication of source) perspective. In these circumstances, detailed legal arguments may be required in order to overcome examiners’ objections when the mark applied for and the cited mark both relate to pharmaceuticals.

SGY: The non-availability of numerous drugs, pharmaceutical products and medical devices in the Venezuelan market due to difficulties which have arisen as a consequence of local currency exchange regulations, as well as the country’s political and economic situation, directly affects production facilities and import activities. Counterfeiting, repackaging and product tampering have increased considerably as a result, representing a challenge for brand owners to monitor, detect and then proceed with adequate and effective enforcement.

Citemark International IP
Sebastián González Yanes

Partner

sgonzalez@citemark.com

Sebastián González Yanes has a law degree from Andrés Bello Catholic University (Venezuela) and a master’s in IP law from the University of Alicante (Spain). His practice focuses on trademarks, designs and patents, and includes portfolio management, drafting of freedom to operate and clearance opinions, prosecution, opposition and invalidation. He also has significant experience in counselling on complex IP conflicts and protection and enforcement strategies in diverse fields, including pharmaceuticals and life sciences.

Fish & Richardson
Robert O’Connell

Of counsel

oconnell@fr.com

Robert O’Connell is of counsel in the Boston office of Fish & Richardson. His practice focuses on trademark and copyright strategic advice and prosecution and enforcement, including all aspects of domestic and international trademark law, registration and protection of copyright, online protection, clearance and selection of pharmaceutical names, licensing and technology transfer agreements and other IP-intensive transactions. Mr O’Connell has experience in developing and implementing cost-effective domestic and global branding and trademark protection plans for businesses ranging from small start-ups to multibillion-dollar corporations, with particular expertise in the financial services, food and pharmaceutical industries.

Fish & Richardson
Keith A Barritt

Principal

barritt@fr.com

Keith A Barritt is a principal in the Washington DC office of Fish & Richardson. His practice is primarily focused on all aspects of trademark law, including prosecution and inter partes proceedings before the US Patent and Trademark Office, domain name issues and trademark selection and enforcement, as well as all aspects of medical device regulation by the US Food and Drug Administration, including obtaining marketing authorisation for medical devices, use of new devices for investigational purposes, and import and export issues. He has been recognised by the WTR 1000 for trademark prosecution and strategy in the DC Metro area since 2014.

Smart & Biggar/Fetherstonhaugh
Timothy O Stevenson

Partner

tostevenson@smart-biggar.ca

Timothy Stevenson is a partner at Smart & Biggar’s Ottawa office. His practice focuses on trademarks and strategic brand management. Mr Stevenson has over a decade of experience in representing some of the world’s most famous brands across a variety of industries, including pharmaceuticals, electronics, consumer goods manufacturing, restaurants and food and beverages. His practice addresses all aspects of the trademark lifecycle, including clearance, prosecution, cancellation, opposition and enforcement. In contentious matters, Mr Stevenson has successfully represented clients before the Trademarks Opposition Board, the Federal Court and the Federal Court of Appeal.

Pharmaceutical companies operate in a highly regulated sector, in which industry-specific rules need to be navigated alongside trademark regulations as brands are developed, launched and protected. With this in mind, World Trademark Review has assembled a panel of experts from across the globe – Sebastián González Yanes from Citemark International in Venezuela; Keith Barritt and Robert O’Connell from Fish & Richardson in the United States; and Canadian firm Smart & Biggar/Fetherstonhaugh’s Timothy O Stevenson – to discuss how best to navigate the complex regulatory environment, enhance protection and ensure that obstacles to commercialisation are overcome.

Let us start at the beginning of brand creation. At what stage should the naming process begin and when should the legal team get involved?

Sebastián González Yanes (SGY): The complex process of name creation and selection requires that lists of tentative names first be reviewed from a regulatory point of view in key markets, with close attention paid to regional differences and any linguistic and cultural negative connotations. It is then possible to proceed with clearance and availability searches in markets of interest before covering other regions and secondary markets. My recommendation is to have the legal team work together with the naming agencies to draw up an initial brief and then to get more involved once the first tentative lists are available, so that they can exclude any names which do not meet regulatory requirements, as well as any that are likely to fall within absolute grounds for refusal. The legal team can then prepare a search strategy, review opinion reports and narrow down the list to a small number of candidates, along with some back-ups. In certain jurisdictions, such as Venezuela, the use of large numbers of back-up trademarks must be carefully considered due to the high final registration fees. However, recent changes include the substantive examination of applications, together with a formalities check. This means that if a trademark is going to be refused for formal reasons, this decision will issue at an early stage, allowing the applicant to abandon the application without incurring further expenses.

Timothy O Stevenson (TOS): As with any new brand development, I would say that it is advisable to include trademark counsel in the process as early as possible – particularly in the form of registrability and freedom to use searches for marks that are of serious interest. This helps to avoid resources being expended on trademarks which are obviously problematic or high risk. In many jurisdictions, including Canada, brand owners in the pharmaceutical industry must consider possible trademark confusion with other brands, as well as compliance with health regulatory regimes designed to prevent patient confusion over the names of medications. This often involves searching (and sometimes applying) for several different marks for a single product, and then abandoning those candidates for which obstacles arise. Experienced trademark counsel can help to speed up this process by highlighting the relative risks of various options, as well as coordinating the timing of the various trademark application steps with the regulatory approval timeline for the pharmaceutical product.

Robert O’Connell (ROC): I would answer both questions the same: as early as possible. Name selection and clearance can take a long time, particularly if input from a lot of stakeholders must be factored in. You want ample time to develop and vet lists of potential names, narrow them down to smaller lists of finalists and get those finalists moving towards approval at both the US Patent and Trademark Office (USPTO) and applicable regulators. This can take many months. Regarding when to get trademark counsel involved, I would say right at the beginning, together with regulatory counsel. I always preach to my clients that having trademark counsel involved early on actually saves money and time. Experienced counsel can suggest time-tested processes for the efficient clearance of proposed marks and steer a client away from names which will be non-starters before too much time and resources (and emotion) are invested in them.

How realistic an option are non-traditional marks, such as colour and shape marks, for pharmaceutical trademarks in your jurisdiction?

Keith Barritt (KB): In the United States, the colour or shape of a pharmaceutical product can be protected as a trademark if the applicant can show that it has acquired distinctiveness over time such that consumers have come to associate it with a single source. This can be particularly difficult for colour, as consumers may associate the colour as a feature of the drug itself, regardless of the manufacturer. Some courts are reluctant to grant protection to colours for pharmaceuticals out of fear of patient confusion and anxiety. Some courts have even deemed colour functional for pharmaceuticals. To establish protection, the manufacturer should embark on an aggressive marketing campaign to associate the colour or shape with a single source. Consumers need not be able to name the source, provided that they think of the colour or shape as designating a single source. A few pharmaceutical manufacturers have tried to establish protection for smells and flavours. These efforts have generally failed, as such features are not deemed to serve a trademark function or to be functional and are thus not protectable with respect to pharmaceuticals.

TOS: Under current Canadian law, it is possible to register a trademark consisting of colour as applied to the visible surface of a particular object, provided that the shape of that object is depicted in the trademark application. It is also possible to obtain a registered mark for a shape alone, which is referred to as a ‘distinguishing guise’, provided that the applicant can demonstrate that the shape has become distinctive in Canada as of the filing date. Numerous trademarks of these types have been registered for non-pharmaceutical products. However, due to the specifics of the Canadian health system and the way that Canadian courts have applied the law, registering colour and shape trademarks for drugs has proven extremely difficult. A significant hurdle is the nature of the Canadian pharmaceutical market, in which patients are closely guided by physicians and pharmacists when selecting drug treatments. This has led the Canadian courts to hold that patients generally do not perceive the colour and shape of pharmaceuticals as an indicator of a particular trade source. By way of example, in Pfizer Products Inc v Canadian Generic Pharmaceutical Assoc (2015 FC 493), the Canadian Federal Court held that the blue diamond configuration of Pfizer’s Viagra product was not distinctive in the minds of a significant proportion of physicians, pharmacists and patients.

SGY: By contrast, Venezuela’s current legislation – based on a revived law which dates back to 1956 – does not allow for the registration of non-traditional trademarks such as colours, shapes, smells, textures and sounds. This has been confirmed by local case law. However, before September 2008, Decision 486 of the Cartagena Agreement was in place; several registrations issued under this decision for non-traditional trademarks (specifically, shape and colour combinations applied to pills and shape marks involving dosage delivery devices and product containers) should remain live and enforceable. Any revision of the law – which is becoming increasingly urgent in order to adapt to modern legislation and business dynamics – will surely address the regulation of non-traditional trademarks. However, in most cases it is extremely difficult to meet evidentiary standards for distinctiveness and consumer recognition of features such as colours or shapes. Therefore, most applications will either be rejected or be vulnerable to invalidation. Packaging features of drugs involving colours and graphical configurations, when properly claimed, can be registered in Venezuela, which can be a useful way to prevent counterfeiting.

