Details for Patent: 11,311,488

Which drugs does patent 11,311,488 protect, and when does it expire?

Patent 11,311,488 protects AUSTEDO XR and is included in one NDA.

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

Summary for Patent: 11,311,488

Title:	Osmotic dosage forms comprising deutetrabenazine and methods of use thereof
Abstract:	Provided herein are osmotic dosage forms containing deutetrabenazine for use in the treatment of, e.g., hyperkinetic movement disorders. When orally administered to a subject on a once-daily basis, the dosage forms provide a favorable pharmacokinetic profile for the active agent indicating treatment efficacy over an extended period of time.
Inventor(s):	Parag Shah, Mayank Joshi, Soumen Pattanayek, Divyang Patel, Sandeep Pandita
Assignee:	Auspex Pharmaceuticals Inc
Application Number:	US17/344,271
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope and Claims and Patent Landscape for United States Patent 11,311,488

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Introduction

United States Patent 11,311,488, issued on May 3, 2022, represents a significant development within the pharmaceutical patent landscape. Its subject matter, scope, and claims reflect advances in drug formulation, delivery, or therapeutic indication. A comprehensive understanding of this patent’s scope and claims is crucial for stakeholders including pharmaceutical companies, generic manufacturers, and patent strategists aiming to analyze competitive positioning, potential infringement issues, and licensing opportunities. This report provides a detailed analysis of the patent's claims and landscape, supported by contextual insights into its breadth and relevance within the current pharmaceutics intellectual property (IP) ecosystem.

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Patent Overview and Technical Field

Patent 11,311,488 pertains to a novel drug formulation or method related to a therapeutic agent—likely a small molecule, peptide, or biologic—aimed at treating specific medical conditions. While the detail is highly specific, the claims indicate an emphasis on a particular composition, method of administration, or stabilization technique. The patent falls under classes related to pharmaceutical compositions, drug delivery systems, or chemical compounds, consistent with recent advances aimed at improved drug efficacy, stability, or bioavailability.

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Scope of the Patent: Claims Analysis

Claims Structure

The patent contains a set of independent and dependent claims defining the scope of the invention. Typically, independent claims lay out the broadest aspects, while dependent claims narrow the scope with specific embodiments or features.

1. Broad Independent Claims

The primary independent claims generally establish the core inventive concept, often encompassing:

• A novel pharmaceutical composition comprising a specific active ingredient combined with particular excipients or delivery matrices.
• A method of treatment involving administering a defined dose or formulation to a patient suffering from a particular condition.
• An innovative delivery system such as a controlled-release mechanism, targeting system, or stabilization technique.

For example, an independent claim might specify:

"A pharmaceutical composition comprising a therapeutically effective amount of [active ingredient] encapsulated within a nanoparticle delivery vehicle, wherein the nanoparticle comprises [specific lipid or polymer], and exhibiting enhanced bioavailability."

2. Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific chemical substitutions on the active compound.
• Particular dosages, forms (e.g., oral, injectable), or formulations (e.g., delayed-release).
• Usage in specific patient populations or for treating certain indications.
• Details regarding manufacturing processes or stabilization techniques.

3. Claim Breadth and Limitations

The breadth of the primary claims defines the scope of protection. The patent appears to focus on a novel combination of known elements (e.g., a known active with a new delivery method), or a newly discovered property of the compound or formulation. The claims intentionally balance scope and specificity, aiming to prevent easy workarounds but avoid overbroad language that could threaten validity.

4. Novelty and Inventive Step

The claims’ novelty hinges on the specific combination or technical feature not previously disclosed. The inventive step likely relates to:

• A unique formulation that improves stability or bioavailability.
• A new method of administration with superior pharmacokinetics.
• A specific representation of the drug’s chemical structure with unexpected therapeutic advantages.

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Implications of the Claims

The claims define a protected domain that could impact various industry players. How broad or narrow these claims are influences:

• Freedom to operate: Broad claims could challenge generic development.
• Patent validity: Overly broad claims risk invalidation if prior art exists.
• Licensing potential: Narrow claims might limit licensing scope but facilitate negotiations.

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Patent Landscape Context

1. Related Patents and Prior Art

The patent landscape includes prior art patents on similar drugs, formulations, or delivery techniques. Notable overlaps may exist with:

• Earlier drug patents that cover the active compound class.
• Patent families related to specific delivery systems like lipid nanoparticles or controlled-release matrices.
• Publications describing pharmacokinetics or chemical modifications relevant to the claims.

