Patent Application Strategies
The first-to-file provisions are embodied in a new version of 35 USC § 102, which sets forth new definitions of prior art and new prior art exceptions. Importantly, applicants will no longer be able to “swear behind” third-party prior art by proving an earlier date of invention.
Additionally, published U.S. and PCT applications that designate the U.S. will be citable as prior art as of any foreign priority date (rather than as of their earliest U.S. filing date). This means that there could be significantly more prior art available against a given application than there would have been under the current law. While applicants cannot do anything to prevent this change in the law, there are several steps that applicants can take to minimize the impact of the transition to a first-to-file system.
The new version of § 102 will only apply to patent applications that include a patent claim that has an effective filing date of March 16, 2013 or later. This means that applications filed up to March 15, 2013, will fall under the current, first-to-invent patent system. Biotechnology companies should discuss this date with their inventors and research and development teams, and review invention disclosures to identify inventions that may be ready for patenting by this date.
Because this date may be associated with a new patent application “bubble,” companies should work closely with patent counsel to ensure that ample time is allotted to prepare and file complete applications by March 15, 2013. Companies also should consider budgeting for more patent application filings than unusual in the time period leading up to March 15, 2013.
Continuation and divisional applications filed on or after March 16, 2013, will remain under the current first-to-invent system, as will new U.S. applications that claim priority to earlier-filed foreign or PCT applications, as long as all claims are entitled to a priority date of March 15, 2013 or earlier. This means that biotechnology companies do not need to identify or file all possible continuation or divisional applications by March 15, 2013.
Once the first-to-file version of § 102 takes effect, it may be important to segregate subject matter that has an effective filing date of March 15, 2013 or earlier from subject matter that has an effective filing date of March 16, 2013 or later. This is because presenting even a single claim that has an effective filing date of March 16, 2013 or later will bring the entire patent application under the first-to-file system.
This situation may arise with applications that straddle March 16, 2013 (e.g., applications with a priority date of March 15, 2013 or earlier and a subsequent filing date of March 16, 2013 or later with added subject matter), such as provisional/nonprovisional applications and parent/continuation-in-part (CIP) applications. Biotechnology companies may want to review provisional applications filed since March 16, 2012, to determine whether nonprovisional applications can be filed by March 15, 2013, even if the provisional year has not expired.
After March 16, 2013, biotechnology companies may want to consider filing parallel applications—one only with claims that have an effective filing date of March 15, 2013 or earlier, and one with claims that have a later effective filing date—in order to preserve the first-to-invent provisions for subject matter with an earlier effective filing date.