Revisions to the US patent law that could have a major impact on medical device industry participants took effect Saturday, March 16.
In a nutshell, the so-called “first-to-file” changes will mean that first inventors’ rights will no longer have patent protection under US law. Instead, protection will be granted to the first company that files a patent application for a particular medical device.
The US Patent and Trademark Office is enacting these changes to harmonize its patent process with those of the European Patent Office and other foreign counterparts. Medical device and technology developers accustomed to the “first-to-invent” system will need to adjust their US FDA registration strategies accordingly—they’ll need to file their patent applications much sooner in their product development process lest competitors with similar devices file ahead of them.