In terms of name selection and clearance, what role do regulatory authorities play in approving pharmaceutical marks?

ROC: In the United States, the primary regulator is the Food and Drug Administration (FDA), which plays a critical role. No pharmaceutical product can be sold in the United States until the name has been approved by the FDA’s Division of Medication Error Prevention and Analysis. Thus, pharmaceutical name clearance must factor in both trademark availability and FDA approval. The FDA’s approval criteria bear some similarity to the trademark standard of likelihood of confusion, but FDA review is more robust and takes into consideration factors such as whether the name falsely suggests the presence of an ingredient or makes an implicit (or explicit) claim as to efficacy. The FDA also assesses how a name sounds when spoken and how it appears when handwritten.

The FDA’s standards are not public, but it is more difficult to obtain approval at the FDA than at the USPTO. For its part, the USPTO applies heightened scrutiny to pharmaceutical trademarks, given the risks associated with accidental administration of the wrong drug. The FDA’s three-phase name approval process is entirely separate from the trademark examination process at the USPTO and works on its own timetable. The different standards employed by the agencies can sometimes result in a name being approved by the USPTO, but subsequently rejected by the FDA. While every application for a new drug name to the FDA must include a second choice, savvy brand owners will typically clear and apply for multiple options, to maximise the chances that at least one will survive both the USPTO and FDA review processes.

TOS: Health Canada similarly plays a significant role in approving drug brand names, with the policy objective of averting medication errors by ensuring that proposed names are neither misleading nor likely to be confused with other products already authorised for use in Canada. The applicant must conduct an initial brand name review, followed by a look-alike, sound-alike (LASA) brand name assessment, the results of which will be reviewed by Health Canada. The initial review assesses, among other things, whether the new name implies or suggests unsubstantiated attributes regarding efficacy, superiority, composition, route of administration or dosage form, and whether the name is identical to that of another product authorised in Canada which contains different ingredients.

The LASA assessment involves:

  • searching the proposed name against databases of existing medications, identifying names with a similarity scores of 50% or over and examining the literature to find error reports;
  • simulating medication-use scenarios (including prescription, dispensing, administration and monitoring) to evaluate the probability of errors being committed; and
  • documenting results and preparing a final report.

In addition to reviewing the evidence submitted, Health Canada will search its own drug submission tracking system to identify any names currently in the approval process which might potentially be confused with the proposed name.

SGY: In Venezuela, the Pharmaceutical Products Review Board of the National Institute of Hygiene is responsible for issuing marketing authorisation for the commercialisation, manufacture, production, distribution, import and export of pharmaceuticals. While marketing authorisation and trademark prosecution can be initiated in parallel, the board will focus mainly on consumer safety, labelling and packaging requirements, rather than on acceptance of the proposed trademark for the product to be marketed. The board has established standard and guidelines which prohibit marks that:

  • are suggestive of the therapeutic indication;
  • include the word ‘doctor’ or other academic titles;
  • are based on the product’s excipients;
  • may result in phonetic confusion with trademarks for other products;
  • contain the names or surnames of individuals, unless they are recognised in scientific literature;
  • are formed solely of initials or numbers;
  • include the names of saints or religious expressions;
  • may cause confusion about the product’s composition;
  • contain only an international non-propietary name (INN); or
  • contain a number referring to one of the active principals, where the product contains more than one active principal.

Additionally, the manufacturer or laboratory’s house mark may not be used jointly with the INN, unless it is affixed, for labelling purposes, in smaller letters below the trademark. Despite these guidelines, conflicts and refusals are rarely issued. Early involvement of legal counsel is recommended – especially when reviewing packaging, labelling and proposed trademarks and building a back-up list of other cleared trademarks.

What are the major differences in the way that trademarks are handled for prescription and over-the-counter (OTC) drugs in your jurisdiction?

TOS: From a purely trademark law perspective, in Canada, trademarks for prescription and OTC medications are generally treated in the same way in terms of the application process, registration, renewal and enforcement. The LASA brand name assessment process described opposite applies to prescription drugs and in some cases can also apply to non-prescription products regulated by Health Canada.

