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):	Brown; Marc Barry (Watford, GB), Crothers; Michael Edward Donald (Hillsborough, GB), Nazir; Tahir (Middlesex, GB)
Assignee:	LEO Laboratories Limited (Dublin, IE)
Application Number:	15/163,295
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;

United States Patent 9,833,429: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 9,833,429, titled "Therapeutic Compositions," is a significant patent in the pharmaceutical sector, particularly related to the formulation and use of ingenol angelate, a potent anticancer agent. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The patent was issued on December 5, 2017, to LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc. (collectively, "LEO")[2].

Patent Scope

The scope of the patent is defined by its claims, which outline the specific inventions and innovations protected under the patent.

Claim Structure

The patent includes multiple claims, with independent claims setting the broad scope and dependent claims adding specific limitations. For example, independent claim 1 of the '428 patent, which is closely related to the '429 patent, requires the dissolution of ingenol angelate in a pharmaceutically acceptable solvent. Dependent claims, such as claim 8 of the '428 patent, add further limitations, including the incorporation of a penetration enhancer[1].

Key Components

• Ingenol Angelate: The patent focuses on the stabilization and formulation of ingenol angelate, an anticancer agent. It specifies the use of an aprotic solvent and an acidic buffer to stabilize this compound[5].
• Solvents and Penetration Enhancers: The patent allows for substances to serve as both penetration enhancers and solvents, provided they can satisfy both functions. This is evident from the specification which identifies substances like propylene glycol and DMSO as serving both roles[1].

Claim Interpretation

The interpretation of patent claims is crucial for understanding the scope of protection.

Claim Language

The claim language must be interpreted in the context of the specification. The Federal Circuit has emphasized that the specification may reveal special definitions given to claim terms by the patentee, which can differ from their ordinary meaning. However, the claims will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope[1].

Doctrine of Claim Differentiation

The doctrine of claim differentiation states that dependent claims are presumed to be narrower than the independent claims from which they depend. In the case of the '428 and '429 patents, dependent claims add specific limitations, such as the inclusion of a penetration enhancer, without restricting the broader scope of the independent claims[1].

Patent Landscape

The '429 patent is part of a larger patent portfolio related to therapeutic compositions, particularly those involving ingenol angelate.

Related Patents

LEO Pharma holds several patents related to ingenol angelate formulations, including U.S. Patent Nos. 9,820,959, 9,833,428, and 9,833,429. These patents collectively cover various aspects of the formulation, stabilization, and use of ingenol angelate[2].

Litigation

The '429 patent has been involved in patent infringement litigation. LEO Pharma has filed complaints against Actavis Laboratories UT, Inc., and Perrigo UK Finco Limited Partnership, alleging infringement of several patents, including the '429 patent. These cases highlight the importance of these patents in protecting LEO Pharma's intellectual property[2].

Jurisdiction and Venue

The patent infringement actions related to the '429 patent are governed by the patent laws of the United States, specifically under 35 U.S.C. § 271(a), (b), (c), (e), and (g). The jurisdiction and venue for these cases are typically in the District Courts, such as the District of Delaware, due to the defendants' corporate organization and the location of the plaintiffs[2].

Expiration and Maintenance

The '429 patent, along with related patents like the '959 and '428 patents, is set to expire on December 18, 2026. The maintenance of these patents involves periodic payments to the USPTO to keep the patents in force[2].

Metrics for Patent Scope

Research on patent scope often uses metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of patent claims. Narrower claims, as seen in the examination process, are associated with a higher probability of grant and a shorter examination process[3].

Global Dossier and Public Search Facilities

For stakeholders interested in the '429 patent, the USPTO's Global Dossier and Public Search Facility provide valuable resources. These services allow users to access file histories, patent families, and other relevant documentation, facilitating a comprehensive understanding of the patent landscape[4].

Key Takeaways

• Scope and Claims: The '429 patent protects specific formulations of ingenol angelate, including the use of aprotic solvents and acidic buffers.
• Interpretation: Claims are interpreted in the context of the specification, with dependent claims presumed to be narrower.
• Related Patents: The '429 patent is part of a broader portfolio related to ingenol angelate formulations.
• Litigation: The patent has been involved in infringement litigation, highlighting its importance in protecting LEO Pharma's IP.
• Jurisdiction and Expiration: The patent is governed by U.S. patent laws and is set to expire on December 18, 2026.

FAQs

What is the main subject of the United States Patent 9,833,429?

The main subject of the patent is the formulation and stabilization of ingenol angelate, a potent anticancer agent, using specific solvents and buffers.

Which companies are involved in the litigation related to this patent?

LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc. are the plaintiffs, while Actavis Laboratories UT, Inc., and Perrigo UK Finco Limited Partnership are the defendants.

What is the significance of the doctrine of claim differentiation in this patent?

The doctrine ensures that dependent claims are presumed to be narrower than the independent claims, which helps in defining the scope of protection without restricting the broader claims unnecessarily.

How can one access detailed information about this patent?

Detailed information can be accessed through the USPTO's Global Dossier and Public Search Facility, which provide file histories, patent families, and other relevant documentation.

When is the '429 patent set to expire?

The '429 patent is set to expire on December 18, 2026.

Sources

1. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - LEO Laboratories Limited ("LEO Labs"), and LEO Pharma, Inc. ("LEO, Inc.") against defendants Actavis Laboratories UT, Inc. and Actavis, Inc.[1]
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - LEO Pharma A/S, LEO Laboratories Limited, and LEO Pharma, Inc. against Actavis Laboratories UT, Inc.[2]
3. Patent Claims and Patent Scope - SSRN paper exploring metrics for measuring patent scope[3]
4. USPTO Public Search Facility - Resources for searching and accessing patent information[4]
5. Unified Patents - Detailed information on the '8716271-B2 patent related to therapeutic compositions[5]

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			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			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
European Patent Office	1988877		14C0058	France
European Patent Office	1988877		300682	Netherlands