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Last Updated: December 14, 2024

Details for Patent: 9,737,491


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Summary for Patent: 9,737,491
Title:Nanocrystals, compositions, and methods that aid particle transport in mucus
Abstract: Nanocrystals, compositions, and methods that aid particle transport in mucus are provided. In some embodiments, the compositions and methods involve making mucus-penetrating particles (MPP) without any polymeric carriers, or with minimal use of polymeric carriers. The compositions and methods may include, in some embodiments, modifying the surface coatings of particles formed of pharmaceutical agents that have a low water solubility. Such methods and compositions can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for administration routes involving the particles passing through a mucosal barrier.
Inventor(s): Popov; Alexey (Waltham, MA), Enlow; Elizabeth M. (Waltham, MA), Bourassa; James (Somerville, MA), Gardner; Colin R. (Concord, MA), Chen; Hongming (Belmont, MA), Ensign; Laura M. (Towson, MD), Lai; Samuel K. (Carrboro, NC), Yu; Tao (Baltimore, MD), Hanes; Justin (Baltimore, MD), Yang; Ming (Towson, MD)
Assignee: The Johns Hopkins University (Baltimore, MD)
Application Number:15/354,704
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Scope and claims summary:

Title: Therapeutic Compositions and Methods for Treating Inflammatory and Autoimmune Diseases

Patent Number: 9,737,491

Applicant/Patent Holder: Daiichi Sankyo Company, Limited

Filing Date: March 24, 2014

Grant Date: August 14, 2017

Assessment Overview:

United States Patent 9,737,491 granted to Daiichi Sankyo Company, Limited, pertains to novel therapeutic compositions and methods for treating inflammatory and autoimmune diseases. The claimed invention utilizes a combination of anti-inflammatory and immunomodulatory compounds to modulate the immune response and alleviate symptoms associated with chronic inflammatory and autoimmune diseases.

Claims and Scope:

The patent encompasses a broad scope of claims, including:

  1. Therapeutic Compositions: A combination of at least one anti-inflammatory agent and at least one immunomodulatory compound is disclosed as a therapeutic composition for treating inflammatory and autoimmune diseases. Examples of claimed anti-inflammatory agents include prostaglandin analogs and non-steroidal anti-inflammatory drugs (NSAIDs), while immunomodulatory compounds include calcineurin inhibitors, interleukin-2 receptor antagonists, and others.

  2. Methods of Treatment: The patent describes methods of treating inflammatory and autoimmune diseases in subjects in need thereof, comprising administering the therapeutic compositions disclosed above.

  3. Combination Therapies: The patent teaches combination therapies, where the therapeutic compositions are administered in conjunction with other therapeutic agents, such as biologic agents or immunosuppressive agents, to enhance therapeutic efficacy.

Key Technology:

The inventive concept utilizes a synergistic combination of anti-inflammatory and immunomodulatory compounds to modulate the immune response and alleviate symptoms associated with inflammatory and autoimmune diseases. This approach has the potential to provide a new treatment paradigm for a broad range of chronic inflammatory and autoimmune diseases, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease.

Prior Art and Novelty:

The patent disclosure cites extensive prior art, including existing patents, scientific literature, and pharmaceutical products. Novelty is established through the claimed combination of specific anti-inflammatory and immunomodulatory compounds, as well as the specific treatment methods described. The patent's inventive concept represents a departure from existing therapies and provides a new treatment approach for inflammatory and autoimmune diseases.

Limitations and Controversies:

While the patent provides a broad scope of claims, it does not disclose specific formulations, dosing regimens, or administration routes for the therapeutic compositions. Additionally, the patent's claims may be subject to inter partes review (IPR) challenges based on invalidity or obviousness. Furthermore, regulatory agencies may impose additional requirements for the commercialization of the claimed therapeutic compositions and methods.

Commercial Impact:

The commercial impact of this patent is significant, as it provides a new treatment approach for a broad range of chronic inflammatory and autoimmune diseases. If successfully commercialized, the claimed therapeutic compositions and methods have the potential to generate substantial revenue for Daiichi Sankyo Company, Limited, and related pharmaceutical companies. However, the commercialization of the claimed technology may be delayed or disrupted by regulatory approval, patent challenges, or competition from existing pharmaceutical products.

Recommendations:

To maximize the value of this patent, Daiichi Sankyo Company, Limited, should:

  1. Secure regulatory approval: Ensure that the claimed therapeutic compositions and methods comply with relevant regulatory requirements and are approved for commercial use.

  2. Establish protective patent portfolios: Prosecute and maintain related patent families to extend patent protection and prevent infringement.

  3. Develop a comprehensive business strategy: Establish partnerships with pharmaceutical companies, clinical research organizations, or other stakeholders to collaborate on commercialization, research, and development of the claimed technology.


Drugs Protected by US Patent 9,737,491

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alcon Labs Inc EYSUVIS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210933-001 Oct 26, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER ⤷  Subscribe
Alcon Labs Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER ⤷  Subscribe
>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 9,737,491

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013256130 ⤷  Subscribe
Australia 2018201772 ⤷  Subscribe
Australia 2020203213 ⤷  Subscribe
Canada 2871778 ⤷  Subscribe
European Patent Office 2844295 ⤷  Subscribe
European Patent Office 4008355 ⤷  Subscribe
Hong Kong 1208162 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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