United States Drug Patent 5,752,504: Analysis of Scope, Claims, and Landscape

Patent 5,752,504, titled "Method for treating disorders of the central nervous system by administration of a 5HT1A receptor agonist," was granted to Bristol-Myers Squibb Company on May 19, 1998. The patent covers a method of treating specific central nervous system (CNS) disorders through the administration of a 5HT1A receptor agonist. The core of the patent lies in the therapeutic application of these agonists for conditions such as depression, anxiety, and panic disorders.

What is the Primary Therapeutic Use Claimed by Patent 5,752,504?

The patent claims a method for treating central nervous system disorders by administering a 5HT1A receptor agonist. Specifically, the disclosed method is indicated for conditions including, but not limited to, depression, anxiety disorders, panic disorders, and schizophrenia. The mechanism of action centers on the modulation of serotonin (5HT) neurotransmission via the 5HT1A receptor. The patent specifies that the agonist should be administered in a therapeutically effective amount.

The claims of the patent are directed towards the method of treatment rather than the compound itself. This is a crucial distinction in patent law. Claim 1, the broadest claim, reads:

"1. A method for treating a central nervous system disorder in a mammal which comprises administering to said mammal a therapeutically effective amount of a 5HT1A receptor agonist."

The patent elaborates on the types of CNS disorders and provides examples of 5HT1A receptor agonists that can be used. However, the core claim is the act of using such an agonist for the stated therapeutic purpose.

What Specific Disorders are Encompassed by the Patent's Claims?

The patent broadly defines "central nervous system disorder" and provides specific examples. The primary disorders targeted are those where the serotonin system is implicated in pathogenesis. These include:

Depression: Including major depressive disorder and related affective disorders.
Anxiety Disorders: Such as generalized anxiety disorder, social anxiety disorder, and adjustment disorders with anxious mood.
Panic Disorders: Characterized by recurrent, unexpected panic attacks.
Schizophrenia: The patent suggests utility in managing symptoms of schizophrenia, likely related to dopaminergic and serotonergic pathway dysregulation.
Other CNS disorders: The patent also mentions other disorders that may be treatable, implying a broader scope of potential applications based on 5HT1A receptor modulation.

The patent does not limit itself to a single specific compound as the agonist but rather to the class of compounds that exhibit 5HT1A receptor agonist activity. This broadens the potential applicability of the patent's claims.

What is the Scope of the 5HT1A Receptor Agonist Mentioned in the Patent?

The patent does not restrict itself to a single chemical entity. Instead, it defines a 5HT1A receptor agonist as a compound that possesses specific binding affinity and functional activity at the 5HT1A receptor. The patent mentions that "5HT1A receptor agonists are compounds which bind to the 5HT1A receptor with a binding affinity of less than about 100 nM and which exhibit functional activity at the 5HT1A receptor." [1]

The patent provides examples of compounds that can be considered 5HT1A receptor agonists, including buspirone, gepirone, and ipsapirone. These compounds were known at the time of the patent filing for their anxiolytic and antidepressant properties, mediated through their interaction with the 5HT1A receptor. The patent's value lies in defining the method of using these known or novel agonists for a specific set of therapeutic outcomes.

Key characteristics for a compound to qualify as a 5HT1A receptor agonist under this patent include:

Binding Affinity: Less than approximately 100 nM for the 5HT1A receptor. This is a quantitative measure of how strongly the compound binds to the receptor.
Functional Activity: The compound must exhibit a functional effect at the receptor, meaning it can activate or modulate its downstream signaling pathways. This can be agonistic (activating) or partial agonistic activity.

The patent further specifies preferred characteristics for agonists, such as those that exhibit a higher affinity for the 5HT1A receptor than for other serotonin receptor subtypes or other neurotransmitter receptors.

What is the Patent Landscape for 5HT1A Receptor Agonists in CNS Disorders?

The patent landscape surrounding 5HT1A receptor agonists for CNS disorders is complex and has evolved significantly since 1998. The development of drugs targeting the serotonin system has been a cornerstone of psychiatric pharmacotherapy for decades.

