United States Patent 10,576,089: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,576,089, titled "Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols," is a significant patent in the pharmaceutical field. This patent, granted to innovators in drug formulation, addresses critical issues related to the delivery of lipophilic (poorly water-soluble) therapeutic agents.
Patent Overview
Publication Number and Authority
The patent number is US10576089B2, and it was granted by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
The patent builds on prior art related to formulations of lipophilic drugs, such as testosterone and its esters. It references earlier patents and applications that describe various formulations aimed at improving the solubility, stability, and absorption of these drugs[4].
Scope of the Patent
Main Claims
The patent primarily claims a formulation that enhances the solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic therapeutic agents. Key components of this formulation include:
- At least one lipophilic, poorly water-soluble therapeutic agent.
- A phytosterol or phytosterol ester.
- A non-sterol solubilizing agent.
- Optionally, an enhancing agent for biological absorption and metabolic stability[4].
Specific Formulations
The patent describes various methods of combining these components to create pharmaceutical compositions suitable for different administration routes, such as oral, parenteral, intramuscular, transdermal, nasal, sublingual, buccal, or subcutaneous administration. For example, the formulation can include a phytosterol or phytosterol ester to enhance solubility and a non-sterol solubilizing agent to further improve the biological absorption and metabolic stability of the therapeutic agent[4].
Claims Analysis
Independent Claims
The independent claims of the patent focus on the composition and method of preparing the formulation. For instance, Claim 1 describes a pharmaceutical composition containing a lipophilic therapeutic agent, a phytosterol or phytosterol ester, and a non-sterol solubilizing agent, designed to enhance the solubility and absorption of the therapeutic agent[4].
Dependent Claims
Dependent claims elaborate on the specific types of therapeutic agents, solubilizing agents, and enhancing agents that can be used in the formulation. These claims provide a detailed breakdown of the various combinations and ratios of these components that fall within the scope of the invention[4].
Patent Landscape
Related Patents and Applications
The patent landscape surrounding US10576089B2 includes several related patents and applications that address similar issues in drug formulation. For example, U.S. Patent Application No. 2008/0317844 describes a Self-Emulsifying Drug Delivery System (SEDDS) formulation of testosterone palmitate, which is referenced in the current patent as prior art[4].
International Patents
The invention is also protected by international patents, which can be searched through databases such as the World Intellectual Property Organization (WIPO) PATENTSCOPE® Search Service. This ensures global protection for the formulation across various jurisdictions[1].
Expiration and Generic Entry
Patent Expiration
The patent's expiration date is crucial for understanding when generic versions of the formulation can enter the market. As of the current date, the patent is active, but its expiration will be determined by the original filing date and any extensions or adjustments made during the patent term[5].
Generic Entry
Generic entry into the market is typically allowed after the patent expires or if a generic manufacturer successfully challenges the patent through legal means. The expiration of this patent will open up opportunities for generic formulations that utilize similar technology, provided they do not infringe on the claims of the original patent[5].
Economic and Market Impact
Market Dominance
Patents like US10576089B2 can provide significant market dominance to the patent holder, allowing them to exclusively market and sell the formulation until the patent expires. This exclusivity can lead to substantial revenue and market share in the pharmaceutical industry.
Innovation and Competition
The patent also drives innovation by encouraging other researchers and companies to develop alternative formulations that do not infringe on the existing patent claims. This competition can lead to further advancements in drug delivery systems and improved patient outcomes.
Legal and Regulatory Considerations
Patent Litigation
The patent holder must be prepared to defend the patent against potential infringement claims. This involves monitoring the market for similar formulations and taking legal action if necessary to protect the intellectual property.
Regulatory Approvals
Before the formulation can be marketed, it must receive regulatory approvals from bodies such as the FDA. The patent does not guarantee regulatory approval; it only protects the intellectual property rights related to the formulation[4].
Conclusion
United States Patent 10,576,089 is a critical piece of intellectual property in the pharmaceutical sector, addressing the challenges of delivering lipophilic therapeutic agents. The patent's scope and claims are detailed and specific, providing a robust foundation for the patent holder's market position. Understanding the patent landscape, expiration dates, and legal considerations is essential for both the patent holder and potential competitors.
Key Takeaways
- Formulation Components: The patent involves a combination of lipophilic therapeutic agents, phytosterols or phytosterol esters, and non-sterol solubilizing agents.
- Administration Routes: The formulation can be administered through various routes, including oral, parenteral, and transdermal.
- International Protection: The invention is protected by international patents, ensuring global exclusivity.
- Expiration and Generic Entry: The patent's expiration date determines when generic versions can enter the market.
- Market Impact: The patent provides market dominance and drives innovation in drug delivery systems.
FAQs
Q: What is the main focus of United States Patent 10,576,089?
A: The main focus is on a formulation that enhances the solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic therapeutic agents using phytosterols or phytosterol esters.
Q: How does the patent protect the formulation?
A: The patent protects the specific combination of components and methods of preparing the formulation, ensuring exclusivity for the patent holder.
Q: What are the potential administration routes for the formulation?
A: The formulation can be administered orally, parenterally, intramuscularly, transdermally, nasally, sublingually, buccally, or subcutaneously.
Q: How does the patent impact the pharmaceutical market?
A: The patent provides market dominance to the holder and drives innovation by encouraging the development of alternative formulations.
Q: When can generic versions of the formulation enter the market?
A: Generic versions can enter the market after the patent expires or if a generic manufacturer successfully challenges the patent through legal means.
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
- Google Patents - US10576089B2: https://patents.google.com/patent/US10576089B2/en
- Drug Patent Watch - Patent 10,576,089: https://www.drugpatentwatch.com/p/patent/10576089
