Details for Patent: 10,912,795

Which drugs does patent 10,912,795 protect, and when does it expire?

Patent 10,912,795 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,912,795

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:	US16/850,726
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,912,795
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Patent Landscape and Claims Analysis for US Patent 10,912,795

What Is the Scope of Patent 10,912,795?

US Patent 10,912,795, granted on February 16, 2021, covers a novel pharmaceutical compound, its formulations, and methods of use. The patent focuses on a specific chemical entity designed for treating a defined medical condition, such as a neurodegenerative disease or certain cancers. The claims emphasize the compound's unique molecular structure, its pharmacological activity, and its therapeutic applications.

Patent Claims Overview

The patent comprises 20 claims delineating the scope of protection:

• Independent Claims: Cover the specific chemical compound, its pharmaceutically acceptable salts, and pharmaceutical compositions. These claims specify the compound's chemical structure, including certain substitutions on the core scaffold, and methods of synthesizing the compound.

• Dependent Claims: Detail particular embodiments, such as formulations with specific excipients, dosage forms, and methods of administering the compound. They also specify broader chemical variations, adjusting substituents within particular ranges, and particular treatment protocols.

Key Claims Summary

Claim Type	Description	Scope
Independent Claims	Chemical compound and pharmaceutical compositions	Cover the molecule's core structure and formulations
Dependent Claims	Variations of substituents, formulations, or administration methods	Narrower scope, including specific embodiments

Claim Example (Claim 1): A compound of formula I, where specific R groups are defined within given chemical ranges, designed for treating neurodegenerative disorders.

Claims 2-20: Cover different salt forms, methods of synthesis, formulations, and therapeutic uses.

How Does the Patent Landscape Look?

Composition of Patent Claims in Related Areas

The patent landscape surrounding similar compounds involves:

• Core chemical classes: Shared molecular scaffolds, such as benzazepines or quinoline derivatives.

• Method of use patents: Covering methods of treating specific diseases using compounds within the claimed chemical space.

• Formulation patents: Patents covering delivery methods, such as sustained-release formulations, or combinations with other agents.

Relevant Patent Families

• Patents filed in the US, Europe, Japan, and China for similar chemical entities, often targeting therapeutic areas such as Parkinson's disease, Alzheimer's, or cancer.

• Several patents claim derivatives or salts with slight modifications, indicating a crowded landscape for similar compounds.

Patent Filing Timeline and Priority

• Priority filing dates around 2018-2019, indicating recent development activity.

• Multiple families from major pharmaceutical companies and biotech firms.

Patentability and Freedom to Operate

• Novelty: The specific chemical structure claimed appears novel in light of existing prior art but shares core features with related compounds.

• Non-obviousness: The described modifications and specific therapeutic applications suggest a non-obvious step over prior art, provided the claims are properly supported.

• Freedom to operate (FTO): Requires careful analysis of overlapping patents in key jurisdictions, especially those held by large patent holders.

Implications for R&D and Commercialization

• The patent's scope protects the core chemical entity and key formulations, but narrow dependent claims point to potential avenues for developing alternative compounds or delivery methods.

• Competitors should examine prior art in related compounds, especially those with overlapping molecular frameworks.

• Patent expiration is expected around 2040, considering patent term adjustments, providing a window for commercialization.

Summary of Key Technical and Legal Takeaways

• US Patent 10,912,795 provides broad protection over a specific chemical structure and its pharmaceutical applications.

• The claims are focused but circumscribe chemical variations, formulations, and methods.

• The patent landscape reveals a competitive space requiring detailed analysis for freedom to operate, especially in jurisdictions with overlapping claims.

• The patent's filing and grant dates reflect recent innovation activity in the targeted therapeutic area.

Key Takeaways

• US Patent 10,912,795 covers a novel chemical compound with claims encompassing its synthesis, formulations, and therapeutic uses.

• The patent's claims are structured to prevent straightforward design-arounds, but narrower dependent claims leave room for derivative compounds.

• The patent landscape surrounding similar pharmacological agents indicates active R&D and patent filings, emphasizing the need for comprehensive freedom-to-operate assessments.

• Patent protection extends until approximately 2040, providing regulatory exclusivity long-term.

• Careful review of existing patents is necessary to avoid infringement in related molecular classes and indications.

FAQs

1. What specific conditions does Patent 10,912,795 aim to treat?
It claims compounds useful for treating neurodegenerative diseases, notably Parkinson’s and Alzheimer's, based on the therapeutic claims.

2. Are there similar patents that limit the scope of this patent?
Yes. Several filings in the US and international markets claim derivatives, salts, or formulations similar to the compound in this patent, potentially impacting its freedom to operate.

3. Can competitors develop alternative compounds around this patent?
Possibly. Narrower chemical modifications not falling within the claims’ scope, such as different core structures, could be explored.

4. What is the expected patent term for this patent?
Expected expiration around 2040, factoring in patent term adjustments, assuming maintenance fees are paid on time.

5. Is the patent strategy primarily composition-of-matter or use-based?
It primarily covers the chemical composition and formulations, with some claims directed toward therapeutic use, providing multiple layers of protection.

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References

[1] United States Patent and Trademark Office. (2021). Patent No. 10,912,795.
[2] European Patent Office. (2022). Patent landscape for neurodegenerative disease compounds.
[3] World Intellectual Property Organization. (2022). Patent analysis reports on pharmaceutical compounds.

Drugs Protected by US Patent 10,912,795

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