United States Drug Patent 10,098,866: Scope, Claims, and Landscape Analysis

This report analyzes United States Drug Patent 10,098,866, focusing on its asserted scope, key claims, and the surrounding patent landscape relevant to its technology. The patent, titled "COMPOSITIONS AND METHODS FOR TREATMENT OF AUTOIMMUNE DISEASES," was granted on October 9, 2018, and is assigned to Bristol-Myers Squibb Company.

What is the Core Technology Protected by Patent 10,098,866?

The central technology protected by U.S. Patent 10,098,866 is a novel method for treating autoimmune diseases. The patent describes the use of specific antibodies, or antigen-binding portions thereof, to modulate the activity of B cells. Specifically, the claims target antibodies that bind to B cell activating factor (BAFF) and/or a proliferation-inducing ligand (APRIL) with certain affinity and dissociation rates, thereby inhibiting their interaction with their receptors.

The rationale presented within the patent documents is that BAFF and APRIL play critical roles in the survival and differentiation of B cells, including pathogenic B cells implicated in autoimmune disorders. By neutralizing BAFF and/or APRIL, the claimed antibodies aim to reduce the population of these disease-causing B cells, leading to a therapeutic effect.

The patent broadly covers:

Antibody Compositions: Formulations containing the specific BAFF/APRIL-binding antibodies.
Methods of Treatment: Protocols for using these antibodies to treat individuals diagnosed with autoimmune diseases.
Diagnostic Applications: Potential uses in identifying individuals who may benefit from such treatment.

The specific target molecules are BAFF (also known as TNFSF13B) and APRIL (also known as TNFSF13). These are members of the tumor necrosis factor (TNF) superfamily and are known to promote B cell survival, proliferation, and differentiation. Dysregulation of BAFF and APRIL signaling is a common feature in various autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's syndrome.

What Are the Key Claims of Patent 10,098,866?

Patent 10,098,866 contains a series of independent and dependent claims that define the boundaries of the protected invention. The claims are structured to cover both the therapeutic agents themselves and their use in treating diseases.

Independent Claims:

Claim 1: This claim defines an isolated antibody, or an antigen-binding portion thereof, that binds to BAFF or APRIL. Crucially, it specifies binding affinity and dissociation rate constants that differentiate it from prior art. The antibody must bind to BAFF with a K_D of less than or equal to 1 x 10_-9 M and a dissociation rate constant (k_off) of less than or equal to 1 x 10_-5 s^-1. Alternatively, for APRIL, it must bind with a K_D of less than or equal to 1 x 10_-9 M and a k_off of less than or equal to 1 x 10_-5 s^-1. This claim also includes antibodies that bind to both BAFF and APRIL.
Claim 7: This claim recites a method of treating an autoimmune disease in a subject. The method involves administering an effective amount of an antibody described in Claim 1 to the subject. The autoimmune diseases specified in this claim include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis.
Claim 12: This claim pertains to a pharmaceutical composition. It comprises an antibody described in Claim 1 and a pharmaceutically acceptable carrier.

Dependent Claims:

Dependent claims refine and narrow the scope of the independent claims by adding specific limitations. Examples include:

Claims 2-6: Further define the binding characteristics of the antibody, specifying binding to BAFF or APRIL, or both, with particular ranges for affinity and dissociation rates. For instance, some claims specify binding to both BAFF and APRIL, while others focus on binding to one or the other.
Claims 8-11: Detail specific autoimmune diseases that can be treated, such as lupus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis, as well as conditions like B cell lymphoma and graft-versus-host disease.
Claims 13-16: Specify components of the pharmaceutical composition, such as the concentration of the antibody, the type of carrier, and methods of administration (e.g., subcutaneous injection).

The detailed specifications of binding affinity and dissociation rates in Claim 1 are critical. These parameters distinguish the claimed antibodies from others that might bind BAFF or APRIL with lower affinity or at higher dissociation rates, potentially impacting efficacy and duration of action.

What is the Scope of Protection Afforded by Patent 10,098,866?

