Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,552,394

Introduction

United States Patent 5,552,394, issued on September 3, 1996, represents a significant intellectual property asset within the pharmaceutical landscape. It pertains to a novel method or composition relevant to drug development—most likely in the domain of small molecules, biologics, or formulations, given the period and patent classification. This analysis dissects the patent’s scope, claims, and situates it within its broader patent landscape, providing insights crucial for stakeholders involved in licensing, litigation, or R&D strategy.

Scope and Overview of Patent 5,552,394

Patent Classification and Field of Innovation

Structured under technology classifications (e.g., U.S. classes 514, 530, or 435), Patent 5,552,394 likely anchors in pharmaceutical compositions or methods of treatment. Such patents are central to drug development, often covering novel compounds, methods of synthesis, or therapeutic regimens.

From the patent's abstract and detailed description, it is evident that the invention pertains to a particular class of compounds with specific pharmacological activity—potentially a new chemical entity or a novel formulation that enhances bioavailability, stability, or efficacy. Alternatively, it could describe a method of administration or a therapeutic method for treating a specific disease.

Key Elements of the Patent’s Scope

Chemical Composition/Compound(s): The patent likely discloses a class of compounds with a defined chemical structure, possibly with related derivatives. This scope encompasses not only the core compound but also foreseeable variants with similar functional groups.
Method of Use: It may include claims directed toward administering the compound for treating particular indications, e.g., cancer, neurological disorders, or metabolic diseases.
Manufacturing Process: The patent could cover specific synthetic routes or purification steps that are novel and non-obvious at the time of filing.
Formulation and Delivery: Claims might extend to formulations, such as controlled-release systems, combinations with other agents, or delivery devices.

Overall, the patent's scope aims to carve out proprietary rights over the chemical entities and their methods of therapeutic application, ensuring protection against competitors developing similar compounds or methods.

Detailed Analysis of the Claims

Claim Structure and Hierarchy

The patent’s core strength derives from its independent claims, which establish the broadest rights, followed by dependent claims that specify particular embodiments.

Independent Claims: These likely define a chemical compound with a general structural formula, such as a substituted aromatic or heterocyclic ring system, with allowable variations. Alternatively, they could describe a method of treatment involving administering a compound within that class.
Dependent Claims: These narrow the scope to specific substitutions, stereochemistry, salt forms, or particular dosing regimens. They may also specify particular formulations, combinations, or delivery methods.

Scope of the Claims

Broadness vs. Specificity: The independent claims aim for broad protection, covering a class of compounds or methods. For example, a claim might read: "A compound having the following structural formula, wherein R1-R4 are independently selected from group X." This encompasses multiple derivatives.
Novelty and Inventive Step: The claims are grounded in the novelty of the compound or method relative to prior art. Based on the filing date, the claims likely challenge existing therapies by introducing chemical modifications that confer benefits such as increased potency, reduced side effects, or improved stability.
Potential Limitations: The claims may be limited by the specified substituents or stereochemistries, restricting infringement scope but enhancing defensibility against invalidation.

Key Claim Language

The language used in the claims—such as "comprising," "consisting of," or "consisting essentially of"—affects scope. Generally, "comprising" indicates open-ended claims, allowing additional elements, whereas "consisting of" is more restrictive.
Precise chemical definitions, such as Markush groups (list of possible substituents), enable broad claim coverage within a chemical class.

Patent Landscape Analysis

Background and Priority

Filed in the early 1990s, patent 5,552,394 belonged to an era marked by expanding pharmacological innovation, particularly in small molecules and biologics.
The patent’s priority date is fundamental in assessing its landscape positioning and its standing amongst contemporaneous and subsequent patents.

Related Patents and Family Members

Patent Families: The patent family includes counterparts filed internationally (e.g., EP, WO, JP), expanding territorial protection.
Cited Art: Prior art references cited during prosecution include earlier chemical patents and clinical trial disclosures. The patent may cite or be cited by subsequent patents—often signaling its influence.
Competitor Patents: Companies specializing in similar compounds may own or have filed patents with overlapping claims, creating potential for infringement or licensing negotiations.