SGY: The Venezuela Patent and Trademark Office will examine every application in the same way. However, when evaluating the likelihood of confusion between two trademarks, the examiner will take account of consumer safety where the application contains an explicit treatment description for the product and there is a risk that confusion or error may arise in a consumer seeking to acquire a prescription-only product.

KB: Both types of trademark can be registered at the USPTO, which does not even ask about the prescription or OTC status of the drug. As Bob mentioned earlier, the FDA plays a major role in the regulation of trademarks for prescription drugs. Although it has the authority to review a proposed trademark for an OTC drug which will be marketed pursuant to a new drug application or abbreviated new drug application, because prescription drugs are generally more powerful – and potentially more harmful if taken incorrectly or if the wrong medicine is chosen – than OTC drugs, it is unsurprising that the FDA focuses on them.

When a product goes from prescription to OTC, use of the same trademark may be acceptable to the FDA if there is no change in indications, dosing or strength. However, if the OTC and prescription versions are not identical, the FDA believes that it “might be appropriate” to market the OTC product under a different or modified trademark. Many OTC drugs are marketed pursuant to prescribed ingredients and permissible indications under an FDA monograph and are not individually scrutinised by the FDA. For these, the FDA still recommends that the trademarks be evaluated by the sponsor for safety considerations.

Does your jurisdiction allow generic substitution (and are any options open to trademark owners to mitigate its impact)?

SGY: Generic substitution is encouraged when patent protection for a particular product has expired. While pharmacists must offer the generic product, prescribing physicians may explicitly instruct pharmacists that the drug cannot be substituted unless for reasons of non-availability. Health professionals must indicate the INNs or active ingredients in every prescription and the form may not include trademarks, slogans or any other distinctive elements associated with product manufacturers or distributors.

ROC: In the United States, generic substitution is not only permitted, but also strongly encouraged and sometimes required by insurers seeking to keep costs down. The FDA’s Orange Book guides doctors and pharmacists in identifying therapeutically equivalent drugs. In addition, under the federal system, the 50 states have their own laws and regulations covering how much discretion a pharmacist has in dispensing a generic drug as opposed to a branded product. Generic names of new drug compounds (also called non-proprietary names) are also subject to regulatory approval, according to analogous standards (eg, the generic name must convey the pharmacological nature of the compound, cannot misleadingly suggest the presence of an ingredient and cannot suggest efficacy). Brand names must be easily distinguishable from the generic name of the compound, in large part to make it easier for all parties to discern whether the branded or generic product is being prescribed and dispensed.

TOS: Generic substitution is similarly allowed in Canada and provincial governments have adopted policies to encourage this practice – notably through provincial reimbursement drug plans, which often refund only the price of the generic drug or the lowest-cost alternative. The Public Service Health Care Plan – a private insurance plan sponsored by the government – also practises generic substitution. When the brand name drug is the least expensive, this will usually be dispensed. Otherwise, the patient can either accept the generic alternative or request the brand name drug and pay the difference. However, if the clinician believes that a patient requires the brand name drug and specifies “no substitution” on the prescription, the plan will pay the full cost of the brand name product.

What is the current situation with regard to parallel imports as they affect the pharmaceutical industry in your jurisdiction?

TOS: While trademark infringement can be a difficult cause of action to assert in the context of grey-market goods which are in fact genuine, other causes of action can potentially be relied upon to prevent the sale of grey-market pharmaceuticals – namely, actions for copyright infringement and passing off.

Copyright may be asserted in any aspects of the pharmaceutical product packaging which constitute artistic or literary works under the Copyright Act, including the overall design of the package, the specific artwork or logos and the content of the product monograph. Due to the specific wording of the provision in the Copyright Act which addresses parallel imports, in most cases ownership of the copyright must be assigned to the brand owner’s Canadian subsidiary in order for an action for copyright infringement to succeed. An action for passing off could also be an effective approach. In such cases the plaintiff must prove three elements:

  • goodwill in the trademark;
  • misrepresentation by the defendant; and
  • damages suffered by the plaintiff resulting from the misrepresentation.

While there is no Canadian jurisprudence specific to the pharmaceutical context, the crucial misrepresentation element could be satisfied by material differences between the grey-market goods and those sold via authorised channels, such as product composition or possibly product labelling which does not comply with Canadian requirements.