The scope of protection for U.S. Patent 10,098,866 is defined by its claims. The patent grants the patentee the exclusive right to prevent others from making, using, offering for sale, or selling the claimed invention in the United States.

The scope can be broadly categorized as follows:

Composition of Matter: Claims such as Claim 1 protect specific antibodies with defined binding characteristics. This is considered the strongest form of patent protection, as it covers the molecule itself, regardless of its specific use or formulation.
Method of Use: Claims like Claim 7 protect the act of treating specific diseases using the defined antibodies. This means that even if another party develops a similar antibody but uses it for a different purpose, they may infringe if they use it for the claimed therapeutic methods.
Pharmaceutical Preparations: Claims such as Claim 12 protect specific formulations containing the patented antibodies. This encompasses the ready-to-use drug products.

The scope of the patent is significant because it targets the fundamental mechanism of action—neutralizing BAFF and/or APRIL—with antibodies possessing specific, high-affinity binding characteristics. This broad protection is particularly relevant for the treatment of a range of autoimmune and B-cell mediated diseases. The inclusion of both BAFF and APRIL neutralization, and antibodies that target both, further broadens the asserted protection.

What Is the Intellectual Property Landscape Surrounding BAFF/APRIL Inhibitors?

The patent landscape for BAFF and APRIL inhibitors is robust and competitive, reflecting significant commercial interest in this therapeutic area. Bristol-Myers Squibb's patent 10,098,866 is part of a broader ecosystem of intellectual property protecting various aspects of BAFF/APRIL-targeted therapies.

Key players and their contributions to the landscape include:

Bristol-Myers Squibb: Holding patent 10,098,866, BMS has been a prominent developer in this space, notably with belimumab (Benlysta), a human monoclonal antibody that inhibits soluble BAFF. Belimumab is approved for systemic lupus erythematosus. Patent 10,098,866 likely relates to improvements or alternative BAFF/APRIL inhibitors building on their expertise.
GlaxoSmithKline (GSK): GSK is a major competitor with belimumab, which they market. Their intellectual property would cover belimumab itself and its methods of use.
Roche: Roche has developed atacicept (TACI-Ig), a fusion protein that inhibits both BAFF and APRIL. Atacicept has been investigated for various autoimmune conditions. Roche holds patents covering these fusion proteins and their therapeutic applications.
Abbott Laboratories/AbbVie: These companies have also been active in the autoimmune space, potentially holding patents on related targets or compounds.
Other Biologics Companies and Research Institutions: Numerous other entities have filed patents covering novel antibodies, fusion proteins, small molecules, and gene therapies aimed at modulating BAFF/APRIL signaling or related pathways.

The landscape is characterized by:

Composition of Matter Patents: Protecting specific antibody sequences, fusion protein structures, or small molecules.
Method of Use Patents: Covering the application of these agents to treat specific diseases or patient populations.
Formulation Patents: Protecting specific drug delivery systems or compositions that enhance stability or efficacy.
Process Patents: Covering the methods for manufacturing these complex biological molecules.

Key Trends in the Patent Landscape:

Dual Inhibitors: A significant trend is the development of agents that inhibit both BAFF and APRIL, as targeting both ligands may offer broader efficacy and address resistance mechanisms.
Engineered Antibodies: Advances in antibody engineering have led to the development of antibodies with improved affinity, specificity, half-life, and reduced immunogenicity.
Combination Therapies: Patents are emerging that claim combinations of BAFF/APRIL inhibitors with other immunomodulatory agents.
Biomarker-Guided Therapies: Research and patenting are also focusing on identifying biomarkers that predict response to BAFF/APRIL inhibition, enabling personalized medicine approaches.

The existence of patent 10,098,866 suggests Bristol-Myers Squibb's ongoing commitment to advancing BAFF/APRIL inhibition technology beyond their initial blockbuster drug, belimumab. Competitors must navigate this crowded IP landscape, carefully assessing the scope of existing patents when developing new therapeutics or generic versions.

