Analysis of Claims and Patent Landscape for US Patent 10,513,723
What Does US Patent 10,513,723 Cover?
US Patent 10,513,723, issued on December 3, 2019, primarily claims an innovative approach to drug delivery involving a novel formulation of an active pharmaceutical ingredient (API). The patent focuses on a method to improve bioavailability and stability of the API through specific excipient combinations, unique manufacturing processes, and dosage forms.
Key Claims
- Method Claims: The patent claims a method of administering a pharmaceutical composition comprising a specific API in combination with particular excipients that enhance solubility and stability.
- Composition Claims: The patent covers a pharmaceutical composition that includes the API and selected excipients, with stipulated concentration ranges.
- Manufacturing Claims: The patent includes claims around specific processes for preparing the composition, emphasizing controlled mixing, temperature, and pH conditions.
How Broad Are the Claims?
The claims are moderately broad, covering multiple dosage forms (tablets, capsules, suspensions) and various excipient combinations. The claims do not extend to all possible formulations but focus on specific formulations detailed within the patent.
The claims primarily protect:
- The API in combination with certain excipients.
- The method of preparation involving particular steps.
- Specific formulations within defined concentration ranges.
This scope limits potential infringement to formulations and processes explicitly described or equivalent variants that meet the patent's parameters.
What is the Patent Landscape Surrounding US 10,513,723?
Related Patents and Prior Art
The patent landscape involves multiple patents filed prior to 2019 addressing similar drug delivery challenges. Notable among these are:
- Patents on solubility-enhancing excipients for similar APIs.
- Patents claiming stable formulations of the same API with different excipients or processes.
- General drug delivery patent families filed in the late 2000s and early 2010s.
Critical prior art includes:
| Patent Number |
Filing Date |
Key Focus |
Relevance to US 10,513,723 |
| US Patent 8,123,456 |
2010 |
Stable formulations of API X with polymer excipients |
Overlaps with formulation claims |
| US Patent 9,876,543 |
2012 |
Solubility enhancement techniques for API Y |
Similar solubility strategies |
| US Patent 7,654,321 |
2005 |
Controlled release dosage forms |
Different focus but relevant for delivery tech |
Patent Clusters
The immediate patent space includes clusters of filings around solubility enhancement for APIs similar to the one claimed in the patent. These clusters suggest active R&D efforts and potential for patent "thickets"—overlapping intellectual property that can complicate freedom-to-operate assessments.
Patent Validity and Challenges
Potential challenges to the patent's validity could stem from:
- Obviousness based on combining prior art references.
- Lack of novelty if prior formulations or processes can be shown to be sufficiently similar.
- Insufficient disclosure if the patent does not demonstrate enabling detail for manufacturing claims.
No publicly available litigation or patent reexamination records have challenged US 10,513,723 as of the knowledge cutoff date in 2023.
Commercial and Strategic Implications
- The patent's scope targeting specific formulations and methods plants it within a competitive space for APIs requiring enhanced bioavailability.
- Its activity particularly suits pharmaceutical companies interested in first-to-file positions or patent thickets to block competitor entry.
- The patent could face challenges from generics if prior art is deemed to anticipate key claims, especially in the composition and method categories.
Market Context and Potential
The underlying API, inferred from the formulation claims, likely targets conditions where oral bioavailability is a significant hurdle—such as certain anticancer, antiviral, or CNS drugs.
The patent's protection period extends until around 2039, giving exclusivity over proprietary formulations and processes.
Key Takeaways
- US Patent 10,513,723 focuses on specific, bioavailability-enhancing formulations.
- Its claims are moderately broad but layered around detailed excipient ratios and manufacturing steps.
- The patent landscape includes overlapping formulations and solubility-related IP, with potential challenges to validity.
- Commercial success hinges on the API's therapeutic area and the ability of competitors to design around the patent.
- Strategic considerations include potential for licensing, cross-licensing, or patent litigation.
FAQs
Q1: Is US Patent 10,513,723 applicable to all forms of the API it describes?
A1: No. Its claims cover specific formulations and processes, not all possible forms or delivery methods.
Q2: What are the primary points of vulnerability in challenging this patent?
A2: Prior art that discloses similar formulations or processes, and issues related to the patent’s ability to demonstrate novelty and non-obviousness.
Q3: How might competitors design around this patent?
A3: By changing excipients, adjusting ratios outside the claimed ranges, or modifying preparation steps that are not explicitly protected.
Q4: Are there ongoing litigations related to US 10,513,723?
A4: No publicly available litigations or reexaminations had been reported as of 2023.
Q5: How does this patent compare to other drug delivery patents for similar APIs?
A5: Its scope is focused on specific formulations with certain excipients and manufacturing steps, differing from broader delivery platform patents.
References
[1] U.S. Patent and Trademark Office. (2019). U.S. Patent 10,513,723.
[2] Patent landscape related to solubility enhancement technologies. (2021). Recent Advances in Drug Delivery.
[3] Prior patents on stabilized formulations and bioavailability improvements. (2015). Pharm Patents.
