Analysis of United States Drug Patent 11,497,750: Scope, Claims, and Landscape

What is the core invention of US Patent 11,497,750?

United States Patent 11,497,750, granted on November 15, 2022, to Bristol-Myers Squibb Company, covers a pharmaceutical composition comprising programmed death-ligand 1 (PD-L1) binding agent. Specifically, the invention relates to an antibody or a fragment thereof that binds to PD-L1 and is formulated for administration to a subject. The patent aims to provide improved methods for treating or preventing diseases, particularly cancers, by modulating the PD-1/PD-L1 immune checkpoint pathway [1].

What are the key claims of US Patent 11,497,750?

The patent contains several independent and dependent claims that define the scope of the invention.

Claim 1: This independent claim defines a pharmaceutical composition comprising an antibody or antibody fragment that binds to programmed death-ligand 1 (PD-L1), wherein the antibody or antibody fragment comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR) having specific amino acid sequences. The claim provides precise sequence identifiers for these variable regions, which are critical for defining the antibody's binding specificity and efficacy [1].
Claim 2: This claim depends on Claim 1 and specifies that the antibody or antibody fragment has a dissociation equilibrium constant (KD) for binding to PD-L1 of less than or equal to 1 x 10^-9 M. This quantifies the high affinity of the antibody for its target, a crucial parameter for therapeutic effectiveness [1].
Claim 3: This claim also depends on Claim 1 and defines the antibody or antibody fragment as having a dissociation rate constant (k_off) for binding to PD-L1 of less than or equal to 1 x 10^-4 s^-1. This further elaborates on the binding characteristics, indicating a slow off-rate from the PD-L1 target, which contributes to sustained immune checkpoint blockade [1].
Claim 4: Dependent on Claim 1, this claim specifies that the antibody or antibody fragment binds to human PD-L1 [1].
Claim 5: Dependent on Claim 1, this claim specifies that the antibody or antibody fragment does not bind to human PD-1 [1]. This claim is important for ensuring target specificity and avoiding off-target effects.
Claim 6: This independent claim defines a method for treating or preventing cancer in a subject. The method involves administering to the subject a therapeutically effective amount of the pharmaceutical composition of Claim 1 [1].
Claim 7: Dependent on Claim 6, this claim specifies that the cancer is selected from the group consisting of melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and bladder cancer [1].
Claim 8: Dependent on Claim 6, this claim specifies that the antibody or antibody fragment is administered intravenously [1].
Claim 9: This independent claim defines a method for enhancing an immune response in a subject. The method involves administering to the subject a therapeutically effective amount of the pharmaceutical composition of Claim 1 [1].
Claim 10: Dependent on Claim 9, this claim specifies that the immune response is an anti-tumor immune response [1].

The claims collectively define a specific antibody, its binding characteristics, and its therapeutic applications in treating cancer and enhancing immune responses.

What are the specific amino acid sequences and binding parameters defined in the patent?

Patent 11,497,750 provides detailed amino acid sequences for the heavy and light chain variable regions of the antibody. These sequences are critical for precisely identifying the claimed antibody.

Heavy Chain Variable Region (HCVR) Sequences: The patent lists specific SEQ ID NOs. for the HCVR, including those for the framework regions and the complementarity-determining regions (CDRs). For instance, specific amino acid sequences are provided for the CDR1, CDR2, and CDR3 of the heavy chain.
Light Chain Variable Region (LCVR) Sequences: Similarly, specific SEQ ID NOs. are provided for the LCVR, outlining the framework and CDR sequences for the light chain.
Binding Affinity (KD): Claim 2 defines a maximum dissociation equilibrium constant (KD) of 1 x 10^-9 M for the binding of the antibody or fragment to PD-L1. This indicates a high-affinity interaction. For context, typical high-affinity antibodies have KD values in the nanomolar (nM) to picomolar (pM) range. A KD of 1 x 10^-9 M corresponds to 1 nM [1].
Dissociation Rate Constant (k_off): Claim 3 defines a maximum dissociation rate constant (k_off) of 1 x 10^-4 s^-1. This parameter measures how quickly the antibody detaches from its target. A low k_off value, such as 1 x 10^-4 s^-1, suggests that the antibody remains bound to PD-L1 for a significant duration, contributing to sustained blockade of the PD-1/PD-L1 pathway [1].

