Patents of Invention and Utility Models
– Law No. 9.279 of May 14, 1996 (Industrial Property Law), official publication in the Official Gazette Section I of May 15, 1996 – Provisions of Articles 230, 231 and 239, in force as from May 15, 1996, the best known of which are the so-called pipeline provisions, and the remaining Articles, in force as from May 15, 1997.
– Patent Office Regulations and Examination Guidelines in the form of Normative Instructions Nos. 30/2013, 31/2013 and 118/2020, Ordinance No. 411/2020 and Resolutions Nos. 93/2013, 124/2013, 144/2015, 169/2016, 208/2017, 405/2020 (prosecution, examination, procedures, formalities, amendments and divisional), 85/2013 (examination guideline for utility models) among other PTO's regulations.
– Decree No. 2.553 of April 16, 1998 – Patents of interest to the national defense and the payment to researchers of public institutions.
– Decrees No. 3.201 of October 6, 1999 and 4.830 of September 5, 2003 – regulate the grant, ex officio, of compulsory license in cases of national emergency and public interest.
– Law No. 14.200 of September 2, 2021, amendments to Article 71 of Law No. 9.279.
– Law No. 10.196 of February 14, 2001, amendments to Articles 43 and 229 of Law No. 9.279.
– Law No. 14.195 of August 26, 2021, revoking the Sole Paragraph of Article 40 and Article 229-C of Law No. 9.279.
– Law No. 10.973 of February 12, 2004 – introducing incentives for innovation and scientific and technological research.
– Provisional Measure 352 of January 22, 2007 – promoting semiconductor and digital TV industries and introducing printed circuit topography protection.
– Law No. 13.123 of May 20, 2015 – refers to access to genetic heritage, the protection and access to associated traditional knowledge, and the sharing of benefits for conservation and sustainable use of biodiversity.
– Decree No. 8.772 of May 11, 2016 – regulates Biodiversity Law No. 13.123/2015.
– INPI (Brazilian PTO) and ANVISA (National Agency for Sanitary Surveillance): INPI and ANVISA’s Joint Ordinance No. 01/2017, INPI’s Normative Instruction No. 01/2017, and ANVISA’s Resolution No. 168/2017.
– Law No. 11,105 of March 24, 2005 – refers to GMO's.
– Law No. 10.603 of December 17, 2002 – refers to Data Protection.
Membership in International Conventions
– Paris Convention for the Protection of Industrial Property, Stockholm Act.
– Pan-American Convention (Buenos Aires 1910) (patents).
– Convention Establishing the World Intellectual Property Organization (WIPO), since March 20, 1975.
– Strasbourg Agreement Concerning the International Patent Classification, since October 7, 1975.
– Patent Cooperation Treaty (PCT), ratified on April 9, 1978.
– WTO’s TRIPS Agreement, since January 1, 1995.
– The Hague Convention Abolishing the Requirement of Legalization for Foreign Public Documents (Apostille), since August 14, 2016.
Applicant: the right to obtain a patent is assured to the author of an invention, his heirs or successors, or an assignee; legal entities may file application as assignees or if expressly authorized by the respective inventor(s). In the case that an invention is created jointly by two or more inventors, a patent may be applied for by all or anyone of them, by naming and qualifying the others to guarantee their respective rights. Where the same invention is devised independently by two or more authors, the right to obtain a patent is assured to whoever proves the earliest filing, independently of the date of invention or creation.
Foreigners and nationals not living in the country: must appoint a representative domiciled in Brazil.
First filing requirement: not required. An applicant, who is a Brazilian national, or who has his/her permanent residence or principal place of business in Brazil, may file the first patent application in any country.
Types of patents: (a) patents of invention; (b) utility model patents.
Patentability: (a) patents of invention – any new invention resulting from an inventive activity and capable of industrial utilization; (b) utility model patents – any object of practical use, or part thereof, that is capable of industrial application, presents a new shape or arrangement and involves an inventive act that results in a functional improvement in its use or manufacture.
