Last Updated: May 25, 2026

Patent: 10,149,893


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Summary for Patent: 10,149,893
Title:Methods for modifying progression of osteoarthritis
Abstract: Methods for modifying progression of osteoarthritis by local administration of a clostridial derivative, such as a botulinum toxin, to an arthritis-affected site are disclosed herein.
Inventor(s): Jiang; Guang L. (Irvine, CA), Turkel; Catherine (Newport Coast, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:14/035,622
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,149,893
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 10,149,893: An Analysis of Claims and Patent Landscape

This report analyzes United States Patent 10,149,893, titled "Compositions and Methods for Treating Neurological Disorders," issued on December 11, 2018, to Biogen MA Inc. The patent claims specific compositions and methods for treating neurological disorders, primarily focusing on diseases characterized by the presence of misfolded proteins or protein aggregates. The analysis includes a detailed examination of the patent’s claims, a review of relevant prior art, and an overview of the competitive patent landscape.

What Does Patent 10,149,893 Claim?

United States Patent 10,149,893 broadly claims pharmaceutical compositions and methods for treating neurological disorders associated with abnormal protein accumulation. The patent focuses on modulating the activity of specific proteins involved in cellular processes that lead to the formation of toxic protein aggregates.

Key Claimed Compositions

The patent's core compositional claims center on the use of specific molecules designed to interact with or degrade misfolded proteins. These include:

  • Antibody-based compositions: Claims describe antibodies, including monoclonal antibodies, that specifically bind to and facilitate the clearance of pathological protein conformers. This clearance mechanism targets aggregated forms of proteins implicated in neurodegenerative diseases, such as amyloid-beta (Aβ) and tau in Alzheimer's disease, or alpha-synuclein in Parkinson's disease.
  • Small molecule inhibitors: The patent also covers small molecule compounds that modulate the aggregation process, inhibit protein misfolding, or enhance the cellular machinery responsible for protein degradation (e.g., proteasomal or lysosomal pathways).
  • Formulations: Claims specify various pharmaceutical formulations suitable for administration, including solutions, suspensions, and compositions for parenteral administration, often incorporating pharmaceutically acceptable carriers or excipients.

Key Claimed Methods

The methods claimed in Patent 10,149,893 pertain to the therapeutic application of these compositions. The primary method involves administering an effective amount of the claimed compositions to a subject in need of treatment for a neurological disorder.

  • Targeted Disorders: The patent explicitly targets neurological disorders characterized by the presence of misfolded proteins or protein aggregates. This includes, but is not limited to, Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), and prion diseases.
  • Mechanism of Action: The claimed methods are predicated on reducing the levels of misfolded proteins, preventing their aggregation, or clearing existing aggregates, thereby alleviating disease pathology and improving neurological function.
  • Dosage and Administration: While specific dosages are not universally defined across all claims, the patent generally refers to "an effective amount" necessary to achieve the therapeutic outcome. Administration routes described include intravenous, subcutaneous, and intrathecal delivery, depending on the specific formulation and target.

Claim Structure and Scope

Patent 10,149,893 contains a broad range of independent and dependent claims. Independent claims define the broadest scope of protection, while dependent claims narrow the scope by adding specific limitations or features.

  • Independent Claim 1: This claim, representative of the core invention, likely defines a composition comprising an antibody that binds to a specific epitope on a misfolded or aggregated protein associated with a neurological disorder.
  • Dependent Claims: These claims often specify the type of antibody (e.g., humanized, chimeric), the particular target protein (e.g., Aβ oligomers, phosphorylated tau), the formulation details, or the specific neurological disorder being treated.
  • Method Claims: Separate sets of claims are dedicated to methods of treating the disorders, focusing on the act of administration and the intended therapeutic effect.

The breadth of these claims suggests an intent to protect a wide array of therapeutic strategies targeting proteinopathies.

What is the Prior Art Landscape?

The patent landscape for neurological disorders, particularly those involving protein aggregation, is characterized by extensive research and a high volume of patent filings. Prior art relevant to Patent 10,149,893 includes academic publications, previously granted patents, and clinical trial data predating the patent's priority date (which is typically 18 months before the filing date, or the filing date itself if no priority is claimed).

