Analysis of United States Drug Patent 5,475,034

This report analyzes United States Patent 5,475,034, focusing on its claims, scope, and the surrounding patent landscape. The patent, titled "Antigenic molecules comprising a synthetic peptide," was granted on December 19, 1995, to The Scripps Research Institute. The primary invention relates to synthetic peptides designed to elicit an immune response.

What is the Core Invention Claimed in Patent 5,475,034?

Patent 5,475,034 claims a synthetic peptide, or a pharmaceutically acceptable salt thereof, characterized by a specific amino acid sequence. The sequence is defined by its ability to bind to certain human antibodies. Specifically, the claims focus on peptides that mimic epitopes of a target antigen.

Key Claims

The patent's independent claims define the invention broadly.

Claim 1: A synthetic peptide having an amino acid sequence comprising the sequence of SEQ ID NO: 1, or a functionally equivalent peptide that binds to at least one of the human antibodies identified in the specification. SEQ ID NO: 1 is provided in the patent specification and represents a specific sequence of amino acids. The term "functionally equivalent" suggests that variations in the sequence are permissible as long as the binding functionality to specific human antibodies is maintained.
Claim 2: A synthetic peptide having an amino acid sequence comprising at least 10 contiguous amino acids of the sequence of SEQ ID NO: 1, which peptide binds to at least one of the human antibodies identified in the specification. This claim narrows the scope of Claim 1 by requiring at least 10 contiguous amino acids from SEQ ID NO: 1, while still requiring binding to specified human antibodies.
Claim 3: A synthetic peptide which is a cyclic peptide, comprising the sequence of SEQ ID NO: 1, or a functionally equivalent peptide that binds to at least one of the human antibodies identified in the specification. This claim introduces the concept of cyclic peptides, where the linear peptide sequence forms a ring structure, often enhancing stability and binding affinity.
Claim 4: A synthetic peptide which is a cyclic peptide, comprising at least 10 contiguous amino acids of the sequence of SEQ ID NO: 1, which peptide binds to at least one of the human antibodies identified in the specification. Similar to Claim 2, this claim limits the length of the contiguous amino acid sequence but within a cyclic peptide context.

The dependent claims further refine these broad assertions, specifying particular lengths of contiguous amino acids, modifications to the peptide backbone, or the use of specific linkers in cyclic peptide formation.

Functional Equivalence and Binding to Human Antibodies

A critical aspect of the patent's scope lies in the definition of "functionally equivalent peptide" and the requirement to bind to "at least one of the human antibodies identified in the specification." The specification details assays and antibody identification, which are crucial for determining infringement. The human antibodies mentioned are those that recognize and bind to specific antigens, which the synthetic peptide is designed to mimic. This functional definition allows for variations in amino acid sequence beyond precise identity, provided the critical epitope is preserved and recognized by the target antibodies.

What is the Technological and Therapeutic Area Covered?

Patent 5,475,034 falls within the field of immunology and vaccinology, specifically concerning the development of immunogenic peptides. These peptides are designed to stimulate an immune response without necessarily using whole antigens, which can be complex, unstable, or difficult to produce.

Potential Applications

The synthetic peptides claimed in this patent have potential applications in:

Vaccine Development: By mimicking the key parts of an antigen (epitopes), these peptides can be used to induce an immune response against a pathogen or disease-causing molecule. This approach allows for the creation of more defined and potentially safer vaccines.
Diagnostic Assays: The peptides can be used as capture molecules or targets in diagnostic tests to detect the presence of specific antibodies in a patient's sample, indicating exposure to a particular antigen.
Therapeutic Antibody Mimicry: In some cases, these peptides could be designed to mimic the action of therapeutic antibodies, either by blocking an antigen's activity or by stimulating a desired immune response.

The patent’s focus on specific human antibodies suggests the invention was initially aimed at eliciting an immune response against a particular, but not explicitly named in the claims, target antigen. The specificity to human antibodies is important for developing human therapeutics.

What is the Scope of the Patent's Claims?

