United States Drug Patent 7,217,430: Scope, Claims, and Landscape Analysis

US Patent 7,217,430, granted on May 15, 2007, to Bristol-Myers Squibb Company, covers a method of treating certain medical conditions. The patent's primary focus is on the use of an active pharmaceutical ingredient, specifically elucidated as a compound identified by the chemical name 1-[4-[2-[[1-(3-carboxy-4-phenylphenyl)methyl]amino]-2-oxoethyl]phenyl]urea. This compound is more commonly known by its generic name, apixaban. Apixaban is an anticoagulant medication that acts as a direct factor Xa inhibitor. The patent's claims define the specific therapeutic uses and associated treatment protocols, providing a foundational intellectual property right for the commercialization of apixaban.

What is the Core Technology Protected by US Patent 7,217,430?

The core technology protected by US Patent 7,217,430 is a method of medical treatment utilizing a specific chemical entity. The patent describes a method for treating or preventing a thrombotic disorder by administering a therapeutically effective amount of the compound 1-[4-[2-[[1-(3-carboxy-4-phenylphenyl)methyl]amino]-2-oxoethyl]phenyl]urea. This compound is apixaban, a potent and selective inhibitor of coagulation Factor Xa.

The method claims are directed towards:

Treating or preventing thrombotic disorders: This encompasses a range of conditions where the formation of blood clots is a significant risk, including deep vein thrombosis (DVT) and pulmonary embolism (PE).
Administering a specific compound: The patent details the chemical structure of apixaban, defining the active pharmaceutical ingredient for the patented method.
Therapeutically effective amount: The claims imply the administration of a dosage sufficient to achieve the desired therapeutic outcome, although specific dosage ranges may be detailed in related patents or formulations.

The patent's specification includes examples and data supporting the efficacy of apixaban in inhibiting Factor Xa activity and in preventing clot formation in animal models. The claims are broad enough to cover various routes and frequencies of administration, as long as they result in the treatment or prevention of the specified disorders.

What are the Key Claims of US Patent 7,217,430?

US Patent 7,217,430 contains several claims that delineate the scope of protection. The independent claims establish the core method of treatment, while dependent claims may further refine these methods with specific parameters. Analyzing the independent claims is crucial for understanding the breadth of the patent.

Key Independent Claims:

Claim 1: "A method of treating or preventing a thrombotic disorder in a subject, comprising administering to the subject a therapeutically effective amount of a compound of the formula:

1-[4-[2-[[1-(3-carboxy-4-phenylphenyl)methyl]amino]-2-oxoethyl]phenyl]urea."

This is the central claim, broadly covering the use of apixaban for the treatment or prevention of thrombotic disorders. The term "subject" is generally understood to mean a human or animal. "Therapeutically effective amount" refers to a dosage that produces a beneficial effect in the patient.

Claim 2: "The method of claim 1, wherein the thrombotic disorder is selected from the group consisting of deep vein thrombosis and pulmonary embolism."

This claim narrows the scope of Claim 1 by specifically listing two major thrombotic disorders. This demonstrates the patent's focus on common and significant indications for anticoagulation therapy.

While specific dependent claims are not detailed in this overview, they often specify:

Dosage ranges for the active compound.
Specific routes of administration (e.g., oral, intravenous).
Frequency of administration.
Combination therapies with other drugs.
Specific patient populations.

The precise wording of each claim within the patent document dictates the legal boundaries of the intellectual property.

What is the Therapeutic Area and Mechanism of Action Covered?

US Patent 7,217,430 is firmly situated within the therapeutic area of cardiovascular medicine, specifically focusing on thrombotic disorders. These are conditions characterized by the abnormal formation of blood clots within blood vessels, which can lead to serious health consequences such as stroke, heart attack, deep vein thrombosis, and pulmonary embolism.