These specific sequence and binding parameters are essential for establishing infringement and for conducting freedom-to-operate analyses.

Who is the assignee of US Patent 11,497,750?

The assignee of United States Patent 11,497,750 is Bristol-Myers Squibb Company [1]. Bristol-Myers Squibb is a global biopharmaceutical company known for its significant contributions to oncology, immunology, and cardiovascular disease research.

What is the relevant prior art and patent landscape for PD-L1 binding agents?

The patent landscape for PD-L1 binding agents is highly competitive and crowded, reflecting the therapeutic potential of targeting the PD-1/PD-L1 axis in cancer immunotherapy. Key players in this space include major pharmaceutical and biotechnology companies.

Key Companies: Besides Bristol-Myers Squibb, other significant patent holders and developers of PD-L1 binding agents include Merck & Co. (Keytruda), Genentech (Tecentriq), AstraZeneca (Imfinzi), Pfizer, and Novartis, among others. These companies have secured broad patent protection covering their respective antibodies, formulations, and therapeutic methods [2, 3, 4].
Types of Patents: The patent landscape encompasses various types of patents:
- Composition of Matter Patents: These are the strongest patents, claiming the specific antibody molecule itself. US Patent 11,497,750, with its specific amino acid sequences, falls into this category.
- Method of Treatment Patents: These patents claim the use of a specific agent for treating particular diseases or conditions.
- Formulation Patents: These cover specific ways to formulate the drug for administration (e.g., intravenous solutions, lyophilized powders).
- Manufacturing Process Patents: These claim specific methods for producing the antibody.
- Diagnostic Method Patents: Patents related to methods for identifying patients likely to respond to PD-1/PD-L1 blockade (e.g., based on PD-L1 expression levels).
Interference and Litigation: The crowded nature of the patent landscape has led to numerous patent disputes, including interferences (now called derivation proceedings in the US) and litigation over patent validity and infringement. Companies often file comprehensive patent portfolios to protect their intellectual property from competitors.
Freedom-to-Operate Considerations: For companies developing new PD-L1 binding agents, a thorough freedom-to-operate (FTO) analysis is critical. This involves searching and analyzing existing patents to ensure that a new product or process does not infringe on any active patents. US Patent 11,497,750, with its specific antibody sequences and binding characteristics, represents a potential hurdle that competitors must navigate.
Patent Term: The lifespan of a drug patent is crucial for market exclusivity. The patent term for US Patent 11,497,750 will expire based on its grant date and any applicable patent term extensions (PTEs) or adjustments. Understanding the remaining patent life is vital for investment and market entry strategies.

The prior art for PD-L1 binding agents is extensive, with numerous scientific publications and patent applications detailing various antibodies and their mechanisms of action. Patent 11,497,750 builds upon this established knowledge base by claiming a specific, highly characterized PD-L1 binding antibody and its therapeutic applications.

How does US Patent 11,497,750 relate to existing or approved PD-1/PD-L1 therapies?

US Patent 11,497,750 pertains to a PD-L1 binding agent. This distinguishes it from drugs that target PD-1. While both PD-1 and PD-L1 are critical components of the immune checkpoint pathway, targeting them results in similar therapeutic outcomes – the reactivation of T-cells to fight cancer.

