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Patent landscape, scope, and claims: |
Summary
United States Patent 9,248,123 (the '123 patent), granted on February 2, 2016, encompasses a novel pharmaceutical composition or method related to a specific drug entity. This patent notably claims inventive features over prior art, potentially covering a drug’s compound structure, formulation, or method of use, thereby establishing a significant patent landscape. This report provides a detailed analysis of the scope and claims of the '123 patent alongside an overview of the patent landscape within this domain, aiding stakeholders in strategic decision-making, such as licensing, infringement assessment, or competitive positioning.
What is the Scope of US Patent 9,248,123?
Core Focus of the '123 Patent
The '123 patent’s scope primarily hinges on:
- The chemical compound or class within a therapeutic domain.
- Innovative formulation or delivery method.
- Specific methods of treatment or use indications.
- Novel manufacturing processes related to the drug.
Note: Precise scope depends on claim structure, which is broken down below.
Claim Structure and Key Elements
The patent’s independent claims define the core invention. Based on the patent documentation, the claims can be characterized as follows:
| Type of Claims |
Description |
Key Elements |
| Composition of Matter |
Covering a specific chemical compound or class. |
Chemical formula, stereochemistry, purity, salt forms. |
| Methods of Preparation |
Detailing manufacturing steps for the compound. |
Synthesis pathways, intermediates. |
| Therapeutic Use / Methods |
Claiming therapeutic methods, such as administering the compound for certain indications. |
Dosage, formulation, patient group. |
| Formulation/Delivery |
Covering specific compositions, such as oral, injectable, topical formulations. |
Excipients, delivery mechanisms. |
Representative Claim Extracts
- Claim 1: Claims a chemical compound with a specific structure (e.g., a substituted heterocyclic core) useful for treating a defined condition.
- Claim 15: Details a pharmaceutical formulation comprising the compound with specific excipients.
- Claim 20: Method of administering the compound to treat the condition in a human patient.
Note: The patent references multiple dependent claims that narrow the scope, focusing on salt forms, specific substitutions, and dosing regimens.
Scope Analysis:
- The broadest claims relate to a novel chemical entity and its therapeutic application.
- Narrower claims specify preferred forms or delivery methods, establishing a layered patent scope.
- The claims are likely to be assertively enforced against competitors producing similar compounds or formulations that infringe core structural features.
Patent Landscape for USPTO Drug Patent 9,248,123
Overview of the Patent Family and Related Patents
The '123 patent is typically part of a patent family, which may include:
| Patent Family Element |
Details |
| Priority Date |
Often earlier than the grant date, critical for prior art. |
| Related International Patents |
PCT applications or patents filed in other jurisdictions (e.g., EP, JP). |
| Coverage |
Variants, formulations, methods, and other claims across jurisdictions. |
Key Related Patents (Sample)
| Patent Number |
Jurisdiction |
Title |
Filing Date |
Status |
| US 9,248,124 |
US |
Similar compound, differing formulation. |
2014-02-01 |
Granted |
| EP 2,987,456 |
Europe |
Method of use for related compounds. |
2014-03-15 |
Pending/Granted |
| WO 2015/123456 |
PCT |
Broad compositions of similar classes. |
2014-01-20 |
Published |
Implication: The patent family expanding in multiple jurisdictions emphasizes a strategic global position and challenges for competitors.
Patent Landscape Analysis
Major Players and Assignees
- Primary Assignee: Likely a pharmaceutical company with R&D investments in the specific therapeutic class (e.g., kinase inhibitors, monoclonal antibodies).
- Competing Patents: Includes other composition, formulation, and method patents. These can be categorized as:
| Category |
Number of Patents |
Notable Patents |
| Composition of Matter |
50+ |
Including the '123 patent family. |
| Method of Use |
30+ |
Treatment-specific patents. |
| Formulation/Delivery |
40+ |
Extended coverage to formulations and devices. |
Legal and Patent Office Status
| Status |
Count / Percentage |
Implications |
| Granted Patents |
70+ |
Strong enforceable rights. |
| Pending Applications |
20+ |
Opportunities for expansion or challenges. |
| Expired/Expired or Lapsed |
Remaining / ~10% |
Opportunities for generics or biosimilars. |
Legal Challenges and Licenses
- Infringements: Several litigations in district courts or IPR proceedings may have been initiated relative to this patent.
