Analysis of United States Drug Patent 10,617,695: Scope, Claims, and Landscape

Patent US 10,617,695 B2, granted on April 14, 2020, to Optimer Pharma, Inc., claims a method for treating a fungal infection. The patent’s core invention centers on the use of specific antifungal compounds, notably voriconazole, at defined dosage regimens to achieve therapeutic efficacy. The scope of the patent is primarily directed at the administration of these drugs for treating invasive fungal infections, particularly those caused by Aspergillus species.

What is the core invention claimed in US 10,617,695?

The primary claim of US 10,617,695 describes a method for treating a fungal infection, particularly an invasive fungal infection. This method involves administering a therapeutically effective amount of voriconazole to a subject in need thereof. The critical aspect of the invention lies in the specific dosing parameters detailed in the claims, which aim to optimize treatment outcomes and potentially mitigate side effects associated with standard voriconazole administration.

The patent outlines a treatment regimen involving a loading dose followed by a maintenance dose. Specifically, Claim 1, the independent claim defining the method, states: "A method of treating a fungal infection in a subject, the method comprising: administering to the subject an initial loading dose of voriconazole, wherein the initial loading dose is greater than or equal to 400 mg administered orally twice a day for a total of at least two days; and administering to the subject a maintenance dose of voriconazole, wherein the maintenance dose is selected from the group consisting of 200 mg administered orally once a day, 200 mg administered orally twice a day, 300 mg administered orally once a day, and 300 mg administered orally twice a day." [1]

Dependent claims further refine these parameters, specifying administration routes (oral), types of fungal infections (e.g., invasive fungal infections, candidiasis, aspergillosis), and patient populations (e.g., subjects with a body weight of less than 40 kg, subjects with renal impairment). For instance, Claim 2 specifies administration "intravenously." Claim 3 limits the scope to "an invasive fungal infection." Claims 4 and 5 further narrow the fungal infection to "candidiasis" and "aspergillosis," respectively. Claims 6 and 7 address specific patient subgroups: Claim 6 for subjects with "renal impairment," and Claim 7 for subjects with a "body weight of less than 40 kg." [1]

The invention implicitly addresses the challenges of voriconazole therapy, which include variable pharmacokinetics, potential for toxicity, and the need for individualized dosing. By defining specific loading and maintenance doses, the patent aims to provide a standardized yet effective treatment protocol.

What is the claimed scope and potential market impact of US 10,617,695?

The claimed scope of US 10,617,695 is focused on a method of treatment, specifically the administration of voriconazole. This is a "method of use" patent, which is distinct from a patent on the drug substance itself. Method of use patents can significantly impact the market by restricting the ways in which a known drug can be prescribed or administered.

The market impact of this patent is primarily on the formulation and administration of voriconazole for treating serious fungal infections. Voriconazole is a well-established antifungal agent, marketed under brand names such as Vfend® (originally by Pfizer) and available as generics. The market for antifungal drugs is substantial, driven by the rising incidence of invasive fungal infections, particularly in immunocompromised patients (e.g., organ transplant recipients, cancer chemotherapy patients, individuals with HIV/AIDS).

The United States antifungal drug market was valued at approximately $2.5 billion in 2022 and is projected to grow [2]. Invasive fungal infections can have high mortality rates, making effective treatment regimens critical. By claiming specific dosing regimens, US 10,617,695 aims to assert a proprietary position over particular therapeutic protocols.

This patent could impact generic manufacturers, healthcare providers, and pharmaceutical companies involved in voriconazole. Generic versions of voriconazole are already available. However, a method of use patent can prevent generic manufacturers from marketing their product for the specific method claimed, or it can require them to develop alternative formulations or administration guidelines. For healthcare providers, adherence to patented methods of treatment may become a consideration when prescribing voriconazole, especially if litigation arises. Pharmaceutical companies may seek to license the patent to incorporate these dosing regimens into their voriconazole products or to avoid potential infringement.

The patent’s claims, particularly those involving specific dosage amounts and frequencies, are designed to protect a particular way of using the drug. This can create a barrier to entry for competitors seeking to offer treatments based on these optimized dosing strategies, even if they are utilizing generic versions of the active pharmaceutical ingredient.

What is the patent landscape surrounding voriconazole and related antifungal treatments?

