March-In Impact, Advice from In-House, and More on Day Two of IPWatchdog’s Women’s IP Forum

From left: Margo Monroe; Becky Kaufman; Laura Peter; Patricia Stepp

Panelists from academia discussed the likely effects of the Biden Administration’s proposed march-in framework on tech transfer departments at universities on day two of IPWatchdog’s Women’s IP Forum, concluding that, while they’re hopeful it may not be finalized as proposed, it would be a huge step backward for university innovation.

Becky Kaufman, Associate Vice President and Senior Associate General Counsel Ohio State University, Office of Legal Affairs; Laura Peter, former Deputy Director at the U.S. Patent and Trademark Office (USPTO) and now Executive Director, Office of Research Commercialization and Partnerships, UNC Charlotte; and Patricia Stepp, Assistant Vice President of Technology Transfer at Rice University joined moderator Margo Monroe, Senior Associate at Choate, Hall & Stewart LLP to discuss the challenges they face in their respective offices with respect to commercialization of federally-funded inventions and how the march-in framework would impact their day to day.

The Biden Administration proposed expanding the scope of the march-in rights provision under the Bayh-Dole Act in December 2023. The comment period for the National Institute of Standards & Technology (NIST) and the Department of Commerce’s Request for Information (RFI) on the proposal closed in early February. Since then, it has been rumored several times that the framework would be finalized and published, but those rumors never materialized.

Under the proposed framework, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

The panelists expressed frustration that the publicly stated impetus for the proposal is chiefly to lower drug prices when it has been widely reported that a very small percentage of drugs would actually be subject to the rule. However, the disincentive for companies would apply to innovation across the board, they explained.

“Bayh-Dole applies much more broadly than drug pricing and life sciences,” said Peter. “I hope it continues to be as strong and supported as it has been in the past.” She noted that the recent Supreme Court decision in Loper Bright Enterprises v. Raimondo has changed the game with respective to agency deference, having overruled the Court’s 1984 ruling in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., and that she is therefore  more “hopeful for the survival of our respective offices.”

Kaufman agreed, noting that NIST received thousands of comments in opposition. “I think, even if the framework is finalized, NIST will take into account the many, many comments it has received – over 50,000. There has been a very strong reaction from the community. I hope the sheer volume will resonate with them and reasonable minds will prevail.”

Stepp noted that, even at her private university, more than 68% of research funding comes from federal grants, so the march-in proposal is likely to have a significant impact even outside of public institutions.

From left: Jennifer Burdman; Sarah Fashena; Erin Wills; Jennifer Kuhn

Another session on Tuesday featured four in-house counsel who shared with attendees what they love most about their roles and what keeps them up at night. While all of the panelists said they appreciate the science and their teams, they lamented practices that have developed post-COVID around platforms meant to make remote work more efficient, among other issues. “There are so many systems being used now,” said panel moderator Jennifer Burdman, Chief IP Officer at Valo Health, Inc. Even lab notebooks are now electronic, she explained, adding: “Our jobs are morphing and expanding into having to know about data and data privacy.”

Another panelist, Jennifer Kuhn, Assistant General Counsel at Tricentis, said what keeps her up at night is the changes to R&D salary deductions under the  2017 Tax Cuts & Jobs Act (TCJA), which “removed an option that previously existed under Section 174 between fully deducting many R&D expenses in the year they were incurred and amortizing them over a 60-month period,” according to an article published on IPWatchdog by John Rogitz last year. Since the law has only been in effect since 2022, the impact has yet to be fully felt, said Kuhn. “I don’t think we’ve seen the net effect on what it means for inventions in the hopper.”

Day two of the Women’s IP Forum also included panels on writing persuasive briefs at the Federal Circuit, patent trolls and efficient infringement, aligning business and IP strategies, and solutions for closing the gender gap.