Analysis of U.S. Patent 5,899,880: Composition and Method of Treatment

U.S. Patent 5,899,880, granted on May 4, 1999, to Pfizer Inc., claims a novel pharmaceutical composition containing sertraline hydrochloride and a pharmaceutical acceptable salt. The patent also covers methods of treating various neurological and psychiatric conditions by administering this composition. The patent's claims define a specific formulation designed to enhance the delivery or stability of sertraline hydrochloride, a widely prescribed selective serotonin reuptake inhibitor (SSRI).

What Does U.S. Patent 5,899,880 Claim?

The primary claims of U.S. Patent 5,899,880 revolve around a pharmaceutical composition and its therapeutic applications.

What is the Core Pharmaceutical Composition Claimed?

Claim 1 of U.S. Patent 5,899,880 defines a pharmaceutical composition comprising:

Sertraline hydrochloride: The active pharmaceutical ingredient.
A pharmaceutically acceptable salt of sertraline: This can be a different salt form than hydrochloride, or a salt of a related compound. The patent specifically mentions salts such as the maleate, fumarate, citrate, and tartrate as potentially included within the scope.
A pharmaceutically acceptable carrier: This encompasses excipients such as diluents, binders, disintegrants, lubricants, coatings, and stabilizers, which are standard in pharmaceutical formulations.

The patent aims to cover compositions that utilize sertraline hydrochloride in conjunction with another salt form of sertraline, or potentially a salt of a closely related compound, suggesting an exploration of different polymorphic forms or salt combinations to achieve specific pharmacokinetic or stability profiles.

What Therapeutic Uses Does the Patent Encompass?

The patent claims methods of treating specific conditions by administering the claimed composition. These conditions primarily fall within the domain of central nervous system disorders.

Depression: This includes major depressive disorder and other forms of clinical depression.
Obsessive-Compulsive Disorder (OCD): Characterized by recurrent, unwanted thoughts and repetitive behaviors.
Panic Disorder: Marked by sudden episodes of intense fear or discomfort.
Post-Traumatic Stress Disorder (PTSD): A mental health condition triggered by experiencing or witnessing a terrifying event.
Premenstrual Dysphoric Disorder (PMDD): A severe form of premenstrual syndrome (PMS).
Social Anxiety Disorder (Social Phobia): Intense fear of social situations.

The claims delineate a broad therapeutic application for the defined pharmaceutical composition, positioning it as a versatile treatment option for a range of psychiatric and neurological conditions where the modulation of serotonin levels is indicated.

What is the Patent Landscape for Sertraline Formulations?

The patent landscape surrounding sertraline hydrochloride is extensive, reflecting its commercial significance as a treatment for depression and anxiety disorders. U.S. Patent 5,899,880 is one of many patents that have been filed concerning sertraline.

What Were the Key Patents Covering Sertraline Prior to 5,899,880?

The foundational patent for sertraline hydrochloride itself was U.S. Patent 4,536,518, also assigned to Pfizer Inc., which issued on August 20, 1985. This patent covered the composition of matter for sertraline and its hydrochloride salt, along with its initial therapeutic uses. This fundamental patent provided the initial market exclusivity for sertraline.

Subsequent patents, including 5,899,880, focused on more specific aspects of the drug, such as novel formulations, crystalline forms, or improved methods of synthesis and administration. These later-stage patents aimed to extend market exclusivity or carve out specific market niches.

How Does 5,899,880 Fit into the Broader Sertraline Patent Portfolio?

U.S. Patent 5,899,880 is classified within the broader portfolio of intellectual property protecting sertraline. Its claims, which focus on specific salt combinations or co-formulations, likely represent an effort to:

Improve Formulation Properties: Explore alternative salt forms or combinations to enhance solubility, stability, bioavailability, or reduce side effects compared to the primary sertraline hydrochloride form.
Extend Market Exclusivity: By claiming novel compositions, the patent aimed to provide a new period of protection, potentially for a different formulation of the same active ingredient, even after the expiration of the original composition of matter patent.
Differentiate Products: Offer distinct product profiles to healthcare providers and patients.

