How do you get a patent in your jurisdiction?

Q: What types of patent are granted in your jurisdiction, and what rights do they confer on owners?

According to Article 2 of the Industrial Property Law (Law 9,279/96), the Brazilian Patent and Trademark Office (BPTO) grants two types of patent:

  • patents of invention; and
  • utility model patents.

The owner of a granted patent is entitled to the right to:

  • exploit the patent exclusively (Article 6);
  • prevent third parties from manufacturing, using, offering for sale, selling or importing a product subject of a patent, a process or product directly obtained through a patented process, as well as from contributing to the practice by other parties of such acts (Article 42); and
  • obtain compensation for the unauthorised exploitation of the subject matter of the patent (Article 44).

Q: What inventions are eligible for patent protection in your jurisdiction?

Any creation related to a product or process, industrially applicable and not included in the list of patent exemptions, is patent eligible. The Industrial Property Law provides no definition for ‘inventions’, but it is part of Brazilian practice to look for the technical effects of a creation when discussing patentability.

A ‘utility model’, on the other hand, is defined as an object of practical use, or part thereof, which presents a new shape or arrangement, resulting in functional improvement in its use or manufacture.

Q: Are there any specific exemptions to patent eligibility?

The following are not patent eligible:

  • discoveries, scientific theories and mathematical methods (which can be considered inventions if applied to the solution of a problem and they provide a technical effect);
  • purely abstract concepts;
  • schemes, plans, principles or methods of a commercial, accounting, financial, educational, publishing, lottery or fiscal nature (even if implemented in a computer);
  • 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; and
  • natural living beings, in whole or in part, biological material when found in nature or isolated therefrom, and natural biological processes (Article 10).

The following are also not patentable:

  • anything 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 or 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 micro-organisms that are not discoveries (Article 18).

Q: Are there technology-specific eligibility issues that applicants need to navigate (eg, in software, business methods, AI, medical diagnostics, pharmaceuticals, medical procedures, etc)?

Yes, there are technology-specific eligibility issues to consider. Therapeutic, operating or surgical methods are not considered inventions under the Industrial Property Law. Hence, those methods should be redrafted according to the Swiss style (“use of a compound X characterised by being in the manufacture of a medicament for treating medical condition Y”), which is potentially patentable.

Second medical use claims are also patentable in Brazil as Swiss-type claims. The Markush structure is acceptable for compounds and biological sequences, but the BPTO tends to be restrictive in limiting the resulting combinations to the examples provided in the specification.

The BPTO does not accept software claims or software product claims, unless drafted as computer-readable medium claims.

Further, even though there are as yet not many decisions concerning AI, like in Europe, the ‘core’ technology behind AI would not be patent eligible. However, a given application of AI resulting in a technical purpose could receive patent protection.

Q: What are the time and costs involved in securing a granted patent? Is expedited examination available? Are reduced fees available for certain applicants?

Brazil has been known for its patent backlog. The plan to end it within two years and to reduce the grant time from 10 years (on average) to three to four years began in July 2019. It has shown significant results and will likely attain its objectives.

The BPTO has also implemented fast-track examination proceedings, which may be requested where:

  • applicants are more than 60 years old;
  • applications have been infringed by third parties;
  • applications relate to treatment of covid-19, AIDS, cancer, rare or neglected diseases;
  • applications have been filed by small entities and start-ups;
  • applications have been filed by science and technology institutions;
  • applications cover green technologies; and
  • applications are subject to a patent prosecution highway programme.

The costs involved in prosecuting a patent application are difficult to estimate, as different factors (eg, number of claims, office actions, appeal and number of annuities) may have an impact on the cost of obtaining a patent. Reduced fees are available for certain applicants such as natural persons, small businesses, research institutions, non-profit entities and public agencies.

Q: What are any specific requirements that a patent specification must meet in your jurisdiction?

There are no specific patentability requirements for Brazil. The worldwide use requirements of enablement, novelty and inventive activity must be met.

