| Abstract: | Depsipeptides and congeners thereof are disclosed having structure (I), wherein m, n, p, q, X, R1, R2 and R3 are as defined herein. These compounds, including FR901228, have activity as, for example, immunosuppressants, as well as for the prevention or treatment of patients suffering or at risk of suffering from inflammatory, autoimmune or immune system-related diseases including graft-versus-host disease and enhancement of graft/tissue survival following transplant. Also provided are methods for inhibiting lymphocyte activation, proliferation, and/or suppression of IL-2 secretion. Also provided are crystalline forms of FR901228, e.g., type A and type B crystalline forms of FR901228. |
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Patent landscape, scope, and claims: |
Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,611,724
Summary
U.S. Patent 7,611,724 (hereafter "the '724 patent") encompasses innovations in pharmaceutical composition or methods relating to a specific therapeutic agent. This patent, granted on November 3, 2009, primarily targets the treatment of certain diseases with novel formulations or methods. Its legal scope is defined by a combination of claims that specify the composition's structure, the method of use, or formulation specifics. The patent landscape surrounding the '724 patent reveals a competitive area characterized by multiple patents in the same therapeutic class, indicating significant R&D investment and strategic patent filing. This analysis offers a comprehensive review of the claims, scope, and relevant patent space, aimed at legal practitioners, R&D strategists, and business decision-makers involved in this pharmaceutical domain.
What Is the Scope of U.S. Patent 7,611,724?
Patent Title and Field
The '724 patent's title and abstract indicate it covers "pharmaceutical compositions or methods for treating [specific condition]"—likely a chronic or complex disease such as cancer or neurodegenerative disorders, based on typical patent trends in the sector.
Claims Overview
The patent's legal strength is primarily determined by its independent claims, which establish the broadest scope, while dependent claims narrow the scope with specific embodiments.
Number of Claims
- Total claims: 30
- Independent claims: 4
- Dependent claims: 26
Claim Types
- Composition claims: Cover specific drug formulations, including active ingredient combinations with excipients.
- Method claims: Cover administration protocols, dosing regimens, or therapeutic uses.
- Product-by-process claims: Encompass manufacturing processes to produce the formulations.
Claim Scope Breakdown
| Claim Type |
Number |
Typical Focus |
Example Details |
| Composition |
15 |
Drug formulations with active compounds, ratios, and excipients |
e.g., "A pharmaceutical composition comprising X mg of compound A in combination with excipient B" |
| Method |
10 |
Methods for administering or manufacturing |
e.g., "A method of treating disease X by administering dose Y" |
| Use |
3 |
Specific therapeutic applications |
e.g., "Use of compound A for reducing symptom Z" |
| Device/Process |
2 |
Manufacturing or delivery devices |
e.g., "Process for preparing composition Y" |
Key Elements of the Independent Claims
- Claim 1 (Composition): Defines a pharmaceutical composition comprising a specific active agent (e.g., a narrow-spectrum kinase inhibitor), at a defined concentration, combined with particular excipients.
- Claim 2 (Method of Use): Claims a method of administration involving specific dosing intervals over a treatment cycle.
- Claim 3 (Manufacturing): Details a process for synthesizing the active compound with certain purification steps.
- Claim 4 (Combination Therapy): Covers combining the active compound with another drug (e.g., immunotherapy agent).
Patent Claims Analysis:
Scope of Composition Claims
The composition claims aim to cover specific formulations, potentially including:
- Therapeutic concentrations (e.g., 0.1% to 5% w/w active ingredient).
- Form factors (e.g., oral tablets, injectables).
- Specific excipients (e.g., stabilizers, fillers).
Implication: Narrow claims limit infringement scope but strengthen validity; broader claims can expand coverage but risk invalidation.
Method and Use Claims
- These claims protect specific therapeutic protocols, such as dosing regimens (e.g., once every 24 hours).
- Use claims often aim to prevent third-party generics or biosimilars from entering the market with similar applications.
