United States Patent 7,205,302: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,205,302, titled "Heterocyclic compound derivatives and medicines," is a significant patent in the pharmaceutical sector, particularly in the development of treatments for vascular diseases. This patent, held by Actelion Pharmaceuticals, covers a range of heterocyclic compounds and their pharmaceutical applications.
Background and Context
The patent was granted for compounds that act as PGI2 (Prostacyclin I2) receptor agonists. PGI2 is a prostaglandin that has vasodilatory, anti-inflammatory, and antiplatelet properties, making it a valuable therapeutic target for conditions such as peripheral arterial occlusive disease, intermittent claudication, and other vascular disorders[1][4].
Scope of the Patent
The scope of the patent is defined by its claims, which describe the specific chemical structures and their uses. Here are the key aspects:
Chemical Compounds
The patent covers various heterocyclic compounds, including those with diphenylpyrazin, butyloxy, alkyl, and isopropylamino groups. These compounds are optionally substituted, allowing for a range of derivatives[1][4].
Pharmaceutical Applications
The compounds are intended for use in treating vascular diseases, including:
- Arteriosclerosis Obliterans
- Arterial embolism
- Intermittent claudication
- Peripheral arterial occlusive disease
- Intermittent vascular claudication[1][4].
Claims Analysis
The patent includes multiple claims that define the scope of protection:
Independent Claims
These claims are crucial as they define the broadest scope of the invention. They typically include the general structure of the heterocyclic compounds and their use as PGI2 receptor agonists[1][4].
Dependent Claims
Dependent claims narrow down the scope by specifying particular substituents, functional groups, or specific uses of the compounds. These claims provide additional protection for specific embodiments of the invention[1][4].
Patent Landscape
The patent landscape surrounding US 7,205,302 is complex and involves several other related patents and legal proceedings.
Related Patents
Other patents related to the same therapeutic area include:
- U.S. Patent Number 8,791,122
- U.S. Patent Number 9,173,881
- U.S. Patent Number 9,284,280
- U.S. Patent Number 10,821,108
- U.S. Patent Number 10,828,298
These patents also cover various aspects of the same or similar compounds and their uses, indicating a broad and ongoing research and development effort in this therapeutic area[2][5].
Litigation and Patent Disputes
The patent has been involved in several legal disputes, particularly with generic drug manufacturers. For instance, Actelion Pharmaceuticals has initiated litigation against companies like Alembic Pharmaceuticals and Zydus Worldwide DMCC for infringement of this and other related patents. These cases highlight the importance of this patent in protecting the intellectual property of the original innovators[2][5].
Expiration and Protection Period
The patent is set to expire on October 31, 2026. This expiration date is crucial for generic drug manufacturers, as it marks the period after which they can legally produce and market generic versions of the drug without infringing on the original patent[5].
Impact on Pharmaceutical Industry
The protection afforded by this patent has significant implications for the pharmaceutical industry. It allows the patent holder to maintain market exclusivity for the drug, which is essential for recouping the substantial investment in research and development. The expiration of this patent will open the market to generic competition, potentially reducing the cost of the medication and increasing accessibility for patients.
Metrics for Patent Scope
Research on patent scope metrics suggests that the breadth and clarity of patent claims can significantly impact the patent's validity and enforcement. Metrics such as independent claim length and independent claim count can provide insights into the patent's scope and its potential for litigation[3].
Key Takeaways
- Chemical Structure: The patent covers heterocyclic compounds with specific functional groups.
- Therapeutic Use: The compounds are used as PGI2 receptor agonists for treating vascular diseases.
- Related Patents: Several other patents cover related compounds and uses.
- Litigation: The patent has been involved in disputes with generic drug manufacturers.
- Expiration: The patent expires on October 31, 2026.
- Impact: The patent protects market exclusivity and affects the availability of generic drugs.
FAQs
What is the main therapeutic use of the compounds described in US 7,205,302?
The compounds are used as PGI2 receptor agonists for treating vascular diseases such as peripheral arterial occlusive disease and intermittent claudication.
Which companies have been involved in litigation related to this patent?
Actelion Pharmaceuticals has initiated litigation against companies like Alembic Pharmaceuticals and Zydus Worldwide DMCC for infringement of this patent.
When is the patent set to expire?
The patent is set to expire on October 31, 2026.
What are the implications of the patent's expiration for the pharmaceutical industry?
The expiration will allow generic drug manufacturers to produce and market generic versions of the drug, potentially reducing costs and increasing accessibility.
How does the scope of this patent compare to other related patents?
The scope is defined by specific claims covering the chemical structure and therapeutic use, similar to but distinct from other related patents in the same therapeutic area.
Cited Sources
- US7205302B2 - Heterocyclic compound derivatives and medicines - Google Patents
- Selexipag Tablets - FDA
- Patent Claims and Patent Scope - SSRN
- US7205302B2 - Heterocyclic compound derivatives and medicines - Google Patents
- II US FOOD & DRUG - FDA
