Profile for Brazil Patent: 112019001398

US Patent Family Members and Approved Drugs for Brazil Patent: 112019001398

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
11,207,311	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate
11,986,468	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate
11,986,469	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate
11,992,486	Jul 28, 2037	Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate

Analysis of Brazilian Patent BR112019001398: Niraparib for Prostate Cancer Treatment

Overview of Patent BR112019001398

Patent BR112019001398-A2, part of the international patent family led by US-11207311-B2, discloses methods for treating prostate cancer using the poly(ADP-ribose) polymerase (PARP) inhibitor niraparib. This patent, assigned to Janssen Pharmaceutica NV, is central to therapeutic strategies for metastatic castration-resistant prostate cancer (mCRPC) and other advanced forms of the disease[1][3].

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Scope and Claims of BR112019001398

Key Claims and Technical Scope

1. Method of Treatment:
   The patent claims methods for administering niraparib to humans with prostate cancer, particularly those with DNA repair anomalies such as mutations in BRCA1, BRCA2, ATM, or PALB2. The claims emphasize targeting patients with biomarker-driven susceptibility to PARP inhibition[1][10].

2. Dosage and Regimen:
   A preferred dosage of 300 mg/day is specified, administered orally in three 100 mg capsules. The claims highlight that this regimen maintains efficacy while minimizing toxicity[1][13].

3. Combination Therapies:
   While not explicitly claimed in BR112019001398, related family patents (e.g., US11986469B2) disclose combinations with androgen receptor (AR)-targeted therapies like abiraterone acetate, reflecting a broader strategy to synergize PARP inhibition with hormonal treatments[1][7].

4. Formulation:
   The patent covers niraparib in freebase or salt forms, with examples including tosylate and hydrochloride salts. This ensures flexibility in drug delivery and stability[3][10].

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Patent Landscape in Brazil

Legal and Regulatory Challenges

1. Patent Term Limitations:
   Brazil’s Supreme Court ruling in ADI 5529 (2021) invalidated patent term extensions, capping protections at 20 years from filing. For BR112019001398 (filed in 2017), this decision shortens potential market exclusivity, with expiration no later than 2037[4][14].

2. Backlog and Examination Delays:
   The Brazilian Patent Office (INPI) faces a backlog exceeding 10 years for pharmaceutical patents. While programs like the Standardized Office Action Initiative aim to accelerate examination, applicants must navigate limited technical feedback and reliance on foreign prosecution results[15][17].

3. Bolar Exemption and Generic Competition:
   Brazil’s broad Bolar exemption (Article 43, LPI) permits generics to prepare for market entry during the patent term. This undermines enforcement of BR112019001398, as competitors can obtain regulatory approval before patent expiration[7][14].

4. Patent Term Adjustment (PTA) Litigation:
   Despite the Supreme Court’s stance, companies like Pfizer (via Warner-Lambert) have filed PTA lawsuits to compensate for INPI delays. However, recent dismissals by Brazil’s Antitrust Authority (CADE) indicate skepticism toward these efforts, deeming them abusive or lacking legal basis[14][16].

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Competitive and Market Implications

Niraparib’s Position in the Brazilian Market

1. Generic Threats:
   Post-2037, niraparib faces competition from generics, exacerbated by Brazil’s lack of patent linkage. Early generic entry could reduce Janssen’s revenue by 50–70% within the first year[7][17].

2. Biomarker-Driven Therapy:
   The focus on BRCA-mutated patients limits the addressable market but aligns with Brazil’s push for precision medicine. Companion diagnostics for BRCA testing will be critical for patient stratification[1][10].

3. Competitor PARP Inhibitors:
   Olaparib (AstraZeneca) and rucaparib (Clovis Oncology) hold overlapping indications. However, niraparib’s once-daily dosing and lower cost (∼30% cheaper than olaparib) may confer advantages in Brazil’s cost-sensitive healthcare system[1][7].

