United States Drug Patent 10,231,964: Claim Scope and Landscape Analysis

Summary

United States Patent 10,231,964, titled "Novel pharmaceutical compositions comprising antibodies to soluble amyloid beta and their use in the treatment of Alzheimer's disease," issued on March 19, 2019. The patent claims pharmaceutical compositions containing specific antibodies targeting soluble amyloid-beta (Aβ) species and their therapeutic applications in Alzheimer's disease (AD). The patent's core innovation lies in the identification and characterization of antibodies that bind to and neutralize specific, soluble forms of Aβ, posited to be the most neurotoxic species driving AD pathogenesis. The patent landscape surrounding this technology involves numerous entities researching and patenting Aβ-targeting therapies, including antibodies, small molecules, and gene therapies. Key competitors focus on various Aβ species and therapeutic modalities, creating a complex and dynamic intellectual property environment.

What Does Patent 10,231,964 Claim?

What are the primary subject matter claims of the patent?

The primary subject matter claims of U.S. Patent 10,231,964 encompass pharmaceutical compositions and methods of use. Claim 1, a representative independent claim, defines a pharmaceutical composition comprising an antibody that specifically binds to a soluble form of amyloid-beta protein. The antibody must exhibit certain characteristics related to its binding affinity and epitope specificity. Specifically, the antibody binds to an epitope within amino acid residues 1-16 of Aβ. The patent further specifies that the antibody neutralizes the neurotoxic effects of soluble Aβ. Additional claims cover methods of treating or preventing Alzheimer's disease by administering these pharmaceutical compositions.

What are the key characteristics of the claimed antibodies?

The patent defines specific characteristics for the claimed antibodies to ensure novelty and inventiveness. These antibodies are designed to target soluble, rather than aggregated, forms of Aβ. This distinction is crucial as it targets species believed to be more directly involved in synaptic dysfunction and neuronal death in AD. The antibody's binding profile is detailed, focusing on its affinity for an epitope on the N-terminus of Aβ, specifically within residues 1-16. This precise targeting differentiates it from antibodies that might bind to plaque-forming or aggregated amyloid species.

What specific therapeutic uses are covered by the patent?

The patent covers the use of the claimed pharmaceutical compositions in the treatment and prevention of Alzheimer's disease. The methods of treatment involve administering a therapeutically effective amount of the antibody composition to a subject diagnosed with or at risk of developing AD. The patent asserts that these antibodies can reduce amyloid burden, inhibit amyloid fibril formation, and mitigate neuroinflammation, thereby ameliorating cognitive decline and other symptoms associated with the disease.

What is the Patent Landscape for Aβ-Targeting Therapies?

Who are the major players in the amyloid-beta targeting therapeutic space?

The Aβ-targeting therapeutic space is highly competitive, with several pharmaceutical giants and emerging biotechs actively developing treatments. Major players include Biogen, known for its Aduhelm (aducanumab) and lecanemab (Leqembi), developed in partnership with Eisai. Eli Lilly and Company is a significant competitor with donanemab, another Aβ-targeting antibody. Other notable entities involved in Aβ research and patenting include Roche, Novartis, Pfizer, Amgen, and various academic institutions. The landscape also features a growing number of smaller biopharmaceutical companies focusing on novel Aβ-targeting modalities, such as small molecules, vaccines, and gene therapies.

What are the different therapeutic modalities being pursued?

Therapeutic modalities for targeting Aβ are diverse and evolving. The most prevalent approach is monoclonal antibodies that bind to various forms of Aβ, including soluble oligomers, protofibrils, and plaques. These antibodies aim to clear amyloid deposits or neutralize toxic species. Other modalities include:

Small Molecules: These aim to inhibit Aβ production by targeting enzymes like beta-secretase (BACE1) or gamma-secretase.
Gene Therapy: Approaches are being explored to modulate Aβ levels or enhance clearance mechanisms through genetic interventions.
Immunotherapies: Active immunization strategies, such as Aβ vaccines, are also under development to stimulate the body's own immune response against Aβ.
Enzyme-based Therapies: Strategies involving enzymes that can degrade Aβ are also being investigated.

How do other patents in this field compare to 10,231,964 in terms of claims and scope?

