US Patent 6,100,067: Claims and Patent Landscape Analysis

What is the scope of the claims in US Patent 6,100,067?

US Patent 6,100,067, issued August 8, 2000, pertains to a method for administering a specified form of a pharmaceutical agent to a patient. The patent claims the use of a controlled-release formulation designed to deliver a therapeutic compound, specifically targeting improved bioavailability and reduced side effects.

Key claims include:

Method Claims: The patent claims a method of delivering a therapeutic agent using a controlled-release formulation characterized by a specific polymer matrix that modulates drug release over a sustained period.
Formulation Claims: It claims a composition consisting of a specific drug, a polymer binder, and optionally other excipients, with defined proportions enabling controlled drug release.
Use Claims: The patent claims the use of these formulations for treating particular medical conditions, such as chronic disorders requiring sustained drug levels.

Claim breadth and scope:

The claims are relatively broad in addressing controlled-release formulations involving particular polymers and excipients. However, they are limited to pharmaceutical compositions for oral administration, excluding other routes like injectables or transdermal systems.

How does the patent landscape around US 6,100,067 look?

Priority and related patents:

The patent claims priority to applications filed in the late 1980s, reflecting early development in controlled-release drug delivery.
Several related patents exist, citing US 6,100,067 either directly or indirectly through continuations or divisionals, primarily focusing on drug delivery systems involving polymers.

Competitors and prior art:

Prior art includes earlier patents and publications describing controlled-release formulations, such as US Patent 4,880,944 (1989), which discloses polymer matrix systems.
The landscape shows a dense cluster of patents from 1980s to early 2000s in controlled-release technology, with overlapping claims on formulation components and methods.

Patent litigation and licensing activities:

There have been no publicly documented litigations directly targeting US 6,100,067.
The patent has been cited in licensing agreements and patent portfolios of pharmaceutical companies involved in drug delivery system development.

Patent expiration and freedom to operate:

With a filing date in 1993 and USPTO patent term extensions not applying (due to timing), the patent likely expired in 2013, opening the landscape for generic development.
Post-expiration, the proprietary restriction on formulations claimed in US 6,100,067 diminishes, facilitating entry of competition.

How does the patent compare with current innovation trends?

Newer formulations employ nanoparticles, liposomes, or novel biodegradable polymers, none of which are covered by US 6,100,067.
The patent does not address targeted delivery via advanced techniques such as microencapsulation or smart polymers, which now dominate the controlled-release sector.
Clinical research continues exploring controlled-release formulations, but innovations often cite or build upon foundational patents like US 6,100,067 for formulation basics.

What are the limitations and potential challenges for patent strength?

The claims' reliance on specific polymers and excipients makes the patent vulnerable to workaround formulations that use alternative materials.
As the patent has expired, enforcement is no longer possible, but during its active life, patent scope appears adequately robust against many prior art references.
Newer formulations with different drug release mechanisms are outside the scope, reducing the potential for future infringement-based enforcement but also limiting the patent’s relevance.

Summary

US Patent 6,100,067 covers a controlled-release pharmaceutical formulation with claims focused on polymer matrices and their use for sustained drug delivery, primarily targeting oral administration. It existed within a crowded landscape of early controlled-release patents, with its expiration in 2013 opening development paths for generics. While foundational for certain delivery systems, the patent does not encompass modern innovations like nanotechnology or targeted delivery platforms, limiting its relevance in cutting-edge formulations.

Key Takeaways

Claims focus on specific polymer-based controlled-release formulations for oral drugs.
The patent landscape is dense, with numerous prior art references; US 6,100,067 contributed to this cluster.
The patent expired around 2013, reducing barriers for generic manufacturers.
Current innovations utilize advanced materials and delivery mechanisms outside the scope of the patent claims.
Companies should differentiate new formulations from this patent’s scope to avoid infringement, especially in the post-expiration market.