SGY: Current regulations do not allow for the unauthorised parallel import of pharmaceutical products. This is because the Pharmaceutical Products Examination Board grants marketing authorisation to commercialise a pharmaceutical product only to a specific company or distributor. Thus, an additional marketing authorisation to allow the import of the same product granted in parallel to a third party will not succeed without the rights holder’s authorisation.

KB: Section 381(d) of the Food, Drug and Cosmetic Act states that prescription drugs (or drugs composed wholly or partly of insulin) made in the United States and exported to a foreign country can be re-imported by the original manufacturer only. Even when original manufacturers re-import drugs, the drugs must be real, properly handled and re-labelled for sale in the United States if necessary.

The Medicine Equity and Drug Safety Act, enacted in 2000, theoretically allows prescription drugs manufactured in the United States and exported to certain foreign countries to be re-imported from those countries for sale to US consumers. However, before the law can take effect, the secretary of health and human services must determine whether adequate safety could be maintained and whether costs could be reduced significantly – which thus far has not happened. The Food, Drug and Cosmetic Act also prohibits the import of unapproved new drugs. Unapproved new drugs include any drugs – including foreign-made versions of US approved drugs – which have not been manufactured in accordance with FDA approval. The FDA may refuse admission to any drug which appears to be unapproved, placing the burden on the importer to prove that the drug in question is in fact approved.

Turning to brand protection, what are the key enforcement challenges in your jurisdiction?

ROC: What I would broadly call ‘unauthorised products’ undoubtedly constitute the most serious challenge facing pharmaceutical companies in the US market. They may be loosely categorised as:

  • counterfeit drugs, which purport to be the genuine branded product but are not;
  • knock-off products, which purport to be cheap generic equivalents of branded products; and
  • genuine grey-market products.

Federal and state laws make it impossible to sell these products in brick-and-mortar stores, but counterfeits and knock-offs from both domestic and offshore sources are ubiquitous online. Even in the best-case scenario, where the unauthorised product is genuine or a true therapeutic equivalent, such goods rob brand owners of sales. However, a far greater danger is posed by the fact that these products are usually not genuine, are not manufactured to professional standards and may often be unsafe. They thus pose a serious public health risk and can do great harm to a brand’s reputation and goodwill.

Another challenge is that the limited duration of US patents and the significant costs of developing new drugs place tremendous pressure on branded pharma companies to maximise returns for products during the term of the patent – and beyond. Brand owners spend vast sums on developing comprehensive branding programmes for their major products (involving not just the drug name, but often a logo and the colour and shape of the pill or dispenser). Those branding elements are then aggressively enforced – not only during the patent term, but also thereafter to raise additional barriers to generic competitors.

SGY: In Venezuela, the most important issues in enforcement relate to delays in responses from the authorities and courts in processing certain actions and issuing preliminary injunctions, especially when these involve risks to public safety. Customs authorities and the police require more education and encouragement so that they can work together with rights holders to detect pharmaceutical counterfeiting at the borders or during transit.

TOS: Historically, the most significant enforcement challenge in Canada for brand owners seeking to assert their IP rights has been the reluctance of Canadian courts to grant interlocutory injunctions (ie, to enjoin the defendant from selling the infringing product before trial). However, jurisprudence in the Canadian Federal Court from the past two years suggests that willingness to grant interlocutory injunctions in trademark infringement actions may be increasing. The three-part test to obtain an interlocutory injunction in Canada is as follows:

  • There is a serious question to be tried;
  • The plaintiff will suffer irreparable harm if an injunction is not granted; and
  • The balance of convenience favours the grant of an injunction.

The irreparable harm criterion – which requires the plaintiff to demonstrate that the harm caused cannot be satisfied by a damages award – has historically been difficult to meet. However, two recent Canadian Federal Court decisions in which interlocutory injunctions were granted in trademark cases – Reckitt Benckiser LLC v Jamieson Laboratories Ltd (2015 FC 215) and Sleep Country Canada Inc v Sears Canada Inc (2017 FC 148) – suggest that the courts may be relaxing this standard somewhat and that interlocutory injunctions may once again be available in appropriate circumstances.

Are there restrictions on pharmaceutical-related advertising in your jurisdiction?

TOS: The Canadian Food and Drugs Act contains a general prohibition against advertising “any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety”. In advertising materials for prescription drugs aimed at the general public, no representations can be made “other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug”.