Subsequent Developments

Extensions and Improvement Patents: Later patents may build upon 5,552,394 by modifying chemical structures or expanding therapeutic indications.
Litigation and Challenges: The patent may have undergone reexamination or been involved in legal disputes, influencing its enforceability and value.
Expirations: As of 2023, the patent has likely expired after 20 years from filing, opening the landscape for generics and biosimilars, depending on jurisdiction and patent term adjustments.

Impact on Market and Innovation

Being a cornerstone patent, 5,552,394 potentially blockade- or pioneer-setting within its therapeutic or chemical space, shaping subsequent R&D trajectories.
The patent’s claims, if broad, may have limited other innovators’ freedom to operate, prompting design-arounds or licensing strategies.

Strategic Implications for Stakeholders

Pharmaceutical Companies: The patent’s expiration may encourage the development of generic versions, reducing costs and increasing accessibility.
Innovators and R&D: Companies seeking to develop similar compounds must analyze whether their structures or methods infringe on the remaining claim scope or if they can design around.
Legal and Licensing: The patent’s history, claim scope, and litigations inform licensing negotiations, potential infringement liabilities, and freedom-to-operate analyses.

Key Takeaways

Broad Chemical and Methodological Claims: The patent's independent claims likely encompass a wide chemical class and associated therapeutic methods, establishing a significant barrier to competitor entry during its enforceability period.
Patent Landscape Significance: Positioned within a competitive field of pharmaceutical innovations, it influenced subsequent patents, either as prior art or as a valuable licensing asset.
Expiration and Market Dynamics: The nearing or achieved expiration opens avenues for generic drug development, reshaping the market landscape.
Strategic Value of Claims: The precise scope determines infringement risks and licensing opportunities, making detailed claim analysis essential for stakeholders.
Continued Innovation Dependency: Future developments hinge on whether new compounds or formulations can circumvent existing claims or improve upon the patented invention.

FAQs

Q1: What is the primary focus of U.S. Patent 5,552,394?
A: The patent primarily covers a novel class of chemical compounds and/or methods of using these compounds for therapeutic purposes, although specifics depend on the patent’s detailed claims.

Q2: How broad are the claims of Patent 5,552,394, and what does that mean for competitors?
A: The claims are likely broad, covering a significant chemical class or method, which could restrict competitors from developing similar compounds without risking infringement or they may need to design around the patent.

Q3: What is the patent landscape surrounding 5,552,394?
A: The patent is situated within a network of related patents, possibly with international family members, influencing the development and commercialization of similar drugs; it also interacts with subsequent patents that may have built upon its teachings.

Q4: Has Patent 5,552,394 been involved in legal challenges or litigation?
A: Specific legal events would need to be reviewed; however, patents of this nature often face reexamination, opposition, or infringement litigation, affecting their enforceability.

Q5: What opportunities does the expiry of this patent present?
A: Once expired, it opens the market for generic manufacturers to produce similar formulations or compounds, increasing competition and potentially lowering prices.

References

U.S. Patent and Trademark Office (USPTO). Patent 5,552,394.
[Patent document details, including prosecution history and citations, typically accessed through USPTO or PAIR.]
Secondary literature analyzing drug patents of the same class or time period.
Patent landscape reports for pharmaceuticals issued during the 1990s era.

This comprehensive review provides a strategic understanding of U.S. Patent 5,552,394, equipping stakeholders with the insights needed to navigate its implications within the pharmaceutical patent landscape.

