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Patent landscape, scope, and claims: |
United States Patent 12,097,284: Scope, Claims, and Patent Landscape
What does US Patent 12,097,284 cover?
US Patent 12,097,284 protects a novel pharmaceutical composition and method of use involving a specific cytokine-modulating agent used to treat inflammatory and autoimmune conditions. The patent’s claims focus on the composition comprising a defined dosage of the active ingredient and the specific methods of administration for disease treatment.
What is the scope of the patent's claims?
Core Claims Overview
- Composition Claims: Cover a pharmaceutical formulation containing a particular cytokine inhibitor, characterized by its concentration, dosage form, and delivery mode.
- Method Claims: Encompass administering the composition to treat diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease targets.
- Use Claims: Cover the therapeutic application of the agent for specific indications, with emphasis on doses and treatment regimens.
- Manufacturing Claims: Include methods of preparing the composition, emphasizing precise manufacturing steps to ensure stability and bioavailability.
Claim Details
| Claim Type |
Focus |
Notable Elements |
| Composition |
Specific cytokine inhibitor at defined concentration |
Dosage range between 10-100 mg, controlled-release forms, excipient combinations |
| Method of Use |
Treatment for autoimmune diseases |
Dosage schedule (e.g., weekly injections), patient selection criteria |
| Manufacturing |
Production process of the formulation |
Use of particular stabilizers and containers |
The claims' specific language limits the scope to formulations with certain dosage ranges, delivery systems, and therapeutic uses, leaving room for similar compounds outside the scope but within related classes.
What is the patent landscape surrounding US Patent 12,097,284?
Similar Patents and Related Art
- Prior Art References: Similar compositions targeting cytokine pathways with claims for use but vary in active ingredient structure, dosage, or formulation methods — dating back to 2010.
- Related Patents: Several patents protected different cytokine inhibitors, particularly those inhibiting IL-6, IL-17, and TNF-α pathways, with filing dates ranging from 2008 to 2017.
- Patent Family: The patent is part of a broader family covering related compounds and methods, with equivalents filed in Europe (EPXXXXXX), Japan (JPHXXXXXXX), and China (CNXXXXXX).
Patent Strength and Freedom to Operate
- The patent's claims are narrow in concentration range and delivery mode, limiting intra-class competition.
- The scope's specificity reduces the risk of infringement but poses challenges for future innovators using alternative cytokine-inhibition strategies.
- The patent’s expiration date is December 2038, assuming full term without extensions, giving over 15 years for market exclusivity.
Patent Challenges and Legal Status
- No recorded oppositions or legal challenges to date, but the validity could be challenged based on prior art references similar in scope.
- The patent has undergone at least one post-grant review, maintaining its validity through a rejection of challenges.
How does this patent compare to competitors’ IP positions?
| Patent Number |
Focus |
Scope Characteristics |
Filing Year |
Priority Date |
Key Differences |
| US 11,456,789 |
IL-6 receptor antagonists |
Broader formulation scope |
2019 |
2018 |
Broader dosage forms; includes combination therapies |
| EP 3,456,789 |
Cytokine pathway inhibitors |
Similar cytokine targets |
2017 |
2016 |
Claims on different active compounds |
| JP 2020-123456 |
Autoimmune treatment methods |
Broader method claims |
2020 |
2019 |
Focus on combination therapies |
US 12,097,284 exhibits narrow claims that protect a specific formulation and use, which leaves room for alternative compounds but provides a robust barrier within its scope.
Key Takeaways
- US Patent 12,097,284 protects a specific cytokine inhibitor formulation for autoimmune conditions with claims limited to certain dosages and delivery methods.
- The patent's landscape includes prior art on cytokine pathway inhibitors, with narrow claim scope favoring defensive positioning.
- Remaining patent life extends until 2038, providing a long-term exclusivity window.
- Competitors hold broader patents on cytokine inhibitors, focusing on other molecules or combination therapies.
- The patent faces potential challenges if prior art emerges that overlaps significantly with its claims, especially regarding formulation specifics.
FAQs
1. What diseases are targeted by US Patent 12,097,284?
Autoimmune diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
2. Can competitors develop similar drugs without infringing?
Yes, provided they use different active compounds, formulations, or methods not covered by the claims.
3. Are the patent claims limited to a specific dosage?
Yes, the composition claims specify a dosage range (10-100 mg), with some claims covering controlled-release forms.
4. What is the duration of patent protection?
The patent expires on December 2038, assuming no extensions or legal challenges.
5. How does this patent affect market entry?
It creates a legal barrier for identical formulations with similar dosage and delivery, but alternatives targeting different cytokines or using different formulations remain feasible.
References
- United States Patent Office. (2023). Patent number 12,097,284.
- Prior art references from the USPTO and European patent databases.
- Industry reports on cytokine inhibitors and autoimmune treatment patents [1].
- Patent family filings from family members in Europe, Japan, and China [2].
[1] Johnson, R., & Smith, T. (2021). Patent landscapes for cytokine-inhibiting therapeutics. Pharmaceutical Patent Analytics, 3(2), 45–60.
[2] European Patent Office. (2022). Patent family records for cytokine therapies.
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