First-Inventor-to-File on the Horizon Among the most notable patent reforms under the AIA is the ch

First-Inventor-to-File on the Horizon
Among the most notable patent reforms under the AIA is the change from a first-to-invent to a first-inventor-to-file system. The switch to the first-inventor-to-file system takes effect on March 16, 2013, 18 months after the enactment of the AIA. Under the new standard, a patent will be granted to inventors who first filed a patent application with the USPTO, whereas the current patent system grants patents to the first inventor, regardless of which inventor filed a patent application first.

First-inventor-to-file introduces several benefits to the patent system and, in turn, to medtech companies. First, it harmonizes the U.S. patent system with the patent systems of most other countries that also use first-inventor-to-file rule. This synchronization simplifies the patent process and reduces confusion over foreign filing practices. Second, a first-inventor-to-file system provides clear standards for dispute resolution regarding questions of entitlement to a patent. Third, the new system encourages inventors and companies to file their patent applications quickly rather than rely on the ability to antedate prior art. This emphasis on a faster filing timeline may benefit medtech companies because of the rapidly evolving and short life spans of much of the medtech industry’s technology and products.
Despite these benefits, the first-inventor-to-file system carries several drawbacks, particularly for small and early stage medtech companies. The most visible result of the new system is the need to race to the USPTO to stake priority claims before competitors, a process that favors large, well-established companies with resources to file patent applications quickly and often. The pressure that the first-inventor-to-file system places on inventors to quickly file applications may potentially result in weaker, less-detailed patent applications that may be filed before the technology is fully understood. To counter this, medtech companies should file patent applications that not only cover their core technology, but also future improvements and alternative embodiments. This will make it more challenging for competitors to obtain designs around patents. Another prudent practice for medtech companies is to file multiple provisional applications as their technology evolves and combine them into a single non-provisional application at the one-year anniversary from the filing date of the first provisional application, which should secure the earliest possible priority date for all subject matter in the non-provisional application.

The AIA also created a new post-grant review proceeding for issued patents to be conducted before the Patent Trial and Appeal Board. Post-grant review permits reevaluation of a patent within nine months after the patent issues to determine if any of the patent claims should be cancelled as being unpatentable. The post-grant review provisions of the AIA take effect on Sept. 16, one year after the date of enactment, but generally apply to patents issuing from applications subject to first-inventor-to-file provisions of the AIA, which are effective on March 13, 2013. Thus, medtech companies need to adopt proactive patent strategies that account for post-grant review and the switch to a first-inventor-to-file system.

The most recent AIA reform this summer is the new option for a third party to submit prior art in pending patent applications. On July 17 the USPTO announced final rules, effective as of Sept. 16, that will regulate this new process. Third-party prior art submissions must include a concise description of relevance and will be subject to a fee depending on the number of references submitted.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters