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Patent landscape, scope, and claims: |
United States Patent 6,251,910: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,251,910, titled "1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists," is a significant patent in the pharmaceutical industry, particularly in the field of cardiovascular diseases. This patent, held by AstraZeneca, protects a class of compounds known as triazolo[4,5-d]pyrimidines, which are used as P2T receptor antagonists.
Background and Invention
The patent describes a series of compounds that act as antagonists to the P2T receptor, which plays a crucial role in platelet activation and aggregation. These compounds are particularly useful in the treatment of various cardiovascular and thrombotic disorders, including myocardial infarction, thrombotic stroke, transient ischemic attacks, peripheral vascular disease, and unstable angina[1].
Claim Scope
The claims of the patent are detailed and specific, defining the structural requirements for the compounds. Here are some key aspects of the claim scope:
- Structural Definition: The patent claims compounds of the formula (I), which include specific substitutions and modifications to the triazolo[4,5-d]pyrimidine core. For example, R1 can be a C1-6 alkyl, C2-6 alkenyl, C3-8 cycloalkyl, or a phenyl group, each optionally substituted by various groups such as halogen, OR8, NR9R10, SR11, or C1-6 alkyl[1].
- Substituents and Modifications: The claims specify various substituents and modifications that can be made to the core structure, including the presence of acyl groups, cycloalkyl groups, and phenyl groups with additional substitutions[1].
- Stereoisomeric and Tautomeric Forms: The patent extends to all stereoisomeric forms, including enantiomers and racemates, as well as any tautomeric forms and mixtures thereof[1].
Therapeutic Applications
The compounds claimed in this patent are therapeutically significant for several conditions:
- Cardiovascular Diseases: They are used to treat myocardial infarction, thrombotic stroke, transient ischemic attacks, peripheral vascular disease, and unstable angina[1].
- Inflammatory Conditions: These compounds are also useful in treating conditions where platelets contribute to the underlying inflammatory disease process, such as atheromatous plaque formation, stenosis, restenosis, and other inflammatory conditions like asthma[1].
Administration and Formulations
The patent describes various methods of administering these compounds, including:
- Topical Administration: Solutions, suspensions, HFA aerosols, and dry powder formulations for lung and airway administration[1].
- Systemic Administration: Oral administration in forms like tablets, pills, capsules, syrups, powders, or granules, and parenteral administration in sterile solutions or suspensions[1].
Patent Landscape and Litigation
The patent landscape surrounding US 6,251,910 is complex and involves several legal battles:
- Litigation Against Generic Manufacturers: AstraZeneca has been involved in multiple lawsuits against generic manufacturers, such as Amneal Pharmaceuticals and Prinston Pharmaceutical Inc., to protect the patent rights of Brilinta (ticagrelor), which is covered by this and other related patents (e.g., RE46,276, 7,250,419, and 7,265,124)[2][5].
- Settlements and Injunctions: These lawsuits have resulted in settlements and injunctions that prevent generic manufacturers from infringing on AstraZeneca's patents. For example, Amneal was enjoined from infringing the specified patents, and all claims and counterclaims were dismissed with prejudice[2].
Importance of Claim Scope
The scope of the claims in this patent is crucial for its validity and enforceability. Overly broad claims can lead to invalidation due to issues such as the abstract idea exception or failure to meet the written description requirement. The claims in US 6,251,910 are carefully defined to ensure they are anchored to the embodiments disclosed in the specification, avoiding the risks associated with overly broad claims[3].
Economic and Social Impact
The patent protects a significant pharmaceutical product, Brilinta (ticagrelor), which is a critical treatment for cardiovascular diseases. The economic impact of this patent includes the protection of AstraZeneca's investment in research and development, as well as the revenue generated from the sale of Brilinta. Socially, it ensures that patients have access to a proven treatment for serious cardiovascular conditions while incentivizing further innovation in the pharmaceutical industry.
Key Takeaways
- Specific Claim Scope: The patent claims are detailed and specific, ensuring they are valid and enforceable.
- Therapeutic Significance: The compounds are crucial for treating various cardiovascular and thrombotic disorders.
- Litigation and Protection: AstraZeneca has actively protected the patent rights through litigation against generic manufacturers.
- Economic and Social Impact: The patent has significant economic and social implications, protecting investment and ensuring patient access to critical treatments.
FAQs
Q: What is the main therapeutic application of the compounds described in US 6,251,910?
A: The compounds are primarily used as P2T receptor antagonists for treating cardiovascular and thrombotic disorders such as myocardial infarction, thrombotic stroke, and unstable angina.
Q: How are the compounds administered according to the patent?
A: The compounds can be administered topically or systemically, including oral, parenteral, subcutaneous, and rectal administration, as well as in various formulations like solutions, suspensions, and dry powder formulations.
Q: What is the significance of the claim scope in this patent?
A: The claim scope is carefully defined to ensure validity and enforceability, avoiding the risks associated with overly broad claims that could lead to invalidation.
Q: Which company holds the patent, and what is the name of the drug protected by this patent?
A: The patent is held by AstraZeneca, and it protects the drug Brilinta (ticagrelor).
Q: What legal actions has AstraZeneca taken to protect this patent?
A: AstraZeneca has been involved in several lawsuits against generic manufacturers to prevent patent infringement, resulting in settlements and injunctions that protect their patent rights.
Cited Sources
- US Patent 6,251,910: "1,2,3-triazolo[4,5-d]pyrimidines as P2T receptor antagonists."
- Robins Kaplan LLP: "ANDA Litigation Settlements."
- Rimon Law: "The Importance of Getting the Claim Scope Right in a US Patent Application."
- Canadian Intellectual Property Office: "Patent 2855242 Summary."
- RPX Corporation: "Case 1:17-cv-01639-RGA Document 1 Filed 11/13/17."
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