Details for Patent: 7,999,007

Which drugs does patent 7,999,007 protect, and when does it expire?

Patent 7,999,007 protects REMODULIN and is included in one NDA.

This patent has sixteen patent family members in seven countries.

Summary for Patent: 7,999,007

Title:	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Abstract:	Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.
Inventor(s):	Jeffs; Roger (Chapel Hill, NC), Zaccardelli; David (Cary, NC)
Assignee:	United Therapeutics Corporation (Silver Spring, MD)
Application Number:	12/276,707
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,999,007
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Formulation;

United States Patent 7,999,007: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 7,999,007, titled "Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same," is a significant patent held by United Therapeutics Corporation (UTC). This patent is central to a notable patent infringement case involving UTC and Sandoz, Inc. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Invention

The patent, issued on August 16, 2011, pertains to buffer solutions designed to maintain a specific pH and solubilize or dilute active pharmaceutical agents (APIs) before administration, such as by injection. Unlike many conventional buffers that can foster microbial growth, these buffer solutions have bactericidal activity preferentially against gram-negative bacteria, reducing the risk of sepsis and other infections[4].

Inventors and Assignee

The inventors of this patent are Roger Jeffs and David Zaccardelli, both associated with United Therapeutics Corporation, which is the assignee of the patent. The research leading to this patent was conducted by Drs. Jeffs and Zaccardelli, who observed a dramatic reduction in gram-negative bacteria using these buffer solutions[1].

Patent Claims

The '007 patent includes multiple claims that can be categorized into several groups:

Method Claims

• The first set of method claims (claims 1-5, 7-10, and 21) is directed to methods of selectively killing gram-negative bacteria and inhibiting the growth of gram-positive bacteria in a pharmaceutical preparation.
• The second set of method claims (claims 11-17 and 19-20) focuses on methods of reducing the occurrence of bloodstream infections by administering solutions that reduce gram-negative bacteria and inhibit the growth of gram-positive bacteria[1].

Composition Claim

• Claim 23, which depends on independent claim 22, is a composition claim related to the buffer solutions themselves[1].

Scope of the Patent

The scope of a patent is crucial in determining its protective breadth and the potential for infringement. Here are some key points regarding the scope of the '007 patent:

Claim Length and Scope

Research indicates that the length of a patent claim is inversely related to its scope. Longer claims typically imply more conditions that must be met for a patent to be violated, making them narrower. The '007 patent's claims, particularly the method claims, are detailed and specific, suggesting a narrower scope but one that is highly protective against direct infringement[3].

Independent and Dependent Claims

The patent includes independent claims (e.g., claims 1 and 11) that define the broadest scope of the invention. Dependent claims, which must be narrower than their corresponding independent claims, serve as fallback positions. This structure helps in maintaining a robust patent portfolio by providing multiple layers of protection[3].

Patent Landscape and Infringement

The '007 patent is part of a larger patent landscape that includes other related patents, such as the '117 patent, also held by UTC.

Patent Infringement Case

In the case of United Therapeutics Corporation v. Sandoz, Inc., UTC alleged that Sandoz's proposed ANDA (Abbreviated New Drug Application) product would infringe and induce infringement of the '007 and '117 patents. The court found that UTC failed to prove infringement of the '007 patent but succeeded in proving infringement of the '117 patent[1][2].

Orange Book Listing

The '007 patent, along with the '117 patent, is listed in the Orange Book in connection with treprostinil sodium injection, a product of UTC. This listing is significant as it requires any generic drug applicant to certify that their product does not infringe the listed patents or to challenge the validity of these patents[2].

Patent Validity

The validity of the '007 patent was challenged by Sandoz, but the court concluded that Sandoz failed to prove by clear and convincing evidence that the asserted claims of the '007 patent are invalid. This ruling upheld the patent's validity and reinforced UTC's intellectual property rights[1].

Expiration and Adjustments

The '007 patent is set to expire on March 29, 2029, with an extension of 205 days due to adjustments under 35 U.S.C. § 154(b)[4].

Key Takeaways

• Specific Claims: The '007 patent includes detailed method and composition claims that provide strong protection against gram-negative bacteria.
• Narrow Scope: The claims are specific, indicating a narrower scope but robust protection.
• Patent Infringement: The patent was part of a significant infringement case, with UTC successfully defending some but not all claims against Sandoz.
• Validity: The patent's validity was upheld against challenges by Sandoz.
• Expiration: The patent is set to expire in 2029, with an extended term due to regulatory adjustments.

FAQs

Q: What is the main subject of the '007 patent?

A: The '007 patent pertains to buffer solutions with selective bactericidal activity against gram-negative bacteria and methods of using these solutions.

Q: Who are the inventors of the '007 patent?

A: The inventors are Roger Jeffs and David Zaccardelli.

Q: What is the significance of the Orange Book listing for this patent?

A: The listing in the Orange Book requires generic drug applicants to certify non-infringement or challenge the patent's validity.

Q: What was the outcome of the patent infringement case involving UTC and Sandoz?

A: The court found that Sandoz did not infringe the '007 patent but did infringe the '117 patent.

Q: When is the '007 patent set to expire?

A: The patent is set to expire on March 29, 2029, with an extended term of 205 days.

Sources

1. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY UNITED THERAPEUTICS CORP., Civil Action Nos. 12-CV-01617 Plaintiff, 13-CV-316 v. MEMORANDUM SANDOZ, INC., Defendant.
2. UNITED THERAPEUTICS CORPORATION v. SANDOZ, INC., No. 3:2012cv01617 - Document 243 (D.N.J. 2014)
3. The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope
4. United States Patent - googleapis.com

Drugs Protected by US Patent 7,999,007

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-007	Sep 28, 2023		RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-008	Sep 28, 2023		RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	AP	RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	AP	RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-006	Sep 28, 2023		RX	Yes	Yes	7,999,007		Y			ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION

International Family Members for US Patent 7,999,007

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2698721
China	101827612
China	103181893
European Patent Office	2200650
European Patent Office	2711024
Spain	2562669
Spain	2728785