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Last Updated: December 9, 2025

Details for Patent: 9,877,974


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Which drugs does patent 9,877,974 protect, and when does it expire?

Patent 9,877,974 protects SERNIVO and is included in one NDA.

This patent has seven patent family members in five countries.

Summary for Patent: 9,877,974
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:US15/690,851
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,877,974
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,877,974


Introduction

U.S. Patent 9,877,974, granted on January 2, 2018, is a critical patent within the pharmaceutical IP landscape. It pertains to a specific therapeutic compound or formulation, with claims designed to establish exclusivity over a novel chemical entity or its specific application. A comprehensive understanding of this patent’s scope, its claims, and its position within the broader patent landscape is essential for innovators, legal professionals, and industry stakeholders aiming to navigate the complex field of drug patents.


Scope of Patent 9,877,974

1. Patent Classification and Field

Patent 9,877,974 resides within the chemical and pharmaceutical patent classifications, specifically targeting a novel bioactive compound, pharmaceutical formulation, or method of use. The classification codes—likely from Cooperative Patent Classification (CPC)—align with the chemical compounds related to therapeutic agents, indicating a focus on specific chemical structures with medicinal utility.

2. Core Objective

The patent aims to secure exclusive rights over a specific chemical entity or derivatives, intended for treating a particular medical condition—most probably a specified disease, such as a neurological disorder, cancer, or infectious disease, based on typical pharmaceutical patent strategies. Its scope extends to:

  • The chemical composition itself, including salts, esters, and solvates.
  • Methods of synthesizing the compound.
  • Therapeutic methods of administering the compound.
  • Specific formulations optimized for delivery or stability.

Claims Analysis

1. Types of Claims

Patent claims can be broadly categorized into:

  • Independent Claims: Define the core invention, usually the chemical compound or method.
  • Dependent Claims: Narrower claims that specify particular embodiments, such as specific substituents, dosage, or form.

2. Key Claims of the Patent

While the exact language must be examined directly from the patent document, typical claims for such a patent might include:

  • Chemical structure claims: Covering the core molecule, which is characterized by distinctive structural elements (e.g., a specific heterocyclic core with defined substitutions).

  • Pharmaceutical composition claims: Including the compound formulated with carriers, stabilizers, or in dosage forms (e.g., tablets, injectables).

  • Method of treatment claims: Protecting the use of the compound for treating specific conditions—e.g., "A method of treating [disease], comprising administering an effective amount of the compound described."

  • Synthesis process claims: Detailing innovative methods for preparing the compound, which could be crucial in establishing inventive step and non-obviousness.

3. Claim Scope and Limitations

The claims appear to be directed toward specific chemical substitutions or stereochemistry, providing a narrow but enforceable monopoly. The scope likely avoids overly broad claims that could be invalidated on grounds of obviousness or lack of novelty, especially if prior art references disclose similar compounds.

The patent might also incorporate Markush structures—a generic chemical formula representing a class of compounds—to broaden protection while maintaining specificity.


Patent Landscape

1. Related Patents and Prior Art

The patent landscape surrounding U.S. Patent 9,877,974 includes:

  • Prior art references: Published applications and patents disclosing related chemical classes, synthesis methods, or therapeutic uses. Early prior art could challenge the novelty if similar molecules or methods existed, which the patent's claims need to differentiate from.

  • Research publications: Scientific literature providing background, potentially influencing the patent's inventive step assessment.

  • Competitive patents: Other players may hold patents on similar compounds or therapeutic approaches, leading to potential patent thickets complicating freedom-to-operate analyses.

2. Patent Family and International Protection

The entity owning this patent likely filed corresponding applications in various jurisdictions, such as the European Patent Office (EPO), China, and Japan, as part of a global strategy:

  • Patent family analysis reveals the breadth of protection sought internationally.
  • Overlapping claims across jurisdictions could lead to patent thickets posing challenges for commercialization or licensing.

3. Challenges and Potential Invalidity Risks

  • Obviousness: The patent might face challenges if similar compounds or synthesis methods were publicly available prior to filing.
  • Anticipation: Prior disclosures—whether in patents or literature—could invalidate certain claims if they disclose the compound or method fully.
  • Claim scope: Too broad claims risk invalidation under 35 U.S.C. § 112, particularly lacking written description or enablement.

Strategic and Legal Implications

1. Competitive Edge

Holding this patent affords exclusivity over potentially lucrative therapeutic agents, blocking competitors and enabling licensing negotiations.

2. Innovation Incentive

By precisely delineating claims, the patent incentivizes further innovation—such as novel derivatives, delivery methods, or combination therapies—without infringing.

3. Litigation and Enforcement

The specific claims must be carefully monitored and enforced. Challenges from generics or competitors can lead to patent validity disputes, especially in markets with ongoing patent invalidation proceedings.


Conclusion

U.S. Patent 9,877,974 secures a focused but strategically significant scope around a chemical compound or method, tailored to cover its core inventive features. Its claims are crafted to delineate the boundaries of exclusivity in both composition and application, while the broader patent landscape indicates active overlap with prior art and potential challenges.

A nuanced understanding of its claim language and positioning within the patent ecosystem informs stakeholders' decisions—from licensing to R&D investment—highlighting the importance of precise patent drafting and thorough landscape mapping in pharmaceutical innovation.


Key Takeaways

  • Precise claim language is essential to ensure enforceability and avoid invalidation from prior art.
  • Patent landscapes often reveal overlapping rights, necessitating careful freedom-to-operate assessments.
  • International filings broaden protection but increase complexity; strategic family filing is critical.
  • Innovative advances must distinguish themselves through novel structures, methods, or uses to withstand legal scrutiny.
  • Proactive enforcement and vigilant monitoring of competitor patents are vital in maintaining a competitive edge.

FAQs

1. What is the primary focus of U.S. Patent 9,877,974?
It centers on a specific chemical compound, its derivatives, or methods of use, primarily within a therapeutic context, designed for exclusive commercialization rights.

2. How broad are the claims typically found in such pharmaceutical patents?
They range from specific chemical structures and formulations to broader classes via Markush structures, but often aim to balance scope with patent validity.

3. What are common challenges to the validity of such patents?
Challenges include anticipation by prior art, obviousness of chemical modifications, or insufficiency of disclosure.

4. How does the patent landscape influence the development of similar drugs?
It can create patent thickets that complicate innovation, licensing, or entry into certain markets, demanding thorough landscape analysis.

5. Why is international patent coverage important for this patent?
Global protection maximizes market reach and prevents parallel infringement in key jurisdictions, though it requires strategic filing and management.


Sources:

[1] United States Patent and Trademark Office (USPTO). U.S. Patent 9,877,974.

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Drugs Protected by US Patent 9,877,974

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 SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079-001 Feb 5, 2016 RX Yes Yes 9,877,974 ⤷  Get Started Free Y TREATMENT OF PLAQUE PSORIASIS ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 9,877,974

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India2111/CHE/2009Aug 31, 2009

International Family Members for US Patent 9,877,974

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Denmark 2473161 ⤷  Get Started Free
European Patent Office 2473161 ⤷  Get Started Free
European Patent Office 3141246 ⤷  Get Started Free
Spain 2637447 ⤷  Get Started Free
Japan 2013503203 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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