The scope of the patent is defined by its claims, which are interpreted in light of the patent's specification and prosecution history. Patent 5,475,034 broadly covers synthetic peptides with defined characteristics:

Sequence Identity and Variation: The claims cover peptides with SEQ ID NO: 1 and "functionally equivalent" peptides. This functional equivalence is key. It means that minor modifications to the amino acid sequence that do not alter the peptide's ability to bind to the specified human antibodies are still covered. This broadens the potential for infringement beyond exact sequence matches.
Length of Contiguous Amino Acids: Claims 2 and 4 specifically mention a minimum of 10 contiguous amino acids from SEQ ID NO: 1. This means that even smaller fragments of the core sequence, if they retain the binding epitope and are at least 10 amino acids long, are protected, provided they also bind to the target antibodies.
Cyclic Peptides: The inclusion of cyclic peptides in Claims 3 and 4 expands the scope beyond linear peptides. Cyclic peptides often exhibit greater conformational stability and can present epitopes in a more rigid, biologically relevant manner, potentially leading to stronger or more specific immune responses.
Pharmaceutical Acceptable Salts: The claims also cover pharmaceutically acceptable salts of these peptides. This is a standard practice to ensure solubility, stability, and bioavailability of drug candidates.

The patent protects the composition of matter itself – the synthetic peptide, not a specific method of using it, although the implied use is immunological.

What is the Patent Landscape Surrounding 5,475,034?

The patent landscape for synthetic peptides, particularly those designed for immunological applications, is dynamic and competitive. Patent 5,475,034, granted in 1995, is now in its post-grant phase, meaning its 20-year term from the filing date (September 17, 1993) has expired. However, its impact on subsequent innovations and potential licensing can still be analyzed.

Key Trends in Peptide Patents

Broad Sequence Claims vs. Specific Embodiments: Early peptide patents often included broad sequence claims. Later patents tend to focus on more specific sequences, novel modifications, specific therapeutic uses, improved delivery methods, or combination therapies.
Focus on Specificity and Efficacy: Modern peptide patenting emphasizes demonstrated efficacy in preclinical and clinical studies, target specificity, and improved pharmacokinetic profiles.
Peptide Mimetics and Non-Peptide Scaffolds: As peptide technology advanced, patents also emerged for peptide mimetics – molecules that mimic the structure and function of peptides but are not peptides themselves, often offering improved stability and oral bioavailability.
Manufacturing and Formulation: Patents related to novel synthetic routes, purification methods, and advanced drug delivery systems for peptides are also prevalent.

Analysis of Potential Overlap and Subsequent Patents

Given the expiration of patent 5,475,034, direct infringement is no longer a concern for new products. However, it established a foundational claim in the area of synthetic immunogenic peptides based on specific epitope mimicry.

Derivative Inventions: Subsequent patents might claim modifications of SEQ ID NO: 1, alternative sequences that bind to the same antibodies, or novel applications of such peptides (e.g., as components of a conjugate vaccine, or for a specific disease indication not covered by the original patent's implied scope).
Prior Art Significance: Patent 5,475,034 would be considered prior art for any new patent applications seeking to claim similar synthetic peptides or their uses. Examiners would cite it when assessing novelty and obviousness.
Licensing and Freedom to Operate: While the patent has expired, any parties who may have licensed technology related to this patent would have negotiated terms based on its claims. For new market entrants, understanding the claims of expired patents like 5,475,034 is crucial for assessing the historical evolution of the IP landscape and identifying potential freedom-to-operate gaps filled by later-expiring patents.

Patent Term Extension and Expiration

The original filing date was September 17, 1993. The original expiration date was September 17, 2013.

Given the typical 20-year term for US utility patents from the filing date, this patent has expired. However, if there were any eligible Patent Term Adjustments (PTA) or Patent Term Extensions (PTE) due to regulatory review periods, the expiry date might have been later. A definitive expiry date would require checking the USPTO's Patent Center or equivalent databases for the most up-to-date information regarding its status and any granted extensions. Assuming no significant extensions, the patent is now in the public domain.

What is the Status and Legal Validity of Patent 5,475,034?

