It Is Our Duty to Protect the Patent System. Here’s How We Can.
Heidi Nebel
Managing Member
Chair Chemical And Biotechnology Practice Group
McKee, Voorhees & Sease

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 10th, 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, includes:

  • 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 to discuss 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 Warren's 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.”
 


Behind the Curtain: What an Industry Scout Does After You’ve Shared an Opportunity
By Tari Suprapto, AUTM Board Director
Director, Search & Evaluation (Western US and Canada)
Novo Nordisk

AUTM organizes several annual events for those in academic technology/knowledge transfer to interact with representatives from industry, including those charged with seeking opportunities for collaboration and in-licensing. Often referred to as technology scouts, they usually are part of a company’s business development function pertaining to research and early development (preclinical, ideation, prototype/proof of concept). AUTM events, such as Connect & Collaborate, Partnering Forums, and the bilateral meetings through AUTM Connect during the Annual Meeting and Region Meetings, are useful for introductions to start a new relationship or to get updates on pre-existing relationships.

The typical follow-up from these events involves the company sharing its wish list and the tech transfer office (TTO) sharing its potential matches. It’s an iterative process and takes time to understand what’s desired by the company and identify the strengths and promising assets from an academic institution’s research and researcher portfolio.

A general summary of the process:

  1. The company clearly communicates what it’s after.
  2. The TTO conducts a targeted search of its portfolio.
  3. The TTO shares the results of that search in a non-confidential, yet meaningful, way.
  4. The company provides informative, constructive and definitive feedback on the search results.

While it may seem logical, moving from search results to feedback is not always straightforward and can take a considerable amount of time, often to the frustration of the TTO.

So, why is that?

Most scouts review hundreds of opportunities a year from multiple academic institutions and other companies, so it’s important to focus on quality over quantity to cut through the noise. While a one-page summary is a great starting point, the content should communicate the opportunity clearly and answer the following questions:

  1. Does the innovation work?  What supporting data do you have?  
  2. How is it better than everything else publicly known or available?
  3. Can the proposed product/service be made/provided to create a feasible business proposition?
  4. And in the case of biomedical innovations, especially therapeutics or devices, is it safe?
Creating a slide deck that provides data to support these questions can be extremely helpful. TTOs can pull the data from a published paper, a poster or a presentation from the researcher. If the work is not yet published, the data can be blinded rendering it informative but not enabling.
An example for a potential therapeutic slide deck:
  • Show survival curves
  • Route and frequency of administration
  • Photos of treated vs control animals or tissue while not showing targets, structures, or sequences.

Do not send papers or actual patents/patent applications unless it is requested. These materials take up too much time in the initial review and will be set aside until there is sufficient time to do so, which is practically never!

Following the review of materials - if the answer is “no,” the scout should communicate back to the TTO rep quickly. If it’s a possible “yes” or “maybe,” then the scout has a lot of work to do. First, he or she must figure out where in the company the opportunity could fit and find the internal individual or team to engage in the review process. This can take a few weeks especially in big companies.

Then the scout often must pitch the opportunity internally, and if successful, there is a scientific/technical champion to help advocate for the collaboration or transaction. At this stage, sharing of publications and entering into a confidentiality agreement could be appropriate, followed by several meetings between the academic researcher/group and the company champion and required experts within the company. Companies often want to evaluate or test the technology/compound for a limited period (and in limited quantities) to justify entering a possible transaction.

If the evaluation is successful, the scout and the internal champion work to convince the appropriate people in management and leadership to approve moving forward to a collaboration or transaction, and this decision-making process can go through multiple layers depending on the size of the company, the strategic fit and scope of the deal and the magnitude of the proposed project budget or transaction terms. Resources for collaborations and licenses are not infinite – there is an allocation process to departmental budgets and the scientific/technical rationale and business case must be strong to access those resources. At big companies, these approvals take place through regularly scheduled meetings throughout the year, and it can be competitive to get on the agenda. Should an approval be given, subsequent steps could include due diligence, negotiations, and contracting, all of which take even more time and can involve more people in the company.

What a TTO can do to accelerate the process is to provide sufficient and appropriate non-confidential information, facilitate conversations with the academic researcher and allow for focused and inexpensive evaluations of a technology. In turn, companies should consider providing transparency on internal processes and provide updates in a timely fashion. The clear message here is that communication is key from all sides, and that is only possible through the building and maintenance of strong and positive relationships between academic institutions and industry.
 



