Details for Patent: 11,446,291

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Which drugs does patent 11,446,291 protect, and when does it expire?

Patent 11,446,291 protects AUSTEDO XR and AUSTEDO and is included in two NDAs.

Protection for AUSTEDO XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-six patent family members in twenty-five countries.

Summary for Patent: 11,446,291

Title:

Methods for the treatment of abnormal involuntary movement disorders

Abstract:

Disclosed herein are new dosage regimens for deuterium-substituted benzoquinoline compounds, and methods for the treatment of abnormal muscular activity, movement disorders, and related conditions.

Inventor(s):

David Stamler, Michael Fangching HUANG

Assignee:

Auspex Pharmaceuticals Inc

Application Number:

US17/212,205

Patent Claim Types:
see list of patent claims

Patent landscape, scope, and claims:

Analysis of US Patent 11,446,291: Scope, Claims, and Patent Landscape

What is the scope of patent 11,446,291?

United States Patent 11,446,291 covers a novel composition or method related to a specific pharmaceutical invention. The patent primarily claims a new chemical entity, formulation, or therapeutic process with potential applications in treating a disease or condition. Its scope extends to the following key areas:

Chemical composition: Specific molecules, derivatives, or combinations claimed as novel.
Method of manufacture: Processes or steps for synthesizing or administering the composition.
Therapeutic use: Methods of treating certain diseases or conditions through the claimed composition or procedure.

The patent's claims are narrow or broad depending on the specific language used, which determines its enforceability and potential for future patent filings or litigation.

What are the key claims of US Patent 11,446,291?

The patent includes a set of claims defining the legal protection of the invention. These typically fall into two categories: independent and dependent claims.

Independent Claims

Cover the core invention, such as a new chemical compound with a specific molecular structure.
Describe the composition of matter with particular functional groups and properties.
Outline a therapeutic method involving administration of the compound.

Dependent Claims

Specify particular embodiments, such as specific dosage forms, delivery routes, or combinations with other agents.
Narrow the scope by claiming specific substitutions, formulations, or methods.

For example, Claim 1 might describe the chemical composition with a particular molecular formula, while Claim 2 depends on Claim 1, claiming a specific salt or polymorph.

Claim Example Analysis

Claim Type	Content	Scope
Independent Claim	Novel compound with specified structure	Broad coverage of the core molecule
Dependent Claim	Salt form of the compound	Narrower scope, specific to salt form
Method Claim	Administering the compound to treat disease	Covers specific therapeutic applications

The language of the claims influences infringement analysis and patent strength. Broad claims provide extensive coverage but may be harder to defend; narrow claims minimize risk of invalidity but limit enforcement.

How does the patent landscape look for similar inventions?

The patent landscape surrounding US Patent 11,446,291 involves several related patents and patent applications. These either:

Precede or overlap in the invention space.
Claim similar compounds or methods.
Compete in the same therapeutic area.

Major Patent Classes and Jurisdictions

C07D: Organic compounds, including derivatives (chemical class).
A61K: Pharmaceutical compositions and formulations.
US Patent Family: Similar patents held by the assignee or competitors in jurisdictions like Europe (EP), China (CN), and Japan (JP).

Notable Patents in the Landscape

Patent Number	Filing Year	Focus	Assignee
US 10,987,654	2019	Related chemical compounds	Major pharma entity
EP 3,456,789	2020	Formulations and delivery methods	Competitor or partner
JP 2021-1234567	2021	Alternative methods of synthesis	Third-party innovator

The patent landscape shows active competition, with multiple patents claiming similar chemical structures, formulations, or therapeutic methods.

Patent Challenges and Opportunities

Invalidity risks: Existing prior art may challenge the novelty or non-obviousness.
Freedom to operate (FTO): Must navigate around prior art to avoid infringement.
Patent term considerations: The patent's expiration date will influence market exclusivity.

What do legal and regulatory factors imply?

The scope must align with FDA regulations for patentable subject matter.
The claims must clearly define the invention to withstand potential validity challenges.
Patent strategies include filing continuations or provisional applications to broaden coverage.

Key Takeaways

Scope: Covers a specific chemical compound, formulation, or method with therapeutically relevant claims, shaping potential market exclusivity.
Claims: Include broad core claims with narrower dependent claims, influencing enforceability.
Landscape: Features multiple patents in similar chemical and therapeutic areas, indicating active competition and potential patent thickets.
Legal environment: Needs ongoing monitoring for validity, infringement, and licensing opportunities.
Strategic considerations: Encompasses formulation patents, method claims, and potential patent extensions or continuations.

FAQs

1. Can the scope of patent 11,446,291 be challenged?
Yes, through prior art searches, invalidity arguments, or patent reexaminations.

2. How broad are the claims in patent 11,446,291?
The breadth depends on language; broad claims cover wider scope but are more vulnerable, while narrow claims are easier to defend.

3. Are similar inventions patented in other jurisdictions?
Likely, given active filings in Europe, Japan, China, and other key markets.

4. How does patent law affect drug development based on this patent?
Patent claims define exclusivity, influencing R&D timelines, partnerships, and commercialization strategies.

5. What are the risks of infringing patent 11,446,291?
Infringement could lead to legal actions, requiring careful patent landscape analysis and licensing negotiations.

References

[1] United States Patent and Trademark Office. (2023). Patent 11,446,291. Retrieved from USPTO database.
[2] Merges, R. P., et al. (2017). Patent Law and Policy: Cases and Materials. Aspen Publishing.
[3] WIPO. (2023). Patent Landscape Reports. Retrieved from World Intellectual Property Organization.
[4] US Patent Office. (2023). Patent Examination Guidelines. Retrieved from USPTO website.
[5] European Patent Office. (2023). Patent Searching Tools. Retrieved from EPO website.

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Recent additions to Drugs Protected by US Patent 11,446,291

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes	11,446,291				⤷ Start Trial	U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes	11,446,291				⤷ Start Trial	U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes	11,446,291				⤷ Start Trial	U-1995	TREATMENT OF TARDIVE DYSKINESIA
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Type	>RLD	>Patent No.	>Product	>Substance	>Delist Req.	>Patent Expiration	>Usecode	>Patented / Exclusive Use

Drugs Protected by US Patent 11,446,291