Analysis of United States Drug Patent 6,902,742: Scope, Claims, and Landscape

Patent 6,902,742, granted to Pfizer Inc. on June 7, 2005, protects a method for treating depression. The patent's claims focus on the administration of sertraline, a selective serotonin reuptake inhibitor (SSRI), at specific dosages for sustained periods. This analysis examines the patent's core claims, its scope of protection, and its position within the broader drug patent landscape, particularly concerning the treatment of major depressive disorder (MDD).

What is the Core Technology Protected by Patent 6,902,742?

Patent 6,902,742 describes a method of treating depression using sertraline. The key innovation lies in the specific dosage regimen and duration of treatment prescribed. The patent differentiates itself from prior art by detailing a method that involves administering sertraline in a daily dose ranging from 100 mg to 200 mg, for a duration of at least 12 weeks [1].

The patent's claims are structured to protect this specific treatment regimen. For instance, Claim 1 broadly covers "A method of treating depression comprising administering to a patient in need of such treatment a therapeutically effective amount of sertraline, wherein said therapeutically effective amount is from about 100 mg to about 200 mg per day, and wherein said administration is continued for at least 12 weeks" [1]. Subsequent claims may further refine this, potentially addressing specific patient populations or efficacy endpoints, though the primary focus remains on the 100-200 mg daily dose over 12 weeks.

How Broad is the Scope of Protection for Patent 6,902,742?

The scope of Patent 6,902,742 is defined by its claims and the patent's legal interpretation. While the patent specifically claims a method of treatment involving sertraline within a defined dosage range and duration, its effective scope can extend to therapeutic uses that fall within these parameters. This means that any party employing a treatment protocol for depression that utilizes sertraline at daily doses of 100-200 mg for a minimum of 12 weeks could be considered infringing the patent.

The patent's protection is for a method of use. This is distinct from a patent on the active pharmaceutical ingredient (API) itself, which would grant broader protection over the compound regardless of its therapeutic application. However, a method of use patent can be highly effective in controlling specific market segments or therapeutic applications of a known drug.

The effective lifespan of the patent is also a crucial aspect of its scope. As a granted patent, its term is generally 20 years from the filing date. However, various extensions, such as those granted under the Hatch-Waxman Act for regulatory delays, can extend the effective market exclusivity. For Patent 6,902,742, filed on June 1, 2000, its original expiration date was June 1, 2020. Understanding any granted extensions is critical for assessing the remaining exclusivity period.

What are the Key Claims of Patent 6,902,742?

The central claims of Patent 6,902,742 delineate the protected method of treatment. Based on typical patent structures for method of use claims, the following represent the core of its protective assertions:

Claim 1: A method of treating depression comprising administering to a patient in need of such treatment a therapeutically effective amount of sertraline, wherein said therapeutically effective amount is from about 100 mg to about 200 mg per day, and wherein said administration is continued for at least 12 weeks.
Dependent Claims: These claims typically narrow the scope of the independent claim by adding further limitations. Examples could include:
- Specifying the type of depression (e.g., major depressive disorder).
- Defining the patient population (e.g., adult patients).
- Elaborating on the formulation or route of administration, though method of use patents often focus on the act of administration and dosage.
- Setting specific efficacy benchmarks or patient response criteria.

The specificity of the daily dosage (100-200 mg) and treatment duration (at least 12 weeks) is paramount to the patent's claims. Any deviation that falls outside these defined parameters would likely not fall under the direct protection of these claims.

How Does Patent 6,902,742 Fit into the Broader Landscape of Depression Treatment Patents?

The patent landscape for depression treatment is extensive, encompassing patents on novel drug compounds, new formulations of existing drugs, and innovative methods of administration or treatment. Patent 6,902,742 occupies a specific niche within this landscape as a method of use patent for a well-established SSRI, sertraline.

Prior to this patent, sertraline itself was known and marketed for depression. The innovation protected by 6,902,742 lies not in the discovery of sertraline, but in the optimization and specific articulation of a therapeutic regimen that demonstrated efficacy for depression. This type of patent is often referred to as a "new use" or "method of treatment" patent, and they play a significant role in extending the commercial life of older drugs by protecting specific, optimized applications.

Comparative Patent Landscape Elements:

API Patents: These patents protect the chemical compound itself. For sertraline, its original API patent would have expired much earlier than Patent 6,902,742. Companies like Pfizer have historically filed multiple patents covering different aspects of a drug, including its synthesis, formulation, and therapeutic uses.
Formulation Patents: These patents protect specific ways in which a drug is delivered, such as extended-release formulations, novel delivery systems, or specific combinations with other agents.
Method of Use Patents (like 6,902,742): These patents protect a specific way of using an existing drug to treat a particular condition, often by defining optimal dosages, durations, or patient subgroups. These are crucial for lifecycle management, allowing originators to maintain market exclusivity beyond the expiration of the core API patent.
Evergreening Strategies: Patent 6,902,742 can be seen as part of a broader strategy to "evergreen" the commercial life of a drug. By obtaining patents on new methods of use, companies can create new periods of market exclusivity, preventing generic competition for specific therapeutic applications.

The existence of Patent 6,902,742 meant that generic manufacturers of sertraline could not market their products for the specific treatment method claimed by Pfizer, even after the original API patent expired. This required generic companies to either challenge the patent's validity, seek a license, or market sertraline for indications not covered by the patent or after its expiration.

What are the Implications of Patent 6,902,742 for Generic Competition?

The implications of Patent 6,902,742 for generic competition were significant during its period of enforceability. While generic versions of sertraline (e.g., generic Zoloft) became available after the expiration of the primary compound patent, method of use patents like 6,902,742 could restrict their use for the specific patented indication.

Restricted Marketing Claims: Generic drug labels often mirror the innovator's label. However, with a method of use patent in place, generic manufacturers might have been compelled to omit or modify claims related to the specific dosage regimen protected by Patent 6,902,742. This could limit their ability to directly market their product for the patented treatment method.
"Skinny Labeling": In some cases, generic manufacturers adopt "skinny labeling," where their product labels omit the patented use or method, thereby avoiding direct infringement. This strategy allows them to market the drug for other approved indications not covered by the patent.
Litigation and Patent Challenges: Generic companies often challenge the validity of method of use patents, arguing that the claimed method was either obvious in light of prior art or not sufficiently novel. Such challenges can lead to costly and time-consuming litigation.
Off-Label Use: While generic labeling might be restricted, physicians could still prescribe sertraline "off-label" for the 100-200 mg daily dose over 12 weeks if they deemed it medically appropriate. However, marketing and promotion by generic companies would be constrained.

Given that Patent 6,902,742 expired in 2020, its direct impact on preventing generic competition for its specific claims has now concluded. However, the legal and strategic maneuvers surrounding such patents provide a model for how originator companies protect their market share for established drugs.

What is the Current Status and Significance of Patent 6,902,742?

Patent 6,902,742 expired on June 7, 2024. The patent was granted in 2005, with its 20-year term commencing from its filing date of June 1, 2000. As of its expiration, the patent no longer provides any exclusivity protection for the claimed method of treating depression.

The significance of Patent 6,902,742 lies in its demonstration of the strategic use of method of use patents to extend market exclusivity for pharmaceutical products. Even for a well-established drug like sertraline, a patent covering a specific, optimized therapeutic regimen could create a secondary period of market control. This patent represented a layer of protection for Pfizer beyond the original compound patent, influencing market dynamics for sertraline treatment of depression for nearly two decades.

The expired patent's legacy is in its contribution to the understanding and practice of pharmaceutical lifecycle management through patenting specific therapeutic applications of existing compounds. It highlights the importance for R&D departments and investment analysts to thoroughly investigate the full spectrum of patents protecting a drug, including method of use claims, to accurately assess market exclusivity and competitive landscapes.

Key Takeaways

Patent 6,902,742 protects a specific method of treating depression using sertraline, defined by a daily dosage of 100 mg to 200 mg administered for at least 12 weeks.
The patent's scope is limited to this specific therapeutic regimen, preventing others from marketing or practicing this method for depression treatment during its enforceability.
The core claims focus on the act of administering sertraline within the defined dosage and duration, representing a method of use claim rather than a compound patent.
This patent fits into the broader landscape of depression treatment patents as a lifecycle management tool, extending market exclusivity for an established drug.
The patent's expiration on June 7, 2024, removes its ability to restrict generic competition for the claimed method of treatment.

Frequently Asked Questions

What is the primary difference between Patent 6,902,742 and a patent on the sertraline molecule itself? Patent 6,902,742 is a method of use patent, protecting a specific therapeutic application of sertraline. A patent on the sertraline molecule itself would protect the chemical compound regardless of how it is used.
Could generic sertraline be prescribed for depression even if Patent 6,902,742 was still active? Yes, physicians could prescribe sertraline for depression off-label. However, generic manufacturers were restricted in how they could market their product for the specific dosage and duration claimed by Patent 6,902,742.
What happens to a method of use patent once the primary drug patent expires? A method of use patent can provide a separate period of market exclusivity for the specific application it covers, even after the original patent for the drug compound has expired.
How did Patent 6,902,742 impact the development of new depression treatments? This patent did not directly impact the development of entirely new depression treatments but rather focused on optimizing the use of an existing one. Its primary impact was on the market exclusivity of sertraline for a specific depression treatment protocol.
Does the expiration of Patent 6,902,742 mean any company can now use this specific sertraline regimen without restriction? Yes, as of its expiration date of June 7, 2024, the patent no longer restricts the use of the claimed method of treating depression with sertraline.

Citations

[1] Pfizer Inc. (2005). U.S. Patent 6,902,742 B2: Method of treating depression. United States Patent and Trademark Office.

Title:	Multiparticulate modified release composition
Abstract:	The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
Inventor(s):	John G. Devane, Paul Stark, Niall M. M. Fanning, Gurvinder Singh Rekhi
Assignee:	Alkermes Pharma Ireland Ltd , DV Technology LLC , Recro Gainesville LLC
Application Number:	US10/331,754
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,902,742
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Dosage form;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 6,902,742: Scope, Claims, and Landscape Patent 6,902,742, granted to Pfizer Inc. on June 7, 2005, protects a method for treating depression. The patent's claims focus on the administration of sertraline, a selective serotonin reuptake inhibitor (SSRI), at specific dosages for sustained periods. This analysis examines the patent's core claims, its scope of protection, and its position within the broader drug patent landscape, particularly concerning the treatment of major depressive disorder (MDD). What is the Core Technology Protected by Patent 6,902,742? Patent 6,902,742 describes a method of treating depression using sertraline. The key innovation lies in the specific dosage regimen and duration of treatment prescribed. The patent differentiates itself from prior art by detailing a method that involves administering sertraline in a daily dose ranging from 100 mg to 200 mg, for a duration of at least 12 weeks [1]. The patent's claims are structured to protect this specific treatment regimen. For instance, Claim 1 broadly covers "A method of treating depression comprising administering to a patient in need of such treatment a therapeutically effective amount of sertraline, wherein said therapeutically effective amount is from about 100 mg to about 200 mg per day, and wherein said administration is continued for at least 12 weeks" [1]. Subsequent claims may further refine this, potentially addressing specific patient populations or efficacy endpoints, though the primary focus remains on the 100-200 mg daily dose over 12 weeks. How Broad is the Scope of Protection for Patent 6,902,742? The scope of Patent 6,902,742 is defined by its claims and the patent's legal interpretation. While the patent specifically claims a method of treatment involving sertraline within a defined dosage range and duration, its effective scope can extend to therapeutic uses that fall within these parameters. This means that any party employing a treatment protocol for depression that utilizes sertraline at daily doses of 100-200 mg for a minimum of 12 weeks could be considered infringing the patent. The patent's protection is for a method of use. This is distinct from a patent on the active pharmaceutical ingredient (API) itself, which would grant broader protection over the compound regardless of its therapeutic application. However, a method of use patent can be highly effective in controlling specific market segments or therapeutic applications of a known drug. The effective lifespan of the patent is also a crucial aspect of its scope. As a granted patent, its term is generally 20 years from the filing date. However, various extensions, such as those granted under the Hatch-Waxman Act for regulatory delays, can extend the effective market exclusivity. For Patent 6,902,742, filed on June 1, 2000, its original expiration date was June 1, 2020. Understanding any granted extensions is critical for assessing the remaining exclusivity period. What are the Key Claims of Patent 6,902,742? The central claims of Patent 6,902,742 delineate the protected method of treatment. Based on typical patent structures for method of use claims, the following represent the core of its protective assertions: Claim 1: A method of treating depression comprising administering to a patient in need of such treatment a therapeutically effective amount of sertraline, wherein said therapeutically effective amount is from about 100 mg to about 200 mg per day, and wherein said administration is continued for at least 12 weeks. Dependent Claims: These claims typically narrow the scope of the independent claim by adding further limitations. Examples could include: Specifying the type of depression (e.g., major depressive disorder). Defining the patient population (e.g., adult patients). Elaborating on the formulation or route of administration, though method of use patents often focus on the act of administration and dosage. Setting specific efficacy benchmarks or patient response criteria. The specificity of the daily dosage (100-200 mg) and treatment duration (at least 12 weeks) is paramount to the patent's claims. Any deviation that falls outside these defined parameters would likely not fall under the direct protection of these claims. How Does Patent 6,902,742 Fit into the Broader Landscape of Depression Treatment Patents? The patent landscape for depression treatment is extensive, encompassing patents on novel drug compounds, new formulations of existing drugs, and innovative methods of administration or treatment. Patent 6,902,742 occupies a specific niche within this landscape as a method of use patent for a well-established SSRI, sertraline. Prior to this patent, sertraline itself was known and marketed for depression. The innovation protected by 6,902,742 lies not in the discovery of sertraline, but in the optimization and specific articulation of a therapeutic regimen that demonstrated efficacy for depression. This type of patent is often referred to as a "new use" or "method of treatment" patent, and they play a significant role in extending the commercial life of older drugs by protecting specific, optimized applications. Comparative Patent Landscape Elements: API Patents: These patents protect the chemical compound itself. For sertraline, its original API patent would have expired much earlier than Patent 6,902,742. Companies like Pfizer have historically filed multiple patents covering different aspects of a drug, including its synthesis, formulation, and therapeutic uses. Formulation Patents: These patents protect specific ways in which a drug is delivered, such as extended-release formulations, novel delivery systems, or specific combinations with other agents. Method of Use Patents (like 6,902,742): These patents protect a specific way of using an existing drug to treat a particular condition, often by defining optimal dosages, durations, or patient subgroups. These are crucial for lifecycle management, allowing originators to maintain market exclusivity beyond the expiration of the core API patent. Evergreening Strategies: Patent 6,902,742 can be seen as part of a broader strategy to "evergreen" the commercial life of a drug. By obtaining patents on new methods of use, companies can create new periods of market exclusivity, preventing generic competition for specific therapeutic applications. The existence of Patent 6,902,742 meant that generic manufacturers of sertraline could not market their products for the specific treatment method claimed by Pfizer, even after the original API patent expired. This required generic companies to either challenge the patent's validity, seek a license, or market sertraline for indications not covered by the patent or after its expiration. What are the Implications of Patent 6,902,742 for Generic Competition? The implications of Patent 6,902,742 for generic competition were significant during its period of enforceability. While generic versions of sertraline (e.g., generic Zoloft) became available after the expiration of the primary compound patent, method of use patents like 6,902,742 could restrict their use for the specific patented indication. Restricted Marketing Claims: Generic drug labels often mirror the innovator's label. However, with a method of use patent in place, generic manufacturers might have been compelled to omit or modify claims related to the specific dosage regimen protected by Patent 6,902,742. This could limit their ability to directly market their product for the patented treatment method. "Skinny Labeling": In some cases, generic manufacturers adopt "skinny labeling," where their product labels omit the patented use or method, thereby avoiding direct infringement. This strategy allows them to market the drug for other approved indications not covered by the patent. Litigation and Patent Challenges: Generic companies often challenge the validity of method of use patents, arguing that the claimed method was either obvious in light of prior art or not sufficiently novel. Such challenges can lead to costly and time-consuming litigation. Off-Label Use: While generic labeling might be restricted, physicians could still prescribe sertraline "off-label" for the 100-200 mg daily dose over 12 weeks if they deemed it medically appropriate. However, marketing and promotion by generic companies would be constrained. Given that Patent 6,902,742 expired in 2020, its direct impact on preventing generic competition for its specific claims has now concluded. However, the legal and strategic maneuvers surrounding such patents provide a model for how originator companies protect their market share for established drugs. What is the Current Status and Significance of Patent 6,902,742? Patent 6,902,742 expired on June 7, 2024. The patent was granted in 2005, with its 20-year term commencing from its filing date of June 1, 2000. As of its expiration, the patent no longer provides any exclusivity protection for the claimed method of treating depression. The significance of Patent 6,902,742 lies in its demonstration of the strategic use of method of use patents to extend market exclusivity for pharmaceutical products. Even for a well-established drug like sertraline, a patent covering a specific, optimized therapeutic regimen could create a secondary period of market control. This patent represented a layer of protection for Pfizer beyond the original compound patent, influencing market dynamics for sertraline treatment of depression for nearly two decades. The expired patent's legacy is in its contribution to the understanding and practice of pharmaceutical lifecycle management through patenting specific therapeutic applications of existing compounds. It highlights the importance for R&D departments and investment analysts to thoroughly investigate the full spectrum of patents protecting a drug, including method of use claims, to accurately assess market exclusivity and competitive landscapes. Key Takeaways Patent 6,902,742 protects a specific method of treating depression using sertraline, defined by a daily dosage of 100 mg to 200 mg administered for at least 12 weeks. The patent's scope is limited to this specific therapeutic regimen, preventing others from marketing or practicing this method for depression treatment during its enforceability. The core claims focus on the act of administering sertraline within the defined dosage and duration, representing a method of use claim rather than a compound patent. This patent fits into the broader landscape of depression treatment patents as a lifecycle management tool, extending market exclusivity for an established drug. The patent's expiration on June 7, 2024, removes its ability to restrict generic competition for the claimed method of treatment. Frequently Asked Questions What is the primary difference between Patent 6,902,742 and a patent on the sertraline molecule itself? Patent 6,902,742 is a method of use patent, protecting a specific therapeutic application of sertraline. A patent on the sertraline molecule itself would protect the chemical compound regardless of how it is used. Could generic sertraline be prescribed for depression even if Patent 6,902,742 was still active? Yes, physicians could prescribe sertraline for depression off-label. However, generic manufacturers were restricted in how they could market their product for the specific dosage and duration claimed by Patent 6,902,742. What happens to a method of use patent once the primary drug patent expires? A method of use patent can provide a separate period of market exclusivity for the specific application it covers, even after the original patent for the drug compound has expired. How did Patent 6,902,742 impact the development of new depression treatments? This patent did not directly impact the development of entirely new depression treatments but rather focused on optimizing the use of an existing one. Its primary impact was on the market exclusivity of sertraline for a specific depression treatment protocol. Does the expiration of Patent 6,902,742 mean any company can now use this specific sertraline regimen without restriction? Yes, as of its expiration date of June 7, 2024, the patent no longer restricts the use of the claimed method of treating depression with sertraline. Citations [1] Pfizer Inc. (2005). U.S. Patent 6,902,742 B2: Method of treating depression. United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

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Details for Patent: 6,902,742

Summary for Patent: 6,902,742