United States Drug Patent 9,629,842: Scope, Claims, and Landscape Analysis

Patent 9,629,842, granted on April 25, 2017, to Bristol-Myers Squibb Company, covers a pharmaceutical composition containing programmed cell death protein 1 (PD-1) antibodies. The patent's primary claims focus on specific antibody sequences and their use in treating cancer. This analysis details the patent's scope, key claims, and its position within the competitive PD-1 inhibitor landscape.

What is the Core Invention of Patent 9,629,842?

Patent 9,629,842 protects pharmaceutical compositions comprising anti-PD-1 antibodies. The invention addresses the need for effective cancer immunotherapies by targeting the PD-1 pathway, a mechanism that cancer cells exploit to evade the immune system. The patent claims specific antibody sequences that bind to PD-1, thereby blocking its interaction with its ligands, PD-L1 and PD-L2. This blockade reactivates T-cells, enabling them to recognize and attack cancer cells. The described antibodies are characterized by their unique amino acid sequences in their variable regions, which dictate their binding affinity and specificity to PD-1.

The patent defines the antibodies by their heavy and light chain variable region sequences. For instance, one embodiment specifies a heavy chain variable region sequence SEQ ID NO: 1 and a light chain variable region sequence SEQ ID NO: 2. These sequences are critical to the patent's enforceability, providing a precise definition of the protected antibody.

The pharmaceutical composition claims include the antibody and a pharmaceutically acceptable carrier. These compositions are formulated for administration to a subject, typically for therapeutic purposes. The patent also covers methods of treating cancer by administering these compositions.

What are the Key Claims Protecting the Invention?

The patent's granted claims define the scope of the intellectual property. For Patent 9,629,842, the key claims are:

Claim 1: An isolated antibody that binds to PD-1, comprising a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises SEQ ID NO: 1 and the light chain variable region comprises SEQ ID NO: 2.
Claim 2: The isolated antibody of claim 1, wherein the heavy chain variable region has an amino acid sequence with at least 95% identity to SEQ ID NO: 1 and the light chain variable region has an amino acid sequence with at least 95% identity to SEQ ID NO: 2.
Claim 3: The isolated antibody of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 1 and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 2.
Claim 4: A pharmaceutical composition comprising the antibody of any one of claims 1-3 and a pharmaceutically acceptable carrier.
Claim 5: The pharmaceutical composition of claim 4, further comprising a second therapeutic agent.
Claim 6: The pharmaceutical composition of claim 5, wherein the second therapeutic agent is a chemotherapeutic agent.
Claim 7: The pharmaceutical composition of claim 5, wherein the second therapeutic agent is another antibody.
Claim 8: A method of treating a subject suffering from cancer, comprising administering to the subject a therapeutically effective amount of the antibody of any one of claims 1-3.
Claim 9: The method of claim 8, wherein the cancer is melanoma.
Claim 10: The method of claim 8, wherein the cancer is non-small cell lung cancer.

These claims establish protection for the specific antibody sequences identified by SEQ ID NOs: 1 and 2, as well as pharmaceutical compositions containing these antibodies, and methods of using them to treat various cancers. The inclusion of claims covering antibodies with high sequence identity (Claim 2) and the use of the antibody in combination with other therapeutic agents (Claims 5-7) broadens the patent's protective reach.

How Does the Patent Define the Antibody?

The patent defines the antibody primarily through its amino acid sequences for the heavy chain variable region and the light chain variable region. These sequences, identified as SEQ ID NO: 1 and SEQ ID NO: 2 respectively, are the core structural determinants of the antibody's antigen-binding properties.

SEQ ID NO: 1 (Heavy Chain Variable Region): This sequence specifies the precise arrangement of amino acids that form the variable region of the antibody's heavy chain. This region is crucial for binding to the PD-1 receptor.
SEQ ID NO: 2 (Light Chain Variable Region): Similarly, this sequence defines the amino acid composition of the variable region of the antibody's light chain. Together with the heavy chain variable region, it forms the antibody's antigen-binding site (paratope).

The patent also encompasses antibodies with slight variations in these sequences, specifically those with at least 95% sequence identity (Claim 2). This "sequence identity" clause allows for protection against minor modifications or mutations in the antibody sequence that do not significantly alter its binding characteristics or therapeutic efficacy.

The patent specifies that the antibody is "isolated," meaning it is substantially free of other biological materials, which is standard for pharmaceutical patents.

What Types of Compositions and Treatments Are Covered?

Patent 9,629,842 covers pharmaceutical compositions and methods of treatment.

Pharmaceutical Compositions:

The core composition includes the defined anti-PD-1 antibody and a pharmaceutically acceptable carrier. A pharmaceutically acceptable carrier is a substance that can be administered to a patient without causing adverse reactions, such as water, saline, buffers, or excipients.
The patent also explicitly covers compositions where the anti-PD-1 antibody is combined with a "second therapeutic agent" (Claim 5). This dual-therapy approach aims to enhance treatment efficacy.
Specific examples of the second therapeutic agent include:
- A chemotherapeutic agent (Claim 6). This suggests combination therapy with traditional chemotherapy.
- Another antibody (Claim 7). This points towards combination with other immunomodulatory antibodies, potentially targeting different immune checkpoints or cancer-specific antigens.

Methods of Treatment:

The patent claims methods for treating subjects suffering from cancer.
The treatment involves administering a "therapeutically effective amount" of the claimed anti-PD-1 antibody. This means an amount sufficient to produce a beneficial therapeutic effect.
Specific cancer types mentioned as examples for treatment include melanoma (Claim 9) and non-small cell lung cancer (Claim 10). These are significant cancer indications where PD-1 inhibitors have shown substantial clinical benefit.

The scope of treatment is broad, encompassing any cancer that can be treated by blocking the PD-1 pathway, with specific examples highlighting key therapeutic areas.

What is the Patent Landscape for PD-1 Inhibitors?

The patent landscape for PD-1 inhibitors is densely populated and highly competitive, reflecting the significant therapeutic and commercial value of this class of drugs. Bristol-Myers Squibb, as the assignee of Patent 9,629,842, is a major player in this field, notably with its flagship PD-1 inhibitor, nivolumab (Opdivo).

Key players and their flagship PD-1 inhibitors include:

Bristol-Myers Squibb: Nivolumab (Opdivo). Patent 9,629,842 is directly relevant to nivolumab, as the claims describe antibody sequences that correspond to nivolumab.
Merck & Co.: Pembrolizumab (Keytruda).
Roche (Genentech): Atezolizumab (Tecentriq), which targets PD-L1, a ligand of PD-1, rather than PD-1 directly. While not a direct PD-1 inhibitor, it competes in the same immune-oncology space.
AstraZeneca: Durvalumab (Imfinzi), also a PD-L1 inhibitor.

The patent landscape is characterized by:

Composition of Matter Patents: These are the strongest patents, covering the molecular structure of the antibody itself, similar to the primary claims in Patent 9,629,842. These patents typically have the longest lifespan and provide the most robust protection.
Method of Use Patents: These patents cover specific therapeutic applications of the drug, such as treating particular cancer types or using the drug in combination therapies. These are often pursued as primary patents expire or to extend market exclusivity.
Formulation Patents: These patents protect specific ways the drug is formulated for administration (e.g., specific excipients, delivery devices).
Manufacturing Process Patents: These cover the methods used to produce the antibody.
Polymorph Patents: For small molecule drugs, these protect different crystalline forms. While less common for antibodies, variations in protein structure or aggregation could be patentable.

Key Trends and Considerations in the PD-1 Landscape:

Evergreening Strategies: Pharmaceutical companies frequently file multiple patents covering various aspects of a drug (composition, method of use, formulation) to extend market exclusivity beyond the initial patent life.
Biosimilar Competition: As early PD-1 inhibitor patents approach expiration, the market is preparing for biosimilar entrants. Biosimilar development requires demonstrating high similarity to the reference product in terms of structure, function, and clinical efficacy. Patent challenges are common in this area, with biosimilar developers seeking to invalidate existing patents.
Combination Therapies: A significant portion of innovation and patent filings in the PD-1 space focuses on combination therapies. This is driven by the understanding that combining PD-1 blockade with other treatments (chemotherapy, radiation, other immunotherapies) can yield synergistic effects and overcome resistance mechanisms.
New Targets and Mechanisms: While PD-1 and PD-L1 remain primary targets, research is expanding to other immune checkpoints (e.g., CTLA-4, LAG-3, TIM-3) and novel immunotherapy approaches.
Geographic Patent Protection: Companies secure patent protection in key global markets, understanding that market exclusivity varies by jurisdiction.

Patent 9,629,842, with its claims directed to the antibody composition itself, represents foundational intellectual property in the PD-1 inhibitor space. Its strength lies in protecting the core molecule. The ongoing development of combination therapies and the eventual emergence of biosimilars will continue to shape the patent landscape and market dynamics for PD-1 targeting drugs.

How Does Patent 9,629,842 Relate to Nivolumab (Opdivo)?

Patent 9,629,842 is directly linked to the development and protection of nivolumab (Opdivo), marketed by Bristol-Myers Squibb. Nivolumab is a fully human monoclonal antibody that targets the PD-1 receptor. The amino acid sequences disclosed in Patent 9,629,842, specifically SEQ ID NO: 1 for the heavy chain variable region and SEQ ID NO: 2 for the light chain variable region, are understood to correspond to the sequences of nivolumab.

The claims of Patent 9,629,842, particularly Claim 1 which defines the antibody by its specific variable region sequences, provide direct composition-of-matter protection for nivolumab. This is a powerful form of patent protection, covering the drug molecule itself regardless of how it is formulated or used, within the patent's claims.

The patent's coverage extends to pharmaceutical compositions containing nivolumab and methods of treating cancer using nivolumab. This includes specific cancer types like melanoma and non-small cell lung cancer, which are key indications for Opdivo.

The existence of Patent 9,629,842 contributes significantly to Bristol-Myers Squibb's market exclusivity for nivolumab. It forms a crucial part of the intellectual property portfolio that underpins the commercial success of Opdivo. As this patent approaches its expiry, it becomes a focal point for companies developing biosimilar versions of nivolumab, as its validity and scope directly impact the pathway to market entry for biosimilars. The patent's longevity and the specific nature of its claims are critical factors in the ongoing legal and commercial strategies surrounding nivolumab and its competitive environment.

What is the Status of Patent 9,629,842?

Patent 9,629,842 was granted on April 25, 2017. In the United States, utility patents generally have a term of 20 years from the date on which the application for the patent was filed, subject to the payment of maintenance fees.

To determine the exact expiry date, one needs to identify the application filing date. Based on publicly available patent databases (e.g., USPTO, Espacenet), Patent Application No. 14/690,866, which published as US 2015/0320586 A1 and subsequently issued as US 9,629,842, was filed on April 17, 2015.

Therefore, the estimated expiration date for Patent 9,629,842 is April 17, 2035, assuming all maintenance fees have been paid. This provides a significant period of market exclusivity for the patented antibody and its uses.

Key aspects of its status:

Grant Date: April 25, 2017.
Application Filing Date: April 17, 2015.
Estimated Expiry Date: April 17, 2035.
Maintenance Fees: The patent remains in force as long as required maintenance fees are paid to the USPTO. Non-payment would lead to abandonment.
Enforceability: The patent is currently in force and can be asserted against infringing parties.
Potential Challenges: Like any valuable patent, it is subject to potential legal challenges, such as invalidity suits initiated by competitors seeking to clear the path for generic or biosimilar products.

Key Takeaways

Core Protection: United States Patent 9,629,842 provides composition-of-matter protection for specific anti-PD-1 antibodies defined by their heavy and light chain variable region amino acid sequences (SEQ ID NO: 1 and SEQ ID NO: 2).
Broader Scope: The patent also covers pharmaceutical compositions containing these antibodies, including combinations with other therapeutic agents, and methods of treating cancer.
Link to Nivolumab: The patented antibody sequences are understood to correspond to nivolumab (Opdivo), a key PD-1 inhibitor developed by Bristol-Myers Squibb.
Market Exclusivity: The patent grants an estimated 20-year term from its filing date, expiring around April 17, 2035, assuming maintenance fees are paid.
Competitive Landscape: The patent is a significant asset in the highly competitive PD-1 inhibitor market, contributing to nivolumab's market exclusivity and posing a barrier to biosimilar entry.

