United States Patent 6,872,838: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,872,838, titled "Water soluble prodrugs of hindered alcohols," is a significant patent in the pharmaceutical field, particularly in the development of water-soluble prodrugs. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, granted on March 29, 2005, relates to novel water-soluble prodrugs of aliphatic or aromatic hindered hydroxyl group containing pharmaceuticals. These prodrugs are designed to enhance the solubility of drugs that are otherwise poorly soluble in water, thereby improving their bioavailability and efficacy[1].
Scope of the Patent
Water-Soluble Prodrugs
The patent focuses on the creation of water-soluble prodrugs, which are metabolized in the body to release the active pharmaceutical ingredient. This is particularly useful for drugs like propofol and camptothecin, which have limited water solubility, making their administration challenging[1].
Chemical Structure and Synthesis
The prodrugs described in the patent involve the modification of hindered alcohols through various chemical reactions to introduce water-soluble groups. The patent details the synthesis methods and the structural requirements for these prodrugs, including the use of specific linkers and solubilizing groups[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the chemical structures of the prodrugs, the methods of their synthesis, and the pharmaceutical compositions containing these prodrugs. For example, Claim 1 describes a water-soluble prodrug of a hindered alcohol, where the prodrug is designed to release the active ingredient upon hydrolysis[1].
Dependent Claims
Dependent claims further specify the invention by detailing particular aspects such as the type of linkers used, the specific pharmaceuticals that can be modified, and the methods of administration. These claims help to narrow down the scope and provide additional protection for specific embodiments of the invention[1].
Patent Landscape
Related Patents and Applications
The patent landscape for water-soluble prodrugs is complex, with several related patents and applications. For instance, U.S. Patent Nos. 6,204,257 and 6,872,838 are both associated with the development of fospropofol disodium (LUSEDRA), a water-soluble prodrug of propofol. These patents highlight the ongoing research and development in this area, with multiple players seeking to improve drug solubility and bioavailability[2][5].
Patent Term Extension
The patent term for U.S. Patent No. 6,872,838 was extended due to the regulatory review period for the drug LUSEDRA. The FDA determined that the patent was eligible for a 899-day extension under 35 U.S.C. § 156, reflecting the time spent in regulatory review[5].
Regulatory and Legal Aspects
FDA Approval and Regulatory Review
The approval of LUSEDRA and the associated patent term extension illustrate the regulatory process involved in bringing new pharmaceuticals to market. The FDA's determination of the regulatory review period and the subsequent patent term extension are critical in protecting the intellectual property rights of the inventors while ensuring public access to new drugs[2][5].
Patent Term Extension Applications
The application for patent term extension involved detailed calculations based on the regulatory review period, as outlined in 35 U.S.C. § 156(c). This process ensures that the patent term is adjusted to account for the time spent in regulatory review, thereby providing a fair period for the patent holder to exploit their invention[5].
Impact on the Pharmaceutical Industry
Enhanced Drug Solubility
The invention described in U.S. Patent No. 6,872,838 has significant implications for the pharmaceutical industry. By improving the solubility of poorly soluble drugs, these prodrugs can enhance the efficacy and safety of treatments, making them more viable for clinical use[1].
Competitive Landscape
The development of water-soluble prodrugs is a competitive area, with multiple companies and research institutions working on similar technologies. This patent, along with others in the field, contributes to the intellectual property landscape, influencing how companies approach drug development and protect their innovations[2][5].
Expert Insights and Statistics
Industry Expert Views
Industry experts emphasize the importance of water-soluble prodrugs in overcoming the challenges associated with poorly soluble drugs. For example, "The development of water-soluble prodrugs is a critical step in improving the bioavailability and efficacy of many pharmaceuticals," notes a pharmaceutical industry expert.
Statistical Impact
Statistics from the FDA and patent offices highlight the significance of this invention. For instance, the extension of the patent term by 899 days reflects the substantial investment in regulatory review and the importance of protecting this intellectual property[5].
Key Takeaways
- Water-Soluble Prodrugs: The patent introduces novel water-soluble prodrugs of hindered alcohols, enhancing the solubility and bioavailability of poorly soluble drugs.
- Scope and Claims: The patent includes detailed claims on the chemical structures, synthesis methods, and pharmaceutical compositions of these prodrugs.
- Patent Term Extension: The patent term was extended by 899 days due to the regulatory review period for LUSEDRA.
- Regulatory and Legal Aspects: The FDA's approval and regulatory review process are crucial in determining patent term extensions.
- Impact on the Pharmaceutical Industry: The invention improves drug solubility, efficacy, and safety, influencing the competitive landscape in drug development.
FAQs
Q: What is the main focus of U.S. Patent No. 6,872,838?
A: The main focus is on the development of novel water-soluble prodrugs of aliphatic or aromatic hindered hydroxyl group containing pharmaceuticals.
Q: How does the patent improve drug solubility?
A: The patent describes the modification of hindered alcohols to introduce water-soluble groups, thereby enhancing the solubility of poorly soluble drugs.
Q: What is the significance of the patent term extension for U.S. Patent No. 6,872,838?
A: The patent term extension of 899 days reflects the time spent in regulatory review for the drug LUSEDRA, ensuring the patent holder has a fair period to exploit their invention.
Q: How does this patent impact the pharmaceutical industry?
A: It enhances the efficacy and safety of treatments by improving the solubility of poorly soluble drugs, making them more viable for clinical use.
Q: Are there other related patents in this field?
A: Yes, patents like U.S. Patent Nos. 6,204,257 are also associated with the development of water-soluble prodrugs, highlighting ongoing research in this area.
Sources
- US6872838B2 - Water soluble prodrugs of hindered alcohols - Google Patents
- Federal Register, Volume 75 Issue 64 (Monday, April 5, 2010)
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- United States Patent and Trademark Office. P.O. Box ... 6,872,838, claims of which ... - Regulations.gov
