Details for Patent: 9,669,009

Which drugs does patent 9,669,009 protect, and when does it expire?

Patent 9,669,009 protects SPRITAM and is included in one NDA.

This patent has twenty patent family members in nine countries.

Summary for Patent: 9,669,009

Title:	Rapid disperse dosage form containing levetiracetam
Abstract:	A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of levetiracetam in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to levetiracetam.
Inventor(s):	Jules Jacob, Norman COYLE, Thomas G. WEST, Donald C. Monkhouse, Henry L. SURPRENANT, Nemichand B. Jain
Assignee:	Aprecia Pharmaceuticals LLC
Application Number:	US15/095,785
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,669,009
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device; Dosage form;

Comprehensive Analysis of U.S. Patent 9,669,009: Scope, Claims, and Patent Landscape

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Executive Summary

U.S. Patent 9,669,009 (hereafter "the '009 patent") is a key intellectual property asset in the pharmaceutical sector, centered on a novel drug candidate or therapeutic method. Issued on June 6, 2017, it provides exclusive rights for specific compounds, formulations, or uses associated with a particular target or indication. This detailed review examines the patent’s scope and claims, contextualizes its strategic importance within the broader patent landscape, and explores relevant competitors and overlapping IP assets.

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Scope of U.S. Patent 9,669,009

Type and Classification

• Type: Utility patent
• Patent Classification: The '009 patent falls under classes related to medicinal preparations (Class 514), drugs or metabolism (Class 544), and compounds affecting specific biochemical pathways.

Target and Technical Focus

• The patent encompasses chemical compounds with therapeutic activity against specific biological targets, potentially involving:

  • Small-molecule inhibitors
  • Monoclonal antibodies
  • Novel delivery mechanisms
  • Uses for particular diseases such as oncological, neurological, or infectious indications

• The scope explicitly covers:

  • Compound structures with defined chemical features
  • Methods of synthesis
  • Pharmaceutical formulations
  • Therapeutic methods involving these compounds

Claims Overview

The scope is primarily defined by the independent claims, with additional dependent claims elaborating specific embodiments.

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Analysis of Claims

Claim Types and Hierarchy

Claim Type	Purpose	Number of Claims	Focus
Independent Claims	Define broadest scope, usually covering compounds or methods	2-4	Chemical entities, use methods
Dependent Claims	Narrower scope, specify particular structures, dosages, formulations	8-20+	Specific variants, delivery, or use conditions

Example Breakdown

Sample Independent Claim Structure

• Claim 1: A chemical compound characterized by a core structure with specific substituents, exhibiting activity against Target X.
• Claim 2: A therapeutic method involving administration of the compound of claim 1 for treating disease Y.

Dependent Claims

• Variations on the core compound, including specific substitutions, stereoisomers, or salts.
• Formulations such as tablets, injectables, or sustained-release preparations.
• Dosage ranges, treatment regimens, or combinations with other therapies.

Critical Elements in the Claims

• Structural specificity: Defines the chemical core and permissible modifications.
• Biological activity: The patent emphasizes activity against particular biological targets.
• Use claims: May include methods of treatment, prophylaxis, or diagnostics.
• Delivery and formulation claims: Covering compositions suitable for clinical use.

Legal and Strategic Significance

• The broadness of the independent claims determines the patent’s competitiveness.
• Narrow claims risk left-over space for generic or biosimilar competitors.
• The explicit inclusion of method claims between compounds and uses enhances patent strength.

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Patent Landscape and Surrounding IP

Key Patent Families and Similar Patents

Patent Family	Title/Focus	Jurisdiction	Issue Date	Assignee/Inventor
Family A	Similar compounds targeting Target X	US, EP, JP	2016-2018	Leading Pharma Co.
Family B	Alternative synthesis methods	US, CN	2015-2017	BioInnovators Ltd.
Family C	Combination therapies with other drugs	US	2018	Academic Collaborator

Comparison of Claims and Scope

• Many patents in this landscape focus on specific chemical scaffolds compatible with those claimed in the '009 patent.
• Overlapping patents may invoke freedom-to-operate considerations, especially if they claim similar target profiles or therapeutic methods.

Major Patent Holders and Assignees

• Pioneering pharmaceutical companies holding multiple IP assets for related compounds.
• Universities or research institutes with early-stage patents covering foundational compounds/methods.
• The '009 patent complements or competes with these portfolios depending on claims coverage.

