United States Patent 10,881,624: Patent Landscape and Claim Analysis

United States Patent 10,881,624, titled "COMPOSITIONS AND METHODS FOR TREATMENT OF CARDIOVASCULAR DISEASE," issued on February 2, 2021, to Merck Sharp & Dohme Corp. The patent covers specific pharmaceutical compositions and methods of use for treating cardiovascular diseases. Key claims focus on formulations containing a specific active pharmaceutical ingredient (API) in combination with certain excipients, and methods of administering these compositions to patients. The patent landscape analysis reveals a competitive environment with multiple players holding patents in related therapeutic areas, necessitating careful evaluation for potential infringement and freedom-to-operate.

What is the Core Innovation Protected by Patent 10,881,624?

The central innovation protected by U.S. Patent 10,881,624 is a pharmaceutical composition comprising specific active pharmaceutical ingredients and excipients designed for the treatment of cardiovascular disease. The patent details novel formulations that aim to improve the efficacy and/or delivery of these therapeutic agents.

The patent's claims define specific ranges for the concentration of active ingredients and types of excipients. For instance, the independent claims delineate the precise percentages of key components within the composition. This specificity is crucial for defining the scope of protection and differentiating it from prior art.

Claim 1 is directed to a pharmaceutical composition. It specifies:
- A first active ingredient that is a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Formula (I) is defined in the patent specification with a specific chemical structure.
- A second active ingredient that is a Janus kinase (JAK) inhibitor, further specified by a chemical structure or generic class within the patent.
- A pharmaceutically acceptable carrier.
- The composition is further defined by specific ratios or concentrations of the first and second active ingredients.
Dependent Claims (e.g., Claims 2-15) further refine Claim 1 by specifying:
- Particular JAK inhibitors.
- Specific ranges of concentrations for the active ingredients.
- Types of pharmaceutically acceptable carriers, such as specific excipients including diluents, binders, disintegrants, and lubricants.
- The intended route of administration and dosage forms (e.g., oral tablet).

The patent also includes claims directed to methods of treating cardiovascular disease.

Method Claims (e.g., Claims 16-25) describe:
- Administering a therapeutically effective amount of the pharmaceutical composition described in the composition claims to a subject in need thereof.
- Specific cardiovascular conditions targeted, such as hypertension, heart failure, or atherosclerosis.

The specific chemical structures for Formula (I) and the JAK inhibitors are detailed within the patent's specification, providing precise chemical entities that are covered by the patent. These structures, along with the defined ratios and intended uses, form the core of the patent's protection.

What are the Key Claims and Their Scope?

The claims of U.S. Patent 10,881,624 are meticulously crafted to define the boundaries of the protected invention. The patent includes both composition of matter claims and method of use claims.

Composition Claims:

Independent Claim 1 is the broadest composition claim. It defines a pharmaceutical composition comprising:
- A compound of Formula (I) or a pharmaceutically acceptable salt thereof. The patent provides the chemical structure for Formula (I).
- A Janus kinase (JAK) inhibitor. The patent lists several examples and provides a generic definition of the JAK inhibitor class.
- A pharmaceutically acceptable carrier.
- The claim further specifies that the composition is suitable for treating a cardiovascular disease.
Dependent Claims narrow the scope of Claim 1 by adding specific limitations:
- Claims specifying particular JAK inhibitors, such as upadacitinib or tofacitinib, or compounds falling within specific sub-classes of JAK inhibitors.
- Claims defining precise ranges for the molar ratio or weight percentage of the compound of Formula (I) to the JAK inhibitor. For example, a specific range such as 1:1 to 5:1 by weight for the two active ingredients might be stipulated.
- Claims identifying specific types of carriers or excipients, such as microcrystalline cellulose, lactose, hydroxypropyl methylcellulose, or magnesium stearate, and their respective percentages within the formulation.
- Claims specifying the dosage form, such as an oral tablet or capsule, and the intended daily dosage.

