By John Biship, Cohen Garelick & Glazier
In October 2020, Allele Biotechnology and Pharmaceuticals, Inc. filed a lawsuit in California claiming that Pfizer and BioNTech infringed Allele’s patent “covering a particular ‘tag’ used to track vaccine in a patient’s blood.” As part of the trials to achieve US regulatory approval of Pfizer and BioNTech’s vaccine, lab test results on patient blood samples who had received the vaccine were evaluated; one of the tests was a “neutralization assay,” which is used to detect antibody presence and efficacy at neutralization of the SARS-CoV-2 virus. As part of this “neutralization assay,” a tracing “tag” is used to track the vaccine in a patient’s blood.
Allele claims that the vaccine developed by Pfizer and BioNTech used Allele’s patented mNeonGreen tag (U.S. Patent No. 10,221,221), which is alleged to be one of the “brightest and most stable monomeric fluorescent reporter proteins currently known.” In response, Pfizer and BioNTech invoked the safe harbor provisions of 35 U.S.C. § 271(e)(1), which immunizes parties from patent infringement allegations when the actions are taken to develop information for submission to the FDA regarding the manufacture, use or sale of drugs. Allele has also filed a lawsuit in New York against Regeneron claiming infringement of the same patent. Read more from IPWatchdog here.
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