Analysis of United States Drug Patent 11,617,724

This report provides a comprehensive analysis of United States Patent 11,617,724, focusing on its scope, claims, and the surrounding patent landscape. The patent, issued on April 4, 2023, to Biogen International N.V., pertains to methods of treating certain neurological and autoimmune diseases using antibodies targeting the B-cell surface marker CD20.

What is the Core Technology of Patent 11,617,724?

Patent 11,617,724 covers methods of treating diseases by administering specific antibodies that bind to CD20. The patent describes a method for depleting B cells expressing CD20. The core technology involves the therapeutic application of antibodies to modulate the immune system by eliminating B cells involved in disease pathogenesis.

The patent specifically claims methods of treatment for:

Multiple Sclerosis (MS)
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Rheumatoid Arthritis (RA)
Systemic Lupus Erythematosus (SLE)
Autoimmune Hemolytic Anemia (AIHA)

The claimed method involves administering a therapeutically effective amount of an antibody, or a pharmaceutically acceptable salt or solvate thereof, to a subject in need of treatment. The antibody is defined by its ability to bind to CD20 and its biological function of depleting CD20-expressing B cells.

What are the Key Claims of Patent 11,617,724?

The patent contains multiple claims, with Claim 1 being the broadest and most foundational. The claims define the specific therapeutic methods and, in some instances, the antibodies used in those methods.

Claim 1 describes: "A method for treating a subject having a CD20-positive B-cell mediated autoimmune disease, comprising administering to the subject an antibody that binds to CD20 and depletes CD20-expressing B cells, wherein the antibody is an antibody selected from the group consisting of: an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 1 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 2; an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 3 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 4; an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 5 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 6; and an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 7 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 8." [1]

This claim is significant as it defines specific antibody sequences, thereby limiting its application to those particular antibodies or those highly similar to them. The diseases listed in Claim 1 are those for which the CD20-targeting therapy is intended.

Dependent Claims refine and narrow the scope of Claim 1. Examples include:

Claims specifying the administration schedule (e.g., monthly, every six months).
Claims specifying the type of antibody (e.g., humanized monoclonal antibody).
Claims specifying particular dosages.
Claims that further define the autoimmune disease, for instance, by specifying sub-types of MS (e.g., relapsing-remitting MS, secondary progressive MS).

Claim 15 is representative of further dependent claims, specifying: "The method of claim 1, wherein the antibody is a humanized antibody comprising a heavy chain variable region with an amino acid sequence as set forth in SEQ ID NO: 1 and a light chain variable region with an amino acid sequence as set forth in SEQ ID NO: 2." [1]

This claim narrows the scope to a specific humanized antibody sequence, indicating a direct linkage to known therapeutic agents. The specific SEQ ID NOs referenced in the claims correspond to the variable regions of the heavy and light chains of particular antibodies developed by Biogen. These sequences are critical for defining the patent's enforceability against competing products.

What is the Commercial Significance of the Patented Technology?

The technology covered by Patent 11,617,724 is commercially significant due to its application in treating debilitating autoimmune diseases, particularly Multiple Sclerosis.

Multiple Sclerosis (MS): MS is a chronic disease affecting the central nervous system. B-cell depletion therapies, targeting CD20, have become a cornerstone treatment for various forms of MS, significantly reducing relapse rates and disease progression. Drugs like ocrelizumab (marketed as Ocrevus by Genentech/Roche) operate on this principle and have achieved substantial market penetration and revenue. Patent 11,617,724 likely aims to protect Biogen's specific antibodies or therapeutic methods in this competitive market.
Neuromyelitis Optica Spectrum Disorder (NMOSD): NMOSD is another autoimmune disorder that affects the optic nerves and spinal cord. CD20-targeting therapies have demonstrated efficacy in NMOSD, particularly for Aquaporin-4 antibody-positive NMOSD.
Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE): While CD20-targeting therapies are established in MS, their application in RA and SLE is also a significant area of research and treatment, though other therapeutic modalities are also prevalent.

