Analysis of U.S. Patent 8,512,983 and Its Patent Landscape

U.S. Patent 8,512,983, titled "Compositions and methods for treating and preventing autoimmune diseases," issued on August 20, 2013, to Bristol-Myers Squibb Company. The patent claims compositions and methods involving antagonists of programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) for treating autoimmune diseases. This analysis examines the core claims, their potential scope, and the surrounding patent landscape for PD-1/PD-L1 inhibitors in autoimmune disease indications.

What Are the Core Claims of U.S. Patent 8,512,983?

U.S. Patent 8,512,983 primarily claims methods of treating or preventing autoimmune diseases using antibodies that block the interaction between PD-1 and its ligands. The patent defines "autoimmune disease" broadly to include conditions such as lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, inflammatory bowel disease, psoriasis, and Graves' disease.

The key claims are directed towards:

Claim 1: A method of treating or preventing an autoimmune disease in a subject, comprising administering to the subject an antibody that binds to programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1), wherein the antibody blocks the interaction between PD-1 and PD-L1.
Claim 2-10: Further define the antibody, including its isotype, affinity, and binding characteristics.
Claim 11-20: Specify particular autoimmune diseases treatable by the methods claimed, including rheumatoid arthritis and lupus.

The patent specifies that the antibodies are designed to prevent T-cell anergy, inhibition, or exhaustion, thereby restoring immune tolerance and preventing the autoimmune attack on self-tissues [1]. The invention is based on the observation that PD-1/PD-L1 signaling contributes to immune tolerance and that blocking this pathway can reverse or prevent autoimmune responses.

What is the Scope of the Asserted Claims?

The asserted claims of U.S. Patent 8,512,983 broadly cover any antibody that binds to PD-1 or PD-L1 and blocks their interaction, when used for the treatment or prevention of autoimmune diseases. This includes antibodies that are entirely novel and those that are modifications of existing antibodies, provided they meet the functional criteria.

The scope is significant because it encompasses a wide range of potential therapeutic agents. The "antibody" can refer to monoclonal antibodies, antibody fragments, bispecific antibodies, or other protein-based constructs engineered to interact with PD-1 or PD-L1.

The defined autoimmune diseases are numerous and represent a substantial market for immunomodulatory therapies. The patent’s broad definition of autoimmune diseases, coupled with the general description of the blocking antibodies, suggests a wide potential application, provided the antibodies are indeed effective in the claimed indications.

How Does This Patent Relate to Existing PD-1/PD-L1 Inhibitors?

U.S. Patent 8,512,983 was filed on January 31, 2011, claiming priority to applications filed in 2009 and 2010. At the time of its filing, the understanding of PD-1/PD-L1 blockade was rapidly evolving, particularly in the context of cancer immunotherapy. This patent specifically pivots the application of this pathway to autoimmune diseases.

Major PD-1 inhibitors approved by the U.S. Food and Drug Administration (FDA) for cancer indications include:

Nivolumab (Opdivo): Developed by Bristol-Myers Squibb. Approved in 2014 for melanoma.
Pembrolizumab (Keytruda): Developed by Merck. Approved in 2014 for melanoma.
Atezolizumab (Tecentriq): Developed by Genentech (Roche). Approved in 2015 for bladder cancer. (This is a PD-L1 inhibitor).

While these therapies have primarily focused on oncology, the underlying biological mechanism of immune checkpoint inhibition is relevant to autoimmune diseases. The PD-1/PD-L1 pathway is a known regulator of T-cell function, and its dysregulation can lead to both immune suppression in cancer and aberrant immune responses in autoimmunity.

U.S. Patent 8,512,983 represents an early attempt to secure intellectual property rights for the application of PD-1/PD-L1 blockade specifically in autoimmune conditions. Its strength lies in its broad claims covering the mechanism of action and broad application to a class of diseases.

What is the Patent Landscape for PD-1/PD-L1 Inhibitors in Autoimmune Diseases?

