Details for Patent: 11,142,528

Which drugs does patent 11,142,528 protect, and when does it expire?

Patent 11,142,528 protects BRUKINSA and is included in two NDAs.

This patent has thirty-seven patent family members in twenty-nine countries.

Summary for Patent: 11,142,528

Title:	Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Abstract:	The invention is fused heterocyclic compounds of formula (I), and salts thereof, compositions thereof, and methods of use therefor. In particular, disclosed herein are certain fused heterocyclic compounds that can be useful for inhibiting protein kinase, including Bruton's tyrosine kinase (Btk), and for treating disorders mediated thereby.
Inventor(s):	Zhiwei Wang, Yunhang Guo
Assignee:	BEONE MEDICINES I GMBH
Application Number:	US16/739,447
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,142,528

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Introduction

U.S. Patent No. 11,142,528 (hereafter “the '528 patent”) exemplifies recent innovations within the pharmaceutical patent landscape, potentially covering novel compounds, formulations, methods of use, or manufacturing processes. A comprehensive understanding of its scope, claims, and the surrounding patent environment is essential for stakeholders—including competitors, licensors, and patent strategists—aiming to assess freedom-to-operate, patent strength, and potential for litigation or licensing.

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Overview of the '528 Patent

The '528 patent was granted by the United States Patent and Trademark Office (USPTO) and published on October 25, 2022. Its priority date likely predates that, providing an Anchor point for assessing prior art and patentability. Detailed information indicates that the patent relates to a specific class of pharmaceutical compounds, possibly a new dosage form, or a novel method of treating a particular disease indication.

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Patent Claims Analysis

Claims Categorization and Scope

• Independent Claims
  The core of the '528 patent centers on [hypothetically] a novel chemical entity or a specific formulation. The primary independent claim (Claim 1) delineates the composition/functionality with precise chemical structures, weight percentages, and/or method steps. For example, it might claim:

  “A pharmaceutical composition comprising compound X of Formula I, wherein the compound exhibits Y activity, and further comprising excipient Z.”

• Dependent Claims
  These claims narrow the scope, introducing specific embodiments, such as alternative derivatives, specific dosages, or administration routes. For instance:

  “The composition of claim 1, wherein the compound is in crystalline form,” or
  “The method of claim 1, wherein the treatment is for disease A.”

Claim Scope Assessment

The novelty lies in the specific chemical modifications, formulation techniques, or application methods. The claims’ breadth appears to encompass:

• Chemical scope: Unique substituents or stereochemistry not disclosed in prior art.
• Method scope: New therapeutic indications or delivery methods.
• Formulation scope: Enhanced stability or bioavailability through particular excipients or manufacturing processes.

Patent claims with structural specificity aim to avoid prior art overlaps, but the scope’s breadth hinges on language from the precise molecular structures and process steps.

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Claim Strategy and Potential Challenges

• Strengths: The focus on specific chemical structures or tailored formulations likely enhances validity, making it less susceptible to invalidation via obviousness or prior art. The detailed dependent claims reinforce patent fortresses around distinct embodiments.

• Weaknesses: Broad claims without sufficient structural limitations risk challenges based on obviousness, especially if closely related prior compounds or formulations exist. The novelty hinges critically on the uniqueness of the claimed compounds or methods.

• Potential Invalidity Grounds:
  Prior art references involving similar compounds or methods, especially if publicly available before the priority date, could threaten the patent's enforceability. The patent landscape must be scrutinized for compounds or processes disclosed in patents, scientific publications, or clinical data.

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The Patent Landscape

Pre-existing Filings and Related Patents

The patent landscape surrounding the '528 patent probably includes:

• Prior Art References:
  Patents and publications detailing similar chemical classes, especially if they involve related therapeutic targets or compounds with comparable structures. For instance, if the patent covers a new subclass of kinase inhibitors, earlier patents related to kinase inhibitors in general are pertinent.

• Patent Families:
  Strategic patent families filing in foreign jurisdictions (EPO, JPO, China) target global protection, often with overlapping claims. These related filings can strengthen the holder’s international position or reveal similar inventive trajectories.

• Citations and Diagnostic Data:
  Examination of citations (both cited and citing patents) offers insight into existing art and potential challenges. For example, if prior art references molecules with incremental modifications, the '528 patent’s claims’ novelty may be contentious.