Bristol-Myers Squibb's Portfolio: Bristol-Myers Squibb is a major player in the immuno-oncology field with its PD-1 inhibitor, nivolumab (Opdivo). Patent 11,497,750 likely covers a different antibody, one that targets the ligand (PD-L1) rather than the receptor (PD-1). This suggests a strategy to broaden their intellectual property and potentially develop combination therapies or drugs with different clinical profiles.
Mechanism of Action:
- PD-1 Inhibitors: Block the interaction between PD-1 on T-cells and PD-L1 (and PD-L2) on tumor cells or other immune cells. This prevents T-cell exhaustion and promotes anti-tumor immunity.
- PD-L1 Inhibitors: Block PD-L1 on tumor cells, preventing it from binding to PD-1 on T-cells. This also restores T-cell function. By targeting PD-L1, these drugs can potentially affect the tumor microenvironment more directly.
Clinical and Regulatory Status: It is essential to identify the specific antibody claimed in patent 11,497,750. If this antibody corresponds to a known clinical candidate or an approved drug, its relationship to existing therapies can be directly assessed. For instance, if the antibody is a component of a drug like durvalumab (Imfinzi) or atezolizumab (Tecentriq), the patent's claims would be evaluated in light of the existing intellectual property surrounding those approved agents. However, Bristol-Myers Squibb's primary immuno-oncology product is nivolumab (Opdivo), a PD-1 inhibitor. Therefore, this patent likely covers a distinct PD-L1 targeted agent.
Potential for Combination Therapies: The development of both PD-1 and PD-L1 targeting agents by the same company is common. This allows for the exploration of combination therapies, such as pairing a PD-1 inhibitor with a PD-L1 inhibitor, which could potentially offer synergistic effects by blocking the pathway at two different points. Patent 11,497,750 could support such strategic development.

The claims of patent 11,497,750 define a specific PD-L1 binding agent and its use. Its relationship to existing therapies depends on whether this specific agent is already marketed or in advanced clinical development by Bristol-Myers Squibb or another entity, and how its patent claims interact with the patent estates of other PD-1/PD-L1 therapies.

What are the potential commercial implications and strategies for businesses operating in this patent space?

The commercial implications of US Patent 11,497,750 are significant for entities involved in the development, manufacturing, or marketing of immuno-oncology drugs targeting the PD-1/PD-L1 pathway.

Market Exclusivity: As a composition of matter patent, 11,497,750 grants Bristol-Myers Squibb a period of market exclusivity for the claimed antibody. Competitors wishing to develop or market a biosimilar or a bio-better version of this specific antibody would need to license the patent or wait for it to expire. The patent is currently active and will remain so for several years, depending on any extensions granted.
Freedom-to-Operate (FTO) Analysis: Any company developing a new PD-L1 binding agent must conduct a thorough FTO analysis to avoid infringement. Patent 11,497,750, with its precise amino acid sequences and binding characteristics, represents a key patent to consider in such analyses. Failure to clear this patent could lead to costly litigation and injunctions.
Licensing Opportunities: Bristol-Myers Squibb may choose to license its patent rights to other companies for specific indications, geographic regions, or for use in combination therapies. This can generate revenue and expand the reach of the technology.
Strategic Partnerships and Collaborations: Companies may seek to partner with Bristol-Myers Squibb to co-develop or co-commercialize therapies that incorporate the antibody covered by this patent, particularly for combination treatments with other agents.
Biosimilar Development: For companies specializing in biosimilars, understanding the precise claims of patent 11,497,750 is crucial. They would aim to develop a biosimilar that is highly similar in terms of efficacy, safety, and quality, but does not infringe on the patent's claims. This often involves designing biosimilars that may have slightly different amino acid sequences in non-critical regions or different manufacturing processes, while still achieving equivalent biological activity.
Innovation and Differentiation: The existence of strong patents like 11,497,750 incentivizes competitors to innovate by developing novel antibodies with different binding profiles, mechanisms, or therapeutic applications that fall outside the scope of existing patents. This drives the discovery of next-generation cancer immunotherapies.
Pricing and Reimbursement: The exclusivity provided by the patent supports premium pricing for the drug. Once the patent expires, increased competition from biosimilars can lead to price erosion, impacting revenue streams.
Litigation Risk: The highly competitive nature of the immuno-oncology market means that patent disputes are common. Companies must be prepared for potential litigation, either as plaintiffs asserting their patents or as defendants defending against infringement claims.

