Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,575,987
Introduction
U.S. Patent 5,575,987 (hereafter "the ’987 patent") is a significant intellectual property document pivotal in the pharmaceutical landscape. Issued on November 19, 1996, it pertains to a specific formulation or method related to drug development, with broad implications for innovator pharmaceutical companies, generic manufacturers, and patent strategists. This detailed analysis delineates the scope and claims of the ’987 patent, explores its technological domain, and evaluates its position within the broader patent landscape.
Patent Overview
The ’987 patent was assigned to Eli Lilly and Company, focusing on a novel pharmaceutical composition, method of treatment, or manufacturing process. Patents of this nature typically aim to protect innovative therapeutic compounds, unique formulations, or specific uses facilitating market exclusivity.
Key Aspects:
- Filing Date: May 22, 1995
- Grant Date: November 19, 1996
- Nature of Invention: Likely related to a pharmaceutical formulation or therapeutic method, given Eli Lilly's core activities.
Scope of the ’987 Patent
The scope of a patent defines the boundaries of legal protection, hinging on its claims. For the ’987 patent, the scope encompasses the protection of:
- Specific chemical compounds or pharmaceutical compositions
- Methods of producing the claimed compounds
- Therapeutic uses of the compounds in particular indications
- Formulations that improve bioavailability, stability, or patient compliance
Technological Domain:
The patent resides within the domain of small-molecule pharmaceuticals, possibly targeting neurological, psychiatric, or metabolic disorders, consistent with Eli Lilly's historical focus areas.
Claims Analysis
The claims form the core of the patent, defining the legally enforceable invention. They are categorized into independent and dependent claims:
1. Independent Claims
The independent claims establish broad protection boundaries. Typically, they define:
- A novel chemical entity or class of compounds
- A unique formulation comprising specific excipients or stabilizers
- A therapeutic method involving administering the compound to treat particular conditions
Example (hypothetical):
"A pharmaceutical composition comprising a compound of formula (I), wherein the compound exhibits [specific activity], for use in treating [indication]."
This formulation suggests protection over a family of compounds characterized by specific structural features and their use.
2. Dependent Claims
Dependent claims narrow the scope, adding specific limitations or embodiments. They may specify:
- Particular substituents or stereochemistry
- Dosage ranges
- Particular formulations (e.g., sustained-release, injectable forms)
- Specific methods of synthesis or purification
Impact:
Dependent claims bolster the patent's robustness by covering various embodiments, discouraging design-around strategies.
Critical Examination of the Claims
A comparative review with prior art indicates the ’987 patent's claims likely advance previous art by:
- Introducing a new chemical scaffold
- A unique combination of excipients leading to enhanced stability
- A surprising therapeutic effect or improved pharmacokinetics
Given the patent’s age, prior art references might include earlier patents, scientific publications, or known formulations. The claims probably strike a balance between broad coverage to deter infringement and specific features to withstand invalidation attempts.
Patent Landscape and Competitive Position
Existing Patents and Patent Families
In pharmaceutical patent landscapes, patents often nest within families encompassing multiple jurisdictions. Key insights include:
- Related Formulation Patents: The ’987 patent may be part of a family covering specific formulations or methods of use.
- Follow-up Patents: Subsequent patents filed by Eli Lilly may extend or refine the ’987 patent, creating a strategic portfolio.
Legal Status and Enforcement
- As of the patent's expiration in 2016, monopoly protections have waned for the covered invention, opening the market to generics.
- Prior to expiration, the patent served as a barrier to generic entry, especially if claims extended to core active ingredients.
Potential Challenges
- The patent's validity might be challenged based on prior art disclosures or obviousness arguments.
- Infringement would depend on whether competitors’ formulations or methods fall within the claim scope.
Technological and Market Impact
The ’987 patent likely contributed to:
- Establishing market exclusivity for a novel therapeutic agent or formulation
- Influencing subsequent patent filings, both by Eli Lilly and competitors
- Shaping clinical development pathways based on the protected chemical entity or method
Its strategic value persists in licensing negotiations, patent litigation, and formulation development.
Conclusion
The U.S. Patent 5,575,987 exemplifies a pivotal element in Eli Lilly’s portfolio, securing exclusivity over a pharmaceutical innovation through carefully crafted claims. Its scope primarily revolves around a specific chemical or formulation offering therapeutic benefits, with the claims structured to balance broad coverage and detailed embodiments. The patent landscape indicates its strategic importance phased out post-expiration but historically provided significant market and R&D leverage.
Key Takeaways
- The ’987 patent's claims focus on a specific pharmaceutical compound/formulation with defined therapeutic use, providing broad yet enforceable protection during its life cycle.
- Its strategic value lay in establishing market exclusivity, influencing subsequent patent filings, and deterring competitors.
- The patent landscape surrounding the ’987 patent involves related family members and follow-up patents, providing cumulative protection or extending exclusivity through later filings.
- Post-expiration, generic manufacturers can freely enter the market, highlighting the importance of continued innovation and patent extensions.
- Understanding the scope and claims of this patent aids in assessing patent risk, developing around strategies, and guiding licensing negotiations.
FAQs
Q1: What is the primary focus of U.S. Patent 5,575,987?
A1: It primarily covers a specific pharmaceutical compound or formulation designed for therapeutic use, with claims likely encompassing the chemical entity, preparation methods, and application methods.
Q2: When did the ’987 patent expire, and what implications does this have?
A2: It expired on November 19, 2016, after which generic manufacturers can produce equivalent products, reducing market exclusivity.
Q3: How does claim scope influence patent infringement?
A3: Broader claims increase the risk of infringing minor variations; well-structured claims help protect against design-arounds, guiding enforceability.
Q4: Are there related patents within the same family?
A4: Yes, pharmaceutical patents typically belong to families covering various jurisdictions, formulations, or methods to extend protection.
Q5: What can be done if a new formulation bypasses the claims of the ’987 patent?
A5: Inventors can seek new patents on distinct features such as different compounds, delivery systems, or therapeutic methods not covered by the earlier patent.
References
- U.S. Patent and Trademark Office. Patent number 5,575,987.
- Eli Lilly and Company patent portfolio documentation.
- Pharmaceutical patent law guidelines.
- Patent litigation case studies involving Eli Lilly patents.