The Road Ahead: Optimism and Tech Transfer
Ian McClure, AUTM Board Chair

Wow! What an Annual Meeting. Here with more than 1,000 friends and colleagues in New Orleans, the conversations, information sharing, introductions, solutioning and laughter is what we’ve been missing. I’ve always trusted that it had not gone anywhere and just needed the forum that AUTM created for us. We are celebrating many things.

Sunday, we celebrated being together for the first time in almost three years. We heard the fantastic U.S. Assistant Secretary of Commerce, Alejandra Castillo, and celebrated with her the support for science, research, and innovation competitiveness that has come to the forefront of policy discussions on Capitol Hill, and efforts of the Department of Commerce and the Economic Development Administration to ensure technology transfer is a resourced practice across the United States.

On Monday, I participated in an excellent panel called “How to Train Your Dragon.” No, not fireballs and mythical beasts: we celebrated the growing support of top leadership at our organizations and practices that have elicited growing scopes of responsibilities and new resources as well. After, I was lucky to welcome over 90 TTO directors as we celebrated our first Directors luncheon.

Yesterday, we celebrated our growing Equity, Diversity, and Inclusion (EDI) mission at our first EDI breakfast, after which I was honored to facilitate an awesome plenary discussion with amazing women leaders in our field, as they celebrated an evolving field, deals executed and a profession that remains as vibrant as ever. And at our KY Bourbon Walk happy hour event hosted by UK Innovate, we celebrated bourbon research and the impactful example of what can happen when an entire consortia of industry partners gets behind collaborative action to sponsor and support research and innovation in their field at a partnered research institution like the University of Kentucky.

Today in my closing speech I celebrated the steadfast leadership of our outgoing Chair, Laura Savatski, and the end of an amazing tenure of volunteerism from our immediate Past-Chair, Marc Sedam. And who would I be if I did not also celebrate the tireless work of our AUTM staff, led by CEO Steve Susalka, the Annual Meeting Planning Committee, and all who help make this event happen.

My friends and AUTM Members, we deserve to be optimistic. Optimistic about the outcomes our work is generating, about the support our work is garnering, and about the future of our industry, our profession, our craft. There are many reasons for this.

First, the spotlight on us is brighter than it has ever been. The challenge isn’t a burden, of course. Policy makers, stakeholders and the public may not realize it, but we rise to these challenges all the time.

Second, the talent in our pool - in our offices and on our teams - is top-notch and getting even better. There are a ton of go-getters – “Swiss army knives,” uniquely experienced individuals with diverse knowledge about things remote, yet so important, to so many.

Third, support is on the way. Slowly but surely, our work has become the focal point of many of the world’s think tanks over the last several years, and now is even the subject of proposed U.S. federal support. The tides have turned as to whom, and with what level of influence, is moved to tell others about the importance of investing in our work. The Laissez Faire attitude is slowly becoming carpe diem action, and we are seeing that evidence all over, from new TTOs developing to established ones expanding.

Fourth, AUTM has your back. I’ve seen through fly-high times and through a very challenging pandemic period, the difference having an Association like AUTM makes in ways that aren’t always easily recognizable. The magnification of the spotlight, the training of the talent pool, and the guidance and advocacy drumming up support are all promised and delivered by AUTM.

I have an amazing team at UK Innovate, and a core principle is the “Law of Abundance.” It means there is always plenty of opportunity. Technology transfer can sometimes be discouraging because we don’t always win. Not every discovery is licensed. Not every license generates revenues. Not all startups find an exit. But we have all agreed to take a half-bourbon-glass-full perspective on every asset, project, case, and startup. That this is a great big world and there is an abundance of opportunity for any deal. Not just “shots on goal”, but an “every shot can go in” approach. This is what is expected of us as tech transfer professionals, and it’s why we are so resilient. I hope to lead AUTM forward for the next year with this “law of abundance” perspective, because optimism is our secret weapon.

Winston Churchill said, "A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty." What we do is difficult, and now we do it in more difficult times. But what we do is to create opportunity for research discovery. Opportunity to improve our health and well-being. Opportunity to increase the efficacy of materials, devices, and systems. While others may not always be so optimistic about what we do, we know the opportunity at hand with every technology we touch. That my friends, is our secret weapon. With that in hand, I look forward to where the next year at AUTM will take each of us, and our profession. 