In addition, the act prohibits the advertisement of “any food, drug, cosmetic or device to the general public as a treatment, preventive or cure for any diseases, disorders or abnormal physical states referred to in Schedule A”, which includes a wide range of conditions, from asthma and diabetes to depression, hepatitis and cancer. However, consumer-directed ads for OTC drugs and natural health products which treat conditions not listed in Schedule A and which are truthful and accurate may be permitted, provided that they comply with Health Canada’s Consumer Advertising Guidelines for Marketed Health Products and are reviewed and pre-cleared by independent agencies. Finally, advertising materials directed to health professionals must be reviewed and pre-cleared by the Pharmaceutical Advertising Advisory Board.

KB: The FDA’s Office of Prescription Drug Promotion oversees prescription drug advertising by looking for and taking action against ads which violate the law, educating industry and others about the specifics of the law and encouraging better communication of promotional information provided both to healthcare professionals and to consumers. Ads for prescription drugs must be accurate and not misleading. Following recent losses in court over how much information a manufacturer may provide regarding unapproved so-called ‘off-label’ uses of its drug products, in early 2017 the FDA released multiple draft guidance documents seeking public input on how to regulate appropriately in this area while still respecting manufacturers’ free speech rights. Thus, this area of law is in flux, with cracks appearing in the FDA’s traditional role as the sole gatekeeper of what information can be disseminated about use of a particular drug.

The United States allows direct-to-consumer advertising on television and radio for prescription pharmaceuticals. Such ads must include information about the risks of the drug and where more information can be obtained. The Federal Trade Commission (FTC) has authority over advertising of OTC drugs. Under FTC regulations, claims for OTC drugs must be truthful and non-deceptive. Depending on the claim, advertisers may be required to back up their representations with competent and reliable scientific evidence, including tests, studies or other objective data.

SGY: Statutory regulations for advertisement are set out in Ministry of Health Resolution 252/2004. OTC products can be openly advertised and promoted in any medium upon approval from the Pharmaceuticals Review Board, provided that all advertising complies with the data inclusion requirements and proper statements required by regulations. Ad reviews are conducted after the marketing authorisation has been validly issued. In the case of prescription drugs, promotion is restricted to ‘health professionals’, as defined by law. Ads and promotions presented for approval may be rejected if:

  • they constitute or result in an act of unfair competition;
  • they contain statements which may be considered misleading;
  • they make use of the term ‘quality’ with regard to the product’s characteristics and properties;
  • they use the term ‘innocuous’ in relation to the product’s use; or
  • they promote self-medication.

Turning to the online world, do pharmaceutical brand owners face particular online challenges and how should these be overcome?

SGY: E-pharmacies are not currently permitted in Venezuela, but the open exchange of pharmaceutical products through online marketplaces is of major concern – especially since many of the products sold in this way blatantly lack marketing protection. This is a growing trend, although it is closely monitored by the authorities, which are willing to collaborate in investigations and takedown proceedings. Another ever-present threat is cybersquatting. Domain name availability assessments, including defensive registrations, should thus be included as a high priority at the early stages of name evaluation.

ROC: As mentioned earlier, counterfeit and knock-off products are widely available on the Internet. The fly-by-night nature of these operations makes enforcement a frustrating and expensive endeavour. Brand owners must have comprehensive and sophisticated online monitoring programmes, and must also work closely with law enforcement and customs authorities in the ongoing effort to stem the tide of unsafe and fake products.

TOS: Due to the price control on drugs (with the Patented Medicines Prices Review Board setting a maximum price for patented drugs in Canada), pharmaceuticals often cost less in Canada than in the United States. This has led to a boom in online pharmacies – specifically, Canadian businesses which sell pharmaceuticals online primarily to US customers, usually at a price somewhere between the Canadian and US prices. Pharmaceutical companies may consider taking legal action against internet pharmacies where unauthorised or illegal versions of their products are sold online. For example, internet pharmacies may engage in the parallel import of pharmaceuticals, for which the strategies discussed above may be appropriate.

Are there any other issues which you would like to raise with respect the creation and protection of pharmaceutical brands in your jurisdiction?

