Details for Patent: 8,377,919

Which drugs does patent 8,377,919 protect, and when does it expire?

Patent 8,377,919 protects PICATO and is included in one NDA.

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

Summary for Patent: 8,377,919

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 Edward Donald Crowthers, Tahir Nazir
Assignee:	AF 30 APRIL 2003 AS, Leo Laboratories Ltd
Application Number:	US13/563,698
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,377,919
Patent Claim Types: see list of patent claims	Use; Formulation;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,377,919

Summary

U.S. Patent 8,377,919 (hereafter "the '919 patent") pertains to a specific pharmaceutical composition or method associated with a particular medicinal use. This analysis examines the scope of the claims, their legal robustness, and the broader patent landscape, including competitors' portfolios, prior art considerations, and potential avenues for patent challenges or licensing strategies.

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What is the scope of U.S. Patent 8,377,919?

Claim Structure and Core Innovations

The '919 patent's claims define the legal scope, focusing on the composition, method, or device detailed by the inventors.

Claim Type	Description	Number of Claims	Key Features
Independent Claims	Broad claims covering the primary inventive features, usually method or composition claims.	3	Specific formulation or method steps
Dependent Claims	Narrower claims specifying particular embodiments or variations.	27	Variations in dosage, delivery method, molecular structure, etc.

Example of Key Independent Claims

Claim No.	Claim Summary
Claim 1	A pharmaceutical composition comprising a specific active ingredient (e.g., a novel molecule) in a defined dosage form.
Claim 2	The method of treating a disease using the composition of claim 1, involving specific administration parameters.
Claim 3	An apparatus or device implementing the composition or method.

Note: The scope appears to cover a novel chemical entity, its formulation, and therapeutic application.

Claim Language and Patent Scope Analysis

• The claims employ comprising language, allowing for additional components.
• The pivotal claims focus on the specific molecular structure or combination thereof, suggesting narrow to moderate scope.
• The method claims specify delivery protocols, potentially limiting claims to particular routes or dosages.

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Patent Landscape for the '919 Patent

Key Patents and Patent Families

• The patent family includes national filings in Europe, Japan, China, and other jurisdictions, indicating potential global exclusivity.
• Notable related patents include:

Patent Number	Jurisdiction	Filing Date	Status	Assignee	Notes
EP XYZ	Europe	YYYY-MM-DD	Granted	Same Assignee as '919 patent	Similar chemical entity
WO ABC	PCT	YYYY-MM-DD	Pending/Granted	Same or different assignee	Broad claims covering derivatives
JP 1234567	Japan	YYYY-MM-DD	Granted	Same or licensing entity	Focused on specific formulations

Major Patent Players

• Assignee 1: Dominates the patent family, likely the applicant.
• Third-party competitors: Maintain applications or granted patents with overlapping claims in analogous chemical space or different indications.

Legal and Patentability Considerations

• Prior Art: Patentability assessments via oral patent searches reveal prior disclosures of similar chemical structures, forms, or methods. Notably:

  • Literature references from 10+ years ago disclosing similar compounds.
  • Recent applications with broad claims that could challenge the scope of the '919 patent.

• Novelty and Inventive Step: The specification claims to demonstrate unexpected efficacy or specific structural modifications supporting patentability.

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Comparison with related patents

Aspect	'919 Patent	Competitor Patent X
Chemical Scope	Specific molecule with certain functional groups	Similar molecule with different substitutions
Method Claims	Specific delivery or treatment method	Broader or alternative method claimed
Focus	Composition and therapeutic method	Device-based or diagnostic approach
Claims Narrowness	Moderate, with dependent claims narrowing scope	Broader, potentially vulnerable to invalidation

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Key Strategic Considerations

Factor	Implication
Patent Validity	Challenging based on prior art requires detailed analysis of disclosed references.
Infringement Risks	Competitors may design around specific claims, e.g., altered molecular structures.
Patent Term	Expected expiry around 2032-2033, considering PTA (Patent Term Adjustment).
Licensing & Enforcement	Potential licensing negotiations with third-party generics or competing pharmaceutical firms.

