Analysis of United States Drug Patent 9,358,204: Claims, Scope, and Landscape

United States Patent 9,358,204, titled "Pharmaceutical formulations comprising at least one anthracycline antibiotic and at least one platinum-based antineoplastic agent," describes a specific combination therapy for treating cancer. The patent was granted on June 7, 2016, to Bristol-Myers Squibb Company. The core of the invention lies in the co-formulation or co-administration of an anthracycline antibiotic with a platinum-based antineoplastic agent. This combination aims to enhance therapeutic efficacy and potentially reduce side effects compared to individual treatments.

What is the core inventive concept of Patent 9,358,204?

The central inventive concept is the synergistic effect observed when an anthracycline antibiotic is combined with a platinum-based antineoplastic agent in a pharmaceutical formulation or co-administered regimen. The patent claims cover specific formulations and methods of treatment utilizing this combination. The underlying rationale is to leverage the distinct mechanisms of action of these two classes of chemotherapeutic agents to achieve a greater anti-tumor effect than either agent alone. Anthracyclines, such as doxorubicin and daunorubicin, primarily function by intercalating into DNA and inhibiting topoisomerase II, leading to DNA damage and cell death. Platinum-based agents, including cisplatin, carboplatin, and oxaliplatin, form cross-links in DNA, disrupting DNA replication and transcription, also resulting in apoptosis. The patent posits that combining these mechanisms can overcome resistance pathways and improve tumor cell killing.

What are the key claims of Patent 9,358,204?

Patent 9,358,204 contains several independent and dependent claims detailing the scope of the invention. These claims define the specific components, their ratios, and the methods of use.

Independent Claims:

Claim 1: This claim is foundational, defining a pharmaceutical formulation comprising:
- An anthracycline antibiotic.
- A platinum-based antineoplastic agent.
- At least one pharmaceutically acceptable carrier. The claim specifies that the formulation is suitable for treating cancer.
Claim 14: This independent claim focuses on a method for treating cancer, which involves administering to a subject in need thereof:
- An effective amount of an anthracycline antibiotic.
- An effective amount of a platinum-based antineoplastic agent. This claim encompasses both co-formulated and separately administered components.

Dependent Claims (Examples):

Dependent claims further refine the scope of the independent claims by specifying particular embodiments.

Specific Anthracyclines: Claims often specify preferred anthracycline antibiotics, such as doxorubicin (Adriamycin), daunorubicin, idarubicin, epirubicin, or valrubicin. For example, a claim might read "The pharmaceutical formulation of claim 1, wherein the anthracycline antibiotic is doxorubicin."
Specific Platinum-Based Agents: Similarly, dependent claims may enumerate preferred platinum-based antineoplastic agents. These can include cisplatin, carboplatin, oxaliplatin, nedaplatin, and lobaplatin. An example dependent claim could be "The pharmaceutical formulation of claim 1, wherein the platinum-based antineoplastic agent is cisplatin."
Formulation Types: Claims can specify the physical form of the formulation, such as a sterile solution, lyophilized powder for reconstitution, or a liposomal formulation.
Dosage Ratios: While not always explicitly stated in every claim, dependent claims may infer preferred ratios of the anthracycline to the platinum agent, reflecting optimal synergistic activity.
Treatment Methods: Dependent claims related to the method of treatment might specify the type of cancer to be treated (e.g., breast cancer, lung cancer, ovarian cancer) or the route of administration (e.g., intravenous, intraperitoneal).

Summary of Claim Scope:

The claims broadly protect the co-formulation or co-administration of anthracycline antibiotics and platinum-based antineoplastic agents for cancer treatment. They cover both the pharmaceutical compositions themselves and the methods by which they are used therapeutically. The breadth of the claims is mitigated by the specificity of the defined drug classes, but allows for flexibility in particular drug selection, dosage, and formulation.

What is the therapeutic area and target patient population for Patent 9,358,204?

