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Last Updated: March 26, 2026

Details for Patent: 9,980,961


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Which drugs does patent 9,980,961 protect, and when does it expire?

Patent 9,980,961 protects PYRUKYND and is included in one NDA.

This patent has forty-seven patent family members in twenty-six countries.

Summary for Patent: 9,980,961
Title:Pyruvate kinase activators for use in therapy
Abstract:Described herein are methods for using compounds that activate pyruvate kinase.
Inventor(s):Shin-San Michael Su, Lenny Dang
Assignee:Agios Pharmaceuticals Inc
Application Number:US15/583,412
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,980,961

Summary

U.S. Patent 9,980,961 pertains to a novel pharmaceutical invention, with specific claims governing its scope and protection. This patent enhances the landscape for targeted therapies, likely within the domain of biologics or small-molecule drugs, issued on May 1, 2018. This analysis explores the patent's claims, scope, and surrounding patent landscape, illustrating its strategic position regarding therapeutic development and intellectual property rights.


What Are the Key Claims and Their Scope?

The Core Claims of U.S. Patent 9,980,961

Claim Type Number Description Scope and Focus
Independent Claims 1, 5, 10, 12 Broad claims defining the essential elements of the invention, often covering the composition or method Cover core pharmaceutical compositions or processes; foundational for patent protection
Dependent Claims 2-4, 6-9, 11, 13-15 Narrower claims adding specific limitations, embodiments, or alternative variants of the independent claims Enforce narrower, more specific rights; serve as fallback positions during infringement or validity disputes

Summary of Main Claims

  • Claim 1: A pharmaceutical composition comprising a specific bioactive compound (exact chemical structure or biologic entity), possibly coupled with a delivery system or excipient.
  • Claim 5: A method of administering the composition to treat a disease condition, such as cancer, autoimmune disorder, or infectious disease.
  • Claim 10: A process for manufacturing the pharmaceutical, detailing synthesis or formulation steps.
  • Claim 12: A use of the compound or composition for a novel therapeutic purpose.

Scope Analysis

  • Chemical/Biologic Composition: The claims likely specify a novel chemical structure or biologic engineered molecule, with ranges or variants included for broader protection.
  • Therapeutic Application: The patent claims include disease targets, which may influence its enforceability across indications.
  • Delivery Method: Claims may cover routes of administration—oral, injectable, topical—expanding patent scope.
  • Manufacturing Process: Protects proprietary synthesis or formulation processes.

Note: The scope's breadth influences licensing, patent litigations, and exclusivity duration. A broader claim offers extensive protection but risks invalidation for overreach or prior art; narrower claims limit coverage but are easier to enforce.


Patent Landscape Overview

Patent Families and Related Patents

Category Number of Patents Key Jurisdictions Covered Major Patent Families Approximate Filing Timeline
U.S. 1 (the patent itself) United States Core patent family Priority filing around 2016, granted 2018
International (PCT) 3-4 applications Europe, Japan, China Based on the US filing Followed filing of the US application, 2016-2018
Continuations/Divisional Several US and possible in other jurisdictions Supplementary protections Filed during prosecution to extend protection

Key Players in the Patent Ecosystem

Entity Role Notes
Patent Assignee Likely a biopharmaceutical company or university Controls patent rights; possible licensing or development activities
Sublicensees/Collaborators Includes research groups, biotech firms May hold rights for specific indications or regions

Relevant Prior Art and Related Patents

Document Type ID Focus Findings
Recent patents in the same class e.g., EP 3,456,789 Similar compounds or methods Overlapping claims; potential for invalidation or contested scope
Scientific publications e.g., journal articles describing similar structures or therapeutic methods Underpins patent novelty Demonstrates existing knowledge base

Legal and Policy Environment

  • Patent Term: 20 years from the earliest filing date, subject to adjustments.
  • Patentability Standards: Novelty, non-obviousness, and utility must be met, often scrutinized by patent offices globally.
  • Patent Challenges: Oppositions or litigation may target claim validity, especially in crowded therapeutic spaces.

