United States Patent 5,929,028: A Comprehensive Analysis of Liquid Gonadotropin-Containing Formulations
Introduction
United States Patent 5,929,028, titled "Liquid gonadotropin containing formulations," addresses a significant advancement in the field of pharmaceuticals, particularly in the stabilization and administration of gonadotropins. This patent, which has since expired, introduced a novel formulation that enhanced the stability and usability of gonadotropins, crucial for various medical treatments.
Background and Context
Gonadotropins, such as Follicle-Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG), are essential in fertility treatments and other hormonal therapies. However, their stability and ease of administration have been longstanding challenges. The invention described in US 5,929,028 aimed to overcome these issues by developing a liquid formulation that could be stored and administered more conveniently than traditional lyophilized forms[1].
Key Components of the Invention
Gonadotropin and Stabilizing Agents
The patent outlines a liquid gonadotropin-containing formulation that includes a gonadotropin and stabilizing amounts of a polycarboxylic acid or its salt, along with a thioether compound. These components work synergistically to enhance the stability of the gonadotropin during prolonged storage[1].
Polycarboxylic Acid and Thioether Compound
Polycarboxylic acids, such as citric acid, are known for their stabilizing properties in pharmaceutical formulations. The addition of a thioether compound further stabilizes the gonadotropin, preventing degradation and ensuring the formulation remains effective over time[1].
Aqueous Solution and pH Buffer
The formulation is typically prepared in an aqueous solution with a phosphate buffer at pH 7, which helps maintain the stability and bioactivity of the gonadotropin[1].
Advantages Over Prior Art
Improved Stability
The inclusion of a thioether compound in the formulation significantly improves the stability of the gonadotropin compared to formulations lacking this component. This stability is crucial for ensuring the efficacy of the treatment over the shelf life of the product[1].
Convenience of Administration
Unlike lyophilized formulations that require reconstitution before use, the liquid gonadotropin formulation can be injected directly. This convenience is particularly beneficial for patients, as it simplifies the administration process and reduces the risk of errors during preparation[1].
Device for Administration
Pen-Type Injectors
The patent also describes the use of pen-type injectors, such as those similar to the B-D Pen by Becton Dickinson and Company, which are well-known for insulin administration. These devices allow for easy adjustment of the dose, making them highly suitable for administering gonadotropins[1].
Patent Landscape and Prior Art
Related Formulations
Previous formulations, such as those described in European Patent 448,146, used polycarboxylic acid salts like citric acid to stabilize lyophilized gonadotropins. However, these required reconstitution before use, which was a significant drawback. The invention in US 5,929,028 offers a more practical solution by providing a ready-to-use liquid formulation[1].
Global Patent Context
The global patent landscape for gonadotropin formulations has evolved significantly since the issuance of US 5,929,028. Modern formulations continue to build on the principles of stability and convenience introduced by this patent. For instance, newer formulations may incorporate additional stabilizers or advanced delivery systems to further enhance patient compliance and treatment efficacy.
Impact on Medical Treatments
Fertility Treatments
The liquid gonadotropin formulation has been particularly beneficial in fertility treatments, where precise and stable dosing is critical. The convenience and stability of this formulation have improved treatment outcomes and patient satisfaction.
Other Therapeutic Uses
Beyond fertility treatments, gonadotropins are used in various other therapeutic applications, including hormone replacement therapy and the treatment of certain hormonal imbalances. The advancements in formulation stability and administration ease have broadened the scope of these treatments.
Legal and Patent Implications
Patent Expiration
The patent for US 5,929,028 has expired, which means that the specific formulation described is now in the public domain. This expiration has allowed other manufacturers to develop similar formulations, increasing competition and potentially driving innovation in the field.
Influence on Future Patents
The principles outlined in US 5,929,028 have influenced subsequent patent applications related to gonadotropin formulations. Future patents must build upon or differentiate from this foundational work to be considered novel and non-obvious.
Conclusion
United States Patent 5,929,028 marked a significant milestone in the development of stable and convenient liquid gonadotropin formulations. The inclusion of polycarboxylic acids and thioether compounds, along with the use of pen-type injectors, has set a standard for subsequent formulations. As the patent landscape continues to evolve, the principles established by this invention remain crucial for advancing medical treatments involving gonadotropins.
Key Takeaways
- Stability and Convenience: The patent introduced a liquid gonadotropin formulation with improved stability and ease of administration.
- Key Components: Polycarboxylic acids and thioether compounds are critical for stabilizing the gonadotropin.
- Device for Administration: Pen-type injectors enhance the convenience and precision of dosing.
- Impact on Treatments: The formulation has significantly improved fertility treatments and other therapeutic applications.
- Legal Implications: The patent's expiration has opened the field to broader competition and innovation.
FAQs
What is the main innovation of US 5,929,028?
The main innovation is the development of a stable liquid gonadotropin formulation that can be administered directly without the need for reconstitution.
What are the key stabilizing agents in the formulation?
The key stabilizing agents are polycarboxylic acids (or their salts) and thioether compounds.
How does the formulation improve patient compliance?
The liquid formulation simplifies the administration process, reducing the risk of errors during preparation and making it more convenient for patients.
What type of devices are recommended for administering the formulation?
Pen-type injectors, similar to those used for insulin administration, are recommended for their ease of use and dose adjustment.
What is the current status of the patent?
The patent has expired, making the specific formulation described in the public domain.
Sources
- US5929028A - Liquid gonadotropin containing formulations - Google Patents
- The Importance of Prong Two of Step 2A for AI Inventions - Baker Botts
- Patent Search Services - Patent Validity Search - Clarivate
- Search for patents - USPTO
- Damages Experts Analysis on the Front Burner - Patently-O
