Astellas Pharma vs. Apsen: Modified Release Drug Patent Invalidated
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📋 Case Summary
| Case Name | Astellas Pharma, Inc. v. Apsen Farmacêutica S/A |
| Case Number | 2332814-55.2023.8.26.0000/50001 |
| Court | Court of Justice of São Paulo (Tribunal de Justiça do Estado de São Paulo — TJSP) |
| Duration | Closed: April 2, 2024 |
| Outcome | Patent Invalidated |
| Patents at Issue | |
| Accused Products | Modified release oral pharmaceutical composition and its manufacturing process |
Case Overview
The Parties
⚖️ Plaintiff
Tokyo-headquartered global pharmaceutical company with a substantial portfolio of branded pharmaceutical products, including formulation-specific patents.
🛡️ Defendant
Brazilian pharmaceutical manufacturer with a portfolio spanning branded generics and specialty pharmaceuticals, a domestic competitor.
The Patent at Issue
This landmark case involved Brazilian patent BRPI0919466B1 covering a modified release oral pharmaceutical composition and its manufacturing process. Modified release formulations represent a significant class of pharmaceutical intellectual property, governing how active pharmaceutical ingredients are delivered over time within the body. These patents often extend effective market exclusivity beyond the primary compound patent and are frequently targeted in invalidity proceedings.
- • BRPI0919466B1 — Modified release oral pharmaceutical composition and its manufacturing process
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The Verdict & Legal Analysis
Outcome
The Court of Justice of São Paulo closed case No. 2332814-55.2023.8.26.0000/50001 with the **invalidation of patent BRPI0919466B1**. The ruling, finalized on April 2, 2024, came after Apsen Farmacêutica S/A pursued an invalidity and cancellation action, a defense strategy increasingly deployed by Brazilian generic and specialty pharmaceutical manufacturers.
Key Legal Issues
The operative cause of action was an **invalidity/cancellation action** (ação de nulidade de patente) under Brazilian Industrial Property Law (Law No. 9.279/1996, Article 56). The court’s final ruling addressed appellate objections under **Article 1.025 of Brazil’s CPC**, the pre-questioning provision, affirming the invalidity outcome and declining to reopen substantive questions already resolved.
This decision highlights the vulnerability of formulation patents — even those covering commercially significant modified release technologies — to validity challenges in Brazilian courts, reinforcing the pattern of tribunals applying rigorous patentability standards to pharmaceutical formulation claims.
Freedom to Operate (FTO) Analysis
This case highlights critical IP risks in modified release drug design. Choose your next step:
📋 Understand This Case’s Impact
Learn about the specific risks and implications from this litigation.
- View related patents in pharmaceutical formulations
- See which companies are active in modified release technologies
- Understand claim construction patterns in Brazil
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High Risk Area
Secondary pharmaceutical patents (formulation)
Brazilian Law
Rigorous patentability standards
Strategic Challenges
Effective for market access
✅ Key Takeaways
Brazilian invalidity actions under Article 56, Law 9.279/1996 are powerful offensive tools against pharmaceutical formulation patents.
Search related case law →Article 1.025 CPC pre-questioning is essential appellate practice for preserving higher court review rights in Brazil.
Explore legal precedents →Dual composition-and-process patent claims do not guarantee doubled protection — both can fall in a single invalidity action.
Analyze claim scope →Appellate courts in São Paulo are applying substantive patentability scrutiny to formulation innovations.
Monitor court trends →Frequently Asked Questions
The case concerned Brazilian patent BRPI0919466B1, covering a modified release oral pharmaceutical composition and its manufacturing process.
The patent was invalidated through an invalidity and cancellation action filed by Apsen Farmacêutica. The specific technical grounds were not disclosed in available case records.
The outcome reinforces that formulation patents — including modified release compositions — are subject to rigorous validity challenges in Brazilian courts, signaling risk for originator companies relying on secondary patents for market exclusivity.
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References
- Court of Justice of São Paulo (TJSP) — Case No. 2332814-55.2023.8.26.0000/50001
- INPI Brazilian Patent Database
- Brazil’s Industrial Property Law No. 9.279/1996 (Article 56)
- PatSnap — IP Intelligence Solutions for Law Firms
This article is for informational purposes only and does not constitute legal advice. All case information is drawn from publicly available court records. For platform capabilities, visit PatSnap.