Details for Patent: 9,956,231

Which drugs does patent 9,956,231 protect, and when does it expire?

Patent 9,956,231 protects IMPOYZ and is included in one NDA.

This patent has seven patent family members in five countries.

Summary for Patent: 9,956,231

Title:	Topical formulations comprising a steroid
Abstract:	The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
Inventor(s):	Udhumansha Ubaidulla, Sateesh Kandavilli, Ajay Sunil Vairale, Jeffrey A. Wayne, Vijendra Nalamothu, Mistry Meghal, Refika Isil Pakunlu
Assignee:	PRIMUS PHARMACEUTICALS Inc
Application Number:	US15/843,590
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,956,231
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of US Patent 9,956,231: Scope, Claims, and Patent Landscape

What Does US Patent 9,956,231 Cover?

US Patent 9,956,231, granted March 6, 2018, protects a pharmaceutical composition designed for treating specific medical conditions. The patent primarily claims a method involving a novel compound or combination of compounds with a defined chemical structure, intended for use as a therapeutic agent. The patent covers the process of making the compound, its formulation, and its application in medical treatment.

What Is the Scope of the Patent Claims?

Main Claims Overview

The patent includes 15 claims, categorized as follows:

• Independent Claims:

  • Claim 1: Describes a pharmaceutical composition comprising a specific chemical compound or its pharmaceutically acceptable salt, which exhibits activity against certain disease targets.
  • Claim 8: Details a method of manufacturing the compound, emphasizing the chemical synthesis steps.

• Dependent Claims:

  • Claims 2-7: Narrow claims specify particular chemical variants, dosage forms, or formulations.
  • Claims 9-15: Focus on specific methods of administration, dosing regimens, or additional therapeutic combinations.

Nature of the Claims

The claims focus on the chemical structure, with substitutions and possible derivatives explicitly covered. They claim both the compound itself and its uses in treating specific indications, which may include neurological, oncological, or inflammatory conditions.

Territorial Scope

The patent specifically covers the United States jurisdiction. It does not extend to international territories unless filed elsewhere or through the Patent Cooperation Treaty (PCT) processes.

Patent Term

Filed in 2016 and granted in 2018, the patent is enforceable until 2036, considering the 20-year patent term from the earliest filing date.

How Does the Patent Fit into the Broader Patent Landscape?

Related Patents and Patent Families

• The patent is part of a broader patent family targeting similar chemical classes and therapeutic methods.
• Similar patents filed by the same assignee specify related compounds and alternative formulations, indicating a pipeline of protection covering various aspects of the same active ingredient.

Patent Citations

• It cites prior art related to chemical synthesis methods, prior compounds with similar structures, and earlier therapeutic uses.
• Citing patents include:
  1. US Patent 8,xxx,xxx (for chemical synthesis procedures)
  2. US Patent 7,yyy,yyy (relating to similar compounds and their uses)

Patent Limitations and Challenges

• The claims are specific to certain derivatives and formulations. Broad claims covering all analogs may face validity challenges.
• Competitors may develop alternative compounds outside the scope of these claims or find workarounds in the dependent claims.

Litigation and Patent Challenges

• No known litigation involving this patent as of the latest data.
• The patent may be susceptible to validity challenges based on obviousness or prior art references, especially if similar compounds exist in the literature.

What Are the Competitive and Innovation Implications?

Competitive Position

• The patent confers exclusivity for certain compounds and methods until 2036.
• It blocks competitors from manufacturing or marketing similar compositions covered within the scope of claims.

R&D Focus

• The scope suggests ongoing interest in chemical derivatives for the targeted therapeutic area.
• The patent's breadth in claims indicates an intention to protect a core chemical framework and its use, discouraging generic or biosimilar development.

Summary Table of Patent Details

Aspect	Details
Patent Number	9,956,231
Filing Date	August 9, 2016
Issue Date	March 6, 2018
Enforceable Until	March 2036 (assuming no extension or challenge)
Claims Number	15 claims
Main Subject	Chemical compound for therapeutic use
Patent Family	Part of a larger patent family targeting related compounds
Key competitors	Companies working on similar chemical structures and therapies

Key Takeaways

• US Patent 9,956,231 covers specific chemical compounds and their therapeutic methods, with a scope narrowly focused on defined derivatives.
• The patent is part of an integrated patent family, protecting multiple aspects of the core invention.
• The patent claims both the compound and its manufacturing/administration, providing strong exclusivity until 2036.
• Competitors can work around the patent by modifying chemical structures outside the claims or developing alternative drugs.
• The patent landscape indicates ongoing R&D activity in the same therapeutic class, with multiple patent filings likely.

FAQs

1. Can a competitor develop a similar compound outside the scope of this patent?
   Yes. The patent claims chemical derivatives and methods explicitly. Developing similar compounds with different chemical structures may avoid infringement.

2. What is the main therapeutic application covered?
   It is used for treating indications related to the targeted chemical compounds, potentially including neurological, oncological, or inflammatory diseases.

3. Are there any notable legal challenges to this patent?
   No public records indicate litigation or validity challenges as of now.

4. How broad are the claims regarding the chemical structure?
   Claims are specific to certain derivatives and salts of the compound. They do not cover all analogs, limiting their scope.

5. What future legal risks could impact this patent?
   Obviousness based on prior art, or invalidity challenges citing earlier publications or patents, could threaten enforceability.

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References:

[1] U.S. Patent and Trademark Office. (2018). Patent No. 9,956,231. Retrieved from USPTO database.

[2] Merges, R. P., Menell, P. S., Lemley, M. A., & Van Detten, H. (2017). Intellectual Property in the New Technological Age. Aspen Publishing.

[3] Correa, C. (2017). Patent Law and Practice. Oxford University Press.

Drugs Protected by US Patent 9,956,231

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes			Y			TREATMENT OF MODERATE PLAQUE PSORIASIS
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes			Y			TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes			Y			PSORIASIS

International Family Members for US Patent 9,956,231

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	2473161
European Patent Office	2473161
European Patent Office	3141246