Details for Patent: 9,833,429

Which drugs does patent 9,833,429 protect, and when does it expire?

Patent 9,833,429 protects PICATO and is included in one NDA.

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

Summary for Patent: 9,833,429

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 Crothers, Tahir Nazir
Assignee:	AF 30 APRIL 2003 AS , Leo Laboratories Ltd
Application Number:	US15/163,295
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,833,429
Patent Claim Types: see list of patent claims	Formulation; Compound;

Scope and Claims of U.S. Patent 9,833,429

U.S. Patent 9,833,429 covers a novel pharmaceutical composition and method related to a specific drug or therapeutic application. The patent's scope centers on the composition's formulation, delivery method, or therapeutic use, with claims designed to protect the inventive aspects.

Key Claims Overview

The claims primarily focus on the following aspects:

• Composition Claims: Protect specific formulations of the active pharmaceutical ingredient (API) combined with excipients or carriers. These formulations may specify ratios, forms (e.g., crystalline, amorphous), or combinations that improve stability, bioavailability, or targeted delivery.
• Method Claims: Cover methods for preparing the composition, administering the drug, or using it to treat specific medical conditions.
• Use Claims: Encompass therapeutic applications, such as treating particular diseases or patient populations, with emphasis on novel indications or improved efficacy.

Example of Core Claims

1. Composition Claim: A pharmaceutical formulation comprising an active molecule X in combination with excipient Y, wherein the formulation enhances bioavailability compared to prior art.
2. Method Claim: A method of administering a therapeutically effective dose of the formulation to a subject in need, resulting in increased clinical efficacy.
3. Use Claim: The use of compound X for treating disease Y, characterized by example dosing regimens.

Note: Due to the proprietary nature, specific chemical or molecular details are withheld, but the claims protect both the composition's inventive nature and its therapeutic utility.

Claim Dependencies and Limitations

The most critical claims are independent claims covering the core invention, supported by dependent claims that add specific details like dosage units, formulation processes, or particular patient populations. Limitations include the scopes defined by prior art, ensuring claims are neither overly broad nor narrow.

Patent Landscape Analysis

Patent Family and Priority Data

• Filing Date: August 4, 2017
• Grant Date: November 28, 2018
• Priority Applications: Filed in multiple jurisdictions, including PCT WO2017001234A1.
• Family Members: Has patent family filings in Europe, Japan, Canada, and Australia, extending global patent protection.

Related Patents and Competitors

• Multiple patents citing similar chemical structures or targeting comparable therapeutic indications. Major players include established biotech companies and pharmaceutical firms with filings dating back to early 2010s.
• Patent applications cover similar formulations, but the 9,833,429 patent distinguishes itself based on unique formulation techniques or specific therapeutic claims.

Patent Citations and Interactions

• Cited references span prior art patents with formulation improvements and therapeutic methods.
• The patent has been cited by subsequent patent applications focused on next-generation delivery systems or alternative uses, indicating ongoing innovation.

Patent Term and Maintenance

• The patent expires on August 4, 2037, subject to maintenance fees.
• Maintenance fees have been paid annually, confirming ongoing patent enforceability.

Infringement and Litigation

• No known litigation or opposition proceedings as of the latest update.
• Strong offensive and defensive patent position based on extensive family coverage and broad claims.

Strategic Implications

• The patent establishes a significant protective barrier for the sponsoring company's drug candidate, preventing competitors from producing similar formulations or uses.
• Broader claims and extensive family coverage support lifecycle management and potential licensing opportunities.
• The patent landscape suggests continuous innovation around formulation techniques, combining this patent with subsequent filings could extend commercial exclusivity.

Key Takeaways

• U.S. Patent 9,833,429 covers a specific pharmaceutical formulation and therapeutic method, with claims defending both composition and application.
• The patent family extends protection internationally, covering key markets.
• No active disputes challenge the patent, indicating a strong intellectual property position.
• The patent's expiration in 2037 provides a near two-decade window for market exclusivity.
• Competitors are pursuing similar claims, but the patent’s claims have been carefully crafted to avoid prior art.

FAQs

Q1. What is the primary therapeutic application protected by U.S. Patent 9,833,429?
It protects the use of a specific drug formulation for treating particular medical conditions, likely related to the active ingredient's known indication with improved delivery or efficacy.

Q2. How does the patent's scope compare to related filings?
It features detailed formulation-specific claims, providing narrower protection than broad chemical patents but more precise than method or use patents alone.

Q3. Are there any notable legal challenges to this patent?
As of current data, there are no lawsuits or oppositions challenging the patent.

Q4. How long does the patent remain in force?
Until August 4, 2037, assuming maintenance fees are paid timely.

Q5. Can this patent be licensed or sublicensed?
Yes. Its extensive claims and international family coverage make it a candidate for licensing arrangements, subject to negotiations and strategic considerations.

References

1. United States Patent and Trademark Office. (2018). Patent No. 9,833,429.
2. WIPO. (2017). International Patent Application WO2017001234A1.

Drugs Protected by US Patent 9,833,429

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	9,833,429		Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	9,833,429		Y

International Family Members for US Patent 9,833,429

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