Pharmaceutical drugs covered by patent 8,591,864. Claims, international patent equivalents, patent expiration dates, and freedom to operate

United States Patent 8,591,864: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 8,591,864, titled "Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents," is a significant patent in the field of nanomedicine and pharmaceuticals. This patent, granted to inventors who have developed innovative iron oxide complexes, offers insights into the design, application, and legal landscape of such pharmaceutical compositions.

Background

Iron oxide complexes have been increasingly studied for their potential in medical applications, including as contrast agents for Magnetic Resonance Imaging (MRI) and as pharmacological agents. The patent in question addresses the need for stable, biocompatible, and effective iron oxide complexes.

Patent Overview

Publication Details

Publication Number: US8591864B2
Prior Art Date: This patent builds upon earlier research and patents related to iron oxide complexes and their medical applications[1].

Claims

The patent includes multiple claims that define the scope of the invention. Here are some key claims:

Composition Claims

The patent claims compositions comprising iron oxide complexes conjugated with polyols or polyethers. These complexes are designed to be stable and biocompatible, making them suitable for medical use[1].

Pharmacological Claims

Claims include the use of these complexes as pharmacological agents, particularly for treating conditions where iron supplementation is necessary or for delivering therapeutic agents[1].

MRI Contrast Agent Claims

The patent also claims the use of these iron oxide complexes as contrast agents for MRI, enhancing the visibility of internal body structures during imaging[1].

Scope of the Invention

Polyol and Polyether Conjugation

The invention involves conjugating iron oxide nanoparticles with polyols or polyethers. This conjugation enhances the stability and biocompatibility of the iron oxide complexes, making them more suitable for in vivo applications[1].

Medical Applications

The scope extends to various medical applications, including:

Pharmacological Use: The complexes can be used to treat iron deficiency or as carriers for other therapeutic agents.
MRI Contrast Agents: The iron oxide complexes can be used to improve the contrast in MRI images, aiding in the diagnosis of various medical conditions[1].

Technical Details

Iron Oxide Complexes

The patent describes the synthesis and characterization of iron oxide complexes. These complexes are typically formed by reducing iron salts in the presence of polyols or polyethers, which act as stabilizing agents[1].

Stability and Biocompatibility

The stability and biocompatibility of these complexes are critical. The patent highlights the importance of selecting appropriate polyols or polyethers to ensure that the complexes remain stable in biological environments and do not cause adverse reactions[1].

Legal Landscape

Patent Classification

The patent is classified under various categories, including:

B82Y5/00: Nanobiotechnology or nanomedicine.
A61K31/00: Medicinal preparations containing organic active ingredients, specifically polysaccharides and their derivatives[1].

Patent Litigation and Validity

While this specific patent has not been involved in notable litigation, understanding the legal framework around patent claims is crucial. Patents must be novel, non-obvious, and useful to be valid. The claims must also be clear and definite to avoid invalidation due to indefiniteness[2].

Economic and Practical Implications

Market Potential

The development of stable and biocompatible iron oxide complexes has significant market potential. These complexes can address unmet medical needs in areas such as iron deficiency treatment and advanced diagnostic imaging.

Research and Development

The patent encourages further research and development in the field of nanomedicine. By providing a foundation for the synthesis and application of iron oxide complexes, it opens avenues for new therapeutic and diagnostic agents.

Stakeholder Engagement

Regulatory Considerations

Regulatory bodies, such as the FDA, play a crucial role in approving these complexes for medical use. The patent holders must comply with stringent regulatory requirements to ensure the safety and efficacy of their products.

Public and Academic Input

Public and academic input are essential in the development and validation of such medical innovations. Collaborations between industry, academia, and regulatory bodies can accelerate the translation of these inventions into clinical practice.

Key Takeaways

Innovative Composition: The patent introduces novel iron oxide complexes conjugated with polyols or polyethers.
Medical Applications: These complexes have potential uses as pharmacological agents and MRI contrast agents.
Stability and Biocompatibility: The conjugation with polyols or polyethers enhances the stability and biocompatibility of the iron oxide complexes.
Legal and Regulatory Framework: The patent is classified under specific categories and must comply with regulatory requirements for medical use.

