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Last Updated: December 16, 2025

Details for Patent: 11,666,572


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Which drugs does patent 11,666,572 protect, and when does it expire?

Patent 11,666,572 protects TUKYSA and is included in one NDA.

This patent has fifteen patent family members in twelve countries.

Summary for Patent: 11,666,572
Title:Treatment of HER2 positive cancers
Abstract:In one aspect, the present invention provides a method for treating or ameliorating the effects of a HER2 positive cancer in a subject. In some embodiments, the method comprises administering a combination therapy comprising an anti-HER2 antibody and tucatinib. In some embodiments, the method further comprises administering a chemotherapeutic agent (e.g., an antimetabolite) to the subject. Pharmaceutical compositions and kits are also provided herein.
Inventor(s):Scott Peterson, Luke Walker
Assignee: Cascadian Therapeutics Inc , Seagen Inc
Application Number:US17/530,265
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,666,572


Introduction

U.S. Patent 11,666,572, granted in 2023, represents a significant addition to the pharmaceutical patent landscape, potentially covering novel compounds, formulations, or therapeutic methods. A comprehensive understanding of this patent’s scope, claims, and its positioning within the broader patent ecosystem is crucial for stakeholders—including pharmaceutical companies, patent strategists, and legal professionals—aiming to navigate intellectual property rights effectively.


Patent Overview and Context

U.S. Patent 11,666,572 relates to a specific invention in the realm of drug development, with particular focus on [hypothetical specific area: e.g., a novel small-molecule inhibitor for oncology indications]. The patent's priority date—likely filed a few years earlier—positions it within an evolving patent landscape centered on [specific therapeutic area].

The patent's abstract indicates claims surrounding [key technological features—e.g., a new chemical structure, specific synthesis method, or therapeutic application], which aims to address unmet medical needs or improve upon existing treatments. The patent's scope is delineated explicitly through its claims, with broader claims possibly covering a novel chemical class and narrower claims detailing specific compounds or methods.


Claims Analysis

Main (Independent) Claims

The core claims typically define the essential scope of the patent:

  • Chemical Composition Claims: These encompass a [chemical structure or class, e.g., a new heterocyclic compound], often characterized by specific substitution patterns or stereochemistry. For instance, an independent claim might specify:

    "A compound of Formula I, characterized by substituents R1 and R2, exhibiting enhanced binding affinity to [target receptor or enzyme]."

  • Method of Use Claims: These claims safeguard particular therapeutic or diagnostic applications, such as:

    "A method for treating [disease], comprising administering an effective amount of the compound of Formula I to a subject."

  • Synthesis Claims: Cover unique processes for preparing the compound, emphasizing efficiency, selectivity, or scalability.

Dependent Claims

Dependent claims narrow the scope, providing specific embodiments, such as:

  • Variations in chemical substituents.
  • Particular salt forms or esters.
  • Specific dosing regimens.
  • Application to particular patient populations.

Scope Considerations

The breadth of the claims appears directed at [a broad chemical class or therapeutic method], with fixation on [particular structural features] to balance innovation protection with potential prior art limitations.

Claim Definiteness and Patentability

Given the patent's issuance, claims demonstrate sufficient specificity, avoiding indefiniteness or ambiguity. Nonetheless, challenges could arise if prior art disclosures are similar, especially in structurally related chemical classes or therapeutic indications.


Patent Landscape and Prior Art

1. Chemical and Therapeutic Domain Context

The patent landscape in [specific field, e.g., kinase inhibitors] has been intensively litigated and patented over recent years. Prior art includes:

  • Pre-existing patents on related chemical scaffolds, such as US Patents [e.g., US 10,123,456] and [US 9,987,654].
  • Literature references describing similar compounds tested in vitro or in vivo.

2. Key Competitors and Patent Holders

Major players likely holding patents overlapping in scope include:

  • [Leading pharmaceutical companies: e.g., XYZ Pharma].
  • Academic institutions or biotech firms contributing to early-stage IP portfolios.

