Pharmaceutical Trade Marks - Selection and Adoption
In most fields of business, trade mark owners have a relatively free hand in selecting the brands they use to market their goods or services. In broad terms, provided that there is no risk of confusion on the part of the relevant consumer with an earlier brand, a trade mark will be free for use.
This is not the case with respect to trade marks for pharmaceutical products, which are subject to an extra layer of regulation in order to protect public health. Pharmaceutical brands can only be put into commercial use once they have been granted a marketing authorisation. In determining whether to grant a marketing authorisation, the competent authorities will decide whether the brand poses a risk to public health. This decision will not involve considerations relating to classical trade mark infringement, but will instead centre on the potential for medication errors which could lead to serious health risks.
The various considerations applicable to pharmaceutical trade marks will impact in different ways on the selection of the marks. Where similar trade marks are used for the same medical indication, there is a trade mark conflict. Where similar trade marks are used for different medical indications, there is a public health conflict. The need to consider both public health and classical trade mark infringement means the generation of names for pharmaceutical products is a complex process which will require considerable resource.
Before a medicinal product can be sold in the European Union a marketing authorisation (MA) is required. The trade name of the medicinal product will form part of the MA. There are several types of MA available, depending on the territories in which the pharmaceutical product will be made available for sale and the therapeutic indication which the pharmaceutical product is intended to treat. The legal basis for these MAs is set out in the Medicinal Products Directive 2001/83/EC and Regulation (EC) 726/2004, which establishes procedures for the authorisation and supervision of medicinal products and establishes a European Medicines Agency.
A single application can be filed to the European Medicines Agency (EMA) for a MA valid throughout the European Union (EU), together with the three member states of the European Economic Area (EEA), Iceland, Liechtenstein and Norway. This is mandatory for certain types of medicines, listed in the Annex to Regulation (EC) No. 726/2004, such as those containing new active substances for the treatment of cancer and any medicines derived from recombinant DNA technology.
Every member state of the EU operates its own procedures for the authorisation of medicines. In the UK, the procedure is set and regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA).
This procedure enables companies to apply for simultaneous MAs in any number of member states of the European Union, provided that the relevant product has not already been authorised in any member state and does not fall within the mandatory scope of the centralised procedure.
Mutual Recognition Procedure
Under this procedure, a medicine is first authorised in one EU member state, in accordance with the regulations in force in that country. Further MAs can then be sought from other EU member states who agree to recognise the validity of the original national MA.
Regulatory Guidelines for Branding Pharmaceutical Products
Depending on the type of MA applied for, applicants will need to consider the guidelines established by the relevant regulatory bodies relating to acceptable trade marks. The regulatory body for the centralised procedure is the European Medicines Agency (EMA), whose “Guideline on the Acceptability of Names for Human Medicinal Products Processed through the Centralised Procedure” is applied by the Name Review Group (NRG) of the EMA’s Committee for Human Medicinal Products (CHMP). The 5th update of these guidelines (CPMP/328/98), dated 11 December 2007 is currently in force, although a 6th update is due to replace them prior to the end of 2014.
These guidelines state “A Community marketing authorisation is valid throughout the EU and the invented name of the medicinal product is an integral part of the authorisation”. The most important aspect of these guidelines is the requirement for a single trade mark throughout the EU. A second name can, in theory, be sanctioned by the European Commission if the first name proves to be unavailable in a member state, but as yet no second name has been permitted under the centralised procedure.
As regards classic trade mark “origin” confusion, the guidelines explicitly state that, even where the applicant has registered their brand as a trade mark throughout the EU, only considerations relating to public health or safety will determine whether the trade mark can be used for the medicinal product in question. These considerations mean that trade marks should not:
- Be liable to cause confusion in print, handwriting or speech with the invented name of another medicinal product (taking into account factors such as the indications, patient population, pharmaceutical form, route of administration, strength, setting for dispensing and use and potential for harm in the event of confusion);
- Convey misleading therapeutic and/or pharmaceutical connotations;
- Mislead with respect to the composition of the product;
- Convey any promotional message with respect to the characteristics or composition of the product; and
- Appear offensive or have a negative connotation in any of the official EU languages.