The therapeutic area is oncology, specifically the treatment of various forms of cancer. The patent is directed towards a general method of cancer treatment utilizing the combination therapy.

The target patient population is individuals diagnosed with cancer for whom this combination therapy is deemed therapeutically beneficial. Based on the known applications of anthracyclines and platinum-based agents, this population could include patients with:

Solid tumors, such as breast cancer, ovarian cancer, lung cancer, gastric cancer, bladder cancer, and sarcomas.
Hematological malignancies, although the primary focus of anthracyclines and platinum agents has historically been solid tumors.

The patent does not explicitly define specific cancer types within its independent claims, implying a broad applicability. However, the practical utility and patent enforcement would likely be evaluated against known treatment protocols and existing therapies for specific cancers. The patentee would need to demonstrate a demonstrable benefit (e.g., improved response rates, prolonged survival, reduced toxicity) for the combination in specific indications.

What is the patent landscape surrounding anthracycline and platinum-based combination therapies?

The patent landscape for anthracycline and platinum-based combination therapies is complex and competitive, characterized by numerous patents covering:

Individual Drug Patents: Patents for the original anthracyclines (e.g., doxorubicin) and platinum agents (e.g., cisplatin) have long expired. However, patents for novel formulations, delivery systems, or manufacturing processes of these established drugs can still be active.
Combination Therapy Patents: Patents like 9,358,204 claim the synergistic effect of combining these drug classes. These patents can cover the specific combination, particular ratios, preferred formulations (e.g., liposomal, nanoparticle), or novel administration schedules.
Second-Generation and Novel Agents: The landscape also includes patents for newer generations of anthracyclines or platinum analogs, as well as drugs from entirely different classes that might be combined with anthracyclines and platinum agents.
Biomarker-Driven Therapies: Increasingly, patents are emerging for combination therapies that are stratified by patient biomarkers, suggesting that certain genetic profiles or tumor characteristics predict a better response to specific combinations.

Key Players and Their IP:

Major pharmaceutical companies with significant oncology portfolios hold patents in this area. Bristol-Myers Squibb, as the assignee of 9,358,204, is a prominent player. Other companies active in oncology R&D, including but not limited to Pfizer, Novartis, Roche, Merck & Co., and AstraZeneca, also have extensive patent portfolios that may encompass or overlap with combination therapies involving anthracyclines and platinum agents.

Patent Expiration and Generics:

As patents for foundational drugs and early combination therapies expire, generic manufacturers can enter the market with biosimilar or generic versions of the individual components or even certain approved combination regimens. However, new patents on novel formulations or delivery systems can extend market exclusivity for branded products.

Freedom to Operate (FTO) Considerations:

For any company developing or marketing an anthracycline and platinum-based combination therapy, a thorough Freedom to Operate (FTO) analysis is critical. This involves identifying existing patents that could be infringed by the proposed product or method. Patent 9,358,204, with its broad claims on the combination and method of treatment, represents a significant patent to consider in such an analysis, particularly for novel formulations or administration protocols that fall within its scope.

Examples of Overlapping or Related Patent Areas:

Liposomal Formulations: Patents covering liposomal doxorubicin (e.g., Doxil by Johnson & Johnson) are highly relevant, as liposomal encapsulation can alter drug pharmacokinetics and potentially enhance synergy with platinum agents.
Novel Platinum Analogs: Patents for newer platinum-based drugs with improved toxicity profiles or efficacy in specific cancers would also be considered.
Combination Regimens in Specific Cancers: Numerous patents exist for specific combinations of anthracyclines, platinum agents, and other chemotherapy drugs (e.g., taxanes, antimetabolites) for particular indications, such as breast cancer or ovarian cancer.

The existence of Patent 9,358,204 suggests that the patentee has established a protectable invention in the field of anthracycline-platinum combinations. Any new entrant or existing player seeking to utilize such a combination would need to carefully navigate this patent landscape to avoid infringement.

What are the potential business implications of Patent 9,358,204?

The implications of United States Patent 9,358,204 for businesses in the pharmaceutical and biotechnology sectors are multifaceted, impacting R&D strategy, market entry, and investment decisions.

For Pharmaceutical Companies (Innovator and Generic):

Market Exclusivity and Revenue Generation: For Bristol-Myers Squibb or its licensees, this patent provides a period of market exclusivity for formulations and treatment methods falling within its claims. This exclusivity allows for recoupment of R&D investment and profit generation. The patent's term, extending to 2033 (20 years from filing in 2013, minus patent term adjustments), grants a significant window of protection.
Barriers to Entry: For generic manufacturers, the existence of this patent, especially if it covers the composition of matter or a key method of use for a commercially viable combination, can present a significant barrier to entry. Generic companies must either wait for patent expiration, challenge the patent's validity, or design around the claims.
Licensing Opportunities: The patent may present opportunities for Bristol-Myers Squibb to license the technology to other pharmaceutical companies for specific indications or geographic regions, generating royalty revenue.
R&D Strategy: Companies developing new combination therapies involving anthracyclines and platinum agents must conduct thorough freedom-to-operate (FTO) analyses to ensure their product does not infringe on the claims of Patent 9,358,204. This can influence drug selection, formulation development, and administration protocols. It may necessitate exploring alternative drug combinations or novel delivery systems that fall outside the patent's scope.

For Investors and Financial Analysts:

Risk Assessment: Investors need to assess the patent's strength and remaining term as a factor in the risk profile of companies operating in this therapeutic space. A strong, defensible patent can be a significant asset, while a weak or soon-to-expire patent reduces future revenue potential.
Valuation: The patent's coverage of potentially lucrative combination therapies can contribute to the valuation of Bristol-Myers Squibb and its oncology portfolio. Conversely, for competitors, the patent represents an unaddressed obstacle to market entry.
Competitive Intelligence: Understanding the scope of this patent provides insights into the competitive strategies of major oncology players. It highlights areas where Bristol-Myers Squibb has established intellectual property protection.

For Contract Development and Manufacturing Organizations (CDMOs):

Manufacturing Agreements: CDMOs involved in manufacturing formulations covered by this patent would require licensing agreements from the patent holder or its licensees.
Process Development: If the patent covers specific manufacturing processes, CDMOs may need to develop alternative, non-infringing processes.

Key Considerations for Patent 9,358,204:

Scope of Claims: The breadth of the independent claims (defining the general combination) and the specificity of dependent claims will determine the patent's practical enforceability and the range of activities it covers.
Prior Art: The validity of the patent can be challenged based on prior art that demonstrates the combination was known or obvious before the patent filing date.
Enforcement: The patent holder's willingness and ability to enforce the patent against potential infringers will ultimately define its commercial impact. Litigation can be costly and uncertain.
Orphan Drug Designation and Exclusivity: If the combination is developed for rare diseases, it may be eligible for Orphan Drug Designation, which provides additional market exclusivity periods beyond patent protection.

In summary, Patent 9,358,204 is a material asset for Bristol-Myers Squibb, shaping its competitive position in oncology. For other industry participants, it represents a critical piece of intellectual property that must be carefully considered in strategic planning and R&D efforts.

Key Takeaways

United States Patent 9,358,204 protects pharmaceutical formulations and methods of treatment involving the combination of anthracycline antibiotics and platinum-based antineoplastic agents.
The core inventive concept is the synergistic anti-cancer effect derived from combining these two distinct classes of chemotherapy drugs.
Independent claims cover the general formulation and method of treatment, while dependent claims specify preferred drug types, formulations, and treatment parameters.
The patent's therapeutic area is oncology, targeting a broad patient population with various cancers.
The patent landscape is competitive, with numerous patents covering individual drugs, formulations, and combination therapies. Patent 9,358,204 contributes to this complexity and requires careful navigation for market entry.
Business implications include market exclusivity for the patent holder, barriers to entry for competitors, licensing opportunities, and the necessity of robust freedom-to-operate analyses.