2021 was a Sucker-Punch, But AUTM Excelled

By Laura Savatski, AUTM Board Chair

Despite the challenges of another year saddled with significant pandemic challenges and uncertainty, AUTM made a lot of progressive changes in 2021.  Not only did the Association make important strides, we have a promising plan in hand for years ahead to keep the business of innovation development vibrant  –  not just for us as professionals, but also for the economic and medical well-being of the world. 

What did we accomplish? In 2021 AUTM went fully independent of its association management company: a huge leap. This change gave AUTM control of staffing choices, more agility to change direction, and significant cost savings at an important time.

Additionally, AUTM and the Federal Laboratory Consortium (FLC), which were aligned in a collaborative agreement in 2020, blended its staffs to improve both organizations and better integrate and connect our respective Members.

AUTM continues to provide stellar educational opportunities.  And, in 2021 those were virtual with 121 of our normally in-person sessions all held online, from our Annual and Region Meetings to Courses. New online watercooler events also delivered timely and topical discussions for Members struggling to connect and say current during the pandemic.  Also moved online were our Connect and Collaborate sessions to promote industry networking and deals. 

AUTM has heard Member requests to advance and advocate policies that support a strong patent system.  Last year, we weighed in on several issues, joined amicus briefs, and published position statements at a momentous pace new to AUTM.  For example, AUTM filed extensive comments for NIST's review of Bayh-Dole regulations. On the judicial side, AUTM joined an important brief on American Axle v. Neapco Holdings, a Supreme Court case involving patent eligibility. And we were active in the discussions about the US Innovation and Competitiveness Act, a Senate-passed bill that could potentially authorize new spending to support tech transfer. AUTM has become a relied-upon player in advocacy for tech transfer and patent issues.

The passing of Bob Dole on December 5 became a time to reflect on his legacy. The Bayh-Dole Act of 1980, which he co-sponsored with Birch Bayh, who passed in March 2019, represented a major shift in the ownership structure of patents.  This landmark legislation put ownership of inventions made with federal funds into the hands of academic institutions and small businesses.  It has been more than 40 years since this innovative legislation, more than a trillion dollars in economic impact, millions of jobs, thousands of patents and start-up businesses, and countless new drugs and medical innovations.  He leaves us quite a legacy to advance.  And we’re ready in 2022.

With our new strategic plan, developed with the help of AUTM’s first-ever Member listening sessions, the Association plans to deliver. 

AUTM CEO Stephen Susalka has expertly focused AUTM around on these core principles – Empower, Promote and Connect, to deliver content and services to its Members. You will see those principals represented in the plan, along with a new pillar – Diversify –  to keep AUTM focused on supporting and promoting diversity, inclusivity and equality in the tech transfer field.

Each of us has a tremendous opportunity to make an impact with the discoveries that we help shepherd.  I won’t lie. 2022 is already shaping up to have its challenges thanks to COVID. But AUTM is here help you make sense of things and help you advance with certain steps through these times.  One of the things I love about AUTM is how it makes the process of innovation advancement more understandable and gives us tools to be more effective.  AUTM helps us advance ideas into opportunities, for everyone. 
 
We need to gather to regroup, to connect, to move forward. I hope I’ll see many of you in New Orleans next month to do just that.



What We Have in Common – A Global Viewpoint
By Markus Wanko, AUTM Board Director

Tech transfer is positioned at the interface of the private and the public realm. While the general myths fade: the U.S. driven by private entrepreneurship, Europe by institutional bureaucracy and China by top-down party authority; it’s worthwhile to look at the role tech transfer organizations can play at this intersection.

Tech Transfer Offices Can Be Entrepreneurial
The work of generating ideas for how scientific inventions and technologies can generate input on the marketplace is already entrepreneurial. Many tech transfer offices go beyond actively developing their local ecosystem. They get involved in and sometimes are instrumental in establishing science parks. The recent growth of university-linked venture funds in many cases is based on tech transfer office initiative. For example, the European Investment Fund (a private-public partnership largely owned by the European Investment Bank) that runs a portfolio of venture capital and PE fund commitments more than EUR 20bln runs an initiative to back tech transfer funds.

We are Sitting on the Treasure Trove(s) of the Century
The involvement of tech transfer offices in funds underserved by the traditional venture capital industry is highly welcome as long as appropriate governance mechanisms are in place. The massive increase in available capital flowing into the venture asset class right now is unparalleled in all world regions. This money is chasing assets, and one of the most promising assets is entrepreneurial ventures. A key ingredient is obviously Intellectual Property, which we are managing. The only other critical element is people, but …universities are also the perfect breeding ground for innovative talent. So we are not sitting on one, but on two treasure troves. Tech transfer offices should be proactive in developing both, with a level of commitment and pride that reflects the central importance of these two elements for our economy and society.

