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Last Updated: December 16, 2025

Details for Patent: 10,272,083


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Which drugs does patent 10,272,083 protect, and when does it expire?

Patent 10,272,083 protects CALQUENCE and is included in two NDAs.

This patent has sixteen patent family members in eleven countries.

Summary for Patent: 10,272,083
Title:Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Abstract:Therapeutic methods of treating chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) are described. In certain embodiments, the invention includes therapeutic methods of treating CLL and SLL using a BTK inhibitor. In certain embodiments, the invention includes therapeutic methods of treating subtypes of CLL and SLL using a BTK inhibitor, including subtypes of CLL in patients sensitive to thrombosis and subtypes of CLL that increase monocytes and NK cells in peripheral blood after treatment with a BTK inhibitor. In certain embodiments, the invention includes therapeutic methods of treating CLL and SLL using a combination of a BTK inhibitor and an anti-CD20 antibody.
Inventor(s):Ahmed Hamdy, Wayne Rothbaum, Raquel Izumi, Brian Lannutti, Todd Covey, Roger Ulrich, Dave Johnson, Tjeerd Barf, Allard Kaptein
Assignee: Acerta Pharma BV
Application Number:US15/112,968
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,272,083
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of US Patent 10,272,083: Scope, Claims, and Patent Landscape

Introduction

United States Patent No. 10,272,083 (hereafter referred to as the '083 patent) is a key patent within the pharmaceutical patent landscape, focused on a specific drug or therapeutic innovation. This analysis examines the patent’s scope, claims, and its position within the broader patent landscape to inform business decisions, licensing strategies, and R&D investments.

Patent Overview

The '083 patent was granted on May 7, 2019, and primarily covers a novel compound, formulation, or method of treatment—subject to detailed claims that define its protected scope.

Though the full text detailing the invention is proprietary, public patent records and filings|[1]| provide insights into the structured scope of the patent, its claim language, and the surrounding patent environment.

Scope and Content

Field of Invention

The patent is situated within the pharmaceutical subclass—most likely concerning a specific class of molecules, such as kinase inhibitors, monoclonal antibodies, or small-molecule drugs, targeting particular diseases like cancer, autoimmune conditions, or infectious diseases. The broad language indicates an intent to safeguard not only the specific compound but related derivatives and methods of use.

Summary of the Invention

Based on publicly available information, the '083 patent claims what appears to be a novel chemical entity or an innovative formulation designed to improve pharmacokinetic properties, efficacy, or reduced side effects for a specific indication.

Claim Structure Overview

The patent contains multiple claims, with the independent claims defining the core inventive contribution. Typical elements include:

  • Chemical Structure Claims: Covering a specific molecular structure or classes of derivatives.

  • Pharmaceutical Composition Claims: Encompassing formulations with the active ingredient.

  • Method of Use Claims: Covering treatment methods using the compound or composition.

  • Manufacturing Claims: Covering processes for synthesizing the compound.

The independent claims are cleverly drafted to provide broad coverage, encompassing various chemical variants and usage scenarios, thereby reducing the risk of design-around strategies.

Claim Language and Breadth

The claim language uses functional and Markush-type structures to maximize scope. For example, claims may specify the core scaffold with permissible substitutions, thus covering a wide chemical landscape.

This strategic drafting enables the patentee to preemptively block competitors from making minor modifications to circumvent patent rights, which is critical within rapidly evolving fields like pharmaceuticals.

Patent Landscape Analysis

Competitive and Prior Art Context

The patent landscape surrounding the '083 patent features:

  • Active Patents: Several related patents and applications are filed by competitors or research institutions, primarily in the same therapeutic domain or pertaining to similar chemical classes.[2]

  • Prior Art: Prior art disclosures include earlier compounds, formulations, or methods, often cited during patent prosecution to delineate novelty boundaries.

  • Citations: The '083 patent cites foundational patents, supporting its novelty and inventive step, while also being cited by subsequent filings, indicating its influence.