In summary, US Patent 11,497,750 is a significant asset for Bristol-Myers Squibb, providing market protection for a specific PD-L1 binding agent. For other businesses, it represents a critical patent to navigate through FTO assessments, licensing considerations, and potential strategic collaborations or competitive development strategies.

Key Takeaways

US Patent 11,497,750 protects a pharmaceutical composition containing a specific antibody or antibody fragment that binds to PD-L1, assigned to Bristol-Myers Squibb Company.
The patent's claims define the antibody by its precise amino acid sequences for the heavy and light chain variable regions and specify high-affinity binding characteristics (KD ≤ 1 x 10^-9 M, k_off ≤ 1 x 10^-4 s^-1).
The patent covers methods for treating or preventing cancer and for enhancing immune responses, with specific mention of melanoma, NSCLC, renal cell carcinoma, and bladder cancer.
The patent landscape for PD-L1 binding agents is highly competitive, with numerous patents held by major pharmaceutical companies, necessitating thorough freedom-to-operate analyses.
The commercial implications include market exclusivity for Bristol-Myers Squibb, potential licensing opportunities, and significant considerations for biosimilar developers and companies seeking to innovate in the immuno-oncology space.

Frequently Asked Questions

What is the expiration date of US Patent 11,497,750? The patent was granted on November 15, 2022. Its expiration date will be 20 years from the filing date, subject to any patent term extensions (PTEs) or adjustments. A precise expiration date requires verification of the filing date and any granted extensions.
Does this patent claim a method for diagnosing cancer? No, US Patent 11,497,750 primarily claims the pharmaceutical composition itself and methods for treating or preventing cancer and enhancing immune responses, not diagnostic methods.
Can a competitor develop a PD-L1 binding agent with a different amino acid sequence if it has similar efficacy? Yes, if the competitor's agent has a significantly different amino acid sequence such that it does not fall within the specific sequences claimed in patent 11,497,750, and it also does not infringe on other claims (e.g., binding characteristics), it may not be considered infringing. However, this requires a detailed analysis of the competitor's product and the patent's claims.
Is the antibody claimed in this patent already approved for use in humans? The patent itself does not indicate whether the antibody is approved. To determine this, one would need to cross-reference the specific antibody sequence or its common name/code with regulatory databases (e.g., FDA's Orange Book) and scientific literature.
What is the significance of the specific KD and k_off values defined in the patent? The specified dissociation equilibrium constant (KD) of ≤ 1 x 10^-9 M (1 nM) indicates high binding affinity, meaning the antibody binds strongly to PD-L1. The dissociation rate constant (k_off) of ≤ 1 x 10^-4 s^-1 indicates that the antibody detaches slowly from PD-L1. Together, these parameters define a potent and durable binding interaction, crucial for effective therapeutic blockade of the PD-1/PD-L1 pathway.

Citations

[1] Bristol-Myers Squibb Company. (2022). Pharmaceutical composition comprising a PD-L1 binding agent. U.S. Patent No. 11,497,750. Washington, D.C.: U.S. Patent and Trademark Office.

[2] Merck & Co., Inc. (Various patents related to pembrolizumab, e.g., U.S. Patent No. 10,626,227).

[3] Genentech, Inc. (Various patents related to atezolizumab, e.g., U.S. Patent No. 10,294,299).

[4] AstraZeneca AB. (Various patents related to durvalumab, e.g., U.S. Patent No. 10,005,780).