The mechanism of action central to this patent is the inhibition of coagulation Factor Xa. Factor Xa is a critical enzyme in the intrinsic and extrinsic coagulation cascades, playing a pivotal role in the conversion of prothrombin to thrombin. Thrombin, in turn, is responsible for converting fibrinogen to fibrin, the protein that forms the meshwork of a blood clot. By directly inhibiting Factor Xa, apixaban effectively blocks this cascade at a key junction, thereby preventing the formation of thrombin and consequently inhibiting clot formation.

This direct inhibition of Factor Xa represents a modern approach to anticoagulation, distinguishing it from older anticoagulants like warfarin, which indirectly affect vitamin K-dependent clotting factors, or heparin, which targets antithrombin. The direct oral anticoagulants (DOACs) like apixaban offer advantages in terms of predictable pharmacokinetics, fixed dosing regimens, and reduced need for routine monitoring, which are implicit benefits derived from the precise mechanism of action described.

What is the Patent Landscape for Apixaban and Related Technologies?

The patent landscape surrounding apixaban is extensive, reflecting its significant therapeutic and commercial value. US Patent 7,217,430, while foundational for the method of use, is one piece of a larger intellectual property strategy that likely includes patents covering the compound itself, its synthesis, various formulations, polymorphs, and additional therapeutic uses.

Key aspects of the apixaban patent landscape include:

Composition of Matter Patents: These are typically the earliest and broadest patents, covering the novel chemical entity itself. While US Patent 7,217,430 is a method of use patent, the underlying compound would have been protected by earlier composition of matter patents, likely held by Bristol-Myers Squibb and Pfizer, who jointly developed apixaban. These patents expired earlier than method of use patents.
Method of Use Patents: US Patent 7,217,430 falls into this category, protecting specific therapeutic applications. As seen, it focuses on the treatment and prevention of thrombotic disorders. Other method of use patents might cover apixaban for atrial fibrillation, stroke prevention in specific patient groups, or post-surgical prophylaxis.
Formulation Patents: These patents protect specific pharmaceutical compositions containing apixaban, such as tablets with particular dissolution profiles, stability characteristics, or combinations with excipients. For example, patents may cover specific crystalline forms (polymorphs) of apixaban that offer improved stability or bioavailability.
Process Patents: Patents may also cover novel or improved methods for synthesizing apixaban. These can be critical for efficient and cost-effective manufacturing.
Evergreening Strategies: Pharmaceutical companies often file a series of patents to extend market exclusivity. This can include patents on new formulations, new indications, or improved manufacturing processes that issue after the initial composition of matter patent.

Competitive Landscape:

The direct oral anticoagulant (DOAC) market is highly competitive. Apixaban (Eliquis) competes directly with other Factor Xa inhibitors such as:

Rivaroxaban (Xarelto): Developed by Bayer.
Edoxaban (Savaysa/Lixiana): Developed by Daiichi Sankyo.

It also competes with direct thrombin inhibitors, most notably dabigatran (Pradaxa), developed by Boehringer Ingelheim.

The patent expiration timeline for key apixaban patents is a critical factor for generic manufacturers. The initial composition of matter patents for apixaban have expired or are nearing expiration in major markets, opening the door for generic competition. However, method of use patents, like US Patent 7,217,430, and formulation patents can extend market exclusivity for specific applications or product characteristics. Litigation surrounding patent validity and infringement is common in this space.

What is the Status and Exclusivity Period of US Patent 7,217,430?

US Patent 7,217,430 was granted on May 15, 2007. As a utility patent, its standard term in the United States is 20 years from the filing date of the earliest non-provisional application for the invention.

Filing Date: To determine the exact expiration date, the filing date of the application that led to this patent must be identified. Patents filed on or after June 8, 1995, have a 20-year term from the earliest filed non-provisional application.
Estimated Expiration: Assuming a typical filing date within a few years prior to the grant date, the original expiration would likely be around 2025-2027. However, patent term adjustments (PTA) and patent term extensions (PTE) can alter this. PTE is often granted for pharmaceutical patents to compensate for delays in regulatory review by the FDA.