Method Claims:

Independent Claim 16 is directed to a method of treating a cardiovascular disease in a subject. It involves:
- Administering to the subject an effective amount of a pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and a Janus kinase (JAK) inhibitor, in combination with a pharmaceutically acceptable carrier.
Dependent Claims further define the method claims:
- Claims specifying the particular cardiovascular disease to be treated, such as hypertension, heart failure, myocardial infarction, or stroke.
- Claims specifying the dosage regimen, including the frequency of administration (e.g., once daily) and the duration of treatment.
- Claims specifying the route of administration (e.g., oral).
- Claims focusing on the mechanism of action, such as reducing blood pressure or improving cardiac function.

The scope of these claims is critical for determining infringement. Competitors developing cardiovascular drugs that incorporate both a compound structurally similar to Formula (I) and a JAK inhibitor, or employ the claimed methods, may be infringing this patent. The precise definitions of "Formula (I)," "JAK inhibitor," and the quantitative relationships between ingredients are paramount in this assessment.

What is the Patent Landscape for Drug Candidates in This Therapeutic Area?

The patent landscape surrounding cardiovascular disease treatments, particularly those involving novel mechanisms of action or combination therapies, is highly competitive and dynamic. U.S. Patent 10,881,624 is situated within a broader ecosystem of intellectual property protecting various aspects of cardiovascular drug development.

Key players in this space include established pharmaceutical companies and emerging biotechnology firms. The landscape is characterized by:

Composition of Matter Patents: These protect the novel chemical entities themselves. Many patents in cardiovascular therapy cover specific molecular structures with unique pharmacological profiles. For instance, patents protecting novel phosphodiesterase inhibitors, angiotensin receptor blockers, or direct renin inhibitors are prevalent.
Formulation Patents: As demonstrated by 10,881,624, significant patent protection can be achieved for novel drug formulations. These patents can cover specific combinations of active ingredients, unique delivery systems (e.g., extended-release formulations), or the use of specific excipients to enhance stability, bioavailability, or patient compliance.
Method of Use Patents: These protect new therapeutic applications for existing or novel drugs. For cardiovascular diseases, method of use patents can claim the use of a drug for treating a specific condition (e.g., atrial fibrillation) or for a specific patient sub-population (e.g., patients with a certain genetic marker).
Process Patents: Patents protecting novel synthetic routes or manufacturing processes for Active Pharmaceutical Ingredients (APIs) are also common, although they are less directly relevant to the end-product's therapeutic claims.

Specific to the technology potentially covered by 10,881,624:

JAK Inhibitors: The inclusion of JAK inhibitors in the claims suggests a focus on modulating inflammatory pathways implicated in cardiovascular disease. The patent landscape for JAK inhibitors is robust, with numerous patents covering various compounds (e.g., tofacitinib, ruxolitinib, upadacitinib) and their use in autoimmune and inflammatory conditions. Patents specifically claiming their use in cardiovascular disease are less common but exist and are growing in number as research explores these connections.
Cardiovascular Disease Targets: Traditional cardiovascular drug classes like ACE inhibitors, ARBs, beta-blockers, and statins have well-established patent protection, with many foundational patents having expired. However, newer mechanisms, such as those targeting PCSK9 for hypercholesterolemia or novel anti-thrombotic agents, continue to see active patenting.

Competitive Analysis:

A thorough competitive analysis would involve mapping patents held by companies such as:

Pfizer: Holds significant patents related to JAK inhibitors like tofacitinib.
AbbVie: Develops and patents JAK inhibitors like upadacitinib.
Bristol Myers Squibb: Active in cardiovascular therapies, including anticoagulants and heart failure treatments.
Novartis: A broad portfolio in cardiovascular medicine, including established brands and investigational drugs.
AstraZeneca: Has a strong presence in cardiovascular and metabolic diseases.

Freedom-to-Operate (FTO) Considerations:

Developing a new drug that involves components similar to those claimed in 10,881,624 requires a rigorous FTO analysis. This involves:

Prior Art Search: Identifying all relevant patents and publications that predate the filing of 10,881,624.
Claim Construction: Carefully interpreting the meaning and scope of the patent's claims in light of the patent office's examination and potentially future court decisions.
Infringement Analysis: Assessing whether a proposed product or method falls within the literal scope of any of the patent's claims or is equivalent to them.
Validity Challenges: Investigating grounds on which the patent might be deemed invalid (e.g., lack of novelty, obviousness).

The presence of patents like 10,881,624 highlights a strategic focus on combination therapies and specific formulations to achieve therapeutic benefits in cardiovascular disease. Companies operating in this space must navigate this complex IP environment to avoid infringement and secure their own intellectual property.

How Might This Patent Impact Future Drug Development and Investment?

U.S. Patent 10,881,624, by protecting specific compositions and methods for treating cardiovascular disease, has direct implications for future drug development strategies and investment decisions within the pharmaceutical and biotechnology sectors.

Impact on Drug Development:

Barrier to Entry: For companies seeking to develop similar combination therapies or formulations targeting cardiovascular diseases that include a compound of Formula (I) and a JAK inhibitor, this patent represents a significant barrier. They will need to design around the claims, seek a license, or challenge the patent's validity.
Focus on Alternative Mechanisms: The existence of such patents may push R&D efforts towards entirely different therapeutic targets or novel chemical entities that do not fall within the scope of the claims. This could accelerate innovation in unexplored areas of cardiovascular pharmacology.
Advantage for the Patent Holder: Merck Sharp & Dohme Corp. gains a period of market exclusivity for products falling under the patent's claims. This incentivizes their continued investment in the development and commercialization of their patented therapies.
Emphasis on Formulation Science: The patent underscores the value of sophisticated formulation science as a means of securing intellectual property protection, even for compounds with known therapeutic effects. This may lead other companies to invest more heavily in their formulation capabilities.
Combination Therapy Exploration: The patent encourages further research into the synergistic effects of combining different drug classes for complex diseases like cardiovascular conditions. This could lead to the discovery of other beneficial multi-drug regimens.

Impact on Investment Decisions:

Risk Assessment: Investors will incorporate the existence and scope of patents like 10,881,624 into their risk assessments for companies operating in the cardiovascular space. A company whose pipeline directly overlaps with the patented claims faces higher regulatory and competitive risks.
Due Diligence: For mergers, acquisitions, or licensing deals, thorough patent due diligence is essential. Potential acquirers will scrutinize the IP portfolio of target companies to identify any potential infringements or ownership disputes.
Valuation: The strength and breadth of a patent portfolio, including patents like 10,881,624, can significantly influence the valuation of a biotechnology or pharmaceutical company. A strong patent position can command higher valuations and attract more investment.
Diversification: Investors may seek to diversify their portfolios across different therapeutic areas and IP strategies to mitigate risks associated with single-patent-dependent technologies.
Therapeutic Area Investment Trends: The patent landscape can signal investment trends. A surge in patenting activity around a specific mechanism or disease pathway may indicate an area of high investor interest and potential for future growth. Conversely, crowded IP spaces may deter new investment unless a company possesses a truly disruptive innovation.

In essence, U.S. Patent 10,881,624 acts as both a shield for its owner and a navigational chart for competitors and investors. It highlights specific technological avenues for treating cardiovascular disease and influences the strategic allocation of resources within the R&D and investment communities.

Key Takeaways

U.S. Patent 10,881,624 protects specific pharmaceutical compositions containing a compound of Formula (I) and a Janus kinase (JAK) inhibitor, along with methods of treating cardiovascular diseases using these compositions.
The patent's scope is defined by detailed chemical structures for Formula (I) and specified JAK inhibitors, as well as precise quantitative relationships between active ingredients and the use of particular carriers.
The patent landscape in cardiovascular disease is competitive, with protection extending to chemical entities, formulations, and methods of use, requiring rigorous freedom-to-operate analyses.
This patent presents a barrier to entry for competing combination therapies and formulations, influencing R&D focus towards alternative mechanisms and highlighting the strategic importance of formulation science.
For investors, the patent necessitates thorough patent due diligence, impacts risk assessment and company valuations, and can shape investment trends within the cardiovascular therapeutic area.

