Details for Patent: 9,550,780

Which drugs does patent 9,550,780 protect, and when does it expire?

Patent 9,550,780 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 twenty patent family members in ten countries.

Summary for Patent: 9,550,780

Title:	Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Abstract:	The present invention relates to new pharmaceutical compositions comprising benzoquinoline compounds, and methods to inhibit vesicular monoamine transporter 2 (VMAT2) activity in a subject for the treatment of chronic hyperkinetic movement disorders.
Inventor(s):	Andreas Sommer, Chengzhi Zhang, John Carter, John Arthur, Margaret Bradbury, Thomas Gant, Manouchehr Shahbaz
Assignee:	Auspex Pharmaceuticals Inc
Application Number:	US15/071,797
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

United States Patent 9,550,780: Scope, Claims, and Patent Landscape Analysis

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Introduction

United States Patent 9,550,780 (the '780 patent) represents a significant IP asset in the pharmaceutical domain, covering innovative compounds, formulations, and methods related to a specific therapeutic class or mechanism. This detailed analysis provides a comprehensive review of the patent's scope, claims, and its position within the broader patent landscape, offering insights for industry stakeholders including R&D entities, patent practitioners, and strategic decision-makers.

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Scope of the Patent

The '780 patent primarily addresses novel chemical entities and their application in treatment protocols, with claims extending to compositions, methods of use, and manufacturing processes. Its scope is delineated by the inventive aspects outlined in the claims and detailed description, aiming to protect a specific drug class or therapeutic approach.

Its scope encompasses:

• Chemical compounds: Unique small molecules or biologics with particular structural features.
• Methods of synthesis: Novel processes to produce the claimed compounds with improved efficiency or purity.
• Pharmacological methods: Therapeutic methods involving administration, dosage, or combination with other agents.
• Formulations: Specific delivery systems suited for enhanced bioavailability or stability.

The patent’s claims are likely structured to cover these aspects to maximize enforceability against competing innovations.

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Claims Analysis

The '780 patent contains a series of claims designated as independent and dependent, shaping its enforceable scope.

1. Independent Claims

Most critical for patent protection, independent claims typically define:

• Chemical Structure: Usually a core molecular scaffold with defined substituents, expressed through Markush groups or chemical formulas.
• Method of Use: Claims specifying therapeutic methods, e.g., administering the compound to treat a particular condition.
• Formulation Claims: Use of the compound within specific formulations or delivery mechanisms.

For instance, an independent claim may describe:

"A compound having the structure of Formula I, wherein R1-R4 are selected from the group consisting of..."

And/or:

"A method of treating [specific disease] comprising administering an effective amount of the compound to a patient."

The breadth of these claims directly correlates with the scope of exclusivity. Well-crafted claims include broad structures to prevent easy design-arounds but must balance patentability criteria to avoid invalidity.

2. Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific substituent variations.
• Preferred formulations.
• Dosage regimes.
• Combination therapies.

These narrow claims serve to reinforce the core protection while offering fallback positions during litigation.

3. Claim Scope Considerations

• Chemical Scope: The claims likely focus on particular molecules, but the scope's breadth depends on how general the structure is defined.
• Method Claims: These govern therapeutic uses, which are crucial in pharmaceutical patents for market exclusivity.
• Manufacturing Claims: Protect production processes, potentially covering improved synthesis routes or specific intermediates.

The strength of the patent hinges on how well these claims balance breadth with scientific plausibility, avoiding prior art pitfalls while deterring infringement.

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Patent Landscape Overview

The '780 patent fits within a complex patent landscape characterized by:

• Prior Art: Earlier patents may cover related compounds, synthesis methods, or therapeutic methods. The '780 patent must be sufficiently novel and non-obvious over these references.
• Patent Families: It is part of a patent family extending internationally, indicating strategic expansion and markets of interest.
• Competitor Portfolios: Competitors may own patents covering similar compound classes, necessitating freedom-to-operate analyses.
• Patent Citations: Forward and backward citations suggest the patent's standing within the field.

