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COVID-19 IP Catch-Up: Hatch-Waxman, Vaccine Patents

By Dani Kass · 2020-08-21 19:13:20 -0400

In this round of intellectual property updates tied to the ongoing pandemic, new data shows patent suits over generic drugs are on the decline, another Texas judge deems trials clear to proceed, and companies move forward with vaccine patents.

District Court Litigation

Sailesh Patel, who co-leads Schiff Hardin LLP's Hatch-Waxman and biosimilars practice group, said Thursday that patent suits over abbreviated new drug applications have dropped significantly since the start of 2020, compared with the same time last year. He attributed the change to pharmaceutical companies diverting their attention from developing generics to responding to the coronavirus pandemic.

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 Patel.

For litigation that's already underway, Western District of Texas Judge Alan Albright on Tuesday said he's ready to get in-person trials going again on Sept. 1, despite an order from the district's chief judge calling for judges to hold off.

Chief Judge Orlando Garcia's order earlier this month called for civil and criminal bench and jury trials through Sept. 30 to be continued, but it also "allows for individual divisions to hold jury trials if the most senior district judge in that division determines they may be held safely."

Judge Albright, as the only district judge in the Waco division, said he feels it's safe to resume in-person bench and jury trials in the division, as the division's counties have seen a meaningful decline in new reported COVID-19 cases.

In California federal court, 3M Co. said on Aug. 13 that it reached another deal to settle trademark litigation accusing companies of capitalizing on the pandemic to gouge the prices of its N95 masks. This deal calls for an Amazon vendor to pay $192,616 and to stop selling 3M products unless authorized.

Vaccines

In China, CanSino Biologics Inc. and a military scientist were granted the country's first patent for a COVID-19 vaccine candidate, state media reported on Aug. 16.

The candidate, Ad5-nCo, was developed by China's CanSino and Chen Wei, an infectious disease specialist at the Academy of Military Medical Sciences, People's Daily said. Citing documentation from China's National Intellectual Property Administration, the state newspaper said the patent was applied for on March 18 and granted on Aug. 11.

Then in the U.S., a biotech company called Aquavit Pharmaceuticals, Inc. on Tuesday announced that it had applied for a drug delivery patent through the U.S. Patent and Trademark Office's COVID-19 Prioritized Examination Pilot Program. In a statement, the company's CEO said its platform would let people self-administer vaccines.

"Our universal platform technology can potentially accommodate any vaccines to be self-administered and pandemic distribution ready," CEO Sobin Chang said. "We are currently in talks with multiple global scale pharmaceutical companies, vaccine makers, and major universities for collaborations and partnerships."

--Additional reporting by Kevin Stawicki, Daniel Siegal and Adam Lidgett. Editing by Haylee Pearl.

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