Comparison of U.S. Patent 10,231,964 with other patents in the Aβ-targeting field reveals both commonalities and distinctions. Many patents focus on antibodies, but differ in their specific epitopes, target species (e.g., plaque vs. soluble Aβ), or antibody engineering (e.g., humanized, fully human, fragment).

Epitope Specificity: While 10,231,964 claims antibodies binding to Aβ residues 1-16, other patents may claim antibodies targeting different regions, such as the C-terminus or specific conformational epitopes on oligomers. For example, patents related to aducanumab often claim binding to N-terminal epitopes of Aβ, including aggregated forms, but the precise binding characteristics and claimed therapeutic benefits can differ.
Targeted Aβ Species: Patents vary in their focus on soluble oligomers, protofibrils, or fibrillar plaques. Patent 10,231,964 emphasizes soluble Aβ, distinguishing it from patents primarily targeting established plaques, which may have different therapeutic profiles and safety considerations.
Therapeutic Applications: While the overarching goal is AD treatment, claims may extend to specific stages of the disease (e.g., early-stage AD, mild cognitive impairment) or related neurological conditions. Some patents may also cover methods for diagnosing or monitoring AD progression using their targeted Aβ species.
Compositional Claims: Beyond antibodies, other patents may claim specific antibody formats (e.g., bispecific antibodies, antibody fragments) or formulations designed for enhanced delivery or efficacy.

A comparative analysis of patent families, such as those associated with lecanemab (e.g., U.S. Patent 10,046,022 claiming antibodies binding to N-terminal amyloid beta, including protofibrils) and donanemab (various patents related to targeting deposited amyloid-beta plaques), highlights the strategic differentiation in targeting strategies and claimed benefits. Patent 10,231,964's specificity for soluble Aβ species and its N-terminal epitope positioning represent a particular segment within this broad patent landscape.

What is the Intellectual Property Status and Strategy for Patent 10,231,964?

What is the current legal status of patent 10,231,964?

U.S. Patent 10,231,964 is an active and granted patent. It was issued on March 19, 2019. As of the current date, it is in its effective term, subject to the payment of maintenance fees. The patent is presumed valid and enforceable unless challenged and invalidated through post-grant proceedings such as inter partes review (IPR) or litigation. Its term generally extends 20 years from its filing date, with potential adjustments for patent term extension (PTE) due to regulatory delays, particularly for pharmaceutical patents.

What is the typical patent term for a drug discovery patent?

The standard patent term for a U.S. utility patent is 20 years from the date on which the application for the patent was filed. For pharmaceutical patents, this term can be extended through Patent Term Extension (PTE) under the Hatch-Waxman Act. PTE aims to compensate patent holders for a portion of the time lost during the Food and Drug Administration (FDA) regulatory review process. The duration of PTE is typically up to five years, and in some cases, can be extended by an additional two years under specific conditions, for a maximum of seven years of additional patent term. This extension is calculated based on the time elapsed between the patent's effective filing date and the date of FDA marketing approval, minus time for certain regulatory steps.

What are potential strategies for leveraging this patent?

Leveraging U.S. Patent 10,231,964 can involve several strategic approaches for entities holding rights to it:

Exclusivity and Licensing: The patent provides market exclusivity for the claimed antibodies and their therapeutic uses. This exclusivity can be leveraged through direct commercialization or by granting non-exclusive or exclusive licenses to other pharmaceutical companies. Licensing agreements can generate revenue through upfront payments, milestone payments, and royalties on sales.
Strategic Partnerships: Collaborating with larger pharmaceutical companies that have established manufacturing, clinical trial, and marketing capabilities can accelerate product development and market entry. Partnerships can involve co-development, co-promotion, or outright sale of the technology.
Defensive Patenting: Continuing to file continuation applications and pursue related patents can broaden the scope of protection and create a stronger defensive portfolio against potential competitors. This includes seeking patents on improved antibody variants, novel formulations, manufacturing processes, or new therapeutic indications.
Litigation and Enforcement: If competitors infringe on the patent claims, legal action can be pursued to halt infringing activities and seek damages. This requires robust monitoring of the competitive landscape.
Pipeline Expansion: For a biopharmaceutical company, this patent can form the foundation of a pipeline for Alzheimer's disease therapies, complementing other assets or serving as a lead program.
Acquisition Target: The patent, along with any associated preclinical or clinical data, could make the owning entity an attractive acquisition target for larger companies seeking to bolster their AD portfolios.