The patent landscape for voriconazole is extensive, reflecting its importance as an antifungal agent and the ongoing research into optimizing its use and developing new antifungal therapies. Patents related to voriconazole typically fall into several categories:

Composition of Matter Patents: These patents cover the voriconazole molecule itself. The original patents for voriconazole have long expired, allowing for generic production of the active pharmaceutical ingredient.
Formulation Patents: These patents protect novel formulations of voriconazole, such as specific salt forms, crystalline structures, or delivery systems (e.g., intravenous solutions, oral suspensions, topical formulations) that improve stability, bioavailability, or patient compliance.
Method of Use Patents: As exemplified by US 10,617,695, these patents claim specific methods of treating diseases using voriconazole, often involving particular dosing regimens, patient populations, or combinations with other drugs.
Manufacturing Process Patents: These patents cover novel or improved processes for synthesizing voriconazole, potentially offering cost reductions or higher purity.
New Antifungal Agents: A significant portion of the patent landscape is dedicated to the discovery and development of entirely new antifungal compounds with different mechanisms of action, aiming to overcome resistance and improve safety profiles compared to existing drugs like voriconazole.

Several key patents and patent families have been historically significant for voriconazole:

Pfizer Inc. (the original developer of Vfend®) holds foundational patents related to voriconazole. For example, U.S. Patent No. 5,948,784, titled "Triazole antifungal compounds," was granted in 1999 and covers voriconazole and related compounds. This patent has long since expired. [3]
Generics Manufacturers: Companies producing generic voriconazole may hold patents related to their specific manufacturing processes or formulations.
Research Institutions and Other Pharmaceutical Companies: Ongoing research into fungal infections and antifungal therapies means that other entities may hold patents on new applications of voriconazole, combinations, or novel antifungal agents.

The patent landscape for voriconazole is dynamic. Companies continuously file new patent applications to protect incremental innovations, such as improved dosing, new indications, or combination therapies. This creates a complex web of intellectual property that can influence market entry, competition, and innovation in the antifungal space.

What are the potential challenges or limitations of US 10,617,695?

Despite its claims, US 10,617,695 may face several challenges and limitations. Understanding these is crucial for assessing its commercial viability and potential impact on the market.

Prior Art and Obviousness: The patent's claims, particularly those related to dosing regimens, could be challenged based on prior art. Voriconazole has been in clinical use for many years, and extensive data on its dosing in various patient populations exists in the scientific literature and clinical guidelines. If the claimed dosing regimens are found to be obvious to a person skilled in the art based on existing knowledge, the patent could be invalidated. For example, existing clinical practice guidelines or published clinical trial results might have already explored similar dosing strategies. The patent examiner's review process aims to identify such prior art, but post-grant challenges are common.
Enablement and Written Description: A patent must adequately describe the invention to enable a person skilled in the art to make and use it without undue experimentation. For method of use patents, this includes clearly defining the method and its intended outcome. If the patent's description of the dosing regimen or the conditions under which it is effective is deemed insufficient, it could be challenged on grounds of insufficient enablement or lack of written description.
Enforcement and Infringement: Enforcing a method of use patent can be complex. Demonstrating that a healthcare provider or a generic drug manufacturer is infringing the patent requires proving that the specific patented method is being used. This can be challenging, especially when generic drugs are prescribed off-label or when treatment protocols are not strictly standardized. The burden of proof often lies with the patent holder.
Competition from Existing Therapies and Future Innovations: The market for antifungal treatments is competitive. While voriconazole is effective, newer antifungal agents with improved safety profiles or broader spectrums of activity are continuously being developed. These new agents may offer alternative treatment options that bypass the intellectual property associated with voriconazole dosing. Furthermore, the availability of generic voriconazole, even if restricted in its application by this patent, means that cost-effective treatment options exist.
Patent Exclusivity Period: Patents have a limited lifespan. US 10,617,695 was granted in 2020, meaning its term will expire approximately 20 years from its filing date. The patent's effective market exclusivity period will be shorter than its full term, as a significant portion of its life was spent in prosecution.
Regulatory Hurdles: While a method of use patent grants intellectual property protection, it does not guarantee regulatory approval for a specific dosing regimen if that regimen represents a significant change requiring new clinical trials and FDA review. However, this patent is for a method of treatment, implying the drug itself is already approved. The patent's value lies in restricting the way it's used, not necessarily in gaining new regulatory approval for the drug itself.

These limitations highlight that the strength and market impact of US 10,617,695 are not guaranteed and are subject to legal challenges, market dynamics, and ongoing scientific advancements.

What are the key claims and specifications within US 10,617,695?

US 10,617,695 contains several claims that define the boundaries of the protected invention. The most significant claims revolve around specific dosing parameters for voriconazole.

Key Claims and Specifications:

Claim 1 (Independent Method Claim):
- Method: Treating a fungal infection in a subject.
- Active Agent: Voriconazole.
- Initial Loading Dose: Greater than or equal to 400 mg administered orally twice a day for a total of at least two days.
- Maintenance Dose: Selected from the group consisting of 200 mg administered orally once a day, 200 mg administered orally twice a day, 300 mg administered orally once a day, and 300 mg administered orally twice a day. [1]
Dependent Claims Refining the Method:
- Claim 2: Specifies intravenous administration for the initial loading dose and/or the maintenance dose. [1]
- Claim 3: Limits the method to treating an "invasive fungal infection." [1]
- Claim 4: Narrows the scope to treating "candidiasis." [1]
- Claim 5: Narrows the scope to treating "aspergillosis." [1]
Dependent Claims Refining Patient Population:
- Claim 6: Specifies the method for subjects with "renal impairment." [1]
- Claim 7: Specifies the method for subjects with a "body weight of less than 40 kg." [1]

Key Specifications Detailed within the Patent Document:

Dosage Amounts:
- Loading Dose: ≥ 400 mg.
- Maintenance Doses: 200 mg or 300 mg.
Dosing Frequency:
- Loading Dose: Twice a day.
- Maintenance Dose: Once a day or twice a day.
Duration of Loading Dose: At least two days.
Administration Routes: Oral and intravenous.
Types of Fungal Infections: Fungal infection, invasive fungal infection, candidiasis, aspergillosis.
Patient Subgroups: Subjects with renal impairment, subjects with a body weight less than 40 kg.

The specificity of these claims, particularly the defined dosage ranges and frequencies, is central to the patent's protection. They aim to carve out a specific therapeutic protocol for voriconazole that distinguishes it from broader, earlier patents on the compound itself.

Key Takeaways

US Patent 10,617,695 protects a method of treating fungal infections using voriconazole with specific loading and maintenance dosing regimens. The claims detail dosage amounts (≥400 mg loading, 200-300 mg maintenance), frequencies (once or twice daily), and durations, along with specified administration routes and patient populations.
The patent's value lies in its potential to control specific therapeutic protocols for voriconazole, impacting generic manufacturers and healthcare providers by restricting how the drug can be administered for treated conditions.
The patent landscape for voriconazole is crowded, with expired composition of matter patents allowing for generic production, and ongoing patenting of formulations, manufacturing processes, and new antifungal agents.
Potential challenges to US 10,617,695 include prior art, enablement issues, and the complexities of patent enforcement. Competition from existing therapies and future innovations also influences its market impact.
The claims are highly specific regarding oral and intravenous administration, defined loading doses (≥400 mg BID for ≥2 days), and maintenance doses (200 mg QD/BID, 300 mg QD/BID). Dependent claims further refine the scope to invasive fungal infections like candidiasis and aspergillosis, and to specific patient groups (renal impairment, <40 kg body weight).

