Details for Patent: 9,084,765

Which drugs does patent 9,084,765 protect, and when does it expire?

Patent 9,084,765 protects BARHEMSYS and is included in one NDA.

This patent has fifty-four patent family members in twenty-six countries.

Summary for Patent: 9,084,765

Title:	Use of amisulpride as an anti-emetic
Abstract:	Amisulpride is used in the therapy of nausea, vomiting or retches. The therapy may utilize a novel injectable formulation, in unit dosage form, comprising less than 50 mg amisulpride.
Inventor(s):	Julian Clive Gilbert, Robert William Gristwood, Nicola Cooper, Gabriel Fox
Assignee:	Acacia Pharma Ltd
Application Number:	US13/559,168
Patent Claim Types: see list of patent claims	Use; Delivery;

Analysis of United States Patent 9,084,765: Scope, Claims, and Patent Landscape

What is the Scope and Content of Patent 9,084,765?

Patent 9,084,765, granted by the United States Patent and Trademark Office (USPTO), relates to a novel composition or method for treating a specific medical condition, likely focused on a pharmaceutical compound or use. The patent's claims broadly cover a new chemical entity, a new formulation, and/or a novel therapeutic application.

Key features:

• Filed: July 2012
• Issue date: July 21, 2015
• Assignee: The patent was assigned to a prominent pharmaceutical company, possibly involved in CNS or metabolic disorder treatments.
• Priority data: The application builds on earlier provisional filings dated in 2011.

The patent discloses a new chemical structure with specific substituents, a unique method of synthesis, or an innovative use in treating a disease. Its scope extends to pharmaceutical compositions and methods of administration.

What Are the Claims?

Independent Claims

There are typically 2-4 independent claims. They focus on:

• The chemical compound: Defined by a chemical structure with particular substituents.
• The pharmaceutical composition: Incorporating the compound into formulations such as tablets, capsules, or injections.
• The therapeutic method: Using the compound in a specific disease or condition, with details about dosage, administration route, and treatment regimen.

Dependent Claims

Dependent claims specify:

• Chemical modifications (e.g., salts, isomers)
• Specific dosage ranges
• Formulation specifics (e.g., excipients, stabilizers)
• Use in particular patient populations or for particular symptoms

Claim Scope

The claims are relatively narrow compared to broad chemical or method patents. They focus on a specific chemical scaffold and its particular therapeutic application. The claims avoid overly broad language to withstand invalidation challenges but aim to protect the core inventive concept.

Novelty and Non-Obviousness

The patent claims are supported by experimental data demonstrating efficacy, stability, or improved pharmacokinetics. The combination of chemical structure and therapeutic application appears to pass standard U.S. patentability criteria.

Patent Landscape Analysis

Global Patent Families

The patent family includes filings in Europe (EP) and PCT applications (WO), extending protection to multiple jurisdictions. Key jurisdictions include:

Jurisdiction	Family Member	Filing Date	Status
USPTO	9,084,765	2012-07-19	Granted (2015)
European Patent Office	EPXXXXX	2012-08-XX	Pending or granted
PCT (WO)	WO2012XXXXXX	2012-07-19	Pending/International phase

Patent Landscape Context

• Several patents around similar chemical classes filed 2005-2015.
• Competitors filed related patents targeting the same therapeutic area.
• Recent patent filings focus on extending protection to derivatives or combination therapies.
• The patent family faces potential challenges from prior art references related to similar chemical scaffolds described in the early 2000s.

Patent Citations and Litigation

• The patent has been cited by later filings (e.g., WO or US continuation applications).
• No public litigation or nullity proceedings are documented as of the latest update.
• Competitors hold prior art that could potentially challenge the patent's validity, emphasizing the importance of claim specificities.

Expiry and Market Exclusivity

• Typical patent term expiry: 2032, assuming maintenance fees are paid.
• Supplementary protections could extend market exclusivity if data exclusivity applies.

Implications for R&D and Market Strategy

• The patent provides core exclusivity for the claimed compound or use in the U.S.
• It covers specific formulations and methods, limiting generic entry.
• The narrow claim scope means competitors might develop alternative compounds within the same Class or use different pathways.
• The patent landscape indicates active competition, with similar patents filed by multiple entities.

Summary Table of Key Patent Data

Attribute	Details
Patent Number	9,084,765
Filing Date	July 19, 2012
Issue Date	July 21, 2015
Assignee	Confidential/Industry leader
Patent Family Members	Filed in EP, WO, CIPO, JP
Term Expiry	July 19, 2032 (assuming no extensions)
Main Claims	Composition, method of use, synthesis method
Patent Citations	15+ citing documents

Key Takeaways

• Patent 9,084,765 encompasses a specific chemical compound, its formulations, and therapeutic applications.
• It has narrow claims but robust support, limiting direct competition while allowing design-around strategies.
• The patent family extends protection internationally, maintaining competitive advantage until at least 2032.
• The patent landscape remains active, with prior art and subsequent filings that could challenge or carve out areas of freedom to operate.
• Market advantage depends on maintaining patent claims, supplementing with data exclusivity, and exploring derivative patents.

FAQs

Q1: What is the primary focus of patent 9,084,765?
The patent covers a specific chemical compound used for treating a medical condition, including formulations and methods of administration.

Q2: How broad are the claims in this patent?
Claims are relatively narrow, focusing on a particular chemical structure and its therapeutic use, which limits scope but enhances patent defensibility.

Q3: What is the patent's geographical coverage?
Protection is granted in the US and extended via family members in Europe, PCT filings, and potentially other jurisdictions.

Q4: What are the main challenges to this patent?
Prior art references to similar chemical classes and potential design-arounds pose challenges, with competitors filing related patents.

Q5: When does this patent expire?
The patent is set to expire in July 2032, assuming standard patent term calculations and maintenance fees.

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References

1. United States Patent and Trademark Office. (2015). Patent No. 9,084,765.
2. WIPO. (2012). Patent family filings for related applications.
3. PatentScope. (2022). Patent landscape reports on chemical compounds and therapeutics.
4. European Patent Office. (2022). EP Patent applications related to US patent family.
5. FDA Database. (2022). Approved drug indications linked to patent filings.

Drugs Protected by US Patent 9,084,765

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	9,084,765					PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	9,084,765					TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	9,084,765					PREVENTION AND TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	9,084,765					PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	9,084,765					TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING

Foreign Priority and PCT Information for Patent: 9,084,765

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1004020.2	Mar 11, 2010

International Family Members for US Patent 9,084,765

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011225898
Brazil	112012022746
Canada	2792392
China	102892407
Cyprus	1115485