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Are Regeneron And Pfizer/BioNTech COVID-19 Products Covered By Patent Safe Harbor?

 
• By Brenda Sandburg

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.

safe harbor
Lawsuits claim patent safe harbor does not apply to Regeneron and Pfizer/BioNTech's use of patented invention • Source: Alamy

Allele Biotechnology and Pharmaceuticals Inc.’s lawsuits against Regeneron Pharmaceuticals, Inc. and Pfizer Inc./BioNTech SE are testing the scope of the safe harbor that allows patented inventions to be used in the submission of information to the US Food and Drug Administration.

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