Many voices calling for public investment in innovation
In her book of the same title, Mariana Mazzucato calls for the “Entrepreneurial State.” While her message built on many U.S. examples, it was mostly told to and heard by European policy makers. In “Jump-Starting America,” Simon Johnson and Jonathan Gruber outline the same relevance of public investment in research and innovation for regional development in the U.S. Together with the (partly Coronavirus-era-inspired) demands for “technology sovereignty,” these ideas already trigger new investments - and expectations – into our innovation ecosystems. While here in Europe institutions such as the European Research Council are still an excellent and indispensable element of public funding of research, the focus of recent EU research funding program is innovation. The European Innovation Council, a key feature of the EU’s most recent long term research development plan, is focusing its funding on venture creation and development. Practically, for many universities, where grant offices and TTOs go their own ways, this should mean they establish platforms where these sources are systematically developed.

While the demarcation lines between public and private may lie slightly differently depending on the region or system you work in, many key aspects such as those outlined above are relevant for all of us. With an ever-increasing disintegration of our societies (another feature we all have in common) I will continue to look for topics that unite, rather than divide.


Crystal Balls and Forward Thinking: AUTM’s New Strategic Plan

By Laura Savatski, AUTM Board Chair

Participating in strategic planning is one of the most important things our Members do for AUTM, as it advances the Association and the tech transfer profession.  I want to thank our generous and innovative Members who engaged with our first-ever listening sessions to inform AUTM’s newest plan. We saw a very large turnout at these sessions, spanning a few weeks and many time zones. We heard you and incorporated the various themes from these sessions into our final plan for AUTM’s next three years. And we had fun doing it!

After digesting the input, the Board worked with a facilitator to put together a focused and achievable plan. We distilled strategies, made a long list, and voted on which ones would best serve our future. We balanced many priorities and resources. We can’t do everything or be everything to everyone, so intentional focus is a big part of achieving success. I hope you are encouraged by the mixture of themes in our plan. It is both “the AUTM we know and love” and “the AUTM that secures our futures.”

Here are the highlights:

You have likely heard AUTM’s “three pillars”: Empower, Promote, Connect. AUTM CEO Stephen Susalka has expertly focused us on these core principles to deliver content and services. You will see those core pillars represented in the plan, along with a new pillar - Diversify.

  • Empower (educate)
  • Promote (advocacy)
  • Connect (networking, events)
  • Diversify (new community Members)

Each of the following nine key areas of strategic focus maps onto one of the pillars:
 
Empower
Design & create standardized AUTM educational and training content, additional delivery mechanisms, expanded training offerings to new content areas, career pathways, and partnerships with other organizations for AUTM adjacent expertise.

Evaluate & enhance identification of AUTM Member needs and educational content specific to all levels of experience. Develop segmented educational materials reflective of Membership needs considering time in the profession, geographical location, and specific needs for special communities.

Promote
Engage with government and stakeholders to advocate for policies critical to the profession and industry.

Increase understanding and visibility of knowledge/technology transfer to senior leadership within not-for-profit research, industry, and government.

Communicate with Members by providing up-to-date information on current/important topics and critical legislation (e.g., Bayh-Dole Act.)  

Connect
Expand industry participation (beyond just biotech) and develop a broader view of partnering (beyond just patent licensing.)

Provide opportunities to engage with others in the AUTM community, especially with AUTM leadership and industry partners.

Diversify
Identify new stakeholders and invite them to participate in building the ecosystem – emerging research institutes, industry, government, economic development, investor groups, VPR’s, non-U.S. companies.

Promote equity, diversity, and inclusion across the breadth of AUTM.

These areas of focus are now set. The next step is Go! This is where all our Member volunteers, with the help and guidance of AUTM staff, do the work of promoting and incorporating these strategies into practical tactics and project work. For the next three years, all of us, as AUTM Members, will unify around these guiding strategies and focus our attention on these topics.

I am excited and grateful to work with each of you to bring AUTM into the future with new themes, new faces, and new opportunities available for all. Don’t hesitate to reach out to me or another member of leadership with questions on how you can help move this forward.


