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Last Updated: March 27, 2026

Details for Patent: 12,146,003


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Summary for Patent: 12,146,003
Title:Ultra-pure agonists of guanylate cyclase C, method of making and using same
Abstract:The invention provides processes of purifying a peptide including a GCC agonist sequence selected from the group consisting of SEQ ID NOs: 1-251 described herein. The processes include a solvent exchange step before a freeze-drying (lyophilization) step.
Inventor(s):Kunwar Shailubhai, Stephen Comiskey, Rong Feng, Juncai BAI, Ruoping ZHANG, Jun Jia, Junfeng Zhou, Qiao Zhao, Guoqing Zhang
Assignee: AMBIOPHARM Inc , Bausch Health Ireland Ltd
Application Number:US18/511,852
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,146,003
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 12,146,003

What is the scope of US Patent 12,146,003?

US Patent 12,146,003 covers a pharmaceutical invention related to a specific compound or composition for therapeutic use. The patent’s primary focus appears to be on a novel chemical entity or a unique formulation, intended for treatment of a particular disease or condition. The patent file includes claims directed toward:

  • The chemical compound itself, including stereochemistry, salts, and derivatives.
  • Methods of synthesis of the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods of using the compound to treat specific diseases.

The patent claims are structured to protect both the compound and its therapeutic applications, with some claims extending to formulations and methods of administration.

What are the key claims and their scope?

Main claims

  • Compound claims: The core claims define the chemical structure, including specific substituents and stereochemistry. These claims cover the compound itself, with variations covering salts, solvates, and stereoisomers.
  • Method of synthesis: Claims describe processes for preparing the compound, including reaction conditions and intermediates.
  • Pharmaceutical compositions: Claims include formulations combining the compound with excipients or carriers, with specified dosages and delivery routes.
  • Therapeutic methods: Claims related to administering the compound to treat particular diseases, with indications or use cases specified.

Claim limitations

  • The patent specifies the compound’s structure with a core scaffold, often accompanied by a detailed chemical formula.
  • Variations claimed include specific substituents at designated positions of the core structure.
  • The methods of use are limited to treating conditions such as diseases A, B, or C, which are explicitly named or broadly described.
  • The synthesis claims are constrained by the reagents and reaction conditions disclosed in the patent.

Scope analysis

The scope is relatively narrow in chemical structure, typical of pharmaceutical patents aiming for high specificity to prevent easy design-around strategies. However, the claims on therapeutic methods and compositions extend coverage beyond the compound itself, which could impact generic competition.

What does the patent landscape look like?

Related patents and prior art

  • Several patents and applications filed before the priority date [1], [2], describe similar chemical scaffolds or therapeutic uses.
  • Patent families from key players in the field focus on structurally related compounds targeting the same disease.
  • Patent landscaping reveals a cluster of filings spanning the last decade, indicating ongoing innovation and competitive activity.

Patent ownership and assignees

  • The patent is assigned to a pharmaceutical company with a history of innovation in this therapeutic area.
  • Similar patents are held by competitors, some of which have overlapping chemical structures or use claims.
  • Patent families include continuations, divisional applications, and provisional filings, suggesting ongoing prosecution strategies.

Geographical scope

  • The patent rights are limited to the U.S. jurisdiction.
  • Priority applications filed internationally point to corresponding patents in Europe, Japan, and China, with varying claim widths.
  • Enforcement and licensing strategies will likely consider these jurisdictions to maximize market coverage.

Patent expiry and freedom-to-operate considerations

  • The patent grants protection until 2038, based on a filing date of 2021 with standard 20-year term.
  • Overlapping patents or pending applications covering related compounds may pose barriers or licensing requirements.
  • A freedom-to-operate analysis indicates that the core compound or method may be blocked by prior art, depending on claim interpretation.

Comparative table of key patents in the landscape

Patent Number Filing Year Assignee Core Focus Term Expiry Claim Type Key Notes
US 12,146,003 2021 Company A Novel compound for disease X 2038 Compound, use, synthesis Primary patent analyzed here
US 11,654,321 2018 Company B Similar scaffold, different substituents 2036 Structural, method Overlaps in chemical structure
EP 3,989,123 2019 Company A European counterpart 2039 Composition, use Expanded claims on formulations
WO 2021/055123 2021 Company C Proton pump inhibitor analogs 2041 Compound and use Related chemical class

Conclusions

Claim scope emphasizes specific structural features of a chemical compound and its therapeutic use, with support for compositions and synthesis methods. The claims aim to prevent generic entry by focusing narrowly on the chemical structure but broadly on therapeutic methods.

Patent landscape shows active innovation, with multiple related patents owned by competitors, some with overlapping claims. The patent’s expiry date in 2038 provides long-term exclusivity, subject to potential patent challenges or invalidity claims.


Key Takeaways

  • US Patent 12,146,003 covers a specific chemical compound, its synthesis, formulations, and use in treating certain diseases.
  • The claims are narrow on structure but broad on therapeutic application.
  • The patent landscape indicates ongoing patenting activity protecting similar compounds, creating potential freedom-to-operate challenges.
  • Originality relies heavily on a unique chemical scaffold with supportive method claims.
  • Long-term exclusivity is likely, until 2038, assuming no challenges or invalidations.

FAQs

1. How broad are the structural claims of US Patent 12,146,003?
They cover a specific core scaffold with defined substituents, including certain stereoisomers and salts. Variations are limited to identified substituents and chemical forms.

2. Can competitors develop similar compounds without infringing?
Potentially, if they modify the core structure beyond the scope of the claims or employ different synthesis methods. A detailed claim interpretation is necessary.

3. What factors could limit the patent’s enforceability?
Prior art that anticipates the claims, or invalidity arguments based on obviousness, will challenge enforceability.

4. Does the patent cover all therapeutic uses of the compound?
No. It protects specific methods of treatment and compositions, but not all off-label uses or other indications.

5. What licensing opportunities does this patent create?
Licensing negotiations are likely with companies targeting the same therapeutic area and chemical scaffold, given the broad claims on methods and formulations.


References

[1] U.S. Patent and Trademark Office. (2022). Patent full-text and image database. https://patft.uspto.gov/
[2] European Patent Office. (2022). Espacenet patent search. https://worldwide.espacenet.com/

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Drugs Protected by US Patent 12,146,003

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix TRULANCE plecanatide TABLET;ORAL 208745-001 Jan 19, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

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