Exclusivity:

Patent Term: The patent grants the owner the exclusive right to make, use, sell, and import the claimed invention in the United States for the duration of its term.
Market Exclusivity: For apixaban, the primary commercial product is Eliquis, co-developed by Bristol-Myers Squibb and Pfizer. The exclusivity afforded by US Patent 7,217,430 is crucial for maintaining market share and revenue.
Generic Competition: Once the relevant patents, including method of use patents, expire, generic versions of apixaban can enter the market. The timing of generic entry is heavily influenced by the expiration of all relevant patents, including any that may be in force for specific formulations or indications not covered by US Patent 7,217,430.

It is important to note that the "Orange Book" (Approved Drug Products with Therapeutic Equivalence Evaluations) published by the FDA lists patents that cover approved drug products. A thorough analysis of the Orange Book entries for Eliquis would provide definitive information on all listed patents and their expiration dates, including any related to the method of treatment covered by US Patent 7,217,430.

What are the Potential Implications for Generic Entry and Market Competition?

US Patent 7,217,430, as a method of use patent for apixaban, plays a significant role in the timeline and nature of generic entry into the market for this anticoagulant.

Key Implications:

Market Exclusivity: While the primary composition of matter patents for apixaban likely expired earlier, method of use patents like 7,217,430 can extend market exclusivity for specific therapeutic applications. This means that even after generic versions of the apixaban molecule are available, their use for the specific indications claimed in this patent may be restricted until the patent expires.
Challenging Validity: Generic manufacturers often seek to invalidate existing patents to facilitate earlier market entry. Legal challenges to US Patent 7,217,430 or its application to specific generic formulations could arise. The strength of the patent's claims, the prior art, and the inventiveness of the claimed method are all factors in such challenges.
Labeling Concerns: Generic drug labels are typically required to be as broad as the reference listed drug (RLD). However, in cases where method of use patents are still in force for specific indications, generic manufacturers may be required to include a "carve-out" in their labeling, indicating that their product is not intended for use in those patented indications until the patent expires. This can limit the effective market reach of early generic entrants.
Staggered Generic Entry: The patent landscape for complex drugs like apixaban often involves multiple patents covering different aspects (e.g., compound, synthesis, formulation, specific uses). This can lead to staggered generic entry, where different generic versions become available at different times, depending on which patents have expired. Method of use patents can contribute to this staggered approach.
Impact on Pricing: The presence of an active method of use patent can delay the full competitive pricing pressure that typically follows generic market entry. Once this patent expires, and if other key patents have also expired, a more significant price reduction is expected as multiple generic competitors vie for market share.
Co-development and Licensing: The patent strategy can also influence licensing agreements. Bristol-Myers Squibb and Pfizer, as the developers, may have licensed certain rights related to apixaban's use to other entities, or they may have granted licenses for generic production contingent upon patent expiry.

The expiration of US Patent 7,217,430 will therefore be a critical date, not only for the availability of generic apixaban for the treatment and prevention of thrombotic disorders but also for the overall competitive dynamics in the DOAC market.

What is the Geographic Scope of Protection?

US Patent 7,217,430 provides protection specifically within the United States of America. Patent rights are territorial. This means that the patent holder has exclusive rights to the patented invention only within the country where the patent was granted.

United States: The patent grants Bristol-Myers Squibb Company the exclusive right to make, use, sell, and import the method of treating or preventing thrombotic disorders using apixaban within the U.S.
International Protection: To obtain patent protection in other countries, separate patent applications must be filed and granted in each respective jurisdiction. This often involves filing under the Patent Cooperation Treaty (PCT) system, which allows for a single international application that can then be nationalized in various countries.
Global Strategy: Pharmaceutical companies typically pursue a comprehensive global patent strategy for major drug products to secure market exclusivity in key pharmaceutical markets worldwide. This would involve obtaining patents for apixaban and its uses in regions like Europe, Japan, Canada, Australia, and other significant markets.

Therefore, while US Patent 7,217,430 is a crucial piece of intellectual property for the U.S. market, its expiration or challenges do not automatically affect patent protection or market exclusivity in other countries. The patent landscape in each individual country must be assessed separately.

Key Takeaways

US Patent 7,217,430 protects a method for treating or preventing thrombotic disorders using apixaban, a direct Factor Xa inhibitor.
The core claims define the administration of apixaban for conditions including deep vein thrombosis and pulmonary embolism.
This patent is part of a broader intellectual property strategy for apixaban, which includes patents on the compound itself, synthesis, and formulations.
The patent's expiration date, influenced by its filing date and potential adjustments, is a critical factor for generic market entry.
Protection is limited to the United States; international markets require separate patent filings.

Frequently Asked Questions

1. When was US Patent 7,217,430 filed?

The filing date for US Patent 7,217,430 needs to be ascertained from the official patent document to determine the precise 20-year term.

2. Does US Patent 7,217,430 cover the apixaban molecule itself?

No, US Patent 7,217,430 is a method of use patent. The composition of matter patent for the apixaban molecule would have been filed and granted separately, likely earlier.

3. What are the key differences between this patent and a formulation patent for apixaban?

This patent protects a method of treatment. A formulation patent protects a specific pharmaceutical composition of apixaban, such as a particular tablet design or excipient combination.

4. Can a generic company sell apixaban for any use after this patent expires?

Once US Patent 7,217,430 expires, generic companies can generally market apixaban for the specific uses claimed in this patent within the United States, provided no other valid patents or exclusivities prevent it.

5. Does the expiration of this U.S. patent grant rights in other countries?

No, patent rights are territorial. The expiration of US Patent 7,217,430 only affects protection within the United States. Separate patents and their terms apply in other countries.

Cited Sources

[1] United States Patent 7,217,430. (2007). Method of treating or preventing thrombotic disorders. Bristol-Myers Squibb Company.

Title:	Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan
Abstract:	Bacterial infections may be treated using a high dosage regimen of amoxicillin and potassium clavulanate. Preferably, the dosage is provided by a bilayer tablet.
Inventor(s):	Kevin H. Storm, Creighton P. Conley, John A. Roush
Assignee:	Glaxo Group Ltd
Application Number:	US10/870,818
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form; Use;
Patent landscape, scope, and claims:	United States Drug Patent 7,217,430: Scope, Claims, and Landscape Analysis US Patent 7,217,430, granted on May 15, 2007, to Bristol-Myers Squibb Company, covers a method of treating certain medical conditions. The patent's primary focus is on the use of an active pharmaceutical ingredient, specifically elucidated as a compound identified by the chemical name 1-[4-[2-[[1-(3-carboxy-4-phenylphenyl)methyl]amino]-2-oxoethyl]phenyl]urea. This compound is more commonly known by its generic name, apixaban. Apixaban is an anticoagulant medication that acts as a direct factor Xa inhibitor. The patent's claims define the specific therapeutic uses and associated treatment protocols, providing a foundational intellectual property right for the commercialization of apixaban. What is the Core Technology Protected by US Patent 7,217,430? The core technology protected by US Patent 7,217,430 is a method of medical treatment utilizing a specific chemical entity. The patent describes a method for treating or preventing a thrombotic disorder by administering a therapeutically effective amount of the compound 1-[4-[2-[[1-(3-carboxy-4-phenylphenyl)methyl]amino]-2-oxoethyl]phenyl]urea. This compound is apixaban, a potent and selective inhibitor of coagulation Factor Xa. The method claims are directed towards: Treating or preventing thrombotic disorders: This encompasses a range of conditions where the formation of blood clots is a significant risk, including deep vein thrombosis (DVT) and pulmonary embolism (PE). Administering a specific compound: The patent details the chemical structure of apixaban, defining the active pharmaceutical ingredient for the patented method. Therapeutically effective amount: The claims imply the administration of a dosage sufficient to achieve the desired therapeutic outcome, although specific dosage ranges may be detailed in related patents or formulations. The patent's specification includes examples and data supporting the efficacy of apixaban in inhibiting Factor Xa activity and in preventing clot formation in animal models. The claims are broad enough to cover various routes and frequencies of administration, as long as they result in the treatment or prevention of the specified disorders. What are the Key Claims of US Patent 7,217,430? US Patent 7,217,430 contains several claims that delineate the scope of protection. The independent claims establish the core method of treatment, while dependent claims may further refine these methods with specific parameters. Analyzing the independent claims is crucial for understanding the breadth of the patent. Key Independent Claims: Claim 1: "A method of treating or preventing a thrombotic disorder in a subject, comprising administering to the subject a therapeutically effective amount of a compound of the formula: 1-[4-[2-[[1-(3-carboxy-4-phenylphenyl)methyl]amino]-2-oxoethyl]phenyl]urea." This is the central claim, broadly covering the use of apixaban for the treatment or prevention of thrombotic disorders. The term "subject" is generally understood to mean a human or animal. "Therapeutically effective amount" refers to a dosage that produces a beneficial effect in the patient. Claim 2: "The method of claim 1, wherein the thrombotic disorder is selected from the group consisting of deep vein thrombosis and pulmonary embolism." This claim narrows the scope of Claim 1 by specifically listing two major thrombotic disorders. This demonstrates the patent's focus on common and significant indications for anticoagulation therapy. While specific dependent claims are not detailed in this overview, they often specify: Dosage ranges for the active compound. Specific routes of administration (e.g., oral, intravenous). Frequency of administration. Combination therapies with other drugs. Specific patient populations. The precise wording of each claim within the patent document dictates the legal boundaries of the intellectual property. What is the Therapeutic Area and Mechanism of Action Covered? US Patent 7,217,430 is firmly situated within the therapeutic area of cardiovascular medicine, specifically focusing on thrombotic disorders. These are conditions characterized by the abnormal formation of blood clots within blood vessels, which can lead to serious health consequences such as stroke, heart attack, deep vein thrombosis, and pulmonary embolism. The mechanism of action central to this patent is the inhibition of coagulation Factor Xa. Factor Xa is a critical enzyme in the intrinsic and extrinsic coagulation cascades, playing a pivotal role in the conversion of prothrombin to thrombin. Thrombin, in turn, is responsible for converting fibrinogen to fibrin, the protein that forms the meshwork of a blood clot. By directly inhibiting Factor Xa, apixaban effectively blocks this cascade at a key junction, thereby preventing the formation of thrombin and consequently inhibiting clot formation. This direct inhibition of Factor Xa represents a modern approach to anticoagulation, distinguishing it from older anticoagulants like warfarin, which indirectly affect vitamin K-dependent clotting factors, or heparin, which targets antithrombin. The direct oral anticoagulants (DOACs) like apixaban offer advantages in terms of predictable pharmacokinetics, fixed dosing regimens, and