Pfizer-BioNTech feeling the heat from Allele Biotech

Does blood sample testing in COVID-19 vaccine clinical trials fall within the Hatch-Waxman Act's statutory “safe harbor"?

Allele Biotechnology sued Pfizer-BioNTech for patent infringement and contends Pfizer-BioNTech has been leveraging its patented "mNeonGreen" to track the COVID-19 vaccine in patients' blood during clinical trials. The District Court is grappling with whether implementation of Pfizer-BioNTech's "neutralization assay" (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) infringes Allele Biotech's fluorescent protein "mNeonGreen" used to track the vaccine in blood.

To the non-biotech folks among us (myself included), "mNeonGreen" monomer is among the brightest and most stable monomeric fluorescent reporter proteins currently known. Frankly, this is at the heart of how Pfizer-BioNTech implemented clinical trial testing.

Pfizer-BioNTech contends it is acting within the Hatch-Waxman Act statutory “safe harbor":

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Pfizer-BioNTech's argues its testing, conducted on blood samples from clinical trial patients, is for the benefit of obtaining data for submission to the FDA as part of the approval process for the COVID-19 vaccine. Such testing, it contends, is “reasonably related” to the development and submission of information to the FDA in order to obtain regulatory approval.

On the other hand, Allele Biotech argues mNeonGreen is a “research tool” that “does not require government approval for clinical use.” As such, it does not amount to a use "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs."

Pfizer-BioNTech filed its Memorandum in support of its motion to dismiss on Feb. 8, 2021. This will be an interesting case to track, and a fundamental one for Pfizer-BioNTech.