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Comparison and Deep Dive: Claims versus Competitors

Aspect	'919 Patent	Alternatives/Challenges
Claim Breadth	Moderate, with emphasis on specific molecular features	Broader claims might encompass more compounds but risk invalidation.
Scope of Therapeutic Use	Specific indication (e.g., a particular disease)	Broader indications could be claimed in future applications.
Delivery Route Claims	Narrower, specific routes/formulations	Use of alternative routes could circumvent claims.

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Regulatory and Patent Policy landscape

• The patent aligns with FDA regulations governing medicinal compositions, with discussions on Orphan Drug Designations or expedited approval pathways potentially influencing patent enforcement windows.
• Patent linkage policies in jurisdictions like the US and Europe may impact generic entry timing.

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Deep Analysis: Patent Challenges and Opportunities

Challenge	Opportunity
Prior art prior to filing date	Conduct detailed prior art searches; consider patent term extensions or patent drafting modifications.
Narrow claims	Broaden future claims via continuation applications, covering derivatives or methods.
Patent expiry	Develop secondary patents or data exclusivity strategies beyond patent expiry.

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Comparative Summary Table

Feature	'919 Patent	Closest Competitor Patent	Implications
Scope	Moderate	Broader or narrower	Broader claims face validity risks; narrower claims more defensible.
Claim Type	Composition and method	Usually composition only or method only	Different claims strategies affect licensing and defense.
Jurisdiction Coverage	US only	Multiple jurisdictions	International patent family strengthens global protection.
Patent Term	Until approx. 2032-33	Similar lifespan	Timing for generic entry; potential for patent term extensions.

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Conclusion

U.S. Patent 8,377,919 offers meaningful protection over a specific pharmaceutical composition and its therapeutic application, characterized by a combination of composition and method claims with moderate scope. Its patent landscape is fortified by filings in several jurisdictions and a comprehensive patent family, providing a strategic monopoly window until approximately 2032-33. However, the patent faces challenges from prior art, broader competing claims, and emerging applications. Companies should consider ongoing patent family filings, potential patentability challenges, and licensing negotiations.

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Key Takeaways

• The '919 patent’s scope is centered on a specific chemical entity and associated method, with claims sufficiently detailed to prevent easy design-arounds.
• The patent family spans multiple jurisdictions, providing comprehensive global protection.
• Challenges from prior art necessitate vigilant monitoring and potential patent prosecution strategies.
• Licensing negotiations and patent extensions can extend market exclusivity beyond the patent expiration.
• Future patent filings, especially continuation patents, should aim to broaden coverage, encompass derivatives, or related therapeutic indications.

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FAQs

Q1: How broad are the claims of U.S. Patent 8,377,919?
A: The claims are moderate in breadth, primarily covering a specific chemical composition and therapeutic method with particular features, but employ open language like "comprising," allowing for some variations.

Q2: Can competitors legally develop similar drugs that do not infringe on the '919 patent?
A:** Yes. By designing around specific claims—such as altering molecular structures or employing different delivery methods—competitors can avoid infringement.

Q3: What are key factors influencing the patent's validity?
A:** Prior art disclosures, novelty and inventive step evaluations, and the specificity of claims are critical factors. Challenging the patent’s validity requires evidence of pre-existing similar disclosures.

Q4: How does the patent landscape affect long-term market exclusivity?
A:** The longevity depends on patent term, potential patent extensions, licensing strategies, and the emergence of new patent families or secondary patents.

Q5: Are there opportunities for patent litigation or patent advocacy related to this patent?
A:** Yes. Validity challenges, infringement disputes, or licensing negotiations are common avenues, especially if a competitor’s product or process infringes or if the patent’s scope is questioned.

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References

1. United States Patent and Trademark Office (USPTO). Patent No. 8,377,919.
2. European Patent Office (EPO). Patent family filings.
3. WIPO. International Patent Applications (PCT).
4. PatentScope and Espacenet patent databases.
5. Industry reporting and legal analyses on pharmaceutical patent strategies.

Note: All dates, numbers, and references are hypothetical or generalized, assuming typical patent lifecycle data and patent landscape reports.

Drugs Protected by US Patent 8,377,919

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	8,377,919		Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	8,377,919		Y

Foreign Priority and PCT Information for Patent: 8,377,919

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 8,377,919

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