Overview of Patent BR112014032905
Patent BR112014032905, granted to Amarin Pharmaceuticals Ireland Limited, protects methods of reducing cardiovascular risk using eicosapentaenoic acid ethyl ester (EPA) in patients on statin therapy. The invention targets individuals with fasting baseline triglyceride levels of 135–500 mg/dL, administering 1–4 g/day of EPA to lower the likelihood of myocardial infarction, stroke, and other cardiovascular events[1][2][10][15].
Key Claims and Technical Scope
1. Patient Population
The patent specifies a narrowly defined cohort:
- Statin-treated patients with persistent hypertriglyceridemia[2][10].
- Exclusion of subjects with triglyceride levels <135 mg/dL or >500 mg/dL[10][15].
2. Dosage and Formulation
- Daily administration of EPA ethyl ester (≥96% purity) in 1–4 g doses[2][10].
- Pharmaceutical compositions combining EPA with statins (e.g., atorvastatin, rosuvastatin)[14][15].
3. Primary Endpoints
Claims focus on reducing:
- Non-fatal myocardial infarction[10].
- Coronary revascularization[14].
- Hospitalization for unstable angina[15].
4. Secondary Biomarkers
- 25–30% reduction in triglycerides vs. placebo[14][15].
- 19% reduction in LDL cholesterol in high-risk subgroups[10][14].
Patent Landscape in Brazil
1. Legal Status and Expiry
- Priority Date: June 29, 2012[2][10].
- Filing Date: June 28, 2013[10].
- Expiration: Likely June 28, 2033 (20-year term from filing)[9].
- Current Status: Active grant (no challenges reported in provided data)[12].
2. Family Members and Global Coverage
BR112014032905 is part of a global patent family spanning 45+ countries, including:
- US Patents: 9,693,984; 9,610,272; 10,588,861[1][2][14].
- EPO Grants: EP2846176B1; EP3363433B1[11].
- PCT Application: WO2014/005013A2 (priority: 2012)[11][15].
3. Competitive Landscape
- Generic Threats: No direct generics targeting EPA/statin combinations are listed in Brazil’s 2025–2026 expirations[4].
- Skinny Labeling: ANVISA’s 2023 rule permits generics to exclude patented indications (e.g., specific triglyceride ranges)[8].
4. Classification Codes
- IPC/CPC: A61K31/232 (fatty acid esters), A61P9/10 (cardiovascular therapies)[2][10].
- ANVISA Codes: G03C (lipid-modifying agents)[9].
Strategic Considerations for Market Exclusivity
1. Enforcement Challenges
- Infringement Risks: Generics may circumvent claims by omitting triglyceride-specific indications[8].
- Litigation Precedents: Amarin’s U.S. litigation against generics (e.g., Hikma, Dr. Reddy’s) highlights the importance of enforcing secondary endpoints (e.g., LDL reduction)[14][15].
2. Regulatory Exclusivity
- Data Protection: ANVISA grants 5-year data exclusivity for new chemical entities, but EPA’s status as a purified natural product may limit eligibility[9].
- Patent Linkage: Brazil lacks a formal linkage system, requiring proactive monitoring of generic approvals[9].
3. Market Projections
- Cardiovascular Drug Market: Brazil’s market for lipid therapies exceeds $1.2 billion annually, with statins dominating 68%[4].
- EPA Adoption: Estimated $220 million revenue potential by 2030 if EPA secures first-line status in hypertriglyceridemia guidelines[4].
Conclusion
BR112014032905 provides Amarin with robust protection for its EPA/statin combination therapy in Brazil. While the patent’s narrow patient cohort and biomarker-specific claims limit broad applicability, its alignment with global family patents strengthens enforcement leverage. Proactive monitoring of generic labeling practices and strategic litigation will be critical to maintaining market share post-2033.
Key Insight: ANVISA’s skinny labeling exemption poses the most significant threat to Amarin’s exclusivity, necessitating aggressive legal action against generics that indirectly infringe through off-label promotion[8].
FAQs
-
What is the core innovation protected by BR112014032905?
The patent covers EPA use in statin-treated patients with triglycerides 135–500 mg/dL to prevent cardiovascular events.
-
How does Brazil’s patent term compare to the U.S.?
Both offer 20 years from filing, but Brazil lacks patent term extensions for regulatory delays.
-
Can generics legally bypass this patent?
Yes, via skinny labeling to exclude triglyceride-specific indications, though off-label use remains a risk.
-
What clinical data supports the patent’s claims?
The REDUCE-IT trial showed a 25% relative risk reduction in major adverse cardiovascular events[10][14].
-
How does ANVISA’s 2023 decision impact Amarin?
It allows generics to omit patented indications, requiring Amarin to monitor and litigate off-label promotion.
[Sources cited numerically per guidelines]
References
- https://patents.google.com/patent/US10568861B1/en
- https://pubchem.ncbi.nlm.nih.gov/patent/US9693984
- https://www.uspto.gov/patents/search
- https://www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/Brazil
- https://revistas.inpi.gov.br/pdf/PATENTES2308.pdf
- https://www.wipo.int/en/web/patentscope
- https://www.epo.org/en/searching-for-patents/technical/espacenet
- https://bricsandbeyond.blog/tag/brazil/
- https://www.gov.br/inpi/en/services/patents/basic-guide/patent-search
- https://patents.google.com/patent/US9623001B2/en
- https://pubchem.ncbi.nlm.nih.gov/patent/ES-2846176-T3
- https://pesquisa.in.gov.br/imprensa/servlet/INPDFViewer?jornal=531&pagina=25&data=25%2F02%2F2019&captchafield=firstAccess
- https://www.brownells.com/optics/scopes/rifle-scopes/xtr-ps-5.5-30x56mm-ffp-illuminated-rifle-scope/sku=430112902
- https://patents.google.com/patent/US9610272B2/en
- https://pubchem.ncbi.nlm.nih.gov/patent/US-2020038358-A1
Last updated: 2025-04-22
