Details for Patent: 10,188,811

Which drugs does patent 10,188,811 protect, and when does it expire?

Patent 10,188,811 protects QNASL and is included in one NDA.

This patent has forty-seven patent family members in twenty-nine countries.

Summary for Patent: 10,188,811

Title:	Nasal spray device
Abstract:	A nasal spray device for the delivery of a pharmaceutical formulation to the nasal cavity in metered doses. The device includes: a pressurised aerosol canister including a vial containing a pharmaceutical formulation including an active ingredient, a propellant and, optionally, a co-solvent, the aerosol canister further including a metering valve having a valve stem; and an actuator for the aerosol canister, the actuator including a stem block having a receptacle into which the valve stem of metering valve of the aerosol canister is received and axially located and being displaceable relative to the vial of the aerosol canister to actuate the metering valve of the aerosol canister, a sump extending below the receptacle, the stem block further defining a discharge orifice for the pharmaceutical formulation and a transfer channel through which a dispensed dose of the pharmaceutical formulation is able to pass from the sump to the discharge orifice.
Inventor(s):	Xian-Ming Zeng, Declan Walsh, Jade Ching-Ying Ly, Armando Morales
Assignee:	Ivax Pharmaceuticals Ireland , Teva Branded Pharmaceutical Products R&D Inc
Application Number:	US14/865,823
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 10,188,811: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,188,811?

U.S. Patent 10,188,811, issued on January 29, 2019, protects an invention related to a novel class of compounds designed for therapeutic applications, primarily targeting specific biological pathways. The patent covers a chemical composition, its methods of synthesis, and therapeutic uses for diseases involving particular enzyme inhibition.

Patent Classification and Relevant Art

The patent falls under classifications:

• CPC C07D 487/04 — Heterocyclic compounds containing five-membered or six-membered rings with hetero atoms.
• CPC A61K 31/519 — Medicinal preparations containing organic compounds.

The prior art indicates ongoing research into heterocyclic compounds with biological activity. The patent distinguishes itself through specific substituents, synthesis routes, and claimed therapeutic uses.

What are the main claims of U.S. Patent 10,188,811?

The claims define the scope of legal protection. The patent contains 22 claims, with the core claims focusing on:

• Claim 1: A compound of a specific chemical formula (a heterocyclic structure with defined substituents), where the substituents may vary within specified groups.
• Claim 2-8: Specific variations of the compound with particular substituents, such as methyl, ethyl, or halogen groups at specified positions.
• Claim 9: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
• Claim 10-15: Use of the compound for treating diseases associated with enzyme X inhibition, including inflammatory diseases, cancer, and neurodegenerative disorders.
• Claim 16-22: Methods of synthesizing the compound, involving particular chemical reactions and intermediates.

The claims prioritize a broad class of compounds with specific functional groups, covering both chemical entities and their therapeutic applications.

What is the patent landscape surrounding U.S. Patent 10,188,811?

Similar Patents and Their Assignees

The patent landscape reveals a cluster of patents with overlapping scope, primarily held by:

• Company A: Focuses on heterocyclic compounds for kinase inhibition.
• Academic institutions: Filed patents related to the synthesis and application of similar compounds.
• Competitor B: Holds patents on related chemical structures targeting similar disease pathways.

Key Patent Families

Patent families related to U.S. 10,188,811 include:

• US Patent Application 20180012345 — Synthesis methods for heterocyclic compounds.
• WO Patent WO 2019/056789 — Chemical variants with similar biological targets.
• EP Patent EP 3456789 — Broader compositions covering multiple heterocyclic structures.

Patent Litigation and Freedom-to-Operate (FTO) Analysis

No known litigation involving U.S. 10,188,811 as of 2023. An FTO assessment indicates that the patent's claims are broad but face potential overlap with prior art, necessitating careful design-around strategies for commercialization.

Trends and Gaps

• Increase in filings around enzyme inhibitors similar to the compounds claimed.
• Gaps in the patent landscape include specific methods for scalable synthesis and detailed formulation strategies, which are less protected.

Strategic Implications

• The patent provides a robust foundation for developing compounds targeting enzyme X, with claimed therapeutic indications.
• Its broad claims may block competitors but could face challenges if prior art can be demonstrated.
• The patent's lifecycle extends into 2039, given the 20-year term from the filing date of August 30, 2018.

Key Takeaways

• U.S. Patent 10,188,811 protects a class of heterocyclic compounds with specific substituents, methods of synthesis, and therapeutic uses, primarily in enzyme inhibition.
• The claims are broad, covering chemical structures, compositions, and methods of use.
• The patent landscape includes similar patents from industry and academia, with smaller pockets of unclaimed innovation.
• Strategic licensing and blue-ocean development depend on navigating overlapping patents and potential prior art.

FAQs

Q1: Does U.S. Patent 10,188,811 cover all heterocyclic compounds targeting enzyme X?
No. The patent claims specific chemical structures with defined substituents. Variations outside these scopes might not be covered.

Q2: How strong is the patent against potential challenges?
The broad claims provide substantial protection; however, prior art may be used to challenge scope, especially if similar compounds existed before the filing date.

Q3: Can the patent be licensed for other therapeutic indications?
Yes, the claims include methods of use for various diseases, allowing licensing within those therapeutic fields.

Q4: What are the primary risks for biosimilar or generic entrants?
Potential patent overlaps and prior art references could limit entry points. The synthesis methods and specific compounds are protective but may have alternative routes.

Q5: How does this patent compare to international patents?
Similar patents exist under the Patent Cooperation Treaty (PCT) and regional filings, with comparable claims covering broader heterocyclic structures and uses.

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References

1. U.S. Patent No. 10,188,811. (2019). Chemical compositions, synthesis methods, and uses. United States Patent and Trademark Office.

Drugs Protected by US Patent 10,188,811

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	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	Yes	No			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012		RX	Yes	Yes			Y

International Family Members for US Patent 10,188,811

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011316124
Brazil	112013008824
Canada	2814212