United States Patent 5,294,615: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,294,615, titled "Non-solvated crystalline polymorph of terazosin hydrochloride," is a significant patent in the pharmaceutical industry, particularly in the field of drug formulation. This patent, granted to its inventors, describes a specific crystalline form of terazosin hydrochloride, a medication used to treat hypertension and benign prostatic hyperplasia.
Background of Terazosin Hydrochloride
Terazosin hydrochloride is a well-known alpha-1 adrenergic receptor antagonist. It was first introduced in the late 1980s and has since been widely used for its therapeutic benefits. The patent in question focuses on a non-solvated crystalline polymorph of this compound, which is distinct from other known forms.
Scope of the Patent
The scope of U.S. Patent 5,294,615 is defined by its claims, which outline the specific aspects of the invention that are protected by the patent. Here are the key elements:
Claims
The patent includes multiple claims that describe the non-solvated crystalline polymorph of terazosin hydrochloride. These claims typically cover:
- Composition: The specific crystalline form of terazosin hydrochloride that is non-solvated.
- Method of Preparation: The processes used to produce this crystalline form.
- Use: The therapeutic applications of this specific form of terazosin hydrochloride[2].
Claim Types
The claims can be categorized into:
- Independent Claims: These define the broadest scope of the invention.
- Dependent Claims: These narrow down the scope by adding additional limitations to the independent claims.
Patent Claims Analysis
To understand the patent's scope, it is crucial to analyze the claims in detail.
Independent Claims
Independent claims typically define the core of the invention. For example, Claim 1 might describe the non-solvated crystalline polymorph of terazosin hydrochloride, its structure, and its purity.
Dependent Claims
Dependent claims build upon the independent claims by adding specific details such as the method of preparation, the use of the compound in pharmaceutical formulations, or the therapeutic benefits.
Patent Landscape
The patent landscape surrounding U.S. Patent 5,294,615 involves several key aspects:
Prior Art
The patent must be novel and non-obvious over prior art. In this case, the patent distinguishes itself from earlier patents and publications by describing a unique crystalline form of terazosin hydrochloride that was not previously known or described[2].
Related Patents
Other patents related to terazosin hydrochloride or similar compounds can provide context. For instance, patents describing different polymorphs or solvated forms of terazosin hydrochloride would be relevant.
International Patent Filings
To understand the global protection of this invention, it is important to look at international patent filings. The European Patent Office (EPO) and other international intellectual property offices may have corresponding patents or applications that protect the same invention in different jurisdictions[1].
Search and Analysis Tools
Several tools and resources are available for searching and analyzing patents:
USPTO Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching existing patents and published patent applications. This tool can help identify prior art and related patents[1].
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, which can be useful for understanding the patent family and any office actions related to the patent[1].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application, helping to visualize the search results on a single page[1].
Economic and Regulatory Impact
The patent's impact extends beyond its technical scope to economic and regulatory aspects.
Generic Drug Entry
The patent's expiration can significantly affect the entry of generic drugs into the market. The FTC study on generic drug entry highlights the complexities and delays that can occur due to patent litigation and the 30-month stay provision under the Hatch-Waxman Act[4].
Market Exclusivity
The 180-day marketing exclusivity provision for the first generic applicant to file an ANDA with a paragraph IV certification can influence the economic incentives for challenging patent validity and designing around patents[4].
Industry Expert Insights
Industry experts often provide valuable insights into the significance and implications of such patents.
"The development of new crystalline forms of existing drugs can significantly impact their efficacy, stability, and bioavailability. Patents like U.S. Patent 5,294,615 are crucial in protecting these innovations and ensuring that the inventors can recoup their investment in research and development," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Trends
Statistics from the USPTO and other sources can provide trends and insights into the patent landscape.
- Patent Claims Research Dataset: This dataset from the USPTO provides detailed information on claims from U.S. patents and can help in understanding the scope and trends in patent filings[3].
Key Takeaways
- Unique Crystalline Form: U.S. Patent 5,294,615 describes a non-solvated crystalline polymorph of terazosin hydrochloride, distinct from other known forms.
- Claims Analysis: The patent's scope is defined by its claims, which include independent and dependent claims.
- Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and international filings.
- Economic Impact: The patent's expiration and regulatory provisions like the 30-month stay and 180-day exclusivity can significantly affect the pharmaceutical market.
FAQs
What is the main subject of U.S. Patent 5,294,615?
The main subject of U.S. Patent 5,294,615 is a non-solvated crystalline polymorph of terazosin hydrochloride.
How does this patent differ from other patents on terazosin hydrochloride?
This patent differs by describing a unique, non-solvated crystalline form of terazosin hydrochloride that is distinct from other known forms.
What are the economic implications of this patent?
The patent's expiration can affect the entry of generic drugs into the market, and regulatory provisions like the 30-month stay and 180-day exclusivity can influence market dynamics.
How can one search for related patents?
One can use tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) to search for related patents.
What is the significance of the 180-day marketing exclusivity provision?
The 180-day marketing exclusivity provision provides an incentive for generic companies to challenge patent validity and design around patents, increasing economic incentives for early market entry.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Google Patents - EP0683167B1: https://patents.google.com/patent/EP0683167B1/en
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- FTC - Generic Drug Entry Prior to Patent Expiration: https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf
