Articles: 1-6 of 6
New EU Rules for Medical Devices
European Union, USA - July 12 2016 After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the…
PTO Cancer Immunotherapy Fast Track
USA - July 6 2016 In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot…
Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry
USA - January 19 2016 Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing…
What’s in a name? That which we call a biological product…
USA - August 28 2015 The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"). One of the most…
Mobile health apps are in a boom phase – why is it so hard for pharmaceutical companies to find users?
USA - November 4 2014 Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had…
Sham Hatch-Waxman infringement suits and FDA citizen petitions; a potential for new liability for innovators?
USA - August 12 2014 Under what is commonly known as "Noerr-Pennington immunity," persons exercising their First Amendment right to petition the government for redress…
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