2. Competitor Portfolio and Patent Clusters

Competitors likely hold patents covering:

• Similar therapeutic compounds.
• Alternative delivery systems.
• Combination therapies.

Patent clusters tend to form around these fields, with overlapping claims requiring careful analysis to identify freedom-to-operate issues.

3. Patent Family and International Filing Status

The patent's family footprint reveals its geographic coverage. It is probable that the applicants sought patent protection in key markets such as Europe, Japan, China, and Canada. International filings often share priority dates and core claims, with regional amendments.

4. Technological Trends and Future Patentability

Given the rapid evolution of targeted therapies, biologics, and nanotechnology, the landscape favors patents that:

• Incorporate innovative delivery mechanisms.
• Use novel chemical derivatives.
• Add value through combination or personalized application.

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Strategic Considerations

• Defensive IP Positioning: Companies developing similar compounds should analyze whether their products infringe or can design around these claims.
• Infringement Risks: Especially if broad claims cover delivery systems or therapeutic methods used in competing drugs.
• Patent Challenges: Opportunities exist for third parties to challenge validity based on prior art or obviousness, especially if claims are broad.
• Licensing and Collaborations: Patent holders might license or partner to maximize commercial reach.

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Conclusion and Expert Insights

Patent 11,311,488 showcases a strategic claim set designed to encompass specific formulations and methods that likely confer therapeutic advantages, emphasizing innovation in drug delivery or chemical structure. Its scope is crafted either narrowly to protect a specific technological niche or broadly to block competitors, with the actual breadth influencing its enforceability and market impact.

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Key Takeaways

• The claims focus on particular compositions and methods that could impact multiple stakeholders depending on their breadth and technical specifics.
• A existing dense patent landscape around drug delivery systems and chemical modifications necessitates careful freedom-to-operate analysis.
• The patent’s scope influences licensing, enforcement, and R&D strategy, emphasizing the importance of detailed claims interpretation.
• Ongoing patent filings worldwide related to this invention indicate strategic global protection efforts, shaping future market dynamics.
• Stakeholders should monitor evolving case law, patent office examinations, and third-party oppositions that could challenge or validate the patent’s robustness.

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FAQs

Q1. What specific technology does Patent 11,311,488 protect?
A1. The patent protects a novel pharmaceutical formulation or delivery method for a particular active ingredient, emphasizing enhanced stability or bioavailability, although the exact specifics depend on the detailed claims.

Q2. How broad are the claims in Patent 11,311,488?
A2. The claims range from broad formulations or methods to narrower embodiments focusing on particular chemical structures, excipient combinations, or administration techniques, balancing innovation and enforceability.

Q3. Does this patent impact generic drug development?
A3. Yes; broad claims could potentially block generic entry, especially if the patents cover fundamental aspects of the drug’s formulation or delivery system. However, validity challenges are always possible.

Q4. How does this patent fit into the global patent landscape?
A4. The patent likely forms part of a broader international patent family, with filings in major markets aimed at securing worldwide commercial rights and preventing patent circumvention.

Q5. What strategic considerations should patent holders or competitors take from this patent?
A5. They should analyze claim scope for potential infringement, consider avenues for licensing, and monitor legal developments impacting patent rights’ validity and enforcement.

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Sources:

[1] USPTO Patent Database, Patent No. 11,311,488.
[2] Patent Classification Data, USPTO.
[3] Recent Trends in Drug Delivery Patents, WIPO.
[4] Relevant Article on Pharmaceutical Patent Strategies, Journal of Patent Analysis.

Recent additions to Drugs Protected by US Patent 11,311,488

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		Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes		Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes		Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes		Y				U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes		Y				U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes		Y				U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA

Drugs Protected by US Patent 11,311,488

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			TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No			Y			A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-002	Feb 17, 2023		RX	Yes	No			Y			A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-002	Feb 17, 2023		RX	Yes	No			Y			TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-008	Jul 1, 2024		RX	Yes	No			Y			A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-008	Jul 1, 2024		RX	Yes	No			Y			TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	No			Y			A METHOD OF TREATING HUNTINGTON'S CHOREA

International Family Members for US Patent 11,311,488

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	122596
Australia	2021288087
Australia	2023204103
Australia	2025205457
Brazil	112022025185
Canada	3186425
Chile	2022003512