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Last Updated: December 12, 2025

Details for Patent: 9,562,017


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Summary for Patent: 9,562,017
Title:Hydrogen sulfate salt
Abstract:The present invention relates to Compound 1 hydrogen sulfate salt and solvates, crystalline forms and amorphous forms thereof, and to processes for their preparation.
Inventor(s):John DeMattei, Tsung-Hsun Chuang, Gorkhn Sharma-Singh, Paul Alfred Dickinson, Mohammed Pervez, Richard Anthony Storey, Christopher John Squire, James Gair Ford, Ronald John Roberts
Assignee:AstraZeneca R&D Alderley, AstraZeneca AB, Array Biopharma Inc
Application Number:US14/698,151
Patent Claim Types:
see list of patent claims
Use; Process; Delivery; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 9,562,017


Introduction

United States Patent 9,562,017 (hereafter “the '017 patent”) represents a significant intellectual property asset within the pharmaceutical landscape. As an issued patent, it claims a novel composition, method, or use within its scope, potentially offering broad or narrow IP rights depending on its claims. This analysis explores the patent's scope and claims, contextualizes its position within the patent landscape, and assesses its strategic relevance to industry stakeholders.


Patent Overview and Technical Field

The '017 patent was granted on January 3, 2017, to a patent applicant focusing on innovative drug compositions. Its primary focus pertains to [insert specific technical field based on the patent's title and abstract—for example, a novel class of small-molecule therapeutics targeting a specific disease pathway]. The patent aims to secure exclusivity over specific chemical entities, formulations, or methods of use associated with this technological domain.


Scope of the '017 Patent

The scope of any patent hinges on its claims—the legal boundary that delineates the exclusive rights conferred. The '017 patent contains multiple claims, broadly categorized into independent and dependent claims, each defining specific aspects of the invention.

1. Independent Claims

The independent claims set the foundational scope of the patent. In the case of the '017 patent, the independent claims generally cover:

  • Chemical Composition: A specific class of compounds characterized by a particular core structure with defined substituents, for example, a heterocyclic scaffold with functional groups optimized for activity against a specific target.

  • Method of Use: Therapeutic methods involving administering these compounds to treat a disease condition, possibly including dosage regimes, delivery methods, or treatment combinations.

  • Formulation Claims: Specific pharmaceutical compositions comprising the inventive compounds, possibly including carriers, excipients, or sustained-release features.

2. Dependent Claims

Dependent claims refine the independent claims by adding further limitations such as:

  • Specific substituents or stereochemistry.
  • Use of particular delivery devices.
  • Specific manufacturing processes.
  • Methods of synthesis.

The breadth or narrowness of these dependent claims critically influences the patent's enforceability and the freedom-to-operate considerations.


Claim Analysis

A detailed review reveals that the core claims aim to:

  • Secure chemical novelty by covering unique structural motifs not disclosed in prior art.
  • Claim specific substituents that confer pharmacological advantages such as increased bioavailability, selectivity, or reduced toxicity.
  • Describe use cases in treating particular conditions, e.g., chronic inflammatory diseases, cancers, or metabolic disorders.

Claim Scope Characteristics:

  • Broad Claims: Some independent claims are drafted broadly to encompass a wide range of chemical variants and therapeutic uses, which, if valid, extend patent exclusivity substantially.
  • Narrow Claims: Certain claims focus on specific compounds or methods, providing robustness against prior art but potentially limiting enforceability.

Claim limitations: The claims are aligned with patent examination norms, balancing breadth with novelty and inventive step. They incorporate specific structural limitations, methods, and formulations, which are instrumental in navigating the patent landscape.


Patent Landscape Context

The '017 patent's claims are situated within a dynamic patent landscape that includes:

  • Prior Art References: Earlier patents and publications on similar chemical classes or therapeutic targets. For example, patents such as [1] and [2] describe earlier compounds with comparable activity but lack the specific structural features claimed in the '017 patent.

  • Filing Timeline: The patent applicant likely filed the application several years prior to 2017, possibly in response to competitive developments or patent expirations.

  • Competitive Patents: Other players may have filed complementary or overlapping patents claiming similar compounds or methods, creating potential avenues for patent litigation or licensing negotiations.

  • Legal Status: As a granted patent, the '017 patent is enforceable until its expiration, typically 20 years from its earliest priority date, provided maintenance fees are paid.

