Licensing patents is not the only way for academic institutions to disseminate technology
May 10, 2024
How do the results of scientific research get out of the universities and into the world where they can make a difference in people’s lives? In 1980 the U.S. Congress tried to solve this problem by passing the Bayh-Dole Act, which allowed universities to patent and commercialize inventions that emerged from federally funded research. Bayh-Dole established the currently dominant “technology transfer” model for university-industry partnerships. Under this model, researchers at academic institutions, funded by U.S. government grants, develop new technologies or potential therapeutics, which they then patent. The patents are then licensed to an industry partner, often a start-up, which develops the technology or drug into a commercial product that members of society can use. Despite some legitimate criticisms that this model doesn’t do enough to make taxpayer-funded medical innovations affordable to the citizens who paid for the initial research, Bayh-Dole has indeed helped move research out of the lab, leading to the production of successful drugs.
Limitations of the patent and technology transfer model
Bayh-Dole is focused on the place academic research at the beginning of the commercialization pipeline. However, as ‘omics comes to play an ever-growing role in biomedical research, it’s worth thinking about other models of academic-industry partnerships that could help bring innovations from the fast-moving ‘omic frontier into the commercialization pipeline. Here is the basic challenge that a new model could address: Advancements in genomics have the potential to improve medicine and drug development with scalable and relatively inexpensive assays, biomarkers, and other clinical tests. But assays based on data-rich ‘omic technologies are less amenable to the traditional patent/tech transfer model of industry partnerships, thanks in large part to changes in patent law that make it much more difficult to patent anything that could conceivable considered a product of nature rather than an invention. Patrick Silva and Kenneth Ramos, of the University of Arizona, argue that that new clinical assays based on ‘omics are “disrupting the market for probe kits in favor of higher-content readouts,” and changing the relevance of the traditional approach to technology transfer. “Patenting a reagent, kit, or decision rule based on a single analyte (or 10 of them) is less frequently a compelling commercialization path,” and this presents new opportunities for academic institutions to partner with industry in ways beyond the Bayh-Dole framework.
The tech hub model
One opportunity can be found not at the beginning of the commercialization pipeline, but somewhere in the middle. Academic medical centers can act as technology hubs, hosting up-to-date ‘omics technology platforms, something that is difficult and not cost-effective in most industry labs. Biomedical science of course always depends on technology, but ‘omic-centered research is especially dependent on instruments that are a) very expensive to acquire and run and b) have a much faster obsolescence cycle than many other biomedical instruments like microscopes or PCR machines. Long-read sequencers, single-cell sequencing and spatial transcriptomics platforms, and mass spectrometers require expert staff to use, need to be run at high volumes in order to be cost-effective, and often become obsolete quickly – your five-year-old, $10,000 PCR machine is fine, but your five-year-old, half-million-dollar PacBio instrument is not. New machines need extensive testing, and machine-learning data analysis pipelines are typically custom-built. None of this is great if you’re a for-profit company. Ryan Confer, CFO of the gene therapy Genprex:
[L]ong development timelines and large R&D expenditures require companies to effectively allocate resources to develop and ultimately reach their goal of commercializing their therapies. A key challenge for developers of disruptive technologies, like cell and gene therapies, is that cutting-edge technologies usually require cutting-edge resources in the form of advanced equipment or processes, researchers or staff with advanced or sophisticated knowledge, and advanced testing or analytical capabilities. As a result, traditional or custom-built lab space or specialized recruitment may not be cost-effective at such early stages of development.
What’s bad for biotech R&D is great for academic genome centers, however. Genome centers maintain up-to-date instruments and employ staff and faculty with the expertise to continually develop new applications. The whole purpose of a genome center is to deploy the latest ‘omic technology and drive the research frontier.
An obsolete sequencer taking up space in a classroom corner
This creates the possibility of a new kind of academic-industry partnership beyond the Bayh-Dole Framework. Universities can disseminate new scientific methods and technology not by licensing them, but by becoming the places where biotechnology companies gain access to the latest ‘omic technologies. Universities thereby help move innovation out of the research lab and into commercialization, while companies do not need to invest in instruments that are not cost-effective for them to run.
What about CDMOs (Contract development and manufacturing organizations)? These companies do provide access to technology and expertise to that wouldn’t be cost-effective for a biotech company to maintain in-house, and they play roles in the longer-term drug development pipeline for which academia often isn’t well-suited. But the innovation in ‘omics isn’t coming out of CDMOs, which also face changing federal biosecurity regulations that could limit the studies they’re able to participate in.
Obviously there are potential complicating factors in any academic-industry partnership, and academic institutions have obligations to act in the public interest that can’t be set aside when working with a for-profit partner. But ultimately we publicly fund scientific innovation so that society as a whole can benefit. To make that happen, universities should always be looking for effective ways to move innovation generated on campus out into the world.
