Details for Patent: 9,364,564

Which drugs does patent 9,364,564 protect, and when does it expire?

Patent 9,364,564 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: 9,364,564

Title:	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):	Duncan; Michelle Renee (Glenview, IL), Gupta; Supriya (Sunnyvale, CA), Haas; David Hartley (Fremont, CA), Stephens; Norma V. (Skokie, IL), Zamiri; Camellia (Fremont, CA)
Assignee:	EKR Therapeutics, Inc. (Cary, NC)
Application Number:	12/645,169
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form; Use;

Understanding the Scope and Claims of United States Patent 9,364,564

Introduction to Patent Law in the United States

Patent law in the United States is governed by the Patent Act (35 U.S. Code) and administered by the United States Patent and Trademark Office (USPTO). The Constitution grants Congress the power to promote the progress of science and useful arts by securing exclusive rights to inventors for limited times[1].

Types of Patents

There are several types of patents, but the most relevant to most inventions is the utility patent. Utility patents protect functional inventions and have a duration of 20 years from the date of filing, although they are not enforceable until the day of issuance. Other types include design patents, which protect ornamental designs, and plant patents, which protect new varieties of asexually reproducing plants[1].

The Patent Application Process

To obtain a patent, an applicant must submit a patent application to the USPTO. The application is reviewed by an examiner to determine if the invention is patentable. The patentee is granted the right to exclude others from making, using, or selling the invention[1].

Patent 9,364,564: Overview

To analyze the scope and claims of United States Patent 9,364,564, one must first identify the type of patent and the specific claims made.

Type of Patent

Without specific details, we can infer that this patent is likely a utility patent given its commonality.

Claims Analysis

Patent claims are the heart of a patent application and define the scope of the invention. Here are some key points to consider:

• Claim Structure: Patent claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

• Claim Scope: The scope of the claims determines what is protected by the patent. Broader claims may cover more variations of the invention, but risk being invalidated if they are too broad. Narrower claims are more specific but may offer less protection[3].

Patent Subject Matter Eligibility

Under Section 101 of the Patent Act, the invention must be eligible for patent protection. This involves two steps as outlined in the Alice test:

• Step One: Determine whether the claim is directed to a judicial exception (e.g., abstract ideas, natural phenomena, laws of nature).
• Step Two: If the claim is directed to a judicial exception, determine whether the claim elements, considered both individually and as an ordered combination, add enough to transform the nature of the claim into a patent-eligible application of such exception[1].

Reissue Patents and Scope Limitations

In cases where a patent is reissued, the claims must be directed to "the invention disclosed in the original patent" as required by 35 U.S.C. § 251. This means that any reissue claims cannot broaden the scope beyond what was originally disclosed[2].

Searching and Analyzing Patent Data

For a detailed analysis, one can use various tools provided by the USPTO:

• Global Dossier: This service allows users to see the patent family for a specific application, including related applications filed at participating IP Offices, along with dossier, classification, and citation data[4].

• Patent Claims Research Dataset: This dataset provides detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014. It includes claim-level statistics and document-level statistics, which can help in understanding the scope and trends of patent claims[3].

Practical Steps for Analysis

1. Retrieve the Patent Document:

   • Use the USPTO's public search facility or the Global Dossier to retrieve the full text of the patent and any related applications[4].

2. Review the Claims:

   • Analyze the independent and dependent claims to understand the scope of the invention.
   • Determine if the claims are directed to a judicial exception and if they add enough to transform the nature of the claim into a patent-eligible application[1].

3. Examine the Specification and Drawings:

   • The written description and drawings must support the claims. Ensure that the claims are fully described and enabled by the specification[2].

4. Check for Reissue Claims:

   • If the patent has been reissued, verify that the reissue claims comply with the original patent requirement under 35 U.S.C. § 251[2].

5. Analyze Prior Art and Citations:

   • Use tools like the Common Citation Document (CCD) to see prior art cited by all participating offices for the family members of the patent application[4].

Key Takeaways

• Patent Type and Duration: Understand the type of patent (likely a utility patent) and its duration.
• Claims Analysis: Carefully review the claims to determine the scope of the invention.
• Subject Matter Eligibility: Ensure the invention meets the criteria under Section 101.
• Reissue Claims: Verify compliance with the original patent requirement if the patent has been reissued.
• Use of USPTO Tools: Utilize USPTO resources like the Global Dossier and Patent Claims Research Dataset for detailed analysis.

FAQs

1. What is the purpose of the Patent Act in the United States?

   • The Patent Act is designed to promote the progress of science and useful arts by securing exclusive rights to inventors for limited times[1].

2. How long does a utility patent last?

   • A utility patent lasts for 20 years from the date of filing but is not enforceable until the day of issuance[1].

3. What is the Alice test in patent law?

   • The Alice test is a two-step process to determine if a claim is eligible for patent protection under Section 101, involving the identification of judicial exceptions and the evaluation of whether the claim elements add enough to transform the nature of the claim[1].

4. What is the Global Dossier service provided by the USPTO?

   • The Global Dossier service allows users to see the patent family for a specific application, including related applications filed at participating IP Offices, along with dossier, classification, and citation data[4].

5. How can one analyze the scope of patent claims using USPTO datasets?

   • One can use the Patent Claims Research Dataset to analyze claim-level statistics and document-level statistics, providing insights into the scope and trends of patent claims[3].

Sources

1. BitLaw - Patent Law in the United States

   • https://www.bitlaw.com/patent/index.html

2. In Re FLOAT'N'GRILL LLC - Court of Appeals for the Federal Circuit

   • https://cafc.uscourts.gov/opinions-orders/22-1438.OPINION.7-12-2023_2156183.pdf

3. Patent Claims Research Dataset - USPTO

   • https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset

4. Search for Patents - USPTO

   • https://www.uspto.gov/patents/search

Drugs Protected by US Patent 9,364,564

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	9,364,564		Y
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	9,364,564		Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	9,364,564		Y

International Family Members for US Patent 9,364,564

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