U.S. Attorney | U.S. Patent Attorney

Legal Publications

As author and co-author with his U.S. attorney colleagues, on the topics of biosimilars and patentability of biological molecules and diagnostic methods, Dr. Ruppert has published the legal papers listed below:

• Co-Author, “The USPTO Issues Its “Myriad” Guidance – a.k.a. What is “Enough”,” Duane Morris Alert, March 04, 2014, Republished Mondaq, March 05, 2014.
• Co-Author, “Virginia Enacts The First State Law Regulating Interchangeable Biosimilar Products,” Duane Morris Alert, March 28, 2013.
• Co-Author, “Path for Generics Open in Biotech,” The Recorder, March 05, 2012; Republished Mondaq, March 15, 2012
• Co-Author, “FDA’s Draft Guidance on ‘Biosimilar’ Pathway Leaves Key Questions on Specific Clinical Data Requirements and Interchangeability Unanswered,” GenericsWeb Newsletter InnSight, February 2012
• Co-Author, “FDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009,” Duane Morris Alert, February 13, 2012.
• Author, “FDA Sends Prescription Drug User Fee Act V to Congress for Reauthorization,” Duane Morris Alert, January 23, 2012.
• Co-Author, “Forecasting Forthcoming ‘Biosimilar’ Drug Regulations,” The Recorder, 30. August 2011.
• Author, “A Look Ahead: FDA’s Approach to Biosimilars – Totality of the Evidence and Risk-Based,” GenericsWeb newsletter InnSight, August 2011, Republished Mondaq, 08. September 2011
• Author, “Biosimilars – Faster Development and Approval?,” GenericsWeb newsletter InnSight, März 2011, Republished Mondaq, 26. April 2011.