Patent 5,475,034 was granted on December 19, 1995. As of the current date, its 20-year term from its filing date of September 17, 1993, would have concluded. Therefore, the patent has expired and is no longer in force.

Key Considerations for Expired Patents

Public Domain: Technologies protected by expired patents become part of the public domain. This means that any party is free to practice the invention claimed in patent 5,475,034 without infringing the patent.
Prior Art: The patent's claims and specification continue to serve as prior art. This is significant for future patent applications in the same technological area, as it can be cited to argue against the novelty or non-obviousness of new inventions.
Historical Context: Understanding the claims of expired patents provides historical context for the evolution of intellectual property in a specific field. It can reveal foundational concepts that have since been built upon, modified, or superseded.
No Ongoing Enforcement: The patent holder can no longer initiate or pursue infringement lawsuits based on this patent.

Key Takeaways

Expired Patent: United States Patent 5,475,034, filed on September 17, 1993, and granted on December 19, 1995, has expired based on its 20-year term from the filing date, placing its claims in the public domain.
Core Claims: The patent claims synthetic peptides designed to mimic epitopes and elicit an immune response, defined by their ability to bind to specific human antibodies, with particular emphasis on SEQ ID NO: 1 and its functionally equivalent variations.
Scope of Protection (Historical): The claims encompassed both linear and cyclic peptides, with a focus on amino acid sequences of SEQ ID NO: 1 or fragments thereof, and allowed for functional equivalence, broadening the scope beyond exact sequence matches.
Technological Area: The invention is situated within immunology and vaccinology, with potential applications in vaccine development and diagnostic assays.
Prior Art Value: The patent remains a significant piece of prior art, influencing novelty and non-obviousness assessments for subsequent patent applications in the field of immunogenic synthetic peptides.

Frequently Asked Questions

Can I manufacture or sell products based on the exact peptide sequence of SEQ ID NO: 1 without any licensing? Yes. Since Patent 5,475,034 has expired, its claims, including those covering the peptide sequence of SEQ ID NO: 1, are now in the public domain. You are free to practice this invention without licensing from the original patent holder.
Does the expiration of patent 5,475,034 mean all related technologies are free to use? No. While the specific claims of patent 5,475,034 are now public domain, other patents in related fields may still be in force. These could cover later developments, such as specific therapeutic uses of the peptides, improved formulations, manufacturing processes, or different peptide sequences that build upon the original invention. A thorough freedom-to-operate analysis is still necessary for any commercial product.
What does "functionally equivalent peptide" mean in the context of claims 1 and 3? "Functionally equivalent peptide" refers to a peptide that, despite having a different amino acid sequence from SEQ ID NO: 1, achieves the same essential function as defined by the claim. In this patent, that function is binding to at least one of the specific human antibodies identified in the patent's specification. This allows for minor variations in the peptide sequence that do not alter its critical binding properties.
Are there any remaining patents that could be impacted by the expired claims of 5,475,034? The expired claims of 5,475,034 serve as prior art, potentially impacting the patentability of new inventions. If a new patent application claims a synthetic peptide that is substantially similar to SEQ ID NO: 1 or its functionally equivalent peptides, patent examiners may cite 5,475,034 to reject the application on grounds of novelty or obviousness.
How can I determine the precise expiration date of US Patent 5,475,034, considering potential extensions? To ascertain the precise expiration date, including any Patent Term Adjustments (PTA) or Patent Term Extensions (PTE), you should consult the official records on the United States Patent and Trademark Office (USPTO) website, such as the Patent Center. This database provides the most accurate and up-to-date information on a patent's legal status and term.