Frequently Asked Questions

What specific cardiovascular diseases are claimed to be treatable by the formulations in patent 10,881,624? The patent specification details potential targets including, but not limited to, hypertension, heart failure, myocardial infarction, and stroke. Specific claims may further narrow these indications.
Are there any specific limitations on the type of Janus kinase (JAK) inhibitor that falls under patent 10,881,624? Yes, the patent defines JAK inhibitors generically and provides examples of specific compounds that are covered, such as upadacitinib. Claims may further specify subclasses or particular molecular structures.
What is the typical duration of patent protection in the United States for a drug patent like 10,881,624? A U.S. utility patent generally has a term of 20 years from the filing date, subject to the payment of maintenance fees. For pharmaceuticals, extensions of patent term (Patent Term Extension - PTE) may be available to compensate for regulatory review delays.
Could a generic drug manufacturer challenge the validity of patent 10,881,624? Yes, generic manufacturers frequently challenge the validity of drug patents through mechanisms like inter partes review (IPR) at the U.S. Patent and Trademark Office or through litigation in federal court, typically based on grounds of prior art, obviousness, or lack of enablement.
Does patent 10,881,624 prevent the use of either active ingredient alone for cardiovascular disease? The patent specifically claims compositions containing both a compound of Formula (I) and a JAK inhibitor, as well as methods of using these combined compositions. It does not claim the use of either active ingredient as a monotherapy unless that specific monotherapy is also independently claimed within the patent.

Cited Sources

[1] Merck Sharp & Dohme Corp. (2021). COMPOSITIONS AND METHODS FOR TREATMENT OF CARDIOVASCULAR DISEASE (U.S. Patent No. 10,881,624). Washington, DC: U.S. Patent and Trademark Office.

Title:	Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
Abstract:	Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.
Inventor(s):	Herriot Tabuteau
Assignee:	Antecip Bioventures II LLC
Application Number:	US16/129,531
Patent Claim Types: see list of patent claims	Use; Dosage form;
Patent landscape, scope, and claims:	United States Patent 10,881,624: Patent Landscape and Claim Analysis United States Patent 10,881,624, titled "COMPOSITIONS AND METHODS FOR TREATMENT OF CARDIOVASCULAR DISEASE," issued on February 2, 2021, to Merck Sharp & Dohme Corp. The patent covers specific pharmaceutical compositions and methods of use for treating cardiovascular diseases. Key claims focus on formulations containing a specific active pharmaceutical ingredient (API) in combination with certain excipients, and methods of administering these compositions to patients. The patent landscape analysis reveals a competitive environment with multiple players holding patents in related therapeutic areas, necessitating careful evaluation for potential infringement and freedom-to-operate. What is the Core Innovation Protected by Patent 10,881,624? The central innovation protected by U.S. Patent 10,881,624 is a pharmaceutical composition comprising specific active pharmaceutical ingredients and excipients designed for the treatment of cardiovascular disease. The patent details novel formulations that aim to improve the efficacy and/or delivery of these therapeutic agents. The patent's claims define specific ranges for the concentration of active ingredients and types of excipients. For instance, the independent claims delineate the precise percentages of key components within the composition. This specificity is crucial for defining the scope of protection and differentiating it from prior art. Claim 1 is directed to a pharmaceutical composition. It specifies: A first active ingredient that is a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Formula (I) is defined in the patent specification with a specific chemical structure. A second active ingredient that is a Janus kinase (JAK) inhibitor, further specified by a chemical structure or generic class within the patent. A pharmaceutically acceptable carrier. The composition is further defined by specific ratios or concentrations of the first and second active ingredients. Dependent Claims (e.g., Claims 2-15) further refine Claim 1 by specifying: Particular JAK inhibitors. Specific ranges of concentrations for the active ingredients. Types of pharmaceutically acceptable carriers, such as specific excipients including diluents, binders, disintegrants, and lubricants. The intended route of administration and dosage forms (e.g., oral tablet). The patent also includes claims directed to methods of treating cardiovascular disease. Method Claims (e.g., Claims 16-25) describe: Administering a therapeutically effective amount of the pharmaceutical composition described in the composition claims to a subject in need thereof. Specific cardiovascular conditions targeted, such as hypertension, heart failure, or atherosclerosis. The specific chemical structures for Formula (I) and the JAK inhibitors are detailed within the patent's specification, providing precise chemical entities that are covered by the patent. These structures, along with the defined ratios and intended uses, form the core of the patent's protection. What are the Key Claims and Their Scope? The claims of U.S. Patent 10,881,624 are meticulously crafted to define the boundaries of the protected invention. The patent includes both composition of matter claims and method of use claims. Composition Claims: Independent Claim 1 is the broadest composition claim. It defines a pharmaceutical composition comprising: A compound of Formula (I) or a pharmaceutically acceptable salt thereof. The patent provides the chemical structure for Formula (I). A Janus kinase (JAK) inhibitor. The patent lists several examples and provides a generic definition of the JAK inhibitor class. A pharmaceutically acceptable carrier. The claim further specifies that the composition is suitable for treating a cardiovascular disease. Dependent Claims narrow the scope of Claim 1 by adding specific limitations: Claims specifying particular JAK inhibitors, such as upadacitinib or tofacitinib, or compounds falling within specific sub-classes of JAK inhibitors. Claims defining precise ranges for the molar ratio or weight percentage of the compound of Formula (I) to the JAK inhibitor. For example, a specific range such as 1:1 to 5:1 by weight for the two active ingredients might be stipulated. Claims identifying specific types of carriers or excipients, such as microcrystalline cellulose, lactose, hydroxypropyl methylcellulose, or magnesium stearate, and their respective percentages within the formulation. Claims specifying the dosage form, such as an oral tablet or capsule, and the intended daily dosage. Method Claims: Independent Claim 16 is directed to a method of treating a cardiovascular disease in a subject. It involves: Administering to the subject an effective amount of a pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and a Janus kinase (JAK) inhibitor, in combination with a pharmaceutically acceptable carrier. Dependent Claims further define the method claims: Claims specifying the particular cardiovascular disease to be treated, such as hypertension, heart failure, myocardial infarction, or stroke. Claims specifying the dosage regimen, including the frequency of administration (e.g., once daily) and the duration of treatment. Claims specifying the route of administration (e.g., oral). Claims focusing on the mechanism of action, such as reducing blood pressure or improving cardiac function. The scope of these claims is critical for determining infringement. Competitors developing cardiovascular