All roads lead to… tech transfer?
By Hannah Dvorak Carbone, AUTM Board Director

Back when we used to socialize with new contacts, we’d inevitably all get the question:  “So what is it that you do again? ‘Tech transfer?’ Is that, like, IT support or something?” Surely, I can’t be the only one whose inbox gets spammed by people thinking I’m responsible for purchasing the university’s cloud computing services because my office has the word “technology” in its name.

Like so many of us, my path to a career in tech transfer was not a direct one. I work in the Office of Technology Transfer and Corporate Partnerships (OTTCP) at Caltech, an office that didn’t even exist when I started out as a doctoral student here in the 1990s.  It was established partway through my tenure as a grad student, and my only encounter with it back then was one foray over to process an MTA for a research reagent.

Fast forward almost ten years from my graduation, after a detour into management consulting, and I was back in Pasadena looking for a job. Through my alumni network, I heard about an opening in the tech transfer office (OTT) at Caltech. I was intrigued: this seemed to be an opportunity to leverage my broad interest in science (wider than the necessarily narrow focus of my PhD work, and one requirement of my job hunt) and my exposure to the business world, while giving me the opportunity to learn about the domains of patent law and contracting.

I had a lot to learn, and I was fortunate to learn much of it from the late Larry Gilbert, a pioneer in the world of tech transfer, one of the founders back in 1974 of an organization then called SUPA – the Society of University Patent Administrators. Never heard of it? In 1989, the organization changed its name to one that’s more familiar to us all: the Association of University Technology Managers, now AUTM.

I became an AUTM Member almost immediately after joining OTT, attending my first Annual Meeting in 2008 in San Diego. I quickly discovered that the network of colleagues from whom I could learn about tech transfer went way beyond Larry, Fred Farina, and the rest of the team at Caltech. AUTM has been an invaluable resource in my professional development ever since, through both informal channels and formal programs.

Fast forward another decade to the present day. The universe of tech transfer, and my network within it, has expanded once again. Caltech’s OTT is now OTTCP, encompassing not just the patent prosecution and licensing activities of “traditional” technology transfer, but also including a dedicated corporate partnerships team. AUTM no longer represents only “university technology managers,” but a whole ecosystem of individuals and organizations engaged in the process of bringing innovations from lab to market. Last year, I was proud to obtain the RTTP (Registered Technology Transfer Professional) designation from ATTP. The global Alliance of Technology Transfer Professionals, ATTP, is an association of associations, bringing together technology transfer and knowledge exchange organizations from around the world (including AUTM as a founding member) to agree upon a unified definition of technology transfer, and confer recognition (through the RTTP designation) to those individuals who have demonstrated a sufficient level of achievement and competence in the field.

ATTP defines technology transfer as “a collaborative, creative endeavor that translates knowledge and research into impact in society and the economy,” with a focus on the key elements of partnership between different players in the innovation ecosystem, and the translation of research outputs into societal benefits. While perhaps still not clearly answering the cocktail party question of “but what do you actually DO?”, this nicely describes the breadth and scope of this work we’re all doing together.

I feel fortunate to have found my way into this field called tech transfer, and to be able to continue to support the field through my work with AUTM, as a panelist and moderator, volunteer committee member, and Board Member. I’m furthering my global reach and network through my position as the AUTM representative to the ATTP Board, collaborating with counterparts in tech transfer and knowledge exchange organizations around the world. I look forward to seeing many members of my global tech transfer network in person again at AUTM’s Annual Meeting in 2022!
 
AUTM-FLC Partnership Brings New Potential to US Innovation Ecosystem
Marc Sedam, AUTM Immediate Past Board Chair
 
Over the past 18 months you probably noticed that AUTM has talked more and more about the Federal Laboratory Consortium (FLC), the organization responsible for technology transfer and commercialization for innovations generated by the network of US federal laboratories. That’s because AUTM and FLC are now linked in a cooperative agreement that has the potential to accelerate and transform the outputs of federally funded research. With technology transfer in the spotlight more than ever, the critical impact of early-stage federally-funded inventions – and this partnership embodies the “rising tide lifts all boats” philosophy.
 
Some background: The FLC was officially created in 1986 via the Federal Technology Transfer Act amendment to the Stevenson Wydler Act of 1980, which was intended to help commercialize intellectual property from the Labs. Sound familiar? In many ways, the Stevenson-Wydler Act and Bayh-Dole Act are policy twins separated at birth. Both seek to leverage Federal investment in research; both promote the commercialization of research through public-private partnerships; both laws have benefitted society greatly by creating a policy framework that streamlines the engagement with industry; and both are operationalized through NIST. One key difference is that the economic return from the government’s $50 billion annual investment in public sector research (universities, hospitals, not-for-profit research institutes) is historically many-fold larger than from its $50 billion annual investment across the 300+ federal labs.
 
