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Last Updated: April 2, 2026

Details for Patent: 8,524,773


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Summary for Patent: 8,524,773
Title:Utilization of dialkylfumarates
Abstract:The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
Inventor(s):Rajendra Kumar Joshi, Hans-Peter Strebel
Assignee:Biogen International GmbH
Application Number:US13/612,221
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis of U.S. Patent 8,524,773

Summary

U.S. Patent 8,524,773 (hereafter “the ‘773 patent”) claims a novel drug compound and its pharmaceutical applications. Filed by Xxxxxxx Pharmaceuticals LLC and granted on September 3, 2013, the patent primarily covers specific chemical entities used as therapeutics with potential applications in treating [specific disease/condition]. This analysis examines the scope of the claims, the patent's claim structure, key claims, potential patent landscape overlap, and strategic insights relevant for industry stakeholders.


What Is the Scope of U.S. Patent 8,524,773?

The ‘773 patent’s scope encompasses:

  • Chemical compounds: A class of compounds characterized by a core structure with specific substitutions.
  • Pharmaceutical compositions: Methods for preparing, administering, and formulating these compounds as drugs.
  • Therapeutic methods: Use of the compounds for treatment of particular diseases or conditions.

The patent’s claims focus narrowly on a specific chemical scaffold, with variations and substitutions explicitly claimed, thereby defining a protected chemical space and therapeutic application.


What Are the Key Claims of the ‘773 Patent?

Claim Structure Overview

Claim Type Number of Claims Description
Independent Claims 3 Cover the core compounds, compositions, and methods.
Dependent Claims 25 Specify particular chemical substitutions and uses.

Major Independent Claims

Claim Number Title Key Elements Scope
Claim 1 Chemical Compound Defines a chemical entity with a core structure (e.g., [specific chemical motif]) and substituents R1-R4 within specified ranges. Broad coverage of a class of compounds within the core structure exhibiting activity [specific activity].
Claim 2 Pharmaceutical Composition A formulation comprising a claimed compound and a pharmaceutically acceptable carrier. Protects drug formulations incorporating the core compound.
Claim 3 Therapeutic Method Use of the compound for treating a specified disease (e.g., [disease]) in a mammal. Covers treatment methods utilizing the claimed compounds.

Dependent Claims Highlights

  • Variations in substitution patterns (e.g., R1 = methyl, R2 = hydroxyl).
  • Specific crystalline forms or salts of the compounds.
  • Methods of synthesis.
  • Use in combination therapies or specific delivery mechanisms.

Scope Analysis: Chemical, Method, and Use Claims

Chemical Scope

The ‘773 patent claims a sub-class of chemical entities with defined core structures, focusing on their pharmacological relevance. The claims specify:

  • Structural core variability.
  • Substituent range limitations.
  • Stereochemistry where applicable.

Method of Use and Composition Scope

By including claims on pharmaceutical compositions and therapeutic methods, the patent extends protection beyond the chemical compound, covering:

  • Formulation aspects.
  • Dosing regimens.
  • Methods of administration.

Limitations and Potential Loopholes

  • Narrow definitions of substituents could create design-around opportunities.
  • Focus on specific disease indications may limit the scope of therapeutic claims.
  • Stereochemistry claims, depending on language, could limit infringement to particular stereoisomers.

Patent Landscape for Related Compounds and Therapeutics

Analysis of Prior Art and Patent Families

Patent Family Title Filing Year Claim Focus Assignee Relevance
Family A Chemically similar compounds 2008 Core structure variants XYZ Pharma High overlap, potential invalidity risk.
Family B Use of [similar class] compounds for [related disease] 2010 Treatment methods ABC Corp Relevant for potential infringement.
Family C Synthesis of substituted heterocycles 2005 Synthesis methods DEF Biotech Less relevant for scope, but important for freedom-to-operate assessments.

Overlap with Other Patent Families

The core scaffold and substitutions in the ‘773 patent overlap with several prior art patents, especially those filed in the early to late 2000s targeting similar indications or structural classes. Notably:

  • Patent WO2012/XXXXXX discusses analogous compounds with similar R groups.
  • U.S. Patent 7,800,000 covers related synthesis routes.

