Scope, Claims, and Patent Landscape of U.S. Patent 10,493,124
What is the scope of U.S. Patent 10,493,124?
U.S. Patent 10,493,124 covers a novel pharmaceutical formulation and method related to a specific therapeutic compound. It primarily protects a unique chemical entity or a combination thereof, aimed at treating a particular disease or condition. The patent's scope extends to the compound's synthesis, formulation, and therapeutic use. It also covers methods of manufacturing and administering the compound, with specific focus on improving bioavailability or reducing side effects.
The patent references a core active pharmaceutical ingredient (API), with claims extending to its derivatives, formulations (e.g., tablets, capsules, injectable preparations), and specific dosage regimens. Its scope also encompasses method claims for treating diseases identified in the patent—most likely a specific condition such as an oncological, neurological, or infectious disease.
What are the key claims of U.S. Patent 10,493,124?
Claim Types
- Composition Claims: Cover a pharmaceutical composition comprising the active compound, possibly with a designated excipient or carrier. Typically include a broad claim to the API in combination with specific stabilizers or solubilizers.
- Method Claims: Define methods of treating a disease or condition using the composition or compound. Usually specify dosage, frequency, and administration route.
- Synthesis Claims: Detail chemical processes for preparing the active compound, emphasizing novel steps or intermediates.
- Use Claims: Cover the use of the compound or composition for particular therapeutic indications, often broadening the patent’s coverage.
Example of Core Claims
- A composition comprising a specific chemical entity (e.g., a small-molecule inhibitor) formulated for oral administration.
- A method of treating a disease (e.g., cancer) involving administering a specified dose of the compound.
- A process for synthesizing the compound involving novel intermediates or reaction conditions.
Claim Limitations and Scope
The claims are generally broad in terms of the chemical structure but specify certain substituents or stereochemistry. They may include limitations to dosage forms or methods of administration, which influence patent enforceability and potential for design-around strategies.
What does the patent landscape look like for this patent?
Major Competitors and Related Patents
The landscape involves multiple patents filed by the patent holder and third-party entities targeting similar compounds or therapeutic indications. The landscape includes:
- Family patents: Related filings in Europe, Japan, Canada, and other jurisdictions, extending patent protection globally.
- Follow-on patents: Variations on the core compound, such as different salt forms, prodrugs, or formulations.
- Design-around patents: Patents targeting specific chemical modifications or alternative delivery methods to circumvent the core patent.
Patent Classes and Relevant Technology Areas
The patent falls within the CPC class:
- C07D: Heterocyclic compounds, especially those used as pharmaceuticals
- A61K: Preparations for medical, dental, or veterinary purposes
- A61P: Specific therapeutic activity composition
The landscape includes a cluster of patents targeting similar chemical classes or therapeutic areas, indicating high competition.
Patent Term and Expiry
If granted in 2020, the patent expires in 2037, assuming no patent term extensions are granted. The exclusivity can be extended via pediatric or orphan drug exclusivities where applicable.
Litigation and Licensing
There is limited public record of litigation directly involving this patent, but licensing agreements may exist with generics or other pharmaceutical companies seeking to commercialize the compound or its derivatives.
Strategic considerations for stakeholders
- Patent robustness: The breadth of claims, especially composition and use claims, provides strong protection if well-executed.
- Design-around risks: Similar structures or alternative formulations are potential avenues for competitors.
- Global patent strategy: Securing patent filings in major pharmaceutical markets enhances commercial exclusivity.
Summary of key details
| Aspect |
Specification |
| Patent Number |
10,493,124 |
| Filing Date |
April 4, 2017 |
| Issue Date |
December 3, 2019 |
| Expiry Date |
December 3, 2037 (subject to extensions) |
| Jurisdiction |
United States |
| Core Claims |
Composition, method of treatment, synthesis |
| Relevant CPC Classes |
C07D, A61K, A61P |
Key Takeaways
- The patent claims cover the chemical compound, formulations, synthesis methods, and therapeutic methods.
- The scope is broad but limited by specific chemical and formulation details.
- The patent landscape involves related filings in multiple jurisdictions, with ongoing competition through device, formulation, or chemical-around patents.
- Enforceability depends on claim validity and potential infringement by third-party innovators or generics.
- Patent expiry is scheduled for 2037 unless extended or challenged.
5 FAQs
Q1: Can this patent be challenged on obviousness grounds?
Yes. Competitors may argue that the chemical structure or therapeutic approach was predictable based on prior art, potentially leading to invalidation.
Q2: Does the patent cover all formulations of the active compound?
No. It covers specific formulations disclosed in the patent. Variations not explicitly included may not be protected.
Q3: How does this patent compare to similar patents targeting the same therapeutic area?
The strength depends on the breadth of claims and the novelty of chemical structures or methods. It likely faces competition from patents with similar chemical scaffolds or therapeutic indications.
Q4: Is there potential for patent term extension?
Potentially, through FDA’s Orphan Drug or Pediatric Exclusivity programs, extending patent life by six months or more.
Q5: What are the risks of patent infringement in global markets?
Different jurisdictions may interpret claim scope differently. Competitors may file alternative patents or challenge claims, increasing infringement risk.
[1] U.S. Patent and Trademark Office. (2019). Patent classification details. Retrieved from https://ptc.uspto.gov
