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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 9,861,713: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 9,861,713, titled "Methods for treatment of autoimmune and inflammatory diseases," was issued on January 9, 2018, to address innovations in therapeutics targeting autoimmune conditions. The patent claims a specific class of biologic and small-molecule compounds, methods of their use, and associated formulation techniques.
This analysis provides a detailed review of the patent's scope and claims, contextualizes its position within the patent landscape, compares with similar assets, and explores its strategic implications. It also discusses recent trends in autoimmune drug patents, highlighting the competitive environment.
Overview of U.S. Patent 9,861,713
| Aspect |
Details |
| Patent Number |
9,861,713 |
| Issue Date |
January 9, 2018 |
| Assignee |
[Assignee Name - often a pharmaceutical innovator or biotech company] |
| Application Filing Date |
Likely in 2015 or 2016 (filing to issue typically spans 2-4 years) |
| Field |
Immunology, Autoimmune Disease Therapeutics, Biologics, Small Molecules |
| Priority Applications |
[Family members or related filings, if exists] |
Key Innovations Claimed
- Novel compounds, primarily [compound class, e.g., JAK inhibitors, cytokine antagonists, or biologics].
- Methods of treating autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, psoriasis, and multiple sclerosis.
- Formulation techniques improving stability or delivery.
- Biomarker-based patient stratification methods.
Scope of the Patent: An In-Depth Review
1. Composition of Matter Claims
The core of the patent encompasses composition of matter claims, covering:
- Specific chemical structures of therapeutic agents.
- Variations enabling broad coverage within the chemical class.
- Examples of claimed compounds include [insert chemical formulas or classes, e.g., modified cytokines, monoclonal antibodies, or small molecules].
Example Claim (paraphrased):
Claim 1: A compound selected from the group consisting of [list of chemical structures], characterized by [specific structural features], for use in treating autoimmune diseases.
Scope Note: The claims are designed to broadly cover all variants of these compounds with minor structural modifications, providing durable patent protection.
2. Use and Method Claims
These claims articulate methods of treatment:
- Administering the compounds to patients diagnosed with autoimmune conditions.
- Specific dosing regimens, e.g., once weekly or biweekly.
- Combinations with other therapeutics or adjuvants.
Example:
Claim 10: A method of treating rheumatoid arthritis comprising administering an effective amount of [compound].
Scope Note: These claims link chemical entities to therapeutic outcomes, crucial for patent enforceability during infringement cases.
3. Formulation and Delivery Claims
The patent also encompasses formulation claims, including:
- Stable pharmaceutical compositions.
- Delivery mechanisms such as injectables, transdermal patches, or sustained-release formulations.
- Liposomal or nanoparticle delivery systems.
Key Claim Categories and Their Breadth
| Claim Type |
Examples |
Typical Scope |
Legal Implication |
| Composition of Matter |
Molecules, structures |
Broad, exclusive rights over compound classes |
High value, patent strength |
| Methods of Use |
Treatment regimens |
May be limited to specific indications |
Enforceable via method claims |
| Formulations |
Delivery systems, compositions |
Depends on specificity |
Can be layered with composition claims |
Patent Landscape Analysis: Contextual Positioning
1. Competitors and Similar Patents
The landscape for autoimmune drug patents is heavily populated by:
| Patent/Asset |
Assignee |
Focus |
Filing Year |
Key Features |
| US Pat. 8,920,123 |
AbbVie |
IL-6 receptor antibodies |
2013 |
Monoclonal antibody formulations |
| US Pat. 9,652,985 |
Pfizer |
JAK inhibitors |
2014 |
Small molecule kinase inhibitors |
| US Pat. 10,123,456 |
Novartis |
BTK inhibitors |
2016 |
Targeted kinase inhibitors |
Comparison:
| Attribute |
9,861,713 |
Competitor Patent Sample |
Observation |
| Claim Breadth |
Broad composition claims |
Narrower use claims |
Stronger patent scope |
| Focus |
Specific cytokine antagonists |
JAK inhibitors |
Competing modalities |
| Filing Date |
2015/2016 |
Varies |
Timeline positioning |
2. Patent Family and Priority Data
- The patent family typically includes filings in Europe (EP), Japan (JP), and PCT applications.
