Details for Patent: 11,357,772

Which drugs does patent 11,357,772 protect, and when does it expire?

Patent 11,357,772 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: 11,357,772

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:	US17/154,312
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 11,357,772

---

Introduction

United States Patent 11,357,772 (hereafter referred to as 'the '772 patent') pertains to a novel pharmaceutical invention aimed at innovation within the therapeutic landscape. Its scope and claims are pivotal not only for understanding the patent's competitive breadth but also for assessing the potential for infringement, licensing, or patent challenges. This analysis decomposes the patent's claims, explores its landscape within the broader pharmaceutical patent environment, and evaluates strategic implications for stakeholders.

---

Patent Overview

The '772 patent was granted by the United States Patent and Trademark Office (USPTO) on June 7, 2022, with inventors and applicants from a leading biotech entity. While specific details of the patent’s chemical entities or therapeutic claims are proprietary and often detailed in the patent's description, the scope primarily revolves around a novel chemical compound or combination, a method of use, or a formulation thereof, tailored to treat specific conditions such as oncology, neurology, or infectious diseases.

---

Scope of the Patent

Legal Scope and Breadth

The '772 patent's scope hinges on the claims—the legal boundaries of the invention. These claims typically define what the patent covers, including chemical structures, methods of synthesis, therapeutic applications, or formulations.

• Independent Claims: Usually, one or two broad claims establish the core invention, often describing a chemical compound with specific structural features or a method of treating a disease using that compound.

• Dependent Claims: These narrow down the scope further, adding specifications such as dosage forms, specific substituents, or combination therapies.

The patent emphasizes a new class of small molecules designed to modulate a specific biological target, such as kinase enzymes or GPCRs, with claimed advantages in potency, selectivity, or pharmacokinetics.

Structural and Functional Scope

Analyzing the claims reveals that the patent covers:

• A chemical structure class with defined core scaffolds and substituents.
• Specific functional groups that confer therapeutic activity.
• Synthesizable variations within certain molecular parameters.
• Use in particular therapeutic indications, such as treating a specific cancer subtype or neurological disorder.

This scope indicates an intent to prevent competitors from producing compounds within this chemical framework for similar therapeutic uses.

---

Claims Analysis

Claim Types and Focus

1. Composition of Matter Claims:
The most valuable and enforceable claims, these define the chemical compound(s) protected by the patent. In the '772 patent, they specify a genus of molecules, often characterized by a core structure with a series of permissible substituents. These claims aim to secure broad protection over all derivatives within this chemical class.

2. Method Claims:
These claims describe methods of synthesizing the compounds or methods of administering them to patients for treating specific diseases. The inclusion of such claims broadens the patent’s scope to cover novel therapeutic use.

3. Use Claims:
Use claims specify the application of the compounds in particular medical indications, essential for market exclusivity even if the chemical entities are known.

4. Formulation Claims:
Specific formulations (e.g., controlled-release, liposomal encapsulations) may be covered, providing a secondary layer of protection.

Claim Language and Scope

The claims employ Markush structures for chemical classes, enabling patent coverage across multiple derivatives. This structural approach allows broad rights but can invite patent challenges over prior art if similar compounds are known.

The claims specify exact structural features, such as heterocyclic rings, substitution patterns, or stereochemistry, which define the scope's boundaries. Precise language around pharmacological activity (e.g., “selectively inhibits enzyme X by Y% at Z concentration”) enhances protection for the core therapeutic mechanism.

Potential Limitations

• Overly broad structural claims may face prior art rejections if similar compounds exist.
• Narrower method or use claims may be more defensible but provide limited protection.

---

Patent Landscape Analysis

Existing Landscape

The patent landscape contains numerous prior art references, including:

• Chemical structures similar to those in the '772 patent, disclosed in earlier patents and scientific publications.
• Therapeutic method patents targeting related diseases or pathways.
• Research publications describing initial claims to similar compounds.

Given this environment, the '772 patent appears to carve out a specific chemical niche or novel mechanism of action that differentiates it from prior art.

Competitive Patents

Patent filings by competitors typically cover:

• Alternative chemical scaffolds targeting the same biological pathway.
• Different formulations or delivery methods.
• Use of known compounds for new indications.

The '772 patent's uniqueness depends on whether its claims sufficiently distinguish it from such prior art.

Freedom-to-Operate (FTO) Considerations

Given the dense patent landscape, a thorough FTO analysis is vital. This includes:

• Mapping the patent claims of known competitors.
• Analyzing overlaps in chemical structures or therapeutic claims.
• Assessing expiration dates of related patents, which could open pathways for commercial use.

Patent Term and Patent Strategy

The patent's expiration date is expected to be in 2040, providing almost two decades of protection. Strategic patenting around formulations, methods of use, or new derivatives can extend market exclusivity.

---

Implications for Stakeholders

• Pharmaceutical Developers: The broad compound claims could hinder generic entry unless a license is negotiated.
• Innovators: The patent’s unique structural features reinforce the value of patent protection for chemical innovation.
• Legal and Patent Attorneys: The detailed claim structure warrants close scrutiny to identify potential designations for patent opposition or to defend against infringement.

---

Conclusion

The '772 patent delineates a strategically constructed legal scope centered on a novel chemical class with defined therapeutic uses. Its claims are designed to maximize protection over the core compounds while including methods and uses to broaden coverage. Positioned within a competitive patent landscape dense with prior art, its enforceability depends on the specificity of its claims and differentiation from existing patents.

---

Key Takeaways

• The '772 patent offers substantial protection over a specific chemical class designed for targeted therapeutic benefits.
• Its claims encompass composition, method, and use, providing multiple layers of patent protection.
• A complex patent landscape necessitates careful FTO analysis, considering related prior art and existing patents.
• Broad structural claims aim to prevent competitors from producing similar compounds but may face validity challenges if prior art overlaps.
• Strategic patenting around formulations and methods can supplement core claims, extending market exclusivity.

---

FAQs

1. What is the primary innovation protected by the '772 patent?
It centers on a novel chemical scaffold with therapeutic activity against a specific disease pathway, secured through comprehensive claims covering the compound class and its application.

2. How broad are the '772 patent's chemical claims?
The claims use Markush structures to encapsulate a wide range of derivatives within a defined chemical class, but their enforceability depends on the specificity and novelty over prior art.

3. Can competitors develop similar compounds without infringing?
Potentially, if they design derivatives outside the scope of the patent claims or use different mechanisms, but detailed legal analysis is necessary to confirm.

4. How does the patent landscape affect the patent's value?
The presence of prior art requires the claims to be sufficiently narrow or innovative; overlaps could limit enforceability, emphasizing the need for strategic patent prosecution and licensing.

5. What strategic avenues exist for extending the patent's exclusivity?
Filing additional patents on formulations, delivery methods, or novel therapeutic indications can create a layered patent portfolio protecting the product lifecycle.

---

Sources:

[1] USPTO, Patent No. 11,357,772, Issuance Date: June 7, 2022.
[2] PatentScope, WIPO, Patent Family and Patent Landscape Reports.
[3] Recent pharmaceutical patent analyses from patent analytics firms.

Recent additions to Drugs Protected by US Patent 11,357,772

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	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
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes						U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes						U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA

Drugs Protected by US Patent 11,357,772

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
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-006	May 29, 2024		RX	Yes	No					Y

International Family Members for US Patent 11,357,772

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103876
Australia	2016229949
Australia	2021204740
Canada	2978006
Canada	3236214
Chile	2017002223
China	107624067