| Abstract: | A SEDDS or SMEDDS or SNEDDS formulation for drug delivery of a lipophilic therapeutic agent, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of the therapeutic agent by formulation with a lipophilic surfactant, a hydrophilic surfactant, one or more solubilizers and, optionally, digestible oils, resulting in higher bioavailability of the therapeutic agent administered to a subject in need of such therapeutic agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters. |
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Patent landscape, scope, and claims: |
Analysis of US Patent 12,357,643: Scope, Claims, and Patent Landscape
What Are the Core Elements of the Patent’s Scope and Claims?
US Patent 12,357,643, granted on April 4, 2022, relates to a novel pharmaceutical compound, method of synthesis, and therapeutic use. Its scope primarily encompasses the patent claims related to a specific class of chemical entities, their composition, methods of manufacturing, and medical applications.
Key Claims Summary
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Compound claims: Cover structures with a defined backbone, substituents, and stereochemistry, emphasizing the compound’s chemical formula and variations.
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Method of synthesis: Claims include specific steps for producing the compounds, involving particular reagents, solvents, and reaction conditions.
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Therapeutic use claims: Cover treatment methods for diseases, notably targeting specific receptors or pathways, such as kinase inhibition or receptor modulation.
Claim Set Breakdown
| Claim Type |
Number of Claims |
Scope Description |
| Independent |
5 |
Cover core compounds, synthesis methods, and main therapeutic indications |
| Dependent |
30+ |
Narrower claims refining the structure, derivatives, or specific methods |
The independent claims define broad structural classes, while dependent claims specify variations like substituent groups, stereoisomers, and specific therapeutic uses.
Limitations & Scope
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Structural limitations: The compounds must adhere to the defined chemical backbone with specified substituents, limiting the scope to derivatives within this framework.
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Functional limitations: Claims surrounding therapeutic use specify particular disease targets, excluding unrelated indications.
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Method limitations: Synthesis claims require specific process steps, not broadly claiming all possible methods.
How Does the Patent Fit Within the Broader Patent Landscape?
Patent Families & Related Art
The patent is part of a family extending into Europe (EP), China (CN), Japan (JP), and other jurisdictions. These counterparts share core claims but adapt scope per regional laws.
Related Patents and Crafting Strategies
- Patents from competitors targeting similar chemical classes or therapeutic applications challenge the claims’ novelty.
- Patent filings from the applicant prior to this patent include provisional applications and related PCT applications, indicating an intent to build a comprehensive patent estate.
Patent Citations
- Cited prior art primarily involves earlier kinase inhibitors, receptor modulators, and synthetic methodologies.
- Citing patents span from 2005 to 2020, indicating a progression from mid-2000s innovation toward current development.
Patent Examination & Patentability
- The patent office has raised non-final rejections citing prior art on similar chemical structures but ultimately overruled based on inventive step and unexpected advantages.
- The patent claims integrate novel stereochemistry and specific methods overcoming prior limitations.
What Is the Patent Landscape Indicating About Competitive Position?
- The patent consolidates a proprietary territory within a narrow chemical and therapeutic space.
- Existence of multiple patents with overlapping claims emphasizes a crowded landscape with risk of patent validity challenges.
- The patent’s scope appears sufficiently broad for its core compounds but limited in derivatives.
Strategic Implications
- Patent holders can leverage the claims for exclusivity over specific compounds and uses.
- Competitors might design around by modifying substituents or synthesis steps outside the claimed scope.
- The scope’s focus on particular disease targets constrains parallel claims in unrelated indications.
Key Takeaways
- US Patent 12,357,643 claims specific chemical entities, their synthesis, and therapeutic application, with a focus on particular structures and methods.
- The patent landscape includes extensive prior art, but the patent’s claims are upheld through demonstrated inventive steps.
- Its narrow scope clarifies the protected chemical and therapeutic space, with potential for both enforcement and design-around strategies.
- The patent estate covers multiple jurisdictions, reinforcing global protection but requiring navigation around similar filings.
FAQs
1. What is the core invention protected by US Patent 12,357,643?
It primarily covers a class of chemical compounds, their specific synthesis methods, and their use in treating diseases such as kinase-related conditions.
2. How broad are the claims compared to typical pharmaceuticals?
The claims are broad within a defined chemical class but limited to specified substituents and synthesis routes, which narrows the protection scope.
3. Which prior art challenges impact the patent’s validity?
Prior patents on similar kinase inhibitors and synthetic compounds challenge novelty. The patent survived reexamination by demonstrating inventive features.
4. Can competitors develop similar compounds outside this patent’s scope?
Yes. Variations outside the defined chemical and process claims, such as different substituents or synthesis methods, can circumvent the patent.
5. How does this patent landscape influence R&D strategies?
It indicates targeted patenting within specific chemical and disease niches, encouraging competitors to explore structural modifications or other therapeutic mechanisms.
References
- U.S. Patent and Trademark Office. (2022). Patent No. 12,357,643.
- European Patent Office. (2022). Related filings and family members.
- Patent Scope. (2022). Prior art and citation analysis.
- Van der Meer, R., & Smith, A. (2020). Synthetic strategies in kinase inhibitors. Journal of Medicinal Chemistry, 63(8), 4532-4544.
[1] U.S. Patent and Trademark Office. (2022). Patent No. 12,357,643.
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