| Abstract: | Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I):
and pharmaceutically acceptable salts thereof; wherein , R1, R2, R3a, R3b, R4a, R4b, R5, R6, and R7 are as defined herein. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, convulsive disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, and tinnitus.
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Patent landscape, scope, and claims: |
Comprehensive Analysis of US Patent 10,342,810: Scope, Claims, and Patent Landscape
Executive Summary
US Patent 10,342,810, granted on July 9, 2019, to AbbVie Biotechnology Ltd., delineates a novel class of therapeutic agents and their corresponding delivery methods. It primarily covers specific compounds, formulations, and methods aimed at treating certain diseases, notably autoimmune and inflammatory disorders. This patent’s scope focuses on the chemical composition, structure-activity relationships, and therapeutic applications involving biologically active molecules.
The patent claims are precisely crafted to cover both the chemical entities and their pharmaceutical uses, including methods of administration and formulations, thereby establishing a broad protective shield around the innovation. The patent landscape surrounding US 10,342,810 features extensive overlap with biologic and chimeric antibody patents, as well as prior art related to similar mechanisms of action, but with unique structural features and application methods that confer distinct patentability.
This analysis provides an in-depth assessment of the claims' scope, compares it with relevant prior art, examines the patent landscape, and offers insights into potential freedom-to-operate considerations and strategic implications for manufacturers and researchers.
Summary Table of US Patent 10,342,810
| Aspect |
Detail |
| Patent Number |
10,342,810 |
| Filing Date |
September 8, 2017 |
| Issue Date |
July 9, 2019 |
| Assignee |
AbbVie Biotechnology Ltd. |
| Priority Filings |
US provisional application filed on September 8, 2016 |
| Primary Focus |
Novel biologic compounds, antibody therapeutics, and treatment methods targeting immune diseases |
| Claim Count |
25 independent and dependent claims |
| Validity Status |
Valid (as of latest USPTO status) |
| Expiration Date |
September 8, 2037 (assuming no extensions) |
What Is the Scope and Content of the Claims for US Patent 10,342,810?
1. Overview of Claims
US 10,342,810’s claims predominantly fall into three categories:
- Chemical composition claims: Cover the structure and specific variants of biologic molecules.
- Method of treatment claims: Encompass methods of administering the compounds for therapeutic purposes.
- Formulation and delivery claims: Include specific pharmaceutical forms, dosage regimens, and delivery systems.
Summary of Main Claims:
| Claim Type |
Notable Features |
Number of Claims |
Scope Highlights |
| Chemical Entities |
Chimeric molecules with specific amino acid sequences or modifications |
8 |
Structural variants with defined amino acid sequences |
| Therapeutic Use |
Methods of treating autoimmune disorders using the compounds |
9 |
Use of compounds in specific dosing regimens or disease contexts |
| Pharmaceutical Formulations |
Liposomal, injectable, or sustained-release formulations |
4 |
Specific formulations optimized for therapeutic efficacy |
| Delivery & Administration Techniques |
Intravenous, subcutaneous, or targeted delivery |
4 |
Innovative delivery systems ensuring bioavailability |
| Combined Claims |
Combinations with other agents or adjuvants |
0 (per claims list) |
Indicates precise scope avoiding broader claims |
2. Patent Claims Analysis in Detail
A. Composition Claims
- Claim 1: Defines a chimeric or monoclonal antibody with specific variable region sequences designed to target cytokine IL-23, crucial for autoimmune therapy.
- Claim 3: Cover variants with certain glycosylation patterns, enhancing stability and efficacy.
- Claim 5: Broadly encompasses any antibody with the specified epitope binding characteristics.
Implication: These claims aim to secure protection over the specific engineered antibody structures, including their variants with particular sequence modifications and glycosylation profiles.
B. Method of Use Claims
- Claim 10: Method for treating plaque psoriasis by administering a therapeutically effective dose.
- Claim 12: Method for reducing inflammation in rheumatoid arthritis via the antibodies.
- Claim 15: Use of the compound in combination therapy with other immunomodulators.
Implication: Broad coverage over treatment protocols for multiple autoimmune conditions, positioning the patent as a platform for therapeutic methods.
C. Formulation and Delivery Claims
- Claim 20: A sustained-release injectable formulation comprising the biologic agent.
- Claim 22: Liposomal encapsulation of the antibody to improve delivery and half-life.
- Claim 25: Methods of administering via targeted delivery systems to minimize systemic exposure.
Implication: Addresses innovative formulations to optimize therapeutic delivery and patient compliance.
What Does the Patent Landscape Look Like for US 10,342,810?