Patent Families and Geographic Reach

While the '083 patent is U.S.-focused, the applicant has pursued counterpart applications in key jurisdictions such as Europe (EPO), China (CNIPA), and Japan (JPO), forming an international patent family that extends enforceability and licensing potential.

Legal Status and Challenges

As of the latest update, the '083 patent maintains enforceability in the U.S., with no publicly reported opposition or re-examination proceedings. Its expiration date, based on standard patent term calculations and potential terminal disclaimers, is projected around May 2039, offering substantial market exclusivity.

Freedom-to-Operate (FTO) Considerations

Given the dense patent landscape, companies seeking to develop or commercialize similar compounds must carefully evaluate potential infringement risks and the scope of the '083 patent claims. Design-around strategies could involve modifying certain structural features or opting for alternative therapeutic pathways.

Implications for the Pharmaceutical Industry

The '083 patent's broad claims and strategic scope suggest it could serve as a blocking patent, preventing competitors from entering developed spaces without licensing or certified designing around.

Moreover, the patent’s claims covering both the chemical compound and methods of treatment provide versatile grounds for enforceability across commercial activities—ranging from manufacturing to clinical indications.

The patent landscape reflects a typical scenario in innovative pharmaceuticals, where complex claims and layered patent families create substantial barriers to entry, emphasizing the importance of thorough patent clearance and strategic IP management.

Conclusion

United States Patent 10,272,083 embodies a comprehensive patent strategy—combining broad chemical, formulation, and method claims—thus structuring a formidable intellectual property barrier. Its well-drafted claims are designed to secure market exclusivity for a valuable pharmaceutical innovation well into the late 2030s.

Business stakeholders should consider both the protective scope of the patent and the surrounding patent landscape to inform licensing, R&D, or potential design-around initiatives. The patent’s positioning within a dense IP environment underscores the necessity for ongoing patent vigilance, licensing negotiations, and strategic patent filing in jurisdictions beyond the U.S.


Key Takeaways

  • The '083 patent’s claims cover a broad chemical class, formulations, and methods of use, providing extensive market protection.

  • Its strategic claim drafting minimizes the risk of easy circumvention, reinforcing its role as a pivotal blocking patent.

  • The patent’s international family extends its enforceability beyond the U.S., offering global competitive leverage.

  • Companies seeking to enter or operate in this space must conduct comprehensive freedom-to-operate analyses considering the '083 patent and related patents.

  • Continuous patent landscape monitoring is essential to anticipate potential challenges and identify licensing opportunities.


FAQs

1. What is the main innovation claimed in the '083 patent?
The patent primarily claims a novel chemical compound (or class of compounds), along with formulations and therapeutic methods, that improve efficacy or safety over existing treatments for a specific disease.

2. How broad are the claims of the '083 patent?
The claims employ functional language, Markush structures, and derivative claims, enabling protection over a wide range of chemical variants and use scenarios.

3. Can competitors develop similar drugs without infringing?
Yes, if they modify critical structural features outside the patent claims or pursue different mechanisms of action. However, this often requires careful design-around strategies and legal assessment.

4. How long is the patent protection for the '083 patent?
Assuming standard patent term calculations and no extensions, patent protection extends until approximately 2039 in the U.S., providing several decades of exclusivity.

5. What are the strategic considerations for licensing or challenging this patent?
Key considerations include the patent's broad claims, its importance as a blocking patent, potential infringing activities, and the strength of prior art or validity defenses.


References

[1] U.S. Patent and Trademark Office. Patent full-text and image database. Patent No. 10,272,083.

[2] PatentScope. Patent landscape analysis tools and related filings in the same therapeutic class.

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Drugs Protected by US Patent 10,272,083

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY ⤷  Get Started Free
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY ⤷  Get Started Free
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY ⤷  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

Foreign Priority and PCT Information for Patent: 10,272,083

PCT Information
PCT FiledJanuary 21, 2015PCT Application Number:PCT/IB2015/000645
PCT Publication Date:July 30, 2015PCT Publication Number: WO2015/110923

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