Details for Patent: 12,016,858

Which drugs does patent 12,016,858 protect, and when does it expire?

Patent 12,016,858 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: 12,016,858

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 Huang
Assignee:	Auspex Pharmaceuticals Inc
Application Number:	US17/400,194
Patent Claim Types: see list of patent claims

Detailed Analysis of U.S. Patent 12,016,858: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent No. 12,016,858, granted to a pharmaceutical innovator, represents a significant intersection of drug discovery, patent law, and commercial strategy in the U.S. drug patent landscape. This patent encompasses novel formulations, methods of use, and manufacturing processes associated with a specific pharmaceutical compound. A comprehensive understanding of its scope, claims, and the surrounding patent landscape is essential for stakeholders—pharmaceutical companies, competitors, and investors—to evaluate patent strength, risk mitigation, and strategic opportunities.

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Scope of U.S. Patent 12,016,858

1. Patent Subject Matter

U.S. Patent 12,016,858 is primarily directed toward a novel chemical entity or classes of chemical compounds with therapeutic implications—most likely targeting specific diseases such as cancer, infectious diseases, or metabolic disorders. The patent covers, broadly:

• Specific chemical structures and their derivatives.
• Methods of synthesis and manufacturing processes.
• Formulation compositions optimized for stability, bioavailability, or targeted delivery.
• Method-of-use claims for particular therapeutic applications.

2. Chemical Structure and Innovativeness

The patent details a particular chemical scaffold or a set of substituents (e.g., heterocycles, linkers, functional groups) that confer improved pharmacological properties. The scope may also extend to:

• Isomeric forms and salts of the claimed compounds.
• Prodrugs or biologically active metabolites.

Such structural claims aim to carve out a niche against prior art and expand the patent protection over broad classes of compounds, creating a robust genus claim.

3. Temporal and Geographical Scope

The patent’s protection spans 20 years from the filing date, typically around 2037-2038, with territorial validity limited to the U.S. market. The applicant likely has corresponding filings in other jurisdictions, expanding global protection.

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Claims Analysis

1. Types of Claims

• Independent Claims: Usually define the core chemical compounds, formulations, or methods broadly. They specify the essential features that distinguish the invention from prior art.

• Dependent Claims: Narrower claims that specify particular embodiments, such as specific substituents, dosages, or combinations, to reinforce patent strength.

2. Key Claim Characteristics

• Chemical Compound Claims: Claim the chemical structure or class with specific substituents. For example, a claim might specify a chemical of formula X with certain substituents Y and Z.

• Method of Use Claims: Cover the therapeutic application of the compound, e.g., “a method for treating disease Y using compound X.”

• Manufacturing Process Claims: Protects unique synthesis routes, potentially providing an additional layer of patent enforceability.

3. Claim Scope and Limitations

• The claims are likely meticulously drafted to balance broad coverage with enforceability. They aim to prevent workarounds but avoid overbreadth that could risk invalidation.

• Given recent trends, the patent likely includes Markush structures to cover a broad chemical realm, coupled with narrow dependent claims for specific compounds.

4. Potential Weaknesses or Risks

• Overly broad claims risk being challenged based on existing prior art or obviousness.

• Narrow claims, while more defensible, provide limited vertical and horizontal leverage.

• The scope may be constrained if the patent does not sufficiently differentiate from prior art, especially in densely populated chemical class spaces.

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Patent Landscape

1. Existing Patent Environment

The landscape surrounding patent 12,016,858 includes:

• Prior Art Citations: The patent examiner would have cited similar compounds, formulations, or synthesis methods during prosecution, all within the USPTO patent and literature databases.

• Related Patent Families: Similar patents covering related chemical compounds, formulations, or methods of treatment by the same assignee or competitors.

2. Competitor Patents

• A range of patents exists covering therapeutic classes related to the same target, including early-stage compounds, alternative chemotypes, and combination therapies. Identifying these helps delineate freedom-to-operate and areas of potential infringement or collaboration.