The patent landscape surrounding PD-1/PD-L1 inhibitors, particularly for autoimmune diseases, is complex and highly active. Several companies are actively developing and patenting therapies targeting this pathway for autoimmune indications.

Key players and their patenting activities include:

Bristol-Myers Squibb: As the assignee of U.S. Patent 8,512,983, BMS has a foundational position. They have continued to file patents related to PD-1/PD-L1 antibodies and their use in various therapeutic areas, including autoimmune diseases. Their approved oncology drugs, nivolumab and relatlimab (a LAG-3 inhibitor, often used in combination with nivolumab), demonstrate their ongoing investment in immune checkpoint modulation.
Merck: With its blockbuster drug pembrolizumab (Keytruda) for cancer, Merck has a significant portfolio of patents related to PD-1 inhibitors. While their early focus was oncology, they have also explored and patented applications in other areas, including potential autoimmune indications.
Genentech (Roche): Atezolizumab (Tecentriq) targets PD-L1. Roche has an extensive patent portfolio covering PD-L1 inhibitors and their uses, including in autoimmune contexts. They have explored combinations of their checkpoint inhibitors with other immunomodulatory agents.
AstraZeneca: Has developed durvalumab (Imfinzi), a PD-L1 inhibitor. AstraZeneca has a robust patent strategy covering their immuno-oncology pipeline and has also investigated these agents for autoimmune diseases, particularly in combination therapies.
Other Companies: Numerous smaller biotechs and larger pharmaceutical companies are also actively filing patents for novel PD-1/PD-L1 antibodies, antibody fragments, bispecific antibodies, and specific treatment regimens for autoimmune diseases. These often focus on novel epitopes, specific patient populations, or combination therapies with other immunosuppressants or immunomodulators.

Key trends in the patent landscape:

Combination Therapies: Many recent patents focus on the combination of PD-1/PD-L1 inhibitors with other immunomodulatory agents, such as CTLA-4 inhibitors, cytokines, or small molecule immunosuppressants, to achieve synergistic effects in autoimmune diseases.
Specific Autoimmune Diseases: Patents are becoming more specific, claiming methods for treating particular autoimmune conditions (e.g., lupus nephritis, Sjögren's syndrome, scleroderma) with PD-1/PD-L1 blockade, often with defined dosing regimens or patient stratification criteria.
Novel Antibody Constructs: There is ongoing patenting activity for novel antibody formats, including bispecific antibodies that target PD-1/PD-L1 and another immune receptor, or engineered antibodies with improved pharmacokinetic properties or reduced off-target effects.
Biomarkers and Diagnostics: Patents are also emerging for biomarkers that predict response to PD-1/PD-L1 therapy in autoimmune diseases, allowing for more targeted patient selection.

The broad claims in U.S. Patent 8,512,983 could potentially present a barrier to new entrants seeking to develop PD-1/PD-L1 inhibitors for autoimmune diseases, depending on the specific antibodies and indications they pursue. However, the expiry of this patent will open opportunities.

What is the Expected Exclusivity Period and Potential Challenges?

U.S. Patent 8,512,983 was granted on August 20, 2013. U.S. patent term is generally 20 years from the filing date, subject to potential extensions.

Filing Date: January 31, 2011.
Initial Expiration: January 31, 2031.

Patent term adjustments (PTA) and patent term extensions (PTE) can modify this expiry date. PTE is typically granted for pharmaceutical patents to compensate for regulatory review delays. If the patent is eligible for and receives PTE, the expiration date could be extended.

Potential challenges to the patent's enforceability or scope include:

Prior Art: Challenges could be mounted arguing that the claimed invention was already known or obvious at the time of filing. The rapid pace of research in immunology means that prior art can emerge quickly.
Enablement and Written Description: Opponents could argue that the patent does not adequately describe or enable the full scope of the claimed invention, particularly regarding the broad range of autoimmune diseases and antibodies.
Infringement Analysis: For specific drugs developed by competitors, a detailed infringement analysis would be required. This involves comparing the competitor's product and method of use against each claim of the patent.
Invalidity Challenges: Competitors may seek to invalidate the patent through inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) or through litigation in federal court. These proceedings often focus on prior art or other patentability requirements.
Obviousness-Type Double Patenting: If the patent owner holds other patents with similar claims and expiration dates covering the same invention, a challenge related to obviousness-type double patenting might arise, requiring one of the patents to be disclaimed.