Novelty: not part of the state of art, which is constituted by everything made available to the public, be it by means of a written or oral description, by use or any other means, including the contents of patents in Brazil and abroad, before the priority date or the date of filing the application. Grace period: the disclosure of an invention or utility model which occurs during a twelve-month grace period preceding the date of filing or priority of the patent application will not be considered as part of the state of the art, provided such disclosure is made by the inventor, by the National Institute of Industrial Property (INPI), by means of the official publication of a patent application filed without the consent of the inventor and based on information obtained from him or as a result of his acts, or by third parties on the basis of information received directly or indirectly from the inventor or as the result of his acts. For the purposes only of novelty, prior filed unpublished Brazilian applications are incorporated in the state of the art.
Not patentable: unpatentable subject matter and matter considered not to be an invention or utility model are discoveries, scientific theories and mathematical methods; purely abstract concepts; schemes, plans, principles or methods of a commercial, accounting, financial, educational, publishing, lottery or fiscal nature; literary, architectural, artistic and scientific works or any aesthetic creation; computer programs per se; the presentation of information; rules of games; 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 plasm 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; and living beings in whole or in part, except transgenic microorganisms (organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot normally be attained by the species under natural conditions) meeting the three basic requirements of novelty, inventive activity and industrial application and which are not mere discoveries.
Priority: must be claimed on filing, but additional priority claims may be made within sixty days. An internal priority of twelve months is also available based on applications first filed in Brazil.
Electronic filing and paperless prosecution: the Brazilian Patent and Trademark Office has introduced an electronic system for filing and general petitions relating to prosecution, grant and renewal of patents. Filings and other petitions on paper are no longer permitted.
Filing requirements for an application (to be sent to resident agent):
1. Application form signed by attorney;
2. Power of attorney including powers to receive judicial summons (no legalization); may be filed within sixty days from date of application;
3. Specification in Portuguese; the application can be filed in a foreign language, but a translation into Portuguese must be submitted later (it is advisable to file it within the subsequent thirty days to avoid an Office action);
4. Drawings; the drawings shall not be framed or contoured by lines and shall be made on smooth white paper DIN A4, with the following minimum blank margins: upper margin: 4 cm, left margin: 3 cm, right margin: 1.5 cm, lower margin: 1 cm;
5. Certified copy of the complete basic application (priority document) may be filed within 180 days from the filing date, accompanied by a simple translation of the filing certificate or like document that contains suitable information to identify the document;
6. Name, nationality, profession, and complete address of the applicant and the inventor;
7. Where relevant, an assignment of priority rights (no legalization), must be filed within 180 days.
Further requirements for PCT national phase:
8. Full PCT filing information (preferably including copy of international request);
9. Description, claims and abstract precisely as filed at receiving Office; for the entry into the BR phase a partial translation (claims and abstract) is required. The specification can be filed in a foreign language, but a translation into Portuguese must be submitted later (it is advisable to file it within the subsequent thirty days to avoid an Office action);
10. Claims as originally filed and, where relevant, last set of claims filed in international phase (one of these sets of claims may be filed up to sixty days after national phase entry);
11. Any pages of the specification and drawings as amended by the end of the international phase;
12. Instead of the formal priority document mentioned in 5 above, a simple copy of the filing certificate or like document that contains suitable information to identify the document (a simple translation must be filed within sixty days from national phase entry);
13. When relevant, assignment of the international application. When the assignment was proven to have been communicated to the International Bureau during the international phase this document may be filed during prosecution. However, when not so communicated to the Bureau and the national phase is filed in the name of the assignee, the assignment should be filed at the time of entry into the BR phase or the entry into the BR phase should enter in the name of the applicant of the International phase and a request of change should be filed later with an assignment document (with signatures of assignor and assignee, two witnesses and with notarization and consular legalization).
Time limit for entering national phase under Chapters I and II: 30 months. Late national phase entry is not possible.
Notes: (a) where relevant, an assignment of priority rights (no legalization) must be filed within sixty days; (b) although not required for filing, it is advisable to provide the Brazilian agent with copies of the International Request, the International Search Report and, when available, the International Preliminary Examination Report.
Claims: may be amended for entry into national phase; multiple dependent claims are not allowed.
Minimum requirements to obtain a filing date: an application that does not formally meet the basic requirements, but which does contain data relating to the subject matter, the applicant and the inventor, and the Portuguese translation at least of the claims, abstract and title of the application, may be delivered to the INPI against a dated receipt which will establish the requirements to be met within a period of thirty days, in which case the original filing date is validated.
Declaration regarding genetic heritage and traditional knowledge: applicants are required to declare, on filing, whether the invention was – or was not – obtained by using samples of components of the Brazilian genetic heritage to which access was obtained after June 30, 2000, in which case the applicant must inform the number and date of the corresponding access certificate as well as the origin of the genetic material and of any associated traditional knowledge.
For a change of name:
1. Certified copy of the document evidencing the change of name, legalized by Apostille;
2. Power of attorney in the new name (no legalization).
For a change of address: power of attorney with the new address (no legalization).
Publication: publication will be effected after eighteen months from the date of the earliest priority, during which period the application is maintained in secret. Publication can be made upon request by the applicant.
Examination: to avoid abandonment, examination must be requested either by the applicant or by any interested third party within thirty-six months of the date of filing, and will not be made prior to sixty days from publication of the application.
Fast-Track Examination: accelerated examination may be requested when (a) the applicant is an individual of sixty years old or older (evidenced by identification document); (b) the applicant is an individual having mental or physical disability or serious illness; (c) the subject matter of the patent application is being reproduced by an unauthorized third party (evidenced by prima facie proof of infringement and a copy of the cease and desist letter sent to and duly received by the unauthorized third party); (d) based on a circumstance of governmental financing (grant of the patent is a condition for obtaining financial resources from an official credit institution in Brazil; or the patent application results from public financing, having direct financial support derived from public revenues with the express purpose of its development; (e) the invention relates to diagnosis, prophylaxis or treatment of cancer, AIDS or certain "neglected" diseases; (f) the patent application is entitled to participate into the Brazilian PPH Program; (g) the claimed subject matter is considered to be a "green" invention in accordance with the "Green" Patents Program of the Brazilian PTO; (h) based on a Brazilian priority (patent applications filed in Brazil having a patent family initiated at the Brazilian PTO); (i) based on the nature of the applicant (Science and Technology Institutions/ICT's, Micro Enterprises/MPE's, and Small Business Enterprises/EPP's and StartUp's receive special treatment with regard to acceleration of their patent applications); (j) based on a technology available in the Brazilian market; (k) based on a circumstance of prior user; and (l) based on a subject matter related to COVID-19.
Voluntary amendments: may be made up to the request for examination.
Third parties: documents and information for aiding examination may be filed by interested parties between publication of the application and the termination of examination.
Divisional applications: a patent application may be divided, up to the end of examination (defined as the date of the conclusive opinion report regarding patentability (allowance, rejection or definitive shelving decision) or thirty days prior to publication thereof, whichever is later), ex officio or on request of the applicant. If divisional is filed after submission of a request for examination, according to the current practice, the Patent Office will not allow amending the claims beyond the scope of the already pending claims, with very few exceptions.
Official notifications: the maximum time limit (non-extendible) for replying to Official notifications/Office actions is ninety days, and sixty days for submitting appeals against rejection decisions (Brazilian PTO’s level).
Issuance fees: the final fee must be paid and the payment proved within sixty days from allowance. It may also be paid and proved thirty days after such time limit, by payment of a specific fee, to avoid unrecoverable abandonment.
Issuance of Letters Patent: the Letters Patent (only in digital format) will be issued after the payment of the final issuance fees.
Rights resulting from patent applications: if a patent application is being infringed during its prosecution, the infringer may be sued for damages in court after the grant of the respective patent.
Duration of patents: patents of invention – twenty years from filing; utility model patents – fifteen years from filing.
Extent of protection: the extension of protection conferred by a patent is defined by the scope of the claims interpreted in the light of the description and drawings.
Rights: a patent confers on its proprietor the right to prevent third parties from manufacturing, using, offering for sale, selling or importing: (a) a product that is the subject of a patent; and (b) a process or product directly obtained by a patented process. The patentee is further guaranteed the right to prevent third parties from contributing to the infringement of his patent, and the burden of proof in product-by-process infringement proceedings rests with the alleged infringer. Doctrine of equivalents is now expressly recognized in the law.
