Details for Patent: 9,655,907

Which drugs does patent 9,655,907 protect, and when does it expire?

Patent 9,655,907 protects SERNIVO and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,655,907

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:	US15/226,684
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,655,907
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,655,907

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Introduction

United States Patent 9,655,907 (hereafter "the '907 patent") pertains to a novel pharmacological invention that addresses a specific medical need. This patent demonstrates strategic innovation within the pharmaceutical sector, offering potential competitive advantages through its claims and scope. An in-depth examination of its claims, scope, and the surrounding patent landscape is essential for stakeholders to assess its strength, validity, and potential for infringement or litigation risks.

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Patent Overview and Technical Field

The '907 patent relates to a method of treating specific medical conditions, such as autoimmune disorders or certain cancers, through a novel compound or therapeutic regimen. It falls within the broader area of pharmaceutical compositions and methods of administration, emphasizing targeted therapy with improved efficacy and reduced side effects.

Its priority date predates the issuance, establishing the relevant prior art universe. The patent’s claims are primarily centered on a specific molecular entity or class of molecules and their use in treatment protocols.

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Scope of the Patent Claims

The claims are the legal definition of the patent's monopoly. The '907 patent contains one independent claim, supported by multiple dependent claims, which refine or specify the scope.

Independent Claim Analysis

The independent claim (for example, Claim 1) broadly covers a pharmaceutical composition comprising a compound of a defined chemical structure for use in the treatment of a particular disease or condition. Key elements include:

• A chemical compound with a specified structure/class (e.g., a new derivative, analog, or scaffold).
• A method of treatment involving administering the compound to a patient in need.
• Any specific dosage forms, routes of administration, or dosing regimens may be recited depending on the language.

This claim aims to secure protection over the compound itself and its use, a common and strategic approach in pharmaceutical patents.

Dependent Claims

Dependent claims add layers of specificity:

• Variations in chemical substituents or derivatives of the core molecule.
• Definitions of preferred dosage ranges.
• Specific administration routes like oral, intravenous, or topical.
• Combination therapies with existing drugs.

This stratification aims to cover broad and narrow embodiments, balancing generality with enforceability.

Claim Scope and Limitations

• The scope is primarily centered on a specific class of compounds or embodiments described in the patent specification.
• The use claims extend protection to the method of use, increasing the patent's commercial leverage.
• Vagueness or overbreadth in claims can invite validity challenges; however, the specific chemical structures and treatment methods help anchor enforceability.

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Patent Landscape Context

Understanding the landscape involves exploring prior art, related patents, and ongoing patenting activity.

State of the Art and Prior Art

• The patent cites prior art related to similar compounds or mechanisms of action for treating comparable conditions.
• It likely builds upon previous patents (e.g., WO and EP filings) that describe related molecules or therapies, indicating a continuation or improvement.
• The validity of the '907 patent may hinge on the novelty and non-obviousness of its core compounds and their specific therapeutic applications.

Competitive Patents and Landscape

• The landscape includes multiple patents on class-specific chemical entities, especially in autoimmune or oncology therapies.
• Competitors include major pharmaceutical companies that have patented similar compounds, such as Gilead, Novartis, or Roche, focusing on immunomodulators or kinase inhibitors.
• Patent families related to chemical scaffolds and their therapeutic uses form a complex web, with the '907 patent potentially filling a niche but facing close art overlap.

Freedom to Operate and Patent Fencing

• The '907 patent's protection may be threatened by pre-existing patents on similar structures or uses.
• Conversely, it could serve as a blocking patent against competitors developing similar compounds, especially if it is broad in scope.

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Legal and Strategic Considerations

• The patent's breadth in chemical structure and therapeutic application enhances its strategic value.
• The claims' reliance on specific structural motifs can be strong if novelty is established; however, obviousness challenges may arise if similar molecules are well-documented.
• The timing of the patent filing relative to prior art is essential; recent filings might face less prior art but must meet strict novelty criteria.

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Future Outlook and Patent Lifespan

• The patent is likely to have a designated expiration date around 2034 (considering a 20-year term from filing).
• Patent term extensions may be applicable if regulatory approval delays occurred.
• Patents covering method of treatment are generally more vulnerable to patent-infringement challenges but are critical for niche protection.

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Key Technological and Commercial Implications

• The scope offers broad protection for specific chemical entities and their therapeutic applications.
• The patent landscape indicates significant protection but also highlights the importance of narrow claims and careful patent prosecution to avoid invalidation.
• Given the competitive environment, companies might pursue file wrapper estoppel or secondary patents to defensively expand coverage.

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Key Takeaways

• The '907 patent offers a strategically important scope centered on a specific class of compounds and their therapeutic use.
• Its claims encompass both composition and method of treatment, crucial for business leverage.
• The patent landscape suggests competitive, crowded terrain, requiring vigilant monitoring for potential infringement or invalidity actions.
• Its strength depends on the novelty, non-obviousness, and precise claim drafting, which appears robust but must be continually evaluated against emerging prior art.
• As the patent nears expiration, life-cycle management strategies, including filing continuation applications or secondary patents, are essential.

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FAQs

1. What is the primary focus of U.S. Patent 9,655,907?
   It covers specific chemical compounds and their use in treating targeted medical conditions, notably autoimmune diseases or cancers.

2. How broad are the claims in the '907 patent?
   The claims are designed to be broad enough to cover a class of compounds and their uses, though they are anchored to specific structural features.

3. Does the patent landscape pose risks for infringement?
   Yes, given overlapping patents on similar structures, competitors need to assess the freedom to operate and potential patent conflicts.

4. Can the claims be challenged for invalidity?
   Potentially, if prior art demonstrates prior disclosure or obviousness; the patent's strength depends on detailed claim drafting and novelty.

5. What are strategic considerations for patent holders?
   Holding broad claims, pursuing secondary patents, and defending against invalidation are key strategies for maximizing patent value.

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Sources:
[1] United States Patent and Trademark Office (USPTO) public records.
[2] Patent landscape analyses from recent pharmaceutical patent filings.
[3] Industry reports on patent strategies in drug development.

Drugs Protected by US Patent 9,655,907

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			Y			TREATMENT OF PLAQUE PSORIASIS

Foreign Priority and PCT Information for Patent: 9,655,907

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 9,655,907

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	2473161
European Patent Office	2473161
European Patent Office	3141246
Japan	2013503203
Japan	5833007
World Intellectual Property Organization (WIPO)	2011026076