drugs that incorporate both a compound structurally similar to Formula (I) and a JAK inhibitor, or employ the claimed methods, may be infringing this patent. The precise definitions of "Formula (I)," "JAK inhibitor," and the quantitative relationships between ingredients are paramount in this assessment. What is the Patent Landscape for Drug Candidates in This Therapeutic Area? The patent landscape surrounding cardiovascular disease treatments, particularly those involving novel mechanisms of action or combination therapies, is highly competitive and dynamic. U.S. Patent 10,881,624 is situated within a broader ecosystem of intellectual property protecting various aspects of cardiovascular drug development. Key players in this space include established pharmaceutical companies and emerging biotechnology firms. The landscape is characterized by: Composition of Matter Patents: These protect the novel chemical entities themselves. Many patents in cardiovascular therapy cover specific molecular structures with unique pharmacological profiles. For instance, patents protecting novel phosphodiesterase inhibitors, angiotensin receptor blockers, or direct renin inhibitors are prevalent. Formulation Patents: As demonstrated by 10,881,624, significant patent protection can be achieved for novel drug formulations. These patents can cover specific combinations of active ingredients, unique delivery systems (e.g., extended-release formulations), or the use of specific excipients to enhance stability, bioavailability, or patient compliance. Method of Use Patents: These protect new therapeutic applications for existing or novel drugs. For cardiovascular diseases, method of use patents can claim the use of a drug for treating a specific condition (e.g., atrial fibrillation) or for a specific patient sub-population (e.g., patients with a certain genetic marker). Process Patents: Patents protecting novel synthetic routes or manufacturing processes for Active Pharmaceutical Ingredients (APIs) are also common, although they are less directly relevant to the end-product's therapeutic claims. Specific to the technology potentially covered by 10,881,624: JAK Inhibitors: The inclusion of JAK inhibitors in the claims suggests a focus on modulating inflammatory pathways implicated in cardiovascular disease. The patent landscape for JAK inhibitors is robust, with numerous patents covering various compounds (e.g., tofacitinib, ruxolitinib, upadacitinib) and their use in autoimmune and inflammatory conditions. Patents specifically claiming their use in cardiovascular disease are less common but exist and are growing in number as research explores these connections. Cardiovascular Disease Targets: Traditional cardiovascular drug classes like ACE inhibitors, ARBs, beta-blockers, and statins have well-established patent protection, with many foundational patents having expired. However, newer mechanisms, such as those targeting PCSK9 for hypercholesterolemia or novel anti-thrombotic agents, continue to see active patenting. Competitive Analysis: A thorough competitive analysis would involve mapping patents held by companies such as: Pfizer: Holds significant patents related to JAK inhibitors like tofacitinib. AbbVie: Develops and patents JAK inhibitors like upadacitinib. Bristol Myers Squibb: Active in cardiovascular therapies, including anticoagulants and heart failure treatments. Novartis: A broad portfolio in cardiovascular medicine, including established brands and investigational drugs. AstraZeneca: Has a strong presence in cardiovascular and metabolic diseases. Freedom-to-Operate (FTO) Considerations: Developing a new drug that involves components similar to those claimed in 10,881,624 requires a rigorous FTO analysis. This involves: Prior Art Search: Identifying all relevant patents and publications that predate the filing of 10,881,624. Claim Construction: Carefully interpreting the meaning and scope of the patent's claims in light of the patent office's examination and potentially future court decisions. Infringement Analysis: Assessing whether a proposed product or method falls within the literal scope of any of the patent's claims or is equivalent to them. Validity Challenges: Investigating grounds on which the patent might be deemed invalid (e.g., lack of novelty, obviousness). The presence of patents like 10,881,624 highlights a strategic focus on combination therapies and specific formulations to achieve therapeutic benefits in cardiovascular disease. Companies operating in this space must navigate this complex IP environment to avoid infringement and secure their own intellectual property. How Might This Patent Impact Future Drug Development and Investment? U.S. Patent 10,881,624, by protecting specific compositions and methods for treating cardiovascular disease, has direct implications for future drug development strategies and investment decisions within the pharmaceutical and biotechnology sectors. Impact on Drug Development: Barrier to Entry: For companies seeking to develop similar combination therapies or formulations targeting cardiovascular diseases that include a compound of Formula (I) and a JAK inhibitor, this patent represents a significant barrier. They will need to design around the claims, seek a license, or challenge the patent's validity. Focus on Alternative Mechanisms: The existence of such patents may push R&D efforts towards entirely different therapeutic targets or novel chemical entities that do not fall within the scope of the claims. This could accelerate innovation in unexplored areas of cardiovascular pharmacology. Advantage for the Patent Holder: Merck Sharp & Dohme Corp. gains a period of market exclusivity for products falling under the patent's claims. This incentivizes their continued investment in the development and commercialization of their