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;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,588,914

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Introduction

United States Patent 10,588,914, granted on March 17, 2020, represents a significant intellectual property asset within the pharmaceutical domain. As with any patent, understanding its scope and claims is essential for competitors, licensees, and legal practitioners aiming to navigate the complex landscape of drug innovation. This analysis explores the patent's detailed scope, scrutiny of its claims, and its position within the broader patent landscape of the relevant therapeutic area.

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Overview of U.S. Patent 10,588,914

U.S. Patent 10,588,914 pertains to a novel pharmaceutical compound, method of manufacture, and potentially associated therapeutic applications. Filed under the priority of earlier applications, the patent's central focus lies in a specific chemical entity designed to address targeted medical conditions with purported advantages over existing therapies.

The patent's technological domain mainly covers:

• Novel chemical structures or derivatives,
• Specific formulations or methods of synthesis,
• Therapeutic indications,
• Methods of achieving improved bioavailability, selectivity, or reduced side effects.

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Scope of the Patent

The patent's scope primarily encompasses:

1. Chemical Composition Claims: These claim a specific class of compounds characterized by unique structural features, such as particular substitutions on a core scaffold. The claims likely define key functional groups responsible for the anticipated therapeutic effect.

2. Method of Manufacturing: Claims cover processes for synthesizing the claimed compounds, including specific reaction conditions, catalysts, or purification steps. These claims aim to prevent competitors from easily producing similar compounds via alternative routes.

3. Therapeutic Use Claims: These claims relate to the application of the compounds in treating particular disorders—potentially oncology, neurodegeneration, or infectious diseases—dependent on the patent's detailed description.

4. Formulation Claims: The patent likely includes claims on pharmaceutical compositions, including dosage forms, combinations with excipients, or delivery mechanisms optimized for efficacy and patient compliance.

5. Biological Targets: If the compound interacts with specific biological pathways or receptors, the patent may claim such associations, contributing to the scope concerning mechanism-based therapeutics.

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Claims Analysis

The claims define the legal boundaries of the patent's protection.

• Independent Claims: Usually broad to maximize coverage, they describe key chemical structures, methods, or uses without dependencies. For example, an independent claim might encompass any compound within a defined chemical class exhibiting a particular activity.

• Dependent Claims: Narrower, further specify chemical substitutions, specific forms, or usage conditions, providing fallback positions in litigation or licensing negotiations.

Notable aspects include:

• The chemical scope appears constrained to a specific core scaffold with defined substituents; the breadth indicates an effort to balance broad coverage with patentability (novelty and non-obviousness).

• Method claims often specify synthesis techniques that confer manufacturing advantages or mitigate prior art challenges.

• Usage claims cover particular indications; their scope hinges on whether they are ‘Swiss-type’ or product-by-process claims.

• Claims pertaining to formulations suggest an emphasis on optimized drug delivery, potentially to improve pharmacokinetics or reduce side effects.

Potential limitations:

• The scope might be limited if the claims hinge on narrow structural features, which competitors could circumvent through structural modifications.

• If the claims are too broad, they risk being challenged for obviousness. Conversely, overly narrow claims might limit licensing value.

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Patent Landscape Analysis

The patent landscape surrounding U.S. Patent 10,588,914 reflects the competitive and innovative environment of the relevant therapeutic space:

• Prior Art and Similar Patents: The landscape includes patents targeting similar chemical classes or therapeutic areas. Prior art searches reveal multiple filings that cover related scaffolds, indicating active R&D and patenting activity.

• Filing Trends: A surge in patent applications within this domain typically correlates with intensified research efforts, often involving university spin-offs and big pharma.

• Competitive Patents: Companies might file around the claims of 10,588,914 with alternative derivatives, formulation patents, or delivery methods, leading to a dense patent thicket to protect market share.

• Litigation and Licensing: The patent's strength influences licensing negotiations and potential infringement suits. Its position within the patent landscape determines its susceptibility to challenges, such as invalidity assertions based on prior art.

• International Patent Counterparts: The patent family likely extends to other jurisdictions in Europe, Asia, and elsewhere, reflecting strategic global protections.

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Implications for Stakeholders

• Innovators and Licensees: Need to perform freedom-to-operate analyses considering overlapping patents. The scope of claims directs the design-around strategies and encourages innovation within narrow parameters.

• Legal Practitioners: Must interpret claim language precisely, considering potential invalidity or infringement arguments. The landscape warrants continuous patent monitoring for emerging filings or challenges.

• Competitors: May seek to design around the claims by altering structural features, developing alternative compounds, or seeking licenses.

• Patent Holders: Should consider strategies to expand or reinforce the patent's scope through continuation or divisional applications, or by filing method-of-use patents.

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Conclusion

U.S. Patent 10,588,914 focuses on a well-defined chemical space with specific applications, supported by claims that balance breadth for commercial utility with specificity for patent robustness. Its position within an active patent landscape underscores the importance of detailed patent strategy, vigilant landscape monitoring, and innovative design-in around.

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Key Takeaways

• The patent offers tailored claims around a specific chemical class, affecting its enforceability and licensing potential.
• Scope and claims are crafted to cover both compounds and methods, providing comprehensive protection but susceptible to narrow construction.
• The patent landscape in this domain is dense, necessitating thorough freedom-to-operate analyses.
• Strategic international filings extend the patent’s protections, influencing global market entry.
• Continuous innovation and patent management are imperative to maintain competitive advantage.

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Frequently Asked Questions

1. How broad are the chemical claims in U.S. Patent 10,588,914?
The claims are designed to cover a specific chemical scaffold with particular substitutions, providing a balance between broad coverage for the core class and narrow specifics to assert novelty and non-obviousness.

2. Can competitors develop similar compounds that circumvent this patent?
Yes, by modifying structural elements outside the claimed features or exploring different mechanisms, competitors can design around the patent, although such routes must be carefully evaluated for infringement risks.

3. How does the patent landscape impact licensing opportunities?
A dense patent environment creates both opportunities for licensing by patent holders and barriers for new entrants. Winning licensing negotiations depend on patent strength, scope, and the value of the patented compounds.

4. What strategies can patent holders employ to strengthen protection?
Filing continuation applications, broadening claim scope, and securing international patents can reinforce protection. Regular landscape monitoring and supplementing with method-of-use patents also bolster defenses.

5. What are the main limitations when analyzing patent claims for freedom-to-operate?
Ambiguous claim language, narrow claim scope, or overlapping patents can pose challenges. Detailed claim interpretation studies and prior art analyses are essential to accurately assess risks.

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References

1. United States Patent and Trademark Office (USPTO). U.S. Patent 10,588,914.
2. Additional patent family filings and scientific literature, as available through patent databases such as Lens.org, Espacenet, or USPTO PAIR.

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
Spain	2637447
Japan	2013503203
Japan	5833007
World Intellectual Property Organization (WIPO)	2011026076