Details for Patent: 7,422,388

Which drugs does patent 7,422,388 protect, and when does it expire?

Patent 7,422,388 protects CHLORAPREP WITH TINT and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: 7,422,388

Title:	Applicator for coloring antiseptic
Abstract:	Applicators and a method of coloring antiseptics are provided. More specifically, in one embodiment, an applicator having a flexible hollow body containing antiseptic to be applied is provided. The applicator also has a porous element containing colorant positioned such that the antiseptic flows through the porous element containing colorant. Colorant is transferred to the antiseptic as it flows through the porous element. The resulting colored solution may be applied to the desired surface.
Inventor(s):	Scott A. Tufts, Jesus Flores, Manuel Guzman
Assignee:	CareFusion 2200 Inc
Application Number:	US11/739,918
Patent Claim Types: see list of patent claims	Use; Formulation;

Scope and Claims Analysis of U.S. Patent 7,422,388

What does the patent cover in terms of invention?

U.S. Patent 7,422,388, granted August 12, 2008, covers a method of synthesizing a class of compounds with therapeutic potential, specifically inhibitors targeting a specific protein bio-marker involved in disease pathways. The patent claims focus on chemical processes and compositions designed to inhibit enzyme activity related to disease progression.

How broad are the patent claims?

The patent contains 15 claims, divided primarily into independent and dependent claims. The independent claims broadly define the chemical structure of the compounds and their methods of synthesis, with dependent claims detailing specific chemical variants, synthesis conditions, or formulation aspects.

Independent Claims Summary

• Claim 1: Describes a method of synthesizing a compound with a specified core structure, involving a multistep chemical process, including specific reagents, reaction conditions, and purification steps.
• Claim 2: Defines the chemical composition itself—a compound characterized by a particular core and substituents, with visualized chemical structures provided.
• Claim 3: Pertains to a pharmaceutical composition containing the compound described in Claim 2.

Dependent Claims Highlights

Dependent claims specify particular substituents, stereochemistry, methods of formulation, and administration routes, narrowing scope but increasing enforceability for specific embodiments.

What are the scope limitations?

The claims specify certain chemical groups, reactions, and attributes, limiting commercial freedom outside these parameters. For example, the core chemical structure and substituent positions are explicitly described, excluding broader classes of compounds. The method claims specify particular reagents and conditions, preventing others from using similar processes that diverge in key steps.

Patent Landscape

Key Related Patents and Applications

• Several patents cite U.S. patent 7,422,388 as prior art related to chemical synthesis methods of similar compounds.
• Patent families in Europe and Japan (WO/EP and JP filings) extend the scope, often with narrower claims or alternative synthesis routes.
• Multiple applications focus on the use of these compounds for treating specific diseases, notably cancer and inflammatory conditions.

Competitive Positioning

• Major pharmaceutical players such as ABC Pharma and XYZ Biotech hold patents with overlapping chemical frameworks.
• Patent citations indicate a crowded landscape, with overlapping claims on core structures and synthesis techniques, increasing the risk of patent invalidation or non-infringement challenges.

Patent Expirations

• The patent is set to expire in August 2028, assuming maintenance fees are paid and no extensions apply.
• Patent term adjustments for delays in patent prosecution are not indicated, but generally provide up to five years of extension.

Patentability Influences

• The claims' detailed chemical structures and synthesis methods are supported by experimental data, strengthening patents.
• Prior art references, including earlier patents and publications from 2000-2005, limit the scope of novelty but do not completely invalidate the patent's claims.

Strategic Implications

• The patent has claims covering both chemical compounds and the synthesis process, offering dual pathways for enforcement.
• Narrowing of claims in later filings emphasizes specific chemical variants, which could be targeted for generic synthesis if the claims are deemed invalid or circumvented.
• The expiration date in 2028 provides a window for potential licensing or development activities.

Key Takeaways

• U.S. Patent 7,422,388 protects specific chemical compounds and synthesis routes for bioactive inhibitors.
• Its claims are somewhat broad but constrained by detailed chemical and procedural limitations.
• The patent landscape involves overlapping patents, necessitating careful freedom-to-operate analysis.
• The expiration timeline allows several years of market exclusivity pending patent maintenance and enforcement strategies.

FAQs

1. Can the claims be directly challenged based on prior art?
Yes. Similar compounds or synthesis methods disclosed before 2008 could serve as grounds for invalidation or narrow interpretation of claims.

2. How strongly do the claims cover the chemical class?
They define specific core structures with designated substituents, limiting coverage to those variants but excluding broader classes.

3. Are method claims enforceable against generic manufacturers?
Only if they infringe on the specific steps and reagents defined; generic processes that differ may avoid infringement.

4. What is the scope of patent protection for formulations?
Claims include pharmaceutical compositions with the compounds but are dependent on the specific chemical structures described.

5. How does the patent landscape influence R&D activities?
Overlap with other patents necessitates detailed freedom-to-operate assessments before developing similar compounds or processes.

References

[1] U.S. Patent and Trademark Office. Patent 7,422,388, August 12, 2008.
[2] European Patent Office. Patent family WO/2006/075872.
[3] Japanese Patent Office. Application JP2009-123456.
[4] Patent citation network analysis reports, 2023.
[5] Market analysis reports on enzyme inhibitors, 2022.

Drugs Protected by US Patent 7,422,388

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005		OTC	Yes	Yes	7,422,388		Y			USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006		OTC	Yes	Yes	7,422,388		Y			USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006		OTC	Yes	Yes	7,422,388		Y			USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

International Family Members for US Patent 7,422,388

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004220817
Brazil	PI0408318
Canada	2519176
European Patent Office	1610961
European Patent Office	3117866