Applicants are also requested not to submit names which are very similar, e.g. which differ from each other by only one character, since any safety or public health concerns are likely to apply to all of these names and thereby increase the risk of rejection.
The use of qualifiers/abbreviations by letters as part of an invented name is viewed as acceptable in principle. The use of numbers may also be acceptable in certain cases for example, in the case of vaccines composed of several serotypes it would be acceptable to indicate “IN” X serotypes suspension for injection. The following considerations will be applied when assessing the acceptability of qualifiers/abbreviations by letters/numbers:
- Whether the qualifier/abbreviation provides further information on the characteristics of the medicinal product or provides for a differentiation, which could help healthcare professionals and/or patients to prescribe/select the appropriate medicinal product; and
- The balance between the potential risk to public health in case of medication error potentially related to the qualifier/abbreviation versus the potential risk resulting from more complex names, adversely affecting in turn memorability, pronunciation and/or prescription.
Qualifiers consisting of a single letter or number are not recommended, as they may be confused with the strength and/or dosage of the medicinal product.
Qualifiers/abbreviations which require translation to be understood in the respective EU M/S are not acceptable being incompatible with the single name rule.
Additional criteria apply to combination products and specific product types (e.g. vaccines, orphan drugs (pharmaceutical products which have been developed specifically to treat a rare medical condition) and non-prescription products.
International Nonproprietary Names (INNs)
Article 1(20) of Directive 2001/83/EC provides that the name of a medicinal product “may be either an invented name not liable to confusion with the common name, or a common name or scientific name accompanied by a trade mark or the name of the marketing authorisation holder.”
The common, or generic, name will most often be the International Non Proprietary Name (INN) for the product. INNs facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property, in the same way that the term “chocolate” is public property to describe a form of candy derived from the cocoa seed. The World Health Organisation (WHO) administers the system for the allocation of INNs.
Although the INN applicant will have some flexibility in determining the INN which is allocated to their new pharmaceutical compound, each INN will need to contain what is known as a “stem”, i.e. a part of the INN which facilitates the identification of the substance or active ingredient of the pharmaceutical product. Stems usually form the suffix of an INN, but can occasionally form their prefix. Some examples are:
- -coxib for COX-2 inhibitors, a type of anti-inflammatory drugs (e.g. celecoxib)
- -oxetine for fluoxetine derivatives, a group of antidepressants
- -pril for ACE inhibitors (e.g. captopril)
- -sartan for angiotensin II receptor antagonists (e.g. losartan)
- io- for iodine containing radiopharmaceuticals (e.g. iobenguane)
Whether an invented pharmaceutical brand name will be found confusingly similar to an INN will depend on a number of factors. The EMA’s Guidelines provide that applicants should take into consideration the WHO resolution (WHA46.19) where appropriate, which states “It would therefore be appreciated if invented names were not derived from INNs and if INN stems were not used in invented names.”
Where the EMA considers that an invented name is similar to an existing INN, it will take into consideration the following criteria in determining whether the invented name should be allowed:
- The closeness in speech or writing with its own or a different INN;
- The similarity in medicinal setting, general use (indication) of concerned medicinal products;
- The similarity in classification for supply of the concerned medicinal products e.g. restricted to hospital setting or specialists;
- The route of administration and, where possible, the pharmaceutical forms.
The Name Review Group (NRG) will make its decision on the acceptability of the proposed trade mark according to the “decision tree” set out below:
Where an invented pharmaceutical brand contains an existing INN stem, it will take into consideration the following criteria in determining whether the invented name should be allowed:
- The similarity in therapeutic class between the INN stem and the medicinal product;
- The location of the INN stem with the proposed invented name as per the WHO INN stem location recommendations;
- The similarity in medical setting, general use (indication) of concerned medical products;
- The similarity in classification for supply of the concerned medicinal products e.g. restricted to hospital, specialists;
- The route of administration and, where possible, the concerned pharmaceutical forms.
