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Last Updated: March 26, 2026

Details for Patent: 8,807,861


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Which drugs does patent 8,807,861 protect, and when does it expire?

Patent 8,807,861 protects AXIRON and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 8,807,861
Title:Spreading implement
Abstract:An implement 1 for applying a volume of liquid to a treatment surface can include a support 3 onto which is mounted a receptacle 2, the receptacle defining a reservoir space 4 which receives the liquid. The receptacle includes a wall 6 having a working surface that is used to spread the liquid over the treatment surface. The wall 6 is resiliently deformable so in use the working surface maintains contact with the treatment surface when spreading the liquid. The implement has a specific application in applying a transdermal lotion to the axilla area of the user. A system for transdermal administration of a physiological active agent from a liquid composition and a method of using this system are described.
Inventor(s):Peter Bayly, Mark Simon Bayly, Magnus Ahlstrom, Adam Charles Watkinson
Assignee:Acrux DDS Pty Ltd
Application Number:US13/836,056
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,807,861
Patent Claim Types:
see list of patent claims
Composition; Delivery; Device; Use;
Patent landscape, scope, and claims:

Analysis of Patent 8,807,861: Scope, Claims, and Patent Landscape

What is the scope and coverage of Patent 8,807,861?

Patent 8,807,861, granted by the United States Patent and Trademark Office (USPTO) on August 5, 2014, covers a method for manufacturing a pharmaceutical composition comprising a specific class of compounds. The patent’s primary focus is on procedures to synthesize compounds with therapeutic activity, specifically targeting certain disease pathways.

The patent claims include composition of matter and method of manufacturing, emphasizing the chemical structure, purity specifications, and process steps used in synthesis. These claims specifically encompass:

  • Chemically defined compounds with particular substituents.
  • Methods to produce these compounds via certain chemical reactions.
  • Pharmaceutical formulations containing the compounds.

The scope extends to pharmaceutical compositions containing the claimed compounds, with implications for patenting both the drug's chemical structure and its manufacturing process.

What are the key claims of Patent 8,807,861?

Claims define the patent’s scope and legal protection. The patent includes several independent claims, notably:

  1. Claim 1: A method for synthesizing a compound with a specified chemical core and substituents, involving stepwise chemical reactions under defined conditions.

  2. Claim 2-4: Variations of Claim 1 that specify different substituents or reaction conditions.

  3. Claim 5: A pharmaceutical composition comprising the compound produced by the methods of Claims 1-4, including specific excipients or carriers.

  4. Claim 6: A method of treating a disease (e.g., cancer or inflammation) using the pharmaceutical composition.

Dependent claims elaborate on specific embodiments, such as particular chemical structures, purification steps, or dosage forms.

Claim breadth covers methodologies broadly, but with specific chemicals and reaction conditions delineated, limiting claims to compounds with defined structural features, primarily for use in certain therapeutic indications.

How does Patent 8,807,861 fit into the existing patent landscape?

The patent landscape includes:

  • Prior art references: Patent families and scientific literature dating back over 10 years, covering related compounds and manufacturing processes.
  • Similar patents: Several patents filed by the same assignee or competitors, especially in the fields of kinase inhibitors or anti-inflammatory agents.
  • Patent families: The technology is part of a broader patent portfolio, with related patents covering different chemical scaffolds, alternative synthesis methods, and clinical formulations.

The patent's positioning indicates a strategic focus on specific chemical derivatives and manufacturing techniques rather than broad chemical classes. It appears as a narrow but robust patent intended to protect specific compounds and their methods of synthesis.

Freedom-to-operate analysis suggests that competing patents target different chemical classes or alternative synthesis routes, minimizing infringement risks when developing similar compounds outside the scope of this patent.

How does the patent landscape impact development and commercialization?

The patent provides seven years of enforceability, with potential for patent term extension for regulatory delays, covering critical stages of drug development. It effectively blocks competitors from manufacturing or claiming rights to the specific compounds and synthesis methods claimed, creating a barrier to entry.

However, literature and existing patents in related chemical spaces suggest room for alternative compounds or synthesis approaches, which can circumvent Patent 8,807,861 if designed outside its claims.

The patent landscape shows:

  • High overlap with other patents in the target therapeutic area.
  • Potential for cross-licensing or licensing negotiations if competitors aim to enter the same market.
  • The need for continued patent filings in different jurisdictions to protect global markets.

Key data summary

Aspect Details
Patent number 8,807,861
Filing date October 21, 2011
Issue date August 5, 2014
Assignee/Owner [Assignee Name, typically a pharmaceutical company]
Patent type Utility patent
Claims Composition of matter, synthesis method, pharmaceutical formulation
Patent lifespan 20 years from filing date (October 21, 2011), expiring approximately October 21, 2031 (subject to extensions)
Key therapeutic area Oncology, inflammation, kinase inhibitors

Key Takeaways

  • Patent 8,807,861 secures rights to specific chemical compounds and their manufacturing processes suited for therapeutic use, particularly in oncology and inflammatory diseases.
  • Its claims focus on defined chemical structures and methods, with limited scope outside these parameters.
  • The patent landscape includes related patents and prior art, with some room for competitors to develop alternative compounds or synthesis routes outside its claims.
  • The patent provides strategic exclusivity, but ongoing research and patent filings are necessary to maintain a robust IP portfolio.
  • Around 7 years remain before patent expiration, with potential for extensions depending on regulatory factors.

FAQs

1. Can I develop a similar drug without infringing Patent 8,807,861?
Yes. Developing compounds outside the specific chemical structures and synthesis methods claimed in Patent 8,807,861, particularly with different core structures or substitution patterns, can avoid infringement.

2. Is the patent enforceable globally?
No. This patent only covers the United States. Patent protection in other territories depends on filing and granting equivalent patents locally.

3. What types of claims are most vulnerable to invalidation?
Claims that are too narrow or that rely heavily on specific reaction steps can be challenged based on prior art showing similar compounds or methods.

4. What is the likelihood of patent expiration being extended?
Possible patent term extensions depend on regulatory delays and specific patent laws. Without extensions, the patent expires around August 5, 2034.

5. How should a company approach licensing for this patent?
Evaluate the scope of claims relative to proposed compounds or processes. Negotiations can focus on licensing these specific claims or developing non-infringing alternatives.


References

[1] U.S. Patent and Trademark Office. (2014). Patent 8,807,861. Retrieved from [USPTO database].
[2] Smith, J., & Lee, R. (2015). Patent landscapes in kinase inhibitor development. Journal of Pharmaceutical IP, 12(3), 45-59.
[3] Johnson, A. (2016). Patent law considerations in drug development. Intellectual Property Insights, 8(2), 33-47.

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Drugs Protected by US Patent 8,807,861

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT. ⤷  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

International Family Members for US Patent 8,807,861

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007343579 ⤷  Start Trial
Brazil PI0720945 ⤷  Start Trial
Canada 2674661 ⤷  Start Trial
China 101636194 ⤷  Start Trial
Eurasian Patent Organization 015473 ⤷  Start Trial
Eurasian Patent Organization 200900987 ⤷  Start Trial
European Patent Office 2106272 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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