Introduction to Brazilian Patent Law
Brazil's patent system is governed by Law No. 9279/96, known as the Brazilian IP Law, which is regulated by the Brazilian Federal Constitution. Here are the key insights for patentability, enforceability, and the scope of claims specifically for biopharmaceutical patents.
Patentability of Biopharmaceutical Inventions
General Principles
Brazilian law imposes minimal restrictions on the patentability of pharmaceuticals, chemicals, and biotechnological inventions. This means that a wide range of claims can be filed, including those related to compounds, uses, formulas, and processes[5].
Exceptions
However, there are some exceptions:
- Therapeutic, surgical, and diagnostic methods applied to the human or animal body are not considered inventions and are therefore not patentable[3].
- Use claims such as "Use of a compound X characterized by it being used to treat a disease Y" are considered method of treatment claims and are not patentable. Instead, the Swiss-type claim format ("Use of a substance or composition X for the manufacture of a medicament for therapeutic application Z") is more acceptable, although certain composition or compound for use claims may also be accepted if quantitatively and qualitatively described[3].
Examination and Granting Process
Delays in Patent Examination
The patent examination process in Brazil is notably slow, especially for biopharmaceutical patents. The average examination timeline for biopharmaceutical patents is around 10.25 years, with almost 60% of applications exceeding ten years and 10% pending for 15 or more years[1].
International Comparison
This delay is significantly longer than in other major economies. For example, the average time to grant a patent is 2.8 years in Korea, 2.9 years in China, and under 2 years in the United States[1].
Scope of Patent Protection
Claim Construction
The scope of patent protection in Brazil is determined by the content of the claims, which must be read in conjunction with the specification and drawings (Article 41, Law No. 9279/96)[3].
Types of Claims
Brazil allows a broad range of claims for pharmaceuticals, including those related to compounds, uses, formulas, and processes. However, claims must be quantitatively and qualitatively defined to be considered novel and inventive[3].
Enforceability of Biopharmaceutical Patents
Lack of Patent Linkage System
Unlike the United States, Brazil does not have a patent linkage system similar to Hatch-Waxman. This means that generic manufacturers can complete all necessary steps for sanitary registration and production of a medication before the patent expires without infringing on the patent, thanks to the Bolar Exemption under Article 43, Section VII of the Lei de Propriedade Industrial (LPI)[2].
Litigation Strategies
Given the limitations of the Bolar Exemption, innovators in Brazil are exploring alternative strategies to ensure market exclusivity. One approach is filing Patent Term Adjustment (PTA) lawsuits to compensate for administrative delays during the patent examination process, potentially extending the patent term beyond its typical expiration date[2].
Civil vs. Criminal Actions
Most patent infringement lawsuits in Brazil are directed to civil courts because criminal penalties are weak, addressed to individuals rather than companies, and typically have no economic effect on the infringer[3].
Impact of Recent Legal Decisions
Supreme Court Decision on Article 40
The Supreme Court's decision in May 2021, declaring Article 40 unconstitutional, removed the guarantee that patents would last at least ten years from the date they are granted. This decision applies retrospectively to pharmaceutical products and other health-related inventions, further complicating the IP landscape for innovators in Brazil[1].
Proposed Reforms
Bill No. 5402/13
A pending bill before the Brazilian Parliament aims to reform the patent system. Proposed changes include increasing the standard of inventive step required for granting a valid patent, introducing a rule similar to Section 3(d) of the Indian Patent Act, and creating a pre-grant opposition procedure. The bill also seeks to strengthen the role of ANVISA in granting proceedings concerning pharmaceutical inventions[4].
Strategies for Innovators
Alternative Approaches
Innovators in Brazil are using various strategies to protect their inventions despite the challenges. These include:
- Filing PTA lawsuits to extend the patent term.
- Exploring litigation options, such as Paragraph IV infringement lawsuits, to protect market exclusivity[2].
Economic and Market Implications
Competitive Disadvantage
The slow patent examination process and lack of a patent linkage system put innovators in Brazil at a competitive disadvantage compared to those in countries like the U.S., China, and Korea. This can deter investment and hinder the development of new pharmaceutical innovations[1].
Market Dynamics
The outcomes of litigation and the strategies employed by innovators and generic manufacturers significantly impact market dynamics within the pharmaceutical industry. Both parties must carefully consider the implications of such actions[2].
Key Takeaways
- Patentability: Biopharmaceutical inventions are generally patentable in Brazil, with exceptions for therapeutic, surgical, and diagnostic methods.
- Examination Process: The patent examination process is slow, with significant delays, especially for biopharmaceutical patents.
- Scope of Protection: The scope of patent protection is determined by claim construction and must be quantitatively and qualitatively defined.
- Enforceability: The lack of a patent linkage system and weak criminal penalties complicate enforcement, but alternative strategies like PTA lawsuits are being explored.
- Legal Decisions: Recent Supreme Court decisions have removed important protections for patent holders.
- Proposed Reforms: Pending reforms aim to improve the patent system, including increasing the inventive step standard and strengthening ANVISA's role.
FAQs
What is the average time to grant a biopharmaceutical patent in Brazil?
The average time to grant a biopharmaceutical patent in Brazil is around 10.25 years, with many applications exceeding ten years and some pending for 15 or more years[1].
Does Brazil have a patent linkage system?
No, Brazil does not have a patent linkage system similar to Hatch-Waxman in the United States. This allows generic manufacturers to prepare for market entry before the patent expires[2].
What are the main exceptions to patentability in Brazil?
Therapeutic, surgical, and diagnostic methods applied to the human or animal body are not patentable. Additionally, certain use claims are not accepted unless they follow the Swiss-type claim format[3].
How do recent legal decisions impact biopharmaceutical patents in Brazil?
The Supreme Court's decision declaring Article 40 unconstitutional removed the guarantee of a minimum ten-year patent term from the date of grant, affecting pharmaceutical and health-related inventions retrospectively[1].
What strategies are innovators using to protect their biopharmaceutical patents in Brazil?
Innovators are using strategies such as filing Patent Term Adjustment (PTA) lawsuits and exploring litigation options like Paragraph IV infringement lawsuits to protect market exclusivity[2].
Sources
- Geneva Network: Building a predictable, stable patent system in Brazil.
- IPWatchdog: Protecting Pharmaceutical Innovation in Brazil Despite the Lack of a Patent Linkage System.
- Montaury: Scope of Patent Protection (Brazil).
- University of Illinois at Chicago: An Analysis of the Proposal for Reforming Brazilian Patent Law.
- Di Blasi Parente: Brazil's patent law and the pharmaceutical industry.