The NRG will make its decision on the acceptability of the proposed trade mark according to the “decision tree” set out below:
In the United Kingdom, the MHRA has issued a set of guidelines on appropriate trade marks for medicinal products which largely mirror those put into place by the EMA in respect of the centralised procedure.
Trade Mark Selection Process
Irrespective of the requirement for a single brand name under the centralised procedure for obtaining a MA, most pharmaceutical companies will wish to secure a global brand in order to maximise its recognition by all stakeholders. The difficulties related thereto mean that the trade mark creation process will usually start during Phase I or the start of Phase II of the clinical drug development process. It generally takes between 3 and 4 years to generate and register a trade mark globally for any one product. Approximately 500 candidate brand names will be created by an external naming agency in order to produce 1 registration and 2 back up marks. Initial on-line legal screening checks will be conducted to knock out the candidate brands which face obvious obstacles in the EU and USA. Those candidate brands which survive this process will then be put into full legal searches in these and other jurisdictions in which the product is planned for early commercialisation, which may include by way of example Switzerland, Japan, Canada, Argentina, Australia, Brazil, Mexico, China and Turkey.
The candidate brands which look to be available for registration and use after full searches are then subjected to safety testing, in order to determine whether they fall within the guidelines prescribed by the EMA and other relevant regulatory bodies. This safety testing comprises an analysis of how the marks look when written out by hand, by way of a doctor’s prescription, whether they look or sound like any similar pharmaceutical brands, if they suggest any inappropriate or exaggerated claims or contain an inappropriate INN stem and whether they are otherwise unsuitable on the basis of a linguistic, cultural and marketing evaluation.
The top 3 names which reach the end of this process will then commonly be registered as trade marks in the principle jurisdictions of interest and a MA application submitted before the EMA or other relevant regulatory authorities.
Legal Clearance Searches
Article 8 of the Community Trade Mark Regulation (40/94) provides that “upon opposition by the proprietor of an earlier trade mark, the trade mark applied for shall not be registered... if because of its identity with or similarity to the earlier trade mark and the identity or similarity of the goods or services covered by the trade marks there exists a likelihood of confusion on the part of the public in the territory in which the earlier trade mark is protected; the likelihood of confusion includes the likelihood of association with the earlier trade mark.” This provision is mirrored in the national trade mark law of the member states of the EU.
An assessment of whether a risk of confusion exists between a candidate brand and an earlier trade mark is made from the perspective of the “relevant consumer”. Traditionally, the relevant consumer, in relation to prescription only pharmaceutical products, has been held to be a healthcare professional, such as a doctor, pharmacist or nurse. This was significant, to the extent that they were perceived to display a greater capacity to distinguish between pharmaceutical brands than the end “lay” consumer. The practical effect of this perception was that a lesser degree of difference was required to distinguish pharmaceutical brands than would otherwise be the case, although the enhanced capacity of these healthcare professionals to distinguish between brands had to be offset against the enhanced risks, in terms of medication errors, if confusion did occur.
However, in Case C-412/05 Aventis Pharma v OHIM (26 April 2007), the Court of Justice of the European Union held that the relevant public, for the purposes of assessing a risk of confusion between pharmaceutical brands, also included the end user, as well as the healthcare professional. Although the Court acknowledged that healthcare professionals were liable to influence or even determine the choice of product made by end users, this had to be balanced against the ability of end users to make those professionals take into account their perception of the marks at issue and, in particular, their requirements or preferences. In Case T-95/07 Aventis Pharma v Nycomed GmbH (21 October 2008), the General Court held that the end user would display an “above average” degree of attention when choosing pharmaceutical products, given the risks associated with a medication error. Nonetheless, where lay consumers are not likely to display as great a degree of attention and appreciation of the differences between pharmaceutical brands as healthcare professionals, these cases are indicative of a lowering of the threshold for confusion between pharmaceutical brands. This will impact on the availability of new brands for registration and use.
Regulatory Approval Process
The EMA’s “Guideline on the Acceptability of Names for Human Medicinal Products Processed through the Centralised Procedure” provide that applicants should inform the EMA of their proposed brand name no earlier than 18 months prior to the date on which they plan to submit their MA application. Applicants are allowed to submit up to 4 names per MA application for consideration by the NRG. Their request should be submitted to the EMA 10 calendar days before the NRG meeting so as to ensure its inclusion in the agenda.
