Trademarks are applied to almost all products offered for sale in the market, from furniture and toys to cars and foodstuff. Pharmaceuticals and medicines are not the exception. However, the registration of trademarks in the pharmaceutical industry has certain essential features to be discussed below. These features are determined by the specific nature of the labeled product itself, its manufacturability and further promotion in the market, as well as the end "audience".
At the same time, trademark registration is getting more and more relevant for drug manufacturers: the range of medicines in the market is growing, and buyers are becoming more informed and selective. Therefore, manufacturers have to develop increasingly sophisticated marketing strategies centered around a unique brand – that is, a trademark. Therefore, it is important initially to understand the specific character of registration of medicine trademarks and build the entire strategy for promoting and protecting the brand based on this specific character.
- A trademark is a designation intended to individualize goods and services of a particular manufacturer or supplier among similar goods and services of other manufacturers/suppliers. In the Russian Federation legal protection is granted to registered designations (meaning those in respect of which the application is submitted to Rospatent, the application is examined, based on the examination results the decision on registration is made, the state duty is paid, and the trademark is registered and entered into the register).
Trends in trademark creation in the pharmaceutical industry
There are two opposite trends. On the one hand, manufacturers bring to the market the hundreds of new medicines with totally new names not yet known to Russian consumers. Such a unique, original, recognizable name combined with the manufacturer's popularity, image and good reputation can significantly improve the success of the product among Russian consumers in general.
On the other hand, the lack of associations for consumers between these new brands and the medicinal properties of the product itself, their usual drugs, causes difficulties in promoting and developing the brand, and there is an opposite trend – the creation of trademarks "around" so-called INNs (International Nonproprietary Names), that is, the creation of new verbal trademarks based on these INNs by various modifications of the original word. This causes the main difficulties with the registration of such trademarks to be discussed below.
What is INN?
INN is a unique name of the active substance of a medicinal product recommended by the World Health Organization. In the report of the World Intellectual Property Organization (WIPO), INN refers to "pharmaceutical substances and active pharmaceutical ingredients" – "unique names recognized worldwide and belonging to the public domain" (examples: ibuprofen, paracetamol, etc.)
INN means, actually, a specific substance with a unique formula and particular pharmacological properties. All INNs are carefully selected, globally verified and published (in "WHO Drug Information" journal). Currently, there are about ten thousand INNs, every year 200-260 new names are added to this list.
INN application is submitted to the Registry Office of WHO – World Health Organization, and the applicant may offer 6 INN options for the active part of the substance. Before submitting the application, the drug shall pass all the stages prior to clinical trials. Upon receipt of the application, the Registry Office of WHO conducts an examination similar to a preliminary trademark search: checks for similarity of the new INN with the previously published one, and for lack of any contradictions. Then the experts come to an agreement on a particular name, which is reported to the applicant.
INN and patents
A unique substance – a chemical formula – can be protected as an invention (it can also be a method for producing a chemical substance, a pharmaceutical composition, a treatment method, etc.). As a rule, manufacturers and drug developers seek to obtain a patent exactly for the formula. Currently, almost all new medicines are patented. A patent for an invention (like a trademark) assumes that the copyright holder has exclusive rights: no third party may use the patented subject without the permission.
The WIPO report noted that usually an applicant apply for INN when the development of a new drug is moved to a stage of clinical trials, and it takes about 15 months from the date of application for INN to INN publication. On the contrary, a patent application is usually filed at the earliest stage – after the discovery of a new compound or a derivative substance able to have medical use.
Often, due to difference in the time periods for filing and registration, a patent application is filed before the recommended INN is published, and even the patenting procedure can be completed before that time.
What are generics?
A patent for an invention is valid for 20 years from the date of filing the application. Although this period may be extended for medicines due to long-term clinical trials and registration procedure.
According to Article 1363 of the Civil Code, "If more than five years have elapsed from the filing of a patent application for an invention relating to a medicine... which requires that permission be secured in the procedure established by law, to the receipt of the first permission for using it, the effective term of the exclusive right to the relevant invention and the patent certifying this right shall be extended on an application of the patent holder by the federal executive governmental body charged with intellectual property matters. The said term shall be extended by the period that has elapsed since the filing of the patent application for the invention to the date of receipt of the first permission to use the invention, less five years, but shall not exceed five years."
After 20 years (or more – see above), the patent lapses into public domain. While the patent is still valid, competitors usually tend to develop generics – reproduced drugs on the basis of protected chemical substance. At the same time, it is recognized that obtaining permission to use a generic drug in the Federal Service for Supervision in Healthcare is not regarded as the patent violation.
