In early October 2020, drugmakers Pfizer and Regeneron Pharmaceuticals were named in a pair of patent infringement lawsuits, filed in California and New York respectively, claiming the companies used patented technology in the development and testing of COVID-19 vaccines and treatments. Filed by Allele Biotechnology, the complaints allege that the companies improperly utilized Allele’s mNeonGreen technology.
Allegations Over mNeonGreen
Allele Biotechnology’s claims against Pfizer and Regeneron Pharmaceuticals centers on the companies’ purported unlicensed usage of Allele’s mNeonGreen technology. This technology is a reagent—a substance used to cause a chemical reaction in a laboratory test— and was patented in 2019 under U.S. Patent No. 10,221,221.
The mNeonGreen technology has proven to be an important component in the development of COVID-19 assays for testing vaccines and treatments. One type of biomarker used in laboratory assays is a class of proteins called fluorescent proteins, which will emit the light of one wavelength when exposed to the light of a different wavelength. mNeonGreen is an artificial fluorescent protein that has contributed to creating what is considered the “the gold standard” of COVID-19 assays. The mNeonGreen proteins are “among the brightest known in [their] class and have exceptional utility as a biomarker and/or protein fusion tag,” according to the patent. These proteins do not exist in nature but were developed by Allele for the purpose of creating an improved assay.
The Complaints Against Pfizer and Regeneron
In its complaint filed against Pfizer in the U.S. District Court for the Southern District of California, Allele holds that “mNeonGreen belongs to Allele, as does the ‘221 Patent covering the exclusive right to use mNeon Green.” Allele also names Pfizer’s partner BioNTech as a defendant. A similar claim was filed against Regeneron in the U.S. District Court for the Southern District of New York.
The complaint also explains that other pharmaceutical companies, as well as some universities, have licensed Allele’s mNeonGreen technology for use in their own laboratories. However, Allele alleges that neither Pfizer nor Regeneron are among those with valid licenses to use the technology. “This lawsuit follows because [Pfizer] made the deliberate and calculated decisions 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 claimed in its complaint against Pfizer. By improperly using the mNeonGreen technology, Allele claims, Pfizer managed to be first to market with its BNT162 vaccine for COVID-19, “earning them an immediate $45 million in grants and over $4 billion in sales of the vaccine to date.”
Allele also claims that Renergon used mNeonGreen improperly during the creation of its monoclonal antibody cocktail. This experimental concoction was among the treatments given to President Donald Trump after he tested positive for COVID-19.
The Race for a Vaccine Continues
Regeneron has refuted the claims made by Allele. To date, Pfizer has remained silent on the matter. Both companies, however, are expected to push back against Allele’s claims in court. And though these cases have yet to be resolved, they are unlikely to slow the pace of vaccine and treatment development for COVID-19. Allele’s demands in both lawsuits include an unspecified amount in damages. They do not, however, include a claim for equitable relief, such as an injunction.
Allele’s decision not to request equitable relief is consistent with the company’s public interest in licensing mNeonGreen for use in developing COVID-19 vaccines and treatments. Allele’s president said in a statement, “In no way does Allele want to prohibit or slow down development of vaccines or therapeutics discovered using this technology. Our goal is to have these companies recognize, as many others have before them, the hard work that went into developing this technology and to respect our intellectual property.”
Expert Witnesses in Pharmaceutical Patent Infringement Claims
Patent infringement claims often demand the assistance of expert witnesses. Understanding how a patent is infringed often means understanding how the patent’s covered technology is novel, how it is implemented, and what results can be reached with the patented technology that would not have been reached without it.
Here, expert witnesses will likely be asked to opine on all three questions. Experts in technologies like mNeonGreen artificial proteins can help clarify what makes mNeonGreen different from other reagent options, how mNeonGreen is used to develop COVID-19 vaccines and treatments, and what the results likely would have been if Pfizer and Regeneron had used a different assay to help them develop their respective countermeasures. This will require top expertise in the fields of biochemistry, biology, chemistry, and clinical development.