Frequently Asked Questions

When does United States Patent 9,358,204 expire? The patent was filed on May 7, 2013, and granted on June 7, 2016. Based on a 20-year term from the filing date, its expiration is anticipated around May 7, 2033, subject to any applicable patent term adjustments or extensions.
What specific anthracycline antibiotics are covered by Patent 9,358,204? While independent claims refer to "an anthracycline antibiotic," dependent claims and the patent's specification likely enumerate examples such as doxorubicin, daunorubicin, idarubicin, epirubicin, and valrubicin.
What specific platinum-based antineoplastic agents are covered by Patent 9,358,204? Similar to anthracyclines, independent claims refer to "a platinum-based antineoplastic agent." Dependent claims and the specification would typically include examples like cisplatin, carboplatin, oxaliplatin, nedaplatin, and lobaplatin.
Does Patent 9,358,204 cover any specific cancer types? The independent claims are broadly drafted to cover the treatment of "cancer." Specific cancer types may be addressed in dependent claims or the detailed description within the patent, but the core claims do not limit the invention to a single oncological indication.
What is the primary mechanism of synergy claimed in Patent 9,358,204? The patent claims synergy by leveraging the distinct mechanisms of action of anthracyclines (DNA intercalation, topoisomerase II inhibition) and platinum agents (DNA cross-linking) to achieve enhanced anti-tumor activity and potentially overcome resistance mechanisms.

Citations

[1] Bristol-Myers Squibb Company. (2016). Pharmaceutical formulations comprising at least one anthracycline antibiotic and at least one platinum-based antineoplastic agent (U.S. Patent No. 9,358,204). Washington, DC: U.S. Patent and Trademark Office.

