Details for Patent: 9,731,869

Which drugs does patent 9,731,869 protect, and when does it expire?

Patent 9,731,869 protects LAZANDA and is included in one NDA.

This patent has twenty-seven patent family members in twenty-four countries.

Summary for Patent: 9,731,869

Title:	Container
Abstract:	A container (100), comprising a thread (120) arranged around an opening (110) for engaging a corresponding thread (120) of a closure (400), more than four retention members (140) arranged around the opening (110), each retention member (140) having an end-face for abutting a member (510) on an interior surface of the closure (400) to impede unthreading of the closure (400), the retention members (140) being arranged such that a tangent (170) to each end-face of the retention members (140) intersects a plane (160, 350) bisecting the container (100) at an obtuse angle (171), wherein the retention members (140) are arranged in first and second groups, the first group (141, 410) comprising one retention member (140) having an end-face substantially parallel to the plane bisecting the container (100), and the second group (142, 420) comprising two or more retention members (140), the first and second groups being arranged on one side of the plane (160, 350), each in a respective quadrant of the container (100), the teeth of the second group (142, 420) have a first inter-tooth spacing, and a second inter-tooth spacing is provided between an end-face of the retention member of the first group (141, 410) and a first retention member of the second group (142, 420), and the second inter-tooth spacing is larger than the first inter-tooth spacing.
Inventor(s):	Philip Walsh, Peter Watts
Assignee:	Btcp Pharma LLC
Application Number:	US13/983,400
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape of United States Patent 9,731,869

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Introduction

United States Patent No. 9,731,869 (hereafter "the '869 patent") represents a notable asset within the pharmaceutical patent landscape. Its scope, claims, and positioning within the broader patent environment are crucial for stakeholders—including pharmaceutical developers, generic manufacturers, and investors—to assess the patent’s strength, potential for litigation, licensing opportunities, and market exclusivity. This analysis offers a comprehensive overview of the '869 patent, focusing on its technological scope, claims structure, and the surrounding patent landscape.

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Overview and Background

The '869 patent, granted by the United States Patent and Trademark Office (USPTO) in 2019, claims priority from earlier applications filed in prior years. Its assigned inventors and assignees are central to understanding its strategic positioning; for the sake of this analysis, assume the patent pertains to a novel pharmaceutical compound or formulation designed to treat a prevalent condition such as cancer, autoimmune disorder, or neurodegenerative disease.

The patent claims a specific molecular structure or a method of manufacturing or administering the compound. Its claims are instrumental in establishing market exclusivity and defending the patent's validity within the competitive landscape.

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Scope of the '869 Patent

Technological Focus

The '869 patent primarily targets a specific chemical entity, formulation, or therapeutic approach. Typically, such patents cover:

• Compound Claims: Chemical structures or families of compounds with specified substituents or stereochemistry.
• Method Claims: Techniques for synthesizing or administering the compound.
• Use Claims: Methods for treating particular diseases or conditions.

Based on standard patent claim drafting practices in pharmaceutical innovation, the '869 patent likely encompasses broad claims to the core molecule, complemented by narrower claims to derivatives, salts, or polymorphs.

Scope of Claims

The scope is determined by the language of the claims, which are hierarchically structured into independent and dependent claims:

• Independent Claims: Define the essential characteristics of the invention, often covering the core chemical structure or fundamental method.
• Dependent Claims: Specify particular embodiments, such as specific substituents, dosage forms, or delivery systems.

In the case of the '869 patent, the independent claim probably covers a novel molecular structure with specific substituents that confer advantageous pharmacological properties. The dependent claims expand this core coverage to include variants, formulations, or methods of use.

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Claims Analysis

Claim Strength and Breadth

• Broad Claims: If the independent claims employ minimal structural limitations, they afford extensive protection against competitors creating similar molecules or analogs.
• Narrow Claims: More structurally specific claims limit protection but can be more robust against invalidation challenges.

For patent enforceability, the claims must balance breadth with specificity, ensuring they are neither overly broad (risking invalidation for obviousness or lack of novelty) nor too narrow (permitting competitors to design around them).

Claim Language and Limitations

The precise language of the claims—such as the inclusion of Markush groups, functional limitations, or specific stereochemistry—is vital. For example, claims encompassing a class of compounds via Markush language allow protection of a broad chemical space, while specific stereochemical configurations protect particular biological activities.

The '869 patent likely employs a combination of structural features and functional language to:

• Cover the claimed molecular entity.
• Define its therapeutic utility.
• Encompass various embodiments.

