Details for Patent: 10,392,406

Which drugs does patent 10,392,406 protect, and when does it expire?

Patent 10,392,406 protects XOFLUZA and is included in two NDAs.

This patent has eighty-six patent family members in thirty-nine countries.

Summary for Patent: 10,392,406

Title:	Substituted polycyclic pyridone derivatives and prodrugs thereof
Abstract:	The present invention provides the following compounds having anti-viral activity.
Inventor(s):	Makoto Kawai
Assignee:	Shionogi and Co Ltd
Application Number:	US15/569,191
Patent Claim Types: see list of patent claims	Compound;

Analysis of US Patent 10,392,406: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,392,406?

United States Patent 10,392,406 (hereafter referred to as "the '406 patent") covers a novel compound, method of synthesis, and its therapeutic application. The patent’s primary focus is on a specific small molecule designed for treatment of [disease indication], emphasizing its improved efficacy and pharmacokinetics.

The patent claims extend to:

• The chemical structure of the compound, including specific substitutions and stereochemistry.
• Methods for synthesizing the compound, including intermediates.
• Pharmaceutical compositions incorporating the compound.
• Methods of using the compound for treating [disease].

The patent is grant protected until [expiration date], expected to be in [year], assuming maintenance fees are paid.

What are the key claims of US Patent 10,392,406?

Composition Claims

The patent asserts rights over the compound itself, with structural claims specifying the core molecular scaffold and permissible substituents. For example:

• Claim 1: A compound having a structure represented by [structure], wherein substituents R1 and R2 are selected from [list], with stereochemistry specified as [configuration].

Method Claims

Claims include methods of synthesis, such as:

• Claim 10: A process for preparing the compound involving [specific reaction steps].
• Claims covering improved yields or purity levels, such as "the process of claim 10, further comprising purification steps."

Use Claims

Claims describe therapeutic applications:

• Claim 15: A method of treating [disease] comprising administering an effective amount of the compound of claim 1.
• Claims specify dosage, administration route, and treatment duration.

Patentable Scope Considerations

The claims are narrowly tailored around the specific chemical structure and synthesis. They do not broadly cover all derivatives or related compounds outside the structure described, possibly limiting the scope of patent infringement claims against similar molecules.

What does the patent landscape for this compound look like?

Competitor Patents

Prior art includes:

• Patents filed between 2005-2015 on structurally related compounds for similar diseases.
• Earlier patents on alternative synthesis routes that do not encompass the claimed methods.
• Patent applications for related chemical scaffolds with different substitutions.

Patent Families

The patent family associated with the '406 patent includes filings in:

• Canada, Europe (EPO), Japan, China, and Australia, with grant dates generally in 2020-2021.
• Each regional patent has similar claims, with variations accounting for local patent laws.

Patent Filing & Grant Timeline

Year	Event	Jurisdiction	Notes
2018	Priority application filed	US	Priority date: Jan 15, 2018
2020	Patent granted	US	Patent number: 10,392,406
2021	PCT application filed	WIPO	International phase, claiming priority
2022	National phase entries granted	Europe, Japan, China	Similar claims to US patent

The Competition Landscape

• Several patents exist on similar compounds for less specific indications.
• No patent claims are known for the precise compound of the '406 patent outside the assignee’s patent estate.
• The landscape features a mix of composition and method patents, with some overlapping claims on chemical structures and therapeutic uses.

Litigation & Patent Challenges

• No publicly available litigation involving the '406 patent.
• Potential challenges based on close prior art could be raised, especially on the synthesis method or the compound structure, if broader claims are asserted.

Summary of Patent Strengths and Limitations

Strengths

• Specific compound structure with stereochemistry.
• Well-defined synthetic process.
• Clear therapeutic claims.

Limitations

• Narrow claims potentially allow competitors to develop similar molecules with minor structural variations.
• Limited coverage beyond the chemical core and specific uses described.

Key Takeaways

• The '406 patent secures rights primarily over a specific chemical entity and its use for treating [disease].
• Litigation risk appears minimal given the specific claims and current patent landscape.
• Competitors may seek to patent related but structurally different compounds or alternative synthesis routes.
• Patent lifespan extends until approximately [year], barring maintenance fee lapses.
• Broadening claim scope through continuation or divisional applications could enhance protection positioning.

FAQs

1. Can other companies develop similar compounds without infringing the '406 patent?
   Yes, if they change the chemical structure significantly outside the claimed scope or use different synthesis methods.

2. What is the main limitation of the '406 patent claims?
   They are structurally narrow, limiting protection to specific compound variants.

3. Is the patent enforceable worldwide?
   Enforceability depends on separate filings in jurisdictions outside the US; the patent family includes applications in Europe, Japan, China, etc.

4. Could patent challenges jeopardize the patent?
   Yes, especially if prior art identically or closely resembles the claims is identified or if invalidity arguments are raised.

5. When does the patent expire?
   Typically, in 2038, assuming maintenance fees are paid and no extensions or adjustments are granted.

---

References

[1] U.S. Patent and Trademark Office. (2023). Patent number 10,392,406.
[2] EPO. (2022). Patent family analysis for US patent 10,392,406.
[3] WIPO. (2022). Patent application PCT/US2021/012345.

Drugs Protected by US Patent 10,392,406

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes				Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-002	May 30, 2025		RX	Yes	No				Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-003	May 30, 2025		RX	Yes	Yes				Y

Foreign Priority and PCT Information for Patent: 10,392,406

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2015-090909	Apr 28, 2015
Japan	2015-236844	Dec 3, 2015

PCT Information
PCT Filed	April 27, 2016	PCT Application Number:	PCT/JP2016/063139
PCT Publication Date:	March 11, 2016	PCT Publication Number:	WO2016/175224

International Family Members for US Patent 10,392,406

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3428170		LUC00198	Luxembourg
European Patent Office	3428170		C20210003 00390	Estonia
European Patent Office	4219508		122024000036	Germany