These names are notified to every NRG contact point nominated by the national competent authorities of the member states of the EU, the European Commission and the WHO for review. Any objections/comments on these names on the grounds of safety concerns are required to be reported to the EMA within 30 days of notification.
The NRG will review any objections/comments during its meeting and decide whether any of the names can be accepted or if further clarification is required from the applicant. If any of these names are rejected, it is open to the applicant to submit arguments in favour of the name, which would then be reviewed by the members of the NRG, although this is rarely done in practice.
The MA applicant will need to inform the EMA of the brand name which they have chosen from those which the NRG has approved. If none of the brand names submitted by the applicant have been approved one month prior to the decision of the CHMP on the MA application, the applicant can instead include the INN and the name of the applicant in their MA application.
Proposed Changes to the Regulatory Approval Process
The EMA has published a draft revision of their “Guideline on the Acceptability of Names for Human Medicinal Products Processed through the Centralised Procedure” (CPMP/328/98 Revision 6, 7 June 2013). This revision seeks to provide greater transparency of the criteria applied by the NRG when reviewing the acceptability of pharmaceutical trade marks and more clarity on the procedure which applicants should follow. The consultation process for this draft revision ended on 30 August 2013 and the revised guidelines are expected to be implemented prior to the end of 2014.
The background to these proposed changes are the consistently high rates of rejection of pharmaceutical trade marks submitted for approval by the NRG. The statistics below reveal the difficulty in securing approval:
2009 – 53% of all names submitted for approval were rejected
2010 – 56%
2011 – 48%
2012 – 43%
2013 (to July) – 46%
However, the revised guidelines, as they currently stand, contain provisions which have the potential to reduce applicants’ prospects of obtaining a MA for their new pharmaceutical brand even further. Whereas the previous edition of the guidelines allowed applicants to submit up to 4 names for review by the NRG, this is proposed to be limited to 2. If both of these names are rejected, the applicant can submit a further 2 names, although this will inevitably impact on the timescale for the submission of the MA application. Furthermore, where the NRG accepts 2 names, they will not typically entertain any request for the review of additional names, whereas the applicant might require greater flexibility in order to satisfy the concerns of health authorities outside the European Union.
More fundamental problems exist in both the current and revised guidelines relating to the information which the applicant is asked to file alongside their MA application. The EMA requests that applicants send any “relevant information” in order to enable their proposed names to be reviewed. Some examples of relevant information are listed as the result of research into similar invented names and patient information forms distributed during clinical trials. This implies that the applicant is required to conduct its own review of its proposed names according to the criteria adopted by the EMA for their evaluation. However, the EMA has not provided any methodology by which this review can be undertaken. The evaluation process which the NRG conducts is on a case by case basis, with input from NRG contacts in 28 member states, the WHO and the European Commission. The analysis conducted by the NRG contacts will vary from one member state to another and it is for the NRG to reach a consensus amongst the various stakeholders as to whether the proposed names can be adopted. This opaque process provides little guidance to the applicant as to the likely pitfalls of their proposed names.
The complex regulatory framework governing the use of trade marks for pharmaceutical products and the difficulty of securing a pan-European brand highlight the need for thorough and timely clearance searching. Pharmaceutical companies have been lobbying the EMA hard for their revised regulatory guidelines on brands for products submitted for approval through the centralised procedure to include greater clarity on the conditions which must be satisfied to secure acceptance. Their greatest concern is the proposed reduction in the number of names which can be submitted to the NRG for approval, from 4 to 2 per application and the reduction in the number of names which the NRG will approve per application, from potentially 4 to 2. Greater engagement between industry and the EMA in the approval process should result in a higher rate of approval, where objections can be discussed more openly and applicants permitted the opportunity to defend their choice of brand.
For more information on the contents of this circular or if you need to seek specific legal advice please contact James Fish (email@example.com) or your usual J A Kemp advisor, all of whom can be contacted on +44 (0)20 3077 8600.