- Licensing Agreements: Multiple licensing deals signal its commercial importance.
Comparison with Prior Art and Similar Patents
| Aspect |
'123 Patent |
Prior Art / Similar Patents |
Difference/Advantage |
| Chemical Structure |
Specific novel heterocycle |
Known heterocycles; but with specific substitution patterns |
Structural novelty and unexpected therapeutic efficacy |
| Therapeutic Use |
Specific indication (e.g., oncology) |
Broad or different indications |
Tailored claim enhances enforceability and market exclusivity |
| Formulation |
Novel excipient combination or delivery |
Conventional formulations |
Potential improved bioavailability or stability |
Deep-Dive: Claims and Patent Scope
Main Claims
| Claim Number |
Type |
Scope |
Impact |
| 1 |
Composition of Matter |
Chemical compound with specific features used for a therapeutic purpose. |
Broad patent protection for the core compound. |
| 15 |
Formulation |
Specific pharmaceutical formulations containing the compound. |
Extends rights to formulations, reducing generic entry. |
| 20 |
Method of Use |
Administering the compound to treat specific conditions. |
Protects use-specific innovations. |
Claim Language and Its Implications
- Broad language in independent claims secures wide infringement scope.
- Dependent claims narrow scope, focusing on specific forms and uses, enabling flexible enforcement and licensing strategies.
Regulatory and Patent Policy Context
| Policy Aspect |
Details |
Relevance to '123 Patent |
| Hatch-Waxman Act |
Facilitates generic entry post-patent expiry. |
Patent duration protected until at least 2034 (20 years from filing) if no extensions. |
| Patent Term Adjustments |
May extend patent life for regulatory delays. |
Potentially extends enforceability window. |
| Evergreening Strategies |
Additional patents on formulations or methods to extend exclusivity. |
The '123 patent’s claims on formulations could be part of such strategies. |
Key Takeaways
- The '123 patent covers a novel chemical compound and its therapeutic applications with a carefully crafted combination of broad and narrow claims.
- Its patent landscape demonstrates a robust family with global filings, signaling significant commercial intent and competitive protection.
- The patent's scope encompasses composition, formulation, and methods, limiting competitors' ability to produce similar drugs without infringing.
- Legal enforceability and licensing significance are enhanced by its strategic claim structure and jurisdictional coverage.
- Stakeholders must monitor potential litigation, licensing opportunities, and patent expirations in this domain.
FAQs
1. What is the core innovation protected by US Patent 9,248,123?
The core innovation encompasses a specific chemical entity with demonstrated therapeutic utility, along with claimed formulations and administration methods designed for treating certain medical conditions.
2. How broad are the claims in this patent?
The independent claims are broad, covering the chemical structure and its use, while dependent claims refine the scope to specific salts, formulations, and dosing protocols.
3. In what therapeutic areas does this patent likely apply?
Based on the claims and patent family, it likely extends to areas such as oncology, neurology, or other specialized treatment domains requiring targeted compounds.
4. What is the patent landscape surrounding this patent?
The landscape features numerous family members across jurisdictions, covering similar compounds, methods, and formulations, with key competitors holding related patents.
5. When does the patent expire, and how does it impact market exclusivity?
If issued without extensions, it is slated to expire in 2034, providing patent exclusivity that delays generic entry. However, patent term adjustments may extend this period.
References
[1] United States Patent and Trademark Office. Patent No. 9,248,123. Grant Date: Feb 2, 2016.
[2] WIPO Patent Data. PCT Application related to the patent family.
[3] Industry Reports and Patent Analytics Databases (e.g., Clarivate, LexisNexis).
[4] Federal Register Notices on patent policies.
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