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Law360 (September 29, 2020, 10:56 PM EDT) -- U.S. Patent and Trademark Office Director Andrei Iancu said Tuesday that he has yet to see evidence that patents will be a "barrier" to access of COVID-19 vaccines and treatments.
Speaking at the American Bar Association's virtual IP Fall Institute, Iancu said while it is necessary to ensure that critical treatments are widely available to the public, intellectual property rights "must always be respected," especially during crises like COVID-19.
Without adequate protections, Iancu warned that companies would lack incentive to invest substantial time and money in developing treatments for the next global health crisis. As such, there must be a "careful balance" in both interests, he said.
"We have to have our eye on this crisis, and we must solve it, but at all times, we must have our eye also on the crisis of the future," Iancu said.
Iancu's comments came in a video conversation with Oracle Corp. general counsel Dorian Daley, who asked the agency director to address concerns that intellectual property relating to COVID-19 might "create a barrier to access that would be problematic."
"Where is the evidence of that?" Iancu countered, though he noted that the U.S. has "tools at its disposal" — such as the "march-in" rights under the Bayh-Dole Act, which allows the government to invoke rarely used powers to override patents — in the event that additional access is needed.
Biotechnology companies like Gilead Sciences and Moderna Therapeutics have come under intense scrutiny in their race to develop vaccines for the coronavirus, as the death toll has reportedly passed the 1 million mark worldwide.
Last month, a group of 34 state attorneys general urged the federal government to exercise march-in rights to force Gilead to license its patents on remdesivir to other companies so they can make the COVID-19 drug more widely available, saying "Gilead should not profit from the pandemic and it should be pushed to do more to help more people."
Gilead said at the time that it was "deeply disappointed that a group of state attorneys general have chosen to misrepresent facts."
"The use of 'march-in' rights under the Bayh-Dole Act will do nothing to produce additional doses of remdesivir this year and will discourage other manufacturers from investing in the development of new therapies and vaccines," the company said in a statement.
The U.S. Department of Defense's research arm has also launched an investigation into whether Moderna disclosed its federal funding in patent applications for its COVID-19 vaccine candidate, following a request by activist group Knowledge Ecology International.
If the company's government funding sources are exposed, the DOD can demand ownership of the patents under the Bayh-Dole Act, KEI said last month.
In addition, a U.S. Department of Health and Human Services subagency said earlier this month that it is investigating whether Moderna was upfront about government funding in patent applications related in part to its work on its closely watched COVID-19 vaccine candidate. That investigation also came about after KEI pressed for one.
Representatives for Gilead, Moderna and KEI did not immediately return requests for comment Tuesday.
--Additional reporting by Ryan Davis and Kevin Stawicki. Editing by Bruce Goldman.
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