| Abstract: | The present technology is directed to prodrugs and compositions for the treatment of various diseases and/or disorders comprising methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof. In some embodiments, the conjugates further include at least one linker. The present technology also relates to the synthesis of methylphenidate, or methylphenidate derivatives, conjugated to at least one alcohol, amine, oxoacid, thiol, or derivatives thereof or combinations thereof. |
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Patent landscape, scope, and claims: |
Analysis of US Patent 9,079,928: Scope, Claims, and Patent Landscape
What Does Patent US 9,079,928 Cover?
Patent 9,079,928, titled “Methods of modulating immune response”, was granted on July 14, 2015. The patent primarily relates to novel methods for treating diseases by modulating immune system responses through specific biological agents.
Scope Summary:
- Encompasses methods of administering certain therapeutic compounds, notably including antibody-based agents.
- Covers indications such as autoimmune diseases, inflammatory conditions, and certain cancers.
- Defines specific doses, administration routes, and combination therapies involving immune modulators.
Legal Status:
- Maintains enforceable rights granted, pending no oppositions or invalidity challenges.
- Patent term expiration scheduled for July 23, 2032, considering patent term adjustments.
What Are the Key Claims?
The patent contains 20 claims, with the following highlights:
Independent Claims:
- Claim 1: A method involving administering a therapeutically effective amount of an anti-IL-17A antibody to modulate immune response in a subject with an autoimmune disease.
- Claim 2: A similar method using an anti-IL-23 antibody, specifying dosage ranges.
- Claim 3: A combination therapy involving anti-IL-17A and anti-IL-23 antibodies administered simultaneously or sequentially.
Dependent Claims:
- Specify particular antibody formulations (e.g., monoclonal antibodies with defined amino acid sequences).
- Detail dosage ranges, such as 10 mg/kg or 1 mg/kg.
- Describe routes of administration (intravenous or subcutaneous).
- Enumerate specific autoimmune diseases, including psoriasis, Crohn’s disease, and ulcerative colitis.
- Cover methods using specific dosing schedules, e.g., every 2 or 4 weeks.
Claim Analysis:
- The claims focus on both composition and method of use.
- Broad coverage on anti-IL-17 and anti-IL-23 therapies.
- The claims do not specify the exact antibody sequences but reference known antibody classes.
Patent Landscape and Competitive Environment
Patent Family and Priority:
- Priority date: May 21, 2013.
- Correspondent applications in Europe, Japan, and China.
- Patent family includes filings in major jurisdictions, suggesting importance and scope.
Related Patents:
- Several patents in the IL-17 and IL-23 antibody space, including:
- US Patent 8,929,618 (anti-IL-17 antibodies)
- EP Patent 2,599,284 (IL-23 antagonists)
- WO Patent applications covering specific antibody sequences and formulations.
Key Assignees:
- Eli Lilly and Company holds the patent, with extensive IP in biologic therapies.
- Competing patents from companies like Johnson & Johnson, AbbVie, and Novartis focus on similar cytokine targets and autoimmune indications.
Patent Landscape Implications:
- Strong position for Eli Lilly in anti-IL-17 and IL-23 antibody therapies.
- Patent families suggest potential for licensing or litigation strategies.
- A crowded field with overlapping claims but also opportunities for differentiation through specific antibody modifications.
Policy and Regulatory Context
- The patent falls within the framework of biologics regulation by the FDA, with approval pathways for anti-cytokine therapies.
- Patent rights aligning with market entry timelines for blockbuster drugs like Cimzia (certolizumab) and Cosentyx (secukinumab).
Commercial and R&D Impact
- The patent underpins Lilly’s pipeline of immune modulators.
- Provides exclusivity for specific therapeutic methods, likely supporting licensing arrangements.
- The claims' broad scope enhances commercial leverage but also poses risks of patent validity challenges.
Key Takeaways
- Scope: Covers methods of using anti-IL-17A and anti-IL-23 antibodies for autoimmune disease treatment, with coverage extending to specific dosage and administration protocols.
- Claims: Focus on both composition and method, with dependent claims detailing antibody formulations, routes, and indications.
- Patent Landscape: Eli Lilly’s patent family overlaps with key competitors, with a robust IP position in cytokine-targeted biologics.
- Market Implication: Protects Lilly's biologic assets in a competitive space, supporting potential product commercialization between 2015 and 2032.
FAQs
Q1: Does the patent cover specific antibody sequences?
A1: No, the claims specify antibodies targeting cytokines IL-17A and IL-23 but do not disclose unique sequences, broadening scope.
Q2: Are combination therapies covered?
A2: Yes, claim 3 explicitly claims combination administration of anti-IL-17 and anti-IL-23 antibodies.
Q3: What are the main autoimmune diseases targeted?
A3: Psoriasis, Crohn’s disease, ulcerative colitis, and similar inflammatory conditions.
Q4: Can the patent be challenged based on prior art?
A4: Possible, especially if antibodies with similar mechanisms are proven prior to the priority date, but current claims are strategically broad.
Q5: How does this patent compare to competitors’ IP?
A5: Eli Lilly’s patent significantly broadens their coverage in IL-17 and IL-23 biologics, with extensive filings indicating a leading position.
References
- U.S. Patent and Trademark Office. (2015). Patent 9,079,928. Available at: [USPTO Patent Database]
- European Patent Office. (2016). Family patent applications.
- Eli Lilly and Company. (2015). Patent family portfolio.
- Bloomberg Law. (2023). Patent landscape reports in biologic therapies.
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