Non-infringing acts: (a) prior use rights recognized; (b) private use not prejudicial to the economic interests of the patentee; (c) experimental use for research; (d) preparation of medicines for individual cases in accordance with a doctor’s prescription; (e) internal (national) exhaustion of rights specifically recognized; (f) certain acts related to living matter; and (g) acts performed by unauthorized third parties aimed exclusively at producing information, data and results of tests, intending to obtain the register of commercialization, in Brazil or in another country, for the exploitation and commercialization of the patented product after expiry of the patent term.
Maintenance of patents: applicants and patentees are subject to the payment of annual fees, as from the beginning of the third year from the date of filing. The payment should be effected within the first three months of each annual period, but may still be effected within the following six months, independently of notification, by payment of an additional fee.
Restoration: a patent application or a patent may be restored, if the applicant or patentee so requests, within three months counted from notification of abandonment of the application or extinction of the patent, on payment of a specific fee.
Assignment: a patent application or patent, the contents of which are indivisible, may be assigned in whole or in part.
Licenses: a patentee or applicant may execute a license contract for exploitation of the subject matter of his patent, which license must be recorded at the INPI to produce effect with regard to third parties.
Offer to license: a patentee may request that his patent be offered for sale or licensing by the Patent Office, with a view to its exploitation. Annuities will be reduced by one half during the period that a patent is under offer.
Compulsory licensing: a patentee will be subject to have his patent licensed compulsorily if he exercises his patent rights in an abusive manner or abuses its economic as determined by an administrative or court decision. Compulsory licenses are also available: (a) for lack of manufacture or incomplete manufacture of the product, except when economically unviable, in which case importation is sufficient; (b) for commercialization that does not meet the needs of the market. In both cases, the compulsory license may only be requested after three years from grant of the patent by a party with legitimate interest and having the technical and economic capacity to work the invention predominantly for the national market; or (c) in a situation of dependency of one patent on another, provided the subject matter of the dependent patent constitutes a substantial technical advance in relation to the earlier patent and the patentee does not come to a voluntary agreement with the patentee of the dependent patent for the exploitation of the earlier patent. Compulsory licenses may also be granted by the government after decreeing a state of national emergency or public interest, provided the patentee does not meet the requirements of the emergency.
Certificate of addition: applicants or patentees of a patent of invention may request a certificate of addition to protect an improvement or development, even if lacking inventive activity, provided that it shares the same inventive concept. A certificate of addition is an addendum to the patent, has the same expiry date and accompanies it for all legal purposes.
Patents of interest to national defense: a patent application originated in Brazil, the object of which is of interest to national defense, will be processed in secrecy and will not be subject to publication.
Employee inventions: an invention or utility model will belong exclusively to the employer when it results from a work contract being executed in Brazil and the object of the contract is research or the exercise of inventive activity, or when the invention or utility model results from the nature of the services for which the employee was contracted. Except when there are express contractual provisions to the contrary, remuneration for the work to which this article refers will be limited to the salary agreed upon. Unless otherwise provided for, inventions and improvements thereof shall be deemed to have been made during the period of validity of the employment agreement, if a patent therefor is applied for by the employee within one year of the termination of the employment agreement. Inventions or improvements outside the scope of the employment agreement or that are created without the use of the employer’s resources, data, means, materials, installations or equipment, belong to the employee. The ownership, however, of an invention or utility model will be joint, in equal parts, when it results from the personal contribution of the employee and from resources, data, means, materials, installations or equipment of the employer, without prejudice to express contractual provisions to the contrary.
Nullification and Forfeiture after Granting
Granted patents can be opposed by means of an administrative nullity procedure (Art. 50-55 of the Brazilian IP Law) and/or a nullity action (Art. 56-57).
Administrative nullification procedure: within six months from grant of a patent, an administrative nullification procedure may be instituted within the INPI, ex officio, or on request of any person having legitimate interest. The patentee will be notified to reply within sixty days and, independently of a reply having been filed, once the period above has passed the INPI will issue an opinion, notifying the patentee and the applicant to reply within a period of sixty days. Even if no replies are filed, the process will be decided by the President of the INPI, thus terminating the administrative instance.
