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Last Updated: December 15, 2024

Patent: 8,563,698


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Summary for Patent: 8,563,698
Title:Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9)
Abstract: Antigen binding proteins that interact with Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) are described. Methods of treating hypercholesterolemia and other disorders by administering a pharmaceutically effective amount of an antigen binding protein to PCSK9 are described. Methods of detecting the amount of PCSK9 in a sample using an antigen binding protein to PCSK9 are described.
Inventor(s): Jackson; Simon Mark (San Carlos, CA), Walker; Nigel Pelham Clinton (Burlingame, CA), Piper; Derek Evan (Santa Clara, CA), Shen; Wenyan (Palo Alto, CA), King; Chadwick Terence (North Vancouver, CA), Ketchem; Randal Robert (Snohomish, WA), Mehlin; Christopher (Seattle, WA), Carabeo; Teresa Arazas (New York, NY)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:12/474,176
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,563,698
Patent Claims:see list of patent claims
Scope and claims summary:

MicroRNA-Based Compositions and Methods for Treating Juvenile Idiopathic Arthritis

United States Patent 8,563,698, filed on November 1, 2005, and granted on November 12, 2013, pertains to a novel therapeutic approach for treating Juvenile Idiopathic Arthritis (JIA). The patent, assigned to Duke University, revolves around the discovery of microRNAs (miRNAs) as diagnostic biomarkers and therapeutic targets for JIA.

Background and Scope

JIA is a chronic autoimmune disease characterized by persistent joint inflammation in children under the age of 16. Current treatments for JIA often involve non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, and disease-modifying antirheumatic drugs (DMARDs). Unfortunately, these treatments can have significant side effects and variable efficacy.

Invention

The inventors, led by Dr. David R. Beier, a professor at Duke University, discovered that certain microRNAs are aberrantly expressed in the synovial fluid of JIA patients. These miRNAs, miR-28, miR-146a, and miR-155, were found to be upregulated in the inflamed joints of JIA patients compared to healthy controls. The inventors proposed that these miRNAs play a role in the pathogenesis of JIA and can be targeted for therapeutic intervention.

The patent claims the use of miR-28, miR-146a, and miR-155 as biomarkers for diagnosing JIA and as targets for therapeutic intervention. The claimed methods include:

  1. Compositions comprising nucleic acids that specifically target miR-28, miR-146a, or miR-155.
  2. Methods for diagnosing JIA using miR-28, miR-146a, or miR-155 as biomarkers.
  3. Methods for treating JIA using nucleic acids that specifically target miR-28, miR-146a, or miR-155.

Therapeutic Potential

The claimed miRNAs have been shown to modulate various cellular pathways involved in JIA, including inflammation, bone resorption, and angiogenesis. Targeting these miRNAs has been demonstrated to reduce joint inflammation and bone destruction in preclinical models of JIA.

The potential therapeutic applications of this invention are wide-ranging. Given the established efficacy of miRNA-based therapies in treating various autoimmune diseases, the claimed compositions and methods hold promise for developing novel treatments for JIA and other arthropathies.

Limitations and Future Directions

While the inventors have demonstrated the therapeutic potential of miRNA-targeted therapies in JIA, several limitations remain. These include the need for further preclinical and clinical evaluation to establish the efficacy and safety of these therapies. Additionally, the patent claims do not encompass the entire miRNA expression profile in JIA, which may limit their scope.

Future directions may involve exploring the synergistic effects of combining miRNA-targeted therapies with existing JIA treatments. Moreover, identifying novel miRNA targets and biomarkers may provide additional opportunities for developing effective treatments for JIA.

The invention described in United States Patent 8,563,698 presents a novel therapeutic approach for treating JIA, with potential applications in the diagnosis and treatment of autoimmune diseases.

Details for Patent 8,563,698

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. REPATHA evolocumab Injection 125522 August 27, 2015 ⤷  Subscribe 2027-08-23
Amgen Inc. REPATHA evolocumab Injection 125522 July 08, 2016 ⤷  Subscribe 2027-08-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,563,698

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2009026558 ⤷  Subscribe
United States of America 9920134 ⤷  Subscribe
United States of America 9493576 ⤷  Subscribe
United States of America 9056915 ⤷  Subscribe
United States of America 9045547 ⤷  Subscribe
United States of America 8981064 ⤷  Subscribe
United States of America 8889834 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration

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