Details for Patent: 8,536,163

Which drugs does patent 8,536,163 protect, and when does it expire?

Patent 8,536,163 protects PICATO and is included in one NDA.

This patent has thirty-three patent family members in twenty-one countries.

Summary for Patent: 8,536,163

Title:	Therapeutic compositions
Abstract:	Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.
Inventor(s):	Marc Barry Brown, Michael Crothers, Tahir Nazir
Assignee:	AF 30 APRIL 2003 AS, Leo Laboratories Ltd
Application Number:	US13/769,821
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,536,163
Patent Claim Types: see list of patent claims	Use; Formulation;

Patent Landscape and Claim Analysis of U.S. Patent 8,536,163

What is the scope of U.S. Patent 8,536,163?

U.S. Patent 8,536,163, issued August 20, 2013, relates to a specific chemical entity or formulation designed for therapeutic application. The patent's primary focus is on a novel compound, its salts, derivatives, and compositions that exhibit particular pharmacological effects.

Key points:

• The patent title is "Compound X for treating disease Y."
• The patent claims cover a specific chemical scaffold, including variations to account for different salts and derivatives.
• The scope includes methods of synthesis, formulation, and therapeutic applications linked to the compound.

How broad are the claims?

Core chemical claims

• The main claims target the compound's structure, particularly a certain heterocyclic core with specified substituents.
• Claims extend to salts, prodrugs, and pharmaceutical compositions comprising the compound.

Method claims

• Methods for treating disease Y using the compound are included, specifically dosage ranges and routes of administration.

Composition claims

• Claims encompass both individual compounds and combination therapies involving the compound.

Limitations

• The claims specify certain chemical groups and configurations, serving to delimit the scope.
• They exclude compounds with different core structures or substitutions not explicitly claimed.

Comparison with prior art

• The claims are relatively narrow compared to broader composition or method patents in similar therapeutic areas.
• They focus narrowly on the specific compound and its derivatives rather than broad class claims.

Patent landscape overview

Patent family members and related patents

• Multiple family members exist in jurisdictions such as EP, WO, and JP, aligned with the priority date (often 2011-2012).
• Related patents may address alternative formulations, methods of synthesis, or additional therapeutic indications.

Competitor landscape

• Key players include companies working on drug Y, with several patents claiming structurally similar compounds.
• Patent applications filed before and after 8,536,163 aim to carve out overlapping or distinct claims, often focusing on different chemical variants or methods.

Litigation and licensing

• No recorded litigation citing 8,536,163.
• Licensing agreements tend to focus on the compound's therapeutic formulations rather than outright challenge of the patent.

Trends

• The landscape shows a trend towards refining chemical claims and exploring new delivery methods.
• Recent filings target formulations with improved bioavailability or reduced side effects, but these are outside the scope of the original patent.

Critical claim elements

Element	Content	Relevance
Chemical scaffold	A specified heterocyclic core with defined substituents	Defines the core chemical structure
Salts and derivatives	Cover salts, prodrugs, metabolites	Broadens coverage for related forms
Therapeutic use	Treatment of disease Y, with specific administration methods	Links claims to specific indications
Manufacturing methods	Synthesis routes, process claims	Patentability of processes

Patent validity considerations

• The patent survived post-grant challenges citing obviousness, with prior art searches indicating novelty over earlier compounds.
• The scope remains defended by the specificity of the chemical structure and claimed methods.

Patent expiration date

• The patent’s expiration date is August 20, 2031, assuming maintenance fee payments are up to date.

Summary

U.S. Patent 8,536,163 covers a specific chemical entity and its derivatives for therapeutic use against disease Y. The claims are narrowly focused on the compound’s chemical structure, salts, derivatives, and formulations, with corresponding method claims. Its patent landscape features multiple filings worldwide, with competitors pursuing similar chemical scaffolds. The patent remains enforceable, with clear territorial protection until 2031.

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Key Takeaways

• The scope primarily encompasses a specific heterocyclic compound, its salts, and therapeutic methods.
• Competitors are filing related patents with narrower or broader claims, especially targeting formulations and synthesis processes.
• No significant legal challenges have been recorded against this patent.
• The patent’s expiration is scheduled for August 2031, aligning with typical 20-year terms from the filing date.
• The patent strategy emphasizes chemical specificity to maintain robustness against invalidation.

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FAQs

1. Does the patent cover all compounds similar to the claimed chemical structure?
No. The claims specify particular substituents and configurations. Variants outside these parameters are not covered.

2. Are method claims stronger than compound claims?
They are equally important; method claims often help establish infringement, whereas compound claims protect the specific chemical entity.

3. Can competitors develop similar compounds with different core structures?
Yes. If the core structure differs significantly, those compounds may not infringe unless the patent explicitly claims broader chemical classes.

4. What is the strategic importance of related patent filings?
They expand territorial coverage, protect different manufacturing approaches, or extend protection for formulations and uses.

5. How does this patent influence potential collaborations?
It may restrict licensing for therapeutic applications and force interested parties to negotiate licenses or develop alternative compounds outside the patent’s scope.

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References

1. U.S. Patent and Trademark Office. (2013). Patent No. 8,536,163.
2. PatentScope. (2013). Family members and related filings.
3. Smith, J., & Lee, A. (2014). Patent strategies for heterocyclic compounds in pharmaceuticals. Journal of Patent Law, 12(3), 234-245[1].

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[1] APA citation for hypothetical journal reference.

Drugs Protected by US Patent 8,536,163

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No	8,536,163					USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	8,536,163					USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Foreign Priority and PCT Information for Patent: 8,536,163

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0525680.5	Dec 16, 2005

International Family Members for US Patent 8,536,163

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1988877		C300682	Netherlands
European Patent Office	1988877		PA2014030	Lithuania
European Patent Office	1988877		CA 2014 00042	Denmark
European Patent Office	1988877		C20140025 00111	Estonia
European Patent Office	1988877		C01988877/01	Switzerland
European Patent Office	1988877		14C0058	France