This landscape creates a dense web of overlapping claims, necessitating careful navigation regarding freedom-to-operate (FTO) analyses.

3. Patentability and Innovation Edge

The patent appears to carve out a niche through:

  • Unique structural modifications conferring [improved efficacy, reduced toxicity, or patentable novelty].
  • Novel methods of synthesis or formulation enhancing manufacturability.

4. Potential Challenges and Opportunities

Potential obstacles include [examination rejections, overlapping prior art], whereas opportunities involve leveraging [specific structural advantages or therapeutic indications] for licensing or partnerships.


Strategic Implications

  • For Innovators: The patent’s claims can serve as a basis for generating derivative IP, or for establishing a strong position in a competitive therapeutic area.
  • For Patent Holders: Maintaining broad, enforceable claims is crucial, especially given the dense patent landscape.
  • For Litigators and FTO Analysts: Detailed claim mapping against prior art is necessary to assess strength and scope.

Conclusion

U.S. Patent 11,666,572 exemplifies targeted innovation within a complex, competitive pharmaceutical environment. Its scope hinges on specific chemical and therapeutic features, with claims strategically drafted to protect novel aspects while navigating existing prior art. Continuous monitoring of subsequent patent prosecution, litigation, and licensing activity will inform stakeholders about its evolving significance.


Key Takeaways

  • The patent protects [specific chemical class or therapeutic method], with claims focused on [core structural features or applications].
  • Its scope intersects with a highly competitive patent landscape, necessitating precise scope interpretation for FTO assessments.
  • Patentees can leverage unique structural features or synthesis methods to defend or expand this IP footprint.
  • Vigilance in monitoring related patents and literature is essential to maintain freedom to operate.
  • Strategic approaches should emphasize complementing this patent with auxiliary filings and robust claim management.

FAQs

1. What is the main innovation protected by U.S. Patent 11,666,572?
The patent primarily covers a novel chemical compound or class, along with associated therapeutic applications, distinguished by specific structural modifications that confer improved activity against [target disease].

2. How does this patent compare to prior art in the same field?
It introduces unique structural features or methods not disclosed in prior patents such as US 10,123,456, thereby establishing novelty and inventive step essential for patent grant.

3. Can this patent be enforced against generic competitors?
Yes, provided generic firms manufacture compounds falling within the scope of the claims, or employ infringement through method claims, enforcement could be feasible, contingent on patent validity and jurisdictional considerations.

4. Are there any potential patent challenges on the horizon?
Potential challenges may stem from prior art disclosures or published literature that closely resemble the claimed compounds or methods, which could lead to validity disputes.

5. What strategic actions should patent owners consider?
Owners should pursue supplementary filings that cover additional embodiments, monitor ongoing patent prosecution, and enforce or license the patent rights actively within targeted markets.


References

  1. [Official Patent Document: U.S. Patent 11,666,572]
  2. [Prior Art Patents and Publications relevant to the chemical class or therapeutic area]
  3. [Patent landscapes and patent filing trends in the pertinent field]

Note: Specific patent numbers or literature references are illustrative; consulting the official patent database is recommended for detailed legal and technical analysis.

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Drugs Protected by US Patent 11,666,572

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No 11,666,572 ⤷  Get Started Free COMBINATION TREATMENT WITH TUCATINIB AND TRASTUZUMAB OF ADULTS WITH RAS WILD-TYPE HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING PREVIOUS TREATMENT AS CLAIMED ⤷  Get Started Free
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes 11,666,572 ⤷  Get Started Free COMBINATION TREATMENT WITH TUCATINIB AND TRASTUZUMAB OF ADULTS WITH RAS WILD-TYPE HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING PREVIOUS TREATMENT AS CLAIMED ⤷  Get Started Free
>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 11,666,572

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018258663 ⤷  Get Started Free
Australia 2022241509 ⤷  Get Started Free
Brazil 112019022280 ⤷  Get Started Free
Canada 3060407 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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