Topic: Medicine

New 2.3% Medical Device Excise Tax Goes into Effect January 1, 2013

Earlier this month, the Department of the Treasury and the Internal Revenue Service issued final rules for the new 2.3% excise tax that will be imposed on medical devices as of January 1, 2013 pursuant to the Patient Protection and Affordable Care Act. For manufacturers, producers, and importers of medical devices, here’s a brief Q&A… Read more »

DNA Eligible for Patent Protection, Court Rules in Myriad (Again)

“Isolated DNA molecules are patent-eligible, reaffirmed the U.S. Court of Appeals for the Federal Circuit in Ass’n for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., lifting a cloud of uncertainty over DNA composition patents. ‘The isolated DNA molecules before us are not found in nature. They are obtained in laboratory and are… Read more »

FDA Proposes Social Media Guidance on Off-Label Drug Use

It’s estimated that one in five prescriptions treat ailments other than those for which the drug was originally intended. Off-label use of pharmaceuticals and medical devices, as this practice is called, is big business. But for manufacturers seeking to inform the public about the benefits and dangers of using medications off-label, it’s also risky business: while… Read more »