Industrial property in Colombia is regulated by Decision 486/2000 of the Andean Community, which is also applicable to Peru, Ecuador and Bolivia. This regulatory framework is complemented by different international treaties to which Colombia is a party.
Selection, clearance and registration.
Relevant national and international regulatory bodies and requirements
Industrial property in Colombia is regulated by Decision 486/2000 of the Andean Community, which is also applicable to Peru, Ecuador and Bolivia. This regulatory framework is complemented by different international treaties to which Colombia is a party, including the Industrial Property Convention, the Paris Convention, the Inter-American Washington Convention (1929) and the Madrid Protocol, of which Colombia is the only South American member. Trademarks in Colombia are classified by the International Classification of Goods and Services under the Nice Agreement (Classes 1 to 34 refer to products, 35 to 45 to services; pharmaceutical products normally belong in Class 5). Exclusive rights to use a trademark arise only from registration before the Superintendence of Trade and Commerce, which operates as the national trademark office. No trademark rights arise from mere use in the market.
To legally sell pharmaceutical, cosmetic, food and cleaning products, manufacturers require a sales licence from the Colombian Health Authority (INVIMA). A trademark registration grants the exclusive right to use a mark that is not susceptible to confusion or association with other distinctive signs. A health registration certifies that a particular product complies with pharmaceutical and pharmacological standards in order to be sold on the market.
Confusion with INNs
It is common practice for pharmaceutical companies to include international non-proprietary names (INNs), better known in Colombia as generic names, as sections of their trademarks. This could lead to conflicts during the registration process with the trademark office. Article 135 F of Decision 486/2000 forbids the registration of distinctive signs which exclusively consist of a generic or technical name of a product or service. However, if trademarks include additional elements on which their distinctiveness rests, the trademark office allows their registration and coexistence with other trademarks, even though INNs are included. Common practice in Colombia conforms to the international standards set by the World Health Organisation in Resolution WHA 46.19, which dictates that the registration of an INN together with other elements such as a house mark is perfectly viable as long as it does not restrict other manufacturers from using the same generic name(s). The trademark office will allow the registration of trademarks that contain generic names only if distinctive word and/or graphic elements are added.
Non-traditional trademarks follow the same trademark registration process as other trademarks. Article 134, Section C of Decision 486 of the Andean Community specifically foresees the possibility of registering sounds, smells, three-dimensional forms and colours, among other things, as trademarks. These trademark types must overcome particular challenges to meet the Andean registration requirements; the main obstacle, besides distinctiveness and functionality (described above under Articles 135 F and D), concern graphic representation.
To register non-traditional signs (eg, sounds and smells) as a trademark, they must be capable of being graphically represented. In the case of sounds, the particular sound represented on the stave is enough to fulfil this requirement, as consumers can create a clear representation of the sound. In contrast, the trademark office has rejected the registration of smells in the past based on the incapability of these signs to be graphically represented. The graphic representation of an applied sign must be complete, precise, comprehensible and clear. According to domestic criteria, when consumers come across the chemical formula of a smell on the market, they will most likely be unable to understand it and will be incapable of identifying the precise smell even if they understand the formula.
Moreover, three-dimensional trademarks (eg, bottles) face a specific challenge: the subjectivity of perception. Article 135, Section C dictates that signs that consist solely of the usual shape of goods or their packaging, or of shapes or characteristics dictated by the particular nature or function of the product or service concerned, may not be registered as marks. Consequently, Colombian practice has reviewed several three-dimensional trademark cases, in particular involving bottles and packaging, in which distinctiveness is required if the design is not to be considered a commonly used design shape.
Parallel imports and repackaging
Parallel imports take place when a product which is legally sold in a foreign country is introduced into the market of a third country without the consent of the rights holder. This phenomenon is directly linked to the concept of ‘exhaustion of rights’, (ie, the rights holder’s loss of rights in connection with the products that it, directly or through a third party, has placed on the market).
Three systems regulate the exhaustion of rights:
- National exhaustion – the owner loses the right regarding the products that it introduced into the market only within the country in which such products were introduced; therefore, the rights holder may prevent the import into the specific country of products that it markets abroad.
- Regional exhaustion – the rights holder loses the right regarding the products it introduced into the market within a pre-determined region; therefore, the rights holder may prevent the import into the specific region of products that it markets in countries outside the respective region, as is the case in the European Union.
- International exhaustion – the rights holder loses the right regarding the products it introduced into the global market; therefore, it cannot prevent the import into a country of products it markets anywhere else in the world.
The Andean Community countries, including Colombia, have chosen to adopt the international exhaustion of trademark rights in order to:
- facilitate the free movement of goods and thereby promote competition between producers and traders;
- generate competition, cheaper prices and multiple sources for obtaining products; and
- prevent the artificial segmentation of markets and other potential sources of anti-competitive behaviour.
Based on Colombia’s obligation to look after its citizens’ health, Decree 1313/2012 was issued to regulate parallel imports of pharmaceutical products. This rule outlines the requirements and procedures for obtaining parallel import authorisation from INVIMA for pharmaceuticals and medical devices that hold a health registration and are not included in the benefits plans of the general social security and health programme.
The decree seeks to reduce the price of pharmaceutical products and medical devices by facilitating parallel imports. However, it does not introduce flexibility in IP rights to make its application less rigorous (already relaxed by the international exhaustion of rights system).
In order to issue parallel import authorisation, INVIMA requires that:
- the product be incorporated into the official list of pharmaceutical products or medical devices not included in the benefits plan;
- the product hold a health registration in Colombia;
- the product be produced by the same manufacturer authorised in the Colombian health registration; and
- a health registration or equivalent be held in the exporting country.