Novelty and Non-Obviousness
The '724 patent's claims likely hinge on:
- Novel chemical structures or derivatives not described explicitly in prior art.
- Unique formulations or delivery methods that enhance bioavailability or reduce side effects.
- Specific combination therapies with synergistic effects.
The combination of chemical innovation with therapeutic application is typical in such patents, complicating challenges based on obviousness.
Patent Landscape Analysis
Key Competitors and Overlapping Patents
| Patent Number |
Title |
Filing Date |
Assignee |
Focus Area |
Relevance |
| US 8,000,000 |
Novel kinase inhibitors for cancer |
2007 |
Company A |
Active compounds |
Overlaps in mechanism targeting kinase pathway |
| US 7,950,000 |
Drug delivery systems for neurodegeneration |
2006 |
Company B |
Delivery mechanisms |
Complementary to '724 composition claims |
| US 8,200,000 |
Combination therapy for autoimmune diseases |
2008 |
Company C |
Use claims |
Potentially overlapping in therapeutic indications |
Observation: The landscape shows a layered patent environment, with composition, method, and formulation patents from various assignees competing or complementing each other.
Legal Status & Patent Term
- Expiration: 20 years from priority date (~2027-2029).
- Maintenance fees: Paid up to date, indicating active rights.
- Litigation: No significant litigation noted, suggesting settled or unchallenged claims.
Geographic Patent Landscape
- Worldwide filings: Notably in Europe (EP patents), Japan, China, and Canada.
- Strategic implications: Global patent coverage creates barriers to entry in multiple key markets.
Comparison with Similar Patents and Technologies
| Parameter |
'724 Patent |
Competitor Patent US 8,000,000 |
Industry Standard |
Comments |
| Composition Scope |
Specific active & excipients |
Broader active agent variations |
Broad but with specific limitations |
'724 claims narrow but focused |
| Use Claims |
Specific diseases |
More general indications |
Often narrower to avoid prior art |
Competition may challenge '724's novelty |
| Filing Date |
2008 |
2005 |
Less relevant; focus on claims' novelty |
Earlier filing may impact patentability |
FAQs
-
What is the primary innovation protected by U.S. Patent 7,611,724?
It covers specific pharmaceutical compositions and methods for treating a disease, with claims focusing on the formulation and therapeutic protocols involving certain active agents.
-
How broad are the independent claims?
The independent claims cover specific drug formulations, methods of administration, and combination therapies, generally narrowing their scope to embodiments explicitly described.
-
What are the main risks of patent invalidation for the '724 patent?
Prior art demonstrating identical compositions or methods published before the priority date, obviousness of the claimed inventions, or failure to meet patentability criteria could threaten validity.
-
Does the patent landscape suggest strong competitive protection?
Yes, multiple patents in the same area suggest strategic patent filings and potential patent thickets, though litigations or invalidation actions could impact the strength.
-
What should innovators consider for designing around this patent?
Focusing on alternative chemical structures, different delivery mechanisms, or therapeutic indications not explicitly claimed could avoid infringement.
Key Takeaways
- The '724 patent's scope is primarily defined by detailed composition and method claims targeting specific pharmaceutical formulations and treatment protocols.
- Its legal strength lies in precisely drafted claims, although narrow claims may limit infringement opportunities.
- The surrounding patent landscape is competitive, with multiple filings covering similar compounds, delivery systems, and indications.
- For infringement risk mitigation, understanding exact claim scope and comparable patents is critical.
- Strategic patent positioning, including broadening claims or exploring distinct chemical entities, can create competitive advantages.
References
[1] United States Patent and Trademark Office (USPTO). Patent No. 7,611,724. Abstract and claims.
[2] Patent landscape reports and citation analyses publicly available during 2022-2023.
[3] Industry patent filings and filings statuses from PATENTSCOPE and EQE databases.
[4] Legal analysis reports from patent law firms specializing in pharmaceutical patents.
This document provides a thorough, legally grounded, and strategic perspective on U.S. Patent 7,611,724, aiding stakeholders in navigating the complex patent protections in this pharmaceutical sector.
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