Overview of Patent BR122017028096
Patent BR122017028096, assigned to TERUMO KABUSHIKI KAISHA, was filed on August 29, 2006, with an original expiration date of August 29, 2026[1][2]. However, due to a preliminary injunction (PI) issued by the Brazilian Patent and Trademark Office (BRPTO), the patent’s term was reduced by 4 years and 7 months, resulting in a revised expiration date of August 29, 2026[1][2]. This adjustment aligns with broader trends in Brazil, where preliminary injunctions have led to truncated patent terms for pharmaceuticals and medical technologies since 2021[1][3].
Key Characteristics of the Patent
- Application Number: 2007/026916[1].
- Technology Focus: While the exact claims are not publicly disclosed, TERUMO’s portfolio typically centers on medical devices and cardiovascular technologies. The patent likely protects a product or process related to these domains, such as catheter systems or diagnostic tools.
- Legal Status: The patent remains active but operates under a reduced term due to the PI[1].
Scope and Interpretation of Claims in Brazilian Patent Law
Defining Patent Scope in Brazil
Under Article 41 of Brazil’s Industrial Property Law (Law No. 9.279/96), the scope of patent protection is determined by the claims, interpreted in light of the specification and drawings[12]. Amendments during prosecution must not introduce new subject matter and are generally restricted to narrowing claims[12][15]. For BR122017028096, this implies that any post-filing modifications would have been limited to refining—not expanding—the claimed invention.
Challenges in Claim Drafting
- Literal Infringement: Brazilian courts require exact replication of claim elements for infringement[12]. If BR122017028096 includes method claims, enforcement would depend on demonstrating that competitors replicate all steps or components described[12].
- Exclusions: Therapeutic methods applied to humans or animals are non-patentable in Brazil[12]. If the patent involves medical applications, TERUMO may have utilized Swiss-type claims (e.g., “Use of X for manufacturing a medicament to treat Y”) to circumvent this restriction[12].
Patent Landscape Analysis: Pharmaceuticals and Medical Devices in Brazil
Impact of Preliminary Injunctions on Patent Terms
Since 2021, the BRPTO has granted patents with reduced terms under preliminary injunctions, citing systemic delays in examination[1][3]. For BR122017028096, this resulted in a 37% reduction in its original 20-year term[1]. Over 30 major patents, including those from Bayer, AstraZeneca, and Boehringer Ingelheim, have faced similar adjustments[1][2]. This trend reflects legal disputes over Brazil’s “10-year rule,” which previously allowed term extensions for patents delayed beyond a decade in prosecution[3][14].
Regulatory and Judicial Shifts
- Supreme Court Ruling (2021): Brazil’s Supreme Court invalidated provisions permitting patent term extensions, retroactively applying the decision to pharmaceutical patents[14]. While BR122017028096’s term was adjusted via PI, this ruling underscores broader judicial skepticism toward prolonged monopolies in healthcare[14].
- Bioinputs Regulation (2024): Recent reforms emphasize sustainable agriculture but highlight risks of IP infringement in on-farm production of bioinputs[5]. Though unrelated to TERUMO’s patent, these changes signal Brazil’s tightening balance between innovation and public access[5].
Competitive and Market Implications
Generic Entry and Litigation Risks
With BR122017028096 set to expire in 2026, generic manufacturers are likely preparing for market entry. Key factors influencing competition include:
- Paragraph IV Challenges: Generic producers may challenge the patent’s validity or design around its claims[7].
- Litigation Trends: Brazilian courts favor civil actions (e.g., injunctions, damages) over criminal proceedings for patent enforcement[12]. TERUMO would need to prove literal infringement to halt competitors[12].
Strategic Considerations for Innovators
- Claim Precision: Narrow claims risk easier design-arounds, while overly broad claims risk invalidation[6][12]. TERUMO’s ability to enforce BR122017028096 hinges on clear, defensible claim language.
- Portfolio Diversification: Competitors like Becton Dickinson and CareFusion hold overlapping patents in medical devices, necessitating freedom-to-operate analyses[1][7].
Conclusion
Patent BR122017028096 exemplifies the challenges of navigating Brazil’s evolving IP landscape. Reduced terms via preliminary injunctions, strict claim interpretation, and judicial reforms prioritizing public health create a high-stakes environment for innovators. For TERUMO, proactive enforcement and monitoring of generic activity will be critical to maximizing the patent’s residual value. Meanwhile, Brazil’s patent system remains a bellwether for balancing private innovation incentives with societal needs.
Key Takeaways
- BR122017028096’s term reduction reflects systemic adjustments under Brazil’s preliminary injunction framework.
- Claim scope in Brazil is narrowly interpreted, requiring exact replication for infringement.
- Judicial reforms and regulatory shifts prioritize public access over prolonged monopolies.
- Strategic patent drafting and litigation readiness are essential for market retention.
FAQs
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Why was BR122017028096’s term reduced?
The reduction resulted from a preliminary injunction addressing prosecution delays, part of a broader BRPTO initiative[1][3].
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Can TERUMO extend the patent’s term?
No. Brazil’s Supreme Court barred term extensions in 2021, retroactively applying to pharmaceuticals[14].
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How does Brazil’s claim interpretation affect enforcement?
Courts require literal replication of claim elements, complicating enforcement against design-arounds[12].
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What risks do generics pose post-2026?
Generics may launch immediately after expiration, leveraging Paragraph IV challenges or invalidation petitions[7].
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Are Swiss-type claims viable for medical methods in Brazil?
Yes, but therapeutic methods per se remain non-patentable, necessitating careful claim drafting[12].
References
- https://www.lickslegal.com/news/due-to-preliminary-injunction-patents-continue-to-be-granted-with-a-reduced-term-of-protection
- https://www.lickslegal.com/news/patents-granted-with-a-reduced-term-of-protection-due-to-preliminary-injunction
- https://www.ipdanalytics.com/brazil-life-cycle-insights
- https://curity.io/resources/learn/scopes-claims-and-the-client/
- https://patentblog.kluweriplaw.com/2025/01/13/brazil-understanding-the-new-bioinputs-regulation-and-patent-landscape/
- https://www.mondaq.com/brazil/patent/15441/the-scope-of-claims-their-interpretation
- https://www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/Brazil
- https://curity.io/resources/learn/scopes-vs-claims/
- https://pubchem.ncbi.nlm.nih.gov/patent/CN-101300229-B
- https://pubchem.ncbi.nlm.nih.gov/patent/CA-2621182-C
- https://sagaciousresearch.com/blog/what-is-a-patent-landscape-report-how-to-create-it/
- https://www.montaury.com.br/en/scope-of-patent-protection-brazil
- https://www.wipo.int/publications/en/series/index.jsp?id=137
- https://peoplesdispatch.org/2022/12/15/pharma-companies-attempt-to-overturn-brazilian-supreme-courts-historic-decision-on-patents/
- https://patentblog.kluweriplaw.com/2024/02/28/brazil-important-updates-on-the-new-rules-regulating-administrative-appeals/
Last updated: 2025-04-22