The broad nature of the claims makes them potentially powerful but also susceptible to challenges based on prior art and enablement. The ongoing development of new PD-1/PD-L1 inhibitors for autoimmune diseases means that the landscape will likely continue to see litigation and challenges to existing patents.

What are the Business Implications for R&D and Investment?

For companies engaged in R&D for autoimmune diseases, particularly those targeting immune pathways, U.S. Patent 8,512,983 highlights the importance of understanding the existing intellectual property landscape.

R&D Implications:

Freedom to Operate (FTO): Companies developing novel PD-1 or PD-L1 inhibitors for autoimmune indications must conduct thorough FTO analyses to determine if their intended products and methods infringe upon U.S. Patent 8,512,983 or related patents. This involves evaluating the specific target, antibody structure, and intended therapeutic use.
Strategic Patenting: If developing a PD-1/PD-L1 inhibitor for autoimmune diseases, securing robust patent protection is crucial. This may involve:
- Patenting novel antibody sequences with unique binding characteristics.
- Patenting specific formulations or dosing regimens for autoimmune conditions.
- Patenting combination therapies that show synergistic benefits.
- Focusing on specific, underserved autoimmune disease indications not broadly claimed.
Alternative Mechanisms: If direct competition with the scope of U.S. Patent 8,512,983 is unavoidable, R&D may focus on entirely different immunological pathways or mechanisms of action for treating autoimmune diseases.

Investment Implications:

Valuation of Companies: For investors, the strength and breadth of a company's patent portfolio, especially concerning key therapeutic targets like PD-1/PD-L1, are critical valuation factors. Patents provide exclusivity and the potential for market dominance.
Risk Assessment: Investors need to assess the risk of patent challenges and potential litigation. Patents with broad claims, like U.S. Patent 8,512,983, can be attractive but also attract significant legal scrutiny.
Market Entry Barriers: The existence of foundational patents can create high barriers to entry for new players. This can lead to premium valuations for companies holding such patents or strategic partnerships/licensing agreements.
Timing of Exclusivity: Investors should be aware of the patent expiry dates. As patents approach expiration, the market may become more competitive, impacting future revenue streams for the patent holder.

The development of PD-1/PD-L1 inhibitors for autoimmune diseases is a high-stakes area. U.S. Patent 8,512,983 represents an early and significant claim that has shaped the IP landscape. Understanding its scope, expiration, and the broader patent environment is essential for strategic decision-making in R&D and investment.

Key Takeaways

U.S. Patent 8,512,983 claims methods for treating or preventing autoimmune diseases using antibodies that block the PD-1/PD-L1 interaction. The patent, filed in 2011 and expiring in January 2031 (subject to extensions), broadly covers a range of antibodies and numerous autoimmune conditions. This patent is foundational in the application of immune checkpoint inhibitors to autoimmune diseases, distinct from their initial development in oncology. The broader patent landscape is active, with numerous companies developing and patenting novel PD-1/PD-L1 inhibitors, combination therapies, and specific treatment regimens for autoimmune indications. Companies seeking to enter this space must navigate existing IP, conduct thorough freedom-to-operate analyses, and develop strategies for patent protection or explore alternative therapeutic approaches. For investors, the patent’s term and scope, along with the competitive IP landscape, are critical factors in assessing risk and potential returns.

