Last Updated: May 12, 2026

Details for Patent: 12,257,252


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Which drugs does patent 12,257,252 protect, and when does it expire?

Patent 12,257,252 protects SEPHIENCE and is included in one NDA.

This patent has nine patent family members in seven countries.

Summary for Patent: 12,257,252
Title:Compositions and methods for increasing tetrahydrobiopterin plasma exposure
Abstract:The present invention features compositions including sepiapterin, or a pharmaceutically acceptable salt thereof, and methods for the treatment of BH4-related disorders. In some embodiments, these compositions and methods result in an increase in plasma exposure of BH4.
Inventor(s):Neil Smith, Jonathan Reis
Assignee: PTC Therapeutics MP Inc
Application Number:US17/059,632
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of United States Patent 12,257,252: Scope, Claims, and Patent Landscape

Summary:
United States Patent 12,257,252 covers a pharmaceutical composition or method specific to a novel drug formulation or treatment approach. Its scope encloses claims related to chemical entities, pharmaceutical formulations, and specific therapeutic methods. The patent’s claims are centered on a unique compound, its combination with excipients, and methods of treating certain diseases. The patent landscape includes filings in biopharmaceutical and chemical drug areas with active research and enforcement in therapeutic indications similar to those claimed.


What Are the Core Claims and Their Scope?

Claim Types and Focus

  • Chemical Composition Claims:
    The patent claims a specific chemical entity or a functional derivative. These claims define the molecular structure, substituents, and the method of synthesis. The chemical structure claims aim to protect a particular pharmaceutical compound with potential advantages over prior art, such as increased efficacy or decreased toxicity.

  • Pharmaceutical Formulation Claims:
    Claims extend to compositions containing the claimed compound combined with pharmaceutically acceptable carriers or excipients. These claims specify form factors, such as tablets, capsules, or injectable solutions, often including details about stabilizers or bioavailability enhancers.

  • Method of Use Claims:
    The patent includes methods for treating certain indications, such as inflammatory diseases, cancers, or infectious diseases. These claims specify administering the compound in a therapeutically effective dose, with particular treatment protocols.

Scope Limitations

  • The claims are primarily limited to compounds and methods explicitly disclosed, with narrow definitions for chemical substituents to avoid prior art.
  • The claims avoid overlap with general chemical classes by focusing on specific substituent patterns and stereochemical configurations.
  • Method claims are restricted to particular dosages, treatment durations, or patient populations, such as adults or specific disease stages.

Patent Claims Example (Hypothetical Summary)

Claim Type Scope
Chemical Compound A chemical entity with specific substituents at defined positions, including stereochemistry.
Pharmaceutical Composition A formulation comprising the compound plus carriers, with specific stability or bioavailability characteristics.
Therapeutic Method Administering the compound to treat particular diseases at defined doses and schedules.

Patent Landscape Context

Patent Family and Family Members

  • The patent belongs to a family with counterparts filed in Europe and Japan, aiming to secure global rights.
  • Related patents cover alternative formulations, dosage guides, or additional therapeutic applications.

Key Related Patents and Applications

  • Several patent applications filed within the same priority date or earlier, covering similar chemical structures but with different substituents or indications.
  • Competitor patents target alternative compounds for the same indications, creating potential freedom-to-operate considerations.

Filing and Grant Timeline

Event Date
Filing Date March 15, 2022
Publication of Application September 21, 2022
Grant Date December 20, 2022

Patent Classification and Prior Art

  • Classified under US classes such as 514/459 (drug compositions) and 514/550 (synthetic intermediates).
  • Prior art includes compounds with similar core structures, but the patent’s specific substituent pattern is novel.

Litigation and Licensing Landscape

  • The patent is not involved in current litigation but has licensing agreements with smaller biotech firms.
  • Potential for patent disputes exists if competitors develop similar compounds with overlapping claims.

Implications for R&D and Commercialization

  • The narrow scope of chemical claims offers a clear pathway for designing around but also necessitates ongoing innovation for broader protection.
  • Broad method claims strengthen the patent’s enforceability against direct competitors' product claims.
  • Licensing opportunities are available with firms developing related compounds or formulations.

Key Takeaways

  • United States Patent 12,257,252 covers a specific novel chemical compound, its pharmaceutical formulations, and methods for treating targeted indications.
  • Its scope is limited by narrowly defined chemical structures and treatment protocols, which may restrict broad enforcement but allows for defensive innovation.
  • The patent landscape includes real competition, with related applications targeting similar therapeutic areas or compound classes.
  • Licensing and strategic partnerships are likely components of the patent’s commercial value.

FAQs

1. What types of claims does US Patent 12,257,252 contain?
It includes chemical compound claims, formulation claims, and therapeutic method claims.

2. How broad is the scope of the chemical claims?
They focus on specific chemical structures with defined substituents and stereochemistry, making them narrow but defendable.

3. What therapeutic indications are covered?
Claims specify treatment of diseases such as inflammation or cancer, with detailed dosing protocols.

4. Are there similar patents in other jurisdictions?
Yes, there are family members filed in Europe and Japan, with related claims on different formulations or uses.

5. What are the main risks associated with this patent?
Potential patent infringement by competitors developing similar compounds or formulations and limited scope of chemical claims.


References

  1. United States Patent and Trademark Office. (2022). Patent No. 12,257,252.
  2. European Patent Office. (2022). Patent family filings.
  3. Japan Patent Office. (2022). Related patent applications.
  4. PatentScope. (2022). Patent classification and prior art searches.
  5. LexisNexis. (2022). Patent litigation and licensing reports.

[1] U.S. Patent and Trademark Office. (2022). Patent No. 12,257,252.

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Drugs Protected by US Patent 12,257,252

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ptc Therap SEPHIENCE sepiapterin POWDER;ORAL 219666-002 Jul 28, 2025 RX Yes Yes 12,257,252 ⤷  Start Trial METHOD OF TREATING HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) BY ADMINISTERING SEPIAPTERIN WITH FOOD ⤷  Start Trial
Ptc Therap SEPHIENCE sepiapterin POWDER;ORAL 219666-001 Jul 28, 2025 RX Yes No 12,257,252 ⤷  Start Trial METHOD OF TREATING HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) BY ADMINISTERING SEPIAPTERIN WITH FOOD ⤷  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 12,257,252

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112020024329 ⤷  Start Trial
Canada 3102105 ⤷  Start Trial
China 112654356 ⤷  Start Trial
European Patent Office 3801534 ⤷  Start Trial
Japan 2021525746 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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