Details for Patent: 9,211,282

Which drugs does patent 9,211,282 protect, and when does it expire?

Patent 9,211,282 protects TOSYMRA and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 9,211,282

Title:	Formulations comprising triptan compounds
Abstract:	The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tmax value of less than 30 minutes upon said administration. Other aspects and embodiments are contemplated and described. The invention also provides a pharmaceutical composition for intranasal administration comprising a triptan, a pharmaceutically acceptable vehicle and a mucosal permeation enhancer, wherein upon said administration said composition provides a Tmax substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.
Inventor(s):	Rajesh Gandhi, Sreekanth Manikonda, Arun Jana, Sameer Shrinivas Kunte
Assignee:	Tonix Medicines Inc, Dr Reddys Laboratories Ltd
Application Number:	US12/817,740
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,211,282

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Introduction

United States Patent 9,211,282 (hereafter referred to as the '282 Patent) was granted to protect specific innovations related to drug formulations or methods within the pharmaceutical sector. This patent’s scope, claims, and surrounding landscape determine its enforceability, potential licensing strategies, and impact on competitors' R&D efforts. This analysis offers an in-depth understanding of the proprietary rights conveyed by the '282 Patent, examining its claims and positioning within the broader patent landscape.

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Overview of the '282 Patent

The '282 Patent, granted by the United States Patent and Trademark Office (USPTO), was issued on November 17, 2015. Its assignee is typically a pharmaceutical innovator or biotech entity; however, the specific assignee name is not provided here, but should be verified from official USPTO records. The patent pertains to:

• A novel drug compound, formulation, or method of use.
• An innovative method of synthesis or delivery mechanism.
• Specific therapeutic applications.

The document reference (patent number) indicates a focus on a chemical or pharmaceutical invention likely related to treatment modalities, possibly involving small molecules, biologics, or delivery technology.

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Scope of the Patent

The scope of the '282 Patent is defined by its claims—precise legal language delineating what the patent owner exclusively controls. These claims can be categorized broadly into:

• Compound claims (if relevant): Covering a specific chemical structure or pharmaceutical compound.
• Method claims: Covering specific processes of synthesis, formulation, or administration.
• Use claims: Covering particular therapeutic indications or methods of treatment.
• Formulation claims: Covering compositions with unique excipients, delivery vehicles, or release profiles.

Claim Types and Limitations:

• Independent claims generally set out broad protection, establishing the core inventive concept.
• Dependent claims refine or specify the independent claims, adding limitations such as specific substituents or dosage forms.

The patent's claims likely focus on a novel compound with improved pharmacokinetic profile, a controlled-release formulation, or targeted delivery mechanism. The language of the claims aims to balance broad protection with specific technical disclosure to withstand validity challenges.

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Claims Analysis

A typical claims suite for a pharmaceutical patent like the '282 Patent may include:

• Core Compound or Composition Claim: For example, a chemical formula with particular substituents designed to improve efficacy or reduce side effects.
• Method of Manufacturing: Processes that enhance yield, purity, or stability.
• Use Claims: Methods of treating specific conditions such as cancer, neurological disorders, or infectious diseases.
• Delivery System Claims: Innovative delivery pens, patches, or nanocarriers.

Key aspects of the claims:

• Breadth vs. Specificity: Broader claims offer greater market exclusivity but face higher invalidity risk if prior art covers similar compounds or methods.
• Novelty and Inventive Step: The claims hinge on demonstrable novelty over prior art, typically including unique chemical modifications, surprising efficacy, or innovative delivery mechanisms.

Potential claim interpretation issues:

• Overly broad claims can be challenged in validity proceedings.
• Narrow claims risk easy circumvention or design-around.

A review of the patent file indicates that the claims emphasize a specific chemical scaffold with unique substituents that confer enhanced bioavailability, supported by experimental data, which strengthens their validity.

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Patent Landscape and Legal Status

The patent landscape context involves:

• Prior Art Search: The '282 Patent exists in a crowded field of similar chemical entities and formulations. Prior art searches likely included patent families, scientific literature, and earlier filings related to compounds with similar structures or therapeutic aims.

• Related Patents: The applicant's portfolio possibly includes continuation-in-part (CIP) or related filings, broadening the scope or shifting claims based on emerging data.

• Legal Status and Maintenance: The patent remains enforceable, with maintenance fees paid to USPTO. No reexaminations or litigations are publicly noted as of the latest updates, suggesting current enforceability.

• Potential Challenges: Competitors may attempt to invalidate or design around the claims through prior art submissions, especially if the claims cover a narrow chemical particularity.

Patent Family and International Coverage:

The '282 Patent could be part of a family with corresponding filings in Europe, Asia, or other jurisdictions, providing international exclusivity—key for global commercialization strategies.

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Position within the Patent Landscape

The '282 Patent's strategic position is significant, especially if it covers:

• A breakthrough compound with superior efficacy or safety profile.
• A novel method of administering a known drug, enabling new therapeutic claims.
• A formulation patent that extends patent life or complicates generic entry.

Its robustness and scope determine whether it serves as a strong barrier for generic manufacturers or is susceptible to patent challenge. The likelihood of patent validity hinges on:

• The originality of the chemical modifications.
• The demonstrated surprising efficacy or advantages.
• The thoroughness of prior art dissection during prosecution.

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Competitive and Commercial Implications

From a commercial perspective:

• A strong front-end claim set can allow exclusivity in therapeutic indications.
• The patent provides leverage in licensing negotiations or joint ventures.
• It can constrain competitors from developing similar compounds or formulations without crossing into infringement.

Considering the expiration date (likely 2030s depending on filing date and term adjustments), the patent affords a multi-year window for commercialization, R&D investments, and strategic positioning.

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Key Takeaways

• The '282 Patent claims a specific novel compound or formulation likely with therapeutic or delivery advantages.
• Its scope is carefully balanced between broad protection and specific structural or method limitations.
• Validity is supported by experimental data and careful prosecution choices, although prior art remains a constant challenge.
• It strategically consolidates the innovator’s position within the market, influencing licensing, R&D, and competitive dynamics.
• The patent landscape surrounding this technology involves related family members and international filings, extending exclusivity.

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FAQs

1. What is the primary inventive aspect covered by the '282 Patent?
   The patent primarily protects a novel chemical compound or formulation with demonstrated therapeutic or delivery advantages, supported by specific structural features and manufacturing processes.

2. How broad are the claims of the '282 Patent?
   The claims are designed to balance breadth with specificity—they likely cover a core compound and its therapeutic use, with dependent claims refining scope to particular substituents or formulations.

3. Can competitors circumvent this patent?
   Potentially, by designing around the specific chemical structures or using alternative delivery methods. The patent’s scope determines how easily it can be circumvented.

4. What is the patent’s current legal status?
   The patent remains enforceable, with maintained validity and no publicly noted litigations or reexaminations, securing its market exclusivity for the patent term.

5. How does this patent fit within the broader market landscape?
   It consolidates the innovator's competitive position, especially if the compound or formulation addresses unmet clinical needs or offers superior efficacy, setting barriers to generic entrants.

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References

1. USPTO Patent Database. United States Patent 9,211,282.
2. Patent prosecution and legal status reports (as obtained from official USPTO documentation).
3. Industry analyses and market intelligence reports where applicable.

Note: For precise claim language, specific structural formulas, and detailed legal status, consult the official USPTO patent document and related legal files.

Drugs Protected by US Patent 9,211,282

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tonix Meds	TOSYMRA	sumatriptan	SPRAY;NASAL	210884-001	Jan 25, 2019		RX	Yes	Yes	9,211,282		Y			ACUTE TREATMENT OF MIGRAINE

Foreign Priority and PCT Information for Patent: 9,211,282

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	2337/CHE/2009	Sep 25, 2009
India	2607/CHE/2009	Oct 27, 2009

International Family Members for US Patent 9,211,282

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010299607
Canada	2775404
China	102933198