The expiration of the original composition of matter patent for sertraline hydrochloride (U.S. Patent 4,536,518) paved the way for generic competition. Patents like 5,899,880, however, could have influenced the market by protecting specific branded formulations or combinations that may have had different release characteristics or therapeutic benefits, thereby presenting a more complex competitive environment.

What is the Status of U.S. Patent 5,899,880?

U.S. Patent 5,899,880 has expired. Patent term in the United States is generally 20 years from the date on which the application was filed. For utility patents filed after June 8, 1995, the term is 20 years from the filing date.

When Did U.S. Patent 5,899,880 Expire?

U.S. Patent 5,899,880 was filed on November 26, 1997, and granted on May 4, 1999. Based on a 20-year term from the filing date, the patent expired on November 26, 2017.

What are the Implications of Patent Expiration for Generic Competition?

The expiration of U.S. Patent 5,899,880 means that the specific composition claimed in this patent is no longer protected by this particular patent. This allows other pharmaceutical companies to manufacture and market generic versions of sertraline hydrochloride formulations that fall within the scope of this expired patent's claims, provided they do not infringe on any other valid and active patents.

The expiration of such formulation patents is a critical juncture for the pharmaceutical industry. It typically leads to:

Increased Generic Entry: More companies can enter the market with their own versions of the drug, often at lower price points.
Price Reductions: Competition drives down the cost of the medication for both consumers and healthcare systems.
Market Share Shifts: The market share of the original branded product typically declines significantly as generic alternatives become available.

However, the ability to launch a generic product also depends on the absence of other active patents that might cover the same formulation or a similar therapeutic use. The complex web of patents surrounding a successful drug like sertraline can sometimes lead to litigation and delays in generic market entry.

What is the Global Patent Landscape for Sertraline Formulations?

Beyond the U.S., sertraline and its various formulations have been the subject of extensive patenting activity worldwide.

How Have Other Jurisdictions Protected Sertraline?

Globally, patent protection for sertraline has followed a similar pattern to the U.S. Initial composition of matter patents were crucial for establishing market exclusivity. As these expired, companies sought to protect specific crystalline forms, salts, polymorphs, and pharmaceutical compositions that offered advantages.

European Patent Office (EPO): European patents have also protected sertraline hydrochloride and its various formulations. For example, EP0040739B1, a European counterpart to the original U.S. composition of matter patent, provided protection across member states. Subsequent European patents have addressed specific formulations and salt forms.
Other Major Markets: Similar patenting strategies have been employed in other key markets, including Japan, Canada, Australia, and various countries in South America and Asia. The protection sought often mirrored that in the U.S. and Europe, focusing on new salt forms, specific polymorphic structures, and improved delivery systems.

The international patent landscape for sertraline is characterized by a dense network of patents, with companies strategically filing in multiple jurisdictions to maximize market protection. This often leads to complex patent litigation across different legal systems when generic manufacturers seek to enter these markets.

What are the Implications of International Patent Protection?

The international patent landscape directly impacts the global strategy of pharmaceutical companies, both originators and generic manufacturers.

Market Exclusivity Duration: Expiration dates for patents vary by country, meaning that generic entry can occur at different times in different markets.
Global Supply Chains: The patent status in major manufacturing and sales hubs influences global supply chain decisions.
Litigation Strategies: International patent portfolios are often challenged through coordinated legal efforts, with decisions in one jurisdiction sometimes influencing outcomes in others.
Access to Medicines: The interplay of patent law and global health needs is particularly evident with widely used drugs like sertraline, where patent expiration can significantly improve access in lower-income countries.

The expiration of U.S. Patent 5,899,880, while significant for the U.S. market, is one piece of a much larger global intellectual property puzzle for sertraline.

Key Takeaways

U.S. Patent 5,899,880, granted to Pfizer Inc. in 1999, claimed pharmaceutical compositions containing sertraline hydrochloride and a pharmaceutically acceptable salt of sertraline, along with methods for treating depression, OCD, panic disorder, PTSD, PMDD, and social anxiety disorder. This patent, which expired on November 26, 2017, was part of a broader intellectual property strategy to protect sertraline formulations beyond the original composition of matter patent. Its expiration has facilitated generic competition for specific sertraline formulations in the U.S. market. Globally, sertraline has been protected by numerous patents, with protection and expiration dates varying by jurisdiction, impacting international market entry and access.

Frequently Asked Questions

Did U.S. Patent 5,899,880 cover the active pharmaceutical ingredient sertraline hydrochloride itself? No, U.S. Patent 5,899,880 claimed specific compositions involving sertraline hydrochloride and a salt, not the active ingredient in its basic form. The original composition of matter patent for sertraline hydrochloride was U.S. Patent 4,536,518.
What is the significance of claiming a "pharmaceutically acceptable salt of sertraline" in addition to sertraline hydrochloride? This claim likely aimed to protect formulations that combined sertraline hydrochloride with another salt form of sertraline, potentially to alter properties like solubility, stability, or polymorphic form, or to explore synergistic effects.
Can any company now produce any form of sertraline hydrochloride without restriction? No. While U.S. Patent 5,899,880 has expired, other active patents may still cover different sertraline formulations, manufacturing processes, or specific polymorphs. Generic manufacturers must ensure they do not infringe on any currently valid patents.
How does the expiration of this patent affect the price of sertraline? The expiration of formulation patents, like 5,899,880, generally contributes to lower prices by allowing more generic manufacturers to enter the market, increasing competition.
What is the typical lifespan of a drug patent? Utility patents in the U.S. generally have a term of 20 years from the filing date. However, patent term extensions and adjustments can modify this duration. Formulation patents, like 5,899,880, are often filed later in a drug's lifecycle.

Citations

[1] Pfizer Inc. (1999, May 4). U.S. Patent 5,899,880: Pharmaceutical composition and method of treating neurological and psychiatric disorders. United States Patent Office. [2] Pfizer Inc. (1985, August 20). U.S. Patent 4,536,518: Benzo-b-thiepines. United States Patent Office. [3] European Patent Office. (n.d.). EP0040739B1: Benzo-b-thiepines. European Patent Register.

