Pfizer and co-defendant BioNTech argue that San Diego-based Allele Biotechnology and Pharmaceuticals Inc.'s allegations of infringement related to a patented fluorescent protein called "mNeonGreen" fall under the "safe harbor" provision of the Drug Price Competition and Patent Term Restoration Act because Pfizer and BioNTech purportedly used the protein to gather clinical trial information while pursuing vaccine approval from the U.S. Food and Drug Administration, according to the motion to dismiss.
Even if the court takes Allele's allegations as true, the claims can't stand because the patented protein was used in pursuit of data for submission to the FDA, Pfizer and BioNTech said.
The companies also noted that Allele is not accusing them of selling mNeonGreen, incorporating the protein into the vaccine itself or using the protein in the process of making the vaccine, according to the motion.
"The safe harbor provision allows companies like Pfizer and BioNTech 'to engage in otherwise infringing activities necessary to obtain regulatory approval,'" the companies said, citing the 1990 U.S. Supreme Court case Eli Lilly & Co. v. Medtronic Inc.
Allele filed suit against Pfizer and BioNTech in October, accusing the companies of infringing its patented mNeonGreen technology, which is used in testing antibody and vaccine candidates. Allele also filed a similar lawsuit against Regeneron Pharmaceuticals Inc. in New York.
Allele said its technology was used in Regeneron's experimental "antibody cocktail" given to former President Donald Trump to treat his COVID-19 infection. Hundreds of organizations and universities have licensed the mNeonGreen technology, but Pfizer and Regeneron aren't among them, according to Allele.
"This lawsuit follows because [Pfizer] made the deliberate and calculated decision to infringe rather than even so much as pick up the phone and seek to obtain the rights to use Allele's valuable intellectual property," Allele said
Fluorescent proteins 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 against vaccine candidates.
In their motion Monday, Pfizer and BioNTech said their alleged use of mNeonGreen was "reasonably related" to developing data for FDA approval, meaning they are protected by the safe harbor provision of the Hatch-Waxman Act.
"In short, throughout the complaint, the accused activity by Pfizer and BioNTech is alleged to be part and parcel of the ongoing clinical trials for the COVID-19 vaccine, which are reasonably related to the development and submission of information to the FDA," the companies said. "These activities are unquestionably within the ambit of the statutory safe harbor."
Counsel for BioNTech declined to comment Tuesday and counsel for Pfizer and Allele did not immediately respond to requests for comment.
The patent-in-suit is U.S. Patent No. 10,221,221.
Allele is represented by Ben L. Wagner, Christopher Franich 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 and Charles L. McCloud 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 Hailey Konnath. Editing by Emily Kokoll.
Clarification: The article has been updated to clarify that BioNTech is a party to the motion to dismiss.
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