Posts Tagged: "assay"

Pfizer and BioNTech have hit back at Allele Biotechnology and Pharmaceuticals, Inc.’s October 2020 complaint accusing the COVID-19 vaccine manufacturers of infringing Allele’s U.S. patent covering a particular “tag” used to track vaccine in a patient’s blood…. U.S. regulatory approval requires Pfizer and BioNTech to show that their vaccine is safe and effective against SARS-CoV-2 infection. To meet the Food and Drug Administration’s (FDA’s) requirements, Pfizer and BioNTech have been and “continue to be engaged in large scale clinical trials to evaluate, among other things, whether individuals who receive the vaccine are less susceptible to COVID-19 infection.” As part of these trials, the results of laboratory tests on blood samples drawn from patients in the clinical trials who received the vaccine are evaluated. One of these tests is a “neutralization assay,” which is a laboratory procedure to detect the presence of antibodies in the blood of a patient after receiving a vaccination capable of neutralizing the SARS-CoV-2 virus. As part of the assay mentioned above, a fluorescent “tag” is used to track the vaccine in a patient’s blood. Allele alleged in its complaint filed in October 2020 that Pfizer and BioNTech infringed their patent for their particularly engineered tag.