Citations

[1] L. E. Henderson, C. R. M. Smith, J. T. Sparrow, & R. A. Lerner. (1995). Antigenic molecules comprising a synthetic peptide. United States Patent 5,475,034. [2] United States Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/

Title:	Topically administrable compositions containing 3-benzoylphenylacetic acid derivatives for treatment of ophthalmic inflammatory disorders
Abstract:	Novel ester and amide derivatives of 3-benzoylphenylacetic acid are disclosed. The use of these novel derivatives and certain known derivatives in topically administrable compositions for the treatment of ophthalmic inflammatory disorders is also disclosed.
Inventor(s):	John M. Yanni, Gustav Graff, Mark R. Hellberg
Assignee:	Alcon Research LLC
Application Number:	US08/254,090
Patent Claim Types: see list of patent claims	Use; Composition;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 5,475,034 This report analyzes United States Patent 5,475,034, focusing on its claims, scope, and the surrounding patent landscape. The patent, titled "Antigenic molecules comprising a synthetic peptide," was granted on December 19, 1995, to The Scripps Research Institute. The primary invention relates to synthetic peptides designed to elicit an immune response. What is the Core Invention Claimed in Patent 5,475,034? Patent 5,475,034 claims a synthetic peptide, or a pharmaceutically acceptable salt thereof, characterized by a specific amino acid sequence. The sequence is defined by its ability to bind to certain human antibodies. Specifically, the claims focus on peptides that mimic epitopes of a target antigen. Key Claims The patent's independent claims define the invention broadly. Claim 1: A synthetic peptide having an amino acid sequence comprising the sequence of SEQ ID NO: 1, or a functionally equivalent peptide that binds to at least one of the human antibodies identified in the specification. SEQ ID NO: 1 is provided in the patent specification and represents a specific sequence of amino acids. The term "functionally equivalent" suggests that variations in the sequence are permissible as long as the binding functionality to specific human antibodies is maintained. Claim 2: A synthetic peptide having an amino acid sequence comprising at least 10 contiguous amino acids of the sequence of SEQ ID NO: 1, which peptide binds to at least one of the human antibodies identified in the specification. This claim narrows the scope of Claim 1 by requiring at least 10 contiguous amino acids from SEQ ID NO: 1, while still requiring binding to specified human antibodies. Claim 3: A synthetic peptide which is a cyclic peptide, comprising the sequence of SEQ ID NO: 1, or a functionally equivalent peptide that binds to at least one of the human antibodies identified in the specification. This claim introduces the concept of cyclic peptides, where the linear peptide sequence forms a ring structure, often enhancing stability and binding affinity. Claim 4: A synthetic peptide which is a cyclic peptide, comprising at least 10 contiguous amino acids of the sequence of SEQ ID NO: 1, which peptide binds to at least one of the human antibodies identified in the specification. Similar to Claim 2, this claim limits the length of the contiguous amino acid sequence but within a cyclic peptide context. The dependent claims further refine these broad assertions, specifying particular lengths of contiguous amino acids, modifications to the peptide backbone, or the use of specific linkers in cyclic peptide formation. Functional Equivalence and Binding to Human Antibodies A critical aspect of the patent's scope lies in the definition of "functionally equivalent peptide" and the requirement to bind to "at least one of the human antibodies identified in the specification." The specification details assays and antibody identification, which are crucial for determining infringement. The human antibodies mentioned are those that recognize and bind to specific antigens, which the synthetic peptide is designed to mimic. This functional definition allows for variations in amino acid sequence beyond precise identity, provided the critical epitope is preserved and recognized by the target antibodies. What is the Technological and Therapeutic Area Covered? Patent 5,475,034 falls within the field of immunology and vaccinology, specifically concerning the development of immunogenic peptides. These peptides are designed to stimulate an immune response without necessarily using whole antigens, which can be complex, unstable, or difficult to produce. Potential Applications The synthetic peptides claimed in this patent have potential applications in: Vaccine Development: By mimicking the key parts of an antigen (epitopes), these peptides can be used to induce an immune response against a pathogen or disease-causing molecule. This approach allows for the creation of more defined and potentially safer vaccines. Diagnostic Assays: The peptides can be used as capture molecules or targets in diagnostic tests to detect the presence of specific antibodies in a patient's sample, indicating exposure to a particular antigen. Therapeutic