United States Patent 7,612,109: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,612,109, titled "Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes," is a significant patent in the field of pharmaceuticals, particularly in the treatment of iron deficiency anemia. This patent, assigned to Luitpold Pharmaceuticals, Inc. (now known as American Regent, Inc.), covers innovative methods and compositions for administering iron.
Background and Inventors
The patent was issued on November 3, 2009, to inventors Mary Jane Helenek, Marc L. Tokars, and Richard P. Lawrence. These inventors have contributed substantially to the development of iron-carbohydrate complexes, which are crucial for treating iron deficiency anemia[4].
Scope of the Patent
Claims Overview
The patent includes several claims that define the scope of the invention. These claims cover:
- Methods of Production: The patent describes methods for producing water-soluble iron-carbohydrate complexes from an aqueous solution of an iron(III) salt and a carbohydrate, such as maltodextrin[4].
- Compositions: The claims include compositions of these iron-carbohydrate complexes, which are formulated for parenteral application, such as intravenous or intramuscular administration[4][5].
- Medicaments: The patent also covers medicaments containing these complexes, which are designed to treat iron deficiency anemia effectively[4].
Key Claim Elements
- Iron(III) Salt: The use of an iron(III) salt is a critical component in the production process.
- Carbohydrate: The carbohydrate, typically maltodextrin, is combined with the iron(III) salt to form a stable and water-soluble complex.
- Parenteral Application: The compositions are specifically formulated for parenteral administration, ensuring efficient delivery of iron to the body[4].
Patent Claims and Their Significance
Claim 1
Claim 1 is a broad claim that covers the method of producing the iron-carbohydrate complex. It includes the steps of mixing an iron(III) salt with a carbohydrate in an aqueous solution and adjusting the pH to form the complex[4].
Claim 2-5
These claims are more specific, detailing the composition of the iron-carbohydrate complex and its formulation for parenteral use. For example, Claim 2 specifies the ratio of iron to carbohydrate and the pH range for the solution[4].
Patent Landscape and Industry Impact
Pharmaceutical Industry
The patent is highly relevant in the pharmaceutical industry, particularly in the treatment of iron deficiency anemia. The water-soluble iron-carbohydrate complexes offer a more efficient and safer alternative to traditional iron supplements[4].
Competitive Landscape
The patent has been involved in several litigation cases, highlighting its importance in the market. For instance, American Regent, Inc. has filed lawsuits against generic drug manufacturers like Mylan and DRL, alleging infringement of the patent claims related to the production and use of ferric carboxymaltose[2][5].
Litigation and Enforcement
Infringement Cases
American Regent, Inc. has actively enforced this patent against generic manufacturers. For example, in the case against Mylan, American Regent alleged that Mylan's ANDA (Abbreviated New Drug Application) product infringed on the claims of the '612 patent, which is related to the '109 patent[5].
Patent Validity
The claims of the '109 patent are presumed valid under 35 U.S.C. § 282. The litigation documents indicate that the defendants did not provide substantive non-infringement allegations, thereby admitting infringement[2][5].
Regulatory and Legal Aspects
FDA Approval and ANDA
The patent's claims are closely tied to FDA approvals for generic versions of the drug. Under 35 U.S.C. § 271(e)(2)(A), submitting an ANDA before the patent's expiration date can be considered infringement[2][5].
Patent Expiration
The '109 patent expires on January 8, 2027, which is crucial for generic manufacturers planning to enter the market after this date[2].
Technical and Scientific Aspects
Production Process
The patent describes a detailed process for producing the iron-carbohydrate complexes, including the use of specific reagents and conditions to ensure the stability and solubility of the complex[4].
Stability and Efficacy
The water-soluble nature of these complexes enhances their stability and efficacy in treating iron deficiency anemia. This is a significant advancement over traditional iron supplements, which often have lower bioavailability and more side effects[4].
Industry Expert Insights
Industry experts emphasize the importance of such patents in driving innovation in the pharmaceutical sector. For example, the ability to claim broad yet specific methods and compositions allows innovators to protect their inventions while still allowing for some degree of competition and improvement[3].
Challenges in Patent Claims
Genus Claims
The pharmaceutical industry faces challenges with genus claims, which are claims that cover a broad class of compounds rather than specific embodiments. The Federal Circuit's recent jurisprudence has made it difficult to obtain meaningful patent protection for drugs and biologics, as claims must be both broad enough to capture the invention and narrow enough to avoid invalidation[3].
Enablement and Written Description
The enablement and written description requirements under 35 U.S.C. § 112(a) pose significant hurdles. Innovators must balance the need to claim the full scope of their invention with the need to provide sufficient disclosure to enable others to make and use the invention[3].
Key Takeaways
- Innovative Method: The patent covers an innovative method for producing water-soluble iron-carbohydrate complexes.
- Parenteral Application: The compositions are specifically formulated for parenteral use, enhancing efficacy and safety.
- Litigation and Enforcement: The patent has been actively enforced against generic manufacturers.
- Regulatory Significance: The patent's expiration date and FDA approval processes are critical for market entry.
- Technical Advancements: The patent represents a significant technical advancement in treating iron deficiency anemia.
FAQs
What is the main subject of the United States Patent 7,612,109?
The main subject of the patent is the production and use of water-soluble iron-carbohydrate complexes for treating iron deficiency anemia.
Who are the inventors of the patent?
The inventors are Mary Jane Helenek, Marc L. Tokars, and Richard P. Lawrence.
What is the current assignee of the patent?
The current assignee is American Regent, Inc., which was previously known as Luitpold Pharmaceuticals, Inc.[2].
When does the patent expire?
The patent expires on January 8, 2027[2].
Why is this patent significant in the pharmaceutical industry?
This patent is significant because it covers innovative methods and compositions for treating iron deficiency anemia, offering a safer and more efficient alternative to traditional iron supplements.
Cited Sources:
- United States Patent and Trademark Office. US10478450.pdf.
- RPX Insight. Case 2:24-cv-06833 Document 1 Filed 06/07/24 Page 1 of 32 PageID.
- DigitalCommons@NYLS. Eviscerating Patent Scope.
- Google Patents. US7612109B2 - Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes.
- RPX Insight. Case 1:19-cv-00126-TSK Document 1 Filed 06/20/19 Page 3 of 18 PageID #: 3.
