Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our California newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (May 5, 2021, 5:18 PM EDT ) A California federal judge has refused to toss Allele Biotechnology and Pharmaceuticals Inc.'s suit claiming Pfizer and BioNTech poached research technology while testing their COVID-19 vaccine.
U.S. District Judge Marilyn L. Huff on Tuesday denied Pfizer Inc. and BioNTech SE's motion to dismiss the suit over Allele's patented fluorescent protein called mNeonGreen, which Allele has alleged Pfizer and BioNTech used to select their vaccine candidates and do clinical trials, enabling them to be first to market a COVID-19 vaccine.
The defendants had urged the court to reject Allele's "doomsday warnings" that dismissing the case under the safe harbor provision of the Hatch-Waxman Act over their vaccine will destroy patent rights.
But Judge Huff's decision said that the Federal Circuit has found that "research tools or devices that are not themselves subject to [U.S. Food and Drug Administration] approval may not be covered" by the provision, and that other federal courts have said that "research tools that are not themselves subject to FDA approval are excluded from the … safe harbor."
Fluorescent proteins such as Allele's patented mNeonGreen artificial fluorescent are a class of proteins capable of emitting the light of one wavelength when exposed to the light of a different wavelength, according to the suit.
Allele said its mNeonGreen is a "breakthrough" artificial fluorescent that's been used to make "the gold standard" COVID-19 assay for testing of vaccine candidates.
Allele claims their use of mNeonGreen enabled Pfizer and BioNTech to save "precious time" and be the first to bring their COVID-19 vaccine to market, and that Congress intended the safe harbor provision to allow generics makers to prepare for commercialization after a patent expires, not to be a greenlighted for infringement.
The biotech companies argued in their bid for dismissal that the suit was a "burden" on their continued work on the vaccine, with Allele countering that the only burden is to Pfizer's effort to rake in billions of dollars from the pandemic.
"We appreciate Judge Huff's prompt action and thoughtful analysis," Allele President and CEO JiWu Wang said in a statement provided to Law360. "The patent rights of research tools like mNeonGreen, developed through knowledge and hard work, must be preserved and respected."
Pfizer said in a statement that it was "disappointed about the ruling." The company said that it stood by its "position that Allele's lawsuit is not supportable."
"Pfizer is continually analyzing the patent landscape to ensure it has or acquires freedom to operate," Pfizer said. "As always, we will respect valid patents, while being prepared to challenge others when appropriate."
Counsel for BioNTech did not immediately respond to requests for comment Wednesday.
Allele is represented by Ben L. Wagner and Robert Schaffer of Troutman Pepper Hamilton Sanders LLP.
Pfizer is represented by David J. Noonan and Genevieve M. Ruch of Noonan Lance Boyer & Banach LLP and Stanley Fisher, Thomas Selby, Charles L. McCloud and Michael Xun Liu of Williams & Connolly LLP.
BioNTech is represented by Elizabeth L. Brann, Bruce M. Wexler and Merri C. Moken of Paul Hastings LLP.
The case is Allele Biotechnology and Pharmaceuticals Inc. v. Pfizer Inc. et al., case number 3:20-cv-01958, in the U.S. District Court for the Southern District of California.
--Additional reporting by Britain Eakin. Editing by Bruce Goldman.
For a reprint of this article, please contact reprints@law360.com.