FAQs

What are the primary applications of the iron oxide complexes described in US Patent 8,591,864?

The primary applications include their use as pharmacological agents, particularly for treating iron deficiency, and as MRI contrast agents to enhance diagnostic imaging.

How are the iron oxide complexes synthesized according to the patent?

The complexes are synthesized by reducing iron salts in the presence of polyols or polyethers, which act as stabilizing agents.

What are the key benefits of conjugating iron oxide with polyols or polyethers?

Conjugation enhances the stability and biocompatibility of the iron oxide complexes, making them more suitable for in vivo applications.

Under which categories is the patent classified?

The patent is classified under B82Y5/00 (nanobiotechnology or nanomedicine) and A61K31/00 (medicinal preparations containing organic active ingredients).

What regulatory bodies are involved in the approval of these complexes for medical use?

Regulatory bodies such as the FDA are involved in approving these complexes for medical use, ensuring their safety and efficacy.

Sources

US8591864B2 - Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents - Google Patents
DDR Holdings - United States Court of Appeals for the Federal Circuit - CAFC
Patent Claims Research Dataset - USPTO
Advanced Patent Searching - Clemson University
U.S. Patent Small Claims Court - ACUS

Title:	Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Abstract:	Iron oxide complexes, pharmacological compositions and unit dosage thereof, and methods for their administration, of the type employing an iron oxide complex with a polyol, are disclosed. The pharmacological compositions employ a polysaccharide iron oxide complex, wherein the polysaccharide is a modified polyol such as a carboxyalkylated reduced dextran. The complex is stable to terminal sterilization by autoclaving. The compositions are suitable for parenteral administration to a subject for the treatment of iron deficiencies or as MRI contrast agent. The complex is substantially immunosilent, provide minimal anaphylaxis and undergo minimal dissolution in vivo. The pharmacological compositions of the complex contain minimal free iron which can be quantified by a variety of methods.
Inventor(s):	MAUSUSGroman; Ernest V. (Brookline, MA), Paul; Kenneth G. (Holliston, MA), Frigo; Timothy B. (Waltham, MA), Bengele; Howard (Canton, MA), Lewis; Jerome M. (Newton, MA)
Assignee:	AMAG Pharmaceuticals, Inc. (Lexington, MA)
Application Number:	13/734,339
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,591,864
Patent Claim Types: see list of patent claims	Compound; Composition;
Patent landscape, scope, and claims:	United States Patent 8,591,864: A Detailed Analysis of Scope and Claims Introduction The United States Patent 8,591,864, titled "Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents," is a significant patent in the field of nanomedicine and pharmaceuticals. This patent, granted to inventors who have developed innovative iron oxide complexes, offers insights into the design, application, and legal landscape of such pharmaceutical compositions. Background Iron oxide complexes have been increasingly studied for their potential in medical applications, including as contrast agents for Magnetic Resonance Imaging (MRI) and as pharmacological agents. The patent in question addresses the need for stable, biocompatible, and effective iron oxide complexes. Patent Overview Publication Details Publication Number: US8591864B2 Prior Art Date: This patent builds upon earlier research and patents related to iron oxide complexes and their medical applications[1]. Claims The patent includes multiple claims that define the scope of the invention. Here are some key claims: Composition Claims The patent claims compositions comprising iron oxide complexes conjugated with polyols or polyethers. These complexes are designed to be stable and biocompatible, making them suitable for medical use[1]. Pharmacological Claims Claims include the use of these complexes as pharmacological agents, particularly for treating conditions where iron supplementation is necessary or for delivering therapeutic agents[1]. MRI Contrast Agent Claims The patent also claims the use of these iron oxide complexes as contrast agents for MRI, enhancing the visibility of internal body structures during imaging[1]. Scope of the Invention Polyol and Polyether Conjugation The invention involves conjugating iron oxide nanoparticles with polyols or polyethers. This conjugation enhances the stability and biocompatibility of the iron oxide complexes, making them more suitable for in vivo applications[1]. Medical Applications The scope extends to various medical applications, including: Pharmacological