Patent lawsuit filed over test for vaccines

One of the most prominent pharmaceutical companies in the race to find a cure to COVID-19 infringed on a patented fluorescent protein to develop its trial vaccine, a lawsuit alleges.

Allele Biotechnology and Pharmaceuticals Inc filed a lawsuit Monday in federal court in San Diego, accusing Pfizer Inc. and BioNTech U.S. Inc. of using its invention known as the mNeonGreen to develop a vaccine called BNT162. Allele's invention, which was patented on March 5, 2019, is widely recognized in the pharmaceutical industry as a breakthrough in testing other vaccines and for other applications involving virus testing. The fluorescent protein is used to see if and how well a vaccine is working against an infectious virus.

"What's more, mNeonGreen has been used throughout defendants' COVID-19 vaccine trials right up to the present," the complaint states. "Only through use of mNeonGreen were defendants able to develop and test the BNT162 vaccine candidate at lightspeed, making them first to market, earning them an immediate in grants and over $4 billion in sales of the vaccine to date."

Leading health experts have estimated that a vaccine could be widely available in the United States by mid-2021, a promising outlook for an end to the public health crisis that eliminated millions of jobs, upended the global economy and killed more than 206,000 people across the nation. Pfizer has been leading a pack comprised of other prominent drugmakers including Moderna, Astrazeneca and Johnson & Johnson in the race to develop a Covid-19 vaccine.

The lawsuit accuses Pfizer and BioNTech of working together to develop their BNT162 vaccine by using Allele's technology without permission. BioNTech sponsored the study, with Pfizer responsible for the design, data collection, analysis and interpretation, and drafting their findings. The pair scored large government grants and secured purchases of their vaccine. Pfizer's vaccine is part of the Phase 3 trial scheduled to enroll 30,000 participants as of Sept. 21. The U.S. government placed an initial order of 100 million doses for up to $1.95 billion, and could acquire up to 500 million additional doses, according to Pfizer. Allele Biotechnology v. Pfizer, et al., 3:20CV01958 (S.D. Cal., filed Oct. 5, 2020)

"Where there is a race against time, weaker fluorescent alternatives are simply no option. mNeonGreen was a critical link in defendants' COVID vaccine development and its continued trial success," the lawsuit states.

Pfizer and BioNTech could not be reached for comment Monday.

Ben L. Wagner, partner at Troutman Pepper Hamilton Sanders LLP, said in an interview Monday that none of the defendants ever contacted his client about the process.

"It's exactly as we expected, which is good, because by all means this fluorescent is the one that should be used to discover which vaccine is the best so we don't fall behind and get something out to the world as quickly as possible," Wagner said. "It's being used the way it was intended; unfortunately, it was just done without Allele's involvement."

The mNeonGreen protein is inserted into a SARS-Co-V-2 virus strain to measure the effectiveness of the vaccine against the virus. The protein is used like a yardstick to see how the virus is replicating inside its host. It measures how much virus is present and how fast it is contracting in terms of replication. The protein was developed by Allele more than six years ago.

BioNTech admitted in its 6-K form that its vaccine candidate was made possible by using the mNeonGreen gene to insert into the virus strain.

BioNTech and Pfizer made headlines since July announcing different agreements with the U.S. and the European Union to provide millions of doses of the BNT162 vaccine. The pair even provided an expression of interest for possible supplies to several health experts, including the World Health Organization.

The case has been assigned to U.S. District Judge Gonzalo P. Curiel of the Southern District of California.

A similar patent lawsuit was filed by Allele in New York against Regeneron Pharmaceuticals on Monday. Regeneron is also accused of using mNeonGreen commercially without permission from Allele. Perkins Coie LLP is representing Allele in the New York action.