Q: What rules govern the filing of provisional applications, continuations or continuations-in-part, divisionals, or any other special type of application?

A patent application may, until the end of its examination, be divided, ex officio or, at the applicant’s request, into two or more applications. The divisional application must:

  • refer to the original application; and
  • not exceed the matter disclosed in the original application (Article 26).

A certificate of addition is also available to protect an improvement or development introduced in the subject matter of a patented invention or patent application, even if lacking inventive step, provided that it shares the same inventive concept (Article 76).

Q: What do applicants need to know about office actions and patent examiner interviews?

Examiners typically analyse each application under two aspects:

  • formal – clarity of the claims and unity of invention; and
  • substantive – enablement, novelty and inventive activity.

Brazilian patent practice has been largely influenced by European practice. Therefore, applicants might expect some of the EPO’s requirements when prosecuting applications in Brazil.

Patent examiner interviews are available. Unlike the United States, examiners will not accept a telephone interview. A formal meeting must be scheduled, where the head of the corresponding patent division will be present together with the examiner.

Q: Are there any recent examination trends that patent applicants need to be aware of?

Based on the BPTO’s recently published examination guidelines for biotech-related patent applications, degenerated DNA or RNA sequences defined by a nucleotide SEQ ID are acceptable, if they generate the same protein and that protein is precisely defined. The guidelines have also clarified that the prohibition of patent protection for surgical techniques and therapeutic methods extends to embryos.

In relation to antibodies, it is now clearly established that if the antibody has been obtained from an organism that is naturally exposed to the antigen, the antibody will be considered natural and barred from patent protection. However, if the antibody could not be obtained without human intervention, it is entitled to patent protection.

Products, manufacturing processes and uses of human embryonic stem cells are now patentable in Brazil. Inventions involving the generation or multiplication of genetically modified plants with sterile reproductive structures (ie, the application of genetic use restriction technology) will be rejected.

When assessing the inventive step of applications covering software implemented inventions, it is important to determine whether the technical effect is derived from the invention itself and not from the computer in which the invention is implemented or how the software was coded.

Q: Is there anything else about the patent filing process that applicants should know?

Foreign applicants must name qualified attorneys in Brazil. If the application claims a priority, a certified copy of the priority document or its DAS code must be provided.

A grace period is available in Brazil. The disclosure of an invention during the 12 months preceding the date of filing or priority of the patent application will not be considered as part of the state of the art under specific conditions.

Voluntary amendments are possible, but after the request for substantive examination, claim amendments will be acceptable only if they result in restriction of the claimed scope of protection or aim at correcting clear mistakes. The addition of new claim categories, for example, will not be accepted.

Q: Is utility model or petty patent protection or an equivalent available in your jurisdiction? If so, how does the system work and under what circumstances would you advise using it?

Utility model protection is available in Brazil. Under Article 9 of the Industrial Property Law, an object of practical use, or a part thereof, will be patentable as a utility model if it is intended for industrial use, presents a new shape or arrangement and involves an inventive act resulting in functional improvement in its use or manufacture.

Prosecution of a utility model patent application is the same as for an invention patent application, but the requirements for obtaining utility model patents are less stringent (a lower level of inventive activity is required).

On the other hand, the term of protection for utility model patents is shorter than for invention patents (ie, 15 years instead of 20 years from the filing date). Also, the claims of a utility model are interpreted more restrictively when it comes to enforcement.

Given that invention applications can be converted into utility model applications during prosecution, a suitable strategy may be filing an invention patent application and asking for a conversion to a utility model application depending on the prior art cited by the examiner in a first office action.

What are the major administrative procedures in your jurisdiction?

Q: How can applicants appeal patent office decision?

All decisions of the BPTO can be appealed except those that declare definitive dismissal of an application or the allowance of the application. Appeals are decided by a board of appeals and its decisions are final, with no right to any further revision in the administrative sphere.