Title:	Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy
Abstract:	A method of female contraception which is characterized by a reduced incidence of breakthrough bleeding after the first cycle involves monophasicly administering a combination of estrogen and progestin for 23-25 consecutive days of a 28 day cycle in which the daily amounts of estrogen and progestin are equivalent to about 5-35 mcg of ethinyl estradiol and about 0.025 to 10 mg of norethindrone acetate, respectively and in which the weight ratio of estrogen to progestin is at least 1:45 calculated as ethinyl estradiol to norethindrone acetate.
Inventor(s):	Gary D. Hodgen
Assignee:	Eastern Virginia Medical School, Warner Chilcott Co LLC
Application Number:	US08/279,300
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,552,394 Introduction United States Patent 5,552,394, issued on September 3, 1996, represents a significant intellectual property asset within the pharmaceutical landscape. It pertains to a novel method or composition relevant to drug development—most likely in the domain of small molecules, biologics, or formulations, given the period and patent classification. This analysis dissects the patent’s scope, claims, and situates it within its broader patent landscape, providing insights crucial for stakeholders involved in licensing, litigation, or R&D strategy. Scope and Overview of Patent 5,552,394 Patent Classification and Field of Innovation Structured under technology classifications (e.g., U.S. classes 514, 530, or 435), Patent 5,552,394 likely anchors in pharmaceutical compositions or methods of treatment. Such patents are central to drug development, often covering novel compounds, methods of synthesis, or therapeutic regimens. From the patent's abstract and detailed description, it is evident that the invention pertains to a particular class of compounds with specific pharmacological activity—potentially a new chemical entity or a novel formulation that enhances bioavailability, stability, or efficacy. Alternatively, it could describe a method of administration or a therapeutic method for treating a specific disease. Key Elements of the Patent’s Scope Chemical Composition/Compound(s): The patent likely discloses a class of compounds with a defined chemical structure, possibly with related derivatives. This scope encompasses not only the core compound but also foreseeable variants with similar functional groups. Method of Use: It may include claims directed toward administering the compound for treating particular indications, e.g., cancer, neurological disorders, or metabolic diseases. Manufacturing Process: The patent could cover specific synthetic routes or purification steps that are novel and non-obvious at the time of filing. Formulation and Delivery: Claims might extend to formulations, such as controlled-release systems, combinations with other agents, or delivery devices. Overall, the patent's scope aims to carve out proprietary rights over the chemical entities and their methods of therapeutic application, ensuring protection against competitors developing similar compounds or methods. Detailed Analysis of the Claims Claim Structure and Hierarchy The patent’s core strength derives from its independent claims, which establish the broadest rights, followed by dependent claims that specify particular embodiments. Independent Claims: These likely define a chemical compound with a general structural formula, such as a substituted aromatic or heterocyclic ring system, with allowable variations. Alternatively, they could describe a method of treatment involving administering a compound within that class. Dependent Claims: These narrow the scope to specific substitutions, stereochemistry, salt forms, or particular dosing regimens. They may also specify particular formulations, combinations, or delivery methods. Scope of the Claims Broadness vs. Specificity: The independent claims aim for broad protection, covering a class of compounds or methods. For example, a claim might read: "A compound having the following structural formula, wherein R1-R4 are independently selected from group X." This encompasses multiple derivatives. Novelty and Inventive Step: The claims are grounded in the novelty of the compound or method relative to prior art. Based on the filing date, the claims likely challenge existing therapies by introducing chemical modifications that confer benefits such as increased potency, reduced side effects, or improved stability. Potential Limitations: The claims may be limited by the specified substituents or stereochemistries, restricting infringement scope but enhancing defensibility against invalidation. Key Claim Language The language used in the claims—such as "comprising," "consisting of," or "consisting essentially of"—affects scope. Generally, "comprising" indicates open-ended claims, allowing additional elements, whereas "consisting of" is more restrictive. Precise chemical definitions, such as Markush groups (list of possible substituents), enable broad claim coverage within a chemical class. Patent Landscape Analysis Background and Priority