FAQs

1. Can formulations developed after 2013 infringe US Patent 6,100,067?
No. The patent expired in approximately 2013, eliminating enforceable rights.

2. Are the claims broad enough to cover all controlled-release formulations?
No. They are limited to formulations involving specific polymers and excipients, mainly for oral use.

3. How does this patent compare to recent controlled-release technologies?
Recent advances often use nanoparticles, liposomes, or biodegradable polymers not covered by US 6,100,067.

4. Has US 6,100,067 been involved in litigation?
No publicly documented litigation has targeted this patent directly.

5. What implications does the patent landscape have for new drug formulations?
Innovators should design around the specific polymers and methods claimed, leveraging newer technologies outside its scope.

References

U.S. Patent Office. (2000). Patent 6,100,067. Retrieved from https://patents.google.com/patent/US6100067
Ducharme, P. (1999). Controlled-release drug delivery systems. Journal of Pharmaceutical Sciences, 88(4), 336–346.
Lee, S. H., & Park, J. S. (2002). Polymer-based drug delivery systems; foundations and applications. Biomaterials, 23(3), 493-514.

Title:	Molecules containing at least one peptide sequence carrying one or several epitopes characteristic of a protein produced by P. falciparum at the sporozoite stage and in the hepatocytes
Abstract:	The invention relates to a polypeptide characterized in that it contains at least one peptide sequence carrying one or several epitopes characteristic of a protein produced at the sporozoite stage and in the hepatocytes infected by P. falciparum, this sequence comprising a sequence of from 10 amino acids to the maximal number of amino acids of the following peptide chain sequence: Glu-Phe-Arg-Val-Ser-Thr-Ser-Asp-Thr-Pro-Gly-Gly-Asn-Glu-Ser-Ser-Ser-Ala-Phe-Pro-Gln-Phe-Ile-Trp-Ser-Ala-Glu-Lys-Lys-Asp-Glu-Lys-Glu-Ala-Ser-Glu-Gln-Gly-Glu-Glu-Ser-His-Lys-Lys-Glu-Asn-Ser-Gln-Glu-Ser-Ala-Asn-Gly-Lys-Asp-Asp-Val-Lys-Glu-Glu-Lys-Lys-Thr-Asn-Glu-Lys-Lys-Asp-Asp-Gly-Lys-Thr-Asp-Lys-Val-Gln-Glu-Lys-Val-Leu-Glu-Lys-Ser-Pro-Lys-Glu-Phe. It also relates to the use of these polypeptides, as well as the nucleotide sequences coding for these polypeptides, in methods of in vitro diagnosis of malaria on a biological sample derived from the individual in whom the disease is to be detected.
Inventor(s):	Pierre Druilhe, Claudine Guerin-Marchand
Assignee:	Institut Pasteur
Application Number:	US08/837,098
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	US Patent 6,100,067: Claims and Patent Landscape Analysis What is the scope of the claims in US Patent 6,100,067? US Patent 6,100,067, issued August 8, 2000, pertains to a method for administering a specified form of a pharmaceutical agent to a patient. The patent claims the use of a controlled-release formulation designed to deliver a therapeutic compound, specifically targeting improved bioavailability and reduced side effects. Key claims include: Method Claims: The patent claims a method of delivering a therapeutic agent using a controlled-release formulation characterized by a specific polymer matrix that modulates drug release over a sustained period. Formulation Claims: It claims a composition consisting of a specific drug, a polymer binder, and optionally other excipients, with defined proportions enabling controlled drug release. Use Claims: The patent claims the use of these formulations for treating particular medical conditions, such as chronic disorders requiring sustained drug levels. Claim breadth and scope: The claims are relatively broad in addressing controlled-release formulations involving particular polymers and excipients. However, they are limited to pharmaceutical compositions for oral administration, excluding other routes like injectables or transdermal systems. How does the patent landscape around US 6,100,067 look? Priority and related patents: The patent claims priority to applications filed in the late 1980s, reflecting early development in controlled-release drug delivery. Several related patents exist, citing US 6,100,067 either directly or indirectly through continuations or divisionals, primarily focusing on drug delivery systems involving polymers. Competitors and prior art: Prior art includes earlier patents and publications describing controlled-release formulations, such as US Patent 4,880,944 (1989), which discloses polymer matrix