It Is Our Duty to Protect the Patent System. Here’s How We Can.April 20, 2022

This article was first published in AUTM Insight.

As an attorney in private practice, time is money – quite literally. The billable hour looms over every business day. With that in mind, people often ask me why I choose to volunteer my time and serve for organizations such as AUTM, the Plant Variety Protection (PVP) Advisory Board, or my recent appointment to the Public Patent Advisory Committee.

It started about 15 years ago, at an Intellectual Property CLE. Former Federal Circuit Chief Judge Randall Radar gave the keynote. He opened his comments with a provocative statement: “We are the first generation of patent practitioners that is in danger of leaving our United States patent system weaker than the one we inherited.”

As time has progressed, I have come to agree. The America Invents Act (AIA), U.S. Supreme Court decisions like Myriad, Prometheus, Ebay, and other unfortunate precedential decisions have had unintended, and devastating, consequences on innovation in this country and particularly on the biotechnology industry.

Equally provocative is the Congressional testimony of former Chief Federal Circuit Judge-turned advocate, Judge Paul Michel. In his testimony before Congress in 2019, he said according to his research:

• Patent value has decreased by 60%
• VC investment has flowed away from science to entertainment and hospitality, and away from the United States to other countries
• Our patent system has dropped from its customary first place in the annual Chamber of Commerce global ranking to an embarrassing 10^th, tied with Hungary.

The United States has devolved from an international thought leader in Intellectual Property to an outlier. The biotech industry has suffered under the AIA, with 70% of patents that enter post grant review emerging with not a single claim surviving.

As a member of the AUTM Board of Directors and liaison to the Public Policy Advisory Committee and the Legal Policy Task Force Committee, I have joined the fight for patent reform. AUTM has a seat at the table with the policy makers and leaders of the country in shaping IP policy.

A summary of some of our more notable actions, which will most certainly be incomplete, follows. We have joined with BIO and others in signing amicus briefs to the United States Supreme Court and Federal Circuit. A personal highlight for me was the opportunity to meet with the Biden Harris transition team discussing objectives for the administration to consider in selecting the next USPTO commissioner of patents. We have authored a letter to the Department of Justice, NIST, and the USPTO opposing licensing restrictions and limitation to injunctive relief for patents deemed Standard Essential Patents. We participated in a call with the Director of Government affairs of Agriculture and International Development on the impact of the DOE declaration for “invent it here make it here” policy which would constrain the ability to license, and its impact on agriculture in the US. We commented on Senator Warrens request of the department of Health and Human Services to exercise march-in in rights for the pancreatic cancer drug Xandti. Finally, we are actively promoting the United States Innovation and Competition Act of 2021. The Act has passed the Senate with critical section 2019 intact. This section creates regional technology transfer centers and would, if funded, infuse billions of dollars into technology transfer. The House versions do not include this provision and we must advocate as the different versions go to reconciliation in committee.

There is much to be done and under the tireless leadership of Steve Susalka, Ian McClure, Mike Waring, and Jeff Depp, to name a few. AUTM is not just a professional association, but a vehicle and platform for change.

I am proud to have worked on these many objectives with AUTM in my role as a Member of its Board of Directors, and I will close with a call to action: work with your institution’s federal relations contacts to get in touch with your congressional representatives, get involved with the many AUTM committees that are creating change, lend your time or success stories to the Bayh-Dole coalition founded by AUTM alum Joe Allen. Find your way to make a difference, as “the care and keeping of our patent system is incumbent upon us all who have benefited so richly from it.”

Heidi S. Nebel is Managing Partner and Chair of the Chemical and Biotechnology Practice Group at McKee, Voorhees & Sease, PLC. She is also a member of the AUTM Board of Directors. For additional information please visit www.ipmvs.com.