Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the ’221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates.  Allele argues that Regeneron, Pfizer and BioNTech have been infringing the ‘221 patent by taking mNeonGreen “for their own unauthorized commercial testing and development.”

Regeneron has been in the news lately for famously providing the “antibody cocktail” given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.

The ‘221 Patent

The ’221 patent, titled “Monomeric Yellow-Green Fluorescent Protein from Cephalochordate,” was assigned to Allele and directed to high performance monomeric yellow-green fluorescent proteins. Although mNeonGreen was “Allele’s breakthrough in fluorescent protein technology,” Allele has many other achievements, including advances in “RNA interference, Fluorescent Proteins, Induced Pluripotent Stem Cells (iPSCs), Genome Editing, and camelid derived Single Domain Antibodies.” Most recently, Allele has also been “actively engaged in combating COVID-19, initiating impactful diagnostic and therapeutic platforms premised on speed, accuracy, and sensitivity.” Allele’s mNeonGreen technology has been licensed to hundreds of organizations and universities. As asserted by Allele, mNeonGreen “facilitates quick, targeted, and precise receptor research, including for potential therapeutics to treat COVID-19.”

Complaint Against Regeneron

Allele filed a Complaint against Regeneron in the U.S. District Court for the Southern District of New York alleging that Regeneron has been using Allele’s patented mNeonGreen technology. Allele cited multiple published articles and papers written by Regeneron representatives. The Complaint noted that Regeneron did not have a license to use Allele’s mNeonGreen technology, despite Allele’s consistent showing “that it is willing to license its mNeonGreen technology on reasonable terms in order to help facilitate the use of that protein by third parties in their efforts to develop new and essential technologies.” Also, according to the Complaint, Allele sought to discuss licensing arrangements with Regeneron after learning of the infringement of the ’221 patent, but Regeneron ignored Allele’s attempts.

The Complaint asserted that Regeneron directly infringed the mNeonGreen technology claimed in the ’221 patent and, by way of its publications, press releases, and other papers, caused others to directly infringe the mNeonGreen technology claimed in the ’221 patent. Thus, Allele asked the court, in part,  for: (1) a finding that the ’221 patent is valid and enforceable, (2) a judgment that Regeneron had “infringed, actively induced infringement of, and/or contributed to the infringement of one or more claims of the ’221 patent”, (3) a judgment that Regeneron’s infringement was willful, and (4) an award of damages or other monetary relief to adequately compensate Allele for Regeneron’s infringement of the ’221 patent, and “such damages be trebled under 35 U.S.C. § 284 and awarded to Allele, with pre-judgment and post-judgment interest as allowed by law.”

Complaint Against Pfizer and BioNTech

The Complaint against Pfizer and BioNTech (collectively, Defendants) was filed in the U.S. District Court for the Southern District of California and alleges that the Defendants infringed Allele’s ‘221 patent using mNeonGreen throughout their COVID-19 vaccine trials. Pfizer was engaged with BioNTech in the development of their BNT162 MRNA-based vaccine candidate. Allele asserted that “[o]nly 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 $400 million in grants and over $4 billion in sales of the vaccine to- date [which]…was simply the downstream benefit that Defendants enjoyed (and presumably the world will enjoy from the vaccine) from their choice to use Allele’s mNeonGreen.”

According to the Complaint, BioNTech adopted Allele’s mNeonGreen technology in its COVID-19 vaccine trial and literally infringed claims 1, 2, 4 and 5 of the ‘221 patent. Allele asserted that it has not granted the “Defendants authorization, license, or permission to practice the inventions claimed in the ‘221 Patent.” Allele also asserted that Defendants’ infringement was willful because the defendants “had actual knowledge of the ’221 Patent and the obvious risk of infringement by continued use of mNeonGreen throughout their development of their COVID-19 vaccine candidate in the United States.”  Thus, Allele requested, in part, that the court (1) find that the ‘221 Patent has been infringed by the Defendants in violation of 35 U.S.C. §271, (2) find that the Defendants’ infringement of the ‘221 Patent was been willful, (3) award adequate damages to compensate Allele for the Defendants’ infringement, and (4) an award of treble damages for the period of any willful infringement by the Defendants pursuant to 35 U.S.C. § 284.

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