Dipl.-Biol. Siegfried J.W. Ruppert
U.S. Rechtsanwalt | U.S. Patentanwalt
Juristische Publikationen
Als Autor und Co-Autor mit seinen Anwaltskollegen in den U.S.A hat Dr. Ruppert die unten aufgeführten juristische Arbeiten zu den Themen Biosimilars und Patentierbarkeit von biologischen Molekülen und diagnostischen Methoden publiziert:
- Co-Autor, “The USPTO Issues Its “Myriad” Guidance – a.k.a. What is “Enough”,” Duane Morris Alert, 04. März 2014, Republished Mondaq, 05. März 2014.
- Co-Autor, “Virginia Enacts The First State Law Regulating Interchangeable Biosimilar Products,” Duane Morris Alert, 28. März 2013.
- Co-Autor, “Path for Generics Open in Biotech,” The Recorder, 5. März 2012; Republished Mondaq, 15. März 2012
- Co-Autor, “FDA’s Draft Guidance on ‘Biosimilar’ Pathway Leaves Key Questions on Specific Clinical Data Requirements and Interchangeability Unanswered,” GenericsWeb Newsletter InnSight, Februar 2012.
- Co-Autor, “FDA Issues Draft Guidance Documents to Implement the Biologics Price Competition and Innovation Act of 2009,” Duane Morris Alert, 13. Februar 2012.
- Autor, “FDA Sends Prescription Drug User Fee Act V to Congress for Reauthorization,” Duane Morris Alert, 23. Januar 2012.
- Co-Autor, “Forecasting Forthcoming ‘Biosimilar’ Drug Regulations,” The Recorder, 30. August 2011.
- Autor, “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
- Autor, “Biosimilars – Faster Development and Approval?,” GenericsWeb newsletter InnSight, März 2011, Republished Mondaq, 26. April 2011.