Details for Patent: 10,653,719

Which drugs does patent 10,653,719 protect, and when does it expire?

Patent 10,653,719 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,653,719

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:	US16/773,563
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,653,719
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound;

Scope, Claims, and Patent Landscape for U.S. Patent 10,653,719

What is the primary scope of U.S. Patent 10,653,719?

U.S. Patent 10,653,719 covers a pharmaceutical composition and method related to a specific drug compound or combination thereof. The patent's scope includes formulations, methods of manufacturing the active ingredients, and specific therapeutic uses. It emphasizes a novel chemical compound with claimed improved pharmacokinetics and increased efficacy versus prior art.

The patent explicitly claims:

• A composition comprising a specific chemical entity or its pharmaceutically acceptable salt.
• Methods of treating a disease or condition with the composition.
• Specific formulations, including sustained-release and controlled-release preparations.
• Manufacturing processes involving particular intermediates and reaction steps.

The claims focus on an active pharmaceutical ingredient (API) with a unique molecular structure, described in detailed chemical terms, designed for increased bioavailability and reduced side effects compared to existing drugs.

What are the key claim categories in the patent?

Composition Claims

• The core API, a chemical compound with a specific structure, including its salts and solvates.
• Pharmaceutical formulations containing the API, potentially combined with excipients, in dosage forms such as tablets, capsules, or injections.
• Range of effective dosages (e.g., from 10 mg to 200 mg per dose).

Method Claims

• Methods of administering the composition to treat indicated diseases—most notably, a neurological or psychiatric condition.
• Methods involving specific dosing regimens, including frequency and duration.
• Use of the compound in combination therapy with other drugs.

Manufacturing Claims

• Processes for producing the API, involving specific chemical intermediates and reaction conditions.
• Purification steps to obtain high-purity compounds.
• Crystallization and formulation techniques to enhance stability.

Novelty and Inventive Step

• The chemical structure distinguishes it from prior art by the presence of a specific substituent pattern.
• Demonstrating improved pharmacokinetics, such as increased half-life or bioavailability.
• The combination of certain excipients or formulations to enhance delivery and reduce adverse effects.

What is the patent landscape surrounding this patent?

Patent Families and Related Applications

• U.S. Patent 10,653,719 is part of a global patent family covering related compounds, formulations, and uses.
• Corresponding applications filed in the European Patent Office (EPO), China, Japan, and Canada.
• Priority date of December 15, 2017, with provisional application underpinning the patent's filing.

Competitor and Prior Art Landscape

• Prior art includes chemical compounds with structural similarities used for neurological or psychiatric disorders.
• Several patents describe molecules targeting similar pathways, such as monoamine reuptake or receptor modulation.
• The patent emerges as a pioneer in claiming a particular substitution pattern linked with improved pharmacokinetics.

Patent Expiry and Lifecycle

• Typical patent term extends to December 15, 2037, assuming no patent term extensions.
• Pending or granted patent applications in developing markets could influence subsequent generic entry.

Patentability and Challenges

• The detailed claims hinge on distinguishing the compound's unique structural features and therapeutic advantages.
• Re-examination or invalidation efforts could target prior art with similar structures or functional data suggesting obviousness.

Patent Enforcement and Litigation

• No publicly reported litigations specific to U.S. Patent 10,653,719.
• Potential for infringement suits if generic or biosimilar versions attempt to manufacture or distribute similar compounds.

What are the implications for drug development and commercialization?

• The patent fortifies market exclusivity for the innovator drug, especially in U.S. markets.
• The scope supports patent protection across multiple formulations and methods, complicating generic challenge strategies.
• The patent's claims covering both the chemical compound and methods of use provide broad protection.

Summary Table: Key Patent Aspects

Aspect	Details
Filing Date	December 15, 2017
Priority Date	December 15, 2016
Patent Expiry	December 15, 2037
Patent Family Countries	US, EPO, China, Japan, Canada
Core Invention	Novel chemical compound with specific substituents
Key Claims	Composition, methods of treatment, manufacturing processes
Therapeutic Focus	Neurological and psychiatric disorders
Patent Landscape	Overlapping patents targeting similar pathways, robust international coverage

Key Takeaways

• U.S. Patent 10,653,719 claims a novel chemical entity and its formulations for treating neurological conditions.
• The patent provides broad protection through composition, use, and manufacturing claims.
• Limited prior art directly overlaps, increasing patent robustness.
• Extended patent life supports market exclusivity until at least 2037.
• Enforcement potential is high given the broad claim scope and international filings.

FAQs

Q1: Can generic companies challenge this patent?
Yes, via litigation or patent invalidation processes if prior art suggests obviousness or lack of novelty.

Q2: Does this patent cover all formulations of the drug?
It covers specific formulations, but other formulations not explicitly claimed may not be covered.

Q3: What is the significance of the patent's chemical structure?
It differentiates the compound from prior art and supports claims of improved therapeutic properties.

Q4: Are method-of-use patents enforceable?
Yes, but enforceability depends on jurisdiction and whether the patent holder actively pursues infringement.

Q5: How does this patent compare to others in the same therapeutic area?
It extends patent coverage by combining a novel chemical structure with specific formulations and methods not claimed in earlier patents.

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References
[1] United States Patent and Trademark Office. (2022). Patent No. 10,653,719.
[2] PatentScope. (2022). Global patent family report.
[3] European Patent Office. (2022). EP application corresponding to US 10,653,719.
[4] World Intellectual Property Organization. (2022). Patent landscape reports on neurological drugs.

Drugs Protected by US Patent 10,653,719

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