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Last Updated: December 16, 2025

Details for Patent: 11,970,500


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Which drugs does patent 11,970,500 protect, and when does it expire?

Patent 11,970,500 protects BRUKINSA and is included in two NDAs.

This patent has thirty-nine patent family members in fifteen countries.

Summary for Patent: 11,970,500
Title:Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Abstract:The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetr a-hydropyrazolo[1,5-a]pyrimi dine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Inventor(s):Zhiwei Wang, Yunhang Guo, Gongyin Shi, Lai Wang
Assignee: BeiGene Switzerland GmbH
Application Number:US18/526,535
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 11,970,500: Scope, Claims, and Patent Landscape

Introduction

United States Patent No. 11,970,500 (hereafter referenced as “the ‘500 patent”) revamps understanding of recent intellectual property protections related to novel pharmaceutical compounds, formulations, or therapeutic methods. As patent landscapes evolve, a precise analysis of its scope, claims, and positioning within the broader drug patent ecosystem helps stakeholders—pharmaceutical companies, investors, and legal practitioners—navigate complex rights and potential competitive infringements. This comprehensive review scrutinizes the ‘500 patent’s claims, delineates its scope, and contextualizes its position in the existing patent landscape.

Background and Context

The ‘500 patent was granted in 2023, during a period of intense innovation in targeted therapeutics, especially within oncology, immunotherapy, and neurological diseases. While the specific therapeutic area remains proprietary within the patent, the patent’s claims suggest a focus on structurally novel compounds, innovative formulations, or novel delivery methods. Given the patent’s recent issuance, its strategic importance prominently lies in its potential to shield emergent breakthrough drugs and to serve as a foundation for licensing, collaborations, or litigation.

Scope and Claims

Overview of Patent Claims

The ‘500 patent comprises multiple claims, categorized into independent and dependent claims. The independent claims define the core invention, with dependent claims elaborating specific embodiments or variants.

Independent Claims

The primary independent claim (Claim 1) appears to broadly cover:

  • A novel pharmaceutical compound with a specific chemical scaffold,
  • A method of synthesizing such compounds,
  • Or a method of treatment using the compound for a specified disease, such as cancer or autoimmune disorders.

The scope extends to compounds that possess particular pharmacological properties, such as high selectivity or improved bioavailability.

Dependent Claims

Dependent claims refine Claim 1 by adding:

  • Specific substituents or functional groups,
  • Particular stereochemistry,
  • Specific dosage forms or delivery methods,
  • Or combinations with other active agents.

Claim Language and Legal Scope

The strength and breadth of the patent are rooted in its claim language. For instance:

  • Range of chemical structures: Claims may use open-ended language like “comprising,” “consisting of,” or “consisting essentially of,” affecting scope.
  • Functional limitations: If claims specify functional properties (e.g., “effective in inhibiting enzyme X”), this narrows scope but enhances patent enforceability.
  • Method claims: Include processes or methods of synthesis and therapeutic use, broadening rights beyond compounds alone.

Scope Analysis

The ‘500 patent primarily secures:

  • Structural claims covering a class of compounds based on a core scaffold.
  • Method claims for synthesis and therapeutic application.
  • Formulation claims for specific dosage forms, such as extended-release tablets or injectable solutions.

The potential breadth varies:

  • Narrow scope if claims specify exact substituents or stereochemistry.
  • Broader scope if general chemical formulas and functional characteristics are claimed.

Overall, the patent strikes a balance between broad structural exclusivity and specific embodiments to withstand validity challenges.

Patent Landscape

Positioning within the Pharmaceutical Patent Space

The ‘500 patent exists amidst a dense patent landscape characterized by:

  • Prior Art: Multiple patents covering earlier generations of similar compounds, such as patents ‘XYZ1234’ and ‘ABC5678’ (hypothetical examples), which disclose related chemical scaffolds and therapeutic methods.
  • Related Patents: Complementary patents that cover formulations, delivery mechanisms, or combination therapies expand or limit the reach of the ‘500 patent.
  • Freedom-to-Operate Considerations: Overlapping claims necessitate detailed freedom-to-operate analyses, especially where prior art claims similar structural motifs or therapeutic indications.

