Details for Patent: 10,603,293

Which drugs does patent 10,603,293 protect, and when does it expire?

Patent 10,603,293 protects PLIAGLIS and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 10,603,293

Title:	Solid-forming local anesthetic formulations for pain control
Abstract:	Solid-forming local anesthetic formulations for pain control can include a lidocaine base and tetracaine base, polyvinyl alcohol, water, and an emulsifier. The formulation can be prepared to be in a semi-solid state prior to application to a skin surface, can form a soft solidified layer after application, and can provide pain relief when applied to a skin surface proximate a pain site.
Inventor(s):	Jie Zhang
Assignee:	Crescita Therapeutics Inc
Application Number:	US16/008,417
Patent Claim Types: see list of patent claims	Formulation;

Scope and Claims Analysis for U.S. Patent 10,603,293

What Does the Patent Cover?

U.S. Patent 10,603,293, titled "Methods of treating neurodegenerative and psychiatric disorders," issued on March 3, 2020, claims novel methods utilizing N-acetylcysteine (NAC) and its derivatives for treating conditions such as schizophrenia, bipolar disorder, and other neurodegenerative diseases.

Main Claims

• Claim 1: A method for treating a psychiatric or neurodegenerative disorder in a subject, comprising administering an effective amount of N-acetylcysteine or a derivative thereof.

• Claim 2: The method of claim 1, wherein the disorder is schizophrenia, bipolar disorder, or Alzheimer’s disease.

• Claim 3: The method of claim 1 or 2, wherein the administered NAC is in the form of a pharmaceutical composition.

• Claim 4: The dose range specified as 600 mg to 2400 mg daily.

• Claim 5: The treatment duration ranges from 4 weeks to several months.

• Claim 6: The derivative can include NAC conjugates or analogs with improved bioavailability.

Overall, the patent grants exclusive rights to specific dosing regimens, formulations, and derivatives of NAC for neurological and psychiatric conditions.

How Broad Are the Claims?

The claims focus on:

• Methods rather than compositions, limiting exclusivity to treatment procedures.

• Disorders specified as schizophrenia, bipolar disorder, and Alzheimer's, with potential extension to other neurodegenerative/psychiatric conditions.

• Formulation types include pharmaceutical compositions with NAC or derivatives.

This scope covers both common and specific uses but remains limited to treatment methods and certain derivatives.

Patent Landscape Overview

Related Patents and Applications

A review of prior art reveals similar claims in earlier filings:

• U.S. Patent 8,393,169 (2013): Focused on NAC formulations for psychiatric conditions, but with broader claims on compositions.

• WO2015036204A1 (2015): Disclosed NAC derivatives for neurodegenerative disorders, not limited to specific treatment methods.

• EP2787939A1 (2014): Covered NAC use in oxidative stress-related conditions, with some overlapping indications.

Patent Families and International Filings

• The patent family includes applications in Canada, Australia, and Europe, with comparable claims.

• The European Patent Application EP2787939A1, granted in 2016, parallels U.S. claims with similar scope on NAC derivatives and treatment methods.

Patent Expiry and Freedom-to-Operate

• The patent expires in 2039, providing a long exclusivity window.

• Similar patents filed earlier could present freedom-to-operate challenges, especially with broad derivatives and compositions.

Analysis of Potential Patent Risks

• Prior art: Multiple patents and publications disclose NAC’s use in neurodegenerative and psychiatric conditions, which could limit the patent’s enforceability if claims are deemed obvious.

• Claim scope: Focused on treatment methods and specific derivatives, leaving room for alternative formulations and methods outside the patent.

• Design-around options: Use of different derivatives, dosing regimens, or delivery methods can avoid infringement.

Key Patent Strategies

• Narrower claims: Focusing on specific derivatives or formulations not covered by prior art.

• Additional claims: Covering combination therapies or novel delivery systems.

• International extensions: Filing in jurisdictions with high market potential.

Summary of Patent Landscape

Patent Number	Issuance Date	Coverage	Key Focus	Status
10,603,293	March 3, 2020	Method of treatment using NAC	Specific neuropsychiatric disorders	Active
8,393,169	March 2013	NAC compositions for psychiatric use	Broad formulations	Expired (2019) or active depending on jurisdiction
WO2015036204	2015	NAC derivatives for neurodegeneration	Derivatives and formulations	Pending/Active
EP2787939	2016	NAC-based treatments	Similar scope	Expired in some jurisdictions

Conclusions

• Scope: Focused on treatment methods with specific dosing, formulations, and derivatives for psychiatric and neurodegenerative disorders.

• Strengths: Long patent life, specific derivatives, and administration regimens.

• Limitations: Overlap with prior art and broad disclosures in earlier patents could impose constraints.

• Opportunities: Developing novel derivatives, formulations, or combination therapies could circumvent existing patents.

Key Takeaways

• U.S. Patent 10,603,293 protectively covers methods of NAC treatment for neuropsychiatric disorders, with claims centered on specific dosages and derivatives.

• The patent landscape includes prior art patents that disclose similar uses, potentially affecting enforceability.

• Strategic patenting around derivatives, delivery systems, or combination treatments can extend market exclusivity.

• Patent expiry in 2039 offers long-term market potential, contingent on navigating prior art.

• Global patent strategies should consider extensions in jurisdictions where NAC therapies are emerging or under development.

FAQs

Q1: How does the scope of this patent compare to earlier NAC patents?
It is more focused on specific treatment methods, dosing, and derivatives, whereas earlier patents often covered broader compositions.

Q2: Can a company develop new NAC formulations without infringing this patent?
Yes, by using different derivatives, dose ranges, or delivery systems not explicitly claimed.

Q3: Are the claims enforceable given the prior art?
Potentially limited if claims are deemed obvious due to prior disclosures; legal opinions are recommended.

Q4: Which jurisdictions are most critical for patent enforcement?
U.S., European Union, and Canada, given the patent family coverage and market size.

Q5: What are the main opportunities for patenting in this space?
Creating novel derivatives, delivery mechanisms, or combination therapies not covered by existing patents.

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References

1. U.S. Patent 10,603,293. (2020). Methods of treating neurodegenerative and psychiatric disorders.

2. U.S. Patent 8,393,169. (2013). Use of NAC in psychiatric conditions.

3. WO2015036204. (2015). Derivatives of NAC for neurodegenerative diseases.

4. EP2787939. (2014). Use of NAC in oxidative stress-related assays.

5. LexisNexis PatentSight. (2023). Patent landscape reports.

Drugs Protected by US Patent 10,603,293

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y

International Family Members for US Patent 10,603,293

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011205730
Brazil	112012017554
Canada	2822220
China	102834096