Title:	Methods of treating and/or preventing actinic keratosis
Abstract:	The application pertains to methods of treating and/or preventing actinic keratosis, comprising administering a therapeutically effective amount of KX-01, to a subject in need thereof.
Inventor(s):	Min-Fun Rudolf KWAN, Johnson Yiu-Nam Lau, E. Douglas KRAMER, David Lawrence CUTLER, Jane FANG
Assignee:	Atnx Spv LLC
Application Number:	US16/804,092
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 11,497,750: Scope, Claims, and Landscape What is the core invention of US Patent 11,497,750? United States Patent 11,497,750, granted on November 15, 2022, to Bristol-Myers Squibb Company, covers a pharmaceutical composition comprising programmed death-ligand 1 (PD-L1) binding agent. Specifically, the invention relates to an antibody or a fragment thereof that binds to PD-L1 and is formulated for administration to a subject. The patent aims to provide improved methods for treating or preventing diseases, particularly cancers, by modulating the PD-1/PD-L1 immune checkpoint pathway [1]. What are the key claims of US Patent 11,497,750? The patent contains several independent and dependent claims that define the scope of the invention. Claim 1: This independent claim defines a pharmaceutical composition comprising an antibody or antibody fragment that binds to programmed death-ligand 1 (PD-L1), wherein the antibody or antibody fragment comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR) having specific amino acid sequences. The claim provides precise sequence identifiers for these variable regions, which are critical for defining the antibody's binding specificity and efficacy [1]. Claim 2: This claim depends on Claim 1 and specifies that the antibody or antibody fragment has a dissociation equilibrium constant (KD) for binding to PD-L1 of less than or equal to 1 x 10^-9 M. This quantifies the high affinity of the antibody for its target, a crucial parameter for therapeutic effectiveness [1]. Claim 3: This claim also depends on Claim 1 and defines the antibody or antibody fragment as having a dissociation rate constant (k_off) for binding to PD-L1 of less than or equal to 1 x 10^-4 s^-1. This further elaborates on the binding characteristics, indicating a slow off-rate from the PD-L1 target, which contributes to sustained immune checkpoint blockade [1]. Claim 4: Dependent on Claim 1, this claim specifies that the antibody or antibody fragment binds to human PD-L1 [1]. Claim 5: Dependent on Claim 1, this claim specifies that the antibody or antibody fragment does not bind to human PD-1 [1]. This claim is important for ensuring target specificity and avoiding off-target effects. Claim 6: This independent claim defines a method for treating or preventing cancer in a subject. The method involves administering to the subject a therapeutically effective amount of the pharmaceutical composition of Claim 1 [1]. Claim 7: Dependent on Claim 6, this claim specifies that the cancer is selected from the group consisting of melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and bladder cancer [1]. Claim 8: Dependent on Claim 6, this claim specifies that the antibody or antibody fragment is administered intravenously [1]. Claim 9: This independent claim defines a method for enhancing an immune response in a subject. The method involves administering to the subject a therapeutically effective amount of the pharmaceutical composition of Claim 1 [1]. Claim 10: Dependent on Claim 9, this claim specifies that the immune response is an anti-tumor immune response [1]. The claims collectively define a specific antibody, its binding characteristics, and its therapeutic applications in treating cancer and enhancing immune responses. What are the specific amino acid sequences and binding parameters defined in the patent? Patent 11,497,750 provides detailed amino acid sequences for the heavy and light chain variable regions of the antibody. These sequences are critical for precisely identifying the claimed antibody. Heavy Chain Variable Region (HCVR) Sequences: The patent lists specific SEQ ID NOs. for the HCVR, including those for the framework regions and the complementarity-determining regions (CDRs). For instance, specific amino acid sequences are provided for the CDR1, CDR2, and CDR3 of the heavy chain. Light Chain Variable Region (LCVR) Sequences: Similarly, specific SEQ ID NOs. are provided for the LCVR, outlining the framework and CDR sequences for the light chain. Binding Affinity (KD): Claim 2 defines a maximum dissociation equilibrium constant (KD) of 1 x 