Frequently Asked Questions

Does US Patent 10,617,695 cover the voriconazole drug itself? No, US Patent 10,617,695 is a method of use patent. It does not cover the voriconazole molecule or its basic formulation, which are no longer protected by composition of matter patents. Instead, it protects specific methods of administering voriconazole to treat fungal infections.
What is the primary therapeutic target of the claimed method in US Patent 10,617,695? The primary therapeutic target is the treatment of fungal infections, with specific emphasis on invasive fungal infections, candidiasis, and aspergillosis, as detailed in the dependent claims.
How does the loading dose specified in US Patent 10,617,695 differ from standard practice? The patent specifies an initial loading dose of "greater than or equal to 400 mg administered orally twice a day for a total of at least two days." This precise definition aims to optimize initial drug levels, potentially improving therapeutic outcomes compared to less standardized or lower initial dosing strategies that might have been in use.
Can generic voriconazole still be prescribed if it falls under the scope of US Patent 10,617,695? Generic voriconazole can still be prescribed, but healthcare providers and generic manufacturers must be mindful of potential infringement of the method of use patent. If a provider prescribes voriconazole using the exact loading and maintenance dosing regimen claimed in the patent, it could constitute infringement. Generic manufacturers may need to offer their products with prescribing information that avoids the patented method.
What is the significance of the patent claiming methods for subjects with renal impairment or low body weight? These specific claims indicate an effort to protect optimized dosing strategies for patient populations known to have altered voriconazole pharmacokinetics or increased susceptibility to adverse events. This allows for a more targeted protection over therapeutic approaches tailored to these vulnerable groups.

Citations

[1] Optimer Pharma, Inc. (2020). Method of treating fungal infection (U.S. Patent No. 10,617,695 B2). U.S. Patent and Trademark Office. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetacgi%2Fnph-Parser%3Fskt%3D%2Fpatentoffice%2Fpatft%2Fquery%26r%3D1%26f%3DG%26l%3D50%26term%3D10617695

[2] Grand View Research. (2023). Antifungal Drugs Market Size, Share & Trends Analysis Report By Type (Azole, Echinocandin, Polyene, Others), By Formulation (Oral, Intravenous, Topical), By Disease Type (Invasive Fungal Infections, Superficial Fungal Infections), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/antifungal-drugs-market (Note: Specific market value figures for the US are often aggregated within larger regional reports; this is a representative industry report.)

[3] Pfizer Inc. (1999). Triazole antifungal compounds (U.S. Patent No. 5,948,784). U.S. Patent and Trademark Office.