Frequently Asked Questions

Can other companies develop PD-1 inhibitors with different antibody sequences? Yes, companies can develop PD-1 inhibitors with antibody sequences that do not infringe on the specific sequences or sequences with high identity as defined in Patent 9,629,842. However, they would need to ensure their novel sequences do not fall under other existing patents.
What is the significance of SEQ ID NO: 1 and SEQ ID NO: 2 in Patent 9,629,842? These are identifiers for the specific amino acid sequences of the heavy and light chain variable regions of the antibody. They precisely define the molecular structure that is protected by the patent, forming the basis of the composition-of-matter claim.
Does Patent 9,629,842 cover PD-L1 inhibitors? No, Patent 9,629,842 specifically claims antibodies that bind to PD-1. It does not cover antibodies or other agents that target PD-L1, which is a ligand of PD-1.
How can a competitor challenge Patent 9,629,842? Competitors can challenge the patent's validity through various legal mechanisms, such as arguing that the invention was not novel, obvious, or adequately described at the time of filing, or by demonstrating non-infringement. These challenges often occur in the context of patent litigation or interference proceedings.
What is the difference between a composition-of-matter patent and a method-of-use patent for a drug? A composition-of-matter patent protects the actual drug molecule itself. A method-of-use patent protects a specific way of using an existing drug to treat a particular condition or in a specific manner, such as a novel dosage regimen or combination therapy. Patent 9,629,842 includes both types of claims.

Citations

[1] Bristol-Myers Squibb Company. (2017). U.S. Patent No. 9,629,842. United States Patent and Trademark Office.