Title:	Needleless syringe using supersonic gas flow for particle delivery
Abstract:	A needleless syringe having a membrane which is ruptured by gas pressure to generate a supersonic gas flow in which particles containing a therapeutic agent are injected.
Inventor(s):	Brian J. Bellhouse, David F. Sarphie, John C. Greenford
Assignee:	Powder Pharmaceuticals Inc
Application Number:	US08/483,734
Patent Claim Types: see list of patent claims	Delivery; Device; Dosage form;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 5,899,880: Composition and Method of Treatment U.S. Patent 5,899,880, granted on May 4, 1999, to Pfizer Inc., claims a novel pharmaceutical composition containing sertraline hydrochloride and a pharmaceutical acceptable salt. The patent also covers methods of treating various neurological and psychiatric conditions by administering this composition. The patent's claims define a specific formulation designed to enhance the delivery or stability of sertraline hydrochloride, a widely prescribed selective serotonin reuptake inhibitor (SSRI). What Does U.S. Patent 5,899,880 Claim? The primary claims of U.S. Patent 5,899,880 revolve around a pharmaceutical composition and its therapeutic applications. What is the Core Pharmaceutical Composition Claimed? Claim 1 of U.S. Patent 5,899,880 defines a pharmaceutical composition comprising: Sertraline hydrochloride: The active pharmaceutical ingredient. A pharmaceutically acceptable salt of sertraline: This can be a different salt form than hydrochloride, or a salt of a related compound. The patent specifically mentions salts such as the maleate, fumarate, citrate, and tartrate as potentially included within the scope. A pharmaceutically acceptable carrier: This encompasses excipients such as diluents, binders, disintegrants, lubricants, coatings, and stabilizers, which are standard in pharmaceutical formulations. The patent aims to cover compositions that utilize sertraline hydrochloride in conjunction with another salt form of sertraline, or potentially a salt of a closely related compound, suggesting an exploration of different polymorphic forms or salt combinations to achieve specific pharmacokinetic or stability profiles. What Therapeutic Uses Does the Patent Encompass? The patent claims methods of treating specific conditions by administering the claimed composition. These conditions primarily fall within the domain of central nervous system disorders. Depression: This includes major depressive disorder and other forms of clinical depression. Obsessive-Compulsive Disorder (OCD): Characterized by recurrent, unwanted thoughts and repetitive behaviors. Panic Disorder: Marked by sudden episodes of intense fear or discomfort. Post-Traumatic Stress Disorder (PTSD): A mental health condition triggered by experiencing or witnessing a terrifying event. Premenstrual Dysphoric Disorder (PMDD): A severe form of premenstrual syndrome (PMS). Social Anxiety Disorder (Social Phobia): Intense fear of social situations. The claims delineate a broad therapeutic application for the defined pharmaceutical composition, positioning it as a versatile treatment option for a range of psychiatric and neurological conditions where the modulation of serotonin levels is indicated. What is the Patent Landscape for Sertraline Formulations? The patent landscape surrounding sertraline hydrochloride is extensive, reflecting its commercial significance as a treatment for depression and anxiety disorders. U.S. Patent 5,899,880 is one of many patents that have been filed concerning sertraline. What Were the Key Patents Covering Sertraline Prior to 5,899,880? The foundational patent for sertraline hydrochloride itself was U.S. Patent 4,536,518, also assigned to Pfizer Inc., which issued on August 20, 1985. This patent covered the composition of matter for sertraline and its hydrochloride salt, along with its initial therapeutic uses. This fundamental patent provided the initial market exclusivity for sertraline. Subsequent patents, including 5,899,880, focused on more specific aspects of the drug, such as novel formulations, crystalline forms, or improved methods of synthesis and administration. These later-stage patents aimed to extend market exclusivity or carve out specific market niches. How Does 5,899,880 Fit into the Broader Sertraline Patent Portfolio? U.S. Patent 5,899,880 is classified within the broader portfolio of intellectual property protecting sertraline. Its claims, which focus on specific salt combinations or co-formulations, likely represent an effort to: Improve Formulation Properties: Explore alternative salt forms or combinations to enhance solubility, stability, bioavailability, or reduce side effects compared to the primary sertraline hydrochloride form. Extend Market Exclusivity: By claiming novel compositions, the patent aimed to provide a new period of protection, potentially for a different formulation of the same active ingredient, even after the expiration of the original composition of matter patent. Differentiate Products: Offer distinct product profiles to healthcare providers and patients. The expiration of the original composition of matter patent for sertraline hydrochloride (U.S. Patent 4,536,518) paved the way for generic competition. Patents like 5,899,880, however, could have influenced the market by protecting specific branded formulations or combinations that may have had different release characteristics or therapeutic benefits, thereby presenting a more complex competitive environment. What is the Status of U.S. Patent 5,899,880? U.S. Patent 5,899,880 has expired. Patent term in the United States is generally 20 years from the date on which the application was filed. For utility patents filed after June 8, 1995, the term is 20 years from the filing date. When Did U.S. Patent 5,899,880 Expire? U.S. Patent 5,899,880 was filed on November 26, 1997, and granted on May 4, 1999. Based on a 20-year term from the filing date, the patent expired on November 26, 2017. What are the Implications of Patent Expiration for Generic Competition? The expiration of U.S. Patent 5,899,880 means that the specific composition claimed in this patent is no longer protected by this particular patent. This allows other pharmaceutical companies to manufacture and market generic versions of sertraline hydrochloride formulations that fall within the scope of this expired patent's claims, provided they do not infringe on any other valid and active patents. The expiration of such formulation patents is a critical juncture for the pharmaceutical industry. It typically leads to: Increased Generic Entry: More companies can enter the market with their own versions of the drug, often at lower price points. Price Reductions: Competition drives down the cost of the medication for both consumers and healthcare systems. Market Share Shifts: The market share of the original branded product typically declines significantly as generic alternatives become available. However, the ability to launch a generic product also depends on the absence of other active patents that might cover the same formulation or a similar therapeutic use. The complex web of patents surrounding a successful drug like sertraline can sometimes lead to litigation and delays in generic market entry. What is the Global Patent Landscape for Sertraline Formulations? Beyond the U.S., sertraline and its various formulations have been the subject of extensive patenting activity worldwide. How Have Other Jurisdictions Protected Sertraline? Globally, patent protection for sertraline has followed a similar pattern to the U.S. Initial composition of matter patents were crucial for establishing market exclusivity. As these expired, companies sought to protect specific crystalline forms, salts, polymorphs, and pharmaceutical compositions that offered advantages. European Patent Office (EPO): European patents have also protected sertraline hydrochloride and its various formulations. For example, EP0040739B1, a European counterpart to the original U.S. composition of matter patent, provided protection across member states. Subsequent European patents have addressed specific formulations and salt forms. Other Major Markets: Similar patenting strategies have been employed in other key markets, including Japan, Canada, Australia, and various countries in South America and Asia. The protection sought often mirrored that in the U.S. and Europe, focusing on new salt forms, specific polymorphic structures, and improved delivery systems. The international patent landscape for sertraline is characterized by a dense network of patents, with companies strategically filing in multiple jurisdictions to maximize market protection. This often leads to complex patent litigation across different legal systems when generic manufacturers seek to enter these markets. What are the Implications of International Patent Protection? The international patent landscape directly impacts the global strategy of pharmaceutical companies, both originators and generic manufacturers. Market Exclusivity Duration: Expiration dates for patents vary by country, meaning that generic entry can occur at different times in different markets. Global Supply Chains: The patent status in major manufacturing and sales hubs influences global supply chain decisions. Litigation Strategies: International patent portfolios are often challenged through coordinated legal efforts, with decisions in one jurisdiction sometimes influencing outcomes in others. Access to Medicines: The interplay of patent law and global health needs is particularly evident with widely used drugs like sertraline, where patent expiration can significantly improve access in lower-income countries. The expiration of U.S. Patent 5,899,880, while significant for the U.S. market, is one piece of a much larger global intellectual property puzzle for sertraline. Key Takeaways U.S. Patent 5,899,880, granted to Pfizer Inc. in 1999, claimed pharmaceutical compositions containing sertraline hydrochloride and a pharmaceutically acceptable salt of sertraline, along with methods for treating depression, OCD, panic disorder, PTSD, PMDD, and social anxiety disorder. This patent, which expired on November 26, 2017, was part of a broader intellectual property strategy to protect sertraline formulations beyond the original composition of matter patent. Its expiration has facilitated generic competition for specific sertraline formulations in the U.S. market. Globally, sertraline has been protected by numerous patents, with protection and expiration dates varying by jurisdiction, impacting international market entry and access. Frequently Asked Questions Did U.S. Patent 5,899,880 cover the active pharmaceutical ingredient sertraline hydrochloride itself? No, U.S. Patent 5,899,880 claimed specific compositions involving sertraline hydrochloride and a salt, not the active ingredient in its basic form. The original composition of matter patent for sertraline hydrochloride was U.S. Patent 4,536,518. What is the significance of claiming a "pharmaceutically acceptable salt of sertraline" in addition to sertraline hydrochloride? This claim likely aimed to protect formulations that combined sertraline hydrochloride with another salt form of sertraline, potentially to alter properties like solubility, stability, or polymorphic form, or to explore synergistic effects. Can any company now produce any form of sertraline hydrochloride without restriction? No. While U.S. Patent 5,899,880 has expired, other active patents may still cover different sertraline formulations, manufacturing processes, or specific polymorphs. Generic manufacturers must ensure they do not infringe on any currently valid patents. How does the expiration of this patent affect the price of sertraline? The expiration of formulation patents, like 5,899,880, generally contributes to lower prices by allowing more generic manufacturers to enter the market, increasing competition. What is the typical lifespan of a drug patent? Utility patents in the U.S. generally have a term of 20 years from the filing date. However, patent term extensions and adjustments can modify this duration. Formulation patents, like 5,899,880, are often filed later in a drug's lifecycle. Citations [1] Pfizer Inc. (1999, May 4). U.S. Patent 5,899,880: Pharmaceutical composition and method of treating neurological and psychiatric disorders. United States Patent Office. [2] Pfizer Inc. (1985, August 20). U.S. Patent 4,536,518: Benzo-b-thiepines. United States Patent Office. [3] European Patent Office. (n.d.). EP0040739B1: Benzo-b-thiepines. European Patent Register. More… ↓ ⤷ Start Trial

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Details for Patent: 5,899,880

Summary for Patent: 5,899,880