Pfizer and BioNTech Claim Immunity from COVID-19 Vaccine Testing IP Claim

Pfizer and BioNTech recently asked the Southern District of California to dismiss a patent infringement claim from Allele Biotechnology related to Pfizer and BioNTech’s Covid-19 vaccine.

Allele holds a patent for a fluorescent protein called mNeonGreen, which causes some cells to glow when exposed to certain kinds of light.  Allele does not claim that mNeonGreen is used in the vaccine or was used by Pfizer and BioNTech to develop the vaccine, but rather that mNeonGreen is used in one of the clinical tests to detect the presence of antibodies in a patient that was given the Covid-19 vaccine.  A third party created a pseudo Covid-19 virus containing mNeonGreen, which then introduced to a sample of a patient’s blood cells.  If the patient has no antibodies to Covid-19, the pseudo virus will infect the blood cells and the cells will fluoresce, allowing the detection of the virus.  No fluorescence means that the cells were not infected with the virus, and that the patient therefore has antibodies to Covid-19.

Allele claims that mNeonGreen was used repeatedly throughout Pfizer and BioNTech’s vaccine trials and was referenced multiple times in their Emergency Use Application to the FDA.  At the same time, Allele filed suit against Regeneron, the maker of an experimental antibody cocktail found to be successful in treating Covid-19 (and was famously given to President Trump just days before Allele filed suit against Regeneron).  Allele claims that its product was infringed by both the antibody cocktail and the vaccine.

Pfizer and BioNTech argue that they fall within the safe harbor in 35 U.S.C. 271(e)(1), which allows the use of patented inventions for “uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs….”  Citing Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 671 (1990), Pfizer and BioNTech claim that they are permitted to “engage in otherwise infringing activities necessary to obtain regulatory approval,” including under their Emergency Use Application to the FDA.  Because Pfizer and BioNTech used mNeonGreen only in the context of clinical trials to asses the presence of Covid-19 antibodies, Pfizer and BioNTech argue that they fall within the safe harbor provision of the statute.

The hearing on Pfizer and BioNTech’s motion to dismiss is set for May 3.  Given the high stakes of the Covid-19 testing and vaccine market, it will certainly be closely watched.