Detailed Analysis of the Scope and Claims of United States Patent 8,926,947
Introduction
The United States Patent 8,926,947, titled "Polyol and Polyether Iron Oxide Complexes as Pharmacological and/or MRI Contrast Agents," is a significant patent in the field of pharmaceuticals, particularly for the treatment of iron deficiencies and as MRI contrast agents. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The patent was issued on January 6, 2015, to AMAG Pharmaceuticals, Inc., with Ernest V. Groman, Kenneth G. Paul, Timothy B. Frigo, Howard Bengele, and Jerome M. Lewis listed as the inventors. AMAG is the sole owner by assignment of all rights, title, and interest in this patent[2].
Patent Scope and Claims
Primary Claims
The patent covers polyol and polyether iron oxide complexes, which are used as pharmacological agents and/or MRI contrast agents. The claims include:
- Composition Claims: These pertain to the specific formulations of iron oxide complexes coated with reduced carbohydrates or polyols/polyethers, ensuring stability and efficacy[4].
- Method Claims: These involve methods for the administration of these complexes, including their preparation, sterilization, and use in medical treatments[4].
Key Features and Innovations
- Stability: The patent emphasizes the stability of these iron oxide complexes, particularly their heat stability, which is crucial for autoclaving and long-term storage. This stability is achieved through the use of reduced carbohydrates or polyols/polyethers[1][4].
- MRI Contrast Agents: The complexes are also designed to serve as effective MRI contrast agents, enhancing the visibility of internal body structures during magnetic resonance imaging[4].
Relationship with Other Patents
The '947 patent is part of a family of patents related to Feraheme®, a drug used to treat iron deficiencies in patients with chronic kidney disease. It is a continuation application of the '864 patent, which in turn is a continuation of the '597 patent. This means that the disclosures of the '947, '864, and '597 patents are essentially the same, with no new matter added[1].
Patent Landscape
Family of Patents
The '947 patent is part of a series of patents that include:
- U.S. Patent 6,599,498 ('498 patent): Focuses on stable carboxyalkylated polysaccharide iron oxide complexes and their sterilization by autoclaving[1][2].
- U.S. Patent 7,553,479 ('479 patent): Covers heat-stable colloidal iron oxides coated with reduced carbohydrates and their uses[2].
- U.S. Patent 7,871,597 ('597 patent): Similar to the '947 patent, it deals with iron oxide complexes but is the base patent for the '864 and '947 patents[1][2].
Litigation and Enforcement
The patents, including the '947 patent, have been involved in litigation. AMAG Pharmaceuticals, Inc. filed a lawsuit against Sandoz Inc. for patent infringement related to Sandoz's Abbreviated New Drug Application (ANDA) for a generic version of Feraheme®. The lawsuit asserts that Sandoz's actions would infringe on the claims of the '947 patent, among others[2].
Impact on the Pharmaceutical Industry
Innovation and Competition
The '947 patent, along with its related patents, has significant implications for innovation in the pharmaceutical industry. It sets a high standard for the development of stable and effective iron oxide complexes, which can act as both pharmacological agents and MRI contrast agents. This innovation can deter generic competition until the patents expire, allowing AMAG to maintain market exclusivity for Feraheme®[1][2].
Regulatory Compliance
The patent is listed in the FDA's Orange Book, which is crucial for regulatory compliance and market approval. This listing ensures that any generic versions of Feraheme® must comply with the patent claims or face potential litigation[2].
Examination and Validation
Patent Examination Process
The examination process for the '947 patent, like other patents in this family, would have involved a thorough review of the claims to ensure novelty, non-obviousness, and utility. The fact that these patents have been granted indicates that they meet these criteria, although the scope of the claims may have been narrowed during the examination process to address any prior art issues[3].
Metrics for Patent Scope
Metrics such as independent claim length and independent claim count can be used to measure the scope of the patent. Narrower claims, as seen in the '947 patent, are often associated with a higher probability of grant and a shorter examination process[3].
Conclusion and Future Implications
The United States Patent 8,926,947 is a critical component of AMAG's intellectual property portfolio, protecting the company's innovations in iron oxide complexes. The patent's scope and claims are well-defined, ensuring that any generic or competing products must adhere to these specifications to avoid infringement.
Key Takeaways
- Stable Iron Oxide Complexes: The patent covers stable polyol and polyether iron oxide complexes.
- Pharmacological and MRI Uses: These complexes are used as pharmacological agents and MRI contrast agents.
- Family of Patents: Part of a series of patents related to Feraheme®, including the '498, '479, and '597 patents.
- Litigation and Enforcement: Involved in litigation to protect against generic competition.
- Regulatory Compliance: Listed in the FDA's Orange Book.
FAQs
What is the primary use of the iron oxide complexes covered by the '947 patent?
The primary use is as pharmacological agents for treating iron deficiencies and as MRI contrast agents.
Who are the inventors of the '947 patent?
The inventors are Ernest V. Groman, Kenneth G. Paul, Timothy B. Frigo, Howard Bengele, and Jerome M. Lewis.
What is the relationship between the '947 patent and other related patents?
The '947 patent is a continuation application of the '864 patent, which is a continuation of the '597 patent, meaning their disclosures are essentially the same.
Why is the '947 patent listed in the FDA's Orange Book?
It is listed to ensure regulatory compliance and to protect against generic competition until the patent expires.
What metrics can be used to measure the scope of the '947 patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope of the patent.
Cited Sources
- AMAG Pharms., Inc. v. Sandoz, Inc. - Casetext
- Case 3:16-cv-01508-PGS-LHG Document 1 Filed 03/17/16 - Insight.RPXcorp
- Patent Claims and Patent Scope - SSRN
- US8926947B2 - Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents - Google Patents