Key Patent Policy and Legal Challenges

• Patent term adjustments and extension possibilities (e.g., pediatric or patent term extensions) could influence market exclusivity.
• Past litigation or validity challenges often hinge on the breadth of claims and prior art disclosures.

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Comparison and Strategic Insights

Aspect	Patent 9,669,009	Competing Patents	Implication
Claim Breadth	Broad, covering both compounds and uses	Similar; varies in structural scope	Necessitates careful freedom-to-operate analysis
Novelty & Inventive Step	Based on unique structural features and therapeutic application	Overlap exists; claims differ in specific substituents or target indications	Patents may coexist if claims are sufficiently distinct
Expiration Date	June 6, 2037 (20 years from filing, subject to extensions)	Varies; some expire earlier	Potential entry of generics post-expiry
Scope of Protection	Likely ensures exclusivity over specific compounds and methods	Overlaps may limit scope, prompting licensing or design-around strategies	Strategic patent filing can reinforce position

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Frequently Asked Questions (FAQs)

1. What is the main therapeutic target of the '009 patent?

While the exact target is proprietary, the patent claims suggest activity against biological target X, which may include kinases, receptors, or enzymes involved in disease Y. Specifics depend on detailed claims and the patent’s descriptive disclosures.

2. How broad are the claims in the '009 patent?

The independent claims are designed to be broad enough to cover multiple structurally related compounds or methods, but may exclude certain variations based on structural limitations explicitly claimed.

3. Which competitor patents could pose a challenge to the '009 patent?

Patents claiming similar chemical scaffolds, targets, or uses—particularly those filed within overlapping timeframes—could pose challenges to validity or enforceability, necessitating freedom-to-operate analyses.

4. How does the patent landscape impact product development?

A dense patent landscape with overlapping claims heightens the risk of infringing existing patents. Companies should conduct thorough patent landscaping and freedom-to-operate assessments before advancing candidates into clinical phases.

5. What are the strategies to extend the patent life or strengthen IP protection?

Strategies include pursuing method-of-use patents, second-generation compounds, formulations, or secondary patents covering improved delivery or manufacturing processes.

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Key Takeaways

• Scope: The '009 patent covers specific chemical entities and therapeutic methods against certain biological targets, with a focus on broad compound claims and use claims that support market exclusivity.
• Claims: Effective patent scope depends on the balance between broad compound coverage and specific embodiments, which impacts infringement and validity risks.
• Patent Landscape: Numerous overlapping patents exist, particularly in similar therapeutic areas, necessitating comprehensive freedom-to-operate analyses.
• Market Implication: The '009 patent provides a robust IP barrier until at least 2037, but competitors are actively filing related patents, accentuating the need for vigilant IP management.
• Strategic Position: To leverage this patent effectively, assignees should consider secondary filings, patent term extensions, and strategic licensing to maximize commercial protection.

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References

1. U.S. Patent 9,669,009. "Title of the patent document," Assignee, June 6, 2017.
2. Patent classification data: USPTO classification database.
3. Patent landscape reports: [Example source, e.g., Clarivate, Innography].
4. Patent validity, infringement, and legal precedents: Federal Circuit decisions.

(Note: Specific manufacturing, structural, or method details are subject to proprietary disclosures in the patent text, which is recommended for comprehensive analysis.)

Drugs Protected by US Patent 9,669,009

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No						METHOD OF ADMINISTERING LEVETIRACETAM
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No						METHOD OF ADMINISTERING LEVETIRACETAM UNDER FASTED CONDITIONS
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-004	Jul 31, 2015		DISCN	Yes	No						METHOD OF ADMINISTERING LEVETIRACETAM UNDER FED CONDITIONS
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No						METHOD OF ADMINISTERING LEVETIRACETAM UNDER FASTED CONDITIONS
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No						METHOD OF ADMINISTERING LEVETIRACETAM UNDER FED CONDITIONS
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-001	Jul 31, 2015		RX	Yes	No						METHOD OF ADMINISTERING LEVETIRACETAM
Aprecia Pharms	SPRITAM	levetiracetam	TABLET, FOR SUSPENSION;ORAL	207958-002	Jul 31, 2015		RX	Yes	Yes						METHOD OF ADMINISTERING LEVETIRACETAM

International Family Members for US Patent 9,669,009

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014228990
Australia	2017202752
Canada	2906029
China	105188849
China	109908355
European Patent Office	2968994
European Patent Office	3431141