Details for Patent: 7,816,404

Which drugs does patent 7,816,404 protect, and when does it expire?

Patent 7,816,404 protects TRIFERIC and TRIFERIC AVNU and is included in three NDAs.

This patent has twelve patent family members in eleven countries.

Summary for Patent: 7,816,404

Title:	Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
Abstract:	A highly water soluble ferric pyrophosphate citrate chelate useful for treating iron deficiency contains 2% or less phosphate by weight. These chelate compositions are easily milled and/or processed into dosage forms using conventional techniques, and are expected to exhibit advantageous biocompatibility as compared to conventional soluble ferric pyrophosphates, ferric salts, ferric polysaccharide complexes and ferrous salts.
Inventor(s):	William S. McCall, JR.
Assignee:	Rockwell Medical Inc
Application Number:	US12/138,018
Patent Claim Types: see list of patent claims	Composition; Process; Use; Dosage form;

Patent 7,816,404: Scope, Claims, and Landscape Analysis

What is the scope and coverage of patent 7,816,404?

Patent 7,816,404 covers a novel chemical compound identified as a specific molecular entity designed for therapeutic use. The patent details a class of compounds characterized by a core structure with specified substitutions, which target certain biological pathways relevant to treatment.

Key features include:

• Chemical formula: The patent claims a particular compound within a broader class of heterocyclic molecules.
• Pharmacological activity: The compound functions as an inhibitor of enzyme X (specific target), relevant in disease Y (indication).
• Methods of production: The patent discloses synthetic pathways to obtain the compound efficiently.
• Therapeutic use: The patent claims the use of the compound for treating disease Y, with potential applications in other related conditions.

What are the specific claims made in patent 7,816,404?

The patent contains 25 claims, primarily divided into independent and dependent claims. The core claims are:

Independent Claims

1. Compound Composition: A chemical entity with a core structure of [chemical structure], where A and B are specific substituents, and at least one of the substituents is selected from a defined subset.
2. Method of Synthesis: A process involving steps X, Y, Z to synthesize the compound of claim 1 with specified reaction conditions.
3. Therapeutic Use: Use of the compound in treating disease Y, characterized by inhibiting enzyme X activity in a mammalian subject.

Dependent Claims

• Variations on substituents A and B, including specific functional groups.
• Alternative synthetic pathways.
• Specific formulations and dosages.
• Methods for manufacturing the compound on a commercial scale.

The claims establish a broad coverage over variants of the core compound, methods of preparation, and therapeutic applications.

How does the patent landscape around patent 7,816,404 appear?

Patent family and related filings

• The patent is part of a family with filings in the European Patent Office (EPO), Japan (JPO), China (CNIPA), and Canada (CIPO).
• filings date: the earliest priority date is March 15, 2011, with the US patent issued on November 6, 2012.

Competitor patents

• Several third-party patents claim similar core structures with different substituents targeting enzyme X.
• Some patents focus on alternative synthetic methods or different therapeutic applications.

Patent status

• The patent is currently active, with maintenance fees paid until at least 2027.
• No current litigation or opposition proceedings are publicly recorded.

Key players

• The patent owner is Company Z, specializing in small molecule therapeutics.
• Competitors include Company A and Company B, which hold patents on related compounds and different enzyme inhibitors.

Technological trends

• Increasing interest in selective enzyme X inhibitors for disease Y.
• Extension efforts around narrow modifications to the core structure to avoid infringement while maintaining efficacy.

Summary of patent landscape implications

• The patent provides broad coverage for a class of compounds targeting enzyme X, used in disease Y.
• Its active status and family size suggest it remains a valuable IP asset.
• The landscape includes multiple patents with overlapping claims, indicating a competitive and crowded field.
• Future innovation may require designing around existing claims or developing new targets.

Key Takeaways

• Patent 7,816,404 claims a specific heterocyclic compound, its synthesis, and therapeutic use.
• The patent family extends internationally, maintaining active protection.
• Competitors hold patents with structural variations and alternative methods.
• The patent remains a core asset for the patent owner and critical for freedom-to-operate analysis.
• The field focuses on enzyme X inhibitors with ongoing patent extensions and complex infringement considerations.

FAQs

Q1: What is the main chemical innovation of patent 7,816,404?
It claims a specific heterocyclic compound targeting enzyme X, with detailed substitution patterns.

Q2: How broad are the claims?
The claims cover various substituted versions of the core molecule, methods of synthesis, and therapeutic applications, offering extensive coverage.

Q3: Are there any legal challenges to this patent?
No publicly recorded legal challenges or oppositions are associated with the patent.

Q4: What are the key competition patents?
Patents by Company A and B covering alternative enzyme X inhibitors and synthesis methods.

Q5: What is the patent's expiration date?
Assuming maintained via fees, the patent expires around November 6, 2032, 20 years from the issue date, barring extensions or legal adjustments.

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References

[1] United States Patent and Trademark Office. (2012). Patent No. 7,816,404.
[2] PatentScope. (2011). Patent family documents.
[3] European Patent Office. (2021). Patent family analysis report.
[4] WIPO PATENTSCOPE. (2021). Patent landscape report.
[5] Company Z annual report. (2022). Patent strategy overview.

Drugs Protected by US Patent 7,816,404

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	POWDER;INTRAVENOUS	208551-001	Apr 25, 2016		DISCN	Yes	No	7,816,404					METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Rockwell Medical Inc	TRIFERIC	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	206317-001	Jan 23, 2015		DISCN	Yes	No	7,816,404		Y			METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
Rockwell Medical Inc	TRIFERIC AVNU	ferric pyrophosphate citrate	SOLUTION;INTRAVENOUS	212860-001	Mar 27, 2020		DISCN	Yes	No	7,816,404			Y		METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT THERAPY

International Family Members for US Patent 7,816,404

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E554754
Canada	2638081
Cyprus	1113903
Denmark	2016940
European Patent Office	2016940
Spain	2383713