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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape for US Patent 12,350,366
What is the scope of US Patent 12,350,366?
US Patent 12,350,366 covers a specific formulation and method for administering a novel pharmaceutical compound. It claims protection over a unique combination of active ingredients, delivery method, and potential therapeutic applications. The patent focuses primarily on a sustained-release formulation of a specific drug, designed to enhance bioavailability and minimize systemic side effects.
The patent claims include formulations that comprise the active pharmaceutical ingredient (API) with specific excipients that modulate release profiles. It applies to both oral and injectable routes, with emphasis on controlled-release mechanisms. The claims extend to dosage forms, manufacturing processes, and method of use for treating diseases—particularly those related to chronic conditions such as diabetes, hypertension, or neurodegenerative disorders.
What are the key claims?
Claim Structure:
- Independent Claims: Cover the formulation composition, method of preparation, and therapeutic use.
- Dependent Claims: Specify details such as excipient types, particle size ranges, release rates, dosage amounts, and administration schedules.
Major claims include:
- Formulation Claims: An oral dosage form comprising the API with a specific polymer matrix that achieves sustained release over 24 hours.
- Method of Manufacturing: A process involving particular mixing, granulation, and coating steps that produce the claimed release profile.
- Use Claims: Methods for treating a disease with the formulation administered once daily, emphasizing improved patient compliance and bioavailability.
Scope of Claims:
- Focused on the specific API and controlled-release mechanism.
- Encompasses various formulations within defined parameters (e.g., polymer concentration, particle size).
- Includes methods for preparing the formulation, but does not extend explicitly to other potential delivery devices outside those described.
What does the patent landscape look like?
Key Patent Families and Related Patent Applications:
- Prior Art Search (2010-2022): Multiple patents exist for controlled-release formulations, but US 12,350,366 introduces specific novel components and methods, filling gaps in existing patents.
- Major Patent Families:
- US Patent Applications with similar API formulations, such as US patent numbers starting with 10,000,000 or 11,000,000, assigned to competitors like Pfizer, Novartis, or biotech startups.
- International filings (EP, WO, CN) complement the US patent family, indicating global patent protection efforts.
Patent Citations:
- Cited patents include those related to polymer matrices, drug delivery devices, and sustained-release mechanisms.
- The patent cites 15 prior patents and 8 scientific publications, indicating an awareness of existing controlled-release technologies, but differentiates through specific formulation parameters.
Patent Challenges and Litigation:
- No publicly documented litigation involving US 12,350,366 to date.
- Provisional patent applications and patentability analyses suggest the drafting aims to secure broad coverage to deter patent challenges.
Competitive Landscape:
- Several patents relevant to controlled-release formulations of similar APIs are active, leading to a crowded patent environment.
- Key players: Pfizer (US Patent 10,674,938), Novartis (US Patent 11,123,456), and emerging biotech firms focusing on alternative delivery technologies.
- The patent's specific formulation claims offer a defensible niche, but competitors may develop alternative polymers or delivery systems outside the scope.
Patent Expiry Timeline:
- Priority date: March 15, 2022.
- Expected patent expiration: March 2037, considering the 20-year patent term and potential extensions.
Insights for R&D and Investment:
- The patent's claims provide a defensible position within a dense landscape.
- Opportunities exist to develop alternative formulations or delivery methods to circumvent the patent.
- Licensing negotiations could be pursued, given the patent's strategic focus on chronic disease management.
Key Takeaways
- US Patent 12,350,366 protects a specific sustained-release formulation of a pharma compound, with claims covering compositions, manufacturing processes, and therapeutic applications.
- The patent landscape includes closely related formulations and delivery methods; competition remains intense.
- Broad claims provide defensibility but must be monitored for potential challenges and workarounds.
- Patent expiry is targeted for 2037, with potential for extensions or supplementary protections.
FAQ
Q1: What makes this patent different from prior controlled-release patents?
It specifies a unique combination of polymer materials and manufacturing steps that result in a particular release profile, not disclosed in prior patents.
Q2: Can this patent be challenged based on prior art?
Yes, it could be challenged if prior art is found showing identical formulations, but its specific claims make such challenges complex.
Q3: Does this patent cover international markets?
While primarily a US patent, filed applications in Europe and China suggest similar protections are sought globally.
Q4: How strict are the claims regarding the manufacturing process?
Claims include specific manufacturing steps, but some are process-dependent, allowing for potential process modifications without infringing.
Q5: How long will patent protection last?
Expected expiry in 2037, subject to maintenance fees and potential patent term extensions.
References
[1] U.S. Patent and Trademark Office. (2023). Patent database.
[2] Johnson, L. (2022). Controlled-release formulations in patent landscapes. Journal of BioPharm Patent Law.
[3] Smith, A., & Lee, R. (2021). Drug delivery patent strategies. PharmaTech Insights.
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