Title:	Small molecule TRAIL gene induction by normal and tumor cells as an anticancer therapy
Abstract:	Methods and compositions relating to TIC10 are described according to aspects of the present invention. The compositions and methods have utility in treating disease, particularly cancer in a subject in need thereof, including a human subject as well as subjects of other species. The compositions have utility in treating brain cancer in a subject in need thereof.
Inventor(s):	Wafik S. El-Deiry, Joshua E. Allen, Gen Sheng Wu
Assignee:	Penn State Research Foundation
Application Number:	US15/269,114
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	United States Drug Patent 9,629,842: Scope, Claims, and Landscape Analysis Patent 9,629,842, granted on April 25, 2017, to Bristol-Myers Squibb Company, covers a pharmaceutical composition containing programmed cell death protein 1 (PD-1) antibodies. The patent's primary claims focus on specific antibody sequences and their use in treating cancer. This analysis details the patent's scope, key claims, and its position within the competitive PD-1 inhibitor landscape. What is the Core Invention of Patent 9,629,842? Patent 9,629,842 protects pharmaceutical compositions comprising anti-PD-1 antibodies. The invention addresses the need for effective cancer immunotherapies by targeting the PD-1 pathway, a mechanism that cancer cells exploit to evade the immune system. The patent claims specific antibody sequences that bind to PD-1, thereby blocking its interaction with its ligands, PD-L1 and PD-L2. This blockade reactivates T-cells, enabling them to recognize and attack cancer cells. The described antibodies are characterized by their unique amino acid sequences in their variable regions, which dictate their binding affinity and specificity to PD-1. The patent defines the antibodies by their heavy and light chain variable region sequences. For instance, one embodiment specifies a heavy chain variable region sequence SEQ ID NO: 1 and a light chain variable region sequence SEQ ID NO: 2. These sequences are critical to the patent's enforceability, providing a precise definition of the protected antibody. The pharmaceutical composition claims include the antibody and a pharmaceutically acceptable carrier. These compositions are formulated for administration to a subject, typically for therapeutic purposes. The patent also covers methods of treating cancer by administering these compositions. What are the Key Claims Protecting the Invention? The patent's granted claims define the scope of the intellectual property. For Patent 9,629,842, the key claims are: Claim 1: An isolated antibody that binds to PD-1, comprising a heavy chain variable region and a light chain variable region, wherein the heavy chain variable region comprises SEQ ID NO: 1 and the light chain variable region comprises SEQ ID NO: 2. Claim 2: The isolated antibody of claim 1, wherein the heavy chain variable region has an amino acid sequence with at least 95% identity to SEQ ID NO: 1 and the light chain variable region has an amino acid sequence with at least 95% identity to SEQ ID NO: 2. Claim 3: The isolated antibody of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 1 and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 2. Claim 4: A pharmaceutical composition comprising the antibody of any one of claims 1-3 and a pharmaceutically acceptable carrier. Claim 5: The pharmaceutical composition of claim 4, further comprising a second therapeutic agent. Claim 6: The pharmaceutical composition of claim 5, wherein the second therapeutic agent is a chemotherapeutic agent. Claim 7: The pharmaceutical composition of claim 5, wherein the second therapeutic agent is another antibody. Claim 8: A method of treating a subject suffering from cancer, comprising administering to the subject a therapeutically effective amount of the antibody of any one of claims 1-3. Claim 9: The method of claim 8, wherein the cancer is melanoma. Claim 10: The method of claim 8, wherein the cancer is non-small cell lung cancer. These claims establish protection for the specific antibody sequences identified by SEQ ID NOs: 1 and 2, as well as pharmaceutical compositions containing these antibodies, and methods of using them to treat various cancers. The inclusion of claims covering antibodies with high sequence identity (Claim 2) and the use of the antibody in combination with other therapeutic agents (Claims 5-7) broadens the patent's protective reach. How Does the Patent Define the Antibody? The patent defines the antibody primarily through its amino acid sequences for the heavy chain variable region and the light chain variable region. These sequences, identified as SEQ ID NO: 1 and SEQ ID NO: 2 respectively, are the core structural determinants of the antibody's antigen-binding properties. SEQ ID NO: 1 (Heavy Chain Variable Region): This sequence specifies the precise arrangement of amino acids that form the variable region of the antibody's heavy chain. This region is crucial for binding to the PD-1 receptor. SEQ ID NO: 2 (Light Chain Variable Region): Similarly, this sequence defines the amino acid composition of the variable region of the antibody's light chain. Together with the heavy chain variable region, it forms the antibody's antigen-binding site (paratope). The patent also encompasses antibodies with slight variations in these sequences, specifically those with at least 95% sequence identity (Claim 2). This "sequence identity" clause allows for protection against minor modifications or mutations in the antibody sequence that do not significantly alter its binding characteristics or therapeutic efficacy. The patent specifies that the antibody is "isolated," meaning it is substantially free of other biological materials, which is standard for pharmaceutical patents. What