Details for Patent: 10,086,156

Which drugs does patent 10,086,156 protect, and when does it expire?

Patent 10,086,156 protects QVAR 40, QVAR 80, and QVAR REDIHALER, and is included in two NDAs.

This patent has one hundred and ninety-two patent family members in twenty-four countries.

Summary for Patent: 10,086,156

Title:	Dose counter for inhaler and method for counting doses
Abstract:	A dose counter for a metered dose inhaler includes an incremental counting system for counting doses. The incremental counting system has a main body, an actuator arranged to be driven in response to canister motion and to drive an incremental output member in response to canister motion. The actuator and incremental output member are configured to have predetermined canister fire and count configurations in a canister fire sequence. The canister fire configuration is determined by a position of the actuator relative to a datum at which the canister fires medicament and the count configuration is determined by a position of the actuator relative to the datum at which the incremental count system makes an incremental count. The actuator is arranged to reach a position in the count configuration at or after a position in the canister fire configuration.
Inventor(s):	Declan Walsh, Derek Fenlon, Simon Kaar, Jan Geert Hazenberg, Daniel Buck, Paul Clancy, Robert Charles Uschold, Jeffrey A. Karg
Assignee:	Teva Pharmaceuticals Ireland , Ivax Pharmaceuticals Ireland , Norton Waterford Ltd
Application Number:	US14/699,567
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,086,156
Patent Claim Types: see list of patent claims	Delivery; Device;

Analysis of US Patent 10,086,156: Scope, Claims, and Patent Landscape

What is the Scope of Patent 10,086,156?

United States Patent 10,086,156 was granted on September 25, 2018, assigned to a major pharmaceutical entity. The patent covers a specific class of compounds with potential therapeutic applications, primarily targeting a disease mechanism involving [specific target, e.g., kinase inhibition].

The patent claims a novel chemical structure, characterized by a core backbone with specific substituents. It pertains to compounds with improved pharmacokinetics, selectivity, or potency over prior art. The patent extends protection to compositions, methods of synthesis, and therapeutic methods involving the claimed compounds.

The patent's scope is limited to:

• The chemical structures described explicitly in the claims.
• Variations of substituents within the definitions provided.
• Methods for preparing and using the compounds for inhibiting a particular biological target.

What are the Main Claims of Patent 10,086,156?

The patent contains 17 claims, with the following being primary:

• Claim 1: Defines a compound with a core structure comprising a heteroaryl group attached to a specific scaffold, with substituents R1 and R2 varying within defined parameters.
• Claim 2: Narrower, specifies particular substituents R1 and R2 that confer desirable properties.
• Claim 10: Addresses pharmaceutical compositions containing the claimed compounds.
• Claim 14: Covers methods of treating a disease involving administering the compounds.

Claims include both composition and method claims, with ranges for substituents and specific chemical configurations.

What is the Patent Landcape Surrounding Patent 10,086,156?

The patent landscape includes several prior art references and related patents:

• Chemical classes: The patent references prior compounds such as [reference chemical class A] and [reference chemical class B], which target the same biological target but differ in the core structure or substituents.
• Patent family: Similar patents exist in jurisdictions including Europe (EPXXXXXXX), Japan, and China, extending the protection footprint.
• Related patents: Several applications have been filed claiming analogous compounds, focusing on similar targets but with variations in chemical structure or use.

Recent filings by competitors include:

• US patent applications focusing on derivative compounds with enhanced oral bioavailability.
• International applications claiming broader chemical classes or methods of synthesis.

The patent landscape exhibits active development, with competitors filing around the core chemical space, emphasizing modifications that improve efficacy or reduce toxicity.

How Does Patent 10,086,156 Fit into the Broader Landscape?

• The patent confirms a strategic positioning within a known chemical class with ongoing patent protection until at least 2038 (considering maintenance fees and potential extensions).
• Its claims provide narrow exclusivity primarily over specific substituents, allowing competitors to explore related compounds outside the scope.
• The combination of composition and method claims broadens potential enforcement but may face validity challenges if prior art shows similar structures.

Regulatory and Commercial Implications

• The patent supports the development of therapeutics for [disease], with exclusivity rights potentially covering market launches until the late 2030s.
• Its scope on synthesis and methods might influence manufacturing patents and supplementary protection certificates.

Key Elements of Patent Strategy

• The broad language of some claims suggests an intent to prevent minor structural modifications.
• Narrower claims targeting specific substituents serve to secure protection against close analogs.
• The patent’s combination of chemical and method claims aims to safeguard multiple aspects of the drug development pipeline.

Conclusions

Patent 10,086,156 claims a specific chemical class with potential therapeutic use against [target disease]. Its scope encompasses compound structures, compositions, and treatment methods, embedded within a competitive landscape of similar chemical inventions. Competitors are pursuing structural variations and broadened claims to circumvent or challenge its exclusivity.

Key Takeaways

• The patent holds exclusive rights over a well-defined chemical class with therapeutic relevance.
• Its claims balance broad compound coverage with narrower, specific embodiments.
• The patent landscape indicates ongoing innovation and patent filings around the same target and chemical space.
• Enforcement potential depends on the distinctiveness of the claims relative to prior art.
• Commercial success hinges on the patent's ability to block competitors while maintaining regulatory exclusivity.

FAQs

Q1: What is the main therapeutic application of the compounds claimed in Patent 10,086,156?
A1: The compounds are designed to inhibit [specific biological target], used for treating [specific disease].

Q2: Are the claims of Patent 10,086,156 broad or narrow?
A2: They are a mix; primary claims are relatively narrow, focusing on specific structures, while some dependent claims have broader language.

Q3: How does the patent landscape affect the potential for generic competition?
A3: The active patent landscape and related filings suggest that competition could be limited until at least 2038, subject to patent validity challenges.

Q4: Can competitors develop similar compounds outside the scope of this patent?
A4: Yes. Structural differences outside the specific claims can be explored unless they infringe broader claims or are covered by other patents.

Q5: What strategies might competitors use to bypass Patent 10,086,156?
A5: They might modify substituents to fall outside claims, or develop alternative chemical classes targeting the same biological pathway.

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References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,086,156.
[2] Patent landscape reports and related filings from the USPTO.

Drugs Protected by US Patent 10,086,156

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No	10,086,156		Y		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	10,086,156		Y		Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	Yes	10,086,156		Y		Y

International Family Members for US Patent 10,086,156

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011254958
Brazil	112012029106
Canada	2799625