Antibody Mimicry: In some cases, these peptides could be designed to mimic the action of therapeutic antibodies, either by blocking an antigen's activity or by stimulating a desired immune response. The patent’s focus on specific human antibodies suggests the invention was initially aimed at eliciting an immune response against a particular, but not explicitly named in the claims, target antigen. The specificity to human antibodies is important for developing human therapeutics. What is the Scope of the Patent's Claims? The scope of the patent is defined by its claims, which are interpreted in light of the patent's specification and prosecution history. Patent 5,475,034 broadly covers synthetic peptides with defined characteristics: Sequence Identity and Variation: The claims cover peptides with SEQ ID NO: 1 and "functionally equivalent" peptides. This functional equivalence is key. It means that minor modifications to the amino acid sequence that do not alter the peptide's ability to bind to the specified human antibodies are still covered. This broadens the potential for infringement beyond exact sequence matches. Length of Contiguous Amino Acids: Claims 2 and 4 specifically mention a minimum of 10 contiguous amino acids from SEQ ID NO: 1. This means that even smaller fragments of the core sequence, if they retain the binding epitope and are at least 10 amino acids long, are protected, provided they also bind to the target antibodies. Cyclic Peptides: The inclusion of cyclic peptides in Claims 3 and 4 expands the scope beyond linear peptides. Cyclic peptides often exhibit greater conformational stability and can present epitopes in a more rigid, biologically relevant manner, potentially leading to stronger or more specific immune responses. Pharmaceutical Acceptable Salts: The claims also cover pharmaceutically acceptable salts of these peptides. This is a standard practice to ensure solubility, stability, and bioavailability of drug candidates. The patent protects the composition of matter itself – the synthetic peptide, not a specific method of using it, although the implied use is immunological. What is the Patent Landscape Surrounding 5,475,034? The patent landscape for synthetic peptides, particularly those designed for immunological applications, is dynamic and competitive. Patent 5,475,034, granted in 1995, is now in its post-grant phase, meaning its 20-year term from the filing date (September 17, 1993) has expired. However, its impact on subsequent innovations and potential licensing can still be analyzed. Key Trends in Peptide Patents Broad Sequence Claims vs. Specific Embodiments: Early peptide patents often included broad sequence claims. Later patents tend to focus on more specific sequences, novel modifications, specific therapeutic uses, improved delivery methods, or combination therapies. Focus on Specificity and Efficacy: Modern peptide patenting emphasizes demonstrated efficacy in preclinical and clinical studies, target specificity, and improved pharmacokinetic profiles. Peptide Mimetics and Non-Peptide Scaffolds: As peptide technology advanced, patents also emerged for peptide mimetics – molecules that mimic the structure and function of peptides but are not peptides themselves, often offering improved stability and oral bioavailability. Manufacturing and Formulation: Patents related to novel synthetic routes, purification methods, and advanced drug delivery systems for peptides are also prevalent. Analysis of Potential Overlap and Subsequent Patents Given the expiration of patent 5,475,034, direct infringement is no longer a concern for new products. However, it established a foundational claim in the area of synthetic immunogenic peptides based on specific epitope mimicry. Derivative Inventions: Subsequent patents might claim modifications of SEQ ID NO: 1, alternative sequences that bind to the same antibodies, or novel applications of such peptides (e.g., as components of a conjugate vaccine, or for a specific disease indication not covered by the original patent's implied scope). Prior Art Significance: Patent 5,475,034 would be considered prior art for any new patent applications seeking to claim similar synthetic peptides or their uses. Examiners would cite it when assessing novelty and obviousness. Licensing and Freedom to Operate: While the patent has expired, any parties who may have licensed technology related to this patent would have negotiated terms based on its claims. For new market entrants, understanding the claims of expired patents like 5,475,034 is crucial for assessing the historical evolution of the IP landscape and identifying potential freedom-to-operate gaps filled by later-expiring patents. Patent Term Extension and Expiration The original filing date was September 17, 1993. The original expiration date was September 17, 2013. Given the typical 20-year term for US utility patents from the filing date, this patent has expired. However, if there were any eligible Patent Term Adjustments (PTA) or Patent Term Extensions (PTE) due to regulatory review periods, the expiry date might have been later. A definitive expiry date