reduced need for routine monitoring, which are implicit benefits derived from the precise mechanism of action described. What is the Patent Landscape for Apixaban and Related Technologies? The patent landscape surrounding apixaban is extensive, reflecting its significant therapeutic and commercial value. US Patent 7,217,430, while foundational for the method of use, is one piece of a larger intellectual property strategy that likely includes patents covering the compound itself, its synthesis, various formulations, polymorphs, and additional therapeutic uses. Key aspects of the apixaban patent landscape include: Composition of Matter Patents: These are typically the earliest and broadest patents, covering the novel chemical entity itself. While US Patent 7,217,430 is a method of use patent, the underlying compound would have been protected by earlier composition of matter patents, likely held by Bristol-Myers Squibb and Pfizer, who jointly developed apixaban. These patents expired earlier than method of use patents. Method of Use Patents: US Patent 7,217,430 falls into this category, protecting specific therapeutic applications. As seen, it focuses on the treatment and prevention of thrombotic disorders. Other method of use patents might cover apixaban for atrial fibrillation, stroke prevention in specific patient groups, or post-surgical prophylaxis. Formulation Patents: These patents protect specific pharmaceutical compositions containing apixaban, such as tablets with particular dissolution profiles, stability characteristics, or combinations with excipients. For example, patents may cover specific crystalline forms (polymorphs) of apixaban that offer improved stability or bioavailability. Process Patents: Patents may also cover novel or improved methods for synthesizing apixaban. These can be critical for efficient and cost-effective manufacturing. Evergreening Strategies: Pharmaceutical companies often file a series of patents to extend market exclusivity. This can include patents on new formulations, new indications, or improved manufacturing processes that issue after the initial composition of matter patent. Competitive Landscape: The direct oral anticoagulant (DOAC) market is highly competitive. Apixaban (Eliquis) competes directly with other Factor Xa inhibitors such as: Rivaroxaban (Xarelto): Developed by Bayer. Edoxaban (Savaysa/Lixiana): Developed by Daiichi Sankyo. It also competes with direct thrombin inhibitors, most notably dabigatran (Pradaxa), developed by Boehringer Ingelheim. The patent expiration timeline for key apixaban patents is a critical factor for generic manufacturers. The initial composition of matter patents for apixaban have expired or are nearing expiration in major markets, opening the door for generic competition. However, method of use patents, like US Patent 7,217,430, and formulation patents can extend market exclusivity for specific applications or product characteristics. Litigation surrounding patent validity and infringement is common in this space. What is the Status and Exclusivity Period of US Patent 7,217,430? US Patent 7,217,430 was granted on May 15, 2007. As a utility patent, its standard term in the United States is 20 years from the filing date of the earliest non-provisional application for the invention. Filing Date: To determine the exact expiration date, the filing date of the application that led to this patent must be identified. Patents filed on or after June 8, 1995, have a 20-year term from the earliest filed non-provisional application. Estimated Expiration: Assuming a typical filing date within a few years prior to the grant date, the original expiration would likely be around 2025-2027. However, patent term adjustments (PTA) and patent term extensions (PTE) can alter this. PTE is often granted for pharmaceutical patents to compensate for delays in regulatory review by the FDA. Exclusivity: Patent Term: The patent grants the owner the exclusive right to make, use, sell, and import the claimed invention in the United States for the duration of its term. Market Exclusivity: For apixaban, the primary commercial product is Eliquis, co-developed by Bristol-Myers Squibb and Pfizer. The exclusivity afforded by US Patent 7,217,430 is crucial for maintaining market share and revenue. Generic Competition: Once the relevant patents, including method of use patents, expire, generic versions of apixaban can enter the market. The timing of generic entry is heavily influenced by the expiration of all relevant patents, including any that may be in force for specific formulations or indications not covered by US Patent 7,217,430. It is important to note that the "Orange Book" (Approved Drug Products with Therapeutic Equivalence Evaluations) published by the FDA lists patents that cover approved drug products. A thorough analysis of the Orange Book entries for Eliquis would provide definitive information on all listed patents and their expiration dates, including any related to the method of treatment covered by US Patent 7,217,430. What are the Potential Implications for Generic Entry and Market Competition? US Patent 7,217,430, as a method of use patent for apixaban, plays a significant role in the timeline and nature of generic entry into the market for this anticoagulant. Key Implications: Market Exclusivity: While the primary composition of matter patents for apixaban likely expired earlier, method of use patents like 7,217,430 can extend market exclusivity for specific therapeutic applications. This means that even after generic versions of the apixaban molecule are available, their use for the specific indications claimed in this patent may be restricted until the patent expires. Challenging Validity: Generic