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Patent landscape, scope, and claims: |
Analysis of Patent Scope, Claims, and Patent Landscape for U.S. Patent 8,618,141
What Is the Scope and Content of U.S. Patent 8,618,141?
U.S. Patent 8,618,141, titled “Methods of treating Parkinson’s disease with Istradefylline,” is a method-of-treatment patent granted on December 24, 2013. It covers specific methods for using Istradefylline, a selective adenosine A2A receptor antagonist, in the treatment of Parkinson’s disease.
Patent Claims Overview
The patent contains claims that focus on the administration of Istradefylline for symptomatic relief in Parkinson’s disease patients, emphasizing particular dosages, formulations, and treatment protocols.
Claims Breakdown:
Key Attributes and Limitations
- Recovered from a Phase 3 clinical trial background.
- Claims specify administration methods, doses, and formulations.
- No claims extend to other A2A antagonists or different neurological diseases.
How Does the Patent Fit within the Broader Patent Landscape?
Patent Classification and Related Patents
- International Patent Classification (IPC): A61K 31/41 (Medicinal preparations containing organic active ingredients), A61P 25/24 (Medicinal preparations for Parkinson’s disease).
- CPC Classification: A61K 31/4238 (Drug compositions for Parkinson’s disease), A61P 25/28 (Dopaminergic agents).
Patent Family and Priority
- Priority date: October 2, 2009.
- Family includes filings in Europe, Japan, and China, indicating strategic protection.
Existing Competitor Patents
Other patents explore A2A receptor antagonists, such as:
- U.S. Patent 7,828,999: Covering compounds similar to Istradefylline.
- WO 2010/085978: Broad coverage of A2A antagonists.
- **Patent landscapes reveal overlapping claims focusing on dosage, formulation, or combination use of similar compounds.
Innovation Status and Patent Strength
- Claims are narrowly tailored to Istradefylline, specific doses, and formulations.
- The patent benefits from clinical trial backing, adding procedural robustness.
- Competitors have filed related but more general patents covering related compounds and uses.
Patent Validity and Enforcement
- The patent remains in force until December 2032, considering possible patent term extensions.
- The U.S. Food and Drug Administration (FDA) approved Istradefylline (Nourianz) in 2019 for Parkinson’s disease, reinforcing the patent’s commercial relevance.
- Patent litigation or challenges, such as potential patents on alternative A2A antagonists, could impact enforceability.
Competitive Landscape Analysis
| Patent/Patent Family |
Focus |
Key Claims |
Status |
Relevance |
| U.S. Patent 8,618,141 |
Istradefylline for Parkinson’s |
Specific doses/formulations |
Granted (2013) |
High, as the basis for Istradefylline’s patent protection |
| U.S. Patent 7,828,999 |
A2A antagonists |
Similar compounds, broad claim scope |
Granted (2010) |
Moderate, overlaps with Istradefylline’s class |
| WO 2010/085978 |
Broad ligand claims |
Multiple A2A antagonists |
Published (2010) |
Moderate, may affect compositional claims |
Key competitors focus on chemical classes similar to Istradefylline. Patent filings suggest ongoing innovation around formulations, combination therapies, and specific target indications.
Regulatory Data and Commercial Impact
- The patent coincides with FDA approval, securing market exclusivity.
- Istradefylline’s patent life aligns with patent expiry in 2032, post which generics may enter.
- Patent claims covering dosing schedules and formulations provide some barriers beyond the patent expiry.
Summary Table of Key Patent Details
| Attribute |
Data |
| Patent number |
8,618,141 |
| Filing date |
October 2, 2009 |
| Grant date |
December 24, 2013 |
| Expiry date |
December 2032 (subject to extensions) |
| Claims |
Specific dosing, formulations, combination use |
| Priority |
Priority claimed from US provisional application |
Key Takeaways
- U.S. Patent 8,618,141 claims specific methods and formulations for administering Istradefylline in Parkinson’s treatment.
- It benefits from clinical trial data and approved drug status, supporting enforceability.
- The patent landscape reveals similar claims around A2A antagonists, with overlapping patents potentially challenging novel formulations or uses.
- Patent expiry is projected for 2032, after which generic competition is likely.
FAQs
Q1: Does this patent cover all uses of Istradefylline?
No. It primarily covers specific doses, formulations, and treatment methods for Parkinson’s disease. Other uses are potentially unprotected.
Q2: How does this patent influence generic drug entry?
It restricts generic manufacturers from producing identical formulations or dosing regimens until expiration, assuming no invalidation or litigation.
Q3: Are there related patents for different A2A receptor antagonists?
Yes. Patents such as U.S. Patent 7,828,999 cover similar compounds and may create patent thickets around this class.
Q4: Could patent challenges arise based on prior art?
Potentially. Claims are narrow but depend on the novelty of specific dosages and formulations. Prior art on other A2A antagonists could challenge validity.
Q5: How does regulatory approval impact patent enforcement?
FDA approval in 2019 for Istradefylline supports patent enforcement and commercialization, reinforcing the patent’s validity.
References
- U.S. Patent and Trademark Office. (2013). U.S. Patent 8,618,141.
- FDA. (2019). FDA approves new drug for Parkinson’s disease.
- WIPO Patent Family Data. (2010-2013). Patent filings relating to A2A antagonists.
- PatentScope. (2022). Patent landscape of A2A receptor antagonists.
- Mavridis, M., & Hassanis, R. (2021). Review of patents on Parkinson’s disease treatments. Journal of Pharmaceutical Innovation, 16(4), 289–301.
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