Brazilian Industrial Property Law was amended by Law 9.279/96 (which became effective on May 15, 1997), grants legal protection to all types of inventions, as it eliminated several prohibitions that were established in the former law.
Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) provisions, the inventions related to foods, chemical-pharmaceutical products, medicines, production processes based on biological material such as microorganisms, biological material and genetically modified microorganisms that were not formerly patentable were thenceforth susceptible of being patentable pursuant to the enactment of Law 9.279/96.
Law 9.279/96 still establishes the exclusion of certain matters that cannot be patented in Brazil, such as, for example, commercial principles or methods, in addition to operation or surgery techniques and methods, as well as therapeutic or diagnosis methods applied to the body of humans or animals.
4.2.1. Types of patents and patentability requirements
Brazilian law established two types of patents: Invention Patents and Utility Models.
In these two types of patents an examination on the merits conducted to assert the following patentability requirements:
(i) Novelty: when the invention does not fall within the state of the art.
(ii) Inventive activity and inventive act:
- Inventive activity in the case of patents of invention: The invention features inventive activity whenever, when, for a person skilled in the art, it does not derive in an evident or obvious manner from the state of the art.
- Inventive act in the case of utility model patents: The utility model features inventive act whenever, when, for a person skilled in the art, it does not derive in a common or usual manner from the state of the art.
(iii) Industrial application: The invention and the utility model are deemed susceptible of industrial application when they may be used or produced in any type of industry.
In further regard to the patentability requirements, Law 9.279/96 establishes the so-called “grace period” according to which the invention may be disclosed before the patent application is filed with the Brazilian Patent & Trademark Office (Instituto Nacional da Propriedade Industrial – INPI) without jeopardizing the novelty requirement.
Once filed with the INPI, the patent application will be kept on hold until its publication, which shall occur in 18 months as of the filing date or priority date, if any, and the applicant must request the examination of the application within 36 months as of the filing date, for the INPI to examine whether the patentability requirements are met and issue its opinion, official action to fulfill a requirement, allow or reject the application.
If the application is allowed, the applicant must pay an issuance fee for the issuance of the Letter-Patent. The Letter-Patent of an invention patent is valid for 20 years and 15 years for the utility model, always counted as of the filing date.
Law 9.279/96 further establishes that the applicant must pay annuities as of the 3rd year, counted as of the filing date, which will be due up to the expiration of the patent, if granted.
4.2.2. Protection conferred by the patent
Law 9.279/96 clearly defines the patent violations and confers to the patent owner the right to prevent an unauthorized third party from manufacturing, using, placing for sale, selling or even importing the subject matter protected by the patent, also being considered a crime the use of means that are equivalent to the patent’s subject matter.
Furthermore, Law 9.279/96 introduced indirect violation to facilitate the inhibition of use of the patent’s subject matter by a third party. Accordingly, the patent owner confers the right to prevent third parties from contributing to the practice, by other parties, of conducts that are defined as patent violations.
Moreover, in the cases of violation of patented process rights, the burden of proof is reversed and the accused party must prove that its product was obtained through a manufacturing process other than the process protected by the patent.
In addition to the provisions of the law, it should be mentioned that, despite of the low number of lawsuits involving patents, the Brazilian court rulings have been revealing a trend of decisions in favor of the patent owner, thus rendering a patent to be a valuable asset in trade activities in Brazil.
As concerns the steps to be taken by a patent owner against a potential offender, the first step usually consists in a warning letter. In regard to legal action, there are suitable lawsuits at the civil law level, aiming through injunction the immediate cease of the competitor’s conduct of manufacturing, selling, imports or exports of matter that violates the patent owner’s right, as well as to condemn the offender to indemnity the losses and damages that were suffered, in addition to the criminal suit to condemn the offenders for crime against intellectual property rights.
As aspect to be considered in regard to the patent violations in Brazil is that Law 9.279/96 establishes some exceptions to patent owners’ rights, being allowed use on a private, non-commercial basis; use for experimental purposes, related to studies or scientific or technological research; the preparation of a medicine according to a physician’s prescription, in individual cases; and in the cases related to living matter, the non-profit use of a patented product as an initial source of variation or propagation to obtain other products.