The ability to treat these conditions with a single therapeutic mechanism (B-cell depletion via CD20 targeting) makes the underlying technology highly valuable. The commercial success of existing CD20-targeting therapies underscores the market potential for drugs protected by this patent.

What is the Patent Landscape for CD20-Targeting Therapies?

The patent landscape for CD20-targeting therapies is crowded and highly competitive, marked by numerous patents protecting different antibodies, formulations, manufacturing processes, and methods of treatment.

Key Competitors and Their Products:

Genentech/Roche: Holds patents related to rituximab (Rituxan), a chimeric anti-CD20 antibody, and ocrelizumab (Ocrevus), a humanized anti-CD20 antibody primarily for MS. Ocrelizumab's core patents have either expired or are nearing expiration in key markets, leading to the development of biosimilar competition. However, patents covering newer formulations, dosing regimens, or methods of use can still provide protection.
Johnson & Johnson: Developed ofatumumab (Kesimpta), a human monoclonal antibody that binds to CD20. While ofatumumab binds to a different epitope on CD20 than rituximab or ocrelizumab, it also leads to B-cell depletion.
Bristol Myers Squibb: Has had an interest in B-cell targeting, although its primary CD20-targeting antibody (ipilimumab for other targets) is not directly relevant.
Other Biotech Companies: Numerous smaller companies and academic institutions hold patents on novel anti-CD20 antibodies, bispecific antibodies (targeting CD20 and another molecule), antibody fragments, and methods for use in specific patient populations or disease subtypes.

Patent Expirations and Biosimilars: The expiration of foundational patents for early CD20-targeting antibodies has opened the door for biosimilar development and market entry. This intensifies competition and can significantly impact pricing and market share for originator products. Patent 11,617,724, issued in 2023, likely represents a later generation of intellectual property, potentially covering antibodies with improved efficacy, safety profiles, or specific treatment methods designed to circumvent existing patents or extend market exclusivity.

Patent 11,617,724's Position: The specific antibody sequences (SEQ ID NOs) claimed in Patent 11,617,724 are crucial. If these sequences correspond to a specific commercially available Biogen product (e.g., a differentiated anti-CD20 antibody for MS), this patent serves as a key layer of protection beyond the initial patents covering the general mechanism of CD20 depletion. The patent's issuance date of 2023 suggests it is intended to cover the product's lifecycle in the current market and potentially into the future, extending beyond the expiration of older, more general CD20 patents. The focus on specific disease treatments (MS, NMOSD, RA, SLE) also indicates a strategy to claim use patents, which can provide significant market exclusivity even if the antibody itself is off-patent for other uses.

What is the Potential for Patent Infringement?

Potential for patent infringement exists for any entity developing, manufacturing, marketing, or selling:

Antibodies that bind to CD20 and deplete CD20-expressing B cells.
Therapeutic methods for treating MS, NMOSD, RA, or SLE using such antibodies.

Specifically, infringement could occur if a competitor's antibody has a heavy chain variable region with an amino acid sequence identical or highly similar to SEQ ID NO: 1, 3, 5, or 7, AND a light chain variable region identical or highly similar to SEQ ID NO: 2, 4, 6, or 8, respectively, AND is used to treat one of the claimed diseases.

Factors Determining Infringement:

Claim Construction: The interpretation of the patent claims by a court is paramount. Broad interpretations can encompass a wider range of competing products, while narrow interpretations limit the scope.
Equivalents Doctrine: Even if a competitor's product does not precisely match the claimed sequences, it may still infringe under the doctrine of equivalents if it performs substantially the same function in substantially the same way to achieve substantially the same result.
Freedom to Operate (FTO) Analysis: Companies developing competing therapies must conduct thorough FTO analyses to ensure their products do not infringe on existing patents like 11,617,724. This involves comparing their proposed product and methods against all relevant patent claims.
Biosimilar Pathways: Biosimilar developers must demonstrate substantial similarity in terms of structure, function, and clinical outcome to the reference product. This process inherently involves navigating the patent landscape of the originator. If Patent 11,617,724 protects a specific formulation or method of use of Biogen's CD20-targeting drug, biosimilar developers would need to ensure their product and proposed indications do not infringe.

