FDA Reduction in Force Actions April 1, 2025 -Significant damage to Agency, Industry and Consumer

As a former Associate Chief Counsel for FDA it was stunning to see the RIFs carried out today were arbitrary and in complete disregard for the wealth of scientific knowledge that will be forever lost.  The way in which employees were dismissed was insulting as there badges inactived and then public servants corralled into a … Read more

Steven A. Johnson, JD authors article in FDLI Top Cases in 2023/2024

This published article was shared with permission of FDLI. United States v. Stoll Steven A. Johnson* Why It Made the List In what is becoming more common, the U.S. Food and Drug Administration (FDA) successfully brought a criminal prosecution through the Department of Justice (DOJ) against a lower-level company individual instead of a responsible company … Read more

Successful Use of Inter Partes Review to Cancel Claims Asserted in Parallel Litigation

In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit. The decisions illustrate … Read more

Court Offers Insights On When the 271(e)(1) Safe Harbor Applies to the Use of Patented

In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit. The decisions illustrate … Read more

Challenges of bringing mHealth products to the market are highlighted in Duane

In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit. The decisions illustrate … Read more