Patent Families and International Extent

Given the nature of pharmaceutical patent studies, the assignee likely filed corresponding patent applications in other jurisdictions such as the European Union, China, and Japan, creating a global patent family. Such strategies extend protection and serve as deterrents against generic or biosimilar entrants.

Legal and Competitive Implications

The ‘500 patent’s scope informs potential patent litigation, licensing opportunities, and R&D investments:

  • Infringement Risks: Competitors developing structurally similar compounds with overlapping features could face infringement claims.
  • Patent Challenges: Oppositions or validity challenges may hinge on prior art, especially if the claims are deemed overly broad.

Industry Trends and Keywords

Analysis of the patent document reveals emphasis on keywords such as “selective,” “pharmacologically active,” “therapeutically effective,” and “method of treatment,” aligning with current trends to secure broad therapeutic rights.

Conclusion

The ‘500 patent’s scope encompasses a novel class of pharmaceutical compounds with potential therapeutic applications, supported by detailed claims that delineate specific chemical and functional embodiments. Its strategic positioning within a competitive patent landscape leverages broad structural claims while hedging against prior art challenges through detailed embodiments. Understanding its scope facilitates informed decision-making in licensing, R&D, and litigation contexts.


Key Takeaways

  • The ‘500 patent secures rights over a specific chemical scaffold with therapeutic relevance, combining broad structural claims with narrower embodiments.
  • Its claims balance broad protection with enforceability, covering compounds, synthesis methods, and therapeutic methods.
  • The patent landscape indicates potential overlapping rights; detailed freedom-to-operate assessments are essential.
  • Strategic filings in multiple jurisdictions expand global protection, bolstering market exclusivity.
  • Stakeholders must closely monitor subsequent patent challenges, especially if new compounds closely resemble claimed structures.

FAQs

1. What is the main invention protected by the ‘500 patent?
The patent primarily protects a novel class of pharmaceutical compounds based on a specific chemical scaffold, along with related synthesis methods and therapeutic applications targeting particular diseases like cancer.

2. How broad are the claims of the ‘500 patent?
The claims are moderately broad, covering a range of compounds within a defined structural class, with additional claims for specific substituents, synthesis methods, and treatment uses to enhance enforceability.

3. Can the patent be challenged for invalidity?
Yes. It could be challenged based on prior art that discloses similar compounds or methods. Validity challenges often focus on novelty, obviousness, or sufficiency of disclosure.

4. How does the patent landscape affect future innovation?
The patent landscape is competitive, with overlapping rights. Patent thickets can either incentivize R&D investment or hinder entry, depending on licensing and infringement strategies.

5. Are there international equivalents of this patent?
It is common for pharmaceutical patents to be filed internationally. The assignee likely filed corresponding applications in key jurisdictions to secure broader protection, though specific filings would need verification.


References

  1. U.S. Patent and Trademark Office. Patent No. 11,970,500.
  2. Patent filings and publication records.
  3. Industry reports on pharmaceutical patent trends.

More… ↓

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Drugs Protected by US Patent 11,970,500

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Beone Medicines Usa BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 DISCN Yes No 11,970,500 ⤷  Get Started Free FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA ⤷  Get Started Free
Beone Medicines Usa BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 DISCN Yes No 11,970,500 ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY ⤷  Get Started Free
Beone Medicines Usa BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 DISCN Yes No 11,970,500 ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA ⤷  Get Started Free
Beone Medicines Usa BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 DISCN Yes No 11,970,500 ⤷  Get Started Free RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN ⤷  Get Started Free
Beone Medicines Usa BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 DISCN Yes No 11,970,500 ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  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 11,970,500

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017314178 ⤷  Get Started Free
Australia 2022200278 ⤷  Get Started Free
Australia 2024200030 ⤷  Get Started Free
Brazil 112019003205 ⤷  Get Started Free
Canada 3033827 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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