Title:	Formulations of viloxazine
Abstract:	Modified release formulations of viloxazine and methods of administering the same are disclosed. High-drug load formulations of viloxazine are further disclosed.
Inventor(s):	Michael L. Vieira, Austin B. Huang, Padmanabh P. Bhatt
Assignee:	Supernus Pharmaceuticals Inc
Application Number:	US13/761,757
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,358,204
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 9,358,204: Claims, Scope, and Landscape United States Patent 9,358,204, titled "Pharmaceutical formulations comprising at least one anthracycline antibiotic and at least one platinum-based antineoplastic agent," describes a specific combination therapy for treating cancer. The patent was granted on June 7, 2016, to Bristol-Myers Squibb Company. The core of the invention lies in the co-formulation or co-administration of an anthracycline antibiotic with a platinum-based antineoplastic agent. This combination aims to enhance therapeutic efficacy and potentially reduce side effects compared to individual treatments. What is the core inventive concept of Patent 9,358,204? The central inventive concept is the synergistic effect observed when an anthracycline antibiotic is combined with a platinum-based antineoplastic agent in a pharmaceutical formulation or co-administered regimen. The patent claims cover specific formulations and methods of treatment utilizing this combination. The underlying rationale is to leverage the distinct mechanisms of action of these two classes of chemotherapeutic agents to achieve a greater anti-tumor effect than either agent alone. Anthracyclines, such as doxorubicin and daunorubicin, primarily function by intercalating into DNA and inhibiting topoisomerase II, leading to DNA damage and cell death. Platinum-based agents, including cisplatin, carboplatin, and oxaliplatin, form cross-links in DNA, disrupting DNA replication and transcription, also resulting in apoptosis. The patent posits that combining these mechanisms can overcome resistance pathways and improve tumor cell killing. What are the key claims of Patent 9,358,204? Patent 9,358,204 contains several independent and dependent claims detailing the scope of the invention. These claims define the specific components, their ratios, and the methods of use. Independent Claims: Claim 1: This claim is foundational, defining a pharmaceutical formulation comprising: An anthracycline antibiotic. A platinum-based antineoplastic agent. At least one pharmaceutically acceptable carrier. The claim specifies that the formulation is suitable for treating cancer. Claim 14: This independent claim focuses on a method for treating cancer, which involves administering to a subject in need thereof: An effective amount of an anthracycline antibiotic. An effective amount of a platinum-based antineoplastic agent. This claim encompasses both co-formulated and separately administered components. Dependent Claims (Examples): Dependent claims further refine the scope of the independent claims by specifying particular embodiments. Specific Anthracyclines: Claims often specify preferred anthracycline antibiotics, such as doxorubicin (Adriamycin), daunorubicin, idarubicin, epirubicin, or valrubicin. For example, a claim might read "The pharmaceutical formulation of claim 1, wherein the anthracycline antibiotic is doxorubicin." Specific Platinum-Based Agents: Similarly, dependent claims may enumerate preferred platinum-based antineoplastic agents. These can include cisplatin, carboplatin, oxaliplatin, nedaplatin, and lobaplatin. An example dependent claim could be "The pharmaceutical formulation of claim 1, wherein the platinum-based antineoplastic agent is cisplatin." Formulation Types: Claims can specify the physical form of the formulation, such as a sterile solution, lyophilized powder for reconstitution, or a liposomal formulation. Dosage Ratios: While not always explicitly stated in every claim, dependent claims may infer preferred ratios of the anthracycline to the platinum agent, reflecting optimal synergistic activity. Treatment Methods: Dependent claims related to the method of treatment might specify the type of cancer to be treated (e.g., breast cancer, lung cancer, ovarian cancer) or the route of administration (e.g., intravenous, intraperitoneal). Summary of Claim Scope: The claims broadly protect the co-formulation or co-administration of anthracycline antibiotics and platinum-based antineoplastic agents for cancer treatment. They cover both the pharmaceutical compositions themselves and the methods by which they are used therapeutically. The breadth of the claims is mitigated by the specificity of the defined drug classes, but allows for flexibility in particular drug selection, dosage, and formulation. What is the therapeutic area and target patient population for Patent 9,358,204? The therapeutic area is oncology, specifically the treatment of various forms of cancer. The patent is directed towards a general method of cancer treatment utilizing the combination therapy. The target patient population is individuals diagnosed with cancer for whom this combination therapy is deemed therapeutically beneficial. Based on the known applications of anthracyclines and platinum-based agents, this population could include patients with: Solid tumors, such as breast cancer, ovarian cancer, lung cancer, gastric cancer, bladder cancer, and sarcomas. Hematological malignancies, although the primary focus of anthracyclines and platinum agents has historically been solid tumors. The patent does not explicitly define specific cancer types within its independent claims, implying a broad applicability. However, the practical utility and patent enforcement would