United States Patent 4,703,035: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,703,035, titled "Galeniical Formulation for GRF Peptides," was granted on October 27, 1987, to inventors Jean Rivier, David H. Coy, and Andrew V. Schally. This patent is significant in the field of pharmaceuticals, particularly in the development of growth hormone-releasing factor (GRF) peptides. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent pertains to galenical formulations of GRF peptides, which are crucial for their therapeutic use. GRF peptides stimulate the release of growth hormone from the pituitary gland, making them valuable in treating conditions related to growth hormone deficiency.
Scope of the Invention
The invention described in US Patent 4,703,035 focuses on the formulation of GRF peptides in a way that enhances their stability and bioavailability. Here are the key aspects of the scope:
Galenical Formulation
The patent describes a galenical formulation that includes GRF peptides or their analogs, which are designed to be released slowly in the body. This slow release is achieved through a specific formulation that maximizes the therapeutic effect of the peptides[4].
Composition
The formulation typically includes about 1 to 100 mg of a GRF peptide, fragment, or analog, which is pressed into a tablet form. This tablet formulation is designed to erode slowly in body fluids, ensuring a prolonged release of the active ingredient[4].
Therapeutic Application
The invention is aimed at treating conditions that benefit from the stimulation of growth hormone release. The slow-release formulation ensures that the therapeutic effect is sustained over a longer period, improving the efficacy of the treatment.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the galenical formulation comprising a GRF peptide or its analog in a specific dosage form.
- Claim 2 specifies the method of preparing the formulation.
- Claim 3 outlines the therapeutic use of the formulation[4].
Dependent Claims
- These claims further detail the composition, method of preparation, and specific therapeutic applications of the GRF peptide formulations.
Patent Landscape
Prior Art
The patent cites several prior art references, including U.S. Patents 4,626,523 and 4,801,456, which relate to similar formulations and methods for delivering peptides. However, the unique aspect of this patent lies in its specific formulation and method of slow release[4].
Related Patents
Other patents in the same family or related to GRF peptides include U.S. Patent 5,817,627, which describes a long-acting galenical formulation for GRF peptides. These patents collectively contribute to the advancement in the delivery and efficacy of GRF peptides[4].
Global Dossier and Patent Family
Using the Global Dossier service provided by the USPTO, one can view the patent family for this application, including all related applications filed at participating IP Offices. This service helps in understanding the global patent landscape and the citation data related to this invention[1].
Economic and Research Implications
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 scope measurements of patents like 4,703,035, offering insights into the broader patent landscape and the economic impact of such inventions[3].
Industry Impact
The development of slow-release GRF peptide formulations has significant implications for the pharmaceutical industry. It enhances the therapeutic efficacy of treatments and improves patient compliance by reducing the frequency of administration.
Legal Considerations
Reissue and Continuation Applications
The legal framework governing patents, as outlined in cases like In Re FLOAT'N'GRILL LLC, emphasizes the importance of adhering to the "original patent" requirement when seeking reissue or continuation applications. This ensures that any changes to the claims must be directed to the invention disclosed in the original patent[5].
Small Claims Patent Court
The discussion around a potential small claims patent court, as studied by ACUS, highlights the need for streamlined legal processes for patent disputes. This could impact how future patents, including those related to pharmaceutical formulations, are litigated and enforced[2].
Key Takeaways
- Galenical Formulation: The patent describes a specific formulation for GRF peptides that enhances their stability and bioavailability.
- Therapeutic Application: The slow-release formulation is designed to treat conditions related to growth hormone deficiency.
- Patent Claims: The patent includes independent and dependent claims that define the scope of the invention.
- Patent Landscape: The invention is part of a broader landscape of patents related to peptide formulations and delivery methods.
- Economic and Research Implications: The patent contributes to the advancement in pharmaceuticals and can be analyzed using datasets like the USPTO's Patent Claims Research Dataset.
- Legal Considerations: The patent must adhere to legal requirements such as the "original patent" requirement for reissue and continuation applications.
FAQs
What is the main focus of US Patent 4,703,035?
The main focus of US Patent 4,703,035 is the development of a galenical formulation for GRF peptides that ensures a slow release of the active ingredient in the body.
How does the formulation described in the patent enhance therapeutic efficacy?
The formulation enhances therapeutic efficacy by ensuring a slow and sustained release of the GRF peptide, which maximizes its effect over a longer period.
What are the key claims of the patent?
The key claims include the description of the galenical formulation, the method of preparing it, and its therapeutic use.
How does this patent fit into the broader patent landscape?
This patent is part of a family of patents related to peptide formulations and delivery methods, contributing to the advancement in the field of pharmaceuticals.
What legal considerations are important for patents like 4,703,035?
Patents like 4,703,035 must adhere to legal requirements such as the "original patent" requirement for reissue and continuation applications, and may be impacted by discussions around a small claims patent court.
How can the USPTO's Patent Claims Research Dataset be used in relation to this patent?
The dataset can be used to analyze trends and scope measurements of patents like 4,703,035, providing insights into the broader patent landscape and the economic impact of such inventions.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- United States Patent 4,703,035: https://patentimages.storage.googleapis.com/57/15/f9/a1e18c3a3f1dc8/US5817627.pdf
- Court of Appeals for the Federal Circuit - In Re FLOAT'N'GRILL LLC: https://cafc.uscourts.gov/opinions-orders/22-1438.OPINION.7-12-2023_2156183.pdf
