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Last Updated: May 8, 2024

Claims for Patent: 9,063,151

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Summary for Patent: 9,063,151

Title:	Methods for detecting antibodies
Abstract:	The present invention relates to methods of detecting Anti-Drug Antibodies. The present invention also relates to methods of monitoring patients undergoing therapeutic antibody treatment. The invention further relates to kits suitable for the implementation of the above methods.
Inventor(s):	Parussini; Ermis (Lentilly, FR), Noguier; Guillaume (Bussy Saint George, FR)
Assignee:	THERADIAG SA (Croissy-Beaubourg, FR)
Application Number:	13/642,874
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,063,151
Patent Claims:	1. A method for immunodetecting an Anti-Drug Antibody (ADA) in a sample from a patient treated with a drug, wherein the drug is a therapeutic antibody or etanercept, said therapeutic antibody or etanercept being directed against a target antigen, the method comprising: a) verifying the presence of the target antigen in the sample; b) if present, treating the sample with acid to neutralize the target antigen in the sample, capture of said target antigen by an affinity reagent or immuno-neutralization of said target antigen; and c) immuno-detecting the presence or amount of said ADA in said sample. 2. The method of claim 1, wherein said target antigen is TNF.alpha.. 3. The method of claim 1, wherein the therapeutic antibody is an anti-TNF.alpha. antibody selected from infliximab, adalimumab, golimumab or certolizumab pegol. 4. The method of claim 1, wherein the sample is a body fluid sample, a blood serum sample or plasma sample. 5. The method according to claim 1, wherein said target antigen, when present, is neutralized by contacting said sample with antibodies that neutralize the activity of said target antigen. 6. The method according to claim 1, wherein said target antigen, when present, is neutralized by treating said sample with an acid to reduce the pH of said sample to below 4 and neutralizing said acid with a base in an amount that raises the pH of the sample to between 5 and 9. 7. The method according to claim 1, wherein said target antigen, when present, is captured by contacting said sample with an affinity reagent comprising a binding reagent specific for said target antigen. 8. The method according to claim 1, wherein said patient is treated with etanercept and said target antigen is TNF.alpha.. 9. The method of claim 1, wherein said target antigen is TNF.alpha. and said therapeutic antibody is infliximab, adalimumab, golimumab or certolizumab pegol.

Details for Patent 9,063,151

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998	⤷ Try a Trial	2030-04-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998	⤷ Try a Trial	2030-04-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999	⤷ Try a Trial	2030-04-29
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004	⤷ Try a Trial	2030-04-29
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007	⤷ Try a Trial	2030-04-29
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017	⤷ Try a Trial	2030-04-29
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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