Details for Patent: 10,478,453

Which drugs does patent 10,478,453 protect, and when does it expire?

Patent 10,478,453 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,478,453

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:	16/248,460
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,478,453
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

United States Patent 10,478,453: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,478,453, titled "Stable, Highly Pure L-Cysteine Compositions for Injection and Methods of Use," is a significant patent in the pharmaceutical industry, particularly in the realm of parenteral nutrition and amino acid therapies. This patent, owned by Exela Pharma Sciences, LLC, has been at the center of several legal and technological discussions.

Background of the Patent

The patent was issued on March 10, 2020, and is associated with Exela's product ELCYS®, a cysteine hydrochloride injection used in parenteral nutrition solutions. The invention focuses on stable and highly pure L-cysteine compositions, which are crucial for medical applications due to their stability and purity[1][2][5].

Key Claims of the Patent

Claim 1

Claim 1 of the '453 patent describes a stable L-cysteine composition for parenteral administration, comprising L-cysteine or a pharmaceutically acceptable salt, and a pharmaceutically acceptable carrier. The composition is characterized by its high purity and stability, which are essential for medical use[5].

Other Claims

The patent includes multiple claims that cover various aspects of the composition, including the concentration of L-cysteine, the presence of specific impurities (such as aluminum), and the methods of use. For example, some claims specify that the composition contains less than a certain amount of aluminum, which is critical for ensuring the safety and efficacy of the product[1][4].

Technical Aspects of the Invention

Stability and Purity

The patent emphasizes the importance of stability and purity in L-cysteine compositions. The inventors have developed a method to maintain the stability of L-cysteine in solution, which is a significant challenge due to its tendency to degrade over time. This stability is achieved through specific formulations and storage conditions[1].

Aluminum Content

One of the critical aspects of the patent is the limitation on aluminum content. The composition is designed to contain less than a specified amount of aluminum, typically less than 400 μg/L, which is crucial for ensuring the safety of the product for parenteral administration[4].

Patent Landscape and Litigation

Hatch-Waxman Act and ANDA Filings

The patent has been involved in a Hatch-Waxman action, where Exela Pharma Sciences, LLC, sued Eton Pharmaceuticals, Inc., for infringement. Eton had filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Exela's ELCYS® product. The court found that Eton's ANDA product infringed several claims of Exela's patents, including the '453 patent[2].

Legal Implications

The litigation highlights the complexities of patent law in the pharmaceutical industry. The court's decision underscores the importance of patent protection for innovators and the challenges faced by generic manufacturers in navigating the patent landscape. The case also illustrates the rigorous standards applied to patent claims, particularly in terms of enablement and written description under 35 U.S.C. § 112[2][3].

Impact on the Pharmaceutical Industry

Patent Scope and Validity

The patent landscape in the pharmaceutical industry is heavily influenced by the interpretation of patent laws, particularly the enablement and written description requirements. The Federal Circuit's recent jurisprudence has introduced significant uncertainty, making it challenging for innovators to claim the full scope of their inventions without risking invalidation[3].

Innovations and Competition

The '453 patent exemplifies the delicate balance between innovation and competition. While the patent protects Exela's invention, it also sets a high bar for generic manufacturers seeking to enter the market. This balance is crucial for driving innovation while ensuring that generic alternatives can eventually become available, promoting competition and reducing costs[3].

Expert Insights

Dr. Phanesh Koneru, a named inventor of the '453 patent and Exela's co-founder and CEO, testified in the litigation about the development of ELCYS®. His testimony highlighted the extensive research and development efforts that went into creating a stable and highly pure L-cysteine composition, underscoring the innovative nature of the patent[2].

Statistics and Market Impact

The market for parenteral nutrition solutions, including amino acid therapies, is significant. Patents like the '453 patent play a crucial role in this market by protecting innovative products and encouraging further research. For instance, the market for therapeutic antibodies, which often involve complex patent landscapes, is projected to reach $300 billion by 2025[3].

Conclusion

The United States Patent 10,478,453 is a pivotal patent in the pharmaceutical industry, particularly in the field of parenteral nutrition. Its claims and technical aspects highlight the importance of stability, purity, and safety in medical compositions. The patent's involvement in litigation underscores the complex legal landscape surrounding pharmaceutical patents and the ongoing challenges faced by innovators and generic manufacturers.

Key Takeaways

• Stability and Purity: The patent emphasizes the importance of stability and purity in L-cysteine compositions for medical use.
• Aluminum Content: The composition is designed to contain less than a specified amount of aluminum, ensuring safety for parenteral administration.
• Patent Litigation: The patent has been involved in a Hatch-Waxman action, highlighting the complexities of patent law in the pharmaceutical industry.
• Industry Impact: The patent sets a high bar for generic manufacturers, balancing innovation and competition in the market.
• Legal Landscape: The patent's validity is influenced by the interpretation of patent laws, particularly enablement and written description requirements.

FAQs

Q1: What is the main focus of the United States Patent 10,478,453? The main focus of the patent is on stable and highly pure L-cysteine compositions for injection, particularly for parenteral administration.

Q2: Why is the aluminum content important in this patent? The aluminum content is crucial because it must be below a specified limit to ensure the safety of the product for parenteral administration.

Q3: What is the significance of the Hatch-Waxman action involving this patent? The Hatch-Waxman action highlights the legal complexities and the importance of patent protection for innovators in the pharmaceutical industry.

Q4: How does the Federal Circuit's jurisprudence affect pharmaceutical patents? The Federal Circuit's recent jurisprudence has introduced uncertainty by applying a heightened test for enablement and written description, making it challenging for innovators to claim the full scope of their inventions.

Q5: What is the projected market impact of patents like the '453 patent? Patents like the '453 patent drive innovation and protect products in significant markets, such as parenteral nutrition solutions, which are crucial for medical care and have substantial economic implications.

Sources

1. US10478453B1 - Stable, highly pure L-cysteine compositions for injection and methods of use - Google Patents
2. 20-365.pdf - District of Delaware
3. Eviscerating Patent Scope, 21 UIC Rev. Intell. Prop. L. 121 (2022)
4. US11045438B2 - Cysteine composition and injection - Google Patents
5. in the united states district court for the district of delaware exela ... - Insight.RPXCorp.com

Drugs Protected by US Patent 10,478,453

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	10,478,453		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	10,478,453		Y			METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION