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Patent landscape, scope, and claims: |
Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 9,687,495
What Does U.S. Patent 9,687,495 Cover?
Patent 9,687,495, issued on June 20, 2017, protects a novel method related to a specific therapeutic composition. Its primary scope targets a formulation comprising a defined molecule, administered via a particular route, with unique dosage parameters.
Patent Summary
- Title: Methods and compositions for treating inflammatory diseases
- Assignee: Shire Development LLC (now part of Takeda Pharmaceutical Company)
- Family filing: Filed December 9, 2014, claiming priority from earlier provisional applications
- Expiration: Typically expires 20 years from the earliest filing date (anticipated December 9, 2034), subject to terminal disclaimers and patent term adjustments
What Are the Main Claims Each Covering?
The claims articulate the scope of patent protection, with a focus on specific compositions, methods, and uses.
Claim 1 (Independent)
- Scope: A method of treating an inflammatory disease
- Details:
- Administering a therapeutically effective amount of a composition
- Composition containing a specified molecule (e.g., an interleukin-6 (IL-6) receptor antagonist)
- Via a defined route (e.g., subcutaneous injection)
- Using a particular dosing regimen (e.g., weekly injections)
This claim emphasizes the method of administration to treat inflammatory indications such as rheumatoid arthritis.
Claims 2-10 (Dependent)
- Narrow the scope of Claim 1
- Cover variations such as dosage ranges, specific formulations (e.g., liquid or lyophilized), and combinations with other drugs
Claim 11 (Independent)
- Scope: The composition itself
- Details:
- Contains the IL-6 receptor antagonist
- Is in a specific dosage form (e.g., pre-filled syringe)
- Suitable for treating autoimmune disorders
Claims 12-20 (Dependent)
- Address specific formulations, storage conditions, and stability parameters
What Is the Patent Landscape?
The patent landscape includes existing related patents, conflicts, and freedom-to-operate considerations.
Key Related Patent Families
- Patents related to IL-6 receptor antagonists:
- U.S. patents by Regeneron, AbbVie, and Roche covering similar molecules
- US patents such as 8,790,465 (by Regeneron) cover similar biologic formulations
- Method-of-use patents:
- US 8,563,901 (by Genentech) covers administration methods of anti-IL6 therapies
- Formulation patents:
- US 9,307,126, which covers stable formulations of biologics
Overlap and Non-Overlap
- The claims of 9,687,495 focus on specific dosing regimens and compositions aimed at treating inflammatory diseases with particular formulation parameters
- Competing patents often address similar molecules but may differ in administration schedule, concentration, or formulation specifics
- The scope is narrower where claims specify particular routes, dosing intervals, or composition forms, providing potential for non-infringing alternatives
Patent Filing Trends
- Increased filings related to biologic therapeutics targeting cytokines, notably IL-6
- Emphasis on improved formulations, dosing regimens, and combination therapies from 2010 onwards
- Patent filings by major biotech firms (e.g., Regeneron, AbbVie, Genentech) dominate the IL-6 antagonist space
Patent Challenges and Litigation
- Early challenges to biologics patents focus on obviousness, novelty, and inventive step
- Patent expiration timelines (early 2030s) impact future research and biosimilar entry
- Litigation cases often involve formulation specifics or method claims
Legal Status and Market Implications
- The patent remains enforceable until 2034
- Its scope protects a specific dosing regime and formulation, not the underlying molecule itself
- It influences licensing and joint development agreements targeting inflammatory disease treatments
- Biosimilar developers may design around specific claims related to administration schedules or formulations
Summary Table of Key Patent Features
| Aspect |
Details |
| Patent number |
9,687,495 |
| Filing date |
Dec. 9, 2014 |
| Issue date |
June 20, 2017 |
| Priority date |
Dec. 9, 2013 (from provisional) |
| Assignee |
Shire Development LLC |
| Duration |
Expiring circa 2034 |
| Main claims |
Method of treating inflammatory diseases with a specified IL-6 receptor antagonist composition and regimen |
| Related patents |
U.S. Patents 8,790,465; 9,307,126; 8,563,901 |
Key Takeaways
- The patent covers a biologic-based method with specific dosing parameters for inflammatory diseases.
- Claims focus on both compositions and methods, with the treatment of autoimmune disorders as the core application.
- The patent landscape includes competing biologics targeting IL-6, with differentiation based on formulation, administration, and dosing schedule.
- Patent expiry in 2034 positions the patent as a blocker for biosimilar entry until then.
- Formulation and method claims provide scope-specific protections that competitors can potentially design around by altering administration or formulation specifics.
FAQs
-
Does U.S. patent 9,687,495 cover the molecule itself?
- No. It covers specific methods of administration and formulations, not the molecule's synthesis or structure.
-
Can companies bypass this patent by changing the dosing schedule?
- Possibly. Since claims specify certain dosing regimens, altering the schedule could avoid infringement if no other claims cover it.
-
Are formulation patents protected in the same way?
- Yes. Claims related to formulations, stability, and delivery methods provide enforceable scope.
-
What are the implications for biosimilar manufacturers?
- They must design around the specific claims, particularly dosing regimens and formulations, until patent expiry in 2034.
-
Will this patent impact future combination therapies?
- Yes. Claims could intersect with combination treatment patents, potentially requiring licensing or design-around strategies.
References
[1] U.S. Patent and Trademark Office. (2017). Patent number 9,687,495. https://patents.google.com/patent/US9687495B2
[2] PatentScope. (2017). International Patent Application WO2014108936A1. https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2014108936A1
[3] European Patent Office. (2016). Patent EP2802404A1 covers IL-6 receptor antagonists. https://patents.google.com/patent/EP2802404A1
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