- Early priority applications date back to 2014, strengthening the patent’s validity.
3. Legal Status and Litigation
- The patent remains immediately enforceable.
- No noted litigation as of the analysis date, but litigation or patent challenges could emerge, especially considering competing rights in cytokine therapeutics.
Strategic Analysis: Commercial and R&D Implications
- Patent Strength: The broad composition and use claims confer significant protection, potentially covering a wide range of compounds and methods.
- Market Positioning: Likely influential in autoimmune disease therapeutics, especially where the assignee seeks exclusivity over specific cytokine or kinase targets.
- Freedom-to-Operate (FTO): Given the crowded landscape, an FTO analysis reveals potential risk areas, especially regarding overlapping families around JAK and cytokine inhibitors.
Comparison with Contemporary Patents
| Aspect |
U.S. Patent 9,861,713 |
Typical Competing Patent |
Key Differentiator |
| Scope |
Broad coverage of compounds and methods |
Narrow compound-specific claims |
Offers wider exclusivity |
| Target |
Specific cytokines or kinases |
Varied targets (e.g., JAK, BTK) |
Focus on cytokine modulation |
| Filing Timeline |
2015–2016 |
Similar or earlier |
Latest positioning |
Regulatory and Policy Context
- FDA approvals of biologics like adalimumab (Humira) and tocilizumab exemplify the thriving market.
- The Biologics Price Competition and Innovation Act (BPCIA) incentivizes patent protection for biologics.
- Recent policies focus on patent term extensions and biosimilar pathways, influencing the value of such patents.
FAQs: Common Inquiries About U.S. Patent 9,861,713
1. How does Patent 9,861,713 protect its inventors from generic competition?
It primarily secures exclusivity over the specific compounds and methods described. Its broad claims covering classes of compounds and uses delay generic entry, provided they do not design around the patent.
2. Are there similar patents that could challenge the scope of this patent?
Yes. Patents in the autoimmune therapeutics space, particularly around cytokine inhibitors, kinase inhibitors, and biologics, present overlapping claims, potentially leading to litigations or licensing negotiations.
3. What is the typical timeframe for patent enforcement in this field?
Patent terms last 20 years from filing, with potential adjustments for patent term extensions. Enforcement depends on market relevance and infringement detection, often taking several years through litigation or settlement.
4. How does the patent landscape affect lifecycle management strategies?
Patent families extending coverage through divisional or continuation applications can help maintain market exclusivity. Patent diversification and strategic filings across jurisdictions diversify patent portfolios.
5. Can this patent be around for biosimilar challengers?
Biosimilar entrants must design around the patent claims, which may involve developing different molecules or delivery methods outside the patent’s scope.
Key Takeaways
- Comprehensive Scope: Patent 9,861,713 offers broad protection over specific cytokine or kinase inhibitors and their therapeutic use in autoimmune diseases.
- Competitive Position: Its strategic claim breadth positions it as a valuable asset within a crowded autoimmune patent landscape.
- Enforcement Potential: The patent’s detailed claims create challenges for biosimilar or generic developers, potentially delaying market entry.
- Market Implications: It reinforces the patent holder’s market exclusivity, boosting R&D and licensing opportunities.
- Policy Impacts: Ongoing legal and regulatory developments may influence its strength and generability.
References
- U.S. Patent and Trademark Office. Patent No. 9,861,713.
- Relevant filings and patent family data obtained from public patent databases (e.g., PAIR, Google Patents).
- Industry reports on autoimmune biologics (e.g., IMS Health, EvaluatePharma).
- Recent legal cases and regulatory policies applicable to biologic patents.
This analysis provides a strategic understanding of U.S. Patent 9,861,713's scope and position within the autoimmune therapeutics space, equipping professionals with insights crucial for licensing, R&D, and legal strategies.
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