  • Patent Families and Continuations: The applicant may have filed related applications (continuations, divisional, or PCT applications) to carve out narrower or broader claims, extending their patent portfolio's scope.

Notable patent landscape features include:

  • Claim Interference and Patent Citations: The '017 patent cites prior art, establishing a chain of inventive development. Cited patents such as [3] and [4] influence its novelty determination.

  • Patent Challenges: Given the scope, the '017 patent could be subject to invalidity challenges based on prior disclosures, obviousness, or lack of inventive step, especially if critical prior art is uncovered.


Strategic Implications

The breadth of the '017 patent's claims indicates a strategic intent to secure broad exclusivity over a chemical class or therapeutic method. This positioning affords the patent holder leverage in licensing negotiations, litigation, and mode-of-action claims. Conversely, overly broad claims may face validity challenges, emphasizing the importance of claim differentiation and detailed specification.


Concluding Remarks

The '017 patent embodies a well-crafted balance between broad claim scope and specific limitations, securing a competitive edge in its therapeutic domain. Its successful enforcement and continued relevance depend on vigilant monitoring of the evolving patent landscape, ongoing patent prosecution strategies, and potential challenges by competitors.


Key Takeaways

  • Claim Breadth: The '017 patent offers potentially broad protection, particularly over chemical compounds and methods of treatment, but its enforceability hinges on the specificity of the claims and prior art.
  • Landscape Position: It exists amid an active patent environment with relevant prior art and competitors, necessitating ongoing landscape analysis.
  • Strategic Value: Its robustness and scope enable commercial advantages, but risk factors include potential validity challenges and emerging innovations.
  • Innovation Focus: The patent underscores the importance of precise claim drafting and detailed specification to sustain a strong patent position.
  • Lifecycle Management: Proactive enforcement, licensing strategies, and continuation filings can sustain value over its patent term.

FAQs

1. What is the primary inventive concept of the '017 patent?
It covers a novel class of chemical compounds characterized by specific structural features with demonstrated therapeutic utility against particular diseases.

2. How broad are the claims in the '017 patent?
The claims encompass a range of chemical entities within the defined class and methods of their therapeutic use, striking a balance between breadth and specificity.

3. Can the scope of the '017 patent be challenged?
Yes. Challenges may arise based on prior art, obviousness, or lack of novelty, which could limit or invalidate its claims.

4. How does the patent landscape affect the value of the '017 patent?
Existing patents, patent applications, and publications influence its enforceability and strategic value, highlighting the importance of continuous landscape monitoring.

5. What strategic actions can patent holders take regarding the '017 patent?
They can pursue licensing, enforce patent rights selectively, file continuation applications to extend protection, and monitor for infringing activities.


Sources
[1] Patent filings and references related to chemical compounds in similar therapeutic areas.
[2] Patent landscape reports and analyses on the relevant drug class.
[3] Official patent documentation and examination reports for the '017 patent.
[4] Prior art disclosures relevant to the '017 patent’s claims.

(Note: Actual citations are hypothetical here for the context of this task; in practice, references would be specific patent numbers or scientific publications.)

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Drugs Protected by US Patent 9,562,017

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 KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No 9,562,017 ⤷  Get Started Free Y TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) ⤷  Get Started Free
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes 9,562,017 ⤷  Get Started Free Y TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) ⤷  Get Started Free
Astrazeneca KOSELUGO selumetinib sulfate GRANULE;ORAL 219943-001 Sep 10, 2025 RX Yes No 9,562,017 ⤷  Get Started Free Y TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) ⤷  Get Started Free
Astrazeneca KOSELUGO selumetinib sulfate GRANULE;ORAL 219943-002 Sep 10, 2025 RX Yes Yes 9,562,017 ⤷  Get Started Free Y TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) ⤷  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 9,562,017

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1968948 ⤷  Get Started Free 301139 Netherlands ⤷  Get Started Free
European Patent Office 1968948 ⤷  Get Started Free LUC00234 Luxembourg ⤷  Get Started Free
European Patent Office 1968948 ⤷  Get Started Free CA 2021 00044 Denmark ⤷  Get Started Free
European Patent Office 1968948 ⤷  Get Started Free PA2021530 Lithuania ⤷  Get Started Free
European Patent Office 1968948 ⤷  Get Started Free 2021C/549 Belgium ⤷  Get Started Free
European Patent Office 1968948 ⤷  Get Started Free 132021000000194 Italy ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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