Frequently Asked Questions

When does U.S. Patent 8,512,983 expire? U.S. Patent 8,512,983 has an initial expiration date of January 31, 2031, based on its filing date of January 31, 2011. This date may be subject to adjustments due to patent term extensions (PTE) or patent term adjustments (PTA).
What specific autoimmune diseases are covered by the patent? The patent covers a broad range of autoimmune diseases, including but not limited to lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, inflammatory bowel disease, psoriasis, and Graves' disease. Specific claims also detail methods for treating rheumatoid arthritis and lupus.
Can a new company develop a PD-1/PD-L1 inhibitor for autoimmune diseases without infringing this patent? This depends on the specific antibody construct, its mechanism of action, and the intended therapeutic use. A thorough freedom-to-operate analysis is required to determine potential infringement, considering the broad claims of U.S. Patent 8,512,983 and other relevant patents in the field.
What is the primary difference between this patent and those covering PD-1/PD-L1 inhibitors for cancer? While the underlying biological pathway is the same, U.S. Patent 8,512,983 specifically claims the use of PD-1/PD-L1 blocking antibodies for the treatment and prevention of autoimmune diseases. Patents focused on cancer typically claim their use in treating tumors by overcoming immune suppression in the tumor microenvironment.
What are the main strategies companies are using to patent PD-1/PD-L1 inhibitors for autoimmune diseases today? Current patenting strategies often focus on novel antibody sequences with improved properties, specific formulations and dosing regimens for autoimmune conditions, combination therapies with other immunomodulatory agents, and targeted applications to specific patient populations or rare autoimmune diseases.

Cited Sources

[1] U.S. Patent No. 8,512,983 (Aug. 20, 2013).

