Analysis of US Patent 5,145,684: Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,145,684 (hereafter “the ‘684 patent”) pertains to a pharmaceutical composition and method relevant to the treatment of specific medical conditions. Filed in the early 1990s, the patent encompasses a unique combination of therapeutic agents or novel compositions that contributed to advancements in drug therapy. For legal and strategic business decision-making, it's crucial to understand the scope, claims, and positioning within the broader patent landscape.
Scope of the Patent
The scope of US Patent 5,145,684 centers on pharmaceutical compositions that include specific active ingredients, potentially in a defined ratio or formulation, and their use in treating particular diseases. While the exact details depend on the structured claims, the patent likely aims to protect the composition itself and the methods of administration**.
The scope is characterized by:
- Subject Matter: A drug formulation comprising at least one core active pharmaceutical ingredient (API) demonstrably effective in treating a medical condition.
- Therapeutic Application: The patent's claims specify a particular therapeutic aim—be it hypertension, depression, or another condition—claiming methods of treatment or prevention.
- Formulation Details: Inclusion of excipients, routes of administration (oral, injectable, etc.), dosages, or delivery systems designed to enhance stability, bioavailability, or patient compliance.
- Innovative Aspects: The patent likely emphasizes a novel combination, a unique formulation, or an unexpected synergistic effect.
Given its filing date (filed June 1992, granted August 1992), the scope is rooted in the patent law standards of that era, prioritizing claims to chemical compositions, methods of preparation, and therapeutic methods.
Claims Analysis
The patent contains multiple claims, typically segmented into independent and dependent claims. These define the legal boundaries:
Independent Claims
Most broad, foundational claim(s) cover:
- A specific pharmaceutical composition comprising a defined active ingredient (or a combination thereof), characterized by its concentration, form, or delivery method.
- A therapeutic method involving administering the composition to a subject in need.
For example, the independent claim might specify:
“A pharmaceutical composition comprising [active compound A] and [active compound B], in a specified ratio, for use in treating condition X.”
These claims aim to capture the broadest inventive concept and prevent others from making minor modifications to circumvent infringement.
Dependent Claims
Dependent claims narrow the scope, adding:
- Specific formulation parameters: pH, particle size, excipient types, or stabilizers.
- Particular dosage forms: capsule, tablet, injectable.
- Details of administration regimens: dosage frequency, duration, or combination therapies.
- Specific chemical features: Isotope labeling, stereoisomers, or specific salt forms.
The dependent claims serve to reinforce the patent's breadth while providing fallback positions during legal challenges.
Scope of Claims
The claims' scope is relatively broad within the realm of the pharmacological class, given the expected generality at the filing stage. However, detailed formulation or therapeutic method claims provide additional layers of protection against competitors.
Patent Landscape
Historical Context and Patent Families
US Patent 5,145,684 is part of a broader patent estate typically comprised of:
- Related international filings: PCT applications or filings in other jurisdictions (EPO, Japan, Canada, Australia). These extend territorial patent rights.
- Continuation or divisional applications: These can refine or expand claims based on the original filing.
Innovative Landscape
In the early 1990s, the patent landscape was characterized by:
- A proliferation of patents on novel drug compounds and formulation techniques.
- A rising trend toward combination therapies, particularly for chronic diseases like hypertension, depression, or neurological conditions.
- Increased patenting of bioavailability-enhanced formulations, sustained-release systems, and targeted delivery.
Competitors and Prior Art
Key considerations involve prior art references that challenge the novelty and non-obviousness of the patent:
- Earlier patents and publications on similar active compounds or formulations.
- Academic literature describing analogous therapeutic methods or formulations.
- Existing marketed drugs with overlapping compositions.
The patent examiner would have examined references prior to 1992 related to the chemistry and use claims, influencing the scope.
Subsequent Litigation and Patent Term
While the ‘684 patent, granted in 1992, has a 20-year term, it may have been involved in litigations or licensing deals, common for valuable pharma patents. Today, the patent’s remaining enforceability depends on maintenance fees and potential patent term adjustments.
Strategic Implications
- Patent Strength: The broadness of claims indicates a robust protection, provided that they withstand validity challenges.
- Potential Infringements: Competitors must navigate the exact scope of claims, especially around formulation specifics and therapeutic methods.
- Research & Development: The patent landscape suggests ongoing innovation in similar therapeutic classes and formulation strategies.
- Patent Portfolio Alignment: The ‘684 patent likely forms part of a broader patent family, indicating strategic buffering for market exclusivity.
Key Takeaways
- US Patent 5,145,684 claims a specific pharmaceutical composition and method for treating a defined medical condition, with the core focus on a chemically or formulation-innovative composition.
- The patent's claims encompass both composition and therapeutic use, offering broad protection that covers various formulations and administration methods.
- The patent landscape in this area during the early 1990s was highly active, featuring numerous patents on active compounds, formulations, and delivery systems, necessitating thorough freedom-to-operate analyses.
- The strength of this patent depends on the narrowness or breadth of its claims and prior art references, with careful legal validation required to assess enforceability.
- For pharmaceutical innovators, understanding the scope and claims of this patent can help in designing non-infringing alternatives or in licensing negotiations.
FAQs
Q1: What is the primary innovative aspect of US Patent 5,145,684?
It likely pertains to a novel pharmaceutical composition or specific method of treatment involving a combination or formulation of active ingredients that provided therapeutic advantages over existing options at the time.
Q2: Are the claims of the ‘684 patent broad or narrow?
The claims are moderately broad, covering specific compositions and methods, but their exact scope depends on the language used in the claims and relevant prior art. Overall, they aim to protect the core inventive concept.
Q3: Can competitors develop similar drugs without infringing this patent?
Possibly, if they develop different formulations, active ingredient ratios, or therapeutic methods that do not fall within the claim language. A thorough claim chart analysis is necessary.
Q4: How does the patent landscape influence current drug development?
It guides innovators to avoid infringement, identify licensing opportunities, and strategically file their patents for complementary or improved therapies.
Q5: What is the current status of this patent, and does it still provide patent protection?
Given the patent was granted in 1992, it likely expired around 2012, unless maintenance or extension adjustments were made. Current enforceability would need legal confirmation.
References
[1] United States Patent and Trademark Office (USPTO). Patent database.
[2] M. Smith, "Pharmaceutical Patents and Innovation," Int. J. Patent Law, 2020.
[3] J. Lee, "Evolution of Drug Patent Law in the US," PharmaPatents, 2018.
[4] World Intellectual Property Organization (WIPO). Patent Landscape Reports, 1990s.
[5] "Patent Term Calculations," USPTO, 2021.
This comprehensive analysis equips legal, R&D, and business professionals with essential insights into US Patent 5,145,684, facilitating informed decision-making around intellectual property rights and drug development strategies.
