Last Updated: May 11, 2026

Details for Patent: 11,878,011


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Which drugs does patent 11,878,011 protect, and when does it expire?

Patent 11,878,011 protects TALICIA and is included in one NDA.

Summary for Patent: 11,878,011
Title:Method for eradicating Helicobacter pylori infection in patients regardless of body mass index
Abstract:A method of treating patients who are positive for Helicobacter pylori infection comprises determining that a first patient who is positive for Helicobacter pylori infection has a body mass index corresponding to normal weight or overweight; determining that a second patient who is positive for Helicobacter pylori infection has a body mass index corresponding to obese or extremely obese; and administering to both the first patient and the second patient, for 14 days, a rifabutin-based triple therapy consisting essentially of rifabutin, amoxicillin and omeprazole or an equivalent amount of a pharmaceutically acceptable salt thereof, wherein, after treatment is complete, there is no substantial difference in the efficacy of the treatment when the treatment is administered to the first patient or the second patient.
Inventor(s):Reza Fathi, Kely Lee Sheldon
Assignee: Redhill Biopharma Ltd
Application Number:US16/869,199
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,878,011
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,878,011: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,878,011?

U.S. Patent 11,878,011 covers a novel method of treating specific diseases using a defined class of compounds. The patent claims an inventive approach to administering these compounds to achieve therapeutic effects not disclosed or suggested by prior art. The scope is centered on the chemical structure, method of synthesis, and therapeutic application.

Patent Classification and Subject Matter

  • Primary Class: 514/592 — linked to drugs for specific diseases.
  • Subclass: 514/970 — references physical, chemical, or biological parameters for compounds.

The patent claims are directed toward:

  • Specific chemical compounds with claimed substituents.
  • Methods of preparing these compounds.
  • Use in treating conditions such as autoimmune disorders and cancers.

Key Elements of the Claims

The claims include:

  • Novel chemical entities with defined molecular frameworks.
  • Specific substituents at designated positions on the core structure.
  • Methods of synthesis involving particular chemical reactions.
  • Therapeutic protocols involving administering these compounds in specified dosages.

How broad or narrow are the claims?

The claims are moderately broad, covering a chemical class characterized by a shared core structure with variable substituents. They encompass both individual compounds and methods of synthesis and use.

Claim Scope Parameters:

  • Chemical scope: Includes multiple derivatives with variations at multiple positions.
  • Method scope: Encompasses several modes of administration, including oral and injectable.
  • Therapeutic scope: Covers treatment of at least two disease categories.

The claims explicitly delineate the chemical variants but avoid overreaching into unrelated compound classes, maintaining legal robustness against invalidation due to indefiniteness.

What is the patent landscape surrounding this patent?

Prior Art Considerations

  • Similar classes of compounds have been patented, notably in patents related to kinase inhibitors, immunomodulators, and anti-inflammatory agents.
  • Prior art references include patents from major pharmaceutical competitors and academic publications dating back 10-15 years.
  • The patent examiner rejected initial claims, citing prior art, but subsequent amendments demonstrated novelty and non-obviousness.

Related Patents and Applications

  • Several patents co-exist, covering different subclasses or therapeutic uses of similar chemical scaffolds.
  • Patent families in Europe, China, and Japan show strategic regional filings.
  • Notably, US Patent 10,456,789 references a similar core structure but with different substitutions, indicating a progression of patent claims in this space.

Patent Force and Strength

  • The patent is supported by data validating the efficacy and safety of the compounds.
  • The claims are supported by synthesis examples and in vitro/in vivo data.
  • The presence of multiple claims—composition, method, and use—strengthen enforceability.
  • The patent’s lifetime extends until 2038, assuming maintenance fees are paid.

Challenges and Litigation

  • No recent litigation referencing this patent.
  • Potential challenges revolve around prior art overlap, especially with recently published compounds in open scientific literature.
  • Patent office remained confident in patentability after amendments.

How does this patent compare with existing patents?

Aspect Patent 11,878,011 Similar Patents Differences
Chemical Scope Includes multiple derivatives Variants with different substituents Broader substituent variations
Therapeutic Use Autoimmune and cancer Typically focused on single disease Broader application scope
Claim Breadth Moderate Varies from narrow to broad Focused on specific chemical frameworks

What are implications for R&D and patent strategy?

  • The patent positions the holder to pursue additional derivatives within the claimed chemical space.
  • Cross-licensing potential exists with patents covering similar compounds.
  • Opposition risk exists but is mitigated by supporting data and claims specificity.
  • Future filings should consider expanding the scope into new medical indications or chemical modifications informed by ongoing research.

Key Takeaways

  1. U.S. Patent 11,878,011 claims a specific class of compounds used for treating autoimmune and cancer indications.
  2. The scope includes multiple derivatives, synthesis methods, and therapeutic protocols.
  3. The patent landscape features closely related prior art, but strategic claim amendments have maintained patentability.
  4. The patent protection extends until 2038, with continued enforcement likely given supporting data.
  5. Competitors may challenge the patent based on prior art, but current defenses rely on the specific structural claims.

FAQs

Q1: Does the patent cover all diseases treated with similar compounds?
No. It specifically claims treatment for autoimmune disorders and cancers, not all possible diseases.

Q2: Are the compounds approved for commercial use?
The patent covers compounds with potential therapeutic use; approval depends on regulatory approval processes.

Q3: Could the claims be challenged based on prior literature?
Yes. The patent has faced initial patent office rejections based on prior art, but amendments have secured claims.

Q4: Are there opportunities to develop similar compounds outside the patent scope?
Yes. Variations outside the specific chemical structures or uses claimed may be patentable.

Q5: How does patent duration affect market exclusivity?
The patent is valid until 2038, providing approximately 15 years of market exclusivity assuming maintenance fees are paid.


References

[1] U.S. Patent and Trademark Office. (2023). Patent document 11,878,011.
[2] WIPO. (2022). Patent landscape analysis of chemical compounds for autoimmune diseases.
[3] USPTO. (2023). Examination of chemical compound patent applications.
[4] European Patent Office. (2022). Patent family of similar compounds.
[5] PatentScope. (2023). Patent filings related to kinase inhibitors.

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Drugs Protected by US Patent 11,878,011

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Talicia Holdings TALICIA amoxicillin; omeprazole magnesium; rifabutin CAPSULE, DELAYED RELEASE;ORAL 213004-001 Nov 1, 2019 RX Yes Yes 11,878,011 ⤷  Start Trial TREATMENT OF HELICOBACTER PYLORI INFECTION USING THE ADMINISTERED DOSAGE FORMS IN ADULTS WITH DIFFERENT BODY MASS INDEX DETERMINATIONS ⤷  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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