How Does This Patent Fit into the Broader Alzheimer's Disease Drug Development Landscape?

What are the unmet needs in Alzheimer's disease treatment?

Despite significant research efforts, Alzheimer's disease (AD) remains a progressive neurodegenerative disorder with profound unmet needs. Current treatments primarily offer symptomatic relief for cognitive and behavioral symptoms but do not halt or reverse disease progression. Key unmet needs include:

Disease-Modifying Therapies: The primary unmet need is for therapies that can slow, stop, or reverse the underlying pathological processes of AD, such as amyloid-beta plaque accumulation, tau tangle formation, neuroinflammation, and synaptic loss.
Early Diagnosis and Intervention: Reliable biomarkers for early and accurate diagnosis are crucial for initiating interventions at the earliest stages of the disease, when they are likely to be most effective.
Effective and Safe Treatments: Treatments need to demonstrate clear efficacy in improving cognitive function and daily living activities, alongside a favorable safety profile, particularly concerning side effects like amyloid-related imaging abnormalities (ARIA).
Prevention Strategies: The development of effective strategies to prevent the onset of AD or delay its progression in at-risk individuals is a major goal.
Heterogeneity of AD: AD is a heterogeneous disease, with varying underlying pathologies and symptom presentations. Personalized medicine approaches that tailor treatments to individual patient profiles are needed.
Caregiver Support: Comprehensive support for caregivers, who bear a significant burden, is also an important aspect of managing AD.

What are the current regulatory pathways for AD drugs?

The regulatory pathways for Alzheimer's disease drugs are evolving, reflecting the complexity of the disease and the challenges in demonstrating efficacy. The U.S. Food and Drug Administration (FDA) has historically utilized traditional approval pathways requiring robust evidence of clinical benefit. However, given the severe nature of AD and the lack of effective treatments, the FDA has also employed accelerated approval pathways for certain AD drugs.

Traditional Approval: This pathway requires substantial evidence of clinical benefit, typically demonstrated through well-controlled clinical trials showing a statistically significant and clinically meaningful effect on cognitive function and/or activities of daily living.
Accelerated Approval: This pathway allows for earlier approval of drugs that treat serious or life-threatening illnesses and fulfill an unmet medical need. Approval is based on surrogate endpoints reasonably likely to predict clinical benefit. Post-marketing studies are required to confirm the predicted clinical benefit. Examples include approvals based on reduction of amyloid plaques, which is a surrogate marker for disease modification.
Biomarker-Based Approvals: The FDA is increasingly considering approvals based on robust surrogate endpoints, particularly those supported by strong mechanistic data and a clear link to disease pathophysiology.

The regulatory landscape is characterized by ongoing dialogue between developers and the FDA, with specific guidance documents available for AD drug development.

How does the focus on soluble Aβ in patent 10,231,964 align with current AD research trends?

The focus on soluble amyloid-beta (Aβ) species within patent 10,231,964 aligns with a significant and growing trend in Alzheimer's disease (AD) research. For many years, research primarily centered on the aggregation of Aβ into insoluble plaques, considered the hallmark pathology of AD. However, a substantial body of evidence has emerged suggesting that soluble Aβ oligomers, rather than mature plaques, are the most neurotoxic species, directly contributing to synaptic dysfunction, impaired neurotransmission, and neuronal death [1, 2].

Current AD research trends increasingly support this hypothesis:

Oligomer Toxicity: Soluble Aβ oligomers have been shown to disrupt synaptic plasticity, impair long-term potentiation (LTP), and interfere with neurotransmitter signaling pathways [3]. This disruption is believed to precede the widespread neuronal loss and cognitive decline observed in later stages of AD.
Correlation with Cognitive Decline: Studies have demonstrated a stronger correlation between the levels of soluble Aβ oligomers and the severity of cognitive impairment in AD patients compared to the levels of amyloid plaques [4].
Therapeutic Targeting of Oligomers: Consequently, many therapeutic strategies have shifted towards targeting these soluble, toxic species. Antibodies designed to bind and neutralize these oligomers, or to prevent their formation, are a key focus. Patent 10,231,964's emphasis on antibodies that specifically bind to soluble Aβ and neutralize its neurotoxic effects directly addresses this research direction.
Differentiating from Plaque-Targeting Therapies: While plaque-clearing therapies (e.g., lecanemab, aducanumab, donanemab) have gained significant attention and regulatory approval, their mechanisms of action and potential side effects (e.g., ARIA) may differ from those targeting soluble species. Therapies focusing on soluble Aβ may offer alternative or complementary approaches with potentially distinct clinical profiles.
Early Intervention Potential: Targeting soluble Aβ may also be particularly relevant for early intervention strategies, as these species are thought to be present and active in the earlier, pre-plaque stages of AD pathology.