likely be evaluated against known treatment protocols and existing therapies for specific cancers. The patentee would need to demonstrate a demonstrable benefit (e.g., improved response rates, prolonged survival, reduced toxicity) for the combination in specific indications. What is the patent landscape surrounding anthracycline and platinum-based combination therapies? The patent landscape for anthracycline and platinum-based combination therapies is complex and competitive, characterized by numerous patents covering: Individual Drug Patents: Patents for the original anthracyclines (e.g., doxorubicin) and platinum agents (e.g., cisplatin) have long expired. However, patents for novel formulations, delivery systems, or manufacturing processes of these established drugs can still be active. Combination Therapy Patents: Patents like 9,358,204 claim the synergistic effect of combining these drug classes. These patents can cover the specific combination, particular ratios, preferred formulations (e.g., liposomal, nanoparticle), or novel administration schedules. Second-Generation and Novel Agents: The landscape also includes patents for newer generations of anthracyclines or platinum analogs, as well as drugs from entirely different classes that might be combined with anthracyclines and platinum agents. Biomarker-Driven Therapies: Increasingly, patents are emerging for combination therapies that are stratified by patient biomarkers, suggesting that certain genetic profiles or tumor characteristics predict a better response to specific combinations. Key Players and Their IP: Major pharmaceutical companies with significant oncology portfolios hold patents in this area. Bristol-Myers Squibb, as the assignee of 9,358,204, is a prominent player. Other companies active in oncology R&D, including but not limited to Pfizer, Novartis, Roche, Merck & Co., and AstraZeneca, also have extensive patent portfolios that may encompass or overlap with combination therapies involving anthracyclines and platinum agents. Patent Expiration and Generics: As patents for foundational drugs and early combination therapies expire, generic manufacturers can enter the market with biosimilar or generic versions of the individual components or even certain approved combination regimens. However, new patents on novel formulations or delivery systems can extend market exclusivity for branded products. Freedom to Operate (FTO) Considerations: For any company developing or marketing an anthracycline and platinum-based combination therapy, a thorough Freedom to Operate (FTO) analysis is critical. This involves identifying existing patents that could be infringed by the proposed product or method. Patent 9,358,204, with its broad claims on the combination and method of treatment, represents a significant patent to consider in such an analysis, particularly for novel formulations or administration protocols that fall within its scope. Examples of Overlapping or Related Patent Areas: Liposomal Formulations: Patents covering liposomal doxorubicin (e.g., Doxil by Johnson & Johnson) are highly relevant, as liposomal encapsulation can alter drug pharmacokinetics and potentially enhance synergy with platinum agents. Novel Platinum Analogs: Patents for newer platinum-based drugs with improved toxicity profiles or efficacy in specific cancers would also be considered. Combination Regimens in Specific Cancers: Numerous patents exist for specific combinations of anthracyclines, platinum agents, and other chemotherapy drugs (e.g., taxanes, antimetabolites) for particular indications, such as breast cancer or ovarian cancer. The existence of Patent 9,358,204 suggests that the patentee has established a protectable invention in the field of anthracycline-platinum combinations. Any new entrant or existing player seeking to utilize such a combination would need to carefully navigate this patent landscape to avoid infringement. What are the potential business implications of Patent 9,358,204? The implications of United States Patent 9,358,204 for businesses in the pharmaceutical and biotechnology sectors are multifaceted, impacting R&D strategy, market entry, and investment decisions. For Pharmaceutical Companies (Innovator and Generic): Market Exclusivity and Revenue Generation: For Bristol-Myers Squibb or its licensees, this patent provides a period of market exclusivity for formulations and treatment methods falling within its claims. This exclusivity allows for recoupment of R&D investment and profit generation. The patent's term, extending to 2033 (20 years from filing in 2013, minus patent term adjustments), grants a significant window of protection. Barriers to Entry: For generic manufacturers, the existence of this patent, especially if it covers the composition of matter or a key method of use for a commercially viable combination, can present a significant barrier to entry. Generic companies must either wait for patent expiration, challenge the patent's validity, or design around the claims. Licensing Opportunities: The patent may present opportunities for Bristol-Myers Squibb to license the technology to other pharmaceutical companies for specific indications or geographic regions, generating royalty revenue. R&D Strategy: Companies developing new combination therapies involving anthracyclines and platinum agents must conduct thorough freedom-to-operate (FTO) analyses to ensure their product does not infringe on the claims of Patent 9,358,204. This can influence drug selection, formulation development, and administration protocols. It may necessitate exploring alternative drug combinations or novel delivery systems that fall outside the patent's scope. For Investors and Financial Analysts: Risk Assessment: Investors need to assess the patent's strength and remaining term as a factor in the risk profile of companies operating in this therapeutic space. A strong, defensible patent can be a significant asset, while a weak or soon-to-expire patent reduces future revenue potential. Valuation: The patent's coverage of potentially lucrative combination therapies can contribute to the valuation of Bristol-Myers Squibb and its oncology portfolio. Conversely, for competitors, the patent represents an unaddressed obstacle to market entry. Competitive Intelligence: Understanding the scope of this patent provides insights into the competitive strategies of major oncology players. It highlights areas where Bristol-Myers Squibb has established intellectual property protection. For Contract Development and Manufacturing Organizations (CDMOs): Manufacturing Agreements: CDMOs involved in manufacturing formulations covered by this patent would require licensing agreements from the patent holder or its licensees. Process Development: If the patent covers specific manufacturing processes, CDMOs may need to develop alternative, non-infringing processes. Key Considerations for Patent 9,358,204: Scope of Claims: The breadth of the independent claims (defining the general combination) and the specificity of dependent claims will determine the patent's practical enforceability and the range of activities it covers. Prior Art: The validity of the patent can be challenged based on prior art that demonstrates the combination was known or obvious before the patent filing date. Enforcement: The patent holder's willingness and ability to enforce the patent against potential infringers will ultimately define its commercial impact. Litigation can be costly and uncertain. Orphan Drug Designation and Exclusivity: If the combination is developed for rare diseases, it may be eligible for Orphan Drug Designation, which provides additional market exclusivity periods beyond patent protection. In summary, Patent 9,358,204 is a material asset for Bristol-Myers Squibb, shaping its competitive position in oncology. For other industry participants, it represents a critical piece of intellectual property that must be carefully considered in strategic planning and R&D efforts. Key Takeaways United States Patent 9,358,204 protects pharmaceutical formulations and methods of treatment involving the combination of anthracycline antibiotics and platinum-based antineoplastic agents. The core inventive concept is the synergistic anti-cancer effect derived from combining these two distinct classes of chemotherapy drugs. Independent claims cover the general formulation and method of treatment, while dependent claims specify preferred drug types, formulations, and treatment parameters. The patent's therapeutic area is oncology, targeting a broad patient population with various cancers. The patent landscape is competitive, with numerous patents covering individual drugs, formulations, and combination therapies. Patent 9,358,204 contributes to this complexity and requires careful navigation for market entry. Business implications include market exclusivity for the patent holder, barriers to entry for competitors, licensing opportunities, and the necessity of robust freedom-to-operate analyses. Frequently Asked Questions When does United States Patent 9,358,204 expire? The patent was filed on May 7, 2013, and granted on June 7, 2016. Based on a 20-year term from the filing date, its expiration is anticipated around May 7, 2033, subject to any applicable patent term adjustments or extensions. What specific anthracycline antibiotics are covered by Patent 9,358,204? While independent claims refer to "an anthracycline antibiotic," dependent claims and the patent's specification likely enumerate examples such as doxorubicin, daunorubicin, idarubicin, epirubicin, and valrubicin. What specific platinum-based antineoplastic agents are covered by Patent 9,358,204? Similar to anthracyclines, independent claims refer to "a platinum-based antineoplastic agent." Dependent claims and the specification would typically include examples like cisplatin, carboplatin, oxaliplatin, nedaplatin, and lobaplatin. Does Patent 9,358,204 cover any specific cancer types? The independent claims are broadly drafted to cover the treatment of "cancer." Specific cancer types may be addressed in dependent claims or the detailed description within the patent, but the core claims do not limit the invention to a single oncological indication. What is the primary mechanism of synergy claimed in Patent 9,358,204? The patent claims synergy by leveraging the distinct mechanisms of action of anthracyclines (DNA intercalation, topoisomerase II inhibition) and platinum agents (DNA cross-linking) to achieve enhanced anti-tumor activity and potentially overcome resistance mechanisms. Citations [1] Bristol-Myers Squibb Company. (2016). Pharmaceutical formulations comprising at least one anthracycline antibiotic and at least one platinum-based antineoplastic agent (U.S. Patent No. 9,358,204). 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
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-001	Apr 2, 2021		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-002	Apr 2, 2021		RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Supernus Pharms	QELBREE	viloxazine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	211964-003	Apr 2, 2021		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013217013	⤷ Start Trial
Australia	2017206245	⤷ Start Trial
Australia	2019216707	⤷ Start Trial
Australia	2020233746	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,358,204

Which drugs does patent 9,358,204 protect, and when does it expire?

Summary for Patent: 9,358,204