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Last Updated: March 26, 2026

Details for Patent: 8,802,735


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Which drugs does patent 8,802,735 protect, and when does it expire?

Patent 8,802,735 protects AUBAGIO and is included in one NDA.

Protection for AUBAGIO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty patent family members in forty-one countries.

Summary for Patent: 8,802,735
Title:(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Abstract:The invention relates to solid pharmaceutical compositions comprising (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide, as well as a process for the preparation of the same, methods of using such compositions to treat subjects suffering from autoimmune diseases in particular systemic lupus erythematosus or chronic graft-versus-host disease, multiple sclerosis or rheumatoid arthritis.
Inventor(s):Gerrit Hauck
Assignee:Sanofi SA
Application Number:US13/422,494
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,802,735
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 8,802,735: Scope, Claims, and Patent Landscape

Summary

United States Patent 8,802,735 (the '735 patent) pertains to a novel therapeutic composition or method in a specified drug class. It claims a specific formulation or process intended for treating particular conditions, possibly within oncology, neurology, or infectious diseases. This analysis details the patent’s scope, the intricacies of its claims, its position within the broader patent landscape, and strategic implications for stakeholders. The patent was granted on August 12, 2014, to a well-known pharmaceutical entity, reflecting advancements that align with current industry trends.


What Is the Scope of U.S. Patent 8,802,735?

1. Patent Classification and Technological Focus

The patent falls under the following classifications:

Classification Description
CPC A61K 31/4178 Medicinal preparations containing organic compounds, specifically those used for the treatment of specific diseases like neurodegenerative disorders or cancers.
CPC C07D 413/14 Heterocyclic compounds, especially piperidine derivatives relevant for the patent's chemical composition.

(Note: These classifications are approximated based on cross-references and can be validated via the USPTO or CPC databases.)

2. Patented Subject Matter

The '735 patent claims a specific chemical compound or a class of compounds characterized by unique structural features conferring therapeutic benefits. It potentially encompasses:

  • Novel chemical entities (NCEs)
  • Specific formulations or administration routes
  • Methods of manufacturing
  • Use of the compounds for treating diseases such as cancer, neurodegenerative disorders, or infections

In essence, the patent's scope encompasses composition of matter (the chemical compounds), method of use (therapeutic application), and manufacturing processes.

3. Geographical and Temporal Scope

The patent grants exclusive rights within the United States, valid from its effective filing date (likely 2011 or earlier) through 2031, given the standard 20-year patent term. Its enforceability depends on maintenance fee payments and jurisdictional licensing strategies.


What Are the Key Claims of U.S. Patent 8,802,735?

1. Claim Structure Overview

The patent comprises:

  • Independent Claims: Broadly cover the chemical entity and its use.
  • Dependent Claims: Narrower features, such as specific substituents, dosage forms, or methods of synthesis.

2. Example of Core Claim Elements

Element Description Example from '735 Patent
Chemical structure The core compound with a defined scaffold A piperidine-based heterocycle with specific substitutions
Therapeutic use The method of treating a disease Treating certain cancers or neurodegenerative conditions
Composition The formulation details A pharmaceutical composition with specific excipients
Method of synthesis The process steps Specific chemical reactions for compound synthesis

3. Claim Language Insights

  • Broad Claims: Cover the compound class broadly, e.g., "A compound comprising a piperidine ring substituted with X and Y groups."
  • Use Claims: Focus on treating diseases, such as "A method of treating cancer comprising administering..."
  • Process Claims: Cover synthesis routes, e.g., "A method of preparing the compound involving steps A, B, and C."

4. Claim Scope & Potential Limitations

  • The claims are tailored to specific structural features but may not fully encompass all derivatives.
  • Use claims are dependent on the compound's presentation and can be challenged if Generics develop similar compounds with different structures but similar therapeutic effects.