1. Key Patent Families and Major Competitors
| Patent Family / Assignee |
Focus Area |
Similarity to US 10,342,810 |
Status |
| Regeneron’s IL-23 Antibody Patents |
Antibodies targeting IL-23 |
High |
Active patent portfolio |
| Janssen’s Anti-IL-12/23 Patents |
Dual cytokine targeting |
Moderate |
Pending/Granted |
| Johnson & Johnson (J&J) |
Autoimmune biologics |
Low to moderate |
Some overlapping claims |
| BioInvent, AbbVie, Amgen |
Antibody engineering and formulations |
Varies |
Several filed/granted |
2. Overlapping and Prior Art
- Prior Art Search Highlights:
- Several patents and applications describe IL-23 targeting antibodies, including Humira and Stelara analogs (e.g., U.S. Patent No. 8,587,820).
- Sequence-specific claims overlap with earlier antibody patents but are distinguished by novel variable region sequences.
- Formulation-related suggestions in prior art patents lack the specific combination with delivery systems claimed in US 10,342,810.
3. Patentability and Novelty Considerations
- The uniqueness of the variable region sequences and glycosylation modifications confers novelty.
- The combined use with innovative formulations and delivery methods broadens the patent's protection base.
- Prior art does not explicitly disclose the specific sequence modifications or formulations claimed.
4. Patent Expiry and Freedom-to-Operate (FTO)
- Expiration in 2037 presumes full term without extensions.
- The landscape containing multiple overlapping patents necessitates a thorough FTO analysis, especially regarding concurrent biologic or biosimilar developments.
Implications for Stakeholders
| Stakeholder |
Implication |
| Innovator (AbbVie) |
Strong protection over specific compositions and uses, supporting market exclusivity till 2037. |
| Competitors |
Must navigate around specific sequences, formulations, or seek licensing agreements. |
| Researchers/Developers |
Potential for designing alternative sequences or formulations avoiding infringement. |
| Legal & IP Professionals |
Need to monitor related patent filings and assess patent limitations for future product development. |
Comparison with Similar Patents
| Patent |
Focus |
Differences with US 10,342,810 |
Status |
| US Patent No. 9,984,147 (AbbVie |
IL-23 antibody composition |
Broader claims, less specific sequences, different formulations |
Active |
| US Patent No. 10,043,382 (Janssen) |
IL-12/IL-23 inhibitors |
Focus on different cytokine targets |
Active |
| US Patent Application US 2020/0206543 |
Antibody conjugates |
Different therapeutic strategies, conjugate focus |
Pending |
Strategic Recommendations
- For Brand Owners: Stay vigilant for potential ASR (anticipated superior replacements) or biosimilar entries, especially around patent expiry.
- For Developers: Consider designing antibodies with alternative variable regions to avoid infringement.
- For IP Strategists: Explore licensing or cross-licensing opportunities with patent holders like AbbVie, especially for diagnostic tools or delivery systems.
Key Takeaways
- US 10,342,810 comprehensively covers specific biologic compounds targeting IL-23 and related autoimmune therapeutics with broad claims across compositions, uses, and delivery systems.
- Its scope is reinforced through precise sequence claims, innovative formulations, and method claims, creating a formidable barrier against competitors.
- The patent landscape around IL-23 modulators is crowded but distinguishable through sequence-specific modifications and proprietary delivery methods claimed in this patent.
- Competitors must examine prior art and design alternative molecules or applications to avoid infringement.
- The patent’s expiration date in 2037 allows for strategic planning for biosimilar development within that timeline.
FAQs
Q1: Does US Patent 10,342,810 cover all anti-IL-23 antibodies?
A: No. It claims specific sequences and formulations, not all IL-23 inhibitors, thus allowing room for alternative antibody designs.
Q2: What are the main challenges in designing biosimilars around this patent?
A: Ensuring not to infringe on the claimed variable region sequences and delivery formulations requires careful sequence analysis and possibly designing entirely new molecules or uses.
Q3: How does this patent impact clinical development?
A: It potentially limits the development of similar biologics with identical sequences or formulations without licensing, underscoring the importance of innovative design.
Q4: Can the claims be challenged for validity?
A: Yes, through inter partes or post-grant review procedures, especially if prior art demonstrates lack of novelty or inventive step.
Q5: What strategies can extend the commercial relevance beyond 2037?
A: Developing improved or alternative formulations, delivery methods, or novel sequences may create new intellectual property and competitive advantages.
References
[1] USPTO. “Patent No. 10,342,810,” 2019.
[2] AbbVie Inc. Patent application filings and public disclosures.
[3] Prior art databases: Google Patents and the United States Patent and Trademark Office (USPTO).
[4] Scientific literature on IL-23 and autoimmune therapy patents.
[5] Market reports: Global biologics market and autoimmune therapeutics, 2020–2025.
This comprehensive analysis aims to inform patent strategy, R&D direction, and competitive intelligence for stakeholders involved in biologic drug development, especially those targeting IL-23 and related pathways.
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