United States Patent 6,004,968: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 6,004,968, titled "Stabilized Preparation Containing Protein," is a significant patent in the field of pharmaceuticals, particularly focusing on the stabilization of protein-containing formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted on December 21, 1999, to inventors Casey et al., addresses a critical issue in the pharmaceutical industry: the stabilization of proteins. With the advancement of genetic engineering, proteins such as antibodies, enzymes, hormones, and cytokines have become crucial as pharmaceutical products. However, these proteins are prone to physical or chemical changes, such as aggregation, which can compromise their efficacy and stability[1].
Technical Field
The patent falls under the technical field of pharmaceutical formulations, specifically focusing on the stabilization of protein-containing preparations. This includes the use of surfactants and other stabilizing agents to prevent the formation of insoluble aggregates and maintain the structural integrity and activity of the proteins.
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim describes a method for stabilizing a protein-containing preparation using a surfactant, specifically a polyoxyalkylene surfactant.
- Dependent Claims: These claims further specify the types of proteins (e.g., antibodies, enzymes), the concentration of the surfactant, and the conditions under which the stabilization is achieved.
These claims are designed to ensure that the invention is clearly defined and distinguishable from prior art, adhering to the requirements of 35 U.S.C. § 112, which mandates that patent claims must "particularly point[] out and distinctly claim[] the subject matter" of the invention[2].
Detailed Analysis of Claims
Independent Claim 1
The independent claim sets the foundation for the invention by describing the method of stabilizing a protein-containing preparation. This includes the steps of mixing the protein with a surfactant and adjusting the conditions to prevent aggregation.
Dependent Claims
The dependent claims provide additional specificity:
- Claim 2: Specifies the type of protein, such as an antibody or enzyme.
- Claim 3: Details the concentration range of the surfactant.
- Claim 4: Describes the storage conditions that maintain the stability of the preparation.
These dependent claims help to narrow down the scope of the invention, ensuring that it is not overly broad and thus more likely to withstand challenges of indefiniteness or lack of novelty.
Patent Landscape
Prior Art
The patent cites several prior art documents, including U.S. patents and foreign patent documents, which highlight the existing solutions and challenges in stabilizing protein-containing formulations. For example, U.S. Patent 5,358,708 A and U.S. Patent 5,696,090 A are referenced as prior art that did not fully address the issue of protein stability[1].
Related Patents
Other patents in the same field, such as U.S. Patent 6,015,568 A and U.S. Patent 6,171,586 B1, also deal with protein stabilization but use different approaches. These patents collectively contribute to the evolving landscape of protein formulation technology.
Economic and Legal Implications
Patent Eligibility
The patent's claims must comply with the criteria for patent eligibility under 35 U.S.C. § 101. This involves ensuring that the claims do not monopolize abstract ideas, laws of nature, or natural phenomena but instead integrate these concepts into a practical application. The Supreme Court's decisions in cases like Alice Corp. Pty. Ltd. v. CLS Bank Int’l and Mayo Collaborative Services v. Prometheus Labs., Inc. provide the framework for this analysis[2].
False Advertising and Lanham Act
Falsely claiming that a product or feature is patented can lead to violations under the Lanham Act, as seen in the Federal Circuit's decision in Crocs, Inc. v. Effervescent, Inc.. This underscores the importance of accurate representation of patent status in marketing and advertising[5].
Data and Research
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceutical formulations. This dataset can be used to analyze trends and statistics in patent claims, offering insights into the scope and breadth of patents like 6,004,968[3].
PatentsView Database
The PatentsView database offers comprehensive data on patents, including disambiguated inventor data, international patent classification, and non-patent citations. This resource can help in understanding the broader patent landscape and the impact of patents on innovation[4].
Key Takeaways
- Stabilization Method: The patent introduces a method for stabilizing protein-containing preparations using a surfactant, which is crucial for maintaining the efficacy of proteins.
- Claims Analysis: The claims are structured to ensure clarity and distinctness, adhering to patent law requirements.
- Patent Landscape: The patent is part of a larger landscape of protein formulation technology, with various approaches and solutions being developed.
- Legal and Economic Implications: The patent must comply with patent eligibility criteria and avoid false advertising claims to maintain its validity and market integrity.
FAQs
What is the main focus of United States Patent 6,004,968?
The main focus is on stabilizing protein-containing preparations using a surfactant to prevent aggregation and maintain protein activity.
What types of proteins are covered by this patent?
The patent covers various proteins, including antibodies, enzymes, hormones, and cytokines.
How does the patent ensure the stability of protein preparations?
The patent describes a method involving the use of a polyoxyalkylene surfactant and specific storage conditions to maintain protein stability.
What are the legal implications of falsely claiming a product is patented?
Falsely claiming a product is patented can lead to violations under the Lanham Act, resulting in claims for false advertising.
Where can detailed data on patent claims be found?
Detailed data on patent claims can be found in the USPTO's Patent Claims Research Dataset and the PatentsView database.
Sources
- United States Patent and Trademark Office, "United States Patent: 6,004,968," July 21, 1999.
- Court of Appeals for the Federal Circuit, "Berkheimer v. HP Inc.," February 8, 2018.
- United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
- PatentsView, "Data Download Tables," accessed December 22, 2024.
- Buchanan Ingersoll & Rooney PC, "Federal Circuit Ruling: False Patent Claims Can Lead to Lanham Act Violations," November 4, 2024.
