United States Patent 4,963,551: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,963,551, titled "Lyophilized Composition Containing S(+)-4,4'-(1,2-Ethanediyldi-2,1-ethanediyl)bis(2,6-dimethyl-4-oxo-3,5-pyridinedicarboxylate)," is a patent that addresses the formulation and stability of a specific lyophilized composition, particularly relevant in the context of pharmaceuticals like doxorubicin hydrochloride. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent focuses on improving the stability and storage conditions of lyophilized compositions, specifically those containing doxorubicin hydrochloride, an anti-cancer drug known for its cardiotoxic side effects[2].
Claims and Scope
Claim Structure
The patent's claims are crucial in defining the scope of protection. Typically, patents with broader claims offer more protection against infringers because they are harder to design around. However, the scope of a patent can also be measured by the length and detail of its claims. A longer claim with more details implies a narrower scope, as it sets more specific conditions that must be met for infringement[3].
Specific Claims
In the case of US Patent 4,963,551, the claims revolve around the specific formulation and characteristics of the lyophilized composition. For example, the patent describes a lyophilized preparation with a cake that appears pink and glossy with cracks, containing about 6% moisture. This specificity narrows the scope, making it clearer what constitutes an infringement.
Patent Scope Measurement
To measure the scope of this patent, one could use the method proposed by researchers, which involves counting the number of words in the first claim. The longer the claim, the less scope the patent has, as it includes more detailed conditions that must be met for infringement[3].
Patent Landscape
Related Patents and Prior Art
The patent landscape around US Patent 4,963,551 includes other patents related to lyophilized compositions and pharmaceutical formulations. Prior art, such as the formulations described in the same patent, highlights the advancements and improvements made by this invention. For instance, the prior art is silent on the effects of moisture and UV light on the stability of the lyophilizate, which this patent addresses[2].
Government Interest and Funding
Some patents, including those related to pharmaceutical research, may have government interest due to funding from federal agencies. For example, the patent on reducing anthracycline-induced cardiotoxicity (US Patent 5,744,455) mentions research support from the Public Health Service, Department of Health and Human Services[4]. However, US Patent 4,963,551 does not explicitly mention government funding or interest.
Patent Data and Databases
USPTO Databases
Patents like US Patent 4,963,551 are part of larger datasets available through the USPTO. These databases, such as the PatentsView Database, provide detailed information on patents, including government-interest statements, which are crucial for understanding the broader context of federally funded research[1].
Government-Interest Statements
For patents that received government funding, the Bayh-Dole Act mandates the inclusion of government-interest statements. These statements are important for tracking patents that may be subject to march-in rights, although such rights have never been exercised in practice[1].
Practical Application and Impact
Storage and Stability
The practical application of this patent lies in its ability to provide a stable lyophilized composition that can be stored at room temperature. The specific formulation and drying process described ensure that the product remains effective and safe for use, addressing a significant issue in pharmaceutical storage[2].
Health and Safety Needs
The invention also aligns with the goals of ensuring health and safety needs are met, as mandated by the Bayh-Dole Act. By providing a more stable and safe formulation, the patent contributes to the broader objective of promoting public health[1].
Legal and Regulatory Context
March-In Rights
Although US Patent 4,963,551 does not involve government funding, understanding march-in rights is relevant for patents in the pharmaceutical sector. March-in rights allow the government to issue additional licenses if the contractor is not taking effective steps to achieve practical application or alleviate health or safety needs[1].
Patent Validity and Infringement
The validity of the patent and potential infringement issues are critical. The specificity of the claims in US Patent 4,963,551 helps in defining what constitutes an infringement, making it easier to enforce the patent rights[3].
Industry Impact and Expert Insights
Expert Opinions
Patent attorneys and industry experts often assess the scope and validity of patents based on their claims and the broader patent landscape. For example, Thomas Kulaga notes that broad patents offer more protection against infringers because they are harder to design around[3].
Market and Competitive Landscape
In the pharmaceutical industry, patents like US Patent 4,963,551 play a crucial role in protecting intellectual property and ensuring market exclusivity. The stability and storage improvements provided by this patent can give the holder a competitive edge in the market.
Conclusion
US Patent 4,963,551 is a significant contribution to the field of pharmaceutical formulations, particularly in the context of lyophilized compositions. Its specific claims and detailed description ensure a clear scope of protection, while its practical application addresses critical issues in drug stability and storage.
Key Takeaways
- Specific Claims: The patent's claims are detailed and specific, narrowing the scope but ensuring clear protection.
- Practical Application: The invention improves the stability and storage conditions of lyophilized compositions.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and prior art.
- Government Interest: Although not applicable here, government-interest statements are crucial for tracking federally funded research.
- Legal and Regulatory Context: Understanding march-in rights and patent validity is essential for enforcing patent rights.
FAQs
What is the main focus of US Patent 4,963,551?
The main focus of US Patent 4,963,551 is the formulation and stability of a lyophilized composition, particularly for pharmaceuticals like doxorubicin hydrochloride.
How does the patent improve drug stability?
The patent describes a specific lyophilized preparation that can be stored at room temperature with about 6% moisture, ensuring stability and safety.
What is the significance of government-interest statements in patents?
Government-interest statements are crucial for tracking patents that received federal funding and may be subject to march-in rights, ensuring practical application and public health needs are met.
How is the scope of a patent measured?
The scope of a patent can be measured by the length and detail of its claims, with longer claims indicating a narrower scope.
What is the competitive impact of this patent in the pharmaceutical industry?
The patent provides the holder with a competitive edge by ensuring market exclusivity and protecting intellectual property related to improved drug formulations.
