On June 4, 2018, Director Andrei Iancu discussed his goals for improving the U.S. patent system at the BIO International Convention taking place in Boston. Director Iancu was sworn in on February 8, 2018 as the new director of the USPTO. Director Iancu spoke very thoughtfully on his vision for bringing clarity to Section 101, modifying the amendment process during an inter partes review (IPR), and celebrating the achievements of the U.S. patent system.
First on his agenda as he begins his new role as Director of the USPTO is to clarify and simplify the requirements for patentable subject matter under 35 U.S.C. § 101 (Section 101) so that inventors, investors, and patent attorneys alike understand which inventions qualify for patent protection. Director Iancu lamented that innovators are discouraged from applying for a patent because they are uncertain as to whether they, first, will be able to obtain a patent, and second, whether that patent will withstand post-grant challenges. According to Director Iancu, such uncertainty is not good for the economy or the system.
Since Section 101 has changed very little since the beginning of the U.S. Patent System in 1793 while technology has changed greatly, Director Iancu views this problem as an opportunity to update the laws to reflect the current state of innovation. He believes that changes to Section 101 should be technology and industry neutral rather than being tailored to any one specific area. In other words, Director Iancu believes that guidance from the USPTO needs to apply to biotech just as it needs to apply to computers. Initial guidance from the USPTO addressing Step 2 in Alice/Mayo is already available and Director Iancu promises that additional guidance on Section 101 will be forthcoming. Initial guidance addressing Step 2 in Alice/Mayo is already available and Director Iancu promises that more will come in the upcoming months. Moreover, Director Iancu cautions that any further changes must operate within the framework set forth by the courts, including U.S. Supreme Court decisions. Given the lack of certainty surrounding the requirements of Section 101, any clarification and simplification of those requirements would certainly be welcomed by many in the industry.
Second, Director Iancu wants to focus on modifying the IPR amendment process during an IPR such that patent holders are provided the opportunity to amend their patents rather than losing their patents entirely. Director Iancu does not want the IPR process to be “all or nothing.” Rather he wants both parties to work together, within the 12 to 18 month timeframe allotted by the IPR process, to come up with patent claims that could be workable in view of the findings of the IPR. The amended patent claims, according to Director Iancu, would then be examined by the PTO. The obvious benefit of having such an amendment process would be that patent holders would be given the opportunity to save their patents, and thus their investments, from loss.
Finally, as we near the ten millionth issued patent, Director Iancu wants to focus on the brilliance of inventors and the patent system rather than focusing on its shortcomings. He believes that focusing on the negatives of the patent system undermines the overall patent system and everything it is trying to achieve. Instead, Director Iancu wants to work within the scope provided by the courts to improve the system so that the next generation has role models to aspire to.
Overall, I was inspired by Director Iancu’s goals for his tenure. I look forward to seeing how his visions translate into specific actions in the upcoming months.
BioPharma Law Blog posts updates and analyses on IP topics, FDA regulatory issues, emerging legal developments, and other news in the constantly evolving world of biotech, pharma, and medical devices.