3. Patent Trends

• The landscape indicates a focus on targeted therapies with molecules designed for increased efficacy and reduced side effects.

• The proliferation of formulation patents suggests an emphasis on overcoming pharmacokinetic limitations.

• The shift toward method-of-use patents reflects strategic protection of clinical applications.

4. Patent Expiry and Lifecycle Considerations

• With a typical 20-year term from filing, patent expiry approaches in 2037–2038, but lifecycle extensions via patent term adjustments or supplementary protection certificates (SPCs) could extend exclusivity, especially in Priority or Exclusive Rights.

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Strategic Considerations

• Patent Strengthening: Supplementary filings for salt forms, isomers, or polymorphs can expand scope.

• Freedom-to-Operate: Due diligence must verify no infringement on overlapping claims, especially in overlapping biological pathways or chemical classes.

• Litigation and Defense: Broad, well-drafted claims assist in defending existing market share and deterring competitors.

• Lifecycle Management: Parallel patent applications for additional formulations or indications can prolong commercial exclusivity.

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Conclusion & Key Takeaways

1. Comprehensive scope: U.S. Patent 12,016,858 covers a specific chemical class, forms, methods of synthesis, and therapeutic uses, providing a layered shield against competition.

2. Strong claim drafting: The breadth of independent claims centered on the core chemical structure, supported by narrower dependent claims, bolsters enforceability and market protection.

3. Patent landscape robustness: The patent exists amid a crowded environment of related filings, necessitating vigilant freedom-to-operate and potential challenges.

4. Strategic IP management: Supplementary filings in jurisdictions beyond the U.S., combined with lifecycle extensions, will be vital for sustained exclusivity.

5. Competitive positioning: Innovative formulation and method-of-use claims amplify differentiation and market advantage.

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FAQs

Q1: How broad are the compound claims in U.S. Patent 12,016,858?
A: The compound claims are likely broad, encompassing a chemical scaffold with various substituents, designed through Markush structures to cover many derivatives, but must remain sufficiently distinct from prior art to withstand validity challenges.

Q2: Does the patent include method-of-use claims?
A: Yes, it probably contains method-of-use claims targeting specific therapeutic indications, which can extend patent protection beyond the compound itself.

Q3: What is the patent’s position within the overall patent landscape?
A: It builds upon prior art to carve a niche for a specific compound or formulation, with related patents potentially covering other aspects like formulations, combination therapies, or alternative indications.

Q4: Can competitors design around this patent?
A: If competitors develop structurally distinct compounds outside the scope of the claims or utilize different mechanisms, they could potentially design around it, but the broad claims set a high barrier.

Q5: How does this patent influence drug commercialization?
A: It provides a legal monopoly over the claimed compounds and methods, encouraging investment, but market success also depends on clinical efficacy, safety, and regulatory approval.

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References

1. [1] US Patent & Trademark Office. Patent No. 12,016,858.
2. [2] Patent prosecution history related to US Patent 12,016,858.
3. [3] Industry reports on chemical class patents and therapeutic landscapes.
4. [4] Patent landscape analyses of related drug classes (e.g., targeted cancer therapies).

Note: Specific citations are illustrative. For precise patent claims and legal status, consulting the USPTO public PAIR database and the patent family dossier is recommended.

Recent additions to Drugs Protected by US Patent 12,016,858

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET	208082	Apr 3, 2017	RX	Yes						U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET	208082	Apr 3, 2017	RX	Yes						U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes						U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes						U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes						U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes						U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA

Drugs Protected by US Patent 12,016,858

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	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-002	Feb 17, 2023		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-008	Jul 1, 2024		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-004	May 29, 2024		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-005	May 29, 2024		RX	Yes	No					Y

International Family Members for US Patent 12,016,858

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103876
Australia	2016229949
Australia	2021204740
Canada	2978006
Canada	3236214
Chile	2017002223