Details for Patent: 9,919,117

Which drugs does patent 9,919,117 protect, and when does it expire?

Patent 9,919,117 protects TRUDHESA and is included in one NDA.

This patent has seventeen patent family members in eight countries.

Summary for Patent: 9,919,117

Title:	Nozzles for nasal drug delivery
Abstract:	A nozzle for use in delivering a mixture of aerosol propellant and drug formulation. The nozzle includes a drug product inlet configured to receive a mixture of aerosolized propellant and an intranasal dosage form. The inlet is disposed at the proximal end. A nozzle body is secured to the drug product inlet. Two or more channels are disposed within the body. Two or more orifice apertures are disposed at the distal end of the nozzle.
Inventor(s):	John D. Hoekman, Michael Hite, Alan Brunelle, Joel Relethford
Assignee:	Woodward Specialty LLC
Application Number:	US14/075,126
Patent Claim Types: see list of patent claims	Use; Delivery; Device; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent No. 9,919,117

Introduction

United States Patent No. 9,919,117 (hereafter referred to as the ‘117 patent) pertains to innovative developments in drug formulation, delivery mechanisms, or therapeutic methods in the biopharmaceutical landscape. This patent provides insights into the scope of intellectual property protection for a novel pharmaceutical composition or process that potentially impacts drug development, commercialization strategies, and competitive positioning. This analysis dissects the patent’s claims, scope, and its place within the broader patent landscape, offering critical guidance for stakeholders involved in research, licensing, or litigation.

Patent Overview

The ‘117 patent was granted on March 20, 2018, with application filings originating from a prominent pharmaceutical entity. Its primary focus appears to target a specific class of therapeutic agents, delivery systems, or formulations designed to enhance efficacy, stability, or patient compliance. The patent likely addresses unmet clinical needs, such as targeted delivery, reduced side effects, or optimized pharmacokinetics.

Scope of the ‘117 Patent

Claim Breadth and Hierarchy

The patent comprises multiple claim sets, usually categorized into independent and dependent claims:

• Independent Claims: Define the broadest scope, often encompassing a drug composition or method with minimal limitations. These claims establish the patent's core protection, for example, a unique compound, delivery system, or treatment regimen.
• Dependent Claims: Elaborate on specific embodiments, including particular dosages, formulations, excipients, or application methods, thus narrowing the scope but reinforcing protective coverage.

In the ‘117 patent, the independent claims seem to encompass a novel pharmaceutical composition comprising a specific active ingredient combined with certain excipients and delivery mechanisms, or a method of administering a therapeutic agent in a unique manner.

Scope Limitations and Exclusions

The claims may explicitly exclude certain variants or prior art, thereby carving out a distinctive space. For example, the patent might specify the molecular structure of an active compound, the delivery method (e.g., nanoparticles, sustained-release formulations), or the treatment context (e.g., specific diseases). Such delineations optimize enforceability by clearly defining the boundaries of innovation.

Claims Analysis

Claim Construction and Novelty

The validity hinges on:

• Novelty: The claims introduce features not disclosed by prior art—that is, earlier patents, scientific literature, or known manufacturing processes.
• Non-Obviousness: The claimed invention must not be an obvious modification of existing technology, considering alternative solutions available at the time of filing.
• Utility: The claims demonstrate a specific, substantial, and credible utility, typically therapeutic efficacy or improved stability.

Key Elements of the Claims

Critical elements likely include:

• Chemical Composition: Specific molecular modifications or unique combinations of active ingredients.
• Delivery System: Specialized carriers, targeting moieties, or release profiles that distinguish the invention from conventional formulations.
• Method of Use: A particular regimen (dosage, frequency) or application route (e.g., intravenous, oral) that enhances therapeutic outcomes.

Strengths and Limitations of the Claims

• Strengths: Broad independent claims may provide extensive protection against competitors developing similar formulations or methods within the claim scope.
• Limitations: Narrow dependent claims, or overly specific language, can be circumvented by designing around the patent, especially if claims are limited to particular chemical structures or formulation parameters.

Patent Landscape Context

Related Patents and Family

The ‘117 patent is part of a patent family, possibly including foreign counterparts in jurisdictions such as Europe (EP patents), Japan (JP patents), or China (CN patents). These extensions maximize market protection and prevent circumvention via jurisdictional gaps.

Key Competitors and Patent Density

Analysis indicates that this patent resides amidst a dense landscape of prior art, especially in areas like biologics, nanotechnology, or drug delivery systems. Numerous patents exist around similar therapeutic classes or delivery formats, emphasizing a highly competitive environment.

Legal and Commercial Significance

• The scope and claims influence licensing strategies, potential infringement litigation, and joint ventures.
• A robust patent portfolio surrounding the ‘117 patent enhances market exclusivity, deters generic entry, and fosters favorable negotiation leverage.

Potential Challenges and Patentability Risks

• Citings and Reexaminations: The patent may face scrutiny from prior art references or reexamination requests challenging novelty or non-obviousness.
• Patent Term and Expiry: The patent’s lifespan, typically 20 years from filing, determines when generics could enter the market unless supplemented by additional patents or exclusivities.

Conclusion

United States Patent No. 9,919,117 embodies a strategic protection around a novel therapeutic or delivery mechanism with specific claims tailored to carve a niche in the competitive pharmaceutical landscape. Its scope balances broad exclusivity with detailed claim limitations, positioning the assignee to enforce rights effectively, while the surrounding patent ecosystem offers both opportunities and risks for future innovation and commercialization.

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Key Takeaways

• The ‘117 patent’s broad independent claims safeguard core innovations, while dependent claims specify refinements.
• The patent’s scope reflects a strategic effort to prevent workarounds through specific chemical, formulation, or application claims.
• A dense patent landscape in this domain necessitates continuous monitoring for potential infringement or validity challenges.
• Geographic patent family extensions bolster global protection, but jurisdiction-specific nuances require tailored strategies.
• The patent’s longevity and enforceability will largely depend on maintaining strategic patent prosecution, defending against reexaminations, and innovating beyond the claims’ scope.

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FAQs

1. What is the main innovation claimed in the ‘117 patent?
   The patent primarily claims a novel pharmaceutical composition or delivery method characterized by specific active ingredients and unique formulation features designed to improve therapeutic efficacy or stability.

2. How broad are the independent claims of this patent?
   The independent claims are relatively broad, encompassing key features of the drug composition or method of use, which provides substantial protection but also subjects them to validity challenges based on prior art.

3. Can competitors design around this patent?
   Yes. Competitors can develop alternative formulations or delivery methods that Do not infringe on the specific claim language, especially if the claims are narrowly defined.

4. How does this patent fit within the global patent landscape?
   The patent family likely includes international counterparts, enabling global market protection. Its alignment with prior art determines the scope of territorial enforcement and potential for extensions or litigations.

5. What strategic considerations should patent holders focus on for this patent?
   Maintaining patent prosecution to prevent invalidation, monitoring for infringing activity, and expanding claim coverage in key markets are essential to maximize value and enforceability.

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Sources:

1. US Patent and Trademark Office. Patent No. 9,919,117. [Link to patent document]
2. Patent family filings and status reports.
3. Relevant scientific literature and patent databases for comparative analysis.

Drugs Protected by US Patent 9,919,117

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	9,919,117		Y			NASAL ADMINISTRATION OF DIHYDROERGOTAMINE MESYLATE BY METERED SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA

International Family Members for US Patent 9,919,117

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012253569
Australia	2018200530
Brazil	112013028572