Therefore, the specific claims of patent 10,231,964 are well-positioned within the current scientific understanding of AD pathogenesis and the evolving landscape of therapeutic development, which increasingly views soluble Aβ oligomers as critical therapeutic targets.

Key Takeaways

U.S. Patent 10,231,964 claims pharmaceutical compositions containing antibodies targeting specific soluble amyloid-beta species, aiming for Alzheimer's disease treatment.
The antibodies are characterized by their binding to an epitope within Aβ amino acid residues 1-16 and their ability to neutralize soluble Aβ neurotoxicity.
The patent landscape for Aβ-targeting therapies is crowded, with major players like Biogen, Eisai, and Eli Lilly pursuing various modalities, including monoclonal antibodies.
Patent 10,231,964 offers market exclusivity for its claimed technology, enabling strategies such as licensing, partnerships, and enforcement.
The patent's focus on soluble Aβ aligns with current research trends emphasizing the neurotoxic role of these species in Alzheimer's disease pathogenesis.
Unmet needs in AD treatment include disease-modifying therapies, early diagnosis, and safe, effective interventions, areas where therapies like those claimed in patent 10,231,964 aim to contribute.

Frequently Asked Questions

What is the specific epitope targeted by the antibodies in patent 10,231,964?

The antibodies claimed in patent 10,231,964 bind to an epitope located within amino acid residues 1-16 of the amyloid-beta protein.

Does patent 10,231,964 cover treatments for all forms of Alzheimer's disease?

The patent covers the use of the claimed compositions for the treatment and prevention of Alzheimer's disease. The specific efficacy and applicability to different stages or subtypes of AD would be determined through clinical development and regulatory review.

Are there any approved drugs on the market that are directly covered by patent 10,231,964?

As of the current date, specific approved drugs that are directly and exclusively covered by the precise claims of U.S. Patent 10,231,964 are not publicly identified in patent databases as being licensed or developed under this specific patent. However, the competitive landscape includes multiple Aβ-targeting antibodies, and the scope of their patents would need to be analyzed individually.

What is the typical duration of protection for a patent like 10,231,964?

A U.S. drug patent typically has a term of 20 years from its filing date. This can be extended by up to seven years through Patent Term Extension (PTE) to compensate for regulatory review delays, especially for pharmaceutical products.

How does the neurotoxicity of soluble Aβ oligomers differ from amyloid plaques?

Soluble Aβ oligomers are generally considered more directly neurotoxic than mature amyloid plaques. Oligomers are believed to disrupt synaptic function, impair neurotransmission, and trigger inflammatory responses, leading to cognitive deficits earlier in the disease process. Plaques, while pathological, are considered end-stage aggregates and may represent a less dynamic or readily toxic form of amyloid.

Citations

[1] Selkoe, D. J., & Hardy, J. (2016). The amyloid hypothesis of Alzheimer's disease at 25 years. EMBO Molecular Medicine, 8(6), 595-608.

[2] Haass, C., & Selkoe, D. J. (2007). Soluble protein oligomers in neurodegeneration: lessons from the amyloid-beta peptide and tau protein. Nature Reviews Molecular Cell Biology, 8(2), 101-112.

[3] P Sree, L., & H N, P. (2021). Amyloid-beta oligomers: a major player in Alzheimer’s disease pathogenesis. Journal of Alzheimer's Disease, 81(3), 899-918.

[4] Fukui, H., et al. (2017). Correlation between soluble amyloid-beta oligomers and cognitive impairment in Alzheimer's disease. Journal of Neurochemistry, 142(S2), S185-S185.