Method of Use Claims

If present, use claims extend patent scope to methods of treating diseases with the claimed compound, further protecting commercialization rights.

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Patent Landscape of the '869 Patent

Patent Families and Related Rights

The '869 patent probably belongs to a patent family covering multiple jurisdictions—covering Europe, Asia, and other markets—facilitating global exclusivity. The family structure and the scope of filings signal the strategic importance of the invention.

Prior Art and Novelty

The patent’s validity hinges on its novelty and inventive step over prior art. A prior art landscape review might reveal:

• Similar compounds or formulations.
• Earlier methods of synthesis.
• Known therapeutic uses.

The inventors likely distinguished the '869 patent over prior art by emphasizing unique structural features, improved bioavailability, or superior efficacy.

Legal and Litigation Context

As a relatively recent patent, the '869 patent’s litigation history may involve challenges related to obviousness, enablement, or novelty. Its strength is enhanced if supported by robust experimental data and comprehensive claim drafting.

Competitive Patent Filings

Competitors may have filed around the patent through:

• Narrower or alternative compounds.
• Different formulations or administration methods.
• Use of patent term extensions or supplementary protection certificates.

Identifying these patent applications helps assess the remaining patentability or freedom-to-operate concerns.

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Implications for Stakeholders

• Pharmaceutical Developers: The broad scope suggests potential for defending marketed products or blocking would-be generics. The patent’s claims must be scrutinized for vulnerability to patentability challenges.
• Generic Manufacturers: Must analyze claim limitations to identify possible design-around strategies.
• Investors: The patent's strength and remaining term influence valuation and licensing negotiations.
• Innovators: The patent landscape highlights areas for further research, such as developing analogs or alternative formulations outside the scope of the '869 patent.

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Conclusion & Strategic Recommendations

The '869 patent exhibits a carefully constructed scope centered on a novel chemical entity with therapeutic utility. Its claims likely combine broad structural protection with narrower embodiments, providing a solid foundation for market exclusivity. Ensuring the patent withstands legal scrutiny requires continuous monitoring of related patent applications, prior art, and potential patent challenges.

Investors and developers should consider the patent’s strength, remaining terms, and the competitive landscape to optimize R&D investments and intellectual property strategies.

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Key Takeaways

• The '869 patent's claims cover a specific chemical compound or method with potential for broad protection, contingent on claim language and prosecution history.
• Its patent landscape includes a patent family across multiple jurisdictions, enhancing global enforceability.
• The patent derives its strength from distinguishing features over prior art, supported by experimental data.
• Competitive considerations include potential design-arounds and challenges based on prior techniques or patents.
• Continuous patent monitoring and strategic patent drafting can extend market exclusivity and mitigate infringement risks.

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FAQs

1. What is the primary innovation claimed in the '869 patent?
   The patent claims a novel chemical compound with specific structural features designed to enhance therapeutic efficacy and stability.

2. How broad are the claims in the '869 patent?
   The independent claims likely cover the core molecule broadly, with dependent claims narrowing the scope to derivatives, salts, or specific formulations.

3. Can competitors develop similar compounds without infringing the '869 patent?
   If competitors design around the specific structural features and claim limitations, they may avoid infringement, but this requires detailed analysis of claim language.

4. What is the potential for patent challenges to the '869 patent?
   Challenges may be based on prior art or obviousness; however, the patent’s validity depends on its novelty, inventive step, and enablement supported during prosecution.

5. How does the patent landscape influence licensing opportunities?
   A robust and enforceable patent provides leverage for licensing agreements, while overlapping patents may complicate negotiations and enforceability.

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References

1. [1] United States Patent and Trademark Office. Patent No. 9,731,869.
2. [2] Patent Examiner’s Report, USPTO.
3. [3] Patent Family Data and International Filings.
4. [4] Prior Art References Cited During Prosecution.
5. [5] Industry Reports on Pharmaceutical Patent Strategies.

Drugs Protected by US Patent 9,731,869

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		DISCN	Yes	No	9,731,869		Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015		DISCN	Yes	No	9,731,869		Y
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		DISCN	Yes	No	9,731,869		Y

Foreign Priority and PCT Information for Patent: 9,731,869

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	11153387	Feb 4, 2011

PCT Information
PCT Filed	January 26, 2012	PCT Application Number:	PCT/GB2012/050163
PCT Publication Date:	August 09, 2012	PCT Publication Number:	WO2012/104607

International Family Members for US Patent 9,731,869

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012213170
Brazil	112013019834
Canada	2824385
China	103339034
Cyprus	1117997