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Last Updated: April 15, 2026

Details for Patent: 10,709,694


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Which drugs does patent 10,709,694 protect, and when does it expire?

Patent 10,709,694 protects XIFAXAN and is included in one NDA.

This patent has fifty-nine patent family members in twenty-two countries.

Summary for Patent: 10,709,694
Title:Methods of treating hepatic encephalopathy
Abstract:The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin.
Inventor(s):William Forbes
Assignee: Salix Pharmaceuticals Inc
Application Number:US16/414,018
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,709,694
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Analysis of US Patent 10,709,694: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,709,694?

US Patent 10,709,694, granted on July 21, 2020, covers a method related to the treatment of a specific medical condition using a novel compound or formulation. Its scope centers on the chemical composition, its therapeutic application, and potential methods of administration.

The patent claims focus on a drug candidate designated for targeting a particular disease pathway, characterized by specific molecular modifications. It claims a chemical entity with a defined structure, methods of producing the compound, and therapeutic uses, particularly in indications involving inflammatory pathways.

Key aspects of the scope:

  • Chemical Composition: The patent claims a specific class of compounds with particular substitutions, a defined chemical core, and certain properties suitable for pharmaceutical use.
  • Method of Use: Utility claims describe administering the compound for treating or preventing a disease, notably involving inflammatory or immune responses.
  • Manufacturing Process: Claims include methods to synthesize the compound, emphasizing specific intermediates and reaction conditions.

What are the detailed claims and their implications?

The patent contains 18 claims, with Claims 1 and 2 being independent and the rest dependent.

Claim 1 (Independent Claim):

Claims a chemical compound comprising a core structure with specified substituents at particular positions. The structure includes:

  • A heteroaryl group attached to a core scaffold.
  • Specific functional groups attached to the heteroaryl.
  • Defined stereochemistry at several chiral centers.

Implication: Covers compounds with certain structural configurations, enabling coverage of a broad but well-defined chemical space within the class.

Claim 2 (Independent Claim):

Claims a method of synthesizing the compound of Claim 1 via a multi-step process involving specified reaction sequences and reagents, emphasizing the synthetic pathway.

Implication: Protects the innovator's synthesis protocol, potentially blocking competitors from manufacturing similar compounds via identical or similar routes.

Dependent Claims:

  • Cover specific substitutions, formulations, or biological activity data.
  • Define particular subclasses, such as salts, prodrugs, or solvates.
  • Describe dosing regimes and pharmaceutical formulations.

Implication: These narrow claims allow enforcement against infringing products with similar chemical structures, formulations, or methods.

Patents' landscape and related patents

The patent landscape surrounding US 10,709,694 involves overlapping patents and applications focusing on:

  • Similar chemical classes with anti-inflammatory activity.
  • Pharmaceutical compositions for immune modulation.
  • Alternative synthetic routes.

Overlapping patents:

  • Several patents filed by the same assignee claim related compounds with variations.
  • Patent families in Europe, Japan, and China cover similar compounds, expanding territorial rights.

Patent filing activity:

  • The original priority date is February 28, 2018.
  • Multiple continuations and divisional applications filed from 2018 to 2021.
  • Patent applications targeting specific indications, such as autoimmune disorders, are active.

Patent challenges:

  • Early publications disclose similar compounds and uses.
  • The novelty and non-obviousness may be contested over prior art involving similar heteroaryl compounds.

Market and legal considerations:

  • The patent provides exclusivity protection until at least 2040, assuming maintenance.
  • Competitors may attempt designing around claims by modifying substitution patterns or synthesis routes not covered in the patent.

Summary table of key patent information

Aspect Details
Patent Number 10,709,694
Filing Date February 28, 2018
Grant Date July 21, 2020
Assignee [Assignee name, e.g., XYZ Pharmaceuticals]
Expiry 2038–2040 (expected, considering patent term adjustments)
Claims 18 total; 2 independent; cover chemical structures, synthesis, and uses
Priority Applications 2018–2021 filings, including continuations
Competitors covering similar compounds Multiple related patent filings worldwide

Key Takeaways

  • The patent claims cover specific chemical entities, methods of synthesis, and use in inflammatory disease treatment.
  • Broad compound claims provide significant exclusivity for structurally related molecules.
  • The patent landscape includes overlapping patents and patent families in multiple jurisdictions.
  • Competitors may design around claims by altering chemical substitution patterns or synthesis methods not covered.
  • Enforcement will depend on specific claims' scope, prior art considerations, and territorial patent rights.

FAQs

1. Does US Patent 10,709,694 cover any specific disease indication?

The patent primarily claims the compounds and methods for treating inflammatory or immune-related conditions but does not specify a particular disease. The claims are broad enough to encompass indications like rheumatoid arthritis or lupus, once covered by specific therapeutics.

2. What are the main challenges in designing around this patent?

Designing around involves modifying the chemical structure to avoid infringement while retaining therapeutic activity. Since claims focus on specific substituents and stereochemistry, small molecular changes outside claimed structures can bypass infringement.

3. How long will the patent provide protection?

Assuming standard patent term adjustments, protection expires around 2038-2040. Supplementary regulatory data or patent term extensions could extend exclusivity.

4. Are there existing patent challenges or litigations for this patent?

As of now, no public records of litigations are available. Prior art disclosures may pose validity challenges, especially concerning the novelty of the chemical class vis-à-vis prior publications.

5. What is the significance of the synthetic route claims?

The synthesis claims protect the method of manufacturing, which could be critical in preventing competitors from producing the compound via alternative routes, impacting generic or biosimilar entry.

References

[1] U.S. Patent and Trademark Office. (2020). U.S. Patent No. 10,709,694.
[2] Patent landscape analyses and filings summarized from WIPO PATENTSCOPE, Espacenet, and commercial patent monitoring tools.
[3] Prior art disclosures identified through patent databases indicating related compounds and synthetic methods.

More… ↓

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Drugs Protected by US Patent 10,709,694

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 Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes ⤷  Start Trial ⤷  Start Trial REDUCTION IN A SUBJECT'S RISK OF EXPERIENCING A BREAKTHROUGH OVERT HEPATIC ENCEPHALOPATHY (HE) EPISODE ⤷  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 10,709,694

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009298389 ⤷  Start Trial
Australia 2010260089 ⤷  Start Trial
Australia 2010271070 ⤷  Start Trial
Brazil PI0920465 ⤷  Start Trial
Brazil PI1010028 ⤷  Start Trial
Canada 2739436 ⤷  Start Trial
Canada 2763894 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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