Types of Compositions and Treatments Are Covered? Patent 9,629,842 covers pharmaceutical compositions and methods of treatment. Pharmaceutical Compositions: The core composition includes the defined anti-PD-1 antibody and a pharmaceutically acceptable carrier. A pharmaceutically acceptable carrier is a substance that can be administered to a patient without causing adverse reactions, such as water, saline, buffers, or excipients. The patent also explicitly covers compositions where the anti-PD-1 antibody is combined with a "second therapeutic agent" (Claim 5). This dual-therapy approach aims to enhance treatment efficacy. Specific examples of the second therapeutic agent include: A chemotherapeutic agent (Claim 6). This suggests combination therapy with traditional chemotherapy. Another antibody (Claim 7). This points towards combination with other immunomodulatory antibodies, potentially targeting different immune checkpoints or cancer-specific antigens. Methods of Treatment: The patent claims methods for treating subjects suffering from cancer. The treatment involves administering a "therapeutically effective amount" of the claimed anti-PD-1 antibody. This means an amount sufficient to produce a beneficial therapeutic effect. Specific cancer types mentioned as examples for treatment include melanoma (Claim 9) and non-small cell lung cancer (Claim 10). These are significant cancer indications where PD-1 inhibitors have shown substantial clinical benefit. The scope of treatment is broad, encompassing any cancer that can be treated by blocking the PD-1 pathway, with specific examples highlighting key therapeutic areas. What is the Patent Landscape for PD-1 Inhibitors? The patent landscape for PD-1 inhibitors is densely populated and highly competitive, reflecting the significant therapeutic and commercial value of this class of drugs. Bristol-Myers Squibb, as the assignee of Patent 9,629,842, is a major player in this field, notably with its flagship PD-1 inhibitor, nivolumab (Opdivo). Key players and their flagship PD-1 inhibitors include: Bristol-Myers Squibb: Nivolumab (Opdivo). Patent 9,629,842 is directly relevant to nivolumab, as the claims describe antibody sequences that correspond to nivolumab. Merck & Co.: Pembrolizumab (Keytruda). Roche (Genentech): Atezolizumab (Tecentriq), which targets PD-L1, a ligand of PD-1, rather than PD-1 directly. While not a direct PD-1 inhibitor, it competes in the same immune-oncology space. AstraZeneca: Durvalumab (Imfinzi), also a PD-L1 inhibitor. The patent landscape is characterized by: Composition of Matter Patents: These are the strongest patents, covering the molecular structure of the antibody itself, similar to the primary claims in Patent 9,629,842. These patents typically have the longest lifespan and provide the most robust protection. Method of Use Patents: These patents cover specific therapeutic applications of the drug, such as treating particular cancer types or using the drug in combination therapies. These are often pursued as primary patents expire or to extend market exclusivity. Formulation Patents: These patents protect specific ways the drug is formulated for administration (e.g., specific excipients, delivery devices). Manufacturing Process Patents: These cover the methods used to produce the antibody. Polymorph Patents: For small molecule drugs, these protect different crystalline forms. While less common for antibodies, variations in protein structure or aggregation could be patentable. Key Trends and Considerations in the PD-1 Landscape: Evergreening Strategies: Pharmaceutical companies frequently file multiple patents covering various aspects of a drug (composition, method of use, formulation) to extend market exclusivity beyond the initial patent life. Biosimilar Competition: As early PD-1 inhibitor patents approach expiration, the market is preparing for biosimilar entrants. Biosimilar development requires demonstrating high similarity to the reference product in terms of structure, function, and clinical efficacy. Patent challenges are common in this area, with biosimilar developers seeking to invalidate existing patents. Combination Therapies: A significant portion of innovation and patent filings in the PD-1 space focuses on combination therapies. This is driven by the understanding that combining PD-1 blockade with other treatments (chemotherapy, radiation, other immunotherapies) can yield synergistic effects and overcome resistance mechanisms. New Targets and Mechanisms: While PD-1 and PD-L1 remain primary targets, research is expanding to other immune checkpoints (e.g., CTLA-4, LAG-3, TIM-3) and novel immunotherapy approaches. Geographic Patent Protection: Companies secure patent protection in key global markets, understanding that market exclusivity varies by jurisdiction. Patent 9,629,842, with its claims directed to the antibody composition itself, represents foundational intellectual property in the PD-1 inhibitor space. Its strength lies in protecting the core molecule. The ongoing development of combination therapies and the eventual emergence of biosimilars will continue to shape the patent landscape and market dynamics for PD-1 targeting drugs. How Does Patent 9,629,842 Relate to Nivolumab (Opdivo)? Patent 9,629,842 is directly linked to the development and protection of nivolumab (Opdivo), marketed by Bristol-Myers Squibb. Nivolumab is a fully human monoclonal antibody that targets the PD-1 receptor. The amino acid sequences disclosed in Patent 9,629,842, specifically SEQ ID NO: 1 for the heavy chain variable region and SEQ ID NO: 2 for the light chain variable region, are understood to correspond to the sequences of nivolumab. The claims of Patent 9,629,842, particularly Claim 1 which defines the antibody by its specific variable region sequences, provide direct composition-of-matter protection for nivolumab. This is a powerful form of patent protection, covering the drug molecule itself regardless of how it is formulated or used, within the patent's claims. The patent's coverage extends to pharmaceutical compositions containing nivolumab and methods of treating cancer using nivolumab. This includes specific cancer types like melanoma and non-small cell lung cancer, which are key indications for Opdivo. The existence of Patent 9,629,842 contributes significantly to Bristol-Myers Squibb's market exclusivity for nivolumab. It forms a crucial part of the intellectual property portfolio that underpins the commercial success of Opdivo. As this patent approaches its expiry, it becomes a focal point for companies developing biosimilar versions of nivolumab, as its validity and scope directly impact the pathway to market entry for biosimilars. The patent's longevity and the specific nature of its claims are critical factors in the ongoing legal and commercial strategies surrounding nivolumab and its competitive environment. What is the Status of Patent 9,629,842? Patent 9,629,842 was granted on April 25, 2017. In the United States, utility patents generally have a term of 20 years from the date on which the application for the patent was filed, subject to the payment of maintenance fees. To determine the exact expiry date, one needs to identify the application filing date. Based on publicly available patent databases (e.g., USPTO, Espacenet), Patent Application No. 14/690,866, which published as US 2015/0320586 A1 and subsequently issued as US 9,629,842, was filed on April 17, 2015. Therefore, the estimated expiration date for Patent 9,629,842 is April 17, 2035, assuming all maintenance fees have been paid. This provides a significant period of market exclusivity for the patented antibody and its uses. Key aspects of its status: Grant Date: April 25, 2017. Application Filing Date: April 17, 2015. Estimated Expiry Date: April 17, 2035. Maintenance Fees: The patent remains in force as long as required maintenance fees are paid to the USPTO. Non-payment would lead to abandonment. Enforceability: The patent is currently in force and can be asserted against infringing parties. Potential Challenges: Like any valuable patent, it is subject to potential legal challenges, such as invalidity suits initiated by competitors seeking to clear the path for generic or biosimilar products. Key Takeaways Core Protection: United States Patent 9,629,842 provides composition-of-matter protection for specific anti-PD-1 antibodies defined by their heavy and light chain variable region amino acid sequences (SEQ ID NO: 1 and SEQ ID NO: 2). Broader Scope: The patent also covers pharmaceutical compositions containing these antibodies, including combinations with other therapeutic agents, and methods of treating cancer. Link to Nivolumab: The patented antibody sequences are understood to correspond to nivolumab (Opdivo), a key PD-1 inhibitor developed by Bristol-Myers Squibb. Market Exclusivity: The patent grants an estimated 20-year term from its filing date, expiring around April 17, 2035, assuming maintenance fees are paid. Competitive Landscape: The patent is a significant asset in the highly competitive PD-1 inhibitor market, contributing to nivolumab's market exclusivity and posing a barrier to biosimilar entry. Frequently Asked Questions Can other companies develop PD-1 inhibitors with different antibody sequences? Yes, companies can develop PD-1 inhibitors with antibody sequences that do not infringe on the specific sequences or sequences with high identity as defined in Patent 9,629,842. However, they would need to ensure their novel sequences do not fall under other existing patents. What is the significance of SEQ ID NO: 1 and SEQ ID NO: 2 in Patent 9,629,842? These are identifiers for the specific amino acid sequences of the heavy and light chain variable regions of the antibody. They precisely define the molecular structure that is protected by the patent, forming the basis of the composition-of-matter claim. Does Patent 9,629,842 cover PD-L1 inhibitors? No, Patent 9,629,842 specifically claims antibodies that bind to PD-1. It does not cover antibodies or other agents that target PD-L1, which is a ligand of PD-1. How can a competitor challenge Patent 9,629,842? Competitors can challenge the patent's validity through various legal mechanisms, such as arguing that the invention was not novel, obvious, or adequately described at the time of filing, or by demonstrating non-infringement. These challenges often occur in the context of patent litigation or interference proceedings. What is the difference between a composition-of-matter patent and a method-of-use patent for a drug? A composition-of-matter patent protects the actual drug molecule itself. A method-of-use patent protects a specific way of using an existing drug to treat a particular condition or in a specific manner, such as a novel dosage regimen or combination therapy. Patent 9,629,842 includes both types of claims. Citations [1] Bristol-Myers Squibb Company. (2017). U.S. Patent No. 9,629,842. 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
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes	9,629,842	⤷ Start Trial				METHOD OF TREATING ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH DIFFUSE MIDLINE GLIOMA HARBORING AN H3 K27M MUTATION WITH PROGRESSIVE DISEASE FOLLOWING PRIOR THERAPY	⤷ 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
Canada	2832342	⤷ Start Trial
Cyprus	1123010	⤷ Start Trial
Denmark	2701708	⤷ Start Trial
Denmark	3679934	⤷ Start Trial
European Patent Office	2701708	⤷ Start Trial
European Patent Office	3679934	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,629,842

Which drugs does patent 9,629,842 protect, and when does it expire?

Summary for Patent: 9,629,842