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Law360 (August 20, 2020, 5:53 PM EDT ) Patent suits over abbreviated new drug applications have dropped significantly since the start of 2020 compared to the same time last year due to pharmaceutical companies diverting their attention from developing generics to responding to the coronavirus pandemic, a Schiff Hardin LLP partner said Thursday.
The number of complaints filed under the Hatch-Waxman Act in federal court has declined from 238 suits from the first three quarters of 2019 to 170 suits filed as of Aug. 14, right before Q3 ends in September. That's a 29% drop, with each quarter of 2020 seeing substantially fewer suits filed, according to data compiled by Sailesh Patel, the firm's Hatch-Waxman and biosimilars practice group co-leader. The data comes from litigation intelligence platform Docket Navigator.
While the number of cases filed in Q3 could conceivably increase within the next few weeks, Patel said that's unlikely since most companies would have already made their Q3 filings by now.
"A lot of companies who would be focusing their resources on filing ANDAs as their regular and routine business have been diverting some of those resources to handle the COVID crisis, ramp up medications to treat COVID and develop COVID medications," Patel told Law360 on Thursday.
In the first quarter of 2020, a total of 89 suits were filed as compared to 102 the same time last year, Patel said, and 51 suits were lodged in the second quarter of 2020 when the virus was taking hold in the United States, as compared to 82 from the second quarter of 2019. Only 30 ANDA suits were filed by Aug. 14, compared to 54 suits filed during the third quarter of 2019. There were a total of 315 cases filed in 2019.
And while Q4 data is not yet known, it seems unlikely that those filings will come close to the 77 suits filed the same time last year, given the continuing effects of the pandemic, Patel said.
Part of the reason for the decline, Patel said, has to do with generic companies diverting resources that would normally be used to developing bioequivalent versions of drugs, completing testing and filing ANDAs to instead deal with the COVID-19-related research and development. Also playing a role in the decline in new filings are quarantines and stay-at-home orders, which affect companies in different ways.
"Since they've been filing less, the number of new cases we've been getting has gone down," Patel said. "We have some cases we've been busy on, but the new filings and the rate at which we would get them has decreased."
The pandemic has also contributed to companies missing the first-to-file deadlines to obtain a six-month exclusivity for their generics as a result of operations being redirected or halted.
"I've heard at least anecdotally that there are sometimes first filing dates that, because of COVID, have not been met," he said. "So some opportunities may have been lost."
But as the country begins to reopen, courts resume operations and companies are on the march to develop generic alternatives to drugs like remdesivir to treat COVID-19 symptoms, Patel said he's confident the filings will eventually return to where they were last year.
"It will go back soon enough," he said.
--Editing by Steven Edelstone.
For a reprint of this article, please contact reprints@law360.com.