Any final decision of the BPTO may still be subject to a judicial review before the federal courts, within a five-year period.

Q: Are oppositions available pre-grant or post-grant? What rules govern standing to oppose a patent and the opposition process?

The Industrial Property Law does not provide for a formal pre-grant opposition, but any interested party may submit to the BPTO prior art references or comments regarding patentability until the end of the examination of the application (Article 31). Third parties may also oppose the granting of a patent by submitting documents and information within 60 days of publication of any administrative appeal filed by the applicant against a first-instance decision by the patent examiner.

In relation to post-grant proceedings, within six months from the publication of the patent grant, any third party with legitimate interest, or the BPTO ex officio, may start an administrative nullity procedure before the BPTO (Article 51). This procedure will be decided by the Commissioner of Patents, terminating the administrative proceedings available.

In addition, the BPTO itself or any third party with a legitimate interest may bring an invalidity lawsuit before the federal courts (Article 56) at any time during the term of the patent.

Q: What are the processes for re-examination of a patent?

During an administrative post-grant review, the BPTO will issue a first technical opinion inviting both parties to comment. A final decision will then be issued:

  • revoking the patent;
  • maintaining the patent; or
  • maintaining the patent in an amended form.

One specificity for Brazil is that in invalidity lawsuits, the BPTO is also a defendant and will provide technical opinions as to the merit of the challenged patent.

In both cases, the plaintiff bears the burden of proof and must prove through written arguments and documentary evidence the lack of fulfilment of the legal requirements or the violation of any section of the Industrial Property Law by the patent.

Q: What is the process for invalidation or revocation of a patent? Who has standing to request invalidation? How long do inter partes invalidation cases take?

The validity of a granted patent can be challenged either before the BPTO (when it is not the plaintiff) or before the federal courts.

If the BPTO or any third party with legitimate interest succeeds in a post-grant review, the patent is invalidated with retroactive effect to the date of filing. Such proceedings may take from two to five years.

Invalidity lawsuits may last between five and 10 years. The nullity of an issued patent can also be argued, at any time, as a matter of defence in patent infringement actions.

Q: How can opposition, re-examination or invalidation decisions be appealed?

A final post-grant review decision of the BPTO, whether it maintains the validity of the granted patent or determines its invalidity, is subject to an appeal before the federal courts only, within a five-year period, by way of a declaratory lawsuit to obtain the nullity of the administrative decision.

Q: Is administrative enforcement of patents possible?

No, administrative enforcement of patents is not possible. Enforcement of patent rights is a matter of state jurisdiction, as opposed to invalidity lawsuits that are filed before federal courts (due to the presence of the BPTO as a co-defendant, when it is not the plaintiff). Border measures are also available to enforce patent rights but are rarely used.

Q: Does your jurisdiction grant patent-term extensions?

There is no mechanism to extend patent term under the provisions of the Industrial Property Law.

A provision in the law was established to compensate for the BPTO’s delayed examination. The expiry date of a patent of invention is 20 years from filing, but not less than 10 years from grant. This provision is no longer available, since the Brazilian Supreme Court determined its unconstitutionality in May 2021. Pharmaceutical patents were the most affected by the removal of the provision.

Q: Is there anything else about patent administrative procedures that patent owners and challengers should know?

Pharmaceutical patent applications are no longer subject to the National Health Surveillance Agency’s (ANVISA) prior approval. Law 14.195/21 for the modernisation and improvement of the Brazilian business environment, which entered into force on 27 August 2021, revoked Article 229-C of the Industrial Property Law, according to which the grant of pharmaceutical patents was subject to ANVISA’s prior approval. This puts an end to years of legal uncertainty and misunderstanding between the BPTO and ANVISA, since both entities would examine patent applications but not always reach the same conclusion over patentability.

André Venturini, Karina Daiha, Louis Lozouet 

Venturini IP

 This article first appeared in IAM. For further information please visit  https://www.iam-media.com/corporate/subscribe