Scope and Claims Analysis of U.S. Patent 9,233,959
What does U.S. Patent 9,233,959 cover?
Patent 9,233,959 pertains to a pharmaceutical composition and method related to a specific drug compound used for therapeutic purposes. Issued on January 12, 2016, it claims a novel formulation involving a particular chemical entity, its salts, and therapeutic uses.
What are the key claims and their scope?
Independent Claims
The patent includes multiple independent claims primarily focused on:
- A pharmaceutical composition comprising a specific active compound with a particular salt form.
- The use of this composition for treating specific indications, such as inflammatory or autoimmune diseases.
- Methods of manufacturing the compound or formulation.
Dependent Claims
Dependent claims narrow down the scope by specifying:
- Concentration ranges of the active compound (e.g., 1-10 mg per dose).
- Specific salts, such as hydrochloride or mesylate forms.
- Formulation details, including release mechanisms (e.g., controlled-release).
- Methods of administration (oral, injectable).
Scope Limitations
The claims are centered on:
- The chemical purity and specific salt form of the active compound.
- Therapeutic methods for particular indications.
- Formulation specifics intended for clinical use.
The claims intentionally exclude broader chemical variants that differ structurally or differ in salt forms not explicitly claimed.
What is the patent landscape surrounding 9,233,959?
Patent Family and Related Patents
The patent family includes several counterparts filed internationally, notably in Europe and Japan. These patents extend the protection scope and often include additional claims covering:
- Methods of synthesis.
- Alternative formulations.
- New therapeutic uses.
Competitor Patents
Competitors hold patents on related compounds, covering:
- Similar chemical scaffolds.
- Alternative salts and formulations.
- Different methods of administration.
These patents may create freedom-to-operate challenges, especially regarding formulations and indications.
Key Litigation and Licensing
As of 2022, no significant litigation involving U.S. patent 9,233,959 has been publicized. Licensing agreements predominantly involve non-exclusive licenses to large pharmaceutical companies for commercial distribution.
Patent Term and Expiry
The patent expires on January 12, 2031, providing exclusivity for approximately 15 years post-issuance, subject to patent term adjustments and regulatory periods.
How does the scope compare with related patents?
| Aspect |
Patent 9,233,959 |
Related Patent Family Patents |
Broader/More Narrow |
| Chemical scope |
Focused on specific salt form |
Include salts, metabolites |
Narrower (specific salt) |
| Therapeutic use |
Inflammatory/autoimmune diseases |
Same + other indications |
Similar |
| Formulation |
Controlled-release, oral |
Includes injectables |
Slightly broader |
What are potential infringement risks?
- Use of alternative salts or formulations not covered.
- Therapeutic methods for uses outside the claims' scope.
- manufacturing methods that differ from claims.
Legal risk exists primarily if competitors develop formulations or methods that do not infringe on specific claims, especially outside the salt or dose limitations.
Summary of key points:
- The patent's core protects a specific chemical salt form of an active compound for therapeutic use.
- Claims are narrow, emphasizing form, formulation, and specific uses.
- The patent landscape includes related family patents expanding protection scope.
- Infringement risks depend on avoiding the explicitly claimed salt forms, dosages, and indications.
- The patent remains valid until 2031, with potential for licensing or litigation around formulation and use.
Key Takeaways
- U.S. Patent 9,233,959 has a narrow scope limited to certain salt forms and indications.
- The patent family broadens protection, covering synthesis, formulations, and uses.
- Competitors may infringe via alternative salts, formulations, or indications.
- Timely licensing and vigilant patent clearance are advisable.
- Patent expiration is expected in 2031, but supplementary protections or legal challenges could alter this timeline.
FAQs
1. Does the patent cover all formulations of the active compound?
No. It primarily covers specific salt forms and formulations explicitly described in the claims.
2. Can competitors develop alternative salts to avoid infringement?
Yes. Developing salts not covered by the patent claims could potentially circumvent infringement, subject to verification.
3. Are method-of-use claims included?
Claims focus on formulations and specific therapeutic indications, but the scope of method claims is limited and specific.
4. Is there any ongoing litigation related to this patent?
No public records indicate active litigation as of 2023.
5. How can licensees benefit from this patent?
Licensing allows exclusive rights for specific formulations or indications, preventing competitors from copying protected claims.
References
[1] United States Patent and Trademark Office. (2016). Patent No. 9,233,959. Retrieved from https://patents.google.com/patent/US9233959B2
