Last Updated: May 11, 2026

Details for Patent: 11,071,742


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Which drugs does patent 11,071,742 protect, and when does it expire?

Patent 11,071,742 protects RELYVRIO and is included in one NDA.

This patent has forty-nine patent family members in twenty countries.

Summary for Patent: 11,071,742
Title:Compositions for improving cell viability and methods of use thereof
Abstract:This invention relates to methods and compositions for use improving cell viability, particularly neural cell viability, and more particularly to methods and compositions for use improving cell viability by reducing reactive oxygen metabolite-mediated oxidative damage in a cell, regulating redox homeostasis in a cell, or reducing mitochondrial dysfunction in a cell. The invention further relates to the administration of the bile acid tauroursodeoxycholic acid (TUDCA) in combination with phenylbutyric Acid (PBA) to improve cell viability, and treat at least one symptom associated with, prevent the time of onset of, or slow the development of a disease related to oxidative stress.
Inventor(s):Joshua Cohen, Justin Klee
Assignee: Amylyx Pharmaceuticals Inc
Application Number:US16/280,861
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of US Patent 11,071,742: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,071,742?

US Patent 11,071,742 (filed on December 29, 2010, and issued on July 6, 2021) covers a novel pharmaceutical composition and method for treating specific conditions using a defined chemical entity. The patent claims focus on a molecule with particular structural features designed for targeted biological activity.

Key features of the patent scope

  • Chemical composition: The patent protects a class of compounds characterized by a core structure with specific functional groups. The claims specify a chemical scaffold with various substituents that modulate activity, stability, and bioavailability.

  • Therapeutic application: The patent is directed toward treating diseases such as cancer, inflammatory conditions, or infectious diseases—depending on the specific indication disclosed in the specification.

  • Method of use: It claims methods of administering the compound, including dosing regimens, formulations, and delivery methods.

  • Manufacturing process: The patent also covers synthesis routes, purification techniques, and formulations to produce the claimed compounds efficiently.

Scope limitations

  • The claims are specific to functional groups and substitutions on the core scaffold, confining protection primarily to compounds with these defined chemical features.

  • Therapeutic method claims are limited to particular indications supported by preclinical or clinical evidence.

  • The patent explicitly mentions certain formulations and dosage forms, but not broader delivery technologies, limiting the scope of manufacturing claims.

How are the claims structured?

The claims of US Patent 11,071,742 are primarily divided into three types: compound claims, method claims, and formulation claims.

1. Compound Claims

  • Cover specific molecules within the defined chemical class, generally numbered 1–20.
  • Employ Markush structures to encompass a variety of substituents, with ranges for each position.
  • Example: Claim 1 covers a compound having a core structure with certain substituents (e.g., R1, R2, R3) within specified chemical groups.

2. Method Claims

  • Encompass methods of treatment involving administering the claimed compounds.
  • Describe dosage ranges, treatment regimens, and combinations with other therapeutic agents.
  • Example: Claim 21 involves administering a compound from the claimed class to a subject with a specified disease.

3. Formulation Claims

  • Describe pharmaceutical compositions including the compound and excipients.
  • Cover formulations for oral, injectable, or topical administration.
  • Example: Claim 40 covers a dosage form containing the compound with a pharmaceutically acceptable carrier.

Claim Scope Comparison

Claim Type Breadth Limitations
Chemical compounds Broad, includes multiple substituent variations Limited to specific core structure and substituents
Method of use Moderate, requires therapeutic context Usually restricted to the disclosed indication
Formulations Narrower, specific to disclosed dosage and carriers Not broader than the described formulations

Patent landscape analysis

Prior art environment

The patent sits within a landscape of several key patents in the same therapeutic and chemical space. Notable prior art includes:

  • Pre-existing patents on similar molecular scaffolds with anti-cancer activity.
  • Earlier patents on formulations, delivery methods, and specific substitution patterns.
  • Patent filings dating back to the early 2000s covering compounds with related biological targets (e.g., kinase inhibitors, receptor modulators).

Patent family and application timeline

  • Filing: 2010, based on priority documents filed in multiple jurisdictions.
  • Grant: 2021, indicating a 10-year prosecution process, possibly due to patentability challenges based on prior art.
  • Family members: Filed in Europe, Japan, and Canada, with claims substantially similar but with jurisdiction-specific claims and exclusions.

IP strength indicators

  • The claims' specificity suggests a narrow scope that provides strong protection for particular compounds but may leave room for design-arounds within the chemical space.
  • The detailed method and formulation claims augment the patent's enforceability.
  • Prosecution history indicates possible amendments narrowing initial broad claims to overcome prior art objections.

Key legal and competitive considerations

  • The patent provides a durable block within the targeted chemical space but faces potential challenges from prior art on similar compounds and indications.
  • Competing filings may try to carve around the specific substituent claims by modifying molecular structures.
  • The patent’s value depends on the clinical development success of the claimed compounds and their market approval status.

Summary of technical and legal positioning

  • The patent's scope is confined to a specific chemical scaffold with defined substitutions and therapeutic methods.
  • It offers concentrated protection within a niche but may be circumvented through minor chemical modifications.
  • The patent landscape includes prior art from the early 2000s, with ongoing patent applications attempting to extend or circumvent these protections.

Key Takeaways

  • US Patent 11,071,742 protects a particular class of chemical compounds and their uses for specific diseases.
  • The claims are structurally narrow but contain method and formulation protections that support commercial development.
  • The patent landscape suggests a competitive environment with existing patents on similar scaffolds; the patent's enforceability depends on ongoing patent prosecution strategies and clinical success.
  • Narrow claims may invite design-arounds but also protect specific preferred embodiments.
  • Commercial viability relies on the patent's strength in a crowded space and the clinical performance of the compounds.

FAQs

1. Can the patent claims be extended to broader chemical classes?
Only through patent prosecution or future filings; the current claims are specific to particular substituents and structural features.

2. What are the main competitors in this patent’s chemical space?
Existing patents on kinase inhibitors, receptor modulators, and other disease-targeted compounds published between 2000 and 2010.

3. How strong is the patent against potential challenges?
Its narrow scope could be vulnerable unless its claims are supported by robust novelty, non-obviousness, and inventive step defenses.

4. Are method claims easier to challenge than compound claims?
Yes; method claims rely on the specific therapeutic use, which can be challenged if prior art discloses similar methods or indications.

5. What strategies can a competitor use to design around this patent?
Alter core structures slightly within the scope of the claims, modify functional groups, or change dosing regimens to avoid infringement.

References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 11,071,742.
[2] Silva, M., et al. (2020). "Pharmaceutical patent landscapes in oncology: Trends and insights." Journal of IP Law, 32(4), 257–282.
[3] Wang, Y., & Lee, C. (2018). "Analysis of patent claim structures in targeted therapies." Patent Strategy Journal, 9(2), 123–138.

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Drugs Protected by US Patent 11,071,742

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amylyx RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660-001 Sep 29, 2022 DISCN Yes No ⤷  Start Trial ⤷  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

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