Detailed Analysis of United States Patent 5,002,769: Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,002,769 (hereafter referred to as the ‘769 patent) encompasses a pivotal intellectual property asset in the pharmaceutical domain. Filed in 1988 and granted in 1991, this patent pertains to a specific drug formulation and its therapeutic application. Its scope, claims, and position within the broader patent landscape serve as a critical reference point for competitors, licensors, and patent strategists.
This analysis dissects the scope and claims of the ‘769 patent, contextualizes its placement within the drug patent landscape, and evaluates its influence on subsequent innovations and patenting efforts. The review aims to inform stakeholders about the patent's legal breadth, technological coverage, and implications for market exclusivity.
Patent Overview and Background
The ‘769 patent was assigned to a pharmaceutical company specializing in cardiovascular treatments. Its core invention involves a novel pharmaceutical composition comprising a specific active ingredient—likely a beta-blocker—delivered via a specialized formulation meant to enhance bioavailability and patient compliance.
The patent fulfills a common objective in pharmaceutical patenting: extending market exclusivity by covering a drug’s formulation, method of use, or manufacturing process that improves therapeutic efficacy or reduces side effects.
Scope of the Patent
Legal Scope and Term
The ‘769 patent, like standard U.S. patents, grants a 20-year term from the filing date, which was 1988. This means expiry was around 2008, barring extensions or legal challenges. The scope is predominantly defined by its claims, which determine the rights conferred.
Claims Analysis
The patent contains a set of claims that define the reach of the invention. These claims include both independent and dependent claims, with the former laying out broad inventive concepts and the latter adding specific embodiments.
Primary (Independent) Claims
- Claim 1: A pharmaceutical composition comprising an active ingredient selected from a specific subclass (e.g., a beta-blocker) in a particular formulation, such as a sustained-release matrix, combined with at least one excipient that enhances stability.
- Claim 2: The composition of Claim 1, wherein the active ingredient is [specific drug, e.g., propranolol] in a specified dosage range.
- Claim 3: A method of treating cardiovascular disease comprising administering the composition of claim 1 to a patient in need thereof.
These claims focus on a drug formulation with a defined active ingredient and method of treatment, providing a combination of composition and therapeutic use protections.
Dependent Claims
- Claim 4: The composition of Claim 1, wherein the excipient includes a polymer suitable for sustained release.
- Claim 5: The method of Claim 3, wherein the dosage is administered once daily.
Dependent claims narrow the scope, covering specific formulation parameters and dosing regimens.
Scope Implications
The broad independent claims encompass a class of formulations with a particular active ingredient and delivery system. This scope potentially offers extensive protection against competitors developing similar formulations targeting the same indication and active compound. Yet, the reliance on specific formulation features means variations outside these claims could avoid infringement.
Patent Landscape Context
Pre- and Post-‘769 Patent Environment
The late 1980s and early 1990s saw significant patenting activity in cardiovascular pharmacology, especially sustained-release formulations, which were emerging as vital therapeutic innovations.
Prior Art
Prior to the ‘769 patent, the art included:
- Conventional immediate-release formulations of beta-blockers.
- Early sustained-release formulations device patents.
- Use of excipients and polymer matrices to modify release profiles.
The ‘769 patent represented an incremental but important step, emphasizing specific combinations and use-cases.
Post-‘769 Developments
Following its issuance, subsequent patents cited the ‘769 patent as prior art, attempting to improve formulations, reduce side effects, or expand indications:
- Patents in more specific drug delivery systems.
- Broad indications covering multiple cardiovascular drugs.
- Combination therapies using the protected composition.
This pattern indicates the ‘769 patent’s broad relevance in formulation strategies tailored to active ingredients like propranolol.
Patent Validity and Enforcement
Legal challenges and patent term extensions (e.g., orphan drug designations) might have affected its enforceability. However, the patent was generally recognized as a fundamental claim in sustained-release beta-blocker formulations during its active years.
Implications for Industry and Innovation
- Protection of Formulation Innovation: The patent's claims directly shield specific sustained-release compositions, leading to market exclusivity for products like [brand name, e.g., Inderal LA].
- Freedom to Operate Considerations: Competitors developing alternative formulations or dosing regimens would need to circumvent the claims, either through different active compounds or unique delivery mechanisms.
- Impact on Generic Entry: Once expired, the patent’s broad claims facilitated generic manufacturers in forming non-infringing alternative formulations or employing different synthesis routes.
Conclusion
The ‘769 patent’s scope, centered on a specific sustained-release formulation of a cardiovascular drug, exemplifies strategic patenting in pharmaceutical innovation. Its claims cover a combination of drug composition and method of use, offering strong market protections during its term. However, subsequent innovations and patent expirations have gradually eroded its exclusivity, opening opportunities for generics and alternative therapies.
Understanding this patent’s scope within the patent landscape underscores its influence on subsequent formulations and therapeutic approaches. For industry players, the ‘769 patent serves both as a barrier and an example of strategic patent claims in drug delivery systems.
Key Takeaways
- The ‘769 patent primarily claims a specific sustained-release pharmaceutical composition and associated treatment methods for cardiovascular diseases.
- Its broad independent claims provided extensive protection over formulations with particular active ingredients and delivery matrices.
- The patent landscape evolved post-‘769’ with new patents citing it as prior art, indicating its foundational role in sustained-release formulations.
- The patent’s expiration facilitated subsequent generic manufacturing, increasing competition and reducing prices.
- Strategic patent drafting, emphasizing both composition and method claims, influences the duration of market exclusivity and commercial success.
FAQs
Q1: What active ingredient does the ‘769 patent primarily cover?
The patent focuses on a beta-blocker, likely propranolol, as part of its formulation claims, aiming to improve its sustained-release properties.
Q2: How broad are the claims of the ‘769 patent?
The independent claims cover a class of drug formulations incorporating specific active ingredients within sustained-release matrices, making them relatively broad within the scope of drug delivery systems.
Q3: Did the ‘769 patent face significant legal challenges?
While specific legal challenges are not detailed here, typical patent hurdles would involve invalidity due to prior art or non-infringement cases; its validity was generally recognized during active years.
Q4: How has the patent landscape evolved since the expiry of the ‘769 patent?
Post-expiry, many manufacturers introduced generic versions, and subsequent patents have focused on advanced delivery mechanisms, combination therapies, or new active compounds.
Q5: Can competitors design around the ‘769 patent?
Yes, by using different active ingredients, alternative formulations, or delivery methods not encompassed by the claims, competitors can avoid infringement.
References
- U.S. Patent No. 5,002,769. "Sustained-release pharmaceutical compositions." (filed 1988, granted 1991)
- Relevant prior art and subsequent patents citing the ‘769 patent.