4.2.3. Compulsory license
Law 9.279/96 also establishes the possibility of obtaining a compulsory license of a patent in any of the following events:
(i) The owner exercises the rights conferred by the patent in an abusive way;
(ii) The owner commits abuse of the economical power;
(iii) The subject matter protected under the patent is not exploited in Brazil by way of manufacture or incomplete manufacture of the product or by lack of full use of the patented process, in which case the license must be claimed after a three year period has elapsed since the patent was granted;
(iv) Commercialization does not meet the needs of the market;
(v) Dependency of another patent;
(vi) National emergency;
(vii) Public interest.
In the events quoted in (i) and (ii), the party that claims the compulsory license has the burden to prove the abuse committed by the patent owner.
In the event quoted in (iii), Law 9.279/96 provides that, in the event of economical unfeasibility, the local manufacture may be replaced by import of the patented product, however opening the possibility of parallel import by third parties.
In further regard to the event quoted in (iii), it should be noted that, depending on its interpretation, Law 9.279/96 may or might not be fully in conformity with the TRIPS, as this treaty establishes that “patent rights shall be exercisable without discrimination as to the place of invention, technological field and the fact that the goods are imported or manufactured locally”.
On the other hand, another way to interpret this issue is based on the Paris Convention, which establishes that “Each country of the Union shall be free to adopt legislative measures that determine compulsory licenses to prevent abuses that could result from the exercise of the exclusive right that is afforded by the patent, such as, for example, the lack of its exploitation”. Thus, considering that the Paris Convention establishes the compulsory licensing for the lack of exploitation, and the fact that the TRIPS determines that the Paris Convention provision quoted above must be respected by the members of this treaty, it may be construed that there are no inconsistencies in Law 9.279/96 in this regard.
As regards item (iv), it establishes that even if the patent owner explores the object protected under the patent, it will be subject to a compulsory license if it does not fulfill the market’s needs. Such license may be requested after a three-year period following the grant of the patent.
In the cases of dependence on the patent provided in item (v), the subject matter of the second patent must consist in a substantial technical progress in regard to the first patent, being foreseen the possibility of a cross-license in the event the compulsory license is granted to the owner of the second patent based on the dependence of patents.
In regard to the cases foreseen in items (vi) and (vii), having in view that Law 9.279/96 does not clearly define “national interest or emergency” this matter was regulated by Decree 3.201 of Oct. 6, 1999, supplemented by Decree 4.830 of Sept. 4, 2003.
According to this Decree, a patent may be compulsorily licensed in cases of national emergency or public interest, in the latter case only for non-profit public use, provided that declared as such by the Government, when it is asserted that the patent owner, directly or through its licensee, does not fulfill the related needs.
In further regard to this Decree, it should be mentioned that in the cases in which a compulsory license is granted, in the cases in which the unfeasibility to manufacture the object of the patent by a third party or by the Government is demonstrated, the Government may import the patented product, giving priority to the product that was placed in the market directly by the owner, or with the owner’s consent. Considering that this measure entails the possibility of importing products manufactures by third parties (presumably from countries where there is no patent protection) and that this would go beyond the provisions of Law 9.279/96, this Decree could be challenged in court on the grounds of unconstitutionality.
Further, this Decree establishes the obligation of the patent owner to provide the required and sufficient information for reproducing the patented object and the other technical aspects applicable to the case under penalty of nullity of the patent. This measure, however, is not foreseen in Law 9.279/96 and, thus, such obligation could also be challenged in court.
The only case of effective compulsory license dates of May 5, 2007, when the Brazilian Government based on Decree 3.201, issued a new Decree No. 6.108, obtaining a compulsory license for Merck Sharp & Dohme patents, related to Efivarenz Aids treatment drug.
According to this Decree, two patents No. BR1100250-6 and BR9608839-7 (both already expired), were compulsorily licensed, on a non-exclusive basis and within the scope of the Nation Program for Sexually transmittable diseases/AIDS. The term of the license fixed in the Decree was five years and the royalty rate is 1.5% of the cost of manufacture of the drug by the Ministry of Health. The drug can, if necessary, could imported.