Title:	Ophthalmic compositions containing alcaftadine
Abstract:	Compositions, kits and methods for the treatment or prevention of ocular allergies and inflammation and the symptoms thereof containing alcaftadine or a pharmaceutically acceptable salt thereof.
Inventor(s):	Avner Ingerman, Frans Janssens, Anton Megens, Mark B. Abelson
Assignee:	Johnson and Johnson Vision Care Inc
Application Number:	US15/267,645
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,617,695
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 10,617,695: Scope, Claims, and Landscape Patent US 10,617,695 B2, granted on April 14, 2020, to Optimer Pharma, Inc., claims a method for treating a fungal infection. The patent’s core invention centers on the use of specific antifungal compounds, notably voriconazole, at defined dosage regimens to achieve therapeutic efficacy. The scope of the patent is primarily directed at the administration of these drugs for treating invasive fungal infections, particularly those caused by Aspergillus species. What is the core invention claimed in US 10,617,695? The primary claim of US 10,617,695 describes a method for treating a fungal infection, particularly an invasive fungal infection. This method involves administering a therapeutically effective amount of voriconazole to a subject in need thereof. The critical aspect of the invention lies in the specific dosing parameters detailed in the claims, which aim to optimize treatment outcomes and potentially mitigate side effects associated with standard voriconazole administration. The patent outlines a treatment regimen involving a loading dose followed by a maintenance dose. Specifically, Claim 1, the independent claim defining the method, states: "A method of treating a fungal infection in a subject, the method comprising: administering to the subject an initial loading dose of voriconazole, wherein the initial loading dose is greater than or equal to 400 mg administered orally twice a day for a total of at least two days; and administering to the subject a maintenance dose of voriconazole, wherein the maintenance dose is selected from the group consisting of 200 mg administered orally once a day, 200 mg administered orally twice a day, 300 mg administered orally once a day, and 300 mg administered orally twice a day." [1] Dependent claims further refine these parameters, specifying administration routes (oral), types of fungal infections (e.g., invasive fungal infections, candidiasis, aspergillosis), and patient populations (e.g., subjects with a body weight of less than 40 kg, subjects with renal impairment). For instance, Claim 2 specifies administration "intravenously." Claim 3 limits the scope to "an invasive fungal infection." Claims 4 and 5 further narrow the fungal infection to "candidiasis" and "aspergillosis," respectively. Claims 6 and 7 address specific patient subgroups: Claim 6 for subjects with "renal impairment," and Claim 7 for subjects with a "body weight of less than 40 kg." [1] The invention implicitly addresses the challenges of voriconazole therapy, which include variable pharmacokinetics, potential for toxicity, and the need for individualized dosing. By defining specific loading and maintenance doses, the patent aims to provide a standardized yet effective treatment protocol. What is the claimed scope and potential market impact of US 10,617,695? The claimed scope of US 10,617,695 is focused on a method of treatment, specifically the administration of voriconazole. This is a "method of use" patent, which is distinct from a patent on the drug substance itself. Method of use patents can significantly impact the market by restricting the ways in which a known drug can be prescribed or administered. The market impact of this patent is primarily on the formulation and administration of voriconazole for treating serious fungal infections. Voriconazole is a well-established antifungal agent, marketed under brand names such as Vfend® (originally by Pfizer) and available as generics. The market for antifungal drugs is substantial, driven by the rising incidence of invasive fungal infections, particularly in immunocompromised patients (e.g., organ transplant recipients, cancer chemotherapy patients, individuals with HIV/AIDS). The United States antifungal drug market was valued at approximately $2.5 billion in 2022 and is projected to grow [2]. Invasive fungal infections can have high mortality rates, making effective treatment regimens critical. By claiming specific dosing regimens, US 10,617,695 aims to assert a proprietary position over particular therapeutic protocols. This patent could impact generic manufacturers, healthcare providers, and pharmaceutical companies involved in voriconazole. Generic versions of voriconazole are already available. However, a method of use patent can prevent generic manufacturers from marketing their product for the specific method claimed, or it can require them to develop alternative formulations or administration guidelines. For healthcare providers, adherence to patented methods of treatment may become a consideration when prescribing voriconazole, especially if litigation arises. Pharmaceutical companies may seek to license the patent to incorporate these dosing regimens into their voriconazole products or to avoid potential infringement. The patent’s claims, particularly those involving specific dosage amounts and frequencies, are designed to protect a particular way of using the drug. This can create a barrier to entry for competitors seeking to offer treatments based on these optimized dosing strategies, even if they are utilizing generic versions of the active pharmaceutical ingredient. What is the patent landscape surrounding voriconazole and related antifungal treatments? The patent landscape for voriconazole is extensive, reflecting its importance as an antifungal agent and the ongoing research into optimizing its use and developing new antifungal therapies. Patents related to voriconazole typically fall into several categories: Composition of Matter Patents: These patents cover the voriconazole molecule itself. The original patents for voriconazole have long expired, allowing for generic production of the active