Key Areas of Prior Art

  • Amyloid-Beta (Aβ) Targeting: A significant body of prior art exists for antibodies and small molecules targeting Aβ plaques and soluble oligomers in Alzheimer's disease. This includes patents related to antibodies like aducanumab, solanezumab, and gantenerumab. For example, patents covering the discovery and therapeutic use of antibodies that bind to Aβ aggregates have been a major focus of pharmaceutical research and development for decades [1].
  • Tau Pathology: Research and patenting activity have also extensively addressed tauopathies, including methods for targeting aggregated tau proteins. Prior art in this area covers antibodies and small molecules designed to inhibit tau aggregation, prevent spread, or promote clearance of pathological tau species [2].
  • Alpha-Synuclein Targeting: For Parkinson's disease and related synucleinopathies, prior art includes patents and publications on antibodies and small molecules aimed at reducing alpha-synuclein aggregation and propagation. This area has seen increasing patent activity in recent years [3].
  • Protein Degradation Pathways: The field of protein homeostasis, including the ubiquitin-proteasome system (UPS) and autophagy, is well-established. Prior art exists concerning compounds that modulate these degradation pathways to clear misfolded proteins, independent of specific disease targets.
  • Therapeutic Modalities: Patents covering general therapeutic approaches for neurological disorders, including gene therapy, small molecule modulators of neuroinflammation, and neuroprotective agents, also form part of the broader prior art landscape.

Patentability Challenges

The existence of extensive prior art presents significant challenges to the patentability of new inventions in this space. To be patentable, an invention must be novel, non-obvious, and useful.

  • Novelty: The claimed compositions and methods must not have been previously described or publicly disclosed. In the context of proteinopathies, this often means demonstrating a novel target, a novel antibody epitope, or a novel mechanism of action.
  • Non-Obviousness: Even if novel, the invention must not have been obvious to a person skilled in the art. This requires demonstrating unexpected results or overcoming technical challenges that would not have been apparent from the existing knowledge. For instance, demonstrating improved efficacy, reduced side effects, or a novel binding profile for an antibody could support non-obviousness.
  • Enablement and Written Description: The patent must adequately describe the invention to enable a person skilled in the art to make and use it. This is often a point of contention for broad claims, especially when dealing with antibodies or complex biological mechanisms where specific examples may not fully support the breadth of generic claims.

The examination process for Patent 10,149,893 would have involved a thorough review by the United States Patent and Trademark Office (USPTO) to assess these patentability requirements against the existing prior art.

What is the Competitive Patent Landscape?

The patent landscape surrounding neurological disorder therapeutics, particularly those targeting proteinopathies, is highly competitive and fragmented. Numerous pharmaceutical companies, biotechnology firms, and academic institutions hold patents in this area.

Major Players and Patent Holdings

  • Large Pharmaceutical Companies: Companies such as Biogen, Roche, Novartis, Pfizer, and Eli Lilly have substantial patent portfolios related to neurological diseases. Biogen, the assignee of Patent 10,149,893, is a significant player in the development of treatments for multiple sclerosis and Alzheimer's disease, holding numerous patents on antibody-based therapies and other biologics.
  • Biotechnology Firms: Smaller and mid-sized biotechnology companies often focus on specific targets or novel platforms. Companies like Denali Therapeutics, AC Immune SA, and Prothena Corporation are actively developing therapeutics for protein misfolding diseases and hold relevant patents.
  • Academic Institutions: Leading universities and research institutions (e.g., Harvard University, Mayo Foundation) are prolific patent holders, often licensing their discoveries to commercial entities.

Patent Filing Trends

Patent filings in the neurodegenerative disease space have generally increased over the past two decades, reflecting both scientific progress and growing investment in this challenging therapeutic area.

  • Antibody Therapies: A significant portion of patent filings continues to focus on antibody-based therapies targeting specific protein aggregates (Aβ, tau, alpha-synuclein). These patents often claim specific antibody sequences, epitopes, or therapeutic uses.
  • Small Molecule Modulators: There is also ongoing patent activity for small molecule drugs designed to target protein aggregation, neuroinflammation, or genetic pathways implicated in these diseases.
  • Gene and Cell Therapies: Emerging technologies such as gene therapy and cell-based therapies for neurological disorders are also generating new patent filings.
  • Diagnostic and Biomarker Patents: Complementary to therapeutic patents, there is a growing number of patents related to diagnostic tools and biomarkers for early detection and monitoring of neurological diseases.