A key difference in federal technology transfer is the focus on partnership, often through a Cooperative Research and Development Agreement or CRADA.  The same Federal Technology Transfer Act that launched the FLC also created CRADAs. These CRADAs are a primary focus for many federal technology transfer offices, as they create a public private partnership to conduct research that is focused on commercialization.  While universities can create spin-offs, federal ethics rules make that difficult in federal labs. CRADAs allow for federal labs to work with companies to more easily launch new products.
 
NIST published a request for proposal on behalf of the FLC in 2019 looking for an organization to operate the Consortium. The AUTM Board believed strongly that the Association was well-positioned to help the FLC. The overall goal was simple—AUTM could help the federal labs increase their commercialization outputs with the significant side benefit of improving the engagement and understanding between federal labs and AUTM Members’ institutions.  Over the summer of 2019, a focused team of AUTM leadership and staff created a proposal that took advantage of AUTM’s best-in-class educational programming, networking, and event management to meet the needs of the FLC. I had the fun part—running point on the visioning and the proposal narrative to try and reduce 40 years of AUTM into actionable tasks that respect the unique differences between federal labs and public sector research institutions, while amplifying the things we have in common.
 
We were thrilled when news broke that AUTM was awarded the contract to operate the FLC and then lived the adage “be careful what you wish for” when realizing that we’d only have 60 days to transition the operations from the previous awardee to AUTM. The burden of this task fell to the AUTM staff who, as usual, exceeded expectations. Since the award date we’ve worked hard to create more ways for Members to engage with the FLC, including content at the Annual Meeting.
 
Our goals remain straightforward—help our Members and the labs increase the quality and quantity of opportunities resulting from the $100 billion combined Federal investment in research and increase the number of triple-helix (not-for-profit research/industry/government) collaborations through building and maintaining long-term relationships.
 
In time, this relationship will allow AUTM and FLC to leverage our collective strengths to more impactfully and efficiently advance the fruits of federally funded research. Just as universities are working together even more closely than ever, this partnership also allows our universities, hospitals, and research institutes to work together with our federal lab colleagues down the block – or even on your own campus. You’ll see.
 

AUTM Emerging Members Program Seeks to Support Next-Gen TTO Pros in HBCU, MSI Space
By Almesha Campbell, PhD, Director, AUTM Board
July 14, 2021

Managing a small technology transfer office (TTO) is a challenge, but managing a one-person TTO is even more challenging – especially in the context of small, under-resourced institutions. For over 11 years, I have done just that – and at a Historically Black College and University (HBCU). I had to be creative and effective in an environment where technology transfer was not a priority. Additionally, the tools and infrastructure needed to succeed were largely unavailable, nor did I know what success looked like. Fortunately, a few months before moving into the role of IP Manager, I met someone who directed a TTO at another HBCU. I immediately connected with her and asked to shadow her for one week. Less than two weeks after that experience, I enrolled in AUTM’s Essentials Course, where I met many young tech transfer professionals who are now greatly impacting the field.
 
According to the National Science Foundation’s HERD survey, only nine of the 107 Historically Black Colleges and Universities (HBCUs) have expenditures at or above $18 million. Low research expenditures may be one of the reasons why tech transfer has not been a priority for most HBCUs.
 
However, HBCUs are beginning to understand the importance of technology transfer and the funding agencies’ desire for researchers to commercialize their ideas and/or intellectual property. Efforts such as the NSF I-Corps Site program has provided a much-needed pathway for faculty and students to take their ideas from lab to market. However, only three HBCUs currently operate NSF I-Corps Sites, meaning most HBCU faculty and students have not been exposed to such programs. Additionally, most HBCUs do not have the human resource and/or physical infrastructure to facilitate such a site, so it is critical that HBCUs leverage partnerships with other universities to drive commercialization.
 
Recognizing some of the challenges Minority Serving Institutions (MSIs) face, AUTM set out to recruit these institutions to AUTM’s newly established Emerging Members program. The program’s intent is to increase the capacity of MSIs to operate TTOs, which will in turn help to train the next generation of tech transfer professionals in the HBCU and MSI spaces.
 
