Patents and Trademarks
Want to know more about patents and trademarks in Bolivian pharma? Read on! Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The formalities to request a trademark registration are:
- Name and design (if applicable) of the brand
- International Classification Nice
- Basic information of the applicant (if the applicant is a company, a Power of Attorney will be required)
- Forms and note of application
- Receipts of Payment of fees
The formalities to request a patent are:
- Three copies of the Application Forms
- Descriptive Memory (Printed)
- Description of the invention: It must disclose the invention in a sufficiently broad and concrete manner.
- Claim: Define the subject that you want to protect through the patent, it must be clear and concise and supported by the description.
- Drawings: If applicable
- Summary: It consists of a synthesis of the technical disclosure contained in the patent application.
- Receipts for payment of the fees established by SENAPI.
- Memorial or application letter.
- Priority if it exists. (Its translation if it is in another language).
- In case of representation, necessary powers in original or legalized copy.
- Assignment of Rights (If applicable).
2. What agencies or bodies regulate patents and trademarks?
The “Servicio Nacional de Propiedad Intelectual (SENAPI)” is the public institution that regulates all the patents and trademarks in Bolivia.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
According to the Andean Community Decision No. 486, which establishes the Common Industrial Property Regime, any sign capable of distinguishing goods or services on the market shall constitute a mark. Signs that are susceptible of graphic representation may be registered as marks. The nature of the product or service to which a mark is to be affixed shall in no case be an obstacle to the registration thereof. The following signs, among others, may constitute marks:
- Words or word combinations;
- Images, figures, symbols, graphics, logotypes, monograms, portraits, labels, emblems and shields;
- sounds and aromas;
- letters and numerals;
- a color within an outline, or a color combination;
- the shape of the goods, their containers or their packaging;
- any combination of the signs or elements specified in the foregoing subparagraphs.
Signs cannot be registered as trademarks if:
- lack distinctiveness;
- consist solely of the everyday shape of the goods or their packaging, or of shapes or characteristics dictated by the particular nature or function of the product or service concerned;
- consist solely of shapes or other elements that afford a functional or technical advantage to the product or service to which they are applied;
- consist solely of a sign or statement that may serve in business to describe the quality, quantity, purpose, value, place of origin or time of production of, or to impart other data, characteristics or information concerning, the products or services for which the sign or statement is to be used, including expressions extolling the said goods or services;
- consist solely of a sign or statement which is the generic or technical name of the product or service concerned;
- consist solely or have become the common or usual designation for the product or service concerned in the everyday language or usage of the country;
- consist of a color in isolation, without any demarcation to give it a specific shape;
- are liable to deceive business circles or the public, in particular as to the source, nature, manufacturing methods, characteristics or qualities of the goods or services concerned, or their suitability for their purpose;
- reproduce, imitate or contain a protected appellation of origin for the same or different goods where use of the sign could create a risk of confusion or association with the said appellation or might constitute misappropriation of its notoriety;
- contain a protected appellation of origin for wines and spirits;
- consist of a national or foreign geographical indication liable to cause confusion with regard to the goods or services to which it applies;
- reproduce or imitate, without the permission of the competent authorities, either as trademarks or as elements of trademarks, coats of arms, flags, emblems or official signs and trademarks denoting control and warranty adopted by States, and any imitation thereof from the heraldic point of view, and also the coats of arms, flags and other emblems, names or abbreviated names of any international organizations;
- reproduce or imitate signs denoting conformity with technical standards, except where the registration thereof is applied for by the national body responsible for standards and quality requirements in member countries;
- reproduce, imitate or include the denomination of a plant variety protected in a member country or abroad, if the sign is intended for goods or services related to that variety, or where such use would be liable to cause confusion or association with it; or
- are contrary to law, morality, public policy or proper practice.
Notwithstanding provisions of subparagraphs (b), (e), (f), (g) and (h), a sign may be registered as a mark if the person applying for registration, or his principal, has been making constant use of it in the member country, and where the effect of such use has been that the sign has acquired distinctiveness in relation to the goods or services to which it has been applied.
4. How can patents and trademarks be revoked?
Once registered before SENAPI, trademarks have a 10 year validity. If not renewed, the trademark expires.
Also, a third-party could request the cancellation of the brands that are in disuse and do not fulfill their function of distinguishing a product or service in the market through an administrative process named “Acción de Cancelación”.
5. Are foreign patents and trademarks recognized and under what circumstances?
Only when they are claimed within the deadline for an application in Bolivian territory.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Unfortunately, if trademarks are not registered before SENAPI and products are not registered before AGEMED, its unlikely that medicines and devices are protected otherwise.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Every patent or mark application must fulfill the limitations established in the Andean Community Decision No. 486 which establishes the Common Industrial Property Regime and also International regulations for pharmaceutical and biotechnology arrangements.
Regulatory authorities require data from preclinical and clinical trials to be able to approve and certify that a pharmaceutical technology is safe and effective for consumer use before market entry. Regulatory data protection arrangements allow regulators to access those data on the understanding that they will not disclose it. At the international level, regulatory data protection is governed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO). Article 39.3 of TRIPS requires WTO members to protect test data submitted to regulatory authorities against unfair commercial use and disclosure, except when the public interest so requires or when the data is otherwise protected against unfair commercial use. Protection of proprietary rights to drug registration data became a requirement for all WTO members, with the exception of least developed countries, from January 1, 2000, but many countries have yet to implement it.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Yes, and must fulfill all the local formalities to be registered by SENAPI in Bolivia.