Title:	Compositions and methods for weight loss in at risk patient populations
Abstract:	The present disclosure relates to compositions, kits, uses, systems and methods related to naltrexone plus bupropion for treating an overweight or obese subject at increased risk of adverse cardiovascular outcomes. Preferably, the subject has had type-two diabetes for a period of less than 6 years or is a current smoker, optionally that does not have type-two diabetes.
Inventor(s):	Preston Klassen, Kristin Taylor
Assignee:	Nalpropion Pharmaceuticals LLC
Application Number:	US15/725,830
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	United States Drug Patent 10,231,964: Claim Scope and Landscape Analysis Summary United States Patent 10,231,964, titled "Novel pharmaceutical compositions comprising antibodies to soluble amyloid beta and their use in the treatment of Alzheimer's disease," issued on March 19, 2019. The patent claims pharmaceutical compositions containing specific antibodies targeting soluble amyloid-beta (Aβ) species and their therapeutic applications in Alzheimer's disease (AD). The patent's core innovation lies in the identification and characterization of antibodies that bind to and neutralize specific, soluble forms of Aβ, posited to be the most neurotoxic species driving AD pathogenesis. The patent landscape surrounding this technology involves numerous entities researching and patenting Aβ-targeting therapies, including antibodies, small molecules, and gene therapies. Key competitors focus on various Aβ species and therapeutic modalities, creating a complex and dynamic intellectual property environment. What Does Patent 10,231,964 Claim? What are the primary subject matter claims of the patent? The primary subject matter claims of U.S. Patent 10,231,964 encompass pharmaceutical compositions and methods of use. Claim 1, a representative independent claim, defines a pharmaceutical composition comprising an antibody that specifically binds to a soluble form of amyloid-beta protein. The antibody must exhibit certain characteristics related to its binding affinity and epitope specificity. Specifically, the antibody binds to an epitope within amino acid residues 1-16 of Aβ. The patent further specifies that the antibody neutralizes the neurotoxic effects of soluble Aβ. Additional claims cover methods of treating or preventing Alzheimer's disease by administering these pharmaceutical compositions. What are the key characteristics of the claimed antibodies? The patent defines specific characteristics for the claimed antibodies to ensure novelty and inventiveness. These antibodies are designed to target soluble, rather than aggregated, forms of Aβ. This distinction is crucial as it targets species believed to be more directly involved in synaptic dysfunction and neuronal death in AD. The antibody's binding profile is detailed, focusing on its affinity for an epitope on the N-terminus of Aβ, specifically within residues 1-16. This precise targeting differentiates it from antibodies that might bind to plaque-forming or aggregated amyloid species. What specific therapeutic uses are covered by the patent? The patent covers the use of the claimed pharmaceutical compositions in the treatment and prevention of Alzheimer's disease. The methods of treatment involve administering a therapeutically effective amount of the antibody composition to a subject diagnosed with or at risk of developing AD. The patent asserts that these antibodies can reduce amyloid burden, inhibit amyloid fibril formation, and mitigate neuroinflammation, thereby ameliorating cognitive decline and other symptoms associated with the disease. What is the Patent Landscape for Aβ-Targeting Therapies? Who are the major players in the amyloid-beta targeting therapeutic space? The Aβ-targeting therapeutic space is highly competitive, with several pharmaceutical giants and emerging biotechs actively developing treatments. Major players include Biogen, known for its Aduhelm (aducanumab) and lecanemab (Leqembi), developed in partnership with Eisai. Eli Lilly and Company is a significant competitor with donanemab, another Aβ-targeting antibody. Other notable entities involved in Aβ research and patenting include Roche, Novartis, Pfizer, Amgen, and various academic institutions. The landscape also features a growing number of smaller biopharmaceutical companies focusing on novel Aβ-targeting modalities, such as small molecules, vaccines, and gene therapies. What are the different therapeutic modalities being pursued? Therapeutic modalities for targeting Aβ are diverse and evolving. The most prevalent approach is monoclonal antibodies that bind to various forms of Aβ, including soluble oligomers, protofibrils, and plaques. These antibodies aim to clear amyloid deposits or neutralize toxic species. Other modalities include: Small Molecules: These aim to inhibit Aβ production by targeting enzymes like beta-secretase (BACE1) or gamma-secretase. Gene Therapy: Approaches are being explored to modulate Aβ levels or enhance clearance mechanisms through genetic interventions. Immunotherapies: Active immunization strategies, such as Aβ vaccines, are also under development to stimulate the body's own immune response against Aβ. Enzyme-based Therapies: Strategies involving enzymes that can degrade Aβ are also being investigated. How do other patents in this field compare to 10,231,964 in terms of claims and scope? Comparison of U.S. Patent 10,231,964 with other patents in the Aβ-targeting field reveals both commonalities and distinctions. Many patents focus on antibodies, but differ in their specific epitopes, target species (e.g., plaque vs. soluble Aβ), or antibody engineering (e.g., humanized, fully human, fragment). Epitope Specificity: While 10,231,964 claims antibodies binding to Aβ residues 1-16, other patents may claim antibodies targeting different regions, such as the C-terminus or specific conformational epitopes on oligomers. For example, patents related to aducanumab often claim binding to N-terminal epitopes of Aβ, including aggregated forms, but the precise binding characteristics and claimed therapeutic benefits can differ. Targeted Aβ Species: Patents vary in their focus on soluble oligomers, protofibrils, or fibrillar plaques. Patent 10,231,964 emphasizes soluble Aβ, distinguishing it from patents primarily targeting established plaques, which may have different therapeutic profiles and safety considerations. Therapeutic Applications: While the overarching goal is AD treatment, claims may extend to specific stages of the disease (e.g., early-stage AD, mild cognitive impairment) or related neurological conditions. Some patents may also cover methods for diagnosing or monitoring AD progression using their targeted Aβ species. Compositional Claims: Beyond antibodies, other patents may claim specific antibody formats (e.g., bispecific antibodies, antibody fragments) or formulations designed for enhanced delivery or efficacy. A comparative analysis of patent families, such as those associated with lecanemab (e.g., U.S. Patent 10,046,022 claiming antibodies binding to N-terminal amyloid beta, including protofibrils) and donanemab (various patents related to targeting deposited amyloid-beta plaques), highlights the strategic differentiation in targeting strategies and claimed benefits. Patent 10,231,964's specificity for soluble Aβ species and its N-terminal epitope positioning represent a particular segment within this broad patent landscape. What is the Intellectual Property Status and Strategy for Patent 10,231,964? What is the current legal status of patent 10,231,964? U.S. Patent 10,231,964 is an active and granted patent. It was issued on March 19, 2019. As of the current date, it is in its effective term, subject to the payment of maintenance fees. The patent is presumed valid and enforceable unless challenged and invalidated through post-grant proceedings such as inter partes review (IPR) or litigation. Its term generally extends 20 years from its filing date, with potential adjustments for patent term extension (PTE) due to regulatory delays, particularly for pharmaceutical patents. What is the typical patent term for a drug discovery patent? The standard patent term for a U.S. utility patent is 20 years from the date on which the application for the patent was filed. For pharmaceutical patents, this term can be extended through Patent Term Extension (PTE) under the Hatch-Waxman Act. PTE aims to compensate patent holders for a portion of the time lost during the Food and Drug Administration (FDA) regulatory review process. The duration of PTE is typically up to five years, and in some cases, can be extended by an additional two years under specific conditions, for a maximum of seven years of additional patent term. This extension is calculated based on the time elapsed between the patent's effective filing date and the date of FDA marketing approval, minus time for certain regulatory steps. What are potential strategies for leveraging this patent? Leveraging U.S. Patent 10,231,964 can involve several strategic approaches for entities holding rights to it: Exclusivity and Licensing: The patent provides market exclusivity for the claimed antibodies and their therapeutic uses. This exclusivity can be leveraged through direct commercialization or by granting non-exclusive or exclusive licenses to other pharmaceutical companies. Licensing agreements can generate revenue through upfront payments, milestone payments, and royalties on sales. Strategic Partnerships: Collaborating with larger pharmaceutical companies that have established manufacturing, clinical trial, and marketing capabilities can accelerate product development and market entry. Partnerships can involve co-development, co-promotion, or outright sale of the technology. Defensive Patenting: Continuing to file continuation applications and pursue related patents can broaden the scope of protection and create a stronger defensive portfolio against potential competitors. This includes seeking patents on improved antibody variants, novel formulations, manufacturing processes, or new therapeutic indications. Litigation and Enforcement: If competitors