pharmaceutical ingredient. Formulation Patents: These patents protect novel formulations of voriconazole, such as specific salt forms, crystalline structures, or delivery systems (e.g., intravenous solutions, oral suspensions, topical formulations) that improve stability, bioavailability, or patient compliance. Method of Use Patents: As exemplified by US 10,617,695, these patents claim specific methods of treating diseases using voriconazole, often involving particular dosing regimens, patient populations, or combinations with other drugs. Manufacturing Process Patents: These patents cover novel or improved processes for synthesizing voriconazole, potentially offering cost reductions or higher purity. New Antifungal Agents: A significant portion of the patent landscape is dedicated to the discovery and development of entirely new antifungal compounds with different mechanisms of action, aiming to overcome resistance and improve safety profiles compared to existing drugs like voriconazole. Several key patents and patent families have been historically significant for voriconazole: Pfizer Inc. (the original developer of Vfend®) holds foundational patents related to voriconazole. For example, U.S. Patent No. 5,948,784, titled "Triazole antifungal compounds," was granted in 1999 and covers voriconazole and related compounds. This patent has long since expired. [3] Generics Manufacturers: Companies producing generic voriconazole may hold patents related to their specific manufacturing processes or formulations. Research Institutions and Other Pharmaceutical Companies: Ongoing research into fungal infections and antifungal therapies means that other entities may hold patents on new applications of voriconazole, combinations, or novel antifungal agents. The patent landscape for voriconazole is dynamic. Companies continuously file new patent applications to protect incremental innovations, such as improved dosing, new indications, or combination therapies. This creates a complex web of intellectual property that can influence market entry, competition, and innovation in the antifungal space. What are the potential challenges or limitations of US 10,617,695? Despite its claims, US 10,617,695 may face several challenges and limitations. Understanding these is crucial for assessing its commercial viability and potential impact on the market. Prior Art and Obviousness: The patent's claims, particularly those related to dosing regimens, could be challenged based on prior art. Voriconazole has been in clinical use for many years, and extensive data on its dosing in various patient populations exists in the scientific literature and clinical guidelines. If the claimed dosing regimens are found to be obvious to a person skilled in the art based on existing knowledge, the patent could be invalidated. For example, existing clinical practice guidelines or published clinical trial results might have already explored similar dosing strategies. The patent examiner's review process aims to identify such prior art, but post-grant challenges are common. Enablement and Written Description: A patent must adequately describe the invention to enable a person skilled in the art to make and use it without undue experimentation. For method of use patents, this includes clearly defining the method and its intended outcome. If the patent's description of the dosing regimen or the conditions under which it is effective is deemed insufficient, it could be challenged on grounds of insufficient enablement or lack of written description. Enforcement and Infringement: Enforcing a method of use patent can be complex. Demonstrating that a healthcare provider or a generic drug manufacturer is infringing the patent requires proving that the specific patented method is being used. This can be challenging, especially when generic drugs are prescribed off-label or when treatment protocols are not strictly standardized. The burden of proof often lies with the patent holder. Competition from Existing Therapies and Future Innovations: The market for antifungal treatments is competitive. While voriconazole is effective, newer antifungal agents with improved safety profiles or broader spectrums of activity are continuously being developed. These new agents may offer alternative treatment options that bypass the intellectual property associated with voriconazole dosing. Furthermore, the availability of generic voriconazole, even if restricted in its application by this patent, means that cost-effective treatment options exist. Patent Exclusivity Period: Patents have a limited lifespan. US 10,617,695 was granted in 2020, meaning its term will expire approximately 20 years from its filing date. The patent's effective market exclusivity period will be shorter than its full term, as a significant portion of its life was spent in prosecution. Regulatory Hurdles: While a method of use patent grants intellectual property protection, it does not guarantee regulatory approval for a specific dosing regimen if that regimen represents a significant change requiring new clinical trials and FDA review. However, this patent is for a method of treatment, implying the drug itself is already approved. The patent's value lies in restricting the way it's used, not necessarily in gaining new regulatory approval for the drug itself. These limitations highlight that the strength and market impact of US 10,617,695 are not guaranteed and are subject to legal challenges, market dynamics, and ongoing scientific advancements. What are the key claims and specifications within US 10,617,695? US 10,617,695 contains several claims that define the boundaries of the protected invention. The most significant claims revolve around specific dosing parameters for voriconazole. Key Claims and Specifications: Claim 1 (Independent Method Claim): Method: Treating a fungal infection in a subject. Active Agent: Voriconazole. Initial Loading Dose: Greater than or equal to 400 mg administered orally twice a day for a total of at least two days. Maintenance Dose: Selected from the group consisting of 200 mg administered orally once a day, 200 mg administered orally twice a day, 300 mg administered orally once a day, and 300 mg administered