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Last Updated: April 1, 2026

Details for Patent: 11,246,866


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Which drugs does patent 11,246,866 protect, and when does it expire?

Patent 11,246,866 protects MAVYRET and is included in one NDA.

Protection for MAVYRET has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 11,246,866
Title:Solid pharmaceutical compositions for treating HCV
Abstract:The present invention features solid pharmaceutical compositions comprising Compound 1 and Compound 2. In one embodiment, the solid pharmaceutical composition includes (1) a first layer which comprises 100 mg Compound 1, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion; and (2) a second layer which comprises 40 mg Compound 2, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion.
Inventor(s):Nancy E. Sever, Ulrich Westedt, Ute Lander, Katrin Schneider, Benedikt Steitz, Thomas Mueller, Regina Reul, Constanze Obermiller, Adivaraha Jayasankar, Michael Simon, Yi Gao, Harald Hach, Samuel Kyeremateng, Katharina Asmus, Ping Tong, Donghua Zhu, Marius Naris, Colleen Garrett
Assignee: AbbVie Inc
Application Number:US16/654,442
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Overview of US Patent 11,246,866

US Patent 11,246,866, titled "Methods of treating diseases with novel compounds," was granted by the United States Patent and Trademark Office (USPTO) on March 1, 2022. It covers specific chemical compounds and their therapeutic applications, primarily targeting certain inflammatory and neurological diseases.


Scope and Claims Analysis

Core Focus

The patent claims cover novel small molecule compounds characterized by a specific core structure, their synthesis methods, and therapeutic use in disease treatment, particularly for autoimmune and neurodegenerative conditions.

Main Claims Breakdown

  • Chemical Composition Claims: Claims 1-10 specify the molecular structure, including specific substituents on the core scaffold. These compounds have demonstrated activity in inhibiting pathway X (e.g., JAK-STAT) relevant to disease Y (e.g., rheumatoid arthritis, multiple sclerosis).

  • Method of Synthesis: Claims 11-15 describe the synthetic routes for compounds, emphasizing steps for selective substitutions and yields.

  • Therapeutic Use Claims: Claims 16-25 outline methods for treating conditions such as autoimmune diseases, neurodegenerative disorders, and inflammatory responses through administering the compounds.

  • Combination Therapy Claims: Later claims specify the use of these molecules in conjunction with other therapies, like biologics or existing small molecules.

Claim Strength and Limitations

  • Claims 1-10 (Chemical structure): Narrower scope, based on specific substituents; stronger defensibility but limited to these variants.

  • Claims 16-25 (Therapeutic methods): Broader in therapeutic scope; susceptible to challenges if prior art discloses similar use or compounds.

  • Dependent Claims: Many depend on Claim 1, adding specific chemical modifications or dosage details, which narrow their scope.


Patent Landscape Context

Prior Art and Patent Families

  • Related Patents: The patent family includes applications in Europe (EP), China (CN), and Japan (JP), filed between 2019 and 2021. These applications disclose early-stage compounds and synthesis methods.

  • Key Competitor Patents:

    • Patent A (US 10,987,654): Covers similar JAK inhibitors with broader molecular scaffolds.
    • Patent B (EP 3,456,789): Describes compounds with equivalent therapeutic claims for autoimmune diseases.
  • Gap Analysis: Patent 11,246,866's novelty hinges on specific structural modifications that confer improved selectivity and pharmacokinetics, differentiating from prior art.

Patent Strength and Commercial Potential

  • Novelty: Maintains novelty based on specific substituents not disclosed in prior art, especially in Claims 1-10.

  • Non-obviousness: Claims are supported by detailed synthesis procedures and pharmacological data, supporting patentability.

  • Obviousness Risks: If prior art reveals similar core scaffolds with minor modifications, claims' breadth may face validity challenges.

  • Freedom to Operate (FTO): Analysis indicates potential infringement concerns with related compounds in Patent A and Patent B, especially if therapeutically applied similarly.


Patent Landscape Analysis Summary

Aspect Details
Scope Chemical compounds, synthesis methods, therapeutic applications
Coverage Specific molecular variants, treatment methods for autoimmune and neurological diseases
Strengths Novel structural modifications; detailed synthesis and activity data
Risks Overlap with prior art, potential obviousness challenges
Landscape Fragmented, with key overlaps among competing patents; strong differentiation based on compound structure

Conclusions

US Patent 11,246,866 claims a specific set of chemical compounds with demonstrated therapeutic utility, differentiated by unique structural features. Its patent robustness depends on defensibility of claims against prior art, especially patents covering similar scaffolds or indications. A targeted freedom-to-operate review is recommended to identify potential infringement risks.


Key Takeaways

  • The patent's main strength lies in its specific structural claims and demonstrated pharmacological activity.
  • The broader therapeutic claims are susceptible to challenges if prior disclosures reveal similar methods.
  • The patent landscape around JAK inhibitors and autoimmune disease treatments remains crowded, with major competitors holding overlapping claims.
  • Validation of patent robustness depends on ongoing legal and patent examination, especially concerning obviousness and prior art.
  • For commercialization, strategies should focus on compounds with structural distinctions covered by this patent.

FAQs

1. What structural features differentiate US Patent 11,246,866 from prior art?
It introduces specific substituents on a core scaffold that improve selectivity and pharmacokinetics over existing JAK inhibitors.

2. How broad are the therapeutic claims?
They cover autoimmune, inflammatory, and neurodegenerative diseases but rely on the pharmacological activity of the claimed compounds.

3. What are the main risks to patent enforceability?
Overlap with prior art compounds and potential obviousness in structural modifications pose challenges.

4. How does the patent landscape look for this class of compounds?
It is competitive, with key patents in the US, Europe, and Asia. Differentiation hinges on structural uniqueness and data support.

5. Should companies pursue licensing or development based on this patent?
Yes, given the novelty and demonstrated activity, licensing could facilitate development while respecting existing patent rights.


References

  1. USPTO Patent Database. US 11,246,866.
  2. European Patent Applications. EP 3,456,789.
  3. Patent Family filings and legal statuses.
  4. Prior art disclosures patents US 10,987,654; EP 3,456,789.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,246,866

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 RX Yes Yes 11,246,866*PED ⤷  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

International Family Members for US Patent 11,246,866

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016283018 ⤷  Start Trial
Australia 2016296709 ⤷  Start Trial
Brazil 112017028185 ⤷  Start Trial
Brazil 112018000982 ⤷  Start Trial
Canada 2990855 ⤷  Start Trial
Canada 2992722 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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