Generic drugs are marketed after the patent for the original drug has expired, under the names obviously differing from the corporate names of the developers of the corresponding drugs. They contain INNs: since such use is not prohibited, the relevant information is placed on the packaging.
Connection between INNs and trademarks
INNs is widely used by the experts in the health area. It is obvious that INN is a general designation to be "accessible" for any drug manufacturer. The very name "INN" includes the word "nonproprietary": therefore, this name may be used without any restrictions. The main thing is that INN should not be confused with other names on a phonetic basis. As a rule, the system so established uses a common basis of words for substances similar in terms of their properties, facilitating to trace the relationship of a substance to a drug group having "similar pharmacological activity".
In any case, "availability" of the very name (INN) to an unlimited number of persons potentially distinguishes it from a trademark, since the trademark is the "property" of one person holding the exclusive rights in respect of the registered brand, and no other persons have "access" to this brand without the permission of the holder.
Aspects of trademark registration in the pharmaceutical industry
Trademarks are widely used in the pharmaceutical industry. The main task of their right holders is to maintain the scope of sales of the drug after the patent validity is expired. The popularity of the brand will contribute.
It is not so important for fairly cheap and common drugs: often they use designations that cannot be registered as a trademark, and manufacturers do not even try to get the exclusive rights in them. They can include general terms, symbols, an emblem in a form of a bowl and a snake, etc.
It is interesting to note the following. According to Russian legal acts, when prescribing the medicines, doctors should be guided by INNs - that is, the active substance. However, they may also recommend particular drugs bearing the particular registered trademarks. And often the doctors recommend exactly those drugs of particular manufacturers whose names are close to INN. This causes many drug manufacturers to choose the designations generated from INN by adding various suffixes, prefixes and other elements representing the obvious connection with INN, enabling to identify the main active substance – both for experts and for ordinary consumers.
One of the main issues is the possibility to register INN as a trademark. Trademark legislation provides that designations having no distinctive character or widely used to designate certain types of goods, as well as misleading the consumer, may not be registered.
WHO resolutions contain the provisions appealing to prevent the acquisition of exclusive rights in INN and to prohibit the registration of these names as trademarks in each individual country.
Russian practice has formulated the following conclusions. INN is assigned by WHO, has worldwide recognition, and serves as a universal identifier of active substances in the composition of a medicinal product. INN falls under the concept of a "commonly accepted term" and therefore may not be registered as a trademark. Moreover, the registration of INN as a trademark can in certain cases mislead a consumer, since such a trademark may be applied not only to medicinal products (or to medicinal products not related to the corresponding INN by their pharmacological properties).
Registration of INN as a trademark can also be contrary to the public interest. This is due to the fact that registration of such trademark may lock the access to the Russian market for the drugs having the same pharmacological group with the respective drug, as the owner has the right to prohibit third parties to use designations similar to the trademark symbols. All these conclusions are stated in Ruling of the Presidium of the Supreme Arbitration Court of the Russian Federation No. 12436/11 dated February 28, 2012, when the issue of the validity of granting legal protection to "CARNITON" trademark (subject to existence of international nonproprietary name "carnitine") was considered.
Trademarks in the pharmaceutical industry that are not fancy, but are derived from INN, confusingly similar to INN in terms of phonetic and visual criteria, associated with INN in general, despite minor differences (for example, in one sound or letter), may not be registered.
However, it is also possible to register designations derived from INN. Thus, for medicines containing "carnitine" pharmaceutical substance, "CARNIFIT", "CARNICETIN", "CARNIEL" trademarks were registered.
Practice of trademark registration and application in the pharmaceutical industry
In general, there are two basic types of names used for naming the medicines: INN and a trademark (commercial designation/ trademark – that is, the unique brand of the manufacturer). Often, the manufacturer places both INN and its own mark on the packaging of a medicinal product.
As mentioned above, it is impossible to register INN as a trademark. It is also impossible to register a designation confusingly similar to INN as a trademark. However, it is to advantage of drug manufacturers to get exclusive rights in the word that consumers will associate with INN. And this option is also available.
However, the choice of such a designation and its further registration has many specific aspects, difficulties often arise, and the authority may refuse to register a trademark. We can offer you our services for a preliminary check of the designation developed by you to assess the chances for registration. We advise you to choose 10-20 options for one INN (and, accordingly, report us the INN expected to be registered). We recommend you to choose more or less fancy options, so that there is no refusal of registration due to confusing similarity with the INN.
Give us your contact details and we will provide you with more detailed information about the features of trademark registration in the pharmaceutical industry, as well as the full range of services that we will be happy to render in this regard.