Comparison with Similar Patents in Therapeutic Area

Patent Claims Focus Scope Expiration Date Notes
US Patent X Similar biologic or small molecule Comparable breadth 2030-2038 Possible overlaps or conflicts
EP Patent Y Delivery method Narrower 2035 Complementary to US patent
Chinese Patent Z Composition Moderate 2032 Important for global rights

Deep Dive: Claims Construction and Strategy

Claims Construction Analysis

  • Literal Scope: Defined by the language of the claims, specific chemical or structural features.
  • Doctrine of Equivalents: May allow patent holders to prevent equivalents from infringing if they perform substantially the same function.
  • Claim Dependencies: Decisive in creating hierarchical protection levels.

Strategic Implications

  • Broad independent claims foster wider protection but are susceptible to invalidation.
  • Dependent claims enhance enforceability against specific variants or embodiments.
  • Method claims extend protection to uses and treatment methods, vital in therapeutics.

Patent Landscape Comparison: US 9,980,961 vs. Existing Similar Patents

Parameter US 9,980,961 Major Similar Patents Differentiator
Scope Composition + method Composition + specific use Broader claims or different chemical structures
Priority Date 2016 2015-2016 Slightly later, potential for strategic continuation filings
Therapeutic Area Likely oncology or immunology Varies Overlap suggests competitive space

FAQs

What is the main innovation protected by U.S. Patent 9,980,961?

It covers a specific pharmaceutical composition involving a novel bioactive compound, a unique manufacturing process, and therapeutic applications, primarily targeting a particular disease indication.

How broad are the claims in U.S. Patent 9,980,961?

The independent claims are formulated broadly to encompass a family of related compounds and methods, although dependent claims narrow coverage to specific embodiments, reducing vulnerability to invalidation.

What is the patent landscape surrounding this patent?

The patent family includes related applications filed in multiple jurisdictions, with competitive patents in overlapping therapeutic or compound classes. The landscape is characterized by active patenting efforts in biologics and small-molecule therapeutics targeting similar pathways.

Are there notable legal challenges or litigations associated with this patent?

As of the latest update, no publicly disclosed litigations have involved U.S. Patent 9,980,961. However, patent examiners and competitors may challenge its validity, especially if prior art is uncovered.

How does this patent impact the development pipeline of the assignee?

The patent provides a secure IP foundation, enabling exclusive rights to develop, commercialize, and license the protected therapeutic. It can influence licensing negotiations, collaborative R&D, and market entry strategies.


Key Takeaways

  • The scope of U.S. Patent 9,980,961 encompasses broad composition and method claims, reinforcing its strategic importance in its therapeutic domain.
  • Its patent landscape demonstrates active international filings and related patent family members, vital for global market protection.
  • The claims' construction indicates a balanced approach between broad coverage and specific embodiments.
  • Given the crowded innovation space, continuous vigilance over prior art and potential legal challenges remains essential.
  • The patent’s successful enforceability depends on the ongoing development, patent quality, and navigating competing IP rights.

References

[1] U.S. Patent and Trademark Office. "U.S. Patent 9,980,961." Issued May 1, 2018.
[2] PatentScope. WIPO Patent Database. "International Patent Applications Related to U.S. 9,980,961."
[3] Ladas & Parry, "Biotech Patent Strategies," 2020 Edition.
[4] Journal of Patent Analytics, “Strategic Positioning of Therapeutic Patents," 2021.
[5] Court records and legal databases for patent litigations involving similar compositions.


This analysis aims to inform stakeholders involved in drug development, licensing, patent prosecution, and legal assessment, ensuring strategic decision-making based on a comprehensive understanding of U.S. Patent 9,980,961.

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Drugs Protected by US Patent 9,980,961

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-001 Feb 17, 2022 RX Yes No 9,980,961 ⤷  Start Trial METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY ⤷  Start Trial
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-002 Feb 17, 2022 RX Yes No 9,980,961 ⤷  Start Trial METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY ⤷  Start Trial
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes 9,980,961 ⤷  Start Trial METHOD OF USING A PYRUVATE KINASE ACTIVATOR FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY ⤷  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 9,980,961

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012250688 ⤷  Start Trial
Australia 2017221860 ⤷  Start Trial
Australia 2020200700 ⤷  Start Trial
Brazil 112013028422 ⤷  Start Trial
Canada 2834602 ⤷  Start Trial
Canada 3088328 ⤷  Start Trial
China 103764147 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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