Details for Patent: 7,754,702

Which drugs does patent 7,754,702 protect, and when does it expire?

Patent 7,754,702 protects INJECTAFER and is included in one NDA.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 7,754,702

Title:	Methods and compositions for administration of iron
Abstract:	The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
Inventor(s):	Helenek; Mary Jane (Brookville, NY), Tokars; Marc L. (Douglassville, PA), Lawrence; Richard P. (Calverton, NY)
Assignee:	Luitpold Pharmaceuticals, Inc. (Shirley, NY)
Application Number:	11/620,986
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,754,702
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

United States Patent 7,754,702: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,754,702, titled "Methods and Compositions for Administration of Iron," is a significant patent in the field of pharmaceuticals, particularly concerning iron therapy. This patent, assigned to American Regent, Inc. (formerly Luitpold Pharmaceuticals, Inc.), has been a focal point in several legal and pharmaceutical discussions.

Inventors and Assignees

The patent was invented by Mary Jane Helenek, Marc L. Tokars, and Richard P. Lawrence, and it was originally assigned to Luitpold Pharmaceuticals, Inc. In 2019, the assignment records were amended to reflect the name change to American Regent, Inc.[2][4].

Patent Claims

The patent claims cover various methods and compositions related to the administration of iron, particularly iron carbohydrate complexes. Key claims include:

• Methods for preparing iron carbohydrate complexes.
• Compositions comprising these complexes.
• Specific formulations and administration methods for these iron complexes[2][4].

Scope of the Patent

The scope of the patent is broad, encompassing both the chemical compositions and the methods of administration. Here are some key aspects:

• Chemical Compositions: The patent includes claims for iron carbohydrate complexes, such as ferric carboxymaltose, which are formulated for parenteral application[2].
• Methods of Administration: It covers various methods for administering these iron complexes, including intravenous and intramuscular injections[4].

Patent Landscape

The patent landscape surrounding U.S. Patent 7,754,702 is complex and has been the subject of several legal disputes.

Litigation and Infringement Claims

American Regent, Inc. has been involved in litigation with other pharmaceutical companies, such as Mylan and Pharmacosmos A/S, over alleged infringement of this patent. For instance, Mylan's ANDA (Abbreviated New Drug Application) product, which involves an aqueous solution of ferric carboxymaltose, was claimed to infringe on the '702 patent. American Regent argued that Mylan's product would induce infringement of the patent claims if approved by the FDA[2].

Overlapping Claims and Patent Family

The '702 patent is part of a larger patent family, including other related patents such as the '109, '612, and '505 patents. There have been discussions about the overlapping claims between these patents, which has led to legal disputes over the relevance and applicability of these patents in infringement cases[5].

Examination and Enforcement

Patent Term and Expiration

The '702 patent is set to expire on February 15, 2028, unless any patent term extensions are granted[2].

Enforcement Actions

American Regent, Inc. has actively enforced this patent, sending warning letters to potential infringers and engaging in legal actions to protect its intellectual property rights. For example, the company sent warning letters to Pharmacosmos A/S regarding the development of Monofer®, a product that allegedly infringed on the '702 patent[5].

Metrics for Patent Scope

The scope of the '702 patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics are useful in assessing the breadth and clarity of patent claims. Research suggests that narrower claims, as measured by these metrics, are associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation and Litigation

The '702 patent, like many others, has been part of broader discussions on patent quality and its impact on innovation. Critics argue that overly broad or unclear patent claims can impede innovation by increasing licensing and litigation costs. However, the enforcement of this patent highlights the importance of protecting intellectual property to incentivize research and development in the pharmaceutical industry[3].

Key Takeaways

• Inventors and Assignees: The patent was invented by Mary Jane Helenek, Marc L. Tokars, and Richard P. Lawrence, and is currently assigned to American Regent, Inc.
• Patent Claims: Covers methods and compositions for administering iron carbohydrate complexes.
• Scope: Broad, including chemical compositions and methods of administration.
• Litigation: Involved in several legal disputes over alleged infringement.
• Patent Term: Set to expire on February 15, 2028.
• Enforcement: Actively enforced by American Regent, Inc.

FAQs

Q: Who are the inventors of U.S. Patent 7,754,702?

A: The inventors are Mary Jane Helenek, Marc L. Tokars, and Richard P. Lawrence.

Q: What is the current assignee of the patent?

A: The current assignee is American Regent, Inc.

Q: What does the patent cover?

A: The patent covers methods and compositions for the administration of iron, particularly iron carbohydrate complexes.

Q: What is the expiration date of the patent?

A: The patent is set to expire on February 15, 2028.

Q: Has the patent been involved in any litigation?

A: Yes, it has been involved in several legal disputes over alleged infringement, including cases against Mylan and Pharmacosmos A/S.

Sources

1. United States Patent and Trademark Office, "Methods and Compositions for Administration of Iron," U.S. Patent No. 7,754,702.
2. RPX Insight, "Mylan's ANDA Product and Patent Infringement Claims."
3. Hoover Institution, "Patent Claims and Patent Scope."
4. United States Patent and Trademark Office, "Methods and Compositions for Administration of Iron," U.S. Patent No. 11,433,091 B2.
5. JD Supra, "Luitpold Pharmaceuticals, Inc. v. Pharmacosmos A/S (Fed. Cir. 2018)."

Drugs Protected by US Patent 7,754,702

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULTS WHO HAVE INTOLERANCE TO OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR A GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON

International Family Members for US Patent 7,754,702

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007205167
Canada	2635894
Canada	2953964
China	101365458
Cyprus	1118780
Denmark	1973549
European Patent Office	1973549