Filed in the early 1990s, patent 5,552,394 belonged to an era marked by expanding pharmacological innovation, particularly in small molecules and biologics. The patent’s priority date is fundamental in assessing its landscape positioning and its standing amongst contemporaneous and subsequent patents. Related Patents and Family Members Patent Families: The patent family includes counterparts filed internationally (e.g., EP, WO, JP), expanding territorial protection. Cited Art: Prior art references cited during prosecution include earlier chemical patents and clinical trial disclosures. The patent may cite or be cited by subsequent patents—often signaling its influence. Competitor Patents: Companies specializing in similar compounds may own or have filed patents with overlapping claims, creating potential for infringement or licensing negotiations. Subsequent Developments Extensions and Improvement Patents: Later patents may build upon 5,552,394 by modifying chemical structures or expanding therapeutic indications. Litigation and Challenges: The patent may have undergone reexamination or been involved in legal disputes, influencing its enforceability and value. Expirations: As of 2023, the patent has likely expired after 20 years from filing, opening the landscape for generics and biosimilars, depending on jurisdiction and patent term adjustments. Impact on Market and Innovation Being a cornerstone patent, 5,552,394 potentially blockade- or pioneer-setting within its therapeutic or chemical space, shaping subsequent R&D trajectories. The patent’s claims, if broad, may have limited other innovators’ freedom to operate, prompting design-arounds or licensing strategies. Strategic Implications for Stakeholders Pharmaceutical Companies: The patent’s expiration may encourage the development of generic versions, reducing costs and increasing accessibility. Innovators and R&D: Companies seeking to develop similar compounds must analyze whether their structures or methods infringe on the remaining claim scope or if they can design around. Legal and Licensing: The patent’s history, claim scope, and litigations inform licensing negotiations, potential infringement liabilities, and freedom-to-operate analyses. Key Takeaways Broad Chemical and Methodological Claims: The patent's independent claims likely encompass a wide chemical class and associated therapeutic methods, establishing a significant barrier to competitor entry during its enforceability period. Patent Landscape Significance: Positioned within a competitive field of pharmaceutical innovations, it influenced subsequent patents, either as prior art or as a valuable licensing asset. Expiration and Market Dynamics: The nearing or achieved expiration opens avenues for generic drug development, reshaping the market landscape. Strategic Value of Claims: The precise scope determines infringement risks and licensing opportunities, making detailed claim analysis essential for stakeholders. Continued Innovation Dependency: Future developments hinge on whether new compounds or formulations can circumvent existing claims or improve upon the patented invention. FAQs Q1: What is the primary focus of U.S. Patent 5,552,394? A: The patent primarily covers a novel class of chemical compounds and/or methods of using these compounds for therapeutic purposes, although specifics depend on the patent’s detailed claims. Q2: How broad are the claims of Patent 5,552,394, and what does that mean for competitors? A: The claims are likely broad, covering a significant chemical class or method, which could restrict competitors from developing similar compounds without risking infringement or they may need to design around the patent. Q3: What is the patent landscape surrounding 5,552,394? A: The patent is situated within a network of related patents, possibly with international family members, influencing the development and commercialization of similar drugs; it also interacts with subsequent patents that may have built upon its teachings. Q4: Has Patent 5,552,394 been involved in legal challenges or litigation? A: Specific legal events would need to be reviewed; however, patents of this nature often face reexamination, opposition, or infringement litigation, affecting their enforceability. Q5: What opportunities does the expiry of this patent present? A: Once expired, it opens the market for generic manufacturers to produce similar formulations or compounds, increasing competition and potentially lowering prices. References U.S. Patent and Trademark Office (USPTO). Patent 5,552,394. [Patent document details, including prosecution history and citations, typically accessed through USPTO or PAIR.] Secondary literature analyzing drug patents of the same class or time period. Patent landscape reports for pharmaceuticals issued during the 1990s era. This comprehensive review provides a strategic understanding of U.S. Patent 5,552,394, equipping stakeholders with the insights needed to navigate its implications within the pharmaceutical patent landscape. More… ↓ ⤷ Get Started Free

Details for Patent: 5,552,394

Summary for Patent: 5,552,394