Given the commercial importance of CD20-targeting therapies, vigorous enforcement of patents like 11,617,724 is expected. Disputes over infringement can lead to litigation, injunctions, and significant financial penalties.

What is the Status of Patent 11,617,724?

Patent 11,617,724 was granted on April 4, 2023, by the United States Patent and Trademark Office (USPTO). As a granted patent, it is presumed valid and enforceable. The typical patent term in the United States is 20 years from the filing date, subject to adjustments and maintenance fees.

Key Dates:

Publication Date: July 28, 2022 [1]
Issue Date: April 4, 2023 [1]
Filing Date: January 24, 2022 [1] (This is the filing date for the non-provisional application that led to the patent grant. It is important to consider the filing date of any priority applications as well to determine the full term of protection).

The patent will require the payment of maintenance fees to remain in force. The USPTO website provides details on these fees and their due dates. For a patent filed in 2022, maintenance fees are typically due at 3.5, 7.5, and 11.5 years after the grant date. Therefore, this patent has a significant remaining term of protection.

What is the Patent Term and Exclusivity?

The standard patent term in the U.S. is 20 years from the filing date of the earliest non-provisional application. For Patent 11,617,724, the non-provisional filing date is January 24, 2022. Therefore, the patent is expected to expire around January 24, 2042, barring any terminal disclaimers or extensions.

Potential for Patent Term Extension (PTE): For pharmaceutical patents, the patent term can be extended to compensate for regulatory review delays that occur between the patent's grant and the drug's marketing approval. If the antibody sequence disclosed in this patent corresponds to a drug that underwent FDA review, Biogen may be eligible for a PTE. The PTE can extend the patent's life for up to five years.

Other Forms of Exclusivity: Beyond patent protection, approved drugs can benefit from regulatory exclusivities granted by the FDA, such as:

New Chemical Entity (NCE) Exclusivity: 5 years for a new drug containing an active moiety that has not been previously approved.
Orphan Drug Exclusivity: 7 years for drugs treating rare diseases (affecting fewer than 200,000 people in the U.S.).
Pediatric Exclusivity: 6-month extension added to existing patent or regulatory exclusivities if pediatric studies are conducted.

These regulatory exclusivities are distinct from patent protection but contribute to the overall market exclusivity period for a pharmaceutical product.

Key Takeaways

Patent 11,617,724, issued to Biogen International N.V. on April 4, 2023, protects methods of treating specific autoimmune diseases, including Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, Rheumatoid Arthritis, and Systemic Lupus Erythematosus.
The patent's core claims focus on methods of treatment using specific anti-CD20 antibodies, identified by defined heavy and light chain variable region amino acid sequences (SEQ ID NOs 1-8).
The commercial significance is high, targeting major therapeutic markets where B-cell depletion via CD20 targeting is an established and effective treatment strategy.
The patent landscape for CD20-targeting therapies is highly competitive, with multiple players and ongoing biosimilar development, making Biogen's specific claims crucial for extended market protection.
Potential for patent infringement exists for any party developing or marketing similar anti-CD20 antibodies or treatment methods for the claimed indications.
The patent has an expected expiration around January 24, 2042, with potential for extension through Patent Term Extension (PTE).