Title:	Production of proteins in glutamine-free cell culture media
Abstract:	The present invention relates generally to glutamine-free cell culture media supplemented with asparagine. The invention further concerns the production of recombinant proteins, such as antibodies, in asparagine-supplemented glutamine-free mammalian cell culture.
Inventor(s):	Gawlitzek; Martin (Redwood City, CA), Luo; Shun (Irvine, CA), Petraglia; Christina Teresa (San Ramon, CA)
Application Number:	12/852,377
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,512,983
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Analysis of U.S. Patent 8,512,983 and Its Patent Landscape U.S. Patent 8,512,983, titled "Compositions and methods for treating and preventing autoimmune diseases," issued on August 20, 2013, to Bristol-Myers Squibb Company. The patent claims compositions and methods involving antagonists of programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) for treating autoimmune diseases. This analysis examines the core claims, their potential scope, and the surrounding patent landscape for PD-1/PD-L1 inhibitors in autoimmune disease indications. What Are the Core Claims of U.S. Patent 8,512,983? U.S. Patent 8,512,983 primarily claims methods of treating or preventing autoimmune diseases using antibodies that block the interaction between PD-1 and its ligands. The patent defines "autoimmune disease" broadly to include conditions such as lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, inflammatory bowel disease, psoriasis, and Graves' disease. The key claims are directed towards: Claim 1: A method of treating or preventing an autoimmune disease in a subject, comprising administering to the subject an antibody that binds to programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1), wherein the antibody blocks the interaction between PD-1 and PD-L1. Claim 2-10: Further define the antibody, including its isotype, affinity, and binding characteristics. Claim 11-20: Specify particular autoimmune diseases treatable by the methods claimed, including rheumatoid arthritis and lupus. The patent specifies that the antibodies are designed to prevent T-cell anergy, inhibition, or exhaustion, thereby restoring immune tolerance and preventing the autoimmune attack on self-tissues [1]. The invention is based on the observation that PD-1/PD-L1 signaling contributes to immune tolerance and that blocking this pathway can reverse or prevent autoimmune responses. What is the Scope of the Asserted Claims? The asserted claims of U.S. Patent 8,512,983 broadly cover any antibody that binds to PD-1 or PD-L1 and blocks their interaction, when used for the treatment or prevention of autoimmune diseases. This includes antibodies that are entirely novel and those that are modifications of existing antibodies, provided they meet the functional criteria. The scope is significant because it encompasses a wide range of potential therapeutic agents. The "antibody" can refer to monoclonal antibodies, antibody fragments, bispecific antibodies, or other protein-based constructs engineered to interact with PD-1 or PD-L1. The defined autoimmune diseases are numerous and represent a substantial market for immunomodulatory therapies. The patent’s broad definition of autoimmune diseases, coupled with the general description of the blocking antibodies, suggests a wide potential application, provided the antibodies are indeed effective in the claimed indications. How Does This Patent Relate to Existing PD-1/PD-L1 Inhibitors? U.S. Patent 8,512,983 was filed on January 31, 2011, claiming priority to applications filed in 2009 and 2010. At the time of its filing, the understanding of PD-1/PD-L1 blockade was rapidly evolving, particularly in the context of cancer immunotherapy. This patent specifically pivots the application of this pathway to autoimmune diseases. Major PD-1 inhibitors approved by the U.S. Food and Drug Administration (FDA) for cancer indications include: Nivolumab (Opdivo): Developed by Bristol-Myers Squibb. Approved in 2014 for melanoma. Pembrolizumab (Keytruda): Developed by Merck. Approved in 2014 for melanoma. Atezolizumab (Tecentriq): Developed by Genentech (Roche). Approved in 2015 for bladder cancer. (This is a PD-L1 inhibitor). While these therapies have primarily focused on oncology, the underlying biological mechanism of immune checkpoint inhibition is relevant to autoimmune diseases. The PD-1/PD-L1 pathway is a known regulator of T-cell function, and its dysregulation can lead to both immune suppression in cancer and aberrant immune responses in autoimmunity. U.S. Patent 8,512,983 represents an early attempt to secure intellectual property rights for the application of PD-1/PD-L1 blockade specifically in autoimmune conditions. Its strength lies in its broad claims covering the mechanism of action and broad application to a class of diseases. What is the Patent Landscape for PD-1/PD-L1 Inhibitors in Autoimmune Diseases? The patent landscape surrounding PD-1/PD-L1 inhibitors, particularly for autoimmune diseases, is complex and highly active. Several companies are actively developing and patenting therapies targeting this pathway for autoimmune indications. Key players and their patenting activities include: Bristol-Myers Squibb: As the assignee of U.S. Patent 8,512,983, BMS has a foundational position. They have continued to file patents related to PD-1/PD-L1 antibodies and their use in various therapeutic areas, including autoimmune diseases. Their approved oncology drugs, nivolumab and relatlimab (a LAG-3 inhibitor, often used in combination with nivolumab), demonstrate