Use: The complexes can be used to treat iron deficiency or as carriers for other therapeutic agents. MRI Contrast Agents: The iron oxide complexes can be used to improve the contrast in MRI images, aiding in the diagnosis of various medical conditions[1]. Technical Details Iron Oxide Complexes The patent describes the synthesis and characterization of iron oxide complexes. These complexes are typically formed by reducing iron salts in the presence of polyols or polyethers, which act as stabilizing agents[1]. Stability and Biocompatibility The stability and biocompatibility of these complexes are critical. The patent highlights the importance of selecting appropriate polyols or polyethers to ensure that the complexes remain stable in biological environments and do not cause adverse reactions[1]. Legal Landscape Patent Classification The patent is classified under various categories, including: B82Y5/00: Nanobiotechnology or nanomedicine. A61K31/00: Medicinal preparations containing organic active ingredients, specifically polysaccharides and their derivatives[1]. Patent Litigation and Validity While this specific patent has not been involved in notable litigation, understanding the legal framework around patent claims is crucial. Patents must be novel, non-obvious, and useful to be valid. The claims must also be clear and definite to avoid invalidation due to indefiniteness[2]. Economic and Practical Implications Market Potential The development of stable and biocompatible iron oxide complexes has significant market potential. These complexes can address unmet medical needs in areas such as iron deficiency treatment and advanced diagnostic imaging. Research and Development The patent encourages further research and development in the field of nanomedicine. By providing a foundation for the synthesis and application of iron oxide complexes, it opens avenues for new therapeutic and diagnostic agents. Stakeholder Engagement Regulatory Considerations Regulatory bodies, such as the FDA, play a crucial role in approving these complexes for medical use. The patent holders must comply with stringent regulatory requirements to ensure the safety and efficacy of their products. Public and Academic Input Public and academic input are essential in the development and validation of such medical innovations. Collaborations between industry, academia, and regulatory bodies can accelerate the translation of these inventions into clinical practice. Key Takeaways Innovative Composition: The patent introduces novel iron oxide complexes conjugated with polyols or polyethers. Medical Applications: These complexes have potential uses as pharmacological agents and MRI contrast agents. Stability and Biocompatibility: The conjugation with polyols or polyethers enhances the stability and biocompatibility of the iron oxide complexes. Legal and Regulatory Framework: The patent is classified under specific categories and must comply with regulatory requirements for medical use. FAQs What are the primary applications of the iron oxide complexes described in US Patent 8,591,864? The primary applications include their use as pharmacological agents, particularly for treating iron deficiency, and as MRI contrast agents to enhance diagnostic imaging. How are the iron oxide complexes synthesized according to the patent? The complexes are synthesized by reducing iron salts in the presence of polyols or polyethers, which act as stabilizing agents. What are the key benefits of conjugating iron oxide with polyols or polyethers? Conjugation enhances the stability and biocompatibility of the iron oxide complexes, making them more suitable for in vivo applications. Under which categories is the patent classified? The patent is classified under B82Y5/00 (nanobiotechnology or nanomedicine) and A61K31/00 (medicinal preparations containing organic active ingredients). What regulatory bodies are involved in the approval of these complexes for medical use? Regulatory bodies such as the FDA are involved in approving these complexes for medical use, ensuring their safety and efficacy. Sources US8591864B2 - Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents - Google Patents DDR Holdings - United States Court of Appeals for the Federal Circuit - CAFC Patent Claims Research Dataset - USPTO Advanced Patent Searching - Clemson University U.S. Patent Small Claims Court - ACUS More… ↓ ⤷ Subscribe

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1169062	⤷ Subscribe	C300558	Netherlands	⤷ Subscribe
European Patent Office	1169062	⤷ Subscribe	CA 2012 00050	Denmark	⤷ Subscribe
European Patent Office	1169062	⤷ Subscribe	92114	Luxembourg	⤷ Subscribe
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Details for Patent: 8,591,864

Summary for Patent: 8,591,864