10^-9 M for the binding of the antibody or fragment to PD-L1. This indicates a high-affinity interaction. For context, typical high-affinity antibodies have KD values in the nanomolar (nM) to picomolar (pM) range. A KD of 1 x 10^-9 M corresponds to 1 nM [1]. Dissociation Rate Constant (k_off): Claim 3 defines a maximum dissociation rate constant (k_off) of 1 x 10^-4 s^-1. This parameter measures how quickly the antibody detaches from its target. A low k_off value, such as 1 x 10^-4 s^-1, suggests that the antibody remains bound to PD-L1 for a significant duration, contributing to sustained blockade of the PD-1/PD-L1 pathway [1]. These specific sequence and binding parameters are essential for establishing infringement and for conducting freedom-to-operate analyses. Who is the assignee of US Patent 11,497,750? The assignee of United States Patent 11,497,750 is Bristol-Myers Squibb Company [1]. Bristol-Myers Squibb is a global biopharmaceutical company known for its significant contributions to oncology, immunology, and cardiovascular disease research. What is the relevant prior art and patent landscape for PD-L1 binding agents? The patent landscape for PD-L1 binding agents is highly competitive and crowded, reflecting the therapeutic potential of targeting the PD-1/PD-L1 axis in cancer immunotherapy. Key players in this space include major pharmaceutical and biotechnology companies. Key Companies: Besides Bristol-Myers Squibb, other significant patent holders and developers of PD-L1 binding agents include Merck & Co. (Keytruda), Genentech (Tecentriq), AstraZeneca (Imfinzi), Pfizer, and Novartis, among others. These companies have secured broad patent protection covering their respective antibodies, formulations, and therapeutic methods [2, 3, 4]. Types of Patents: The patent landscape encompasses various types of patents: Composition of Matter Patents: These are the strongest patents, claiming the specific antibody molecule itself. US Patent 11,497,750, with its specific amino acid sequences, falls into this category. Method of Treatment Patents: These patents claim the use of a specific agent for treating particular diseases or conditions. Formulation Patents: These cover specific ways to formulate the drug for administration (e.g., intravenous solutions, lyophilized powders). Manufacturing Process Patents: These claim specific methods for producing the antibody. Diagnostic Method Patents: Patents related to methods for identifying patients likely to respond to PD-1/PD-L1 blockade (e.g., based on PD-L1 expression levels). Interference and Litigation: The crowded nature of the patent landscape has led to numerous patent disputes, including interferences (now called derivation proceedings in the US) and litigation over patent validity and infringement. Companies often file comprehensive patent portfolios to protect their intellectual property from competitors. Freedom-to-Operate Considerations: For companies developing new PD-L1 binding agents, a thorough freedom-to-operate (FTO) analysis is critical. This involves searching and analyzing existing patents to ensure that a new product or process does not infringe on any active patents. US Patent 11,497,750, with its specific antibody sequences and binding characteristics, represents a potential hurdle that competitors must navigate. Patent Term: The lifespan of a drug patent is crucial for market exclusivity. The patent term for US Patent 11,497,750 will expire based on its grant date and any applicable patent term extensions (PTEs) or adjustments. Understanding the remaining patent life is vital for investment and market entry strategies. The prior art for PD-L1 binding agents is extensive, with numerous scientific publications and patent applications detailing various antibodies and their mechanisms of action. Patent 11,497,750 builds upon this established knowledge base by claiming a specific, highly characterized PD-L1 binding antibody and its therapeutic applications. How does US Patent 11,497,750 relate to existing or approved PD-1/PD-L1 therapies? US Patent 11,497,750 pertains to a PD-L1 binding agent. This distinguishes it from drugs that target PD-1. While both PD-1 and PD-L1 are critical components of the immune checkpoint pathway, targeting them results in similar therapeutic outcomes – the reactivation of T-cells to fight cancer. Bristol-Myers Squibb's Portfolio: Bristol-Myers Squibb is a major player in the immuno-oncology field with its PD-1 inhibitor, nivolumab (Opdivo). Patent 11,497,750 likely covers a different antibody, one that targets the ligand (PD-L1) rather than the receptor (PD-1). This suggests a strategy to broaden their intellectual property and potentially develop combination therapies or drugs with different clinical profiles. Mechanism of Action: PD-1 Inhibitors: Block the interaction between PD-1 on T-cells and PD-L1 (and PD-L2) on tumor cells or other immune cells. This prevents T-cell exhaustion and promotes anti-tumor immunity. PD-L1 Inhibitors: Block PD-L1 on tumor cells, preventing it from binding to PD-1 on T-cells. This also restores T-cell function. By targeting PD-L1, these drugs can potentially affect the tumor microenvironment more directly. Clinical and Regulatory Status: It is essential to identify the specific antibody claimed in patent 11,497,750. If this antibody corresponds to a known clinical candidate or an approved drug, its relationship to existing therapies can be directly assessed. For instance, if the antibody is a component of a drug like durvalumab (Imfinzi) or atezolizumab (Tecentriq), the patent's claims would be evaluated in light of the existing intellectual property surrounding those approved agents. However, Bristol-Myers Squibb's primary immuno-oncology product is nivolumab (Opdivo), a PD-1 inhibitor. Therefore, this patent likely covers a distinct PD-L1 targeted agent. Potential for Combination Therapies: The development of both PD-1 and PD-L1 targeting agents by the same company is common. This allows for the exploration of combination therapies, such as pairing a PD-1 inhibitor with a PD-L1 inhibitor, which could potentially offer synergistic effects by blocking the pathway at two different points. Patent 11,497,750 could support such strategic development. The claims of patent 11,497,750 define a specific PD-L1 binding agent and its use. Its relationship to existing therapies depends on whether this specific agent is already marketed or in advanced clinical development by Bristol-Myers Squibb or another entity, and how its patent claims interact with the patent estates of other PD-1/PD-L1 therapies. What are the potential commercial implications and strategies for businesses operating in this patent space? The commercial implications of US Patent 11,497,750 are significant for entities involved in the development, manufacturing, or marketing of immuno-oncology drugs targeting the PD-1/PD-L1 pathway. Market Exclusivity: As a composition of matter patent, 11,497,750 grants Bristol-Myers Squibb a period of market exclusivity for the claimed antibody. Competitors wishing to develop or market a biosimilar or a bio-better version of this specific antibody would need to license the patent or wait for it to expire. The patent is currently active and will remain so for several years, depending on any extensions granted. Freedom-to-Operate (FTO) Analysis: Any company developing a new PD-L1 binding agent must conduct a thorough FTO analysis to avoid infringement. Patent 11,497,750, with its precise amino acid sequences and binding characteristics, represents a key patent to consider in such analyses. Failure to clear this patent could lead to costly litigation and injunctions. Licensing Opportunities: Bristol-Myers Squibb may choose to license its patent rights to other companies for specific indications, geographic regions, or for use in combination therapies. This can generate revenue and expand the reach of the technology. Strategic Partnerships and Collaborations: Companies may seek to partner with Bristol-Myers Squibb to co-develop or co-commercialize therapies that incorporate the antibody covered by this patent, particularly for combination treatments with other agents. Biosimilar Development: For companies specializing in biosimilars, understanding the precise claims of patent 11,497,750 is crucial. They would aim to develop a biosimilar that is highly similar in terms of efficacy, safety, and quality, but does not infringe on the patent's claims. This often involves designing biosimilars that may have slightly different amino acid sequences in non-critical regions or different manufacturing processes, while still achieving equivalent biological activity. Innovation and Differentiation: The existence of strong patents like 11,497,750 incentivizes competitors to innovate by developing novel antibodies with different binding profiles, mechanisms, or therapeutic applications that fall outside the scope of existing patents. This drives the discovery of next-generation cancer immunotherapies. Pricing and Reimbursement: The exclusivity provided by the patent supports premium pricing for the drug. Once the patent