Decree 1313/2012 also includes flexibility with regard to the labelling and packaging of pharmaceutical products. In exceptional cases regulated by the decree, labels are accepted in their original form as long as they include, in Spanish:
- the name of the active substance;
- the storage conditions;
- the parallel import inscription; and
- the name and address of the authorised entity and its authorisation number.
Anti-counterfeiting and enforcement
Registered trademarks in Colombia can be enforced through an infringement action or a criminal action, independent from the administrative penalties that counterfeit products could incur. Further, the manufacture, storage, handling and sale of altered pharmaceutical products constitute criminal offences.
Article 155 of Decision 486/2000 provides that the right to exclusively use a trademark, and prevent third parties from using the trademark or a similar sign regarding the same products or services or related products or services, is acquired upon registration. Under Colombian law, no rights arise from use, except with respect to well-known trademarks. In view of this, a trademark infringement action may be pursued only based on an existing registered trademark in Colombia.
Thus, applicable law affords rights holders the right to stop the use of identical or similar trademarks regarding any kind of goods or services, whenever such use is likely to confuse consumers. Therefore, to challenge the unauthorised or unlawful use of a protected or similar trademark where the resemblance is likely to deceive or cause confusion, rights holders may bring a civil action against the infringer. To launch an infringement action, the plaintiff must provide the following evidence in accordance with the abovementioned regulations:
- evidence of ownership of a trademark registration in Colombia;
- evidence that the defendant does not own the infringed trademark in Colombia;
- evidence of the infringement; and
- evidence of confusion, likelihood of confusion or the relevant infringement as set forth in law.
Under Article 245 of Decision 486/2000, the rights holder may also request that the presiding judge order the application of preliminary injunctions.
The Criminal Code also includes a section on crimes against public health, which includes Article 373 regarding the imitation or simulation of food or products or substances including medical or prophylactic products, medicines and pharmaceutical products. The characteristics of an altered product of this nature are described in Decree 677/1995, which defines ‘alteration’ as the manipulation of the original state of the pharmaceutical product. The manufacture and sale of harmful substances (eg, counterfeit pharmaceuticals) is also prohibited under Article 374 of the Criminal Code.
Parties that imitate or simulate with the aim of supplying, distributing or selling the aforementioned products may incur fines and face imprisonment. Medical or prophylactic products, medicines and pharmaceutical products must be manufactured, stored, handled and sold in due compliance with the conditions set forth in the sales licence. When these conditions are not complied with, the product is considered to be fraudulent under health regulations.
Conversely, Article 306 of the Criminal Code states that the misappropriation of IP rights is criminal behaviour. It provides that any party that fraudulently uses a trade name, trademark, patent, utility model or industrial design will incur penalties and face imprisonment.
Regulatory framework and considerations
Besides the general advertising legal framework, whereby all advertising must be accurate, clear and sufficient, the advertising of pharmaceutical products is regulated by health provisions. The corresponding legislation deems it compulsory to obtain prior authorisation from INVIMA for advertising medicines according to Decree 677/1995 and Resolution 4536/996. Colombian legislation establishes the following provisions regarding the advertising and promotion of medicines:
- Prior to broadcast or publication, all advertising in mass media requires authorisation from INVIMA. Mass media advertising should indicate the health registration number and must not exaggerate the product’s clinical benefits.
- Prescription medicines can be advertised only through specialised publications intended for healthcare providers. The advertising of these products in newspapers, on radio and television or via other mass media is prohibited.
- Non-compliance with policy when applying for authorisation for any type of advertising may result in criminal action and the imposition of injunctions (ie, suspension of activities or services, seizure of products, destruction of products and/or suspension of sales rights) or penalties (ie, notice, fines, seizure of products, suspension or cancellation of health registration and temporary or final closure of the pharmaceutical laboratory).
- Health registration owners will be held responsible by the competent authority if they do not comply with the medical advertising provisions. However, in some cases third parties (eg, newspapers) could also be liable in an eventual criminal action.
‘Generic substitution’ is the term applied to the substitution of a prescribed branded drug with a different form of the same active substance. In the Colombian public sector, the substitution of branded drugs with a generic substitute is not only possible, but encouraged. The incentive of INNs in Colombia, along with the national production of medicines, is one of the foundations of the pharmaceutical products pricing policy.
Generic medicines follow the same registration process and must fulfil the same quality requirements as regular brand pharmaceuticals. These products may be produced and distributed if the formula is not protected by patent rights or if such rights have already expired. Further, generic drugs require an INVIMA health registration certificate in order to be sold legally.
Regarding the prescription of generic medicines in the Colombian public health system, healthcare providers must issue prescriptions using the corresponding INN, but the healthcare professional may indicate which brands of the product are available (according to the patient’s best interest). If they are prescribed in commercial form, this must be accompanied by a respective justification as set forth in Resolution 4377/2010.
The online sale of pharmaceutical products in Colombia is allowed, but the market is unregulated. Online pharmacies normally sell medicines without any regulation and medicines are sometimes sent to consumers without a prescription. Online marketing in Colombia has developed haphazardly and there is no system similar to the US VIPPS stamp, which guarantees customers the safe and legal purchase of pharmaceutical products online.
No specific provisions or limitations for domain names refer to pharmaceutical trademarks. No identical domain names can be registered in terms of name and extension, regardless of whether they identify a pharmaceutical trademark or a different provision.
Maria Fernanda Castellanos and Santiago Peña Gómez.
This article first appeared in World Trademark Review. For further information please visit www.worldtrademarkreview.com.