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Strategic Considerations for Patent Holders

1. Litigation Defense:
   Proactive monitoring of PTA lawsuits and generic challenges is essential. Recent CADE rulings suggest courts may reject term extensions, necessitating reliance on data exclusivity or regulatory strategies[14][16].

2. Collaborations with Public Health Programs:
   Partnering with Brazil’s Unified Health System (SUS) for subsidized access could preempt compulsory licensing threats, as seen with HIV therapies[4][12].

3. Post-Patent Lifecycle Management:
   Developing extended-release formulations or combination therapies (e.g., niraparib + abiraterone) could justify secondary patents, though INPI’s strict inventiveness standards pose hurdles[10][17].

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Conclusion

Patent BR112019001398 positions niraparib as a targeted therapy for biomarker-selected prostate cancer patients in Brazil. However, its commercial viability is constrained by the 20-year patent term cap, Bolar exemptions, and generic competition. Janssen’s success hinges on leveraging precision medicine initiatives, defending against litigation, and exploring public-health partnerships to sustain access post-exclusivity.

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Key Takeaways

• BR112019001398 emphasizes biomarker-driven use of niraparib but faces term limitations under Brazil’s 2021 Supreme Court ruling.
• Generic erosion is likely post-2037 due to Brazil’s regulatory landscape and Bolar provisions.
• Strategic litigation and partnerships with SUS are critical for maintaining market presence.

FAQs

1. How does Brazil’s Bolar exemption affect niraparib’s market exclusivity?
   It allows generics to prepare for launch during the patent term, accelerating post-expiration competition.

2. What biomarkers are central to BR112019001398’s claims?
   BRCA1/2, ATM, and PALB2 mutations are highlighted as predictors of niraparib response.

3. Can patent term adjustments extend niraparib’s protection in Brazil?
   Recent CADE rulings suggest PTA lawsuits face high dismissal rates, making extensions unlikely.

4. How does niraparib’s cost compare to other PARP inhibitors in Brazil?
   It is ∼30% cheaper than olaparib, aiding adoption in cost-sensitive settings.

5. What strategies can mitigate generic competition post-2037?
   Developing combination therapies, securing SUS partnerships, and investing in companion diagnostics.

“The Supreme Court’s decision to cap patent terms at 20 years prioritizes public health over private monopolies, reshaping Brazil’s pharmaceutical innovation landscape.” – Analysis of ADI 5529 (2021)[4]

References

1. https://pubchem.ncbi.nlm.nih.gov/patent/US11207311
2. https://www.uspto.gov/patents/search
3. https://patents.google.com/patent/US11207311B2/en
4. https://peoplesdispatch.org/2022/12/15/pharma-companies-attempt-to-overturn-brazilian-supreme-courts-historic-decision-on-patents/
5. https://curity.io/resources/learn/scopes-claims-and-the-client/
6. https://www.wipo.int/publications/en/series/index.jsp?id=137
7. https://ipwatchdog.com/2024/10/07/protecting-pharmaceutical-innovation-brazil-despite-lack-patent-linkage-system/id=181622/
8. https://curity.io/resources/learn/scopes-vs-claims/
9. https://www.wipo.int/en/web/patentscope
10. https://patents.google.com/patent/AU2017302660B2/en
11. https://patents.google.com/patent/KR20240115925A/en
12. https://pubmed.ncbi.nlm.nih.gov/27804784/
13. https://patents.google.com/patent/US11986469B2/en
14. https://www.lickslegal.com/news/brazilian-antitrust-authority-dismisses-investigation-into-alleged-term-extension-of-pharmaceutical-related-patents-indicating-position-in-favor-of-patent-holders
15. https://www.daniel-ip.com/en/articles/brazilian-patent-backlogs-days-are-numbered-meet-the-standardized-office-action-program/
16. https://www.wipo.int/patent-judicial-guide/en/full-guide/brazil/3.2
17. https://www.daniel-ip.com/en/blog/patents/understanding-patents-in-brazil-a-comprehensive-guide/

Last updated: 2025-04-22