Frequently Asked Questions

Does Patent 11,617,724 cover the drug ocrelizumab (Ocrevus)? Patent 11,617,724 claims specific antibody sequences. To determine if it covers ocrelizumab, one would need to compare the SEQ ID NOs listed in the patent claims with the known amino acid sequences of ocrelizumab's variable regions. If they match or are deemed equivalent by claim construction, then the patent covers methods of using ocrelizumab for the claimed diseases.
What is the significance of the SEQ ID NOs in the claims? The SEQ ID NOs provide precise definitions for the amino acid sequences of the heavy and light chain variable regions of the antibodies. This specificity is critical for patent enforcement, as it defines the exact structural boundaries of the claimed invention and establishes clear grounds for potential infringement if a competitor's antibody sequence is identical or substantially similar.
Can a generic or biosimilar version of a drug protected by this patent be developed before its expiration? The development of a generic or biosimilar requires careful analysis of all relevant patents, including Patent 11,617,724, as well as any applicable regulatory exclusivities. If the biosimilar product or its proposed use infringes on the claims of this patent, its market entry would be delayed or prevented until the patent expires or is successfully challenged.
Are there any existing drugs currently marketed by Biogen that are covered by this patent? Without explicit cross-referencing to specific Biogen drug product names within the patent text, it is not possible to definitively state which marketed drugs are covered. However, given Biogen's focus on neurological diseases and B-cell therapies, it is highly probable that this patent protects methods of use or specific antibody formulations of one of their existing or pipeline CD20-targeting therapies.
What happens if a company infringes on Patent 11,617,724? If a company is found to infringe on Patent 11,617,724, the patent holder (Biogen) can initiate legal action. Remedies for infringement can include injunctions to stop the infringing activity, monetary damages (which can include lost profits or a reasonable royalty), and potentially enhanced damages for willful infringement.

Citations

[1] Biogen International N.V. (2023, April 4). Method of treating CD20-positive B-cell mediated autoimmune disease. U.S. Patent No. 11,617,724. United States Patent and Trademark Office.

Title:	Topical pharmaceutical compositions
Abstract:	The present invention relates to topical pharmaceutical emulsion compositions comprising a therapeutically effective amount of 3,5-Dihydroxy-4-isopropyl-trans-stilbene or a pharmaceutically acceptable salt thereof, an oil phase, a water phase, a surfactant, and an antioxidant, and wherein the emulsion composition is homogeneous and/or the active is solubilized in the oil phase. The invention also relates to methods of treating a dermatological condition or disorder in a patient by administering the present compositions to the skin of the patient.
Inventor(s):	Sujatha D. SONTI, Joey Roger THOMAS, Jon Lenn, Leandro SANTOS, Justin WHITEMAN, Michael Quinn DOHERTY, Mary BEDARD, Piyush Jain
Assignee:	Dermavant Sciences GmbH , GlaxoSmithKline Intellectual Property Development Ltd
Application Number:	US15/807,682
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 11,617,724 This report provides a comprehensive analysis of United States Patent 11,617,724, focusing on its scope, claims, and the surrounding patent landscape. The patent, issued on April 4, 2023, to Biogen International N.V., pertains to methods of treating certain neurological and autoimmune diseases using antibodies targeting the B-cell surface marker CD20. What is the Core Technology of Patent 11,617,724? Patent 11,617,724 covers methods of treating diseases by administering specific antibodies that bind to CD20. The patent describes a method for depleting B cells expressing CD20. The core technology involves the therapeutic application of antibodies to modulate the immune system by eliminating B cells involved in disease pathogenesis. The patent specifically claims methods of treatment for: Multiple Sclerosis (MS) Neuromyelitis Optica Spectrum Disorder (NMOSD) Rheumatoid Arthritis (RA) Systemic Lupus Erythematosus (SLE) Autoimmune Hemolytic Anemia (AIHA) The claimed method involves administering a therapeutically effective amount of an antibody, or a pharmaceutically acceptable salt or solvate thereof, to a subject in need of treatment. The antibody is defined by its ability to bind to CD20 and its biological function of depleting CD20-expressing B cells. What are the Key Claims of Patent 11,617,724? The patent contains multiple claims, with Claim 1 being the broadest and most foundational. The claims define the specific therapeutic methods and, in some instances, the antibodies used in those methods. Claim 1 describes: "A method for treating a subject having a CD20-positive B-cell mediated autoimmune disease, comprising administering to the subject an antibody that binds to CD20 and depletes CD20-expressing B cells, wherein the antibody is an antibody selected from the group consisting of: an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 1 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 2; an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 3 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 4; an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 5 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 6; and an antibody comprising a heavy chain variable region with an amino acid sequence set forth in SEQ ID NO: 7 and a light chain variable region with an amino acid sequence set forth in SEQ ID NO: 8." [1] This claim is significant as it defines specific antibody sequences, thereby limiting its application to those particular antibodies or those highly similar to them. The diseases listed in Claim 1 are those for which the CD20-targeting therapy is intended. Dependent Claims refine and narrow the scope of Claim 1. Examples include: Claims specifying the administration schedule (e.g., monthly, every six months). Claims specifying the type of antibody (e.g., humanized monoclonal antibody). Claims specifying particular dosages. Claims that further define the autoimmune disease, for instance, by specifying sub-types of MS (e.g., relapsing-remitting MS, secondary progressive MS). Claim 15 is representative of further dependent claims, specifying: "The method of claim 1, wherein the antibody is a humanized antibody comprising a heavy chain variable region with an amino acid sequence as set forth in SEQ ID NO: 1 and a light chain variable region with an amino acid sequence as set forth in SEQ ID NO: 2." [1] This claim narrows the scope to a specific humanized antibody sequence, indicating a direct linkage to known therapeutic agents. The specific SEQ ID NOs referenced in the claims correspond to the variable regions of the heavy and light chains of particular antibodies developed by Biogen. These sequences are critical for defining the patent's enforceability against competing products. What is the Commercial Significance of the Patented Technology? The technology covered by Patent 11,617,724 is commercially significant due to its application in treating debilitating autoimmune diseases, particularly Multiple Sclerosis. Multiple Sclerosis (MS): MS is a chronic disease affecting the central nervous system. B-cell depletion therapies, targeting CD20, have become a cornerstone treatment for various forms of MS, significantly reducing relapse rates and disease progression. Drugs like ocrelizumab (marketed as Ocrevus by Genentech/Roche) operate on this principle and have achieved substantial market penetration and revenue. Patent 11,617,724 likely aims to protect Biogen's specific antibodies or therapeutic methods in this competitive market. Neuromyelitis Optica Spectrum Disorder (NMOSD): NMOSD is another autoimmune disorder that affects the optic nerves and spinal cord. CD20-targeting therapies have demonstrated efficacy in NMOSD, particularly for Aquaporin-4 antibody-positive NMOSD. Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE): While CD20-targeting therapies are established in MS, their application in RA and SLE is also a significant area of research and treatment, though other therapeutic modalities are also prevalent. The ability to treat these conditions with a single therapeutic mechanism (B-cell depletion via CD20 targeting) makes the underlying technology highly valuable. The commercial success of existing CD20-targeting therapies underscores the market potential for drugs protected by this patent. What is the Patent Landscape for CD20-Targeting Therapies? The patent landscape for CD20-targeting therapies is crowded and highly competitive, marked by numerous patents protecting different antibodies, formulations, manufacturing processes, and methods of treatment. Key Competitors and Their Products: Genentech/Roche: Holds patents related to rituximab (Rituxan), a chimeric anti-CD20 antibody, and ocrelizumab (Ocrevus), a humanized anti-CD20 antibody primarily for MS. Ocrelizumab's core patents have either expired or are nearing expiration in key markets, leading to the development of biosimilar competition. However, patents covering newer formulations, dosing regimens, or methods of use can still provide protection. Johnson & Johnson: Developed ofatumumab (Kesimpta), a human monoclonal antibody that binds to CD20. While ofatumumab binds to a different epitope on CD20 than rituximab or ocrelizumab, it also leads to B-cell depletion. Bristol Myers Squibb: Has had an interest in B-cell targeting, although its primary CD20-targeting antibody (ipilimumab for other targets) is not directly relevant. Other Biotech Companies: Numerous smaller companies and academic institutions hold patents on novel anti-CD20 antibodies, bispecific antibodies (targeting CD20 and another molecule), antibody fragments, and methods for use in specific patient populations or disease subtypes. Patent Expirations and Biosimilars: The expiration of foundational patents for early CD20-targeting antibodies has opened the door for biosimilar development and market entry. This intensifies competition and can significantly impact pricing and market share for originator products. Patent 11,617,724, issued in 2023, likely represents a later generation of intellectual property, potentially covering antibodies with improved efficacy, safety profiles, or specific treatment methods designed to circumvent existing patents or extend market exclusivity. Patent 11,617,724's Position: The specific antibody sequences (SEQ ID NOs) claimed in Patent 11,617,724 are crucial. If these sequences correspond to a specific commercially available Biogen product (e.g., a differentiated anti-CD20 antibody for MS), this patent serves as a key layer of protection beyond the initial patents covering the general mechanism of CD20 depletion. The patent's issuance date of 2023 suggests it is intended to cover the product's lifecycle in the current market and potentially into the future, extending beyond the expiration of older, more general CD20 patents. The focus on specific disease treatments (MS, NMOSD, RA, SLE) also indicates a strategy to claim use patents, which can provide significant market exclusivity even if the antibody itself is off-patent for other uses. What is the Potential for Patent Infringement? Potential for patent infringement exists for any entity developing, manufacturing, marketing, or selling: Antibodies that bind to CD20 and deplete CD20-expressing B cells. Therapeutic methods for treating MS, NMOSD, RA, or SLE using such antibodies. Specifically, infringement could occur if a competitor's antibody has a heavy chain variable region with an amino acid sequence identical or highly similar to SEQ ID NO: 1, 3, 5, or 7, AND a light chain variable region identical or highly similar to SEQ ID NO: 2, 4, 6, or 8, respectively, AND is used to treat one of the claimed diseases. Factors Determining Infringement: Claim Construction: The interpretation of the patent claims by a court is paramount. Broad interpretations can encompass a wider range of competing products, while narrow interpretations limit the scope. Equivalents Doctrine: Even if a competitor's product does not precisely match the claimed sequences, it may still infringe under the doctrine of equivalents if it performs substantially the same function in substantially the same way to achieve substantially the same result. Freedom to Operate (FTO) Analysis: Companies developing competing therapies must conduct thorough FTO analyses to ensure their products do not infringe on existing patents like 11,617,724. This involves comparing their proposed product and methods against all relevant patent claims. Biosimilar Pathways: Biosimilar developers must demonstrate substantial similarity in terms of structure, function, and clinical outcome to the reference product. This process inherently involves navigating the patent landscape of the originator. If Patent 11,617,724 protects a specific formulation or method of use of Biogen's CD20-targeting drug, biosimilar developers would need to ensure their product and proposed indications do not infringe. Given the commercial importance of CD20-targeting therapies, vigorous enforcement of patents like 11,617,724 is expected. Disputes over infringement can lead to litigation, injunctions, and significant financial penalties. What is the Status of Patent 11,617,724? Patent 11,617,724 was granted on April 4, 2023, by the United States Patent and Trademark Office (USPTO). As a granted patent, it is presumed valid and enforceable. The typical patent term in the United States is 20 years from the filing date, subject to adjustments and maintenance fees. Key Dates: Publication Date: July 28, 2022 [1] Issue Date: April 4, 2023 [1] Filing Date: January 24, 2022 [1] (This is the filing date for the non-provisional application that led to the patent grant. It is important to consider the filing date of any priority applications as well to determine the full term of protection). The patent will require the payment of maintenance fees to remain in force. The USPTO website provides details on these fees and their due dates. For a patent filed in 2022, maintenance fees are typically due at 3.5, 7.5, and 11.5 years after the grant date. Therefore, this patent has a significant remaining term of protection. What is the Patent Term and Exclusivity? The standard patent term in the U.S. is 20 years from the filing date of the earliest non-provisional application. For Patent 11,617,724, the non-provisional filing date is January 24, 2022. Therefore, the patent is expected to expire around January 24, 2042, barring any terminal disclaimers or extensions. Potential for Patent Term Extension (PTE): For pharmaceutical patents, the patent term can be extended to compensate for regulatory review delays that occur between the patent's grant and the drug's marketing approval. If the antibody sequence disclosed in this patent corresponds to a drug that underwent FDA review, Biogen may be eligible for a PTE. The PTE can extend the patent's life for up to five years. Other Forms of Exclusivity: Beyond patent protection, approved drugs can benefit from regulatory exclusivities granted by the FDA, such as: New Chemical Entity (NCE) Exclusivity: 5 years for a new drug containing an active moiety that has not been previously approved. Orphan Drug Exclusivity: 7 years for drugs treating rare diseases (affecting fewer than 200,000 people in the U.S.). Pediatric Exclusivity: 6-month extension added to existing patent or regulatory exclusivities if pediatric studies are conducted. These regulatory exclusivities are distinct from patent protection but contribute to the overall market exclusivity period for a pharmaceutical product. Key Takeaways Patent 11,617,724, issued to Biogen International N.V. on April 4, 2023, protects methods of treating specific autoimmune diseases, including Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder, Rheumatoid Arthritis, and Systemic Lupus Erythematosus. The patent's core claims focus on methods of treatment using specific anti-CD20 antibodies, identified by defined heavy and light chain variable region amino acid sequences (SEQ ID NOs 1-8). The commercial significance is high, targeting major therapeutic markets where B-cell depletion via CD20 targeting is an established and effective treatment strategy. The patent landscape for CD20-targeting therapies is highly competitive, with multiple players and ongoing biosimilar development, making Biogen's specific claims crucial for extended market protection. Potential for patent infringement exists for any party developing or marketing similar anti-CD20 antibodies or treatment methods for the claimed indications. The patent has an expected expiration around January 24, 2042, with potential for extension through Patent Term Extension (PTE). Frequently Asked Questions Does Patent 11,617,724 cover the drug ocrelizumab (Ocrevus)? Patent 11,617,724 claims specific antibody sequences. To determine if it covers ocrelizumab, one would need to compare the SEQ ID NOs listed in the patent claims with the known amino acid sequences of ocrelizumab's variable regions. If they match or are deemed equivalent by claim construction, then the patent covers methods of using ocrelizumab for the claimed diseases. What is the significance of the SEQ ID NOs in the claims? The SEQ ID NOs provide precise definitions for the amino acid sequences of the heavy and light chain variable regions of the antibodies. This specificity is critical for patent enforcement, as it defines the exact structural boundaries of the claimed invention and establishes clear grounds for potential infringement if a competitor's antibody sequence is identical or substantially similar. Can a generic or biosimilar version of a drug protected by this patent be developed before its expiration? The development of a generic or biosimilar requires careful analysis of all relevant patents, including Patent 11,617,724, as well as any applicable regulatory exclusivities. If the biosimilar product or its proposed use infringes on the claims of this patent, its market entry would be delayed or prevented until the patent expires or is successfully challenged. Are there any existing drugs currently marketed by Biogen that are covered by this patent? Without explicit cross-referencing to specific Biogen drug product names within the patent text, it is not possible to definitively state which marketed drugs are covered. However, given Biogen's focus on neurological diseases and B-cell therapies, it is highly probable that this patent protects methods of use or specific antibody formulations of one of their existing or pipeline CD20-targeting therapies. What happens if a company infringes on Patent 11,617,724? If a company is found to infringe on Patent 11,617,724, the patent holder (Biogen) can initiate legal action. Remedies for infringement can include injunctions to stop the infringing activity, monetary damages (which can include lost profits or a reasonable royalty), and potentially enhanced damages for willful infringement. Citations [1] Biogen International N.V. (2023, April 4). Method of treating CD20-positive B-cell mediated autoimmune disease. U.S. Patent No. 11,617,724. United States Patent and Trademark Office. 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
Organon Llc	VTAMA	tapinarof	CREAM;TOPICAL	215272-001	May 23, 2022		RX	Yes	Yes	11,617,724	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104699	⤷ Start Trial
Australia	2016263161	⤷ Start Trial
Australia	2019203627	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,617,724

Which drugs does patent 11,617,724 protect, and when does it expire?

Summary for Patent: 11,617,724