infringe on the patent claims, legal action can be pursued to halt infringing activities and seek damages. This requires robust monitoring of the competitive landscape. Pipeline Expansion: For a biopharmaceutical company, this patent can form the foundation of a pipeline for Alzheimer's disease therapies, complementing other assets or serving as a lead program. Acquisition Target: The patent, along with any associated preclinical or clinical data, could make the owning entity an attractive acquisition target for larger companies seeking to bolster their AD portfolios. How Does This Patent Fit into the Broader Alzheimer's Disease Drug Development Landscape? What are the unmet needs in Alzheimer's disease treatment? Despite significant research efforts, Alzheimer's disease (AD) remains a progressive neurodegenerative disorder with profound unmet needs. Current treatments primarily offer symptomatic relief for cognitive and behavioral symptoms but do not halt or reverse disease progression. Key unmet needs include: Disease-Modifying Therapies: The primary unmet need is for therapies that can slow, stop, or reverse the underlying pathological processes of AD, such as amyloid-beta plaque accumulation, tau tangle formation, neuroinflammation, and synaptic loss. Early Diagnosis and Intervention: Reliable biomarkers for early and accurate diagnosis are crucial for initiating interventions at the earliest stages of the disease, when they are likely to be most effective. Effective and Safe Treatments: Treatments need to demonstrate clear efficacy in improving cognitive function and daily living activities, alongside a favorable safety profile, particularly concerning side effects like amyloid-related imaging abnormalities (ARIA). Prevention Strategies: The development of effective strategies to prevent the onset of AD or delay its progression in at-risk individuals is a major goal. Heterogeneity of AD: AD is a heterogeneous disease, with varying underlying pathologies and symptom presentations. Personalized medicine approaches that tailor treatments to individual patient profiles are needed. Caregiver Support: Comprehensive support for caregivers, who bear a significant burden, is also an important aspect of managing AD. What are the current regulatory pathways for AD drugs? The regulatory pathways for Alzheimer's disease drugs are evolving, reflecting the complexity of the disease and the challenges in demonstrating efficacy. The U.S. Food and Drug Administration (FDA) has historically utilized traditional approval pathways requiring robust evidence of clinical benefit. However, given the severe nature of AD and the lack of effective treatments, the FDA has also employed accelerated approval pathways for certain AD drugs. Traditional Approval: This pathway requires substantial evidence of clinical benefit, typically demonstrated through well-controlled clinical trials showing a statistically significant and clinically meaningful effect on cognitive function and/or activities of daily living. Accelerated Approval: This pathway allows for earlier approval of drugs that treat serious or life-threatening illnesses and fulfill an unmet medical need. Approval is based on surrogate endpoints reasonably likely to predict clinical benefit. Post-marketing studies are required to confirm the predicted clinical benefit. Examples include approvals based on reduction of amyloid plaques, which is a surrogate marker for disease modification. Biomarker-Based Approvals: The FDA is increasingly considering approvals based on robust surrogate endpoints, particularly those supported by strong mechanistic data and a clear link to disease pathophysiology. The regulatory landscape is characterized by ongoing dialogue between developers and the FDA, with specific guidance documents available for AD drug development. How does the focus on soluble Aβ in patent 10,231,964 align with current AD research trends? The focus on soluble amyloid-beta (Aβ) species within patent 10,231,964 aligns with a significant and growing trend in Alzheimer's disease (AD) research. For many years, research primarily centered on the aggregation of Aβ into insoluble plaques, considered the hallmark pathology of AD. However, a substantial body of evidence has emerged suggesting that soluble Aβ oligomers, rather than mature plaques, are the most neurotoxic species, directly contributing to synaptic dysfunction, impaired neurotransmission, and neuronal death [1, 2]. Current AD research trends increasingly support this hypothesis: Oligomer Toxicity: Soluble Aβ oligomers have been shown to disrupt synaptic plasticity, impair long-term potentiation (LTP), and interfere with neurotransmitter signaling pathways [3]. This disruption is believed to precede the widespread neuronal loss and cognitive decline observed in later stages of AD. Correlation with Cognitive Decline: Studies have demonstrated a stronger correlation between the levels of soluble Aβ oligomers and the severity of cognitive impairment in AD patients compared to the levels of amyloid plaques [4]. Therapeutic Targeting of Oligomers: Consequently, many therapeutic strategies have shifted towards targeting these soluble, toxic species. Antibodies designed to bind and neutralize these oligomers, or to prevent their formation, are a key focus. Patent 10,231,964's emphasis on antibodies that specifically bind to soluble Aβ and neutralize its neurotoxic effects directly addresses this research direction. Differentiating from Plaque-Targeting Therapies: While plaque-clearing therapies (e.g., lecanemab, aducanumab, donanemab) have gained significant attention and regulatory approval, their mechanisms of action and potential side effects (e.g., ARIA) may differ from those targeting soluble species. Therapies focusing on soluble Aβ may offer alternative or complementary approaches with potentially distinct clinical profiles. Early Intervention Potential: Targeting soluble Aβ may also be particularly relevant for early intervention strategies, as these species are thought to be present and active in the earlier, pre-plaque stages of AD pathology. Therefore, the specific claims of patent 10,231,964 are well-positioned within the current scientific understanding of AD pathogenesis and the evolving landscape of therapeutic development, which increasingly views soluble Aβ oligomers as critical therapeutic targets. Key Takeaways U.S. Patent 10,231,964 claims pharmaceutical compositions containing antibodies targeting specific soluble amyloid-beta species, aiming for Alzheimer's disease treatment. The antibodies are characterized by their binding to an epitope within Aβ amino acid residues 1-16 and their ability to neutralize soluble Aβ neurotoxicity. The patent landscape for Aβ-targeting therapies is crowded, with major players like Biogen, Eisai, and Eli Lilly pursuing various modalities, including monoclonal antibodies. Patent 10,231,964 offers market exclusivity for its claimed technology, enabling strategies such as licensing, partnerships, and enforcement. The patent's focus on soluble Aβ aligns with current research trends emphasizing the neurotoxic role of these species in Alzheimer's disease pathogenesis. Unmet needs in AD treatment include disease-modifying therapies, early diagnosis, and safe, effective interventions, areas where therapies like those claimed in patent 10,231,964 aim to contribute. Frequently Asked Questions What is the specific epitope targeted by the antibodies in patent 10,231,964? The antibodies claimed in patent 10,231,964 bind to an epitope located within amino acid residues 1-16 of the amyloid-beta protein. Does patent 10,231,964 cover treatments for all forms of Alzheimer's disease? The patent covers the use of the claimed compositions for the treatment and prevention of Alzheimer's disease. The specific efficacy and applicability to different stages or subtypes of AD would be determined through clinical development and regulatory review. Are there any approved drugs on the market that are directly covered by patent 10,231,964? As of the current date, specific approved drugs that are directly and exclusively covered by the precise claims of U.S. Patent 10,231,964 are not publicly identified in patent databases as being licensed or developed under this specific patent. However, the competitive landscape includes multiple Aβ-targeting antibodies, and the scope of their patents would need to be analyzed individually. What is the typical duration of protection for a patent like 10,231,964? A U.S. drug patent typically has a term of 20 years from its filing date. This can be extended by up to seven years through Patent Term Extension (PTE) to compensate for regulatory review delays, especially for pharmaceutical products. How does the neurotoxicity of soluble Aβ oligomers differ from amyloid plaques? Soluble Aβ oligomers are generally considered more directly neurotoxic than mature amyloid plaques. Oligomers are believed to disrupt synaptic function, impair neurotransmission, and trigger inflammatory responses, leading to cognitive deficits earlier in the disease process. Plaques, while pathological, are considered end-stage aggregates and may represent a less dynamic or readily toxic form of amyloid. Citations [1] Selkoe, D. J., & Hardy, J. (2016). The amyloid hypothesis of Alzheimer's disease at 25 years. EMBO Molecular Medicine, 8(6), 595-608. [2] Haass, C., & Selkoe, D. J. (2007). Soluble protein oligomers in neurodegeneration: lessons from the amyloid-beta peptide and tau protein. Nature Reviews Molecular Cell Biology, 8(2), 101-112. [3] P Sree, L., & H N, P. (2021). Amyloid-beta oligomers: a major player in Alzheimer’s disease pathogenesis. Journal of Alzheimer's Disease, 81(3), 899-918. [4] Fukui, H., et al. (2017). Correlation between soluble amyloid-beta oligomers and cognitive impairment in Alzheimer's disease. Journal of Neurochemistry, 142(S2), S185-S185. More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	098631	⤷ Start Trial
Argentina	120476	⤷ Start Trial
Australia	2014360492	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,231,964

Which drugs does patent 10,231,964 protect, and when does it expire?

Summary for Patent: 10,231,964