Are Regeneron And Pfizer/BioNTech COVID-19 Products Covered By Patent Safe Harbor?
Allele claims Regeneron’s monoclonal antibody cocktail and Pfizer/BioNTech’s COVID-19 vaccine infringe its fluorescent protein patent. Regeneron asks court to toss suit against it, arguing use of protein for FDA submission is protected. A different court denied Pfizer/BioNTech’s motion to dismiss similar suit.
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Pharma industry critics herald the agreement for allowing many manufacturers around the world to make the COVID-19 therapeutic and for its transparency. If Merck can do it, they ask, why can’t other companies?
Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.
Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.