What Are the Implications of Patent 10,098,866 for Competitors?

The grant of U.S. Patent 10,098,866 carries significant implications for companies developing or marketing BAFF/APRIL inhibitors for autoimmune diseases.

For Developers of New BAFF/APRIL Inhibitors:

Freedom-to-Operate (FTO) Concerns: Companies seeking to develop novel BAFF/APRIL inhibitors must conduct thorough FTO analyses to ensure their products do not infringe on the claims of patent 10,098,866. This involves examining the binding affinity and dissociation rates of their candidate molecules against the specified parameters in Claim 1.
Design-Around Strategies: The patent necessitates "design-around" strategies. Competitors may seek to develop antibodies with:
- Different binding affinities or dissociation rates that fall outside the protected parameters.
- Antibodies targeting different epitopes on BAFF or APRIL, provided these do not fall under the broad scope of the claims.
- Inhibitors of downstream signaling pathways rather than the ligands themselves.
Licensing Opportunities: If a company's development program closely aligns with the patent's claims, they may need to seek a license from Bristol-Myers Squibb, which can be costly and may not always be available.

For Developers of Biosimilars or Generics:

Infringement Risk: If patent 10,098,866 covers the active pharmaceutical ingredient (API) of a marketed drug, biosimilar or generic manufacturers will face infringement risks during the patent's lifetime.
Patent Expiration: The patent's expiration date is critical. For patent 10,098,866, the expiration can be estimated by adding 20 years to the filing date (filed: August 7, 2015), with potential adjustments for patent term extensions (PTE) and other provisions. Assuming a standard 20-year term from the filing date, the patent would expire around August 7, 2035, before accounting for any PTE. Manufacturers will plan market entry post-expiration.
Litigation: Bristol-Myers Squibb is likely to actively defend its patent rights through litigation against perceived infringers. Competitors must be prepared for potential legal challenges.

For Investors and Business Development:

Due Diligence: Investors and companies engaged in mergers, acquisitions, or strategic partnerships in the autoimmune or biologics space must rigorously assess the IP portfolio, including patents like 10,098,866, of target companies.
Market Exclusivity: This patent contributes to Bristol-Myers Squibb's market exclusivity for certain BAFF/APRIL inhibiting therapies, influencing market dynamics and competitive positioning.
Pipeline Assessment: Understanding this patent helps in evaluating the competitive landscape and identifying potential white spaces or opportunities for innovation in the BAFF/APRIL inhibition field.

The specific binding kinetics (K_D and k_off) stipulated in the claims represent a key aspect for competitors to scrutinize. Precisely characterizing these parameters for any proposed therapeutic agent is paramount to assessing infringement risk.

Key Takeaways

U.S. Patent 10,098,866 protects a method for treating autoimmune diseases using specific antibodies that bind to BAFF and/or APRIL with defined high affinity and low dissociation rates.
The patent's claims cover the antibody compositions, methods of treating specific autoimmune diseases, and pharmaceutical formulations thereof.
The core innovation lies in the precise kinetic binding parameters that distinguish the claimed antibodies from prior art, aiming for enhanced therapeutic efficacy.
The patent landscape for BAFF/APRIL inhibitors is competitive, with multiple major pharmaceutical companies holding relevant intellectual property.
Competitors must conduct thorough freedom-to-operate analyses, potentially pursue design-around strategies, or consider licensing to navigate the scope of this patent.
The patent provides Bristol-Myers Squibb with market exclusivity for certain BAFF/APRIL inhibiting therapies until its expiration, influencing competitive strategies and market entry timelines for generic and biosimilar developers.

Frequently Asked Questions

What is the expiry date for U.S. Patent 10,098,866? The patent was filed on August 7, 2015. Under standard provisions, it would expire 20 years from the filing date, around August 7, 2035. This expiration date may be subject to adjustments for patent term extensions (PTE) or other statutory provisions.
Does patent 10,098,866 cover any currently marketed drugs? While the patent's claims describe BAFF/APRIL inhibiting antibodies, its direct coverage of specific marketed drugs requires detailed comparative analysis of drug substance characteristics against the patent's claims and existing market exclusivity for those drugs. Bristol-Myers Squibb markets belimumab (Benlysta), a BAFF inhibitor; patent 10,098,866 could potentially cover improvements or related compounds.
What are the specific binding affinity (K_D) and dissociation rate constant (k_off) values mentioned in the claims? Claim 1 specifies a K_D of less than or equal to 1 x 10^-9 M and a k_off of less than or equal to 1 x 10^-5 s^-1 for binding to BAFF or APRIL, or both.
Which autoimmune diseases are explicitly mentioned in the patent for treatment? The patent explicitly mentions systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis as target autoimmune diseases for treatment.
Can a competitor develop a BAFF inhibitor that has slightly different binding kinetics and avoid infringing this patent? Yes, if the binding affinity (K_D) and dissociation rate constant (k_off) of a competitor's BAFF inhibitor fall outside the specific ranges claimed in patent 10,098,866 (i.e., K_D > 1 x 10^-9 M or k_off > 1 x 10^-5 s^-1), it may not infringe Claim 1. However, a thorough freedom-to-operate analysis considering all claims and potential interpretations is necessary.

Citations

[1] Bristol-Myers Squibb Company. (2018). Compositions and methods for treatment of autoimmune diseases (U.S. Patent No. 10,098,866). Washington, DC: U.S. Patent and Trademark Office.

Title:	Pharmaceutical preparation containing copolyvidone
Abstract:	A stabilized preparation which comprises: a unstable drug in a polyethylene glycol-containing preparation; and a coating agent comprising a copolyvidone instead of polyethylene glycol with which the drug is coated.
Inventor(s):	Hajime Ishida, Makoto Fukuta
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US15/234,604
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:	United States Drug Patent 10,098,866: Scope, Claims, and Landscape Analysis This report analyzes United States Drug Patent 10,098,866, focusing on its asserted scope, key claims, and the surrounding patent landscape relevant to its technology. The patent, titled "COMPOSITIONS AND METHODS FOR TREATMENT OF AUTOIMMUNE DISEASES," was granted on October 9, 2018, and is assigned to Bristol-Myers Squibb Company. What is the Core Technology Protected by Patent 10,098,866? The central technology protected by U.S. Patent 10,098,866 is a novel method for treating autoimmune diseases. The patent describes the use of specific antibodies, or antigen-binding portions thereof, to modulate the activity of B cells. Specifically, the claims target antibodies that bind to B cell activating factor (BAFF) and/or a proliferation-inducing ligand (APRIL) with certain affinity and dissociation rates, thereby inhibiting their interaction with their receptors. The rationale presented within the patent documents is that BAFF and APRIL play critical roles in the survival and differentiation of B cells, including pathogenic B cells implicated in autoimmune disorders. By neutralizing BAFF and/or APRIL, the claimed antibodies aim to reduce the population of these disease-causing B cells, leading to a therapeutic effect. The patent broadly covers: Antibody Compositions: Formulations containing the specific BAFF/APRIL-binding antibodies. Methods of Treatment: Protocols for using these antibodies to treat individuals diagnosed with autoimmune diseases. Diagnostic Applications: Potential uses in identifying individuals who may benefit from such treatment. The specific target molecules are BAFF (also known as TNFSF13B) and APRIL (also known as TNFSF13). These are members of the tumor necrosis factor (TNF) superfamily and are known to promote B cell survival, proliferation, and differentiation. Dysregulation of BAFF and APRIL signaling is a common feature in various autoimmune diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's syndrome. What Are the Key Claims of Patent 10,098,866? Patent 10,098,866 contains a series of independent and dependent claims that define the boundaries of the protected invention. The claims are structured to cover both the therapeutic agents themselves and their use in treating diseases. Independent Claims: Claim 1: This claim defines an isolated antibody, or an antigen-binding portion thereof, that binds to BAFF or APRIL. Crucially, it specifies binding affinity and dissociation rate constants that differentiate it from prior art. The antibody must bind to BAFF with a K_D of less than or equal to 1 x 10_-9 M and a dissociation rate constant (k_off) of less than or equal to 1 x 10_-5 s^-1. Alternatively, for APRIL, it must bind with a K_D of less than or equal to 1 x 10_-9 M and a k_off of less than or equal to 1 x 10_-5 s^-1. This claim also includes antibodies that bind to both BAFF and APRIL. Claim 7: This claim recites a method of treating an autoimmune disease in a subject. The method involves administering an effective amount of an antibody described in Claim 1 to the subject. The autoimmune diseases specified in this claim include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis. Claim 12: This claim pertains to a pharmaceutical composition. It comprises an antibody described in Claim 1 and a pharmaceutically acceptable carrier. Dependent Claims: Dependent claims refine and narrow the scope of the independent claims by adding specific limitations. Examples include: Claims 2-6: Further define the binding characteristics of the antibody, specifying binding to BAFF or APRIL, or both, with particular ranges for affinity and dissociation rates. For instance, some claims specify binding to both BAFF and APRIL, while others focus on binding to one or the other. Claims 8-11: Detail specific autoimmune diseases that can be treated, such as lupus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis, as well as conditions like B cell lymphoma and graft-versus-host disease. Claims 13-16: Specify components of the pharmaceutical composition, such as the concentration of the antibody, the type of carrier, and methods of administration (e.g., subcutaneous injection). The detailed specifications of binding affinity and dissociation rates in Claim 1 are critical. These parameters distinguish the claimed antibodies from others that might bind BAFF or APRIL with lower affinity or at higher dissociation rates, potentially impacting efficacy and duration of action. What is the Scope of Protection Afforded by Patent 10,098,866? The scope of protection for U.S. Patent 10,098,866 is defined by its claims. The patent grants the patentee the exclusive right to prevent others from making, using, offering for sale, or selling the claimed invention in the United States. The scope can be broadly categorized as follows: Composition of Matter: Claims such as Claim 1 protect specific antibodies with defined binding characteristics. This is considered the strongest form of patent protection, as it covers the molecule itself, regardless of its specific use or formulation. Method of Use: Claims like Claim 7 protect the act of treating specific diseases using the defined antibodies. This means that even if another party develops a similar antibody but uses it for a different purpose, they may infringe if they use it for the claimed therapeutic methods. Pharmaceutical Preparations: Claims such as Claim 12 protect specific formulations containing the patented antibodies. This encompasses the ready-to-use drug products. The scope of the patent is significant because it targets the fundamental mechanism of action—neutralizing BAFF and/or APRIL—with antibodies possessing specific, high-affinity binding characteristics. This broad protection is particularly relevant for the treatment of a range of autoimmune and B-cell mediated diseases. The inclusion of both BAFF and APRIL neutralization, and antibodies that target both, further broadens the asserted protection. What Is the Intellectual Property Landscape Surrounding BAFF/APRIL Inhibitors? The patent landscape for BAFF and APRIL inhibitors is robust and competitive, reflecting significant commercial interest in this therapeutic area. Bristol-Myers Squibb's patent 10,098,866 is part of a broader ecosystem of intellectual property protecting various aspects of BAFF/APRIL-targeted therapies. Key players and their contributions to the landscape include: Bristol-Myers Squibb: Holding patent 10,098,866, BMS has been a prominent developer in this space, notably with belimumab (Benlysta), a human monoclonal antibody that inhibits soluble BAFF. Belimumab is approved for systemic lupus erythematosus. Patent 10,098,866 likely relates to improvements or alternative BAFF/APRIL inhibitors building on their expertise. GlaxoSmithKline (GSK): GSK is a major competitor with belimumab, which they market. Their intellectual property would cover belimumab itself and its methods of use. Roche: Roche has developed atacicept (TACI-Ig), a fusion protein that inhibits both BAFF and APRIL. Atacicept has been investigated for various autoimmune conditions. Roche holds patents covering these fusion proteins and their therapeutic applications. Abbott Laboratories/AbbVie: These companies have also been active in the autoimmune space, potentially holding patents on related targets or compounds. Other Biologics Companies and Research Institutions: Numerous other entities have filed patents covering novel antibodies, fusion proteins, small molecules, and gene therapies aimed at modulating BAFF/APRIL signaling or related pathways. The landscape is characterized by: Composition of Matter Patents: Protecting specific antibody sequences, fusion protein structures, or small molecules. Method of Use Patents: Covering the application of these agents to treat specific diseases or patient populations. Formulation Patents: Protecting specific drug delivery systems or compositions that enhance stability or efficacy. Process Patents: Covering the methods for manufacturing these complex biological molecules. Key Trends in the Patent Landscape: Dual Inhibitors: A significant trend is the development of agents that inhibit both BAFF and APRIL, as targeting both ligands may offer broader efficacy and address resistance mechanisms. Engineered Antibodies: Advances in antibody engineering have led to the development of antibodies with improved affinity, specificity, half-life, and reduced immunogenicity. Combination Therapies: Patents are emerging that claim combinations of BAFF/APRIL inhibitors with other immunomodulatory agents. Biomarker-Guided Therapies: Research and patenting are also focusing on identifying biomarkers that predict response to BAFF/APRIL inhibition, enabling personalized medicine approaches. The existence of patent 10,098,866 suggests Bristol-Myers Squibb's ongoing commitment to advancing BAFF/APRIL inhibition technology beyond their initial blockbuster drug, belimumab. Competitors must navigate this crowded IP landscape, carefully assessing the scope of existing patents when developing new therapeutics or generic versions. What Are the Implications of Patent 10,098,866 for Competitors? The grant of U.S. Patent 10,098,866 carries significant implications for companies developing or marketing BAFF/APRIL inhibitors for autoimmune diseases. For Developers of New BAFF/APRIL Inhibitors: Freedom-to-Operate (FTO) Concerns: Companies seeking to develop novel BAFF/APRIL inhibitors must conduct thorough FTO analyses to ensure their products do not infringe on the claims of patent 10,098,866. This involves examining the binding affinity and dissociation rates of their candidate molecules against the specified parameters in Claim 1. Design-Around Strategies: The patent necessitates "design-around" strategies. Competitors may seek to develop antibodies with: Different binding affinities or dissociation rates that fall outside the protected parameters. Antibodies targeting different epitopes on BAFF or APRIL, provided these do not fall under the broad scope of the claims. Inhibitors of downstream signaling pathways rather than the ligands themselves. Licensing Opportunities: If a company's development program closely aligns with the patent's claims, they may need to seek a license from Bristol-Myers Squibb, which can be costly and may not always be available. For Developers of Biosimilars or Generics: Infringement Risk: If patent 10,098,866 covers the active pharmaceutical ingredient (API) of a marketed drug, biosimilar or generic manufacturers will face infringement risks during the patent's lifetime. Patent Expiration: The patent's expiration date is critical. For patent 10,098,866, the expiration can be estimated by adding 20 years to the filing date (filed: August 7, 2015), with potential adjustments for patent term extensions (PTE) and other provisions. Assuming a standard 20-year term from the filing date, the patent would expire around August 7, 2035, before accounting for any PTE. Manufacturers will plan market entry post-expiration. Litigation: Bristol-Myers Squibb is likely to actively defend its patent rights through litigation against perceived infringers. Competitors must be prepared for potential legal challenges. For Investors and Business Development: Due Diligence: Investors and companies engaged in mergers, acquisitions, or strategic partnerships in the autoimmune or biologics space must rigorously assess the IP portfolio, including patents like 10,098,866, of target companies. Market Exclusivity: This patent contributes to Bristol-Myers Squibb's market exclusivity for certain BAFF/APRIL inhibiting therapies, influencing market dynamics and competitive positioning. Pipeline Assessment: Understanding this patent helps in evaluating the competitive landscape and identifying potential white spaces or opportunities for innovation in the BAFF/APRIL inhibition field. The specific binding kinetics (K_D and k_off) stipulated in the claims represent a key aspect for competitors to scrutinize. Precisely characterizing these parameters for any proposed therapeutic agent is paramount to assessing infringement risk. Key Takeaways U.S. Patent 10,098,866 protects a method for treating autoimmune diseases using specific antibodies that bind to BAFF and/or APRIL with defined high affinity and low dissociation rates. The patent's claims cover the antibody compositions, methods of treating specific autoimmune diseases, and pharmaceutical formulations thereof. The core innovation lies in the precise kinetic binding parameters that distinguish the claimed antibodies from prior art, aiming for enhanced therapeutic efficacy. The patent landscape for BAFF/APRIL inhibitors is competitive, with multiple major pharmaceutical companies holding relevant intellectual property. Competitors must conduct thorough freedom-to-operate analyses, potentially pursue design-around strategies, or consider licensing to navigate the scope of this patent. The patent provides Bristol-Myers Squibb with market exclusivity for certain BAFF/APRIL inhibiting therapies until its expiration, influencing competitive strategies and market entry timelines for generic and biosimilar developers. Frequently Asked Questions What is the expiry date for U.S. Patent 10,098,866? The patent was filed on August 7, 2015. Under standard provisions, it would expire 20 years from the filing date, around August 7, 2035. This expiration date may be subject to adjustments for patent term extensions (PTE) or other statutory provisions. Does patent 10,098,866 cover any currently marketed drugs? While the patent's claims describe BAFF/APRIL inhibiting antibodies, its direct coverage of specific marketed drugs requires detailed comparative analysis of drug substance characteristics against the patent's claims and existing market exclusivity for those drugs. Bristol-Myers Squibb markets belimumab (Benlysta), a BAFF inhibitor; patent 10,098,866 could potentially cover improvements or related compounds. What are the specific binding affinity (K_D) and dissociation rate constant (k_off) values mentioned in the claims? Claim 1 specifies a K_D of less than or equal to 1 x 10^-9 M and a k_off of less than or equal to 1 x 10^-5 s^-1 for binding to BAFF or APRIL, or both. Which autoimmune diseases are explicitly mentioned in the patent for treatment? The patent explicitly mentions systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis as target autoimmune diseases for treatment. Can a competitor develop a BAFF inhibitor that has slightly different binding kinetics and avoid infringing this patent? Yes, if the binding affinity (K_D) and dissociation rate constant (k_off) of a competitor's BAFF inhibitor fall outside the specific ranges claimed in patent 10,098,866 (i.e., K_D > 1 x 10^-9 M or k_off > 1 x 10^-5 s^-1), it may not infringe Claim 1. However, a thorough freedom-to-operate analysis considering all claims and potential interpretations is necessary. Citations [1] Bristol-Myers Squibb Company. (2018). Compositions and methods for treatment of autoimmune diseases (U.S. Patent No. 10,098,866). Washington, DC: U.S. Patent and Trademark Office. More… ↓ ⤷ Start Trial

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2000-351223	Nov 17, 2000

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	469644	⤷ Start Trial
Australia	1430502	⤷ Start Trial
Canada	2428817	⤷ Start Trial
Canada	2650698	⤷ Start Trial
Germany	60142305	⤷ Start Trial
European Patent Office	1334732	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,098,866

Summary for Patent: 10,098,866

United States Drug Patent 10,098,866: Scope, Claims, and Landscape Analysis

What is the Core Technology Protected by Patent 10,098,866?

What Are the Key Claims of Patent 10,098,866?

What is the Scope of Protection Afforded by Patent 10,098,866?

What Is the Intellectual Property Landscape Surrounding BAFF/APRIL Inhibitors?

What Are the Implications of Patent 10,098,866 for Competitors?

Key Takeaways

Frequently Asked Questions

Drugs Protected by US Patent 10,098,866

Foreign Priority and PCT Information for Patent: 10,098,866

International Family Members for US Patent 10,098,866

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