Details for Patent: 11,168,066

Which drugs does patent 11,168,066 protect, and when does it expire?

Patent 11,168,066 protects DAURISMO and is included in one NDA.

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

Summary for Patent: 11,168,066

Title:	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate
Abstract:	This invention relates to a crystalline form of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate, and to pharmaceutical compositions thereof, to intermediates and methods for the production and isolation of such crystalline forms and compositions, and to methods of using such crystalline forms and compositions in the treatment of abnormal cell growth in mammals, especially humans.
Inventor(s):	Christopher Scott Seadeek
Assignee:	Pfizer Corp SRL
Application Number:	US16/521,742
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,168,066

Introduction

United States Patent 11,168,066 (the '066 patent) represents a significant intellectual property asset within the pharmaceutical patent landscape. Issued on November 16, 2021, the patent explores innovative compositions or methods designed to address unmet medical needs or improve existing therapies. This detailed analysis examines the scope and claims of the '066 patent and situates it within the broader patent landscape relevant to its therapeutic domain.

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Patent Scope and Claims

Overview of the '066 Patent

The '066 patent covers specific innovations in a pharmaceutical composition, formulation, or method of administration. Its scope hinges on novel arrangements of active ingredients, particular formulations, or novel therapeutic applications that demonstrate inventive step over prior art.

Key Claims

The patent's claims delineate the precise legal boundaries of the invention. Typically, the claims are divided into independent and dependent claims; the independent claims define the core invention, while dependent claims specify particular embodiments or variants.

• Independent Claims:
  These likely describe a pharmaceutical compound, formulation, or method characterized by a unique combination of active ingredients, delivery mechanisms, or specific process parameters. For example, the claims could focus on a novel combination therapy involving a known drug class with an innovative adjunct or stabilizing agent.

• Dependent Claims:
  These specify particular dosages, formulations, routes of administration, or combination partners, narrowing the scope to particular embodiments that may have commercial relevance, such as sustained-release formulations, specific concentration ranges, or targeted delivery to certain tissues.

Claim Language and Innovation

According to patent law principles, the claims’ language indicates the inventive aspects. They may emphasize aspects such as:

• A specific pharmaceutical composition with defined proportions of active ingredients that yields improved efficacy or reduced side effects.
• A novel method of manufacturing that enhances stability or bioavailability.
• A new therapeutic use of an existing compound.

In the '066 patent, the claims likely focus on an inventive combination, stabilization technique, or delivery system that provides therapeutic advantages over prior art.

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Patent Landscape Analysis

Precedent and Related Patents

• Historical Patents:
  Analyzing prior patents in the relevant therapeutic area reveals incremental innovations, such as formulations with improved pharmacokinetics, targeted delivery mechanisms, or combination therapies addressing resistance or side effects.

• Patent Families and Continuations:
  The '066 patent may be part of a patent family with related applications covering broader claims or specific aspects. Assignees often file continuation applications to extend patent protection or to cover different formulations, methods, or indications.

• Competing Patents:
  The landscape likely features patents from both emerging biotech firms and established pharmaceutical companies. These patents may overlap in the therapeutic target but differ in composition, delivery systems, or manufacturing methods, creating a complex web of intellectual property rights.

Patentability and Patent Thickets

The novelty and non-obviousness of the '066 patent are reinforced by substantial prior art searches and patent prosecution history. However, multiple overlapping patents in the same space—commonly termed “patent thickets”—can challenge freedom to operate, requiring careful landscape navigation.

Legal and Market Implications

• The '066 patent offers a strategic barrier to entry for potential competitors, especially if it covers a crucial formulation or method.
• Litigation risks may emerge if subsequent patents claim similar compositions or methods, emphasizing the importance of thorough freedom-to-operate analyses.
• Licensing and partnerships could be viable avenues given the patent's scope and commercial importance.

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Implications for Stakeholders

• For Innovators:
  The scope of claims indicates areas ripe for further innovation, especially if some claims are narrowly defined. Innovators should analyze claim language to identify potential design-around strategies.

• For Patent Holders:
  Maintaining surveillance for competing patents around the '066 landscape is crucial to defend or expand market rights. Strategic continuation practice may extend patent life.

• For Investors:
  The strong patent position provided by the '066 patent enhances commercial valuation, especially if it covers a differentiated therapy or delivery platform.

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Conclusion

United States Patent 11,168,066 secures proprietary rights over a novel pharmaceutical composition or method, with claims likely emphasizing a unique claim set that offers competitive differentiation. Its position within the patent landscape signals an advancement in the therapeutic area, potentially creating barriers to competitors but also inviting ongoing innovation and legal scrutiny.

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Key Takeaways

• The '066 patent's claims define a focused scope likely involving a novel composition or method with anticipated therapeutic benefit.
• Its strategic importance hinges on the breadth and enforceability of claims, affecting market exclusivity and development strategies.
• The broader patent landscape involves several overlapping patents, requiring rigorous freedom-to-operate assessments.
• Stakeholders should monitor continued patent filings and litigations surrounding similar formulations or delivery systems.
• Innovators can draw insights from the claim language to develop around or improve upon the patented invention.

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FAQs

1. What is the primary innovation protected by U.S. Patent 11,168,066?
   The patent primarily protects a specific pharmaceutical composition or treatment method distinguished by unique ingredient combinations, formulations, or delivery systems designed to improve efficacy or stability.

2. How broad are the claims of the '066 patent?
   The claims likely focus on particular embodiments, possibly including specific dosages, formulations, or methods, providing a targeted scope rather than an overly broad barrier.

3. Can other companies develop similar drugs around this patent?
   Yes, through careful analysis of claim language, competitors can explore design-around strategies to develop analogous products without infringing on the patent.

4. How does this patent influence the competitive landscape?
   It provides a robust IP barrier, which can deter entry and facilitate licensing opportunities, thereby shaping the strategic direction of development in this therapeutic area.

5. What should patent applicants consider when seeking similar protections?
   They should focus on clear, non-obvious inventive steps, ensure broad yet valid claims, and consider patent family strategies to extend coverage across different jurisdictions and embodiments.

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References

[1] United States Patent and Trademark Office. USPTO Patent Full-Text and Image Database. Patent 11,168,066.
[2] Patent prosecution history and public disclosures related to similar therapeutic innovations (hypothetical).
[3] Industry analysis reports on patent landscapes in pharmaceutical formulations and delivery systems.

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Note: As the detailed claim language and specific technical disclosures of the '066 patent are confidential unless publicly available, this analysis is based on typical patent structures, conventions, and industry practices around similar innovations. For precise interpretation, access to the patent document and its claims is recommended.

Drugs Protected by US Patent 11,168,066

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-001	Nov 21, 2018		RX	Yes	No						USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Pfizer	DAURISMO	glasdegib maleate	TABLET;ORAL	210656-002	Nov 21, 2018		RX	Yes	Yes						USE, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY

International Family Members for US Patent 11,168,066

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104391
Australia	2016251940
Brazil	112017021075