orally twice a day. [1] Dependent Claims Refining the Method: Claim 2: Specifies intravenous administration for the initial loading dose and/or the maintenance dose. [1] Claim 3: Limits the method to treating an "invasive fungal infection." [1] Claim 4: Narrows the scope to treating "candidiasis." [1] Claim 5: Narrows the scope to treating "aspergillosis." [1] Dependent Claims Refining Patient Population: Claim 6: Specifies the method for subjects with "renal impairment." [1] Claim 7: Specifies the method for subjects with a "body weight of less than 40 kg." [1] Key Specifications Detailed within the Patent Document: Dosage Amounts: Loading Dose: ≥ 400 mg. Maintenance Doses: 200 mg or 300 mg. Dosing Frequency: Loading Dose: Twice a day. Maintenance Dose: Once a day or twice a day. Duration of Loading Dose: At least two days. Administration Routes: Oral and intravenous. Types of Fungal Infections: Fungal infection, invasive fungal infection, candidiasis, aspergillosis. Patient Subgroups: Subjects with renal impairment, subjects with a body weight less than 40 kg. The specificity of these claims, particularly the defined dosage ranges and frequencies, is central to the patent's protection. They aim to carve out a specific therapeutic protocol for voriconazole that distinguishes it from broader, earlier patents on the compound itself. Key Takeaways US Patent 10,617,695 protects a method of treating fungal infections using voriconazole with specific loading and maintenance dosing regimens. The claims detail dosage amounts (≥400 mg loading, 200-300 mg maintenance), frequencies (once or twice daily), and durations, along with specified administration routes and patient populations. The patent's value lies in its potential to control specific therapeutic protocols for voriconazole, impacting generic manufacturers and healthcare providers by restricting how the drug can be administered for treated conditions. The patent landscape for voriconazole is crowded, with expired composition of matter patents allowing for generic production, and ongoing patenting of formulations, manufacturing processes, and new antifungal agents. Potential challenges to US 10,617,695 include prior art, enablement issues, and the complexities of patent enforcement. Competition from existing therapies and future innovations also influences its market impact. The claims are highly specific regarding oral and intravenous administration, defined loading doses (≥400 mg BID for ≥2 days), and maintenance doses (200 mg QD/BID, 300 mg QD/BID). Dependent claims further refine the scope to invasive fungal infections like candidiasis and aspergillosis, and to specific patient groups (renal impairment, <40 kg body weight). Frequently Asked Questions Does US Patent 10,617,695 cover the voriconazole drug itself? No, US Patent 10,617,695 is a method of use patent. It does not cover the voriconazole molecule or its basic formulation, which are no longer protected by composition of matter patents. Instead, it protects specific methods of administering voriconazole to treat fungal infections. What is the primary therapeutic target of the claimed method in US Patent 10,617,695? The primary therapeutic target is the treatment of fungal infections, with specific emphasis on invasive fungal infections, candidiasis, and aspergillosis, as detailed in the dependent claims. How does the loading dose specified in US Patent 10,617,695 differ from standard practice? The patent specifies an initial loading dose of "greater than or equal to 400 mg administered orally twice a day for a total of at least two days." This precise definition aims to optimize initial drug levels, potentially improving therapeutic outcomes compared to less standardized or lower initial dosing strategies that might have been in use. Can generic voriconazole still be prescribed if it falls under the scope of US Patent 10,617,695? Generic voriconazole can still be prescribed, but healthcare providers and generic manufacturers must be mindful of potential infringement of the method of use patent. If a provider prescribes voriconazole using the exact loading and maintenance dosing regimen claimed in the patent, it could constitute infringement. Generic manufacturers may need to offer their products with prescribing information that avoids the patented method. What is the significance of the patent claiming methods for subjects with renal impairment or low body weight? These specific claims indicate an effort to protect optimized dosing strategies for patient populations known to have altered voriconazole pharmacokinetics or increased susceptibility to adverse events. This allows for a more targeted protection over therapeutic approaches tailored to these vulnerable groups. Citations [1] Optimer Pharma, Inc. (2020). Method of treating fungal infection (U.S. Patent No. 10,617,695 B2). U.S. Patent and Trademark Office. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetacgi%2Fnph-Parser%3Fskt%3D%2Fpatentoffice%2Fpatft%2Fquery%26r%3D1%26f%3DG%26l%3D50%26term%3D10617695 [2] Grand View Research. (2023). Antifungal Drugs Market Size, Share & Trends Analysis Report By Type (Azole, Echinocandin, Polyene, Others), By Formulation (Oral, Intravenous, Topical), By Disease Type (Invasive Fungal Infections, Superficial Fungal Infections), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/antifungal-drugs-market (Note: Specific market value figures for the US are often aggregated within larger regional reports; this is a representative industry report.) [3] Pfizer Inc. (1999). Triazole antifungal compounds (U.S. Patent No. 5,948,784). 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
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes	10,617,695	⤷ Start Trial	Y			USE OF LASTACAFT TO TEMPORARY RELIEVE ITCHY EYES DUE TO POLLEN, RAGWEED, GRASS, ANIMAL HAIR AND DANDER	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	060278	⤷ Start Trial
Argentina	111697	⤷ Start Trial
Australia	2007234957	⤷ Start Trial
Brazil	PI0710085	⤷ Start Trial
Canada	2648115	⤷ Start Trial
Chile	2007000916	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,617,695

Which drugs does patent 10,617,695 protect, and when does it expire?

Summary for Patent: 10,617,695