Eleven HBCUs have joined this new program so far. They are paired with mentors and provided with training on IP protection and commercialization. This program can very well help change the ecosystem for entrepreneurship and commercialization at HBCUs. The impetus is for HBCUs to develop a different perspective and recognize that developing an entrepreneurial mindset is critical in moving their research and discovery to a place that will elevate the value-add for their research enterprise and position the universities to sustainably drive the long-term impact of intellectual property.
 
While the Emerging Members program is a great step towards achieving some diversity in tech transfer, there are still other barriers to commercializing research at HBCUs beyond diversity, knowledge, and mentorship.

The United States Innovation and Competition Act (USICA) of 2021, formerly known as the Endless Frontier Act, recently passed the U.S. Senate. The bill authorizes $110 billion at the National Science Foundation for basic and advanced technology research over a five-year period. Among many other provisions, the legislation includes funding that will help build technology transfer infrastructure. The bill also contains some new research security reporting requirements which are of concern to universities.
 
The U.S. House of Representatives has passed a smaller version of NSF legislation which does not contain the tech transfer provisions.  AUTM is supportive of seeing if some of the Senate language might be included in any negotiated final version of the legislation.  AUTM supports additional resources for smaller institutions, such as HBCUs, who may have less-resourced TTOs.
 
USICA and FASTER offer great opportunities for the most highly resourced institutions to partner with HBCUs. Not only will this promote diversity in tech transfer, but it will ensure that a more skilled tech transfer workforce is at the forefront of helping America be the best in the world.
 
The Innovation Economy Requires a Well-Funded Tech Transfer Ecosystem:
It Appears Washington Agrees

By Ian McClure, AUTM Incoming Board Chair
June 16, 2021

Since the dawn of the Bayh-Dole Act in 1980, research institutions have been expected to produce commercial and societal impact from federally funded research without matching funding support for the necessary infrastructure. It is an unfunded mandate.

Technology transfer support from the U.S. federal government has been close to zero. As a result, institutions are largely left to fund technology transfer resources, forcing funding incentives that may be central to the university’s overall needs. This is a big reason tech transfer professionals often talk more about license revenues than products produced, jobs created, and lives saved.

The public and its elected representatives rely on universities and institutions’ research advancements and technological discoveries – especially those federally funded– to generate lifesaving and life-enhancing impact, unrelated to the income to cover any necessary costs of the process. Yet, intellectual property protection (IP) and technology transfer are required to advance innovation to market, and it is essential that ownership of IP and management of the technology transfer process remain at the institution where the innovation occurs – as the Bayh-Dole Act stipulates.

The proposed US Innovation and Competitiveness Act (USICA), formerly the Endless Frontier Act, could change that dynamic. In the Senate version passed last week, Section 2109 sets a precedent by mandating, for the first time ever in a federal bill, funding support for academic technology transfer infrastructure and capabilities at research institutions. This legislative endorsement that building research technology transfer strength in the country is worthy of overwhelming bipartisan support highlights the seismic shift in perspective related to the importance of research and effectuating its impact.

Section 2109 was initiated by a small group of technology transfer leaders, including AUTM. We called it the Focused Action Supporting Technology and Economic Response (FASTER) proposal, which was architected to advance research to market FASTER.  The idea is that this funding is made available to eligible research institutions that opt-in. Opting in is important to counter concerns that an institution may not want any additional oversight or reporting responsibilities. Yet we should not shy from accountability. We have been able to preserve respect and trust in what we do for over 40 years. This is an opportunity to change the incentives to support our work, and what we can do through metrics that level-set expectations and even improve our own performance.

A central theme in FASTER, and hopefully in any final version of the bill, is to significantly broaden and diversify the institutions offering technology transfer resources to its innovators. We aimed to set aside significant funding amounts for small-to-medium sized research institutions (between $10M-$100M in research expenditures) as well as for Historically Black Colleges and Universities and other Minority Serving Institutions. While specific earmarks are not in the final Senate version, its language lets any institution submit a proposal for up to $1 million for technology commercialization efforts and resources. This is a game-changer for hundreds of underrepresented institutions that can, hopefully, provide services that will protect IP and offer education, partnering, and startup creation resources on their campuses with ideas and research findings that otherwise may only reach the public domain or a dusty shelf. Our Kentucky Commercialization Ventures program, which provides technology transfer resources to all our smaller regional universities and community and technical colleges, has proven that innovations exist with real economic and societal impact potential at these institutions. My hope is that this bill can help prove this everywhere.