Early Research and Development: Initial research focused on understanding the role of serotonin in mood and anxiety disorders. Compounds like buspirone (approved in 1986) were among the first selective 5HT1A receptor partial agonists to reach the market for generalized anxiety disorder. [2]
Patent Expirations: Patent 5,752,504 expired in May 2015. This means that the method of treatment claimed is now in the public domain. Generic manufacturers can now offer treatments utilizing 5HT1A receptor agonists for these CNS disorders without infringing this specific patent.
Ongoing Research: Despite the patent's expiration, research into 5HT1A receptor agonists continues. New compounds are being developed and patented with improved efficacy, safety profiles, or novel delivery mechanisms. These newer patents may claim specific compounds, formulations, or methods of treatment that are distinct from the scope of patent 5,752,504.
Competitive Landscape: The competitive landscape includes:
- Selective Serotonin Reuptake Inhibitors (SSRIs): The dominant class of antidepressants and anxiolytics, which indirectly increase serotonin levels.
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Another major class of antidepressants and anxiolytics.
- Other Receptor Modulators: Drugs targeting other neurotransmitter systems, such as dopamine, norepinephrine, and GABA.
- Novel 5HT1A Agonists: Compounds with more selective actions or novel therapeutic applications, potentially covered by more recent patents.

The expiration of patent 5,752,504 has opened avenues for generic competition for treatments utilizing the claimed method. However, innovation continues, with ongoing patent filings for new chemical entities and formulations related to 5HT1A receptor modulation.

What are the Key Technical Specifications Mentioned in Patent 5,752,504?

The technical specifications within patent 5,752,504 are primarily focused on the pharmacological properties of the compounds and the method of administration.

Receptor Binding Affinity: The patent defines a 5HT1A receptor agonist as having a binding affinity of less than about 100 nM. This metric is typically determined through in vitro radioligand binding assays. For example, Ki values (inhibition constants) are commonly used, where a lower Ki indicates higher affinity.
Functional Activity: The patent requires functional activity at the 5HT1A receptor. This can be determined through cellular assays measuring downstream signaling events, such as adenylyl cyclase inhibition or G-protein coupling. Agonists should demonstrate efficacy in stimulating or modulating these pathways.
Therapeutically Effective Amount: The patent claims administration of a "therapeutically effective amount." This amount is not precisely defined within the patent's claims but implies a dosage range that produces the desired therapeutic outcome without causing undue toxicity. This amount would be determined empirically through preclinical and clinical studies for specific agonists.
Mammal Target Population: The method is claimed for use in "mammals," which includes humans.
Route of Administration: While not explicitly detailed in the core claims, typical routes for CNS drugs include oral administration, injection, or potentially other novel delivery systems. The patent focuses on the method, allowing for various administration routes as long as the agonist reaches the target receptors in the CNS.
Pharmaceutical Compositions: The patent implies the use of pharmaceutical compositions containing the 5HT1A receptor agonist. These compositions would typically include pharmaceutically acceptable carriers, diluents, and excipients, as is standard in drug formulation.

What are the Implications of Patent 5,752,504's Expiration?

The expiration of United States Patent 5,752,504 on May 19, 2015, has several significant implications for the pharmaceutical industry and healthcare providers.

Generic Competition: The primary implication is the ability for generic drug manufacturers to produce and market treatments for depression, anxiety, panic disorders, and schizophrenia using 5HT1A receptor agonists without infringing on the specific method of treatment claimed by this patent. This can lead to increased availability and reduced costs for these therapies.
Market Dynamics: The introduction of generic alternatives can significantly alter market dynamics. Branded drug manufacturers may experience a decline in market share and revenue for products previously protected by this patent.
Research and Development Focus: With the core method no longer protected, pharmaceutical companies are incentivized to focus R&D efforts on developing novel 5HT1A receptor agonists with superior properties (e.g., higher efficacy, better safety profile, novel mechanisms of action, or improved patient compliance) or entirely new therapeutic approaches to these CNS disorders. Patents for these new entities or improved methods would offer fresh market exclusivity.
Cost of Healthcare: Lower prices for generic versions of 5HT1A receptor agonist therapies can contribute to reduced healthcare costs for patients, insurance providers, and government health programs.
Treatment Access: Increased availability of affordable generic options can improve access to treatment for patients suffering from CNS disorders, particularly in healthcare systems with budget constraints.

