As AstraZeneca charts a lucrative new path for FluMist with a self-administration nod and an at-home delivery service for the nasal spray-based influenza vaccine, the school that had a hand in the drug’s provenance is demanding its dues.
The University of Michigan is suing AZ over claims that the British drugmaker continues to market and sell the vaccine despite not renewing a key contract with the school that was crucial to FluMist’s development.
In turn, the university is seeking damages that it expects to exceed $50 million before any additional enhancements, interest or fees are applied, according to a legal complaint filed in a Michigan district court this week.
Key to the argument against AZ is that FluMist “was directly created based on virus strains developed at the University of Michigan’s School of Public Health,” lawyers for the university wrote in their complaint.
Now, however, AstraZeneca has purportedly declined to re-up its contract with the school and allegedly “absconded with the University’s property”—a pair of influenza “master strains”—which it continues to market via FluMist in violation of its contractual obligations to the school, the university’s argument continues.
AstraZeneca did not immediately respond to Fierce Pharma’s request for comment on the matter. Michigan news outlet MLive noted in its own report that both AZ and the university declined to comment on the ongoing litigation.
The flu strains underpinning FluMist originated with the University of Michigan’s Hunein “John” Maassab, Ph.D., who worked within the department of epidemiology at the university’s school of public health. Specifically, Maassab developed cold-adapted flu strains and the “associated know-how to use the strains to create vaccines,” the complaint states.
Maassab passed away in February 2014.
The university subsequently sought out commercial partnerships with the industry to bring Maassab’s innovation to the public, first signing on with the company Aviron in 1995. The materials and intellectual property deal armed Aviron with “two of the most valuable, cold-adapted influenza virus strains” and the vaccine development expertise pioneered by Maassab, the lawsuit states.
Ultimately, Aviron was acquired by the company MedImmune in 2002, which itself was gobbled up by AstraZeneca in 2007, making AZ the final holder of the Maassab-developed flu master strains.
The contract covered a 20-year span during which the licensee was allowed to “use and improve upon” those strains from the initial date FluMist was sold commercially. During this period, AZ was required to pay royalties (1.25% of net product sales) to the school. FluMist was first approved and launched in the U.S. in 2003, with the 20-year timeline going into effect that year.
Once the contract period was up, the lawsuit claims AstraZeneca had to make a choice: Negotiate to extend the agreement or stop use of the Maassab-developed strains and return them—along with “all the improvement AstraZeneca had made”—to the University of Michigan.
AstraZeneca began paying FluMist royalties to the university in early 2004 after booking its first revenue from the vaccine in 2003’s third quarter, the lawsuit states. But the British drugmaker stopped communicating FluMist sales numbers after 2023’s third quarter and has not paid any royalties since, the university’s lawyers claim, arguing that AZ “failed to enter into a new agreement” with the school.
Complicating the matter further, AZ apparently did reach out to the university to extend its contract in early 2021, according to a company email disclosed in the lawsuit. “I am working with our team regarding FluMist for which the technology is used, and we would like to discuss extension of this contract,” the AZ email to the university states.
Shortly thereafter, AZ allegedly “abandoned all discussions with the university and reversed its position,” arguing that it was no longer using the Maassab-developed master strains and that the university was “improperly leveraging” its intellectual property, according to the lawsuit.
With the agreement un-renewed and royalties no longer coming in, the school demanded the return of the master strains it had licensed out to AZ, but AZ refused to provide them, the school’s legal team has argued.
“AstraZeneca has a successful commercial product in FluMist,” the University of Michigan’s lawyers said. “It wants to retain the revenue and profit from that product, but cut the university out of its share for its contribution.” The legal team further contended that AstraZeneca does not want to hand over any improvements it has made to the strains because then the university would be able to license them, “which would threaten AstraZeneca’s monopoly on FluMist.”
The school argues that AZ is not allowed to continue marketing and selling FluMist without the university’s ongoing participation and permission, which the drugmaker has failed to obtain.
The timing of the lawsuit is key, given that FluMist could soon experience a sales jump now that it's been approved for self-administration. Following that FDA nod last September, which made FluMist the only flu vaccine U.S. patients can give to themselves, AstraZeneca kicked off at-home deliveries of the vaccine earlier this month.
This isn’t the first time the University of Michigan has taken a litigious bent against the pharma industry.
Back in 2022, the Michigan college—along with the University of South Florida—sued Novartis for allegedly infringing a co-crystal patent held by the schools through the marketing of its popular heart failure drug Entresto.
The patent at issue in that case was concerned with a technology to make multicomponent solid drugs with “improved drug solubility, dissolution rate, stability and bioavailability.”