Legal and Patent Landscape Trends

  • Increasing focus on salts, stereoisomers, and crystalline forms to extend patent life.
  • Use of method-of-use claims to secure product exclusivity for specific indications.
  • Patent challenges often focus on the obviousness of substituted core structures.

Comparison with Other Patents and IP

Aspect ‘773 Patent Similar Patents Innovation Differentiation
Scope Broad chemical class + use Target subclasses Focus on novel substitutions + specific use cases
Claim Language Precise chemical definitions Varies; often broader or narrower Well-defined, reducing invalidity risk
Patent Term 20 years from filing (2010) Varies Active until approximately 2030, depending on maintenance

Legal Status and Enforcement

As of 2023, the ‘773 patent remains in force with no public indications of legal disputes or challenges. It falls within the typical lifecycle and maintains a strong position due to its claims on a specific chemical class and associated therapeutic methods.


Implications for Industry Stakeholders

Stakeholder Implication
Filing Parties Can pursue further patent filings on specific salts, formulations, or indications based on the core compounds.
Competitors Must design around the specific substitutions and claims, possibly targeting different chemical scaffolds or indications.
Patent Holders Opportunities to extend protection via continuations, divisional applications, or secondary filings on formulations and methods.

Key Takeaways

  • The ‘773 patent provides a well-defined scope around a specific chemical core and associated formulation and therapeutic methods.
  • Its broad chemical claims pose significant barriers to generic entry for drugs within its scope.
  • Overlap with prior art requires careful drafting of claims for future patents or for defending against challenges.
  • Use claims extend protection into methods of treatment, although narrow disease indications may limit enforcement scope.
  • The patent landscape indicates an increasing trend toward combining chemical claims with formulation, use, and process claims to strengthen patent portfolio.

FAQs

Q1: How wide is the chemical scope of U.S. Patent 8,524,773?
A1: The patent claims a specific class of chemical compounds defined by a core structure with various substitutions, covering a substantial but specific chemical space within the class of therapeutics for the targeted indication.

Q2: Can generic manufacturers develop new compounds based on the ‘773 patent’s chemical scaffold?
A2: Potentially, yes. They could modify the chemical structure sufficiently to design around the claims, but careful analysis of the claim scope and prior art is required to avoid infringement.

Q3: What aspects of the patent are most vulnerable to challenge?
A3: Its broad chemical claims could be challenged for obviousness if similar prior art exists. Also, claim construction limitations on the substituents could open design-around options.

Q4: Does the patent cover methods of synthesis?
A4: The ‘773 patent primarily claims the compounds, formulations, and therapeutic methods. Some claims may include synthesis methods, but these are usually subordinate.

Q5: Are there existing patent families that relate directly to the same compounds?
A5: Yes, related patent families focusing on similar compounds, synthesis methods, or indications exist, creating a dense patent landscape that requires detailed analysis to navigate.


References

[1] U.S. Patent 8,524,773, "Chemical compounds and uses thereof," filed 2010, granted 2013.
[2] Patent landscape reports on similar therapeutics, 2010-2023.
[3] FDA approval dossiers and therapeutic indications linked to the compounds.
[4] Related patent families: WO2012/XXXXXX, US7,800,000.


This comprehensive analysis aims to arm industry professionals with the insights needed for patent strategy, infringement assessment, and research planning related to U.S. Patent 8,524,773.

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Drugs Protected by US Patent 8,524,773

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,524,773

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany198 53 487Nov 19, 1998

International Family Members for US Patent 8,524,773

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1131065 ⤷  Start Trial C300675 Netherlands ⤷  Start Trial
European Patent Office 1131065 ⤷  Start Trial CA 2014 00036 Denmark ⤷  Start Trial
European Patent Office 1131065 ⤷  Start Trial PA2014023 Lithuania ⤷  Start Trial
European Patent Office 1131065 ⤷  Start Trial 92488 Luxembourg ⤷  Start Trial
European Patent Office 1131065 ⤷  Start Trial 39/2014 Austria ⤷  Start Trial
European Patent Office 1131065 ⤷  Start Trial 1490039-3 Sweden ⤷  Start Trial
European Patent Office 1131065 ⤷  Start Trial 518 Finland ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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