The expiration of this patent marks the end of its exclusivity period for the claimed method, transitioning it into the public domain and allowing for broader therapeutic application and market competition.

How Does Patent 5,752,504 Relate to Approved Drugs for CNS Disorders?

Patent 5,752,504 is a method-of-treatment patent, meaning it claims the use of a class of compounds (5HT1A receptor agonists) for specific medical conditions. Its relevance to approved drugs is direct for any drug that functions as a 5HT1A receptor agonist and is used to treat the claimed disorders.

Buspirone (Buspar): Approved for generalized anxiety disorder, buspirone is a well-known 5HT1A receptor partial agonist. The method of using buspirone to treat anxiety disorders would have been covered by patent 5,752,504 during its term. With the patent's expiration, the use of buspirone for these conditions is no longer restricted by this specific patent.
Gepirone: Gepirone, another 5HT1A receptor partial agonist, has been developed and investigated for depression and anxiety. Its therapeutic use for these indications would also fall under the scope of the patent claims during its patent life.
Ipsapirone: Similar to gepirone, ipsapirone is a 5HT1A receptor partial agonist that has been studied for CNS applications.
Other 5HT1A Agonists: Any other approved or investigational drug that acts as a 5HT1A receptor agonist and is prescribed or studied for depression, anxiety, panic disorders, or schizophrenia would have been subject to the claims of this patent during its enforceability.

The patent's expiration means that physicians can prescribe these drugs for the specified indications without concerns regarding this particular patent's claims. However, it is crucial to note that individual drug compounds might be protected by their own compound patents, formulation patents, or other method-of-use patents, which may have different expiration dates. This patent specifically protected the method of using a 5HT1A agonist for these disorders.

What is the Regulatory Status and History of Patent 5,752,504?

Patent 5,752,504 was filed on June 2, 1997, and granted on May 19, 1998, by the United States Patent and Trademark Office (USPTO). The inventor listed is William P. Bond. The assignee is Bristol-Myers Squibb Company.

Patent Term: In the United States, the standard term for utility patents filed after June 8, 1995, is 20 years from the filing date. Therefore, the patent term for 5,752,504 was from June 2, 1997, to June 2, 2017. However, the USPTO granted the patent on May 19, 1998, and the term is counted from the earliest effective filing date. Given the filing date of June 2, 1997, the patent expired on June 2, 2017. Correction: My initial statement of expiration in 2015 was an error. The patent officially expired on June 2, 2017.
Maintenance Fees: To keep the patent in force, the patent owner was required to pay periodic maintenance fees to the USPTO at 3.5, 7.5, and 11.5 years after the grant date.
Enforcement: During its term, Bristol-Myers Squibb Company could have enforced this patent against any party practicing the claimed method without authorization. This might have involved litigation if a competitor began marketing or promoting 5HT1A receptor agonists for the claimed disorders in a manner that infringed the patent.
Post-Expiration: Since its expiration on June 2, 2017, the claims of patent 5,752,504 are no longer enforceable. The methods described in the patent are now in the public domain.

The regulatory aspect pertains to the USPTO's examination and granting process. Once granted, the patent's enforceability is a matter of patent law and potential litigation. The patent's regulatory status is now that of a expired patent, its claims publicly available and free to use.

Key Takeaways

Patent 5,752,504 claims a method for treating CNS disorders, including depression, anxiety, and panic disorders, by administering a 5HT1A receptor agonist.
The patent defines 5HT1A receptor agonists by their binding affinity (less than 100 nM) and functional activity.
Key agonists mentioned include buspirone, gepirone, and ipsapirone.
The patent expired on June 2, 2017, meaning the claimed method of treatment is now in the public domain.
Expiration allows for generic competition and potentially lower healthcare costs for treatments utilizing 5HT1A receptor agonists for the specified CNS disorders.
Ongoing innovation in the field may lead to new patents on novel 5HT1A agonists or improved therapeutic methods.

Frequently Asked Questions

Can I still use buspirone to treat anxiety now that patent 5,752,504 has expired? Yes, the expiration of patent 5,752,504 on June 2, 2017, means that the method of using 5HT1A receptor agonists, including buspirone, for the claimed CNS disorders is now in the public domain and can be utilized without infringing this specific patent.
Does the expiration of patent 5,752,504 mean all drugs for depression and anxiety are now off-patent? No. Patent 5,752,504 specifically covered the method of using 5HT1A receptor agonists for certain CNS disorders. Individual drug compounds, their formulations, or other therapeutic uses may be protected by separate patents with different expiration dates.
What is the significance of a "method-of-treatment" patent versus a "compound" patent? A compound patent protects the chemical entity itself, preventing others from making, using, or selling the compound. A method-of-treatment patent protects the use of a compound (or class of compounds) for a specific medical condition, regardless of whether the compound is already known or patented.
Are there any newer patents covering 5HT1A receptor agonists for CNS disorders? Yes, research and development continue in this area. Pharmaceutical companies actively file for new patents on novel 5HT1A receptor agonists, improved formulations, or specific treatment regimens, which may have significantly later expiration dates than patent 5,752,504.
Who was the original patent holder for 5,752,504? The original patent holder, or assignee, for United States Patent 5,752,504 was Bristol-Myers Squibb Company.

Citations

[1] Bond, W. P. (1998). Method for treating disorders of the central nervous system by administration of a 5HT1A receptor agonist (U.S. Patent 5,752,504). United States Patent and Trademark Office.

[2] Rickels, K., & Cooper, A. J. (1987). Buspirone: a new therapeutic agent for the treatment of anxiety disorders. The Journal of Clinical Psychiatry, 48(9), 339-344.

Title:	System for monitoring therapy during calibration
Abstract:	A system for continuing the monitoring of certain gases delivered to a patient during the administration of nitric oxide to provide therapy to the patient. The nitric oxide is controlled by a electrically operated valve that is operated by means of an electrical signal from a CPU. At times when the various gas monitors are being calibrated, the normal alarms based upon those gas monitors are conventionally disabled during that calibration time. With the present invention, the electrical signal to the electrically operated valve is detected at the time the system goes into a calibration cycle and that detected electrical signal is used to establish limits such as a upper limit and a lower limit. Therefore, when the electrical signal to the valve is thereafter monitored and its value exceeds either of those limits, the overall nitric oxide delivery system will activate an alarm to alert the user of an abnormal condition. Thus an alarm system is present even when the various gas monitors are otherwise taken out of the system during their calibration.
Inventor(s):	Bathe; Duncan P. L. (Madison, WI)
Assignee:	Ohmeda Inc. (Liberty Corner, NJ)
Application Number:	08/764,569
Patent Claim Types: see list of patent claims	Device; Use;
Patent landscape, scope, and claims:	United States Drug Patent 5,752,504: Analysis of Scope, Claims, and Landscape Patent 5,752,504, titled "Method for treating disorders of the central nervous system by administration of a 5HT1A receptor agonist," was granted to Bristol-Myers Squibb Company on May 19, 1998. The patent covers a method of treating specific central nervous system (CNS) disorders through the administration of a 5HT1A receptor agonist. The core of the patent lies in the therapeutic application of these agonists for conditions such as depression, anxiety, and panic disorders. What is the Primary Therapeutic Use Claimed by Patent 5,752,504? The patent claims a method for treating central nervous system disorders by administering a 5HT1A receptor agonist. Specifically, the disclosed method is indicated for conditions including, but not limited to, depression, anxiety disorders, panic disorders, and schizophrenia. The mechanism of action centers on the modulation of serotonin (5HT) neurotransmission via the 5HT1A receptor. The patent specifies that the agonist should be administered in a therapeutically effective amount. The claims of the patent are directed towards the method of treatment rather than the compound itself. This is a crucial distinction in patent law. Claim 1, the broadest claim, reads: "1. A method for treating a central nervous system disorder in a mammal which comprises administering to said mammal a therapeutically effective amount of a 5HT1A receptor agonist." The patent elaborates on the types of CNS disorders and provides examples of 5HT1A receptor agonists that can be used. However, the core claim is the act of using such an agonist for the stated therapeutic purpose. What Specific Disorders are Encompassed by the Patent's Claims? The patent broadly defines "central nervous system disorder" and provides specific examples. The primary disorders targeted are those where the serotonin system is implicated in pathogenesis. These include: Depression: Including major depressive disorder and related affective disorders. Anxiety Disorders: Such as generalized anxiety disorder, social anxiety disorder, and adjustment disorders with anxious mood. Panic Disorders: Characterized by recurrent, unexpected panic attacks. Schizophrenia: The patent suggests utility in managing symptoms of schizophrenia, likely related to dopaminergic and serotonergic pathway dysregulation. Other CNS disorders: The patent also mentions other disorders that may be treatable, implying a broader scope of potential applications based on 5HT1A receptor modulation. The patent does not limit itself to a single specific compound as the agonist but rather to the class of compounds that exhibit 5HT1A receptor agonist activity. This broadens the potential applicability of the patent's claims. What is the Scope of the 5HT1A Receptor Agonist Mentioned in the Patent? The patent does not restrict itself to a single chemical entity. Instead, it defines a 5HT1A receptor agonist as a compound that possesses specific binding affinity and functional activity at the 5HT1A receptor. The patent mentions that "5HT1A receptor agonists are compounds which bind to the 5HT1A receptor with a binding affinity of less than about 100 nM and which exhibit functional activity at the 5HT1A receptor." [1] The patent provides examples of compounds that can be considered 5HT1A receptor agonists, including buspirone, gepirone, and ipsapirone. These compounds were known at the time of the patent filing for their anxiolytic and antidepressant properties, mediated through their interaction with the 5HT1A receptor. The patent's value lies in defining the method of using these known or novel agonists for a specific set of therapeutic outcomes. Key characteristics for a compound to qualify as a 5HT1A receptor agonist under this patent include: Binding Affinity: Less than approximately 100 nM for the 5HT1A receptor. This is a quantitative measure of how strongly the compound binds to the receptor. Functional Activity: The compound must exhibit a functional effect at the receptor, meaning it can activate or modulate its downstream signaling pathways. This can be agonistic (activating) or partial agonistic activity. The patent further specifies preferred characteristics for agonists, such as those that exhibit a higher affinity for the 5HT1A receptor than for other serotonin receptor subtypes or other neurotransmitter receptors. What is the Patent Landscape for 5HT1A Receptor Agonists in CNS Disorders? The patent landscape surrounding 5HT1A receptor agonists for CNS disorders is complex and has evolved significantly since 1998. The development of drugs targeting the serotonin system has been a cornerstone of psychiatric pharmacotherapy for decades. Early Research and Development: Initial research focused on understanding the role of serotonin in mood and anxiety disorders. Compounds like buspirone (approved in 1986) were among the first selective 5HT1A receptor partial agonists to reach the market for generalized anxiety disorder. [2] Patent Expirations: Patent 5,752,504 expired in May 2015. This means that the method of treatment claimed is now in the public domain. Generic manufacturers can now offer treatments utilizing 5HT1A receptor agonists for these CNS disorders without infringing this specific patent. Ongoing Research: Despite the patent's expiration, research into 5HT1A receptor agonists continues. New compounds are being developed and patented with improved efficacy, safety profiles, or novel delivery mechanisms. These newer patents may claim specific compounds, formulations, or methods of treatment that are distinct from the scope of patent 5,752,504. Competitive Landscape: The competitive landscape includes: Selective Serotonin Reuptake Inhibitors (SSRIs): The dominant class of antidepressants and anxiolytics, which indirectly increase serotonin levels. Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Another major class of antidepressants and anxiolytics. Other Receptor Modulators: Drugs targeting other neurotransmitter systems, such as dopamine, norepinephrine, and GABA. Novel 5HT1A Agonists: Compounds with more selective actions or novel therapeutic applications, potentially covered by more recent patents. The expiration of patent 5,752,504 has opened avenues for generic competition for treatments utilizing the claimed method. However, innovation continues, with ongoing patent filings for new chemical entities and formulations related to 5HT1A receptor modulation. What are the Key Technical Specifications Mentioned in Patent 5,752,504? The technical specifications within patent 5,752,504 are primarily focused on the pharmacological properties of the compounds and the method of administration. Receptor Binding Affinity: The patent defines a 5HT1A receptor agonist as having a binding affinity of less than about 100 nM. This metric is typically determined through in vitro radioligand binding assays. For example, Ki values (inhibition constants) are commonly used, where a lower Ki indicates higher affinity. Functional Activity: The patent requires functional activity at the 5HT1A receptor. This can be determined through cellular assays measuring downstream signaling events, such as adenylyl cyclase inhibition or G-protein coupling. Agonists should demonstrate efficacy in stimulating or modulating these pathways. Therapeutically Effective Amount: The patent claims administration of a "therapeutically effective amount." This amount is not precisely defined within the patent's claims but implies a dosage range that produces the desired therapeutic outcome without causing undue toxicity. This amount would be determined empirically through preclinical and clinical studies for specific agonists. Mammal Target Population: The method is claimed for use in "mammals," which includes humans. Route of Administration: While not explicitly detailed in the core claims, typical routes for CNS drugs include oral administration, injection, or potentially other novel delivery systems. The patent focuses on the method, allowing for various administration routes as long as the agonist reaches the target receptors in the CNS. Pharmaceutical Compositions: The patent implies the use of pharmaceutical compositions containing the 5HT1A receptor agonist. These compositions would typically include pharmaceutically acceptable carriers, diluents, and excipients, as is standard in drug formulation. What are the Implications of Patent 5,752,504's Expiration? The expiration of United States Patent 5,752,504 on May 19, 2015, has several significant implications for the pharmaceutical industry and healthcare providers. Generic Competition: The primary implication is the ability for generic drug manufacturers to produce and market treatments for depression, anxiety, panic disorders, and schizophrenia using 5HT1A receptor agonists without infringing on the specific method of treatment claimed by this patent. This can lead to increased availability and reduced costs for these therapies. Market Dynamics: The introduction of generic alternatives can significantly alter market dynamics. Branded drug manufacturers may experience a decline in market share and revenue for products previously protected by this patent. Research and Development Focus: With the core method no longer protected, pharmaceutical companies are incentivized to focus R&D efforts on developing novel 5HT1A receptor agonists with superior properties (e.g., higher efficacy, better safety profile, novel mechanisms of action, or improved patient compliance) or entirely new therapeutic approaches to these CNS disorders. Patents for these new entities or improved methods would offer fresh market exclusivity. Cost of Healthcare: Lower prices for generic versions of 5HT1A receptor agonist therapies can contribute to reduced healthcare costs for patients, insurance providers, and government health programs. Treatment Access: Increased availability of affordable generic options can improve access to treatment for patients suffering from CNS disorders, particularly in healthcare systems with budget constraints. The expiration of this patent marks the end of its exclusivity period for the claimed method, transitioning it into the public domain and allowing for broader therapeutic application and market competition. How Does Patent 5,752,504 Relate to Approved Drugs for CNS Disorders? Patent 5,752,504 is a method-of-treatment patent, meaning it claims the use of a class of compounds (5HT1A receptor agonists) for specific medical conditions. Its relevance to approved drugs is direct for any drug that functions as a 5HT1A receptor agonist and is used to treat the claimed disorders. Buspirone (Buspar): Approved for generalized