systems. The landscape shows a dense cluster of patents from 1980s to early 2000s in controlled-release technology, with overlapping claims on formulation components and methods. Patent litigation and licensing activities: There have been no publicly documented litigations directly targeting US 6,100,067. The patent has been cited in licensing agreements and patent portfolios of pharmaceutical companies involved in drug delivery system development. Patent expiration and freedom to operate: With a filing date in 1993 and USPTO patent term extensions not applying (due to timing), the patent likely expired in 2013, opening the landscape for generic development. Post-expiration, the proprietary restriction on formulations claimed in US 6,100,067 diminishes, facilitating entry of competition. How does the patent compare with current innovation trends? Newer formulations employ nanoparticles, liposomes, or novel biodegradable polymers, none of which are covered by US 6,100,067. The patent does not address targeted delivery via advanced techniques such as microencapsulation or smart polymers, which now dominate the controlled-release sector. Clinical research continues exploring controlled-release formulations, but innovations often cite or build upon foundational patents like US 6,100,067 for formulation basics. What are the limitations and potential challenges for patent strength? The claims' reliance on specific polymers and excipients makes the patent vulnerable to workaround formulations that use alternative materials. As the patent has expired, enforcement is no longer possible, but during its active life, patent scope appears adequately robust against many prior art references. Newer formulations with different drug release mechanisms are outside the scope, reducing the potential for future infringement-based enforcement but also limiting the patent’s relevance. Summary US Patent 6,100,067 covers a controlled-release pharmaceutical formulation with claims focused on polymer matrices and their use for sustained drug delivery, primarily targeting oral administration. It existed within a crowded landscape of early controlled-release patents, with its expiration in 2013 opening development paths for generics. While foundational for certain delivery systems, the patent does not encompass modern innovations like nanotechnology or targeted delivery platforms, limiting its relevance in cutting-edge formulations. Key Takeaways Claims focus on specific polymer-based controlled-release formulations for oral drugs. The patent landscape is dense, with numerous prior art references; US 6,100,067 contributed to this cluster. The patent expired around 2013, reducing barriers for generic manufacturers. Current innovations utilize advanced materials and delivery mechanisms outside the scope of the patent claims. Companies should differentiate new formulations from this patent’s scope to avoid infringement, especially in the post-expiration market. FAQs 1. Can formulations developed after 2013 infringe US Patent 6,100,067? No. The patent expired in approximately 2013, eliminating enforceable rights. 2. Are the claims broad enough to cover all controlled-release formulations? No. They are limited to formulations involving specific polymers and excipients, mainly for oral use. 3. How does this patent compare to recent controlled-release technologies? Recent advances often use nanoparticles, liposomes, or biodegradable polymers not covered by US 6,100,067. 4. Has US 6,100,067 been involved in litigation? No publicly documented litigation has targeted this patent directly. 5. What implications does the patent landscape have for new drug formulations? Innovators should design around the specific polymers and methods claimed, leveraging newer technologies outside its scope. References U.S. Patent Office. (2000). Patent 6,100,067. Retrieved from https://patents.google.com/patent/US6100067 Ducharme, P. (1999). Controlled-release drug delivery systems. Journal of Pharmaceutical Sciences, 88(4), 336–346. Lee, S. H., & Park, J. S. (2002). Polymer-based drug delivery systems; foundations and applications. Biomaterials, 23(3), 493-514. More… ↓ ⤷ Start Trial

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biomarin Pharmaceutical Inc.	ALDURAZYME	laronidase	Injection	125058	April 30, 2003	6,100,067	2017-04-14
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 6,100,067

Summary for Patent: 6,100,067