United States Patent 10,576,090: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,576,090, 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 delivery, outlines a formulation that enhances the properties of lipophilic drugs. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US10576090B2
- Authority: United States
- Prior Art Date: The patent application was filed on October 26, 2017, and it builds upon earlier research and patents in the field of drug delivery formulations[2].
Invention Summary
The patent describes a formulation designed to improve the solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs. This is achieved through the use of sterols, such as phytosterols, which are incorporated into the drug formulation to enhance these properties. The formulation is particularly relevant for drugs like testosterone, where improving bioavailability and reducing variability in absorption are critical[2].
Scope of the Invention
Key Components
- Sterols: The patent highlights the use of sterols, including phytosterols, to modulate the properties of lipophilic drugs. These sterols help in creating a stable and soluble formulation that enhances the drug's bioavailability[2].
- Drug Examples: The patent specifically mentions testosterone and its esters, such as testosterone palmitate, as examples of lipophilic drugs that can benefit from this formulation[2].
Technical Details
- Formulation Types: The patent discusses various formulation types, including Self-Emulsifying Drug Delivery Systems (SEDDS) and delayed release formulations. These formulations are designed to prolong the circulation of the drug in the body, thereby improving its pharmacokinetic profile[2].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition of the formulation, the method of preparation, and the specific sterols used.
- Claim 1: This claim describes a pharmaceutical composition comprising a lipophilic drug, a sterol, and optionally other excipients. The claim specifies the types of sterols that can be used and the proportions in which they are combined with the drug[2].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the independent claims. For example:
- Claim 2: This claim is dependent on Claim 1 and specifies the use of phytosterols as the sterol component[2].
Claim Construction
The claims are constructed to ensure broad coverage while maintaining specificity. The use of terms like "comprising" and "optionally" allows for flexibility in the formulation while ensuring that the core components of the invention are protected.
Patent Landscape
Prior Art
The patent builds on existing research in drug delivery formulations. For instance, earlier patents like U.S. Patent Application No. 2008/0317844 and U.S. Patent Application No. 2010/0173882 describe SEDDS formulations and delayed release formulations of testosterone, respectively. The current patent innovates by introducing the use of sterols to enhance these formulations[2].
International Context
The global patent landscape for drug delivery formulations is highly competitive. Similar patents and applications can be found in various international databases, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Competing Patents
Other patents in the field of drug delivery may overlap or compete with the claims of US10576090B2. For example, patents related to different types of drug delivery systems or formulations that also aim to improve the pharmacokinetic profiles of lipophilic drugs could be considered competitors.
Inventorship and Ownership
Determination of Inventorship
Inventorship for this patent would be determined based on who conceived the idea of using sterols to modulate the properties of lipophilic drugs. According to US patent law, an inventor is someone who conceives the subject matter of at least one claim of the patent. The conception must be definite and permanent, meaning it should be clear and complete enough for someone with ordinary skill in the field to reduce it to practice without undue experimentation[4].
Assignment and Licensing
The patent could be assigned or licensed to other entities, which would affect its ownership and use. The USPTO provides tools like the Patent Assignment Search to track changes in ownership and assignments[1].
Economic and Market Impact
Market Dominance
This patent could provide a significant competitive advantage in the pharmaceutical market, particularly in the area of drug delivery formulations. By improving the solubility, stability, and bioavailability of lipophilic drugs, the formulation can enhance patient outcomes and reduce variability in drug response.
Economic Benefits
The economic benefits of this patent include potential increased sales and market share for the pharmaceutical company holding the patent. Additionally, the improved drug formulations could lead to better health outcomes, reducing healthcare costs in the long run.
Legal and Regulatory Considerations
Patent Validity
The validity of the patent depends on several factors, including the novelty and non-obviousness of the invention. Any errors in inventorship or deceptive intent in naming inventors could render the patent unenforceable[4].
Regulatory Approvals
The formulation described in the patent would need to undergo regulatory approvals, such as those from the FDA, before it can be marketed. The FDA Orange Book, which lists approved drug products with their corresponding patents, would be relevant in this context[5].
Conclusion
The United States Patent 10,576,090 represents a significant advancement in the field of drug delivery formulations. By using sterols to enhance the properties of lipophilic drugs, this patent offers a promising solution for improving the bioavailability and pharmacokinetic profiles of these drugs. Understanding the scope, claims, and broader patent landscape is crucial for navigating the competitive pharmaceutical industry.
Key Takeaways
- Innovation in Drug Delivery: The patent introduces the use of sterols to improve the solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs.
- Competitive Advantage: This formulation can provide a competitive edge in the pharmaceutical market by enhancing patient outcomes and reducing variability in drug response.
- Regulatory and Legal Considerations: The patent's validity and regulatory approvals are critical for its enforcement and marketability.
- International Context: The global patent landscape for drug delivery formulations is highly competitive, with similar patents and applications found in various international databases.
FAQs
Q: What is the main innovation of US Patent 10,576,090?
A: The main innovation is the use of sterols to enhance the solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs.
Q: Which drugs are specifically mentioned in the patent?
A: The patent specifically mentions testosterone and its esters, such as testosterone palmitate.
Q: How does the formulation improve drug properties?
A: The formulation uses sterols, like phytosterols, to create a stable and soluble formulation that enhances the bioavailability of the drug.
Q: What are the regulatory steps required for this formulation?
A: The formulation must undergo regulatory approvals, such as those from the FDA, before it can be marketed.
Q: How can errors in inventorship affect the patent?
A: Errors in inventorship, especially those involving deceptive intent, can render the patent unenforceable.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Google Patents - US10576090B2: https://patents.google.com/patent/US10576090B2/en
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Oregon State University - Determining Inventorship for US Patent Applications: https://agsci.oregonstate.edu/sites/agsci/files/main/research/vrc_release_inventorship-gattari.pdf
- PharmaCompass - US Patent 10576090: https://www.pharmacompass.com/us-patent-10576090