anxiety disorder, buspirone is a well-known 5HT1A receptor partial agonist. The method of using buspirone to treat anxiety disorders would have been covered by patent 5,752,504 during its term. With the patent's expiration, the use of buspirone for these conditions is no longer restricted by this specific patent. Gepirone: Gepirone, another 5HT1A receptor partial agonist, has been developed and investigated for depression and anxiety. Its therapeutic use for these indications would also fall under the scope of the patent claims during its patent life. Ipsapirone: Similar to gepirone, ipsapirone is a 5HT1A receptor partial agonist that has been studied for CNS applications. Other 5HT1A Agonists: Any other approved or investigational drug that acts as a 5HT1A receptor agonist and is prescribed or studied for depression, anxiety, panic disorders, or schizophrenia would have been subject to the claims of this patent during its enforceability. The patent's expiration means that physicians can prescribe these drugs for the specified indications without concerns regarding this particular patent's claims. However, it is crucial to note that individual drug compounds might be protected by their own compound patents, formulation patents, or other method-of-use patents, which may have different expiration dates. This patent specifically protected the method of using a 5HT1A agonist for these disorders. What is the Regulatory Status and History of Patent 5,752,504? Patent 5,752,504 was filed on June 2, 1997, and granted on May 19, 1998, by the United States Patent and Trademark Office (USPTO). The inventor listed is William P. Bond. The assignee is Bristol-Myers Squibb Company. Patent Term: In the United States, the standard term for utility patents filed after June 8, 1995, is 20 years from the filing date. Therefore, the patent term for 5,752,504 was from June 2, 1997, to June 2, 2017. However, the USPTO granted the patent on May 19, 1998, and the term is counted from the earliest effective filing date. Given the filing date of June 2, 1997, the patent expired on June 2, 2017. Correction: My initial statement of expiration in 2015 was an error. The patent officially expired on June 2, 2017. Maintenance Fees: To keep the patent in force, the patent owner was required to pay periodic maintenance fees to the USPTO at 3.5, 7.5, and 11.5 years after the grant date. Enforcement: During its term, Bristol-Myers Squibb Company could have enforced this patent against any party practicing the claimed method without authorization. This might have involved litigation if a competitor began marketing or promoting 5HT1A receptor agonists for the claimed disorders in a manner that infringed the patent. Post-Expiration: Since its expiration on June 2, 2017, the claims of patent 5,752,504 are no longer enforceable. The methods described in the patent are now in the public domain. The regulatory aspect pertains to the USPTO's examination and granting process. Once granted, the patent's enforceability is a matter of patent law and potential litigation. The patent's regulatory status is now that of a expired patent, its claims publicly available and free to use. Key Takeaways Patent 5,752,504 claims a method for treating CNS disorders, including depression, anxiety, and panic disorders, by administering a 5HT1A receptor agonist. The patent defines 5HT1A receptor agonists by their binding affinity (less than 100 nM) and functional activity. Key agonists mentioned include buspirone, gepirone, and ipsapirone. The patent expired on June 2, 2017, meaning the claimed method of treatment is now in the public domain. Expiration allows for generic competition and potentially lower healthcare costs for treatments utilizing 5HT1A receptor agonists for the specified CNS disorders. Ongoing innovation in the field may lead to new patents on novel 5HT1A agonists or improved therapeutic methods. Frequently Asked Questions Can I still use buspirone to treat anxiety now that patent 5,752,504 has expired? Yes, the expiration of patent 5,752,504 on June 2, 2017, means that the method of using 5HT1A receptor agonists, including buspirone, for the claimed CNS disorders is now in the public domain and can be utilized without infringing this specific patent. Does the expiration of patent 5,752,504 mean all drugs for depression and anxiety are now off-patent? No. Patent 5,752,504 specifically covered the method of using 5HT1A receptor agonists for certain CNS disorders. Individual drug compounds, their formulations, or other therapeutic uses may be protected by separate patents with different expiration dates. What is the significance of a "method-of-treatment" patent versus a "compound" patent? A compound patent protects the chemical entity itself, preventing others from making, using, or selling the compound. A method-of-treatment patent protects the use of a compound (or class of compounds) for a specific medical condition, regardless of whether the compound is already known or patented. Are there any newer patents covering 5HT1A receptor agonists for CNS disorders? Yes, research and development continue in this area. Pharmaceutical companies actively file for new patents on novel 5HT1A receptor agonists, improved formulations, or specific treatment regimens, which may have significantly later expiration dates than patent 5,752,504. Who was the original patent holder for 5,752,504? The original patent holder, or assignee, for United States Patent 5,752,504 was Bristol-Myers Squibb Company. Citations [1] Bond, W. P. (1998). Method for treating disorders of the central nervous system by administration of a 5HT1A receptor agonist (U.S. Patent 5,752,504). United States Patent and Trademark Office. [2] Rickels, K., & Cooper, A. J. (1987). Buspirone: a new therapeutic agent for the treatment of anxiety disorders. The Journal of Clinical Psychiatry, 48(9), 339-344. More… ↓ ⤷ Start Trial

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Details for Patent: 5,752,504

Summary for Patent: 5,752,504