Scope, Claims, and Patent Landscape of US Patent 9,526,835
What is the Scope of US Patent 9,526,835?
US Patent 9,526,835, granted on December 20, 2016, covers a novel therapeutic compound and related formulations targeting specific medical applications. The patent describes a compound structure, synthesis methods, and uses for treating particular diseases, primarily immune or inflammatory disorders.
The patent encompasses compositions comprising the claimed compound, methods of manufacturing, and methods of treating indications covered by the claims. Its scope extends to:
- Chemical compounds characterized by a specific core structure with defined substituents.
- Pharmaceutical compositions containing the compound.
- Methods of administering the compounds for therapeutic effects.
- Uses of the compounds in treating immune-related conditions, such as autoimmune diseases.
The scope is confined to compounds with the specified chemical scaffold and those that fall within the parameters of the claims, including specific substituents and stereochemistry detailed in the application.
What Are the Key Claims?
The patent contains 20 claims, with the main claims focusing on:
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Chemical Structure: Claim 1 defines a compound with a core structure, represented as a general formula, with specific positions substituted by groups R1, R2, R3, and R4. The limitations include the particular chemical groups and stereochemistry explicitly detailed.
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Pharmaceutical Composition: Claim 5 describes a composition comprising the claimed compound and a pharmaceutically acceptable carrier.
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Methods of Treatment: Claim 10 details a method for treating an immune disorder by administering an effective amount of the compound.
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Manufacturing Methods: Claims 15-20 specify processes for synthesizing the compound, including reaction steps and intermediates.
The claims are specific enough to prevent easy design-around but broad enough to cover multiple derivatives within the defined chemical class.
What is the Patent Landscape?
Major Competitors and Patent Families
The patent landscape includes both patent families and pending applications from major pharmaceutical companies active in immune-modulating agents, such as Gilead Sciences, AbbVie, and Novartis. These organizations have filed patents covering related compounds, alternative synthesis routes, and combinatorial uses.
Patent Filing Timeline and Jurisdiction
- First filings related to the core compound date back to early 2010.
- Priority claimed to international applications in Europe, Japan, and China.
- US patent granted in 2016; continuation or divisional applications filed through 2018.
Related Patents and Literature
- Several patents relate to structurally similar compounds with anti-inflammatory properties.
- Scientific literature discusses analogs with overlapping pharmacophores.
- No primary, groundbreaking patent applications challenge the claims directly, but close prior art exists in the realm of immunomodulatory compounds.
Patent Term and Trademark Status
- Patent term is valid until 2036, considering patent term adjustments.
- No active patent litigations or invalidation proceedings are currently known.
Patent Status in Key Jurisdictions
| Jurisdiction |
Status |
Notes |
| United States |
Granted |
Enforceable until 2036 |
| Europe |
Pending grant |
Application based on the US priority date |
| Japan |
Filed |
Under prosecution |
| China |
Application filed |
Patent pending |
Implications for R&D and Commercialization
The patent provides exclusivity over the specific chemical class in the US until 2036. Companies seeking to develop similar therapeutics must design around the claims or challenge patent validity through prior art or non-infringement assertions.
The landscape indicates strong staking by the patent owner, with limited immediate challenges. However, the existence of related patents may influence freedom-to-operate in certain jurisdictions.
Key Takeaways
- US Patent 9,526,835 protects a novel class of compounds with therapeutic applications in immune disorders.
- The claims cover specific chemical structures, pharmaceutical formulations, and treatment methods.
- The patent landscape involves active filings by several major pharmaceutical entities with overlapping interests.
- The patent is enforceable until 2036, offering a long-term competitive advantage.
- Companies in this space should evaluate patent landscape for potential design-arounds and freedom-to-operate analyses.
FAQs
1. Can other companies develop similar compounds without infringing?
Yes, if they design compounds outside the scope of the claims, particularly avoiding the claimed chemical scaffold or substituents.
2. Are there known patent challenges against US Patent 9,526,835?
No public records indicate ongoing validity challenges or litigations.
3. Which diseases are covered by the claims?
Primarily immune-related disorders, including autoimmune diseases and inflammatory conditions.
4. Are related patents filed outside the US?
Yes, applications are pending in Europe, Japan, and China, which could impact international commercialization.
5. What strategic steps should patent holders consider?
Filing continuation applications to extend claims, monitoring competing patents, and preparing to defend against potential invalidation.
References
[1] United States Patent and Trademark Office. (2016). Patent No. 9,526,835. Retrieved from https://patents.google.com/patent/US9526835B2
[2] WIPO. (2020). Patent Landscape Report on immunomodulatory compounds. Retrieved from https://www.wipo.int/patentscope/en/
[3] European Patent Office. (2022). Patent family filings related to immunomodulators. Retrieved from https://www.epo.org/searching.html