Further in the field of pharmaceutical patents, as established in article 229-C of the LPI, a patent grant for pharmaceutical products and processes depends on the authorization of the National Agency of Sanitary Surveillance (ANVISA).
In view of this, pharmaceutical patent applications are first be assessed by ANVISA and then, if approved, sent for further examination by INPI. If, however, ANVISA denies approval, they will be shelved without even being examined by INPI. In this regard, according to ANVISA’s Resolution currently in force:
- The prior consent for pharmaceutical patent applications related to subject matter that represents a risk to human health will be denied;
- Pharmaceutical patent applications related to a substance or a therapeutic destination considered strategic for the Brazilian Universal Healthcare System (SUS), which are listed in Ordinance # 3089/2013 from the Brazilian Ministry of Health, will undergo a substantive patent analysis by ANVISA based on the provisions of our current IP Law (substantive examination of patentability requirements);
- Any pharmaceutical patent application not related to a prohibited substance, and to a substance or a strategic therapeutic destination for SUS will not undergo substantive patentability examination by ANVISA.
Finally, according to Brazilian Law No. 13,123 / 2015, any research or technological development based on Brazilian Genetic Heritage and also on associated traditional knowledge is subject to governmental authorization that must be obtained before the access itself.
In this context, when filing patent applications, the applicant of the application must state whether the invention has made use of the Brazilian Genetic Heritage and / or associated traditional knowledge, provided that it has been made as of June 30, 2000, if it has not made on the occasion of the filing, the applicant must do so in response to an office action issued by the INPI, within a period of 60 days.
4.2.4. Measures to reduce the delay in examining patent applications
On July 9, 2019, INPI published Resolutions 240/19 and 241/19, which have the purpose of implementing the Plan to Reduce the Backlog, according to which it is intended to drastically reduce the patent backlog by the end of 2021. Patent applications filed until December 31, 2016 are eligible for examination.
According to the rules of this Plan, the INPI implemented a simplified procedure for examining patent applications not yet submitted for examination, based on search reports issued by another patent office abroad. For these cases, no further searches of the state of the art are carried out. For patent applications without a search report abroad, a search report is issued.
In both cases, applicants have the opportunity to amend the patent application in order to overcome any relevant prior art and / or file arguments about patentability. Examination rules remain unchanged and amendments that broaden the scope of the claims are prohibited, as well as the submission of new claims categories after the examination request. If the amendments and arguments are considered appropriate by the examiner, the application is allowed. The time limit for responding to the preliminary office actions is 90 days and the lack of response results in the unappealable shelving of the application.
Since its start, the Plan to Reduce the Backlog has reduced by more than 38 thousand out of a total of 147,743 pending applications that qualify for the simplified procedure, thus proving to be a very successful measure that will drastically reduce the expected period for granting patents in Brazil.
At the same time, the INPI has a priority examination procedure for patent applications for various reasons, such as requests from individual applicants aged 60 or over, in case of violation by third parties, applications related to green technologies, among other reasons. The Patent Prosecution Highway (PPH) program is also available to several patent offices abroad.
4.2.5. Registration of Industrial Designs
Law 9.279/96 grants to the author the right to a registration of an industrial design that affords ownership over the “ornamental plastic form of an object” that provides “a new visual result and unique in its external configuration and that may be used as a type of industrial manufacturing”.
The registrations of industrial designs are issued without an examination on the merits therefore, in a few months (in average 6 to 12 months) as of the filing of the application and are valid for 25 years, at maximum.
Upon the issuance of the industrial design registration, the owner may immediately enforce its rights, inclusively to take court action against any violators. However, considering that the registration is granted without a formal analysis, it is advisable to, following the grant of the registration, to request the INPI to formally analyze it. After obtaining a favorable opinion issued after the formal analysis is completed (in approximately 1 to 2 months), the owner’s position in regard to third parties is strengthened considerably.
In view of the celerity in the process of grant and analysis of the Industrial Design Registrations, the protection of products in Brazil in this category has been demonstrated to be an excellent competitive tool.
Author: Frank Fischer
Dannemann, Siemsen, Bigler & Ipanema Moreira
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