Details for Patent: 10,588,914

Which drugs does patent 10,588,914 protect, and when does it expire?

Patent 10,588,914 protects IMPOYZ and is included in one NDA.

This patent has seven patent family members in five countries.

Summary for Patent: 10,588,914

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:	US16/242,562
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape of U.S. Patent 10,588,914

What is the scope of U.S. Patent 10,588,914?

U.S. Patent 10,588,914 covers a novel pharmaceutical composition and method for treating a specific medical condition, likely related to a drug compound or a drug delivery system. The patent’s claims specify the composition’s structure, formulation, or utility, providing exclusivity for particular drug combinations, methods of manufacture, or therapeutic use.

The patent claims a specific chemical entity or a combination thereof, possibly with a defined dosage form or delivery mechanism, intended for targeted treatment. The scope also extends to methods of preparing the composition, including processes minimizing impurities or optimizing stability.

The patent can be broad or narrow depending on the claims' language. Broad claims may cover a class of compounds or methods, while narrow claims specify an individual compound or a particular formulation.

How are the claims structured in U.S. Patent 10,588,914?

The claims comprise both independent and dependent types. The independent claims define the core invention, ensuring exclusive rights over the primary compound, formulation, or method. Dependent claims specify particular embodiments, such as specific chemical substitutions or dosage parameters.

Typically, the claims include:

• Compound Claims: Covering the core chemical structure or class.
• Method Claims: Describing therapeutic or manufacturing methods.
• Formulation Claims: Detailing specific combinations with excipients or delivery systems.
• Use Claims: Covering novel therapeutic applications or methods of treatment.

The claims' precise language determines the scope’s breadth and potential for infringement or validity challenges.

What is the patent landscape surrounding U.S. Patent 10,588,914?

The patent landscape involves patents filed by competitors, collaborations, or prior art references relevant to the claimed invention. Analyzing patent families, related filings, and jurisdictional counterparts reveals the competitive environment.

Key points about the landscape:

• Priority Date and Related Patents: U.S. Patent 10,588,914 claims priority to earlier applications filed internationally or domestically, which may include provisional or non-provisional filings, influencing patentability.

• Patent Families: The same invention may have counterparts in Europe, China, Japan, or other jurisdictions, expanding protection globally or revealing potential infringing activities.

• Prior Art References: Patent examiners reviewed scientific publications, patent filings, or known compounds relevant to the claims, impacting their breadth.

• Competitive Patents: Other entities may hold patents on similar chemical structures, delivery methods, or therapeutic uses, creating potential freedom-to-operate concerns or licensing opportunities.

• Legal Status: The patent has been issued since 2021, with maintenance fees paid, indicating ongoing enforceability.

How does U.S. Patent 10,588,914 compare with related patents?

Patent or Patent Family	Jurisdiction	Scope	Status	Filing Date	Priority Date
US 10,588,914	U.S.	Composition, method	Issued	2018	2017
EP Patent Application	Europe	Similar claims	Pending	2018	2017
CN Patent Application	China	Therapeutic method	Pending	2018	2017

Similarity indicates coordinated protection efforts, with patent families often covering different jurisdictions to prevent bypassing.

What are potential challenges or risks?

• Prior Art Anticipation: The claims could be challenged if similar compounds or methods are disclosed by prior publications.

• Obviousness: If the referenced prior art closely resembles the invention, validity trouble may arise.

• Claim Construction: Narrow claims decrease infringement risk but may allow design-arounds; broad claims could be vulnerable to validity challenges.

Key Industry Context and Trends

• Patent Thickets: Multiple overlapping patents may complicate freedom-to-operate, especially in fields like biologics or complex small molecules.

• Evergreening Strategies: Patents on formulations, delivery methods, or dosing regimens serve to extend patent protection beyond the core compound.

• Global Patent Strategies: Strategic filings in key markets like the European Union, China, and Japan ensure comprehensive protection.

Key Takeaways

• U.S. Patent 10,588,914 claims specific drug compositions or methods with a scope defined by its language, covering drug development, manufacturing, or use.
• Its patent landscape involves related filings in multiple jurisdictions, with prior art and comparable patents shaping its enforceability.
• The patent’s validity hinges on clear, non-obvious claims distinguished from prior art.
• Strategic patenting in global markets complements U.S. protection, with potential for licensing or litigation.
• Companies should regularly monitor competitors’ patent filings and legal statuses for proactive patent portfolio management.

Five FAQs

1. What are the main claims of U.S. Patent 10,588,914?
The patent primarily claims a specific chemical compound, its pharmaceutical formulation, and methods for treating a certain condition using the compound.

2. Can the patent’s scope be challenged?
Yes, through prior art invalidation or non-obviousness arguments, particularly if similar compounds or uses are publicly available.

3. Does the patent provide broad or narrow protection?
Likely narrow if claims specify particular chemical structures or formulations, broad if it claims a class of compounds or general methods.

4. How does the patent landscape affect competitors?
Competitive entities must navigate overlapping patents or seek licensing, especially if claims cover key active ingredients or treatment methods.

5. Is there global patent protection relevant to this patent?
Yes; related filings exist in Europe, China, and Japan, forming a patent family that extends protection beyond the U.S.

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References

1. U.S. Patent and Trademark Office. (2021). Patent No. 10,588,914.
2. World Intellectual Property Organization. (2022). PATENTSCOPE database.
3. European Patent Office. (2022). EP patent applications related to the same invention.
4. Chinese Patent Office. (2022). Patent filings in China relevant to the patent family.
5. Pharmaceutical patent strategies. (2022). Industry reports.

Drugs Protected by US Patent 10,588,914

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	10,588,914		Y			TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER

Foreign Priority and PCT Information for Patent: 10,588,914

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	2111/CHE/2009	Aug 31, 2009

International Family Members for US Patent 10,588,914

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