Patents and Trademarks
An overview of the legal framework for patents and trademarks for pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for USD 99, here.
1. What are the basic requirements to obtain patent and trademark protection?
Intellectual Property Rights are regulated in Brazil through Federal Law No. 9,279/1996 (“IP Law”).
Under its Article 8, the main requirements for a patent to be granted are novelty, inventive step and industrial application. Other requirements such as sufficient description, and prohibitions, such as impossibility to add subject matter after the patent examination request is filed, are also provided in the Law.
In regards to trademarks, Brazil is a first-to-file country, meaning that the registration of a trademark is granted to the first person who files the application. Article 129 of the IP Law sets forth that the ownership of a trademark (and the exclusive rights of use thereof) is obtained through the issuance of a valid registration by our local trademark office.
Article 124 of the IP Law states that the following are not registrable as trademarks:
- crests, armorial bearing, medals, flags, emblems, official public distinctions and monuments, be they national, foreign or international, as well as any respective designations, figures or imitations;
- an isolated letter, digit or date, except when sufficiently distinctive;
- expressions, figures, drawings or any other contrary to morals and good customs or which offend a person’s honor or image or are an affront to the liberty of conscience, beliefs, religious cults or to ideas and sentiments worthy of respect and veneration;
- signs of a generic, necessary, common, usual or simply descriptive character, when related to the product or service to be distinguished, or those commonly used to be designated a characteristic of the product or service with respect to its nature, nationality, weight, value, quality and moment of production or of giving service, except when present in a sufficiently distinctive manner;
- signs or expressions used only as a means of advertising;
- colors or their names, except when arranged or combined in an unusual and distinctive manner;
- reproductions or imitations of titles, bonds, coins and bank notes of the Union, the States, the Federal District, the Territories, the Municipalities or of any country;
- technical terms used in the industry, science or art that is related to the product or service to be distinguished; and
- necessary, common or usual shapes of a product or of its packaging, or, furthermore, shapes that cannot be disassociated from a technical effect.
- designations or acronyms of a public entity or establishment, when registration is not requested by that public entity or establishment;
- reproductions or imitations of a characteristic or differentiating element of a title of an establishment or the name of an undertaking belonging to a third party, which are likely to cause confusion or association with such distinctive signs;
- geographic indications, imitations thereof likely to cause confusion or signs that might falsely suggest a geographic indication;
- signs that suggest a false indication with respect to origin, source, quality or utility of the product or service to which the mar is directed;
- reproductions or imitations of official seals, normally adopted for the guarantee of a standard of any type nature;
- reproductions or imitations of signs that have been registered as a collective or a certification mark by a third party, without prejudice to the provisions of article 154 [the collective and certification mark that have already been used and whose registrations are extinct cannot be registered in the name of a third party, before 5 years, counted from the expiration date];
- names, prizes or symbols of sporting, artistic, cultural, social, political economic or technical official or officially recognized events, as well as the imitations likely to cause confusion, except when authorized by the competent authority or entity prior to the event;
- personal names or signatures thereof, family or patronymic names and images of third parties, except with the consent of the owner, his heirs or his successors;
- literary, artistic or scientific works, as well as titles protected by copyright and likely to cause confusion or association, except with the consent of the author or owner;
- reproductions or imitations, in whole or in part, even with additions, of a mark registered by a third party, to distinguish or certify a product or service that is identical, similar or akin, and which are likely to cause confusion or association with the third party’s mark;
- duplications of marks of a single proprietor for the same product or service, except when, in the case of marks of the same nature, they are presented in a sufficiently distinctive manner;
- objects that are protected by industrial design registrations in the name of third parties; and
- signs that imitate or reproduce, wholly or in part, a mark of which the applicant could obviously not fail to have knowledge in view of his activity, and of which the proprietor is established or domiciled in the national territory or in a country with which Brazil maintains an agreement or guarantees reciprocity treatment, if the mark is intended to distinguish a product or service that is identical, similar or akin, and is likely to cause confusion or association with such third party mark.
Additionally, Articles 125 and 126 of the IP Law prohibit the registration of marks that reproduce or imitate famous and well-known marks, respectively.
2. What agencies or bodies regulate patents and trademarks?
Patent and trademarks applications are analyzed and granted by the Instituto Nacional da Propriedade Industrial – INPI (Brazilian Patent and Trademark Office – “BPTO”) in the administrative sphere.
As to the judicial sphere, Brazilian courts are divided in two main jurisdictions, State and Federal courts. As a general rule, State courts deal with patent/trademark infringement cases, while validity issues are ruled by Federal courts.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Under the Brazilian IP Law, all products, substances and processes can be protected, except for those that incur on the prohibitions of Articles 10 and 18 of the IP Law, being worth mentioning: “operating or surgical techniques and therapeutic or diagnostic methods, for use on the human or animal body“; “natural living beings, in whole or in part, and biological material, including the genome or germ plasma of any natural living being, when found in nature or isolated therefrom, and natural biological processes“; “that which is contrary to morals, good customs and public security, order and health“; “substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus“.
According to Article 128 of the Brazilian IP Law, applicants may only request the registration of a mark relating to the activity they effectively and licitly exercise directly or through entities that they control directly or indirectly. Further, the specification of products and services must not be too general, as this can lead to the BPTO to issue an office action for the applicant to explain it or restrict it. The Office can also (i) remove products/services if they are not deemed to be included in the claimed class; and (ii) rephrase the specification for accuracy. The BPTO has recently adopted the 11th edition of the Nice Classification.
4. How can patents and trademarks be revoked?
Patents may be revoked through an administrative invalidity request or court action, if one of the legal requirements for its validity are not present. Moreover, under Article 78 of the IP Law, patents may be revoked on expiry of the term of protection; on waiver by the patentee, without prejudice to the rights of third parties; on forfeiture; on non-payment of the annual fee; and on non-observance of the provisions of Article 217 (“a person domiciled abroad must maintain permanently a duly qualified attorney resident in the country, with powers to represent him administratively and judicially, including for receiving summons“).
Revocation of a trademark registration may be pursued through:
- administrative nullity actions before the BPTO (Article 168 and following articles of the IP Law). Such action can be filed within 180 days from the grant date and must include a statement of grounds. A power of attorney is required if an agent/counsel is signing on behalf of the interested party. Supporting documents, if not attached to the action, may be submitted within 60 days from its filing date.
- non-use cancellation actions before the BPTO. Such action may only be filed after 5 years from the grant of the registration and must include a statement of grounds. A power of attorney is required if an agent/counsel is signing on behalf of the interested party.
- court nullity actions before a Federal Court. Such action can be filed within 5 years from grant of the registration. Having filed an administrative nullity action with the BPTO is not a condition for filing the court nullity action.
5. Are foreign patents and trademarks recognized and under what circumstances?
Foreign patents do not have an effect in the Brazilian territory.
Foreign trademarks are recognized in Brazil if they are considered as well-known in their field of activity. Such marks enjoy special protection under Article 6 bis (1) of the Paris Convention and Article 126 of the IP Law, regardless of whether they have been previously filed or registered in Brazil. There are no certification proceedings for well known marks. The holder must oppose an application for a mark identical or similar to its well-known mark, or an administrative nullity action against a registration granted for a mark identical or similar to its well known mark, and submit evidence of its well known status (so that the applicant for the infringing mark could not have ignored it). If the well-known mark is not applied for or registered in Brazil, the holder must file an application within 60 days from the opposition/administrative nullity action date, and submit the filing receipt to the BPTO. The BPTO may reject, ex officio or at the outcome of an opposition, an application for a mark that wholly or partially reproduces or imitates a well-known mark.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
A regulatory barrier in Brazil is the data package exclusivity, although its application by Brazilian Courts is controversial. Such protection is provided for in Article 39.3 from the TRIPs, which was internalized in Brazil by Decree No. 1,355, dated of 12/31/1994, and is considered internal law, and in Article 195, XIV, of IPL, as follows:
“SECTION 7: PROTECTION OF UNDISCLOSED INFORMATION
- Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”
Article 195 – A crime of unfair competition is committed by he who:
XIV – divulges, exploits or uses, without authorization, the results of tests or other undisclosed data the elaboration of which involved considerable effort and which has been presented to government entities as a condition for approving the commercialization of products.”
Although the judicial recognition of data package exclusivity is still controversial in Brazil, especially due to the lack of a term of protection, there are judicial decisions applying the rule of Article 39.3 of TRIPs, in order to prevent the National Health Surveillance Agency (“ANVISA”) from granting registrations to copies, by “relying”, even if indirectly, from the dossier of the reference product.
The most emblematic case on the subject is Lundbeck v. ANVISA, in which a final decision on the case merits was rendered by the 7th Federal Court of Brasilia recognizing the application of Article 39.3 of the TRIPs to invalidate several sanitary registrations granted by ANVISA for copies of Lexapro. The decision was subsequently reformed by the Federal Court of Appeals of the 1st Circuit – TRF1, and the case is currently pending before the Superior Court of Justice (STJ), but the lower court decision is well founded and applies the analogy to establish a 10-year term of protection, based on the provisions of Law 10,603, of 2002, which provides for the protection of confidential data for agrochemicals and veterinary products.
Another regulatory barrier in Brazil is set forth in Article 5, caput, of Federal Law n. 6,630/76, which deals with sanitary surveillance in Brazil. Such Article establishes that medicines, drugs, pharmaceutical inputs and related products may not have names, designations, labels or packages leading to error. Paragraph 1 of the same article also states that the adoption of an identical or similar name for products having different compositions is forbidden, even if they are from the same manufacturer.
Finally, regulation issued by the ANVISA may also apply for specific types of medicines or medical devices.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There is no specific restriction on types of medicines or devices that can be granted patent protection, being the general exceptions those of Articles 10 and 18 of the IP Law, as mentioned above. Likewise, there is no specific restrictions on types of medicines or devices that can be granted trademark protection, except for the legal obligation arising from Article 128 of the IP Law, as described above.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
According to Article 211 of Brazil’s IP Law, all technology transfer agreements and IP license agreements must be registered by the BPTO. This procedure is a legal requirement for (i) remittance of royalties abroad, (ii) tax deductibility of payments, and (iii) validity of the agreement against third parties. The following categories of contracts are defined by the BPTO and shall be registered within the Office:
- Exploitation of Patents (EP): contracts involving the licensing of granted patents or patent applications filed with the BPTO.
- Use of Marks (UM): contracts involving the licensing of registered trademarks or trademark applications filed with the BPTO.
- Supply of Technology (ST): contracts which main propose is the acquisition of knowledge not protected by industrial property rights filed or granted by the BPTO, for the production of industrial goods and services.
- Technical Assistance (SAT): contracts establishing conditions for obtaining techniques, planning methods and programming, as well as research, studies and projects for execution or specialized services.
- Franchise (FRA): contracts aimed at obtaining a temporary concession of rights involving the use of trademarks, technical assistance services, together or not, with any other kind of transfer of technology necessary required to execution of its object.
Please note that Brazil’s Central Bank requires a copy of the agreement duly recorded at the BPTO (or a decision from the office stating that the contract does not need to be recorded, if it fits a few exceptions foreseen by the law) to allow payments to be remitted abroad for technology transfer agreement or IP licenses.