With the final implementation of the “first-inventor-to-file” provision of the Leahy-Smith America Invents Act (AIA) ratified on March 16, 2013, the United States Patent and Trademark Office (USPTO) has taken a major step towards revising the U.S. patent process and law to allow for greater consistency in the prosecution and enforcement of US-based patents in respect to much of the foreign patent procedures overseas.
The foremost modification under the new provision is the change from a “first to invent” system to a “first to file” system. In effect, first inventors’ rights will no longer have patent protection under U.S. law, but instead, protection will be granted to the first company that files a patent application. Therefore under the new system, the first inventor to file a patent application will normally prevail in obtaining a patent over a second inventor who filed later in time, regardless of which inventor was first to invent.
Another implication of the new system under AIA is that the first-to-file rules expand the amount of foreign prior art that is available to a patent examiner to reject a patent application. That is, sales outside of the U.S., as well as any prior public use, may be considered prior art under the new law, whereas these would not have been considered prior art previously. Moreover, published applications (both international and U.S.) will be considered prior art dated as of their earliest filing date, even if such filing date is a foreign application.
However, the AIA first-to-file system does differ from other first-to-file systems abroad as it permits a one-year grace period to ensure that the patentability of an invention is not defeated by the inventor’s own disclosures, disclosures of information obtained from the inventor, or third party disclosures of the same information as the inventor’s previous public disclosures. With the grace period stipulation, an inventor can publicly disclose their invention through mediums such as in a blog post, and still file a patent application within one year of that public disclosure and not lose the rights to that patent to a competitor. Thus, some consider the new structure to really be a “first-to-disclose” system.
Nonetheless, USPTO believes this migration to a first-inventor-to-file system will bring greater transparency, objectivity, predictability, and simplicity to patentability determinations and harmonizes U.S. patent law more closely with that of other industrialized countries.
With the new regulations already in place, medical device companies accustomed to the “first-to-invent” system will need to adjust their strategies accordingly by filing patent applications or disclosing novel technology sooner in their product development processes as competitors with similar devices could do so before them.