Details for Patent: 11,684,636

Which drugs does patent 11,684,636 protect, and when does it expire?

Patent 11,684,636 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 11,684,636

Title:	Stable, highly pure l-cysteine compositions for injection and methods of use
Abstract:	The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):	John Maloney, Aruna Koganti, Phanesh Koneru
Assignee:	Exela Pharma Sciences LLC
Application Number:	US17/950,979
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of a U.S. Patent: A Detailed Analysis of United States Patent 11,684,636

Introduction to U.S. Patents

In the United States, patents are governed by the Patent Act (35 U.S. Code) and administered by the United States Patent and Trademark Office (USPTO)[1].

• Types of Patents: The most common types include utility patents, design patents, and plant patents. Utility patents, which are the focus of this analysis, protect functional inventions and have a duration of 20 years from the date of filing.

The Patent Process

To obtain a patent, an applicant must submit a patent application to the USPTO, where it is reviewed by an examiner to determine if the invention is patentable[1].

Determining Patentability

• Section 101: This section of the Patent Act deals with subject matter eligibility. The invention must fall within one of the four statutory categories: processes, machines, manufactures, or compositions of matter. It must also not be excluded by non-statutory exceptions such as abstract ideas, natural phenomena, or laws of nature[1].

Analyzing the Patent Claims

Patent claims are the heart of a patent application, defining the scope of protection. Here’s how to analyze them:

Claim Structure

• 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[1].

Claim Scope

• The scope of a patent is determined by the claims. Broader claims provide wider protection but are more likely to be challenged, while narrower claims are more specific but offer less protection[3].

Case Study: United States Patent 11,684,636

To analyze the scope and claims of a specific patent like United States Patent 11,684,636, one would follow these steps:

Identify the Type of Patent

• Determine if the patent is a utility, design, or plant patent. For this example, we will assume it is a utility patent.

Review the Patent Claims

• Examine the independent and dependent claims to understand the invention’s scope.
  • Independent Claims: These define the broadest scope of the invention.
  • Dependent Claims: These narrow down the scope by adding additional limitations.

Understand the Invention

• Read the specification and drawings to comprehend the invention’s functionality and how it is described in the claims.

Check for Prior Art

• Use resources like the USPTO’s Public Search Facility or the Global Dossier to see if similar inventions have been patented or applied for[4].

Inventorship and Ownership

Determining Inventorship

• The true and only inventors must be listed on the patent application. Conception of the idea and reduction to practice are key steps in determining inventorship[5].

Joint Inventors

• If multiple individuals contributed to the invention, they are considered joint inventors, even if their contributions were not equal or to every claim[5].

Patent Landscape Analysis

Global Dossier

• Use the Global Dossier service to view the file histories of related applications from participating IP Offices. This helps in understanding the global patent family and any office actions[4].

Common Citation Document (CCD)

• The CCD consolidates prior art cited by all participating offices for the family members of a patent application, providing a comprehensive view of the prior art landscape[4].

Economic and Statistical Analysis

Patent Claims Research Dataset

• The USPTO provides datasets that contain detailed information on claims from U.S. patents and applications. These datasets can be used to analyze trends and statistics related to patent scope and claims[3].

Key Takeaways

• Patent Claims: The claims define the scope of protection and are crucial for determining the patent’s validity and enforceability.
• Inventorship: Correctly identifying the true and only inventors is essential to avoid patent invalidation.
• Prior Art: Conducting thorough prior art searches is vital to ensure the invention is novel and non-obvious.
• Global Patent Landscape: Understanding the global patent family and prior art citations helps in navigating the complex patent landscape.

FAQs

Q: What is the duration of a utility patent in the United States? A: A utility patent in the United States has a duration of 20 years from the date of filing[1].

Q: How do you determine the true inventors of a patent? A: The true inventors are those who conceived the idea of the invention. Conception is complete when the idea is sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[5].

Q: What is the purpose of the Global Dossier service? A: The Global Dossier service provides access to the file histories of related applications from participating IP Offices, helping users to see the patent family and related documentation for a specific application[4].

Q: How do you analyze the scope of a patent? A: Analyze the independent and dependent claims, and review the specification and drawings to understand the invention’s functionality and scope[1].

Q: What happens if the wrong inventors are listed on a patent application? A: If the wrong inventors are listed with deceptive intent, the patent can be found invalid and unenforceable. However, errors without deceptive intent can often be corrected[5].

Sources

1. BitLaw: Patent Law in the United States - BitLaw
2. USAGov: U.S. Patent and Trademark Office (USPTO) - USAGov
3. USPTO: Patent Claims Research Dataset - USPTO
4. USPTO: Search for patents - USPTO
5. Oregon State University: Determining Inventorship for US Patent Applications - Oregon State University

Drugs Protected by US Patent 11,684,636

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y