As we approach ten months of living, working, and studying in our homes, isolated from friends and family and facing ever-increasing numbers of cases, deaths, and further isolation during the winter months, one can be forgiven for occasionally slipping into moments of despair. Yet, despite the public health nightmare, economic tragedy, and the lingering health impacts of the ongoing COVID-19 pandemic, there are silver linings.
Never in recent memory has the public learned so much about the procurement of personal protective equipment and ventilators, the fragility of the supply chain, Health Canada and FDA medical device, therapeutic and vaccine approval procedures, and emergency use authorizations. By and large, we have taken these ever-present activities for granted, or more likely, were previously utterly oblivious to both their existence and importance. At least in this respect, it has been an enlightening ten months.
In the fog of a new pandemic, the immediate primary focus is, as it should be, on stemming the spread of the virus and blunting the death toll with the tools at hand. But in the shadows of the feverish effort to develop easy to use yet accurate diagnostics and effective and safe therapeutics and vaccines, another fight is brewing. Do the manufacturers of these essential products have the right to use some of the technology they incorporate into those products?
This fight has spilled into the open with Allele Biotechnology and Pharmaceuticals Inc.’s (“Allele”) U.S. Patent No. 10,221,221, titled “Monomeric Yellow-Green Fluorescent Protein from Cephalochordate” issued March 5, 2019. The patent protects mNeonGreen, a synthetic fluorophore, and antibody technology used to identify neutralizing antibodies and vaccine candidates. It is now also the focus of a patent infringement lawsuit brought by Allele against Regeneron Pharmaceuticals, Inc. (“Regeneron”), Pfizer, Inc. (“Pfizer”), and BioNTech SE and BioNTech US, Inc. (together “BioNTech”). As it turns out, mNeonGreen may not only have been the lynchpin that allowed the pharma companies to test vaccine candidates at warp speed but was also part of the Regeneron antibody cocktail administered to President Donald Trump during his COVID-19 treatment.
Over the arc of translation and commercialization, blockbuster products, including diagnostics, therapeutics, and vaccines, are developed, tested, and built on the shoulders of thousands of inventions, some of which are not owned by the product manufacturer. In some cases, licensing agreements for rights to use various inventions or technologies are negotiated among companies upfront. In others, licensing negotiations to follow a cease and desist letter threatening litigation for patent infringement. For some, however, licensing only follows a successful patent infringement lawsuit in which the highest court in the land upholds the validity of the patent at issue. In this case, as a conscientious intellectual property owner exercising is exclusionary (or negative) rights, Allele reached out to Regeneron on multiple occasions to negotiate a license for Regeneron’s use of mNeonGreen. Given the lawsuit, Regeneron ostensibly ignored those calls.
While messy on any ordinary day, amid a raging pandemic when first to market advantage of a game-changing product is the equivalent of netting the proverbial golden goose, the stakes of high-profile litigation are astronomical. On November 9, 2020, Pfizer announced that its COVID-19 vaccine showed a staggering 90% efficacy. Could they have achieved that result in such a short time without Allele’s technology? And so, the brewing fight begins!