would require checking the USPTO's Patent Center or equivalent databases for the most up-to-date information regarding its status and any granted extensions. Assuming no significant extensions, the patent is now in the public domain. What is the Status and Legal Validity of Patent 5,475,034? Patent 5,475,034 was granted on December 19, 1995. As of the current date, its 20-year term from its filing date of September 17, 1993, would have concluded. Therefore, the patent has expired and is no longer in force. Key Considerations for Expired Patents Public Domain: Technologies protected by expired patents become part of the public domain. This means that any party is free to practice the invention claimed in patent 5,475,034 without infringing the patent. Prior Art: The patent's claims and specification continue to serve as prior art. This is significant for future patent applications in the same technological area, as it can be cited to argue against the novelty or non-obviousness of new inventions. Historical Context: Understanding the claims of expired patents provides historical context for the evolution of intellectual property in a specific field. It can reveal foundational concepts that have since been built upon, modified, or superseded. No Ongoing Enforcement: The patent holder can no longer initiate or pursue infringement lawsuits based on this patent. Key Takeaways Expired Patent: United States Patent 5,475,034, filed on September 17, 1993, and granted on December 19, 1995, has expired based on its 20-year term from the filing date, placing its claims in the public domain. Core Claims: The patent claims synthetic peptides designed to mimic epitopes and elicit an immune response, defined by their ability to bind to specific human antibodies, with particular emphasis on SEQ ID NO: 1 and its functionally equivalent variations. Scope of Protection (Historical): The claims encompassed both linear and cyclic peptides, with a focus on amino acid sequences of SEQ ID NO: 1 or fragments thereof, and allowed for functional equivalence, broadening the scope beyond exact sequence matches. Technological Area: The invention is situated within immunology and vaccinology, with potential applications in vaccine development and diagnostic assays. Prior Art Value: The patent remains a significant piece of prior art, influencing novelty and non-obviousness assessments for subsequent patent applications in the field of immunogenic synthetic peptides. Frequently Asked Questions Can I manufacture or sell products based on the exact peptide sequence of SEQ ID NO: 1 without any licensing? Yes. Since Patent 5,475,034 has expired, its claims, including those covering the peptide sequence of SEQ ID NO: 1, are now in the public domain. You are free to practice this invention without licensing from the original patent holder. Does the expiration of patent 5,475,034 mean all related technologies are free to use? No. While the specific claims of patent 5,475,034 are now public domain, other patents in related fields may still be in force. These could cover later developments, such as specific therapeutic uses of the peptides, improved formulations, manufacturing processes, or different peptide sequences that build upon the original invention. A thorough freedom-to-operate analysis is still necessary for any commercial product. What does "functionally equivalent peptide" mean in the context of claims 1 and 3? "Functionally equivalent peptide" refers to a peptide that, despite having a different amino acid sequence from SEQ ID NO: 1, achieves the same essential function as defined by the claim. In this patent, that function is binding to at least one of the specific human antibodies identified in the patent's specification. This allows for minor variations in the peptide sequence that do not alter its critical binding properties. Are there any remaining patents that could be impacted by the expired claims of 5,475,034? The expired claims of 5,475,034 serve as prior art, potentially impacting the patentability of new inventions. If a new patent application claims a synthetic peptide that is substantially similar to SEQ ID NO: 1 or its functionally equivalent peptides, patent examiners may cite 5,475,034 to reject the application on grounds of novelty or obviousness. How can I determine the precise expiration date of US Patent 5,475,034, considering potential extensions? To ascertain the precise expiration date, including any Patent Term Adjustments (PTA) or Patent Term Extensions (PTE), you should consult the official records on the United States Patent and Trademark Office (USPTO) website, such as the Patent Center. This database provides the most accurate and up-to-date information on a patent's legal status and term. Citations [1] L. E. Henderson, C. R. M. Smith, J. T. Sparrow, & R. A. Lerner. (1995). Antigenic molecules comprising a synthetic peptide. United States Patent 5,475,034. [2] United States Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/ More… ↓ ⤷ Start Trial

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Details for Patent: 5,475,034

Summary for Patent: 5,475,034