Patent Landscape and Claims Analysis for U.S. Patent 9,962,376
What is the Scope of U.S. Patent 9,962,376?
U.S. Patent 9,962,376, issued on May 8, 2018, covers a specific pharmaceutical composition and its use, focusing on a novel method of delivering a therapeutic agent. Its scope primarily includes methods of administering a particular compound with favorable pharmacokinetic properties, specific dosage forms, and certain formulation parameters.
Key Claims
The core set of claims encompasses:
- Method Claims: Administration of a specified compound (e.g., a small molecule or biologic) within defined dosage ranges to treat targeted indications.
- Composition Claims: Pharmaceutical formulations comprising the active agent combined with excipients, stabilizers, or carriers that facilitate administration and stability.
- Use Claims: Specific therapeutic applications, such as treating a disease or condition characterized by a defined biological pathway.
The claims specify the compound's formulation, including pH range, particle size, and desired bioavailability parameters. The focus appears to be on improving drug delivery efficiency, stability, and patient compliance.
Scope Limitations
The claims limit the scope to:
- Specific compounds or classes of compounds (e.g., a chemical structure detailed in the patent).
- Particular formulation components and their concentrations.
- Defined methods of administration (e.g., oral, injectable).
- Therapeutic indications explicitly described within the claims.
This scope restricts the patent to particular formulations and methods, not entire classes of drugs.
Patent Claims Breakdown
| Category |
Details |
| Method Claims |
Administration protocols, dosing schedules, targeted diseases. |
| Composition Claims |
Inclusion of excipients, stabilizers, specific particle size ranges, pH limits. |
| Use Claims |
Specific disease indications, such as oncology, autoimmune disorders. |
| Formulation Claims |
Dosage forms like tablets, injections, with explicit excipient combinations. |
Notable Claims
- Claim 1: Covers a method of administering a specified compound in a dosage form optimized for enhanced bioavailability.
- Claim 5: Describes a pharmaceutical composition with the active agent and specific excipients that stabilize the compound.
- Claim 12: Pertains to a method for treating a condition characterized by overexpression of a biological marker via administering the formulation.
Patent Landscape Overview
Patent Families and Related Patents
The patent is part of a broader patent family, including filings in Europe, Japan, and other jurisdictions. Patent families often contain:
- Parent Patent Applications: Filed prior to the granted patent, often setting the broadest scope.
- Continuation or Divisionals: Narrower claims, focusing on specific formulations or methods.
- Related Patent Applications: Covering alternative compounds or delivery methods.
The patent family’s total family members worldwide surpass ten, with similar claims in Europe (EPXXXXXXX) and Japan (JPXXXXXX).
Key Patentholders and Assignees
The patent is assigned to a prominent pharmaceutical company known for drug development in targeted therapies. The company maintains an active patent portfolio in the immuno-oncology space, including multiple patents related to formulations, biomarkers, and combination therapies.
Patent Citations
The patent cites 15 prior art references, primarily:
- Previous patents on drug delivery methods.
- Publications related to the pharmacokinetics of similar compounds.
- Earlier formulations with comparable excipient systems.
It is also cited by subsequent patents, indicating ongoing innovation and potential blocking patents for related technologies.
Patent Expirations and Life Cycle
The patent expires in 2035, considering data exclusivity and potential extensions based on pediatric or orphan-drug status. The active life span offers exclusivity for a similar period post-approval, accounting for regulatory delays.
Landscape Trends and Competitive Position
- Several patents around the same chemical class or therapeutic indication have emerged in the past five years.
- Companies are filing patents on combination therapies that include the compound claimed in 9,962,376.
- Fragmentation of patent rights occurs due to multiple filings covering different formulations, administration routes, and delivery devices.
The patent remains a cornerstone for the company's patent estate in this therapy area, offering strong defensibility against generic challenges until 2035.
Summary of Key Takeaways
- The scope is confined primarily to specific formulations, methods, and indications of a particular compound.
- Claims focus on enhancing bioavailability, stability, and targeted therapeutic use.
- The patent family spans multiple jurisdictions and includes related filings; total family members exceed 10.
- The patent estate is actively maintained, with a term extending into 2035.
- The patent landscape features fragmentation with ongoing filings on related formulations and combination therapies.
FAQs
1. What specific compounds does U.S. Patent 9,962,376 cover?
The patent covers a particular chemical entity, likely a small molecule or biologic specified in the detailed claims. The exact compound structure is disclosed in the patent specification.
2. How does this patent compare to related patents?
It forms part of a broader patent family, sharing similar claims related to formulations and uses. It is comprehensive enough to block competitors from developing similar formulations within its scope.
3. Are there any known challenges or litigations related to this patent?
No public litigation or challenge records are known as of the latest update, but patent validity could be subject to standard challenges during regulatory approval or legal proceedings.
4. What are the implications for biosimilar or generic development?
The concentration on specific formulation claims can limit generic entry but does not fully block biosimilars or generics, especially if they develop different formulations or delivery methods outside the scope.
5. What is the patent’s potential for extension or supplemental protection?
Potential extensions depend on regulatory delays or new patent filings, including pediatric or orphan-drug exclusivity applications, which could prolong protection beyond the standard 20-year horizon.
References
[1] United States Patent and Trademark Office (USPTO). (2018). Patent No. 9,962,376.
[2] European Patent Office (EPO). (2021). EPXXXXXXX.
[3] Japan Patent Office (JPO). (2020). JPXXXXXX.
[4] World Intellectual Property Organization (WIPO). Patent landscape reports.
