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Last Updated: June 21, 2025

Details for Patent: 10,391,094


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Which drugs does patent 10,391,094 protect, and when does it expire?

Patent 10,391,094 protects INREBIC and is included in one NDA.

This patent has forty-eight patent family members in thirty-four countries.

Summary for Patent: 10,391,094
Title:Compositions and methods for treating myelofibrosis
Abstract: Provided herein are compositions and methods for treating myelofibrosis in a subject. The methods comprise administering to the subject an effective amount of compound which is which is N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyr- imidin-4-yl)amino]benzenesulfonamide or a pharmaceutical salt thereof or a hydrate thereof.
Inventor(s): Jayan; Arvind (La Jolla, CA), Cacace; Janice (Miami, FL)
Assignee: Impact Biomedicines, Inc. (Summit, NJ)
Application Number:13/888,096
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,391,094
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 10,391,094: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 10,391,094, titled "Compositions and methods for treating myelofibrosis," is a significant patent in the field of medical treatments, particularly for myelofibrosis, a type of bone marrow disorder. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of Myelofibrosis

Myelofibrosis is a rare type of blood cancer characterized by the buildup of scar tissue in the bone marrow, leading to anemia, fatigue, and other complications. The treatment options for myelofibrosis are limited, making innovative therapies crucial for improving patient outcomes.

Patent Overview

Publication Details

  • Publication Number: US10391094B2
  • Prior Art Date: The patent application was filed on December 14, 2012, indicating that the research and development of the compositions and methods began prior to this date[1].

Inventors and Assignees

The patent lists the inventors and assignees involved in the development of these compositions and methods. Understanding the background of the inventors and the assignees can provide insights into the expertise and resources behind the invention.

Scope of the Patent

Compositions

The patent describes specific compositions designed to treat myelofibrosis. These compositions typically include a combination of active pharmaceutical ingredients and excipients such as amino compounds, pyrimidin derivatives, and microcrystalline cellulose. The detailed description of these compositions highlights the chemical and structural aspects that make them effective for treating myelofibrosis[1].

Methods of Treatment

The methods outlined in the patent involve administering the compositions to patients suffering from myelofibrosis. The patent specifies dosages, administration routes, and potential combinations with other therapies. These methods are designed to improve the efficacy and safety of the treatment.

Claims

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims cover the specific compositions, their formulations, and the methods of treating myelofibrosis using these compositions. For example, Claim 1 might describe a particular compound or a class of compounds useful for treating myelofibrosis, while Claim 2 might detail a specific method of administration[1].

Dependent Claims

Dependent claims further narrow down the scope of the independent claims by adding additional limitations. These claims help to protect specific aspects of the invention, such as particular dosages or formulations, and ensure that the patent covers a range of variations that are still within the inventive concept.

Patent Landscape

Relevant Prior Art

The patent cites prior art related to myelofibrosis treatments, including other compounds and methods that have been previously disclosed. Understanding the prior art is crucial for determining the novelty and non-obviousness of the invention[1].

Competing Patents

The landscape of patents related to myelofibrosis treatments is complex, with multiple patents covering different aspects of diagnosis, treatment, and management. This patent must differentiate itself from existing patents to establish its unique contribution to the field.

Regulatory and Legal Context

USPTO Guidelines

The U.S. Patent and Trademark Office (USPTO) has specific guidelines for patenting medical treatments. The patent must comply with Section 101 of the Patent Act, which defines patent-eligible subject matter. The Alice/Mayo framework, which clarifies the eligibility of abstract ideas and natural phenomena, is also relevant for ensuring that the patent claims are valid and enforceable[5].

Litigation Trends

Patent litigation trends, as analyzed by the Government Accountability Office (GAO), indicate that the number of patent infringement lawsuits can fluctuate based on changes in patent law and industry practices. The increase in lawsuits involving software-related patents, for example, highlights the importance of robust patent claims and thorough examination processes[4].

Economic and Industry Impact

Innovation Incentives

The patent system is designed to incentivize innovation by providing exclusive rights to inventors. For myelofibrosis treatments, this patent could drive further research and development by protecting the intellectual property of the inventors and encouraging investment in clinical trials and commercialization[5].

Market Competition

The presence of this patent in the market can influence competition among pharmaceutical companies. It may encourage other companies to develop alternative treatments or to license the patented technology, thereby promoting a more dynamic and innovative market.

Expert Insights

Industry experts and researchers often provide valuable insights into the impact of such patents. For instance, experts might highlight the clinical significance of the treatments described in the patent and the potential for these treatments to improve patient outcomes.

Statistics and Data

Patent Data

The USPTO's Patent Claims Research Dataset provides detailed information on patent claims, including those related to medical treatments. Analyzing this data can reveal trends in patent filings, grant rates, and litigation patterns, which can be useful for understanding the broader patent landscape[3].

Clinical Trial Data

Clinical trial data on the compositions and methods described in the patent can provide evidence of their efficacy and safety. Positive outcomes from clinical trials can strengthen the patent's position and pave the way for regulatory approvals.

Key Takeaways

  • Innovative Compositions and Methods: The patent introduces new compositions and methods for treating myelofibrosis, offering potential improvements in patient care.
  • Regulatory Compliance: The patent must comply with USPTO guidelines and legal frameworks such as the Alice/Mayo framework.
  • Economic Impact: The patent can drive innovation and influence market competition in the pharmaceutical industry.
  • Clinical Significance: The treatments described have the potential to significantly improve outcomes for patients with myelofibrosis.

FAQs

Q: What is the primary focus of United States Patent 10,391,094?

A: The primary focus is on compositions and methods for treating myelofibrosis, a type of bone marrow disorder.

Q: What are the key components of the compositions described in the patent?

A: The compositions include amino compounds, pyrimidin derivatives, and microcrystalline cellulose, among other ingredients.

Q: How does the patent differentiate itself from existing treatments for myelofibrosis?

A: The patent differentiates itself through specific formulations and methods of administration that are novel and non-obvious compared to prior art.

Q: What is the significance of the Alice/Mayo framework in relation to this patent?

A: The Alice/Mayo framework is crucial for ensuring that the patent claims are directed to patent-eligible subject matter and do not cover abstract ideas or natural phenomena.

Q: How might this patent impact the pharmaceutical industry?

A: The patent could drive further innovation, encourage licensing agreements, and influence market competition among pharmaceutical companies developing treatments for myelofibrosis.

Sources

  1. US10391094B2 - Compositions and methods for treating myelofibrosis - Google Patents
  2. U.S. Patent and Trademark Office (USPTO) | USAGov
  3. Patent Claims Research Dataset - USPTO
  4. Assessing Factors That Affect Patent Infringement Litigation ... - GAO
  5. Patent-Eligible Subject Matter Reform: An Overview - CRS Reports

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Drugs Protected by US Patent 10,391,094

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes 10,391,094 ⤷  Try for Free Y TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY MYELOFIBROSIS ⤷  Try for 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

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