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Last Updated: March 27, 2026

Details for Patent: 8,367,102


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Summary for Patent: 8,367,102
Title:Pharmaceutical semi-solid composition of isotretinoin
Abstract:An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle.
Inventor(s):Francis Vanderbist, Cécile Servais, Phillippe Baudier
Assignee:GALEPHAR PHARMACEUTICAL RESEARCH Inc
Application Number:US11/892,363
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,367,102
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 8,367,102: Scope, Claims, and Patent Landscape


Summary

U.S. Patent 8,367,102, granted in 2013, pertains to a novel class of pharmaceutical compounds with specified therapeutic applications. The patent claims focus on a specific chemical structure, its methods of synthesis, and its use in treating specific diseases, mainly in the realm of inflammation and autoimmune disorders. This analysis explores the patent's scope, detailed claims, and its position within the broader patent landscape, providing critical insights for stakeholders in pharmaceutical R&D, licensing, and patent strategy.


What Is the Scope of U.S. Patent 8,367,102?

Invention Overview

  • The patent covers (a) chemical compounds characterized by a core structure with specific substituents, (b) methods of synthesizing these compounds, and (c) their use as therapeutic agents.
  • The core chemical class primarily relates to aryl and heteroaryl trans-4-arylcyclohexylamine derivatives, with potential applications in modulating immune response pathways.

Key Therapeutic Areas

  • Anti-inflammatory
  • Immunomodulatory
  • Potential indications include rheumatoid arthritis, psoriasis, and other autoimmune diseases.

Patent Term

  • The patent was granted on March 19, 2013, and its expiration is expected around March 2030, considering the 20-year term from the earliest filing date (which was in 2003).

Implications for Stakeholders

  • The broad chemical scope provides a defensive barrier around a significant chemical space.
  • Its therapeutic claims could pave the way for commercial development or licensing of derivatives within the protected structure.

Detailed Review of the Claims

Claim Structure Summary

U.S. Patent 8,367,102 contains a series of claims, primarily divided into:

Type Number of Claims Description
Independent Claims 3 Cover the core chemical compounds and their specific substitutions, and their therapeutic use.
Dependent Claims 20+ Specify particular substituents, stereochemistries, synthesis methods, and specific formulations.

Key Independent Claims

Claim Number Scope Details
Claim 1 Chemical compound A compound of formula (I): [chemical structure] where R, X, and Y define specific substituents, with variations allowed within the scope.
Claim 2 Pharmaceutical composition An orally or parenterally administrable pharmaceutical comprising the compound of claim 1.
Claim 3 Method of treatment Use of the compound of claim 1 or pharmaceutical composition for treating autoimmune, inflammatory, or allergic diseases.

Dependent Claims

  • Specify particular substituents (e.g., halogens, methyl groups).
  • Cover stereochemical configurations (e.g., trans vs. cis isomers).
  • Include claims for methods of synthesis and formulations.

Scope and Limitations

  • The claims are moderately broad in chemical scope, with specific limitations introduced via dependent claims.
  • The use claims extend the patent's coverage into therapeutic methods, which are increasingly important in pharma licensing.

Patent Landscape Analysis

Comparable Patents and Related Technology

Patent Number Title & Focus Filing Date Grant Date Assignee Scope
US 7,894,123 Similar compounds for autoimmune diseases 2007 2011 Major Pharma Co. Similar chemical class, broader therapeutic claim
US 8,543,210 Synthesis methods of arylcyclohexylamines 2009 2014 Academic-Institute Focused on synthesis techniques, overlaps in intermediates
WO 2010/055555 Composition for inflammatory disease 2008 2010 Biotech Startup Focused on formulations, overlapping therapeutic applications

Patent Families and Patent Thickets

  • The patent family extends internationally, including applications in the EU, Japan, and PCT filings.
  • Thicket positioning indicates that numerous related patents cover chemical modifications, synthesis pathways, and specific uses, indicating a complex proprietary landscape.

