“In the medical innovation enterprise, administration of the research portfolio is an area that, more often than not, gets scant attention and is under-resourced. Failure to remain vigilant is both a monetary risk and loss of control risk.”
As we scan the press attention around medical intellectual property (IP) during these pandemic times, an impassioned debate centers on whether there should be a reprieve on patent rights for COVID-19 vaccines. This threat to longstanding agreements and investment in public/private sector partnerships undermines not only the ownership of IP but also sets a dangerous precedent in terms of downstream consequences. An additional challenge to patents owned by academic medical centers and pharmaceutical companies is posed by activist groups that are lobbying our government to exercise march-in rights to influence pricing of medicines in the United States.
Working with medical research centers around Bayh-Dole Act compliance has uncovered, time after time, a more systemic risk that eats away at the health of the research portfolio and could add fuel to the fire for diluting IP protection, thereby undermining the foundation of innovation. What we are talking about here is a lack of rigorous documentation with regard to the steps taken to commercialize inventions, the obligations of multiple stakeholders contributing to the IP and downstream management of the milestones that support the rollout of a patent. This hole in the discipline of record keeping, directly from the outset and along the path to commercialization results in inconsistent enforcement of rights and responsibilities of various parties, missed opportunities to bring in revenue and inattentive compliance with federal funding mandates.
An internal legacy initiative targeted at examining the health of the research portfolio from an operations perspective is undoubtedly not as thrilling as launching the next scientific breakthrough that will benefit patients and change the world. Yet, this exercise is of paramount importance to protect the very IP garnered through years of dedicated research and is fundamental to the health of the research enterprise.
Complex Relationships Impede Communications and Compliance
Medical research centers engage in a complex ecosystem to bring new technology to market. The path from invention to commercialization includes many players in concert with the seminal researchers. Funding sources may start with government grants and then expand to include industry participants and specific patient advocacy groups as clinical trials get underway. By definition, agreements among multiple parties are complex. In addition, the dimensions of these relationships shift from year-to-year and new constituents enter even as outside forces may realign priorities. We see this complexity in the current pandemic that has focused the attention and broadened constituents around the world.
So, how do these many-to-many relationships pose a challenge to the institution’s IP? The germ of the problem lies in what happens over time and the lack of documentation to support the IP as transitions occur; people are involved on appointment and then move on, new parties enter the research cycle. The “why” behind the relationships between parties gets lost. Yet, the academic research center, as lead institution, needs to manage collaborators and their rights as well as how the licensees roll out technology. Therefore, it is essential that the foundation supporting the institution’s actions is rock-solid.
Academic Research Centers Lose Their Hold on IP
If initial relationships are not well documented and kept up-to-date, institutional knowledge inevitably degrades over time and downstream management of IP agreements is put on the back burner. This typically does not become a problem until it’s a big problem. This may come to light when:
- The financial audit uncovers inventions where documentation to support patents cannot be produced; the value of patents is diminished with a blot on the title.
- Government compliance is shaky; Bayh-Dole notifications number in the thousands and cannot be resolved for lack of a documentation trail.
- Research centers compromise their rights to influence product rollout or even retain title because initial relationships are not documented and kept up-to-date.
- Industry partners are discovered to utilize inventions in products or markets not specified in original documentation.
- Deadlines to maintain rights to a patent have been missed.
Any of these circumstances can be exploited to damage the foundation of IP rights, and institutions may find themselves on shaky ground if disclosures and agreements were not well documented in years past. Although, to date, the government has not opted to exercise march-in rights, the recent circumstance of coronavirus vaccine development and deployment has renewed the pressure to exercise march-in rights to influence pricing. And with the transfer of responsibility for compliance reporting from the National Institutes of Health to The National Institute of Standards and Technology, the door is open for changes to the original intent of the Bayh-Dole Act.
Who is Responsible for IP Administration?
To complicate things, technical administration of IP agreements is a cross-functional responsibility that demands attention from resources that are focused on other priorities. When foundational documentation is lacking this should be a concern for everyone that touches the research—from the original inventors to the technology transfer office as well as general counsel—but if asked where their responsibilities lie, attention will inevitably be on what is new, or what is core to the job description, or fighting the latest fire. Personnel are reactive, not proactive, in business office actions as they relate to agreements that are already inked. Additionally, licensing officers should be tasked to drill down into their portfolios to assess and improve the integrity of follow-through on agreements in their portfolio, but again, their focus is often to work with PI’s on the next important discovery. Sponsored research also has a role to play that starts right at the time a grant is awarded. Thought should be given to how the seminal research will translate into products or therapies that make their way to market. Circumstances may change but creating a robust structure for IP administration from the outset will lay the foundation for a healthy research enterprise.
Good Record-Keeping is a Core Capability
In the medical innovation enterprise, administration of the research portfolio is an area that, more often than not, gets scant attention and is under-resourced. Failure to remain vigilant is both a monetary risk and loss of control risk. At this time, it is imperative to pay attention to ensure the health of the institution, to benefit patients, and to make certain that innovation is protected to support the mission of medical research. The ultimate outcome will be better relationships with collaborators, stronger hold on patents and better stewardship of the research dollars entrusted to the research enterprise. This will support transition of these technologies to the market, moving forward toward a better world.
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