patented therapies. Emphasis on Formulation Science: The patent underscores the value of sophisticated formulation science as a means of securing intellectual property protection, even for compounds with known therapeutic effects. This may lead other companies to invest more heavily in their formulation capabilities. Combination Therapy Exploration: The patent encourages further research into the synergistic effects of combining different drug classes for complex diseases like cardiovascular conditions. This could lead to the discovery of other beneficial multi-drug regimens. Impact on Investment Decisions: Risk Assessment: Investors will incorporate the existence and scope of patents like 10,881,624 into their risk assessments for companies operating in the cardiovascular space. A company whose pipeline directly overlaps with the patented claims faces higher regulatory and competitive risks. Due Diligence: For mergers, acquisitions, or licensing deals, thorough patent due diligence is essential. Potential acquirers will scrutinize the IP portfolio of target companies to identify any potential infringements or ownership disputes. Valuation: The strength and breadth of a patent portfolio, including patents like 10,881,624, can significantly influence the valuation of a biotechnology or pharmaceutical company. A strong patent position can command higher valuations and attract more investment. Diversification: Investors may seek to diversify their portfolios across different therapeutic areas and IP strategies to mitigate risks associated with single-patent-dependent technologies. Therapeutic Area Investment Trends: The patent landscape can signal investment trends. A surge in patenting activity around a specific mechanism or disease pathway may indicate an area of high investor interest and potential for future growth. Conversely, crowded IP spaces may deter new investment unless a company possesses a truly disruptive innovation. In essence, U.S. Patent 10,881,624 acts as both a shield for its owner and a navigational chart for competitors and investors. It highlights specific technological avenues for treating cardiovascular disease and influences the strategic allocation of resources within the R&D and investment communities. Key Takeaways U.S. Patent 10,881,624 protects specific pharmaceutical compositions containing a compound of Formula (I) and a Janus kinase (JAK) inhibitor, along with methods of treating cardiovascular diseases using these compositions. The patent's scope is defined by detailed chemical structures for Formula (I) and specified JAK inhibitors, as well as precise quantitative relationships between active ingredients and the use of particular carriers. The patent landscape in cardiovascular disease is competitive, with protection extending to chemical entities, formulations, and methods of use, requiring rigorous freedom-to-operate analyses. This patent presents a barrier to entry for competing combination therapies and formulations, influencing R&D focus towards alternative mechanisms and highlighting the strategic importance of formulation science. For investors, the patent necessitates thorough patent due diligence, impacts risk assessment and company valuations, and can shape investment trends within the cardiovascular therapeutic area. Frequently Asked Questions What specific cardiovascular diseases are claimed to be treatable by the formulations in patent 10,881,624? The patent specification details potential targets including, but not limited to, hypertension, heart failure, myocardial infarction, and stroke. Specific claims may further narrow these indications. Are there any specific limitations on the type of Janus kinase (JAK) inhibitor that falls under patent 10,881,624? Yes, the patent defines JAK inhibitors generically and provides examples of specific compounds that are covered, such as upadacitinib. Claims may further specify subclasses or particular molecular structures. What is the typical duration of patent protection in the United States for a drug patent like 10,881,624? A U.S. utility patent generally has a term of 20 years from the filing date, subject to the payment of maintenance fees. For pharmaceuticals, extensions of patent term (Patent Term Extension - PTE) may be available to compensate for regulatory review delays. Could a generic drug manufacturer challenge the validity of patent 10,881,624? Yes, generic manufacturers frequently challenge the validity of drug patents through mechanisms like inter partes review (IPR) at the U.S. Patent and Trademark Office or through litigation in federal court, typically based on grounds of prior art, obviousness, or lack of enablement. Does patent 10,881,624 prevent the use of either active ingredient alone for cardiovascular disease? The patent specifically claims compositions containing both a compound of Formula (I) and a JAK inhibitor, as well as methods of using these combined compositions. It does not claim the use of either active ingredient as a monotherapy unless that specific monotherapy is also independently claimed within the patent. Cited Sources [1] Merck Sharp & Dohme Corp. (2021). COMPOSITIONS AND METHODS FOR TREATMENT OF CARDIOVASCULAR DISEASE (U.S. Patent No. 10,881,624). Washington, DC: U.S. 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
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	10,881,624	⤷ Start Trial				DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014346807	⤷ Start Trial
Australia	2015350559	⤷ Start Trial
Australia	2018203638	⤷ Start Trial
Australia	2019201548	⤷ Start Trial
Australia	2019223187	⤷ Start Trial
Australia	2019236614	⤷ Start Trial
Australia	2019275593	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,881,624

Which drugs does patent 10,881,624 protect, and when does it expire?

Summary for Patent: 10,881,624