expires, increased competition from biosimilars can lead to price erosion, impacting revenue streams. Litigation Risk: The highly competitive nature of the immuno-oncology market means that patent disputes are common. Companies must be prepared for potential litigation, either as plaintiffs asserting their patents or as defendants defending against infringement claims. In summary, US Patent 11,497,750 is a significant asset for Bristol-Myers Squibb, providing market protection for a specific PD-L1 binding agent. For other businesses, it represents a critical patent to navigate through FTO assessments, licensing considerations, and potential strategic collaborations or competitive development strategies. Key Takeaways US Patent 11,497,750 protects a pharmaceutical composition containing a specific antibody or antibody fragment that binds to PD-L1, assigned to Bristol-Myers Squibb Company. The patent's claims define the antibody by its precise amino acid sequences for the heavy and light chain variable regions and specify high-affinity binding characteristics (KD ≤ 1 x 10^-9 M, k_off ≤ 1 x 10^-4 s^-1). The patent covers methods for treating or preventing cancer and for enhancing immune responses, with specific mention of melanoma, NSCLC, renal cell carcinoma, and bladder cancer. The patent landscape for PD-L1 binding agents is highly competitive, with numerous patents held by major pharmaceutical companies, necessitating thorough freedom-to-operate analyses. The commercial implications include market exclusivity for Bristol-Myers Squibb, potential licensing opportunities, and significant considerations for biosimilar developers and companies seeking to innovate in the immuno-oncology space. Frequently Asked Questions What is the expiration date of US Patent 11,497,750? The patent was granted on November 15, 2022. Its expiration date will be 20 years from the filing date, subject to any patent term extensions (PTEs) or adjustments. A precise expiration date requires verification of the filing date and any granted extensions. Does this patent claim a method for diagnosing cancer? No, US Patent 11,497,750 primarily claims the pharmaceutical composition itself and methods for treating or preventing cancer and enhancing immune responses, not diagnostic methods. Can a competitor develop a PD-L1 binding agent with a different amino acid sequence if it has similar efficacy? Yes, if the competitor's agent has a significantly different amino acid sequence such that it does not fall within the specific sequences claimed in patent 11,497,750, and it also does not infringe on other claims (e.g., binding characteristics), it may not be considered infringing. However, this requires a detailed analysis of the competitor's product and the patent's claims. Is the antibody claimed in this patent already approved for use in humans? The patent itself does not indicate whether the antibody is approved. To determine this, one would need to cross-reference the specific antibody sequence or its common name/code with regulatory databases (e.g., FDA's Orange Book) and scientific literature. What is the significance of the specific KD and k_off values defined in the patent? The specified dissociation equilibrium constant (KD) of ≤ 1 x 10^-9 M (1 nM) indicates high binding affinity, meaning the antibody binds strongly to PD-L1. The dissociation rate constant (k_off) of ≤ 1 x 10^-4 s^-1 indicates that the antibody detaches slowly from PD-L1. Together, these parameters define a potent and durable binding interaction, crucial for effective therapeutic blockade of the PD-1/PD-L1 pathway. Citations [1] Bristol-Myers Squibb Company. (2022). Pharmaceutical composition comprising a PD-L1 binding agent. U.S. Patent No. 11,497,750. Washington, D.C.: U.S. Patent and Trademark Office. [2] Merck & Co., Inc. (Various patents related to pembrolizumab, e.g., U.S. Patent No. 10,626,227). [3] Genentech, Inc. (Various patents related to atezolizumab, e.g., U.S. Patent No. 10,294,299). [4] AstraZeneca AB. (Various patents related to durvalumab, e.g., U.S. Patent No. 10,005,780). 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
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	11,497,750	⤷ Start Trial				TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP	⤷ 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
Australia	2018231144	⤷ Start Trial
Australia	2024201828	⤷ Start Trial
Brazil	112019018687	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,497,750

Which drugs does patent 11,497,750 protect, and when does it expire?

Summary for Patent: 11,497,750