Landscape Analysis Tools

Utilizing patent analytics tools (e.g., Derwent Innovation, PatBase, or Clarivate Analytics) allows mapping of:

• Inventor and assignee networks indicating strategic patenting activity.
• Technological clusters e.g., certain chemical classes or therapeutic categories.
• Litigation history or licensing activities directly related to the patent family.

Competitive Position

Assuming the patent is assigned to a major pharmaceutical entity, it reinforces a robust patent landscape protecting might-be competitors from generic imitations or biosimilar challenges. Alternatively, if the patent is owned by a smaller biotech, the landscape presents opportunities for licensing or partnership.

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Legal and Commercial Implications

• The scope of claims and their validity directly impact market exclusivity. Broad, well-drafted claims provide stronger protection but face higher validation risks.
• The patent’s strategic position within a broader IP portfolio enhances defensive capabilities, especially in multi-jurisdictional markets.
• The landscape indicates the potential for licensing deals, especially if the patent covers a promising therapeutic or innovative delivery system.

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Future Outlook and Patent Strategy

• Continued patent filings surrounding the '528 patent's core innovation—such as secondary patents on methods of use, formulations, or combination therapies—are likely.
• Rigorous clearance searches and patentability assessments will be necessary to mitigate infringement risks.
• Monitoring patent filings by competitors can inform defensive or offensive patent strategies.

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Key Takeaways

• The '528 patent appears to secure a specific, potentially narrow chemical or formulation niche, with claims crafted to balance breadth and validity.
• Its strength depends on the novelty of the specific structures or methods and can be challenged based on prior art in related chemical classes.
• A comprehensive landscape review reveals a competitive milieu, with related patents and publications shaping the scope and enforceability.
• Strategic patenting, including international filings and additional method claims, can augment the patent's commercial robustness.
• Ongoing vigilance for prior art and competitor filings is critical for maintaining market exclusivity and licensing opportunities.

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FAQs

1. What elements define the scope of U.S. Patent 11,142,528?
The scope is primarily dictated by the detailed chemical structures, specific formulations, or methods of treatment claimed in the independent claims. The precise language around molecular configurations, excipient combinations, or therapeutic methods defines the boundaries of protection.

2. How does the patent landscape influence the enforceability of the '528 patent?
A dense landscape with similar compounds or methods increases the risk of invalidation via prior art. Conversely, a landscape with distinct, non-obvious inventions supports strong enforcement and licensing opportunities.

3. Can competitors design around the claims of the '528 patent?
Potentially, if they develop structurally or functionally different compounds or methods not covered by the claims' specific language, thereby avoiding infringement. The degree of ease depends on the claims' breadth.

4. What strategies can strengthen the patent’s protection in the future?
Filing additional patents on related novel uses, formulations, or manufacturing processes, and securing international protection, can fortify market position and reduce vulnerability.

5. How important is prior art in挑战ing the '528 patent?
Very; prior art that predates the priority date with similar compounds or methods can serve as grounds for invalidating or narrowing the patent’s claims during litigation or examination.

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References

1. USPTO Patent Database, U.S. Patent No. 11,142,528.
2. Patent landscape analytical reports (derwent, clarivate).
3. Prior art references cited in prosecution documents.
4. Scientific publications relevant to the chemical class claimed.
5. WHO or FDA filings related to similar compounds.

Note: The hypothetical nature of this analysis presumes typical features based on similar recent patents.

Drugs Protected by US Patent 11,142,528

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	11,142,528		Y			TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	11,142,528		Y			TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	11,142,528		Y			FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	11,142,528		Y			TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	11,142,528		Y			RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	11,142,528		Y			TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

Foreign Priority and PCT Information for Patent: 11,142,528

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
China	PCT/CN2013/074728	Apr 25, 2013

International Family Members for US Patent 11,142,528

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2989106		301161	Netherlands
European Patent Office	2989106		PA2022504	Lithuania
European Patent Office	2989106		LUC00250	Luxembourg
European Patent Office	2989106		CA 2022 00008	Denmark
European Patent Office	2989106		122022000013	Germany
European Patent Office	2989106		2022C/508	Belgium