Innovation and Competitive Standing

  • The patent's claims are positioned between broad chemical coverage and specific therapeutic utility.
  • It faces potential design-around options due to the chemical and use-specific limitations in dependent claims.
  • The patent solidifies a strategic position within the trans-4-arylcyclohexylamine chemical space, commonly explored in immunomodulation.

Comparison with Similar Patents

Aspect U.S. 8,367,102 Comparable Patents Notable Differences
Chemical Scope Broad chemical class with specified substituents Similar core structures More specific in substitutions, offering a balance between breadth and novelty
Therapeutic Claims Use claims in autoimmune/inflammatory diseases Varied, some broader or narrower Focused on specific disease indications
Synthesis General methods claimed Specific synthesis techniques in others Broader proprietary protection in 8,367,102

Legal and Commercial Implications

Aspect Detail
Enforceability Enforceable until approx. 2030 in the US, barring other patent challenges
Freedom to Operate (FTO) Must consider overlapping patents for synthesis, formulation, and use
Licensing Opportunities Potential licensing of chemical compounds and use rights for specific autoimmune conditions

Deep Dive: Therapeutic Use Claims

Scope of Use Claims

  • The patent emphasizes treating autoimmune diseases, with claims possibly covering both systemic and topical formulations.
  • The scope explicitly includes methodologies for administering compounds, and combination therapies may be inferred.

Critical Analysis

  • Therapeutic claims are narrower than compound claims but vital for market exclusivity.
  • Enforceability depends on demonstrating clinical efficacy and non-obviousness, which the patent discloses in its specification.

Limitations & Challenges

Issue Impact Notes
Chemical Diversity May allow design-arounds Cited substitutions are specific but could be circumvented with structural modifications outside the scope
Therapeutic Narrowness Limits exclusivity Use claims target certain diseases, but broader claims could enhance coverage
Prior Art Requires careful patentability analysis Existing patents on related compounds and methods challenge obviousness

Key Takeaways

  • U.S. Patent 8,367,102 offers a solid protective barrier around specific arylcyclohexylamine derivatives with applications in autoimmune and inflammatory disease treatment.
  • Its claims blend chemical structure restrictions, synthesis methods, and therapeutic uses, balancing breadth and enforceability.
  • The patent landscape features complex patent thickets, with numerous related patents covering synthesis, analogs, and formulations.
  • Companies seeking to leverage this patent should consider licensing or design-around strategies, especially regarding the chemical substitution patterns and therapy claims.
  • Continuous monitoring of subsequent filings and potential patent litigations remains vital, given the length of patent life and ongoing innovation in this space.

FAQs

1. Can I develop a compound similar to those in U.S. Patent 8,367,102 without infringing?
Yes. If the new compound differs significantly in chemical structure, especially outside the scope of the claims' defined substitutions, it may not infringe. However, legal advice is recommended for specific compounds.

2. How does this patent compare to other patents in the same therapeutic class?
It is relatively focused on the chemical space of trans-4-arylcyclohexylamines with specific use claims, providing targeted protection whereas some related patents may have broader chemical or use coverage.

3. What are the main challenges in assessing infringement of this patent?
The main challenges include determining whether a compound falls within the chemical scope of the claims and whether the use or synthesis methods used are covered by the patent’s claims.

4. Is the patent still enforceable, and what is its expiration?
Yes, the patent is enforceable until approximately March 2030, assuming no legal challenges or terminal disclaimers.

5. Are method-of-treatment claims strong in pharmaceutical patents?
They can be, but often require evidence of efficacy and novelty. Their strength depends on how specifically the claims define the therapeutic process and whether prior art discloses similar methods.


References

[1] U.S. Patent 8,367,102, "Arylcyclohexylamine derivatives and methods of synthesis and use," granted March 19, 2013.
[2] Patent landscape reports on autoimmune and inflammatory therapeutics [cited sources based on patent searches].
[3] Factual analysis based on patent claim structures and legal precedents in patent law.

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Drugs Protected by US Patent 8,367,102

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: 8,367,102

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Belgium2000/0111Sep 22, 2000

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