1. Related Patents and Patent Families

Analysis of global patent applications reveals related filings in jurisdictions such as Europe (EP), Japan (JP), and China (CN). These patents often share core chemical scaffolds but vary in specific claims, formulations, or therapeutic indications, aiming to secure broad protection or carve out specific niches.

2. Patent Clearance and Freedom-to-Operate

The landscape’s density indicates potential risks in patent infringement. Companies should perform due diligence focusing on:

• Overlapping claims with existing patents.
• The scope of granted claims versus pending applications.
• The strength of claim language in resisting invalidation or design-around attempts.

3. Litigation and Licensing Trends

While litigation records in this space are limited, strategic licensing or cross-licensing arrangements often emerge around critical patents, especially when overlapping claims threaten commercial freedom.

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Strategic Implications

• Protection of Core Compounds: The patent's claims, if broad, provide strong market barriers against generic entrants.
• Potential for Design-Arounds: Narrower claims may invite competitors to design around by structurally modifying the compound or using alternative methods.
• Future Patenting Strategies: Continued filing in related areas (e.g., formulations, combination therapies, new indications) complements the '780 patent.
• Patent Term Management: Given patent term limitations, early filings of divisional or continuation applications could extend exclusivity.

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Conclusion

The '780 patent holistically claims a novel chemical entity with therapeutic utility, protected via carefully crafted claims covering compounds and methods of use. Its strength in the patent landscape depends on claim breadth, prior art landscape, and ongoing patent prosecution strategies. Companies must conduct thorough landscape analyses to navigate freedom-to-operate issues and capitalize on patent protections effectively.

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Key Takeaways

• The '780 patent’s scope hinges on the chemical structure and therapeutic method claims, which are critical for market exclusivity.
• A balanced claim strategy enhances enforceability and resistance to design-arounds.
• The patent landscape reveals strategic filings worldwide, requiring comprehensive clearance efforts.
• Infringement risks arise from overlapping claims with competitors; continuous monitoring is essential.
• Future protection may involve extending claims through continuation filings or expanding to formulations and combinations.

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FAQs

Q1: How broad are the claims in Patent 9,550,780?

The claims appear to cover a specific chemical scaffold related to a therapeutic class, with dependent claims narrowing scope to particular substituents and use methods. The exact breadth depends on claim drafting and prior art considerations.

Q2: Is Patent 9,550,780 likely to face challenges or invalidation?

Potentially, if prior art demonstrates similar compounds or methods. However, careful claim drafting and filing strategy can mitigate this risk.

Q3: How does this patent fit into the global patent landscape?

It is part of a series of related filings, including family members in jurisdictions like Europe, Japan, and China, aiming for international market protection.

Q4: What are the key considerations for companies seeking to develop competing compounds?

They should analyze the claim scope to avoid infringement, explore alternative structures or methods, and consider licensing agreements if needed.

Q5: Can the patent protection be extended beyond the original term?

Potentially through continuation or divisional applications, or by patent term extensions where applicable under USPTO rules, especially if supplemental data can support new claims.

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References

[1] USPTO Patent Full-Text and Image Database, Patent 9,550,780.
[2] World Intellectual Property Organization (WIPO) Patent Landscape Reports.
[3] PatentScope Database.
[4] Patent prosecution and litigation databases.

Recent additions to Drugs Protected by US Patent 9,550,780

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	9,550,780	Y	Y			U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes	9,550,780	Y	Y			U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes	9,550,780	Y	Y			U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes	9,550,780	Y	Y			U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes	9,550,780	Y	Y			U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes	9,550,780	Y	Y			U-3055	A METHOD OF TREATING HUNTINGTON'S CHOREA

Drugs Protected by US Patent 9,550,780

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	9,550,780*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-002	Feb 17, 2023		RX	Yes	No	9,550,780*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-008	Jul 1, 2024		RX	Yes	No	9,550,780*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	No	9,550,780*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-004	May 29, 2024		RX	Yes	No	9,550,780*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-005	May 29, 2024		RX	Yes	No	9,550,780*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-006	May 29, 2024		RX	Yes	No	9,550,780*PED				Y

International Family Members for US Patent 9,550,780

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013318182
Australia	2018222896
Australia	2020205297
Brazil	112015005894
Canada	2883641
Canada	3124804
China	104684555