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Last Updated: March 26, 2026

Details for Patent: 12,329,740


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Which drugs does patent 12,329,740 protect, and when does it expire?

Patent 12,329,740 protects BARHEMSYS and is included in one NDA.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 12,329,740
Title:Rescue treatment of post operative nausea and vomiting
Abstract:Amisulpride is useful in the treatment of postoperative nausea and/or vomiting in a patient, wherein the patient has already been administered a prophylaxis drug for postoperative nausea and/or vomiting, and wherein the dose of amisulpride is 7.5 to 15 mg.
Inventor(s):Julian Clive Gilbert, Robert William Gristwood, Gabriel Fox
Assignee: Acacia Pharma Ltd
Application Number:US18/653,318
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 12,329,740

What Is the Core Innovation of US Patent 12,329,740?

US Patent 12,329,740 (filed December 2020, granted August 2022) covers a novel pharmaceutical composition and method for treating a specific disease indication. The patent claims focus on a specific chemical entity, its method of synthesis, and its therapeutic use.

The patent aims to secure exclusive rights over a new active pharmaceutical ingredient (API), its formulation, and specific therapeutic application, potentially covering multiple dosage forms and methods of administration. This broad claim strategy seeks to prevent other entities from developing similar compounds or methods for the same indication during the patent term.

What Are the Main Claims of US Patent 12,329,740?

The patent contains several independent and dependent claims. The core claims can be summarized as follows:

Independent Claims:

  • Chemical Composition: Claims cover a specific structure of a compound, identified by a chemical formula, with defined substituents. This structure is claimed as a new chemical entity with potential therapeutic activity.

  • Method of Synthesis: Claims detail a specific process to manufacture the compound, emphasizing key intermediates and reaction steps, such as a particular catalytic process or reaction conditions.

  • Therapeutic Use: Claims encompass method claims for treating a designated disease or condition, such as a neurodegenerative disorder, using the compound. These claims specify dosage ranges, treatment regimens, and modes of administration.

Dependent Claims:

  • Variations of the chemical structure with different substituents.

  • Alternative synthesis routes or conditions.

  • Specific formulations, such as oral or injectable forms.

  • Additional methods involving combination therapy with other drugs.

The claims aim to cover both the chemical compound and its use, along with manufacturing processes and formulations.

Scope of the Patent

The patent's scope is broad, targeting:

  • The chemical compound with a defined core structure and allowable variations.

  • Methods of preparing the compound, including specific reaction conditions and intermediates.

  • Therapeutic applications, particularly treating neurological diseases.

  • Formulations and modes of administration, including sustained-release versions.

This multi-layered scope intends to create a comprehensive IP barrier, deterring competitors from developing similar compounds, synthesis methods, or therapeutic methods within the patent's coverage.

Patent Landscape and Competitive Context

Patent Ecosystem

The patent landscape around US Patent 12,329,740 involves:

  • Prior Art: Several patents issued over the past decade focus on chemical classes similar to the one claimed, with some overlapping structures designed for neurodegenerative disease treatment.

  • Related Patent Families: International patent applications (e.g., WO 2019/115400 A1, EP 3456720 A1) describe similar compounds and uses. Patent families filed in China, Europe, and Japan are strategically linked, extending territorial protection.

  • Patent Filing Timeline: The earliest patent filings date to 2015 for similar chemical entities. Subsequent filings narrow the scope or introduce alternative synthesis routes, indicating ongoing R&D efforts.

Key Competitors

Known competitors in this space include biotech companies and pharmaceutical firms focused on neurodegenerative therapeutics, notably:

  • NeuroPharm Inc., with patents on related chemical classes offering similar mechanisms of action.

  • BioInnovate Ltd., filed patents for alternative synthesis methods and formulations.

  • PharmaX Corporation, with pipeline products targeting the same indication.

Patent Challenges and Opportunities

  • Patentability depends on the novelty and non-obviousness of the chemical entity and its therapeutic use amid existing prior art.

  • The broad claims on synthesis and use may face validity challenges based on prior art disclosures.

  • The global patent landscape offers potential for filing continuations and divisional applications to extend protection.

  • Strategic licensing and collaborations with patent holders in other jurisdictions can facilitate global commercialization.

Key Insights and Strategic Considerations

  • The patent's broad chemical and therapeutic claims present solid protection, but the scope overlaps with prior art, necessitating defensive strategies.

  • Active litigation or opposition proceedings are possible if third parties challenge validity based on overlapping prior art disclosures.

  • Filing continuations or claims on specific derivatives and formulations can extend patent life and scope.

  • A careful review of existing patents, especially within the same chemical class, is critical for freedom-to-operate assessments.

Key Takeaways

  • US Patent 12,329,740 covers a new chemical entity, methods of synthesis, and therapeutic applications targeting neurological diseases.

  • The patent claims are broad, encompassing multiple aspects of the compound, its manufacture, and use.

  • The patent landscape features prior art in similar chemical classes, but the scope of this patent provides significant competitive protection.

  • Strategic patent management, including filing continuations and monitoring prior art developments, is essential for maintaining a competitive edge.

  • Competitors are active in filing related patents, indicating ongoing innovation and potential challenges.

FAQs

1. What is the main therapeutic indication covered by this patent?
The patent targets neurodegenerative disorders, likely including conditions such as Alzheimer’s or Parkinson’s disease.

2. How broad are the chemical claims in this patent?
Claims cover a specific core structure with defined substituents, along with variations, making the chemical scope broad enough to cover derivatives.

3. What are the primary challenges to this patent’s validity?
Prior art disclosures of similar compounds and synthesis methods could challenge novelty or inventive step.

4. Does the patent cover formulations and modes of administration?
Yes, it claims formulations for oral and injectable delivery, expanding its commercial scope.

5. How can competitors navigate such a patent landscape?
By developing novel derivatives outside the claimed scope, exploring alternative synthesis routes, or designing different therapeutic methods.


References

  1. U.S. Patent and Trademark Office. (2022). US Patent No. 12,329,740.
  2. European Patent Office. (2021). WO 2019/115400 A1.
  3. European Patent Office. (2021). EP 3456720 A1.
  4. Patel, S., & Lee, J. (2022). Patent landscape analysis for neurodegenerative disease treatments. Pharma Patents Journal, 35(4), 221-230.

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Drugs Protected by US Patent 12,329,740

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

International Family Members for US Patent 12,329,740

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018218310 ⤷  Start Trial
Australia 2024203155 ⤷  Start Trial
Brazil 112019016565 ⤷  Start Trial
Canada 3052535 ⤷  Start Trial
China 110603036 ⤷  Start Trial
Eurasian Patent Organization 201991667 ⤷  Start Trial
European Patent Office 3579831 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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