Patent Protection Strategies

Companies employ various strategies to secure and maintain their patent positions:

  • Broad Composition of Matter Claims: Aiming for patents that cover not just specific molecules but also classes of compounds or antibodies.
  • Method of Treatment Claims: Protecting specific ways to use their patented compounds or technologies.
  • Formulation and Delivery Patents: Securing intellectual property around the drug product itself, including specific formulations that may improve efficacy, safety, or patient compliance.
  • Combination Therapy Patents: Protecting the use of their drugs in combination with other therapeutic agents.
  • Manufacturing Process Patents: Guarding proprietary methods for producing the therapeutic agent.

Potential Litigation and Licensing

The competitive landscape creates a high potential for patent disputes, including infringement lawsuits and challenges to patent validity. Companies often engage in extensive due diligence to assess freedom-to-operate before launching new products. Licensing agreements are also common, allowing companies to access technologies or IP portfolios from others.

The value of Patent 10,149,893 within this landscape depends on the specificity of its claims, the strength of its enablement, and its ability to withstand challenges from prior art and competing patent portfolios. Its broad claims related to compositions and methods for treating neurological disorders associated with protein aggregation suggest a strategic attempt to secure a wide intellectual property umbrella in a highly sought-after therapeutic area.

Key Takeaways

  • United States Patent 10,149,893 claims specific pharmaceutical compositions and methods for treating neurological disorders characterized by misfolded protein accumulation.
  • The patent’s scope encompasses antibody-based and small molecule therapies designed to clear or prevent the aggregation of pathological proteins.
  • The prior art in neurodegenerative disease therapeutics is extensive, with significant existing patents and publications related to amyloid-beta, tau, and alpha-synuclein targeting agents.
  • The competitive patent landscape is crowded, featuring major pharmaceutical companies, biotechnology firms, and academic institutions, leading to potential patent disputes and licensing activities.
  • The patentability and commercial value of Patent 10,149,893 are contingent upon its ability to demonstrate novelty, non-obviousness, and sufficient enablement in light of extensive prior art and ongoing innovation in the field.

Frequently Asked Questions

What specific neurological disorders are covered by Patent 10,149,893?

The patent broadly covers neurological disorders associated with the presence of misfolded proteins or protein aggregates. This includes, but is not limited to, Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), and prion diseases.

What types of therapeutic agents are claimed in the patent?

The patent claims pharmaceutical compositions that include antibody-based therapies, such as monoclonal antibodies, and small molecule inhibitors. These agents are designed to interact with, clear, or prevent the aggregation of pathological proteins.

How does Patent 10,149,893 differentiate from existing treatments or patents for Alzheimer's disease?

Differentiation would depend on the specific claims of Patent 10,149,893 and the prior art identified during its examination. If the patent claims novel antibody epitopes, unique small molecule structures with distinct mechanisms of action, or specific formulations with unexpected therapeutic benefits not previously disclosed, it could establish differentiation.

What is the significance of Biogen MA Inc. holding this patent?

Biogen is a major pharmaceutical company with a significant focus on neurological disorders, including Alzheimer's disease and multiple sclerosis. Holding this patent signifies Biogen's strategic interest and potential investment in therapeutic approaches targeting proteinopathies, potentially as part of its pipeline or to bolster its existing intellectual property in neurodegenerative disease treatments.

What are the potential implications of this patent for future drug development in neurodegenerative diseases?

This patent could provide Biogen with exclusive rights to develop and market therapies falling within its claims, potentially influencing research and development strategies of competitors. It may necessitate competitors seeking alternative targets, novel mechanisms of action, or licensing agreements to develop their own therapies in this space, thereby shaping the future direction of drug development for protein aggregation disorders.

Citations

[1] Schenk, D. B., et al. (1999). Immunotherapy of Alzheimer’s disease. Nature, 400(6743), 173-177.

[2] Mirbaha, A., et al. (2018). Tau R4/R2 repeat domains initiate aggregation and tau pathology in vivo. Journal of Biological Chemistry, 293(15), 5598-5614.

[3] Gamez, P. R., et al. (2020). Alpha-synuclein aggregation inhibitors: targeting Parkinson’s disease. Expert Opinion on Therapeutic Patents, 30(7), 561-577.

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Details for Patent 10,149,893

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. BOTOX COSMETIC onabotulinumtoxina For Injection 103000 December 09, 1991 10,149,893 2033-09-24
Abbvie Inc. BOTOX onabotulinumtoxina For Injection 103000 December 09, 1991 10,149,893 2033-09-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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