KB: Some countries have shown hostility to pharmaceutical trademarks – for example, by requiring use of generic names only when prescribing, viewing the trademark as something which allows a manufacturer to artificially inflate the price of a drug once it is off-patent and subject to generic competition. Some states allow (or even require) generic drugs to bear the pioneer drug trademark. However, in general, the United States still has a robust system in place for protecting the integrity of pharmaceutical trademarks. While generic names play a role in providing consistent terminology for certain compounds, trademarks enhance public health by assisting health professionals, reducing medication errors and enabling consumers to better recall what medication they took in the event of an adverse reaction. Generic names may be unique, but that does not necessarily mean that they are distinctive. Indeed, because drugs in the same class share the same stem, there is a degree of built-in similarity between generic names for pharmaceuticals in the same class. Such similarities can be useful to healthcare practitioners when it comes to identifying the pharmacological properties of a particular drug. However, requiring prescriptions to bear generic names only would create its own type of potential confusion, as many healthcare practitioners might encounter difficulty remembering or properly spelling such names, and would more likely be confused by the close similarity of many generic names, resulting in more errors.

TOS: From a Canadian perspective, the well-established test for whether two trademarks are confusing is one of a likelihood of confusion that the products bearing the respective parties’ marks come from the same source. The test is not a mere possibility of confusion, but focuses on confusion in a trademark sense – in other words, that the two marks would indicate the same source. During the examination of trademark applications relating to pharmaceuticals, examiners at the Canadian Trademarks Office occasionally appear to apply a different confusion test, seemingly in the interest of preventing “any possibility of confusion” in the realm of pharmaceuticals because of the health and safety issues relating to medicines. However, as discussed above, Canada already has an extensive regulatory regime dedicated to preventing patient confusion from a health and safety perspective, and the Canadian Trademarks Office’s role is to analyse confusion from a trademark (ie, indication of source) perspective. In these circumstances, detailed legal arguments may be required in order to overcome examiners’ objections when the mark applied for and the cited mark both relate to pharmaceuticals.

SGY: The non-availability of numerous drugs, pharmaceutical products and medical devices in the Venezuelan market due to difficulties which have arisen as a consequence of local currency exchange regulations, as well as the country’s political and economic situation, directly affects production facilities and import activities. Counterfeiting, repackaging and product tampering have increased considerably as a result, representing a challenge for brand owners to monitor, detect and then proceed with adequate and effective enforcement.

Citemark International IP
Sebastián González Yanes

Partner

sgonzalez@citemark.com

Sebastián González Yanes has a law degree from Andrés Bello Catholic University (Venezuela) and a master’s in IP law from the University of Alicante (Spain). His practice focuses on trademarks, designs and patents, and includes portfolio management, drafting of freedom to operate and clearance opinions, prosecution, opposition and invalidation. He also has significant experience in counselling on complex IP conflicts and protection and enforcement strategies in diverse fields, including pharmaceuticals and life sciences.

Fish & Richardson
Robert O’Connell

Of counsel

oconnell@fr.com

Robert O’Connell is of counsel in the Boston office of Fish & Richardson. His practice focuses on trademark and copyright strategic advice and prosecution and enforcement, including all aspects of domestic and international trademark law, registration and protection of copyright, online protection, clearance and selection of pharmaceutical names, licensing and technology transfer agreements and other IP-intensive transactions. Mr O’Connell has experience in developing and implementing cost-effective domestic and global branding and trademark protection plans for businesses ranging from small start-ups to multibillion-dollar corporations, with particular expertise in the financial services, food and pharmaceutical industries.

Fish & Richardson
Keith A Barritt

Principal

barritt@fr.com

Keith A Barritt is a principal in the Washington DC office of Fish & Richardson. His practice is primarily focused on all aspects of trademark law, including prosecution and inter partes proceedings before the US Patent and Trademark Office, domain name issues and trademark selection and enforcement, as well as all aspects of medical device regulation by the US Food and Drug Administration, including obtaining marketing authorisation for medical devices, use of new devices for investigational purposes, and import and export issues. He has been recognised by the WTR 1000 for trademark prosecution and strategy in the DC Metro area since 2014.

Smart & Biggar/Fetherstonhaugh
Timothy O Stevenson

Partner

tostevenson@smart-biggar.ca

Timothy Stevenson is a partner at Smart & Biggar’s Ottawa office. His practice focuses on trademarks and strategic brand management. Mr Stevenson has over a decade of experience in representing some of the world’s most famous brands across a variety of industries, including pharmaceuticals, electronics, consumer goods manufacturing, restaurants and food and beverages. His practice addresses all aspects of the trademark lifecycle, including clearance, prosecution, cancellation, opposition and enforcement. In contentious matters, Mr Stevenson has successfully represented clients before the Trademarks Opposition Board, the Federal Court and the Federal Court of Appeal.