Details for Patent: 10,583,155

Which drugs does patent 10,583,155 protect, and when does it expire?

Patent 10,583,155 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,583,155

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 O.sub.2 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):	Maloney; John (Salisbury, NC), Koganti; Aruna (Lenoir, NC), Koneru; Phanesh (Waxhaw, NC)
Assignee:	Exela Pharma Sciences, LLC (Lenoir, NC)
Application Number:	16/665,702
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,583,155
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Detailed Analysis of the Scope and Claims of United States Patent 10,583,155

Introduction

The United States Patent 10,583,155, titled "Stable, Highly Pure L-cysteine Compositions for Injection and Methods of Use," is a critical patent in the pharmaceutical industry, particularly in the field of parenteral nutrition and amino acid therapy. This patent is owned by Exela Pharma Sciences, LLC, and has been at the center of several legal disputes, including a notable Hatch-Waxman action.

Patent Overview

The patent was issued on February 2, 2021, and is a continuation of several earlier applications, highlighting the evolutionary nature of the invention[4][5].

Claims and Scope

Claim Structure

The patent includes multiple claims, with Claim 1 being particularly significant. Claim 1 describes a method of treating a subject having an adverse health condition responsive to L-cysteine administration. This method involves parenterally administering a parenteral composition that includes a mixture of one or more amino acids, an intravenous fluid, and a stable L-cysteine composition[2].

Key Claims

• Claim 27: This claim is central to the legal disputes surrounding the patent. It pertains to the method of treating a subject using a specific composition that includes L-cysteine and other components. The claim's validity and infringement have been contested by Eton Pharmaceuticals, Inc.[1][2].

Patent Scope Metrics

The scope of the patent can be analyzed using metrics such as independent claim length (ICL) and independent claim count (ICC). These metrics help in understanding the breadth and clarity of the patent claims. Generally, narrower claims with shorter lengths and fewer independent claims are associated with a higher probability of grant and a shorter examination process[3].

Infringement and Validity Disputes

Hatch-Waxman Action

Exela Pharma Sciences, LLC, filed a Hatch-Waxman action against Eton Pharmaceuticals, Inc., alleging that Eton's Abbreviated New Drug Application (ANDA) for a generic version of Exela's ELCYS® product would infringe several claims of the '155 patent, among others. The court found that Eton's ANDA product infringed claims 27 of the '155 patent, as well as other related patents[1].

Infringement Findings

The court concluded that Eton's ANDA product directly and contributorily infringed, and induced infringement of, claim 27 of the '155 patent. Additionally, the court found that Eton failed to prove the invalidity of claim 27 for anticipation or obviousness[1].

Patent Landscape

Related Patents

The '155 patent is part of a larger family of patents related to L-cysteine compositions. Other patents, such as the '713 and '795 patents, also owned by Exela, cover similar subject matter and have been involved in the same legal disputes[1].

Competitive Environment

The pharmaceutical industry, particularly the segment dealing with amino acid compositions for parenteral administration, is highly competitive. Patents like the '155 patent play a crucial role in protecting intellectual property and market share. Companies like Exela and Eton are actively involved in developing and marketing these products, leading to frequent patent disputes[1][2].

Legal and Regulatory Context

FDA Approval and Orange Book Listing

The '155 patent is listed in the FDA's Orange Book, which provides notice of patents covering FDA-approved drugs. This listing is crucial for regulatory compliance and for notifying potential generic manufacturers of the existing patent landscape[2].

Paragraph IV Certification

Eton's ANDA filing included a Paragraph IV certification, which asserts that the '155 patent is invalid or will not be infringed by Eton's generic product. This certification is a common mechanism in Hatch-Waxman actions, allowing generic manufacturers to challenge the validity of existing patents[2].

Industry Impact

Innovation and Competition

Patents like the '155 patent influence innovation and competition in the pharmaceutical industry. They provide incentives for research and development by protecting the intellectual property of innovators. However, they can also create barriers to entry for generic manufacturers, potentially affecting the availability and affordability of critical medications[3].

Litigation and Licensing

The disputes surrounding the '155 patent highlight the complex and often contentious nature of patent litigation in the pharmaceutical sector. These disputes can lead to significant legal and licensing costs, impacting the overall efficiency of the innovation process[3].

Expert Insights

Industry experts often emphasize the importance of clear and narrow patent claims to avoid litigation and ensure that patents serve their intended purpose of promoting innovation. For example, a Federal Trade Commission (FTC) report noted that overly broad and unclear claims can impede innovation by increasing licensing and litigation costs[3].

Illustrative Statistics

• The examination process for patents tends to narrow the scope of claims, with longer examination durations resulting in more significant scope reductions[3].
• Litigated patents, which are often more valuable, experience longer and more complex prosecutions at the Patent and Trademark Office (PTO)[3].

Key Takeaways

• The '155 patent is a significant intellectual property asset in the pharmaceutical industry, particularly for L-cysteine compositions.
• The patent has been at the center of a Hatch-Waxman action, with findings of infringement against Eton Pharmaceuticals.
• The scope and validity of the patent claims are critical factors in determining the patent's impact on innovation and competition.
• Clear and narrow patent claims are essential for avoiding litigation and promoting efficient innovation.

FAQs

What is the main subject matter of the '155 patent?

The '155 patent pertains to stable, highly pure L-cysteine compositions for injection and methods of use, particularly in parenteral administration.

Which company owns the '155 patent?

The '155 patent is owned by Exela Pharma Sciences, LLC.

What was the outcome of the Hatch-Waxman action involving the '155 patent?

The court found that Eton Pharmaceuticals' ANDA product infringed claim 27 of the '155 patent and that Eton failed to prove the invalidity of this claim.

How does the '155 patent impact the pharmaceutical industry?

The patent influences innovation and competition by protecting Exela's intellectual property and potentially creating barriers to entry for generic manufacturers.

What metrics can be used to analyze the scope of the '155 patent?

Metrics such as independent claim length (ICL) and independent claim count (ICC) can be used to analyze the scope and clarity of the patent claims.

Cited Sources:

1. District of Delaware Opinion: "Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc." (August 8, 2022)
2. Complaint in the United States District Court for the District of Delaware: "Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc." (March 16, 2020)
3. Hoover Institution Paper: "Patent Claims and Patent Scope" (August 18, 2024)
4. Justia Patent Database: "Stable, highly pure L-cysteine compositions for injection and methods of use" (June 20, 2023)
5. Unified Patents Portal: "US-10583155-B1 - Stable, Highly Pure L-cysteine Compositions for Injection and Methods of Use"

Drugs Protected by US Patent 10,583,155

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	10,583,155		Y			METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,583,155		Y			METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION