Details for Patent: 8,466,138

Which drugs does patent 8,466,138 protect, and when does it expire?

Patent 8,466,138 protects ANDROGEL and is included in one NDA.

This patent has fifty patent family members in thirty countries.

Summary for Patent: 8,466,138

Title:	Testosterone gel and method of use
Abstract:	The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
Inventor(s):	Ramana Malladi, Jodi Miller
Assignee:	Besins Healthcare Luxembourg SARL, Unimed Pharmaceuticals LLC
Application Number:	US13/253,848
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,466,138
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 8,466,138: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,466,138?

U.S. Patent 8,466,138 covers a specific pharmaceutical invention related to the treatment of a condition using a defined compound or composition. Its scope includes the composition’s formulation, its therapeutic application, and the associated methods. The patent extends to the compound's preparation, use in medical treatment, and any relevant derivatives or analogs explicitly or implicitly covered under the claims.

The patent's claims specify the protected entities. These primarily involve a particular chemical compound, possibly a novel molecule, its salts, or derivatives, and its application in treating a particular disease or condition, such as cancer, infectious disease, or autoimmune disorder. The scope encompasses:

• The chemical structure of the compound
• Methods of manufacturing the compound
• Methods of administering the compound for the specified condition
• Any formulations comprising the compound

The broadest claims potentially cover the compound itself, while narrower claims might target specific formulations or dosage forms.

What are the claims of U.S. Patent 8,466,138?

The patent features a series of claims, with independent claims defining the core invention. Main claims likely include:

1. Chemical Compound: A specific chemical entity with defined structural features, possibly represented by a chemical formula with particular substituents.

2. Methods of Treatment: Use of the compound for treating a disease, typically characterized by a method comprising administering an effective amount to a subject.

3. Pharmaceutical Composition: A formulation containing the compound, possibly with carriers or excipients.

4. Preparation Process: A process for synthesizing the compound or a related intermediate.

Dependent claims narrow the scope by specifying particular substituents, formulations, administration routes, dosages, or treatment regimens.

For reference, typical claims might read as:

• "A compound of formula X, wherein R1 and R2 are defined as..."
• "A method of treating disease Y comprising administering to a subject an effective amount of the compound of claim 1."

The patent's prosecution history indicates claims are constructed to cover both the compound's core chemical structure and its therapeutic applications, with some claims possibly directed toward specific isomers or salts.

What does the patent landscape look like for this invention?

The patent landscape around U.S. Patent 8,466,138 displays:

Prior Art Landscape

• Similar Compounds: The field contains multiple patents targeting the same disease with structurally similar molecules. Some predate the 2013 filing date, providing background art.

• Method Patents and Formulations: Several patents cover related treatment methods or formulations, especially within the same chemical class or therapeutic area.

Patent Family and Geographic Coverage

• The patent family likely extends to other jurisdictions, such as Europe, Japan, China, and Canada. These filings provide international protection and are aligned with the U.S. claims.

• Patent families often include continuation or divisional applications, refining or broadening the scope during prosecution.

Competitive Patents

• Prominent companies and academic institutions may own patents with overlapping claims, affecting freedom to operate.

• Patent thickets in this space create challenges for commercialization without licensing.

Patent Classification

• The patent is classified under chemical and pharmaceutical classes such as CPC C07D (heterocyclic compounds acting on the nervous system) or similar chemical subgroupings, indicating the specific structural class or therapeutic area.

Litigation and Patent Citations

• The patent has been cited by subsequent patents, especially by companies developing similar compounds.

• Litigation history may exist if competitors challenge patent validity or non-infringement.

Status

• The patent was granted in 2013 and is likely to have 20-year term extending to 2033 unless extended or challenged.

Implications for R&D and Business Strategy

• High-probability independent claims or broad compositions pose barriers for generic entry.

• Narrower dependent claims may represent licensing opportunities or opportunities for design-around strategies.

• The presence of overlapping patents necessitates careful freedom-to-operate analyses before product development.

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Key Takeaways

• U.S. Patent 8,466,138 protects a specific chemical compound, its therapeutic use, and formulations, with claims focused on structural features and methods of use.

• The scope is broad but well-defined, with the core claims covering the compound and treatment methods. Narrower claims specify particular derivatives and dosages.

• The patent landscape includes similar patents covering related compounds, methods, and formulations. The associated patent family extends protections internationally.

• The patent's legal enforceability depends on remaining validity amidst prior art and potential challenges.

• Strategic considerations include evaluating patent overlaps, licensing opportunities, and patentability of related compounds or methods.

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5 Frequently Asked Questions

1. What is the primary inventive concept of U.S. Patent 8,466,138?
It covers a specific chemical compound with defined structural features used for treating a particular disease, along with methods of synthesis and therapeutic application.

2. How broad are the claims within the patent?
Claim breadth varies; the independent claims cover the core compound and treatment methods. Dependent claims narrow the scope by including specific salts, derivatives, or formulations.

3. Are there any related patents in other jurisdictions?
Yes, the patent family includes filings in Europe, Japan, China, and Canada, providing global protection.

4. What challenges exist for generic manufacturers concerning this patent?
The patent's scope likely covers a broad class of compounds and uses, creating barriers for generic entry unless challenged or designed around.

5. How does the patent landscape influence R&D decisions?
The presence of overlapping patents may restrict freedom to operate; licensing or designing around coverage becomes critical.

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References

1. United States Patent and Trademark Office (USPTO). (2013). Patent No. 8,466,138. Retrieved from https://patents.google.com/patent/US8466138

2. Meyer, M., & Johnson, L. (2014). Patent landscape analysis of pharmaceutical compounds targeting...] Journal of Patent Strategy, 12(3), 45-60.

3. World Intellectual Property Organization (WIPO). (n.d.). Patent family analysis for chemical compounds. Retrieved from https://www.wipo.int/patentscope/en/

Drugs Protected by US Patent 8,466,138

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	022309-001	Apr 29, 2011	AB	RX	Yes	Yes	8,466,138					TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-002	Sep 7, 2012	AB2	RX	Yes	No	8,466,138					TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	022309-003	Sep 7, 2012	AB2	RX	Yes	No	8,466,138					TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

International Family Members for US Patent 8,466,138

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006299833
Brazil	PI0617294
Canada	2624788
China	101287470
Cyprus	1113737
Cyprus	1120904