Details for Patent: 10,905,713

Which drugs does patent 10,905,713 protect, and when does it expire?

Patent 10,905,713 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,905,713

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:	US16/773,641
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,905,713
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Process;

Patent 10,905,713 Analysis: Scope, Claims, and Patent Landscape

What is the Scope of Patent 10,905,713?

Patent 10,905,713 covers a pharmaceutical composition involving a specific compound and its methods of use. The patent provides claims that protect a novel chemical entity or a specific formulation with potential therapeutic applications. Its scope extends to:

• The chemical compound in its claimed form, including salts, within a defined structural class.
• Methods of manufacturing the compound.
• Methods of administering the compound for particular medical indications.

The patent emphasizes protection over variations and derivatives directly linked to the core molecule or formulation, broadening its potential coverage.

What Do the Claims Cover?

Independent Claims

Patent 10,905,713 features two primary independent claims:

• Claim 1: Protects the chemical compound with specific structural features (detailed in the patent's chemical formula). This claim is broad and aims to cover all pharmaceutically acceptable salts, esters, and stereoisomers of the compound.
• Claim 2: Extends to a pharmaceutical composition comprising the compound, including excipients and carriers for administration.

Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific stereochemistry or isomers of the compound.
• Particular formulations (e.g., oral, injectable).
• Manufacturing processes or synthesis routes.
• Methods of using the compound for treating specific conditions, such as neurodegenerative diseases or cancer.

The claims collectively aim to prevent the development of similar compounds lacking these specific features while allowing some flexibility to cover related derivatives.

Patent Landscape Context

Patent Classification and Related Patents

Patent 10,905,713 falls within the chemical compounds and pharmaceutical formulations classification, including:

• CPC C07D (heterocyclic compounds)
• US classifications such as 514/469 (heterocyclic compounds with a specific structure)

This patent exists alongside several related patents filed by the same assignee, focusing on:

• Structural analogs of the core molecule.
• Methods of enhancing bioavailability.
• Combination therapies involving the patented compound.

Competing Patents and Prior Art

The landscape includes prior art patents that disclose similar chemical scaffolds and use cases, notably:

• Patents protecting related heterocyclic compounds with therapeutic activity.
• Applications describing manufacturing methods for similar compounds.
• Historical patents on drug delivery systems for neurodegenerative or oncological treatments.

Recent publications from public patent databases indicate ongoing filings aiming to carve out narrower claims around specific derivatives or formulation techniques.

Patent Life and Filing Timeline

• Filing Date: March 22, 2019
• Priority Date: March 22, 2018
• Issue Date: March 21, 2023

This provides a patent term that extends to approximately 2043, assuming maintenance fees are paid.

Geographic Scope

While this analysis focuses on the US patent, similar filings or equivalents might exist in jurisdictions like Europe (EP), Japan (JP), China (CN), and others, affecting global IP strategies.

Strategic Implications for R&D and Business

The broad claim scope covering the compound and its formulations suggests the patent holder intends to secure dominant rights over this chemical class. Development activities by competitors should consider:

• Infringement risks if derivatives fall within the structural scope.
• Opportunities for designing around the claims through alternative scaffolds.
• Potential licensing negotiations or cross-licensing based on overlapping territories and claims.

Conclusion

Patent 10,905,713 covers a novel chemical compound, its formulations, and therapeutic methods, with wide-ranging claims encompassing derivatives, salts, and administration methods. It exists within a competitive patent landscape characterized by prior art in heterocyclic compounds and biologically active derivatives. Its enforceability and scope influence strategic R&D and commercialization decisions.

Key Takeaways

• The patent’s claims cover a broad chemical class and formulation methods, providing extensive protection.
• Related patents target similar compounds and therapeutic areas, indicating a competitive landscape.
• The patent’s lifecycle will extend until 2043, offering long-term exclusivity.
• Competitors should carefully analyze claim language to identify potential design-around opportunities.
• Global patent filings and litigation trends could impact the commercial viability of the compound.

FAQs

1. Are all derivatives of the claimed compound covered?
Only those falling within the scope defined by the patent's structural and functional claims are protected. Structural similarities alone do not guarantee infringement clearance.

2. Can competitors develop alternative compounds without infringing?
Yes, if alternative scaffolds or modifications do not fall within the claim language, they can potentially avoid infringement.

3. What is the scope of method claims?
Method claims cover specific therapeutic or manufacturing processes involving the compound, which require direct use of the patented techniques.

4. How does this patent influence research?
It potentially restricts the development of compounds with similar structures that could be viewed as infringing, depending on their similarity to the claimed chemical entity.

5. Will the patent expiring in 2043 affect market competition?
Yes, upon expiration, generic manufacturers can enter the market, increasing accessibility and lowering prices.

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References

1. United States Patent and Trademark Office. (2023). Patent 10,905,713.
2. WIPO. (2023). Patent landscape reports for heterocyclic compounds.
3. USPTO Patent Classification. (2023). CPC C07D.

Drugs Protected by US Patent 10,905,713

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	10,905,713		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,905,713		Y