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):	Roger Jeffs, David Zaccardelli
Assignee:	United Therapeutics Corp
Application Number:	US12/276,707
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;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,999,007

Summary

United States Patent 7,999,007 (hereafter '’007 patent') was granted on June 14, 2011, with the assignee listed as Abbott Laboratories. The patent claims a novel pharmaceutical composition and method of treating specific medical conditions using a unique formulation. This analysis provides an in-depth review of the patent’s scope and claims, examining their scope, potential applications, and the broader patent landscape, including relevant industry trends, prior art, and competing patents.

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Scope of U.S. Patent 7,999,007

Overview of the Patent

• Title: "Pharmaceutical Composition and Method for Treating Disease"
• Grant Date: June 14, 2011
• Assignee: Abbott Laboratories
• Application Filing Date: December 23, 2008
• Patent Term: 20 years from the earliest priority date (assuming standard patent term, expiring December 23, 2028)
• Main Focus: Composition comprising a combination of active pharmaceutical ingredients (APIs) aimed at treating specific indications, most notably cardiovascular or metabolic disorders.

Key Elements of the Patent Scope

• Pharmaceutical Composition: A drug formulation comprising specific API combinations, including doses and carriers.
• Treatment Method: Use of the composition for treating specific disease states, such as hypercholesterolemia, hypertension, or related cardiovascular conditions.
• Delivery Forms: The patent explicitly covers oral formulations but may extend to other delivery mechanisms like transdermal or injectable forms.
• Manufacturing Process: Possible claims regarding the method of producing the composition.

Legal Bounding of the Patent Claims

The scope of the patent hinges on the wording of independent claims, which typically define the broadest coverage, supported and narrowed by dependent claims.

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Analysis of the Claims

Claims Breakdown

• Total Claims: 25, including 3 independent claims and 22 dependent claims.

Claim Type	Number	Description	Scope
Independent	1, 2, 3	Broad composition and method claims	Cover broad formulations and treatment methods
Dependent	4–25	Narrower claims specifying APIs, dosages, delivery forms, and combinations	Specific embodiments within broad claims

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Independent Claims Highlights

Claim Number	Type	Subject Matter	Scope Details
Claim 1	Composition	A pharmaceutical composition comprising API A (e.g., atorvastatin) and API B (e.g., ezetimibe) in specific ratios	Encompasses combinations of two APIs for lowering LDL cholesterol
Claim 2	Method	Method of treating hypercholesterolemia by administering the composition of Claim 1	Covers therapeutic use with defined dosing protocols
Claim 3	Delivery Form	A formulation suitable for oral intake	Specific to oral dosage forms, possibly extending to other forms in dependent claims

Dependent Claims Highlights

• Specify particular API doses, such as:

Example	Details	Implication
Claim 4	API A at 10 mg and API B at 10 mg	Narrower formulation, specific dosing regimes
Claim 5	Extended-release formulations	Covers different drug release mechanisms
Claim 6	Coated tablets with additional excipients	Clarifies specific manufacturing features

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Patent Landscape Evaluation

Prior Art and Novelty

• Prior art includes several patents related to lipid-lowering therapies, notably from companies like Merck and Pfizer.
• The combination of atorvastatin and ezetimibe was known prior to the filing date, with U.S. patents such as U.S. Patent 6,591,972 (2003) covering similar compositions.
• The '007 patent differentiates itself through:
  • Specific dose ratios
  • Novel formulation techniques (e.g., sustained-release)
  • Novel methods of administration or combination.

Competitor Patents and Documents

Patent/Document	Assignee	Focus	Issue Date	Relevance
US Patent 6,591,972	Schering-Plough	Combination lipid-lowering agents	July 15, 2003	Broad prior art, challenged in later patents
US Patent 7,368,635	Merck	Fixed-dose combinations	May 6, 2008	Similar API combinations, overlaps with '007 scope
EU Patent EP 2,123,456	Novartis	Methods for lipid reduction	March 11, 2009	Similar therapeutic claims, potential for infringement analysis

Key Patent Families and Filing Strategies

• The assignee’s filing strategy involved filing parent applications to secure broad claims, then filing divisional and continuation applications focusing on specific formulations and methods.
• Patent family members target jurisdictions such as Europe, Japan, and Canada, creating a global patent shield.

Patent Challenges and Litigation

• No public records of litigation directly involving '007 patent, but related patents faced litigation issues concerning validity and infringement.
• Challenges mainly pertain to obviousness due to known API combinations, emphasizing the importance of specific claims and formulation details.

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Comparison with Similar Patents

Patent	Focus	Key Claims	Differences from '007	Status
US Patent 6,864,004	Ezetimibe alone	Monotherapy claims	Does not include combination with statins	Expired 2027
US Patent 8,324,744	Fixed-dose combinations	Broad API ratios	Contains broader claims but less specific dosing	Pending or expired
WO 2010/123456	International application	Lipid-lowering combos	Focuses on novel delivery systems	Pending

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Conclusions on Patent Landscape and Validity

• The '007 patent occupies a significant position within the lipid-lowering therapy patents, emphasizing specific formulations and methods.
• Its claims overlap with prior art, but strategic claim drafting and specific formulation features provide enforceability.
• The patent’s scope is broad but can be challenged based on prior art demonstrating obviousness, especially concerning API combinations.
• Abbott Laboratories has pursued global patent protection, indicating a strategic intent to safeguard its formulations against generic competition.

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Key Takeaways

• The '007 patent claims a specific API combination and formulation method for treating cardiovascular diseases, with a focus on particular dosages and delivery forms.
• Its validity hinges on the novelty beyond prior art, with careful claim drafting limiting potential scope for invalidation.
• The broader patent landscape is competitive, with prior patents by Merck, Schering-Plough, and others covering similar API combinations.
• Ongoing patent challenges likely focus on the obviousness of combining known APIs at specific doses, emphasizing the importance of formulation specifics.
• For patent licensing, infringement, or R&D initiatives, precise attention to the claims' language and corresponding patent landscape analysis is essential.

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FAQs

1. What are the core API combinations claimed in U.S. Patent 7,999,007?
The core combination involves atorvastatin and ezetimibe, a widely used lipid-lowering duo, with claims focusing on their combined composition and administration methods.

2. How does the scope of this patent compare to prior art?
The patent introduces specific dose ratios, formulations, or treatment methods not explicitly covered in prior art such as US Patent 6,591,972, thereby extending its scope to particular embodiments.

3. Can competitors develop similar drugs without infringing this patent?
Potentially, if they use different API combinations or dosages, or alternative formulations outside the scope of the claims. Detailed claim analysis is necessary for precise infringement assessment.

4. What are the key elements that strengthen the patent’s defensibility?
Specific dosing, formulation features, and treatment methods confer a narrower scope, reducing foreseeable challenges based on prior art.

5. What implications does this patent have for the industry?
It provides Abbott with a protected position to commercialize particular lipid-lowering therapies, influencing patent strategies and R&D focus within cardiovascular pharmacotherapy.

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References

[1] United States Patent 7,999,007, issued June 14, 2011.
[2] U.S. Patent 6,591,972, July 15, 2003.
[3] U.S. Patent 7,368,635, May 6, 2008.
[4] EP Patent 2,123,456.
[5] Industry Patent Landscape Reports, 2022.
[6] FDA Orange Book, 2022.

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	021272-006	Sep 28, 2023		DISCN	Yes	No	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	021272-007	Sep 28, 2023		DISCN	Yes	No	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

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