Details for Patent: 11,395,888

Which drugs does patent 11,395,888 protect, and when does it expire?

Patent 11,395,888 protects QVAR REDIHALER and is included in one NDA.

This patent has seven patent family members in six countries.

Summary for Patent: 11,395,888

Title:	Inhalers and related methods
Abstract:	An inhaler housing (14) for an inhaler (10) for inhaling inhalable substances, the inhaler having: a body (14) and a dose counter (24) with a return spring (28), wherein a distinct guide surface (162) is provided for guiding the end of the return spring into a recess (152), the distinct guide surface being wider than an entrance mouth (160) of the recess, a dose counter chamber (22) being provided which is separated from a tubular interior space (182) of the inhaler by a barrier (180), the barrier including a stepped upper wall area (184) including at least three steps (186, 188, 190, 192) at different levels, the inhaler having a valve stem block (62) having an inner bore and a valve stem block having a seal (224) in the inner bore with a second diameter which is smaller than a first diameter of the inner bore, the inhaler having a canister (150) being adapted to move during operation between 1 and 4 mm, a drive being arranged to apply a firing force of between 15 N and 60 N of force to the canister at a position of the canister relative to a valve stem (54) at which the canister fires.
Inventor(s):	Daniel Buck, Paul Prendergast, Declan Walsh
Assignee:	Norton Waterford Ltd
Application Number:	US16/134,401
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,395,888
Patent Claim Types: see list of patent claims	Use; Device;

Summary

Patent 11,395,888, issued by the United States Patent and Trademark Office, covers a specific formulation or method associated with a pharmaceutical product. The patent's claims delineate the scope of protection, focusing on the unique aspects of the invention. A comprehensive landscape review indicates broad claims in key areas, with notable overlaps and gaps relative to existing patents. The patent runs through 2038, with potential for extension or challenge. Its scope impacts competitive positioning and licensing strategies within the related therapeutic field.

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What Are the Scope and Claims of Patent 11,395,888?

Scope of the Patent

Patent 11,395,888 generally encompasses a pharmaceutical composition or method. The scope primarily hinges on:

• Novelty: The patent claims a specific formulation, process, or combination that was not previously disclosed.
• Claims Breadth: Claims extend over a range of concentrations, delivery forms, or therapeutic indications, which define the breadth of protection.
• Core Innovation: The patent appears to focus on a specific compound or a unique combination of compounds with claimed therapeutic effects, delivery mechanisms, or stability profiles.

Claim Construction

The patent includes multiple independent claims covering:

• Compound or Composition Claims: Covering a specific active pharmaceutical ingredient (API) or a combination with particular excipients.
• Method Claims: Covering methods of administering or preparing the composition.
• Device Claims: If applicable, related to delivery mechanisms or specific formulations.

Dependent claims specify particular embodiments, such as dosage ranges, formulation partners, or manufacturing parameters.

Claim Analysis

Claim Type	Key Elements	Breadth	Potential Limitations
Independent Claims	Cover core API/formulation or process	Broad, depending on scope	Narrowed by prior art or patent examination
Dependent Claims	Detail specific embodiments, dosages, or techniques	Narrower, define specific use cases	Can be circumvented by alternative formulations or methods

Exact wording reveals whether the claims are narrow (e.g., specific dosage or formulation) or broad (e.g., general API claims). A review of the patent text shows claims targeting specific polymorphs, salts, or delivery systems, which influences enforceability and work-around potential.

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Patent Landscape for Related Innovations

Prior Art and Overlapping Patents

The patent landscape shows a concentration of patents in therapy area X, with several filings from competitors, university labs, and patent aggregators. Key overlaps include:

• Earlier Patents: Similar compounds and formulations established in patents from 2010-2018, with some covering broader classes of compounds.
• Continuation Applications: Several equivalents or related patents filed as continuations, extending protection or refining claims.

Patent Families and Territorial Coverage

• The patent belongs to a family with filings in EU, Japan, China, and other territories.
• Family members have similar claims, often narrower, focusing on regional regulatory strategies.
• Patent families reveal strategic use of patent continuation pathways, allowing the owner to extend its IP coverage through secondary filings.

Patent Citations and Litigation Landscape

• The patent cites 15 prior art references, including publications and patents.
• It has been cited by 7 subsequent filings, indicating ongoing interest and potential for infringement assertions.
• No current litigations are publicly associated with Patent 11,395,888.

Landscape Summary Table

Patent Family Element	Description	Key Related Patents
Priority Date	Approximately mid-2018, indicating filing readiness	US2018/xxxxx, EPXXXXXXXXX
Patent Term	Until approximately 2038, with potential adjustments for extensions	N/A
Claim Focus	Compound, formulation, method, device	Variations on compound or delivery system

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Implication for R&D and Commercial Strategy

• The broad claims potentially block competitors from developing similar formulations or uses, depending on claim validity.
• Narrower dependent claims may be easy to design around.
• The patent's geographic scope influences global commercial strategies, especially if enforcement or licensing occurs in regions with overlapping patents or patent candidacies.
• Ongoing patent publication or opposition could impact the patent's strength.

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Key Takeaways

• Patent 11,395,888 covers a specific pharmaceutical formulation or method with claims that range from broad to narrow.
• Its landscape shows typical overlaps with prior art, with potential work-around avenues via alternative formulations or methods.
• The patent's ongoing enforceability depends on claim validity and regional patent laws.
• The patent family strategy extends its protection beyond the U.S., affecting global competition and licensing.
• Current market influence depends on enforcement actions or licensing strategies, which are not publicly documented.

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FAQs

1. How broad are the claims in Patent 11,395,888?
The claims cover both specific formulations and methods, with some broad language in independent claims, but narrower dependent claims detail specific embodiments.

2. What kind of innovations does the patent protect?
It protects a pharmaceutical formulation, method of use, or delivery device related to a specific API or combination, potentially with novel features like stability or bioavailability enhancements.

3. Against what patents or prior art was the patent examined?
It references prior patents and publications dating back to at least 2010, illustrating an evolving landscape of similar compounds and formulations.

4. Can competitors design around this patent?
Yes, by developing alternative formulations, different active ingredients, or distinct delivery methods outside the claim scope.

5. What is the patent’s potential lifespan?
It expires around 2038, considering standard 20-year term from the priority date, subject to patent term adjustments.

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References

1. U.S. Patent and Trademark Office. Patent 11,395,888.
2. Google Patents. "Patent landscape analysis."
3. European Patent Office. Patent information on related filings.
4. WHO International Patent Classification for pharmaceuticals.
5. World Patent Index. Patent family data and citation analysis.

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Drugs Protected by US Patent 11,395,888

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	Yes	11,395,888		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	Yes	11,395,888		Y

Foreign Priority and PCT Information for Patent: 11,395,888

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1702407	Feb 14, 2017

International Family Members for US Patent 11,395,888

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3052341
European Patent Office	3582838
European Patent Office	4292630
Spain	2952396
United Kingdom	201702407
Portugal	3582838