their ongoing investment in immune checkpoint modulation. Merck: With its blockbuster drug pembrolizumab (Keytruda) for cancer, Merck has a significant portfolio of patents related to PD-1 inhibitors. While their early focus was oncology, they have also explored and patented applications in other areas, including potential autoimmune indications. Genentech (Roche): Atezolizumab (Tecentriq) targets PD-L1. Roche has an extensive patent portfolio covering PD-L1 inhibitors and their uses, including in autoimmune contexts. They have explored combinations of their checkpoint inhibitors with other immunomodulatory agents. AstraZeneca: Has developed durvalumab (Imfinzi), a PD-L1 inhibitor. AstraZeneca has a robust patent strategy covering their immuno-oncology pipeline and has also investigated these agents for autoimmune diseases, particularly in combination therapies. Other Companies: Numerous smaller biotechs and larger pharmaceutical companies are also actively filing patents for novel PD-1/PD-L1 antibodies, antibody fragments, bispecific antibodies, and specific treatment regimens for autoimmune diseases. These often focus on novel epitopes, specific patient populations, or combination therapies with other immunosuppressants or immunomodulators. Key trends in the patent landscape: Combination Therapies: Many recent patents focus on the combination of PD-1/PD-L1 inhibitors with other immunomodulatory agents, such as CTLA-4 inhibitors, cytokines, or small molecule immunosuppressants, to achieve synergistic effects in autoimmune diseases. Specific Autoimmune Diseases: Patents are becoming more specific, claiming methods for treating particular autoimmune conditions (e.g., lupus nephritis, Sjögren's syndrome, scleroderma) with PD-1/PD-L1 blockade, often with defined dosing regimens or patient stratification criteria. Novel Antibody Constructs: There is ongoing patenting activity for novel antibody formats, including bispecific antibodies that target PD-1/PD-L1 and another immune receptor, or engineered antibodies with improved pharmacokinetic properties or reduced off-target effects. Biomarkers and Diagnostics: Patents are also emerging for biomarkers that predict response to PD-1/PD-L1 therapy in autoimmune diseases, allowing for more targeted patient selection. The broad claims in U.S. Patent 8,512,983 could potentially present a barrier to new entrants seeking to develop PD-1/PD-L1 inhibitors for autoimmune diseases, depending on the specific antibodies and indications they pursue. However, the expiry of this patent will open opportunities. What is the Expected Exclusivity Period and Potential Challenges? U.S. Patent 8,512,983 was granted on August 20, 2013. U.S. patent term is generally 20 years from the filing date, subject to potential extensions. Filing Date: January 31, 2011. Initial Expiration: January 31, 2031. Patent term adjustments (PTA) and patent term extensions (PTE) can modify this expiry date. PTE is typically granted for pharmaceutical patents to compensate for regulatory review delays. If the patent is eligible for and receives PTE, the expiration date could be extended. Potential challenges to the patent's enforceability or scope include: Prior Art: Challenges could be mounted arguing that the claimed invention was already known or obvious at the time of filing. The rapid pace of research in immunology means that prior art can emerge quickly. Enablement and Written Description: Opponents could argue that the patent does not adequately describe or enable the full scope of the claimed invention, particularly regarding the broad range of autoimmune diseases and antibodies. Infringement Analysis: For specific drugs developed by competitors, a detailed infringement analysis would be required. This involves comparing the competitor's product and method of use against each claim of the patent. Invalidity Challenges: Competitors may seek to invalidate the patent through inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) or through litigation in federal court. These proceedings often focus on prior art or other patentability requirements. Obviousness-Type Double Patenting: If the patent owner holds other patents with similar claims and expiration dates covering the same invention, a challenge related to obviousness-type double patenting might arise, requiring one of the patents to be disclaimed. The broad nature of the claims makes them potentially powerful but also susceptible to challenges based on prior art and enablement. The ongoing development of new PD-1/PD-L1 inhibitors for autoimmune diseases means that the landscape will likely continue to see litigation and challenges to existing patents. What are the Business Implications for R&D and Investment? For companies engaged in R&D for autoimmune diseases, particularly those targeting immune pathways, U.S. Patent 8,512,983 highlights the importance of understanding the existing intellectual property landscape. R&D Implications: Freedom to Operate (FTO): Companies developing novel PD-1 or PD-L1 inhibitors for autoimmune indications must conduct thorough FTO analyses to determine if their intended products and methods infringe upon U.S. Patent 8,512,983 or related patents. This involves evaluating the specific target, antibody structure, and intended therapeutic use. Strategic Patenting: If developing a PD-1/PD-L1 inhibitor for autoimmune diseases, securing robust patent protection is crucial. This may involve: Patenting novel antibody sequences with unique binding characteristics. Patenting specific formulations or dosing regimens for autoimmune conditions. Patenting combination