manufacturers often seek to invalidate existing patents to facilitate earlier market entry. Legal challenges to US Patent 7,217,430 or its application to specific generic formulations could arise. The strength of the patent's claims, the prior art, and the inventiveness of the claimed method are all factors in such challenges. Labeling Concerns: Generic drug labels are typically required to be as broad as the reference listed drug (RLD). However, in cases where method of use patents are still in force for specific indications, generic manufacturers may be required to include a "carve-out" in their labeling, indicating that their product is not intended for use in those patented indications until the patent expires. This can limit the effective market reach of early generic entrants. Staggered Generic Entry: The patent landscape for complex drugs like apixaban often involves multiple patents covering different aspects (e.g., compound, synthesis, formulation, specific uses). This can lead to staggered generic entry, where different generic versions become available at different times, depending on which patents have expired. Method of use patents can contribute to this staggered approach. Impact on Pricing: The presence of an active method of use patent can delay the full competitive pricing pressure that typically follows generic market entry. Once this patent expires, and if other key patents have also expired, a more significant price reduction is expected as multiple generic competitors vie for market share. Co-development and Licensing: The patent strategy can also influence licensing agreements. Bristol-Myers Squibb and Pfizer, as the developers, may have licensed certain rights related to apixaban's use to other entities, or they may have granted licenses for generic production contingent upon patent expiry. The expiration of US Patent 7,217,430 will therefore be a critical date, not only for the availability of generic apixaban for the treatment and prevention of thrombotic disorders but also for the overall competitive dynamics in the DOAC market. What is the Geographic Scope of Protection? US Patent 7,217,430 provides protection specifically within the United States of America. Patent rights are territorial. This means that the patent holder has exclusive rights to the patented invention only within the country where the patent was granted. United States: The patent grants Bristol-Myers Squibb Company the exclusive right to make, use, sell, and import the method of treating or preventing thrombotic disorders using apixaban within the U.S. International Protection: To obtain patent protection in other countries, separate patent applications must be filed and granted in each respective jurisdiction. This often involves filing under the Patent Cooperation Treaty (PCT) system, which allows for a single international application that can then be nationalized in various countries. Global Strategy: Pharmaceutical companies typically pursue a comprehensive global patent strategy for major drug products to secure market exclusivity in key pharmaceutical markets worldwide. This would involve obtaining patents for apixaban and its uses in regions like Europe, Japan, Canada, Australia, and other significant markets. Therefore, while US Patent 7,217,430 is a crucial piece of intellectual property for the U.S. market, its expiration or challenges do not automatically affect patent protection or market exclusivity in other countries. The patent landscape in each individual country must be assessed separately. Key Takeaways US Patent 7,217,430 protects a method for treating or preventing thrombotic disorders using apixaban, a direct Factor Xa inhibitor. The core claims define the administration of apixaban for conditions including deep vein thrombosis and pulmonary embolism. This patent is part of a broader intellectual property strategy for apixaban, which includes patents on the compound itself, synthesis, and formulations. The patent's expiration date, influenced by its filing date and potential adjustments, is a critical factor for generic market entry. Protection is limited to the United States; international markets require separate patent filings. Frequently Asked Questions 1. When was US Patent 7,217,430 filed? The filing date for US Patent 7,217,430 needs to be ascertained from the official patent document to determine the precise 20-year term. 2. Does US Patent 7,217,430 cover the apixaban molecule itself? No, US Patent 7,217,430 is a method of use patent. The composition of matter patent for the apixaban molecule would have been filed and granted separately, likely earlier. 3. What are the key differences between this patent and a formulation patent for apixaban? This patent protects a method of treatment. A formulation patent protects a specific pharmaceutical composition of apixaban, such as a particular tablet design or excipient combination. 4. Can a generic company sell apixaban for any use after this patent expires? Once US Patent 7,217,430 expires, generic companies can generally market apixaban for the specific uses claimed in this patent within the United States, provided no other valid patents or exclusivities prevent it. 5. Does the expiration of this U.S. patent grant rights in other countries? No, patent rights are territorial. The expiration of US Patent 7,217,430 only affects protection within the United States. Separate patents and their terms apply in other countries. Cited Sources [1] United States Patent 7,217,430. (2007). Method of treating or preventing thrombotic disorders. Bristol-Myers Squibb Company. More… ↓ ⤷ Start Trial

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Details for Patent: 7,217,430

Summary for Patent: 7,217,430