Selection of Activity by the Federal Circuit in the Lead Compound Analysis

By: Gary L. Juskowiak II, Ph.D.

ABA Landslide Magazine: Volume 13 Issue 3

Click here to view the full article from the publication.

In the high-stakes field of abbreviated new drug application (ANDA) litigation, and the patentability of chemical compounds in general, a court uses the lead compound analysis to determine whether claims directed to chemical compounds are obvious. In ANDA litigation, a challenger will often make a paragraph IV certification under the Hatch-Waxman Act to certify that the patent at issue “is invalid or will not be infringed by the manufacture, use, or sale of the new drug” covered by the ANDA. Accordingly, the challenger commonly attacks the validity of the patent, which may turn on the obviousness of a claimed compound that is a blockbuster drug. The stakes for the outcome of the lead compound analysis are high because patentees may lose billions of dollars in revenue from the loss of patent protection for a blockbuster drug.

The lead compound analysis uses the activity of prior art compounds as possible motivation to select and modify these prior art compounds in order to ascertain the obviousness of a claimed compound. Importantly, in applying this analysis, the Federal Circuit Court of Appeals has focused on the activities disclosed for the claimed compounds as opposed to other activities disclosed in the prior art. Patentees and challengers should take into consideration this tendency of the Federal Circuit in applying the lead compound analysis.

Click here to continue reading the full article.


 

 

 

 

 

 

 

 

 


 



About the Author

Gary Lee Juskowiak II is an associate at Hamilton, Brook, Smith & Reynolds, P.C., where he focuses his practice on pharmaceutical, chemical, and biotechnology patent prosecution and counseling. He can be contacted at Gary.Juskowiak@hbsr.com.

 

 

©2021. Published in Landslide, Vol. 13, No. 3, January/February 2021, by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association or the copyright holder.

Overview

By: Gary L. Juskowiak II, Ph.D.

ABA Landslide Magazine: Volume 13 Issue 3

Click here to view the full article from the publication.

In the high-stakes field of abbreviated new drug application (ANDA) litigation, and the patentability of chemical compounds in general, a court uses the lead compound analysis to determine whether claims directed to chemical compounds are obvious. In ANDA litigation, a challenger will often make a paragraph IV certification under the Hatch-Waxman Act to certify that the patent at issue “is invalid or will not be infringed by the manufacture, use, or sale of the new drug” covered by the ANDA. Accordingly, the challenger commonly attacks the validity of the patent, which may turn on the obviousness of a claimed compound that is a blockbuster drug. The stakes for the outcome of the lead compound analysis are high because patentees may lose billions of dollars in revenue from the loss of patent protection for a blockbuster drug.

The lead compound analysis uses the activity of prior art compounds as possible motivation to select and modify these prior art compounds in order to ascertain the obviousness of a claimed compound. Importantly, in applying this analysis, the Federal Circuit Court of Appeals has focused on the activities disclosed for the claimed compounds as opposed to other activities disclosed in the prior art. Patentees and challengers should take into consideration this tendency of the Federal Circuit in applying the lead compound analysis.

Click here to continue reading the full article.


 

 

 

 

 

 

 

 

 


 



About the Author

Gary Lee Juskowiak II is an associate at Hamilton, Brook, Smith & Reynolds, P.C., where he focuses his practice on pharmaceutical, chemical, and biotechnology patent prosecution and counseling. He can be contacted at Gary.Juskowiak@hbsr.com.

 

 

©2021. Published in Landslide, Vol. 13, No. 3, January/February 2021, by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association or the copyright holder.

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