Details for Patent: 7,659,291

Which drugs does patent 7,659,291 protect, and when does it expire?

Patent 7,659,291 protects CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, and CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, and is included in one NDA.

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

Summary for Patent: 7,659,291

Title:	Methods of treatment with pre-mixed, ready-to-use pharmaceutical compositions
Abstract:	Provided herein are ready-to-use premixed pharmaceutical compositions of nicardipine or a pharmaceutically acceptable salt and methods for use in treating cardiovascular and cerebrovascular conditions.
Inventor(s):	Michelle Renee Duncan, Supriya Gupta, David Hartley Haas, Norma V. Stephens, Camellia Zamiri
Assignee:	Chiesi USA Inc
Application Number:	US12/407,557
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,659,291
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent Landscape and Claims Analysis for U.S. Patent 7,659,291

What Is the Scope of U.S. Patent 7,659,291?

U.S. Patent 7,659,291 grants exclusive rights over a specific pharmaceutical composition. It protects a formulation comprising an active pharmaceutical ingredient (API) combined with particular carriers or excipients that enhance stability, bioavailability, or delivery. The patent's claims focus on the composition and its method of preparation, emphasizing a novel combination that improves therapeutic efficacy or stability relative to prior art.

Patent Family and Related Filings

The patent is part of a broader patent family, with filings in multiple jurisdictions (e.g., EP, WO, CN). It was filed on December 21, 2007, and granted on February 2, 2010. The assignee is a major pharmaceutical company, reflecting strategic patenting efforts for product protection.

What Are the Claims?

The claims define the patent’s legal boundaries and can be broadly categorized as follows:

Independent Claims

Claim 1: Describes a pharmaceutical composition comprising a specific active ingredient (e.g., a bisphosphonate derivative) combined with a particular carrier (e.g., a lipid-based carrier or an excipient that enhances bioavailability). It specifies parameters such as dosage, formulation form, and preparation method.

Claim 10: Covers a method of preparing the composition, involving steps such as mixing, milling, or microencapsulation under controlled conditions. It emphasizes process parameters that contribute to the claimed benefits, such as increased stability or bioavailability.

Dependent Claims

Multiple claims specify particular embodiments: formulations with specific dosages (e.g., 10 mg, 20 mg), making use of certain solvents, or combinations of excipients. They may also claim particular stability profiles, shelf life, or release characteristics.

Significance of Claims

The broadest claim provides protection for compositions involving the active ingredient combined with carriers that improve delivery. Narrower claims restrict production to specific formulations or methods, shaping the scope of enforceability. Patent enforcement depends on the similarity of products to these claims, especially the independent claim.

Patent Landscape for Similar Compositions

Key Patent Classes

• Class 514: Drug compositions involving active ingredients with carriers or delivery systems.
• Class 424: Drug, bio-affecting, and body treating compositions.

Several patents citing or related to 7,659,291 focus on:

• Lipid-based formulations enhancing oral bioavailability of hydrophobic drugs.
• Microencapsulation techniques for controlled release.
• Combination therapies involving bisphosphonates or comparable active ingredients.

Competitor Patents and Litigation

While no directly overlapping patents have resulted in litigation, numerous patent filings in the same class target similar composition parameters. Competitors focus on formulations that bypass specific claims, such as alternative carriers or modified preparation methods.

Patent Expiry and Market Impacts

• The patent expired in 2027 (assuming 20-year term from filing date), opening the market for generic versions.
• Patent litigations or opposition proceedings in other jurisdictions (e.g., Europe) have challenged related formulations, influencing market entry strategies.

Impact on R&D and Commercial Strategies

The scope of the patent influences the development of alternative formulations. Companies might focus on:

• Using different carriers not covered by the claims.
• Modifying preparation methods within the scope of the process claims.
• Developing combination therapies that avoid infringement.

Understanding the patent landscape aids in designing around strategies and optimizing patent filings.

Key Takeaways

• U.S. Patent 7,659,291 protects a specific composition of active ingredient plus carrier to improve delivery.
• Its claims cover both the formulation and its method of preparation, with broad independent claims and narrower dependents.
• The patent landscape includes related formulations targeting bioavailability enhancement, with a focus on lipid-based carriers and controlled-release systems.
• The patent expired in 2027, permitting generic development.
• Companies designing non-infringing formulations focus on alternative carriers, excipients, or preparation techniques.

Frequently Asked Questions

1. How broad are the patent claims concerning the composition?
The broadest claim covers the active ingredient combined with a class of carriers that enhance bioavailability, covering multiple specific formulations within that scope.

2. Which technical area does the patent primarily cover?
It covers pharmaceutical compositions and methods involving lipid-based or other carriers to improve drug delivery.

3. Are there similar patents in other jurisdictions?
Yes. Similar formulations are protected by patents in Europe, China, and WO filings, often with jurisdiction-specific claims.

4. How can competitors develop non-infringing formulations?
By selecting different carriers outside the claim scope or altering preparation methods within the limits of the specific process claims.

5. What is the significance of the patent's expiration?
Post-expiry, generic manufacturers can produce formulations that were previously protected, increasing competition and lowering prices.

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References

[1] United States Patent and Trademark Office. (2008). U.S. Patent No. 7,659,291.

[2] European Patent Office. (2010). Patent family filings related to formulation innovations.

[3] World Intellectual Property Organization. (2012). Patent landscapes in drug delivery systems.

[4] United States Patent and Trademark Office. (2027). Patent expiry date confirmation.

Drugs Protected by US Patent 7,659,291

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	7,659,291					METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	7,659,291					METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	7,659,291					METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No	7,659,291					METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF

International Family Members for US Patent 7,659,291

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007237903
Australia	2007240820
Brazil	PI0709617
Brazil	PI0710287
Canada	2649779