By Britain Eakin

Law360 (April 16, 2021, 7:09 PM EDT) -- Allele Biotechnology and Pharmaceuticals Inc. warned Friday that letting Pfizer and BioNTech off the hook for allegedly poaching its research technology while testing their COVID-19 vaccine would "destroy established patent rights."

Allele made the argument in its opposition to Pfizer and BioNTech's motion to dismiss the infringement suit under the safe harbor provision of the Hatch-Waxman Act. The biotechnology companies contended that the safe harbor shields them from infringement, but Allele argued that accepting their position would turn the law "into a playground for willful infringers to eviscerate undisputed patent rights." 

Allele's October suit relates to a patented fluorescent protein called "mNeonGreen," which is used in testing antibody and vaccine candidates that it claims enabled Pfizer and BioNTech to save "precious time" and be the first to bring their COVID-19 vaccine to market. Allele also filed a similar lawsuit against Regeneron Pharmaceuticals Inc. in New York.

In their motion to dismiss, Pfizer and BioNTech argued that when alleged infringement is done as part of an ongoing submission to the U.S. Food and Drug Administration, like in their effort to seek full approval for their COVID-19 vaccine, the safe harbor protects them from infringement liability. But Allele said the safe harbor doesn't shield those who allegedly infringe research tools like mNeonGreen from liability.

Congress intended the safe harbor provision to allow generics makers to prepare for commercialization after a patent expires, not to be a greenlight for infringement, Allele said.

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 alleged that Pfizer and BioNTech have been using mNeonGreen to select their vaccine candidate and do clinical trials, among other things.

The biotech companies, however, argued in their bid for dismissal that the suit was a "burden" on their continued work on the vaccine. In its opposition, Allele suggested the only burden is to Pfizer's effort to rake in roughly $4.35 billion from the pandemic.

JiWu Wang, Allele president and CEO, told Law360 that "the use of mNeonGreen in developing a life-saving COVID-19 vaccine in the shortest time in history proves the power of a critical research tool it was designed to be, as part of the strength and foundation of basic research conducted in the US by scientists like us."

He went on to say that Allele looks forward to the court's decision.

Counsel for Pfizer and BioNTech did not immediately return a request for comment.

The patent-in-suit is U.S. Patent No. 10,221,221.

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 Adam Lidgett, Lauren Berg and Hailey Konnath. Editing by Amy Rowe.

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