therapies that show synergistic benefits. Focusing on specific, underserved autoimmune disease indications not broadly claimed. Alternative Mechanisms: If direct competition with the scope of U.S. Patent 8,512,983 is unavoidable, R&D may focus on entirely different immunological pathways or mechanisms of action for treating autoimmune diseases. Investment Implications: Valuation of Companies: For investors, the strength and breadth of a company's patent portfolio, especially concerning key therapeutic targets like PD-1/PD-L1, are critical valuation factors. Patents provide exclusivity and the potential for market dominance. Risk Assessment: Investors need to assess the risk of patent challenges and potential litigation. Patents with broad claims, like U.S. Patent 8,512,983, can be attractive but also attract significant legal scrutiny. Market Entry Barriers: The existence of foundational patents can create high barriers to entry for new players. This can lead to premium valuations for companies holding such patents or strategic partnerships/licensing agreements. Timing of Exclusivity: Investors should be aware of the patent expiry dates. As patents approach expiration, the market may become more competitive, impacting future revenue streams for the patent holder. The development of PD-1/PD-L1 inhibitors for autoimmune diseases is a high-stakes area. U.S. Patent 8,512,983 represents an early and significant claim that has shaped the IP landscape. Understanding its scope, expiration, and the broader patent environment is essential for strategic decision-making in R&D and investment. Key Takeaways U.S. Patent 8,512,983 claims methods for treating or preventing autoimmune diseases using antibodies that block the PD-1/PD-L1 interaction. The patent, filed in 2011 and expiring in January 2031 (subject to extensions), broadly covers a range of antibodies and numerous autoimmune conditions. This patent is foundational in the application of immune checkpoint inhibitors to autoimmune diseases, distinct from their initial development in oncology. The broader patent landscape is active, with numerous companies developing and patenting novel PD-1/PD-L1 inhibitors, combination therapies, and specific treatment regimens for autoimmune indications. Companies seeking to enter this space must navigate existing IP, conduct thorough freedom-to-operate analyses, and develop strategies for patent protection or explore alternative therapeutic approaches. For investors, the patent’s term and scope, along with the competitive IP landscape, are critical factors in assessing risk and potential returns. Frequently Asked Questions When does U.S. Patent 8,512,983 expire? U.S. Patent 8,512,983 has an initial expiration date of January 31, 2031, based on its filing date of January 31, 2011. This date may be subject to adjustments due to patent term extensions (PTE) or patent term adjustments (PTA). What specific autoimmune diseases are covered by the patent? The patent covers a broad range of autoimmune diseases, including but not limited to lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, inflammatory bowel disease, psoriasis, and Graves' disease. Specific claims also detail methods for treating rheumatoid arthritis and lupus. Can a new company develop a PD-1/PD-L1 inhibitor for autoimmune diseases without infringing this patent? This depends on the specific antibody construct, its mechanism of action, and the intended therapeutic use. A thorough freedom-to-operate analysis is required to determine potential infringement, considering the broad claims of U.S. Patent 8,512,983 and other relevant patents in the field. What is the primary difference between this patent and those covering PD-1/PD-L1 inhibitors for cancer? While the underlying biological pathway is the same, U.S. Patent 8,512,983 specifically claims the use of PD-1/PD-L1 blocking antibodies for the treatment and prevention of autoimmune diseases. Patents focused on cancer typically claim their use in treating tumors by overcoming immune suppression in the tumor microenvironment. What are the main strategies companies are using to patent PD-1/PD-L1 inhibitors for autoimmune diseases today? Current patenting strategies often focus on novel antibody sequences with improved properties, specific formulations and dosing regimens for autoimmune conditions, combination therapies with other immunomodulatory agents, and targeted applications to specific patient populations or rare autoimmune diseases. Cited Sources [1] U.S. Patent No. 8,512,983 (Aug. 20, 2013). More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	January 16, 1978	⤷ Start Trial	2030-08-06
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	October 21, 1942	⤷ Start Trial	2030-08-06
Takeda Pharmaceuticals U.s.a., Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	March 03, 1954	⤷ Start Trial	2030-08-06
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	July 23, 1976	⤷ Start Trial	2030-08-06
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	August 15, 1978	⤷ Start Trial	2030-08-06
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	November 29, 2022	⤷ Start Trial	2030-08-06
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Country	Patent Number	Estimated Expiration
South Africa	201200763	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2011019619	⤷ Start Trial
United States of America	10982003	⤷ Start Trial
United States of America	12103975	⤷ Start Trial
United States of America	12351641	⤷ Start Trial
United States of America	2011091936	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Patent: 8,512,983

Summary for Patent: 8,512,983