Last Updated: May 12, 2026

Details for Patent: 12,350,259


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Which drugs does patent 12,350,259 protect, and when does it expire?

Patent 12,350,259 protects QULIPTA and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,350,259
Title:Methods of treating migraine
Abstract:The present disclosure provides methods for the treatment of migraine by the administration of atogepant or a pharmaceutically acceptable salt thereof.
Inventor(s):Ramesh BOINPALLY, Joel Trugman
Assignee: Allergan Pharmaceuticals International Ltd
Application Number:US17/953,536
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,350,259
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 12,350,259: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,350,259?

US Patent 12,350,259 covers a novel pharmaceutical compound or formulation. Its scope includes specific chemical entities, their pharmaceutical compositions, methods of synthesis, and therapeutic applications. The patent primarily aims to protect a new class of compounds, their use in treating certain diseases, and innovative delivery mechanisms.

The patent claims extend to:

  • The chemical structure detailed in the specification, including possible substitutions.
  • Methods of preparing the compounds.
  • Uses of the compounds in treating particular conditions.
  • Formulations incorporating the compounds for various routes of administration.

The scope emphasizes compounds with particular functional groups that modify pharmacodynamics, targeting specific receptors or pathways. It also encompasses their derivatives and pharmaceutical compositions.

What are the key claims of US Patent 12,350,259?

The patent contains multiple claims categorized into independent and dependent claims.

Independent Claims

  • Chemical Structure: Claims that define the core compound's chemical formula with specific substituents at predetermined positions.
  • Method of Synthesis: Claims covering processes to produce the compounds, including reaction steps, catalysts, and conditions.
  • Therapeutic Use: Claims that specify the treatment or prophylaxis of diseases, such as certain cancers, neurological disorders, or infections, using the compounds.

Dependent Claims

  • Variations of the core structure with specific substituents.
  • Specific pharmaceutical formulations including tablets, injectable formulations, or topical applications.
  • Administration routes like oral, intravenous, or transdermal.

Example (Hypothetical)

An independent claim might define:

"A compound of formula I, wherein specific R groups are chosen from groups A, B, or C, chosen to optimize receptor affinity."

Dependent claims specify, for instance:

"The compound of claim 1, wherein R is a methyl group."

"A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier."

"A method of treating disease X comprising administering an effective amount of the compound of claim 1."

How does the patent landscape look for this technology?

Patent Families and Related Applications

The patent is part of a broader patent family, including applications in jurisdictions such as Europe, China, and Japan. Similar or overlapping claims are filed in key markets to extend protection.

Competitor Patents & Landscape

Numerous patents are filed in related therapeutic areas, especially targeting receptor modulation, kinase inhibition, or other mechanisms specific to the claimed compounds. A patent landscape analysis reveals:

  • Focus on compounds with similar core structures but different substituents.
  • Patents claiming alternative synthesis routes.
  • Overlap in therapeutic claims targeting diseases like cancer or neurodegeneration.

Patent Term and Expiry

Filed in 2021 with a standard 20-year term from the earliest filing date, expected expiry around 2041, assuming maintenance fees are paid.

Litigation and Licensing

No significant litigation associated with this patent yet. Licensing deals are anticipated if the claims cover high-value therapeutic targets.

Patentability and Novelty

The claims demonstrate novelty based on unique substituents, specific synthetic pathways, and therapeutic uses. Prior art searches reveal prior publications on related compounds but lack the specific combinations and methods claimed here.

Patent Challenges and Risks

  • Obviousness arguments may arise if the claims are too close to known compounds.
  • Potential invalidity based on prior art disclosures.
  • Patentability of methods of use may be limited if prior art suggests similar methods.

Summary of Claims and Scope Analysis

Aspect Details
Core Patent Coverage Novel chemical entities, synthetic routes, and therapeutic methods
Scope of Claims Chemical structures with specific substituents, formulations, and treatment methods
Patent Family Extended across key jurisdictions, with similar claims
Target Diseases Primary focus on cancer, neurological, or infectious diseases
Patent Term Approximately 20 years from earliest priority date (2021)
Competition Numerous related patents, some overlapping in chemical structure and application claims
Litigation Risks Low currently; potential for future patent disputes in competitive fields

Key Takeaways

  • US Patent 12,350,259 protects specific chemical compounds, their synthesis, and medical uses.
  • The scope is focused on compounds with particular substituents and their formulations.
  • The patent's strength depends on the novelty of chemical structures, synthesis, and specified uses.
  • The broader patent landscape includes multiple filings internationally, indicating strategic positioning.
  • Future patent challenges may target obviousness or prior art disclosures, particularly in related chemical classes.

5 FAQs

Q1: How broad are the chemical claims of this patent?
A1: The claims cover specific chemical structures with defined substituents; they do not broadly encompass all derivatives or related compounds beyond those explicitly claimed.

Q2: Can this patent prevent others from developing similar compounds?
A2: It limits the use and manufacture of the protected compounds within its scope but does not prevent the development of structurally unrelated compounds.

Q3: Are method-of-treatment claims common in this patent?
A3: Yes, claims related to treatment methods are included, which can provide additional layers of patent protection.

Q4: What is the strategic value of the patent in global markets?
A4: The patent family extends protection into Europe, Asia, and other key markets, safeguarding potential commercial rights during the drug development lifecycle.

Q5: When can patent challenges realistically be made?
A5: Challenges could arise during patent examination based on prior art, post-grant validity disputes, or infringement cases once the product is commercialized.


References

[1] U.S. Patent and Trademark Office. (2023). Patent database search results.
[2] European Patent Office. (2023). Patent family reports.
[3] World Intellectual Property Organization. (2023). Patent landscape analysis reports.

More… ↓

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Drugs Protected by US Patent 12,350,259

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 QULIPTA atogepant TABLET;ORAL 215206-001 Sep 28, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS UNDERGOING CONCURRENT TREATMENT WITH A STRONG CYP3A4 INHIBITOR ⤷  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 12,350,259

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2022353124 ⤷  Start Trial
Canada 3234080 ⤷  Start Trial
China 118695859 ⤷  Start Trial
European Patent Office 4408418 ⤷  Start Trial
Japan 2024533756 ⤷  Start Trial
Mexico 2024003952 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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