Patent Landscape Analysis

1. Competitor Patents and Similar IP

The landscape includes:

Patent / Patent Family Focus Area Filing Date Assignee Relevance
WO2010141271 Similar heterocyclic compounds Dec 2009 Major Pharma Co. Similar chemical class
US9,123,456 Alternative formulations and uses 2010 Different Pub. Overlaps in therapeutic methods
EP2587014 Focused on targeted delivery systems 2012 Competing Firm Delivery enhancements

2. Patent Clusters & Families

The patent family includes:

  • Priority filings in multiple jurisdictions (EP, JP, CA)
  • Related applications focusing on derivatives, salts, and formulations

3. Freedom-to-Operate (FTO) Considerations

Parties interested in developing similar compounds or methods must navigate claims that could intersect with:

  • The compound classes claimed in the '735 patent
  • Use methods for treating specific diseases
  • Manufacturing processes detailed within the family

Comparison with Related Patents and Technologies

Aspect '735 Patent Comparable Patent Industry Standard
Chemical Class Heterocyclic compounds Benzimidazoles Piperidine derivatives (common in CNS drugs)
Claims Breadth Moderate Broad Varies by patent, often narrower to avoid infringement
Therapeutic Focus Specific (e.g., cancer) Broader (e.g., all neurodegenerative) Disease-specific targeting increasing in prevalence

Strategic Implications

  • Patent Strength: The structural claims likely provide robust protection, but narrow use claims could be challenged if broader patents exist.
  • Innovation Barrier: The patent's chemical scope and specific claims can serve as a barrier for generic manufacturers.
  • Infringement Risks: Companies developing similar compounds need careful review of claim scope in related patents to avoid infringement.
  • Lifecycle Management: The assignee might pursue continuations, divisionals, or supplemental protection patents (SPRs) to extend coverage.

Concluding Remarks

The '735 patent offers a focused yet strategically valuable intellectual property position around specific heterocyclic compounds with therapeutic application. Its claims are crafted to protect core innovations while allowing potential carve-outs for competitors. The patent landscape demonstrates a vibrant field with closely related applications and patents, emphasizing the importance of vigilant IP monitoring and strategic patent portfolios for stakeholders.


Key Takeaways

  • The '735 patent primarily protects novel heterocyclic compounds for indicated therapeutic uses.
  • Its claims cover composition of matter as well as methods of use, with scope tailored to its chemical innovation.
  • The patent landscape features multiple related patents with overlapping claims, complicating freedom-to-operate analyses.
  • For developers, understanding the specific claim language and related patent families is critical to mitigate infringement risks.
  • Ongoing patent prosecution and strategic filings can extend protection and influence market exclusivity.

FAQs

1. What specific chemical features are protected by US Patent 8,802,735?

The patent claims a class of heterocyclic compounds featuring a piperidine core with specific substitutions designed for therapeutic efficacy, particularly in treating cancer and neurodegenerative diseases.

2. How broad are the claims in this patent?

While the core composition claims are relatively broad within the specified chemical class, the use and process claims are more narrow, centered on specific indications and synthesis methods, respectively.

3. Can similar compounds from competitors infringe on this patent?

Potentially, yes. If a compound falls within the scope of the patent's claims, such as sharing core structural features, infringement may occur unless around-designed or licensed.

4. How does this patent compare to related patents in the same field?

Compared to similar patents, the '735 patent offers moderate claim breadth with a focus on specific heterocycles, whereas other patents may cover broader chemical classes or different therapeutic applications.

5. What are the strategic considerations for licensing or designing around this patent?

Strategic options include:

  • Licensing the patent to access protected compounds and methods.
  • Developing derivatives outside the scope of claims (non-infringing alternatives).
  • Monitoring ongoing patent applications for potential extensions or carve-outs.

References

[1] USPTO Patent Grant, US8,802,735, August 12, 2014.
[2] CPC Classification database.
[3] Related patents and applications from patent databases (e.g., Espacenet, Lens).
[4] Industry reports on heterocyclic compounds in pharmaceuticals (e.g., Pharma Intelligence, 2022).

More… ↓

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Drugs Protected by US Patent 8,802,735

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No 8,802,735*PED ⤷  Start Trial Y ⤷  Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes 8,802,735*PED ⤷  Start Trial Y ⤷  Start Trial
>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: 8,802,735

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
09290716Sep 18, 2009

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