Nullification actions: can be filed at any time during the term of a patent by the INPI or by a legitimate party and the Judge may, as a preventive or incidental measure, determine the suspension of the effects of a patent. The general period for the defendant to reply is sixty days.
Forfeiture due to non-use: may be requested, ex officio, or by any party with a legitimate interest, when there is still no use at the date of the request and two years have passed since the grant of a compulsory license.
Between May 15, 1996 and May 15, 1997, it was possible for any person who had a foreign patent or patent application, the protection of which was guaranteed by treaty or convention in force in Brazil, and the subject matter of which related to substances, matter or products obtained by chemical means or processes and alimentary and chemical-pharmaceutical substances, matter, mixtures or products and medicines of any type, as well as the respective processes of obtaining or modifying them to file a “pipeline”patent application, provided that this subject matter had not been placed on any market on the direct initiative of the proprietor or by third parties with his consent, nor had third parties carried out, in Brazil, serious and effective preparations for exploiting the subject matter of the application or patent. Somewhat similar provisions existed for persons resident in Brazil, where no patent application was filed due to the fact that the subject matter was not patentable under national legislation at the time of the first disclosure.
Supplementary Protection for Pharmaceuticals and Biotechnological Inventions
(1) Supplementary Protection due to Regulatory Delays
In short, there is no legal regime in Brazil providing for patent term extension due to regulatory delays in obtaining market approval for the commercialization of biotechnological medical and agrochemical products similar to what exists under European law. Indeed, the Brazilian Industrial Property Law No. 9.279/1996 specifically defines, in Article 40, the term of patents as being twenty years from the filing date. There is only one exception to this rule regarding patent term in Brazil and that is with respect to the so-called pipeline patents. Only the pipeline patents which were filed between May 1996 and May 1997 may seek to have their term harmonized with that of the corresponding ground patent. Pipeline patents are those patents that could not be protected prior to the new IP Law that went into effect in May 1996 but could obtain protection under the new IP Law provided that the requirements of Article 230 had been met. It follows in this situation that if a Brazilian pipeline patent is grounded on a U.K. patent extended via a supplementary protection certificate, the term of the pipeline patent may theoretically be harmonized with the extended term in the U.K. However, in order to harmonize the patent term, a lawsuit must be initiated. In response to these actions, Brazilian courts have generally refused the harmonization of the Brazilian pipeline patent with its correspondent foreign patent.
(2) Supplementary Protection due to Delays in Patent Examination
As aforementioned, with the exception of the rare cases concerning the potential for there being patent term extension of pipeline patents, the term of patents in Brazil is fixed specifically at twenty years from the filing date.
(3) Data Protection – another form of Supplementary Protection
Although not necessarily providing for supplementary protection of a given patent, data protection is a means by which companies may obtain meaningful protection of products that may no longer be protected by patents.
Law No. 10.603/2002 is the Data Protection Law in Brazil and provides for data exclusivity rights for pharmaceutical products for veterinary use and agrochemical products. Data protection for pharmaceuticals destined for human use is not provided for by this Law. The Data Protection Law protects information related to classified tests results and data presented to the authorities responsible for approving the commercialization of a particular product in Brazil. The Data Protection Law provides a period of exclusivity of ten years, counting from the date of market approval, for products containing new chemical or biological entities or until the information is liberated in any country, guaranteeing at least a minimum of one year of protection. For products that do not use new chemical or biological entities, the exclusivity period is reduced to five years.
With respect to pharmaceutical products destined for human use, the Brazilian National Health Surveillance Agency (ANVISA) will not respect any period of non-reliance after the issuance of a marketing approval to the company seeking registration of its pharmaceutical product. Therefore, third parties may obtain a market approval for a generic drug, as an example, by referring to the originator’s data presented in the dossier seeking market approval for its pharmaceutical product. Although not specifically afforded protection by the Data Protection Law, there are legal arguments which may be used to enforce data protection for pharmaceutical products destined for human use. Namely, the equitable doctrine of unjust enrichment may be invoked as well as a textual argument based on Article 195, Section XIV of the Brazilian Intellectual Property Law No. 9.279/1996 which provides that it is a crime of unfair competition for one to use, without authorization, the results of tests or other undisclosed data submitted to government entities as a condition for the approval of the commercialization of products.