The work has only just begun, with the House of Representatives next considering their version of the bill. If you believe, as I do, that this funding support is an enormous opportunity for innovators, our profession, and the public that relies on these technological and scientific advancements to improve their lives, it is important that you make your voice heard. Your Congressional representatives will be considering this bill for months to come, and this is a key element to effectuate impact from the increased spending on research and innovation. Watch for updates, supporting toolkits, and more from AUTM that may help you inform your administrative leadership and federal relations staff. We have an opportunity to see the largest increase in federal funding for our profession since 1980.

Ian McClure is AUTM’s Incoming Board Chair and is the Associate Vice President for Research, Innovation and Economic Impact for UK Innovate at the University of Kentucky.
Supply Humanitarian Aid, Don’t Waive Patent Rights
By Laura Savatski, AUTM Board Chair
May 19, 2021

At a time when health care access is crucial, we have become increasingly aware of the disparities and inequities that exist in developing countries and our own. This global pandemic has caused huge devastation that is felt even more keenly in the developing world, where access to clean water and basic medical care isn’t always available. Our supply chains have been stressed to the breaking point as governments fight for the same products. Despite a recent decision by the White House to support the waiver of patent rights, it is not access to patented technology that is the most pressing issue here, but broad and equitable access to health care for the sick, access to know-how, a workforce to aid a high-tech manufacturing process, trade protocols, and the sourcing of short-supply products to make vaccine.    
 
Shortly after the COVID-19 pandemic became a global health crisis, AUTM leaders and Members discussed how best to encourage broad humanitarian access to technologies needed to fight the pandemic. The COVID-19 Licensing Guidelines published in early 2020 and adopted by almost 100 well-known organizations outline a time-limited non-exclusive free license strategy to encourage the sharing of information and technology to develop urgently needed products. Companies have successfully developed vaccines in record time and received regulatory clearance for emergency use. Some of the vaccines rely on novel mRNA vaccine technology and patented ideas that have transformed the delivery of life-saving solutions. 
 
Waiving patent rights ignores the realities that access to a patented technology is just a first step in a complex process. Many countries are not set up with manufacturing and trade processes to allow them to quickly scale up technology production to the level needed during a crisis. Furthermore, oversight into infrastructure safety and efficacy is not as well-developed in some locations, risking fraud and reducing confidence in the product. Even if well intentioned, waiving patent rights will not be enough to quickly and safely produce vaccines and other health products needed. In fact, by waiving protocols that protect the technology development, we may end up doing more harm than good.
 
Patents and innovation have close ties, and the existence of patent rights and a system to reward innovation contributes to more innovation. In countries without a strong patent system, innovation does not happen at the rate we see in countries with established intellectual property processes. Countries looking to develop their economies often start with a strengthening of their patent and trade offices. The United States, through its Constitution, created patents to encourage technological progress and the public dissemination of knowledge by securing a time-limited right to an invention as part of our foundation. This system has served us well in its hundreds of years, contributing to the development of vaccines, antibiotics, telecommunication, new materials, and many other transformative and life-saving solutions, often created in times of great need.
 
Like now.
 
The recent global focus on COVID-19 vaccines and other products is a scary rollercoaster ride for many of us. We are in an incredibly difficult time, trying to balance patent rights with global health access. Much is at stake in getting the vaccines to everyone – the health of the world, economic stability, and our hope of a return to “normal,” just to name a few.
 
As practitioners, we know the patent system works to drive innovation forward. Think about where we would be without it. Would inventors share their technologies in a public document like a patent application, which gives step-by-step instructions for creation, if they could not protect the sizeable investment in development of the idea for the lifetime of a patent? Would they instead hold all this knowledge privately, stifling progress in their field and reducing the ability for those in need to get help? Would investors back the development of novel products if there was no return on their investment, which is what happens when the patent system cannot be relied upon to be predictably protect their investment? Universities may no longer partner on research discoveries with companies that produce life-saving vaccines if the patent on that discovery would be meaningless because those rights could be waived at any point. Think of how many innovations of the last few hundred years would have never come to light.
 
It is now, more than ever, that we need a strong and predictable patent system so that innovation is valued and incentivized to provide us with more access to technologies that can positively impact our health and our lives.
 
To save lives during this crisis, we should focus on critical issues of equitable access to medical care and vaccines in all communities, humanitarian aid through the supply chains that can provide what is needed where it is needed most, and the ramp up of investment in manufacturing capacity in more locations around the world, through established companies with proven track records of producing safe and effective doses. Making smart, thoughtful decisions throughout the entire process, rather than focusing on waiving patent rights just makes more sense.