United States Patent 6,063,927: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,063,927, titled "Paroxetine Derivatives," is a patent that has been at the center of significant legal and regulatory discussions, particularly in the context of generic drug approvals and patent infringement. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent in question, U.S. Patent No. 6,063,927, was issued to SmithKline (now part of GlaxoSmithKline) and relates to novel compounds and processes for preparing paroxetine derivatives. Paroxetine is a selective serotonin reuptake inhibitor (SSRI) commonly used in the treatment of depression, anxiety disorders, and other mental health conditions[1].
Scope of the Patent
The patent covers specific derivatives of paroxetine and the methods for their preparation. Here are the key aspects of its scope:
Claims
The patent includes four claims that define the invention:
- Claim 1: A novel compound, specifically a paroxetine derivative.
- Claims 2-4: Processes for preparing these derivatives.
These claims are crucial as they define the boundaries of what is protected under the patent[5].
Processes and Compounds
The patent describes novel compounds that are derivatives of paroxetine and the chemical processes involved in their synthesis. These processes are significant because they provide a distinct method of producing these compounds, which can be used in pharmaceutical applications[5].
Claims Analysis
To understand the patent's impact, it's essential to analyze the claims in detail:
Claim Coverage
Each claim must be evaluated to determine what specific aspects of the paroxetine derivatives and their preparation methods are protected. This involves identifying the scope concepts and categorizing the claims to understand their coverage and potential gaps or opportunities[3].
Claim Charts
Using tools like ClaimScape® software, one can generate interactive claim charts to review the patent coverage. These charts help in determining whether a particular scope concept is applicable to a target product or method, making it easier to identify gaps in current coverage and future design opportunities[3].
Patent Landscape
The patent landscape surrounding U.S. Patent No. 6,063,927 is complex and involves several other related patents and regulatory issues.
Related Patents
SmithKline also held other patents related to paroxetine, including U.S. Patents No. 6,080,759, 6,113,944, 6,121,291, and 6,172,233. These patents cover different aspects such as processes for making paroxetine hydrochloride anhydrate, compositions containing paroxetine hydrochloride hemihydrate, and new methods of use for paroxetine hydrochloride[1].
Orange Book Listings
The patent was listed in the FDA's Orange Book, which is a critical database for generic drug manufacturers. The listing of these patents in the Orange Book required generic drug applicants to certify that the patents were invalid or would not be infringed by their generic versions of paroxetine[1].
Regulatory and Legal Issues
The listing of these patents in the Orange Book led to legal challenges. Apotex, a generic drug manufacturer, filed a lawsuit challenging the FDA's practice of listing these patents and the associated 30-month stays for ANDA approvals. The case highlighted issues with the Hatch-Waxman Act and the FDA's regulations regarding patent listings and stays[1].
Impact on Generic Drug Approvals
The patent and its listings in the Orange Book had significant implications for generic drug approvals. The FDA's decision to list these patents and the subsequent legal battles delayed the approval of generic versions of paroxetine. This is a common issue in the pharmaceutical industry where patent strategies can significantly impact the timeline for generic drug entry into the market[1].
Global Patent System
The patent is part of a broader global patent system. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the search and analysis of patent applications across different jurisdictions. These tools help in understanding the global patent landscape and ensuring that patents are not infringed upon across different regions[4].
Public Access and Search Facilities
Public access to patent information is crucial for understanding the scope and claims of patents like U.S. Patent No. 6,063,927. The USPTO's Public Search Facility and Patent and Trademark Resource Centers (PTRCs) provide resources and assistance for conducting patent searches, which can help in analyzing the patent landscape[4].
Expert Insights
Industry experts and legal practitioners often advise on the methodology for quantitative, qualitative, and legal research related to patent analytics. For example, consultative groups like the one assembled by ACUS for the small claims patent court study include experts who can provide insights into the complexities of patent claims and their impact on the industry[2].
Key Takeaways
- Scope and Claims: U.S. Patent No. 6,063,927 covers specific paroxetine derivatives and their preparation methods.
- Patent Landscape: The patent is part of a complex landscape involving related patents and regulatory issues.
- Regulatory Impact: The patent's listing in the Orange Book and associated legal battles significantly impacted generic drug approvals.
- Global Context: The patent is part of a global system, and tools like the Global Dossier and CCD facilitate cross-jurisdictional analysis.
- Public Access: Public search facilities and resources are essential for understanding and analyzing patent claims.
FAQs
Q: What is the main subject of U.S. Patent No. 6,063,927?
A: The patent covers novel compounds that are derivatives of paroxetine and the processes for their preparation.
Q: Why was this patent significant in the context of generic drug approvals?
A: The patent's listing in the FDA's Orange Book led to legal challenges and delays in the approval of generic versions of paroxetine.
Q: How do claim charts help in analyzing patent coverage?
A: Claim charts, generated using tools like ClaimScape® software, help in reviewing patent coverage, identifying gaps, and determining future design opportunities.
Q: What is the role of the Global Dossier in patent search and analysis?
A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, facilitating a single-point access to citation data and patent family information.
Q: Why is public access to patent information important?
A: Public access to patent information through facilities like the USPTO's Public Search Facility and PTRCs is crucial for conducting thorough patent searches and understanding the patent landscape.
Cited Sources
- 347 F.3d 1335
- ACUS - U.S. Patent Small Claims Court
- Patent Analytics | Intellectual Property Law
- USPTO - Search for patents
- United States Patent (19) 11 Patent Number: 6,063,927
