Welcome to Immuno-Innovation, Mayer Brown’s blog reporting at the intersection of Immunotherapy and Intellectual Property law with legal analysis, updates on case law and legislative developments, as well as trend-spotting and best practices. Over the last twenty-five years, immunotherapy has been a fast-moving field (even if its newsworthy advances have appeared to proceed in increments), and the innovations that drive it are an abundant source of potentially valuable intellectual property rights. The goal of Immuno-Innovation is to provide the pharmaceutical and biotech industry, our peers and colleagues with timely insights into where the science is headed—and where patents and other IP might follow.
Even in ordinary times, the launch of this blog at the threshold of the 2020s would have been opportune, if not auspicious. As 2019 came to a close, the preceding ten years were hailed as the Decade of Immunotherapy. From cancer vaccines, to the “living drugs” and personalized medicine of CAR-T cells, and viruses reprogrammed to target and kill tumors, the 2010s saw the research of earlier decades culminate in a series of life-saving FDA-approved therapies that harness the human immune system to treat disease. The standard bearer immunotherapy of the 2010s were the checkpoint inhibitors—game-changing therapeutic antibodies that “release the brakes” on the immune system and allow T cells to attack cancer cells, and for which James Allison and Tasuku Honjo won the Nobel Prize in Physiology or Medicine in 2018. As 2019 ushered in 2020, the future of immunotherapy appeared even brighter: investigators using artificial intelligence identified genetic markers that make tumor cells more responsive to antibody treatment; CRISPR gene-editing of T cells proved to enhance their cancer-killing effectiveness; and the gut microbiome emerged as an important factor in the efficacy of immunotherapy.
But these are not, of course, ordinary times. In the early weeks of 2020, nobody could have predicted the scale of the global hopes pinned on immunotherapy or the outsized role immunotherapy would be expected to play for the foreseeable future. COVID-19 (the acute respiratory disease caused by the SARS-CoV-2 coronavirus strain) and the associated pandemic have triggered an appropriately worldwide call to action across hundreds of companies in the life sciences sector, many in collaboration with academic labs and institutions. In the biopharma industry’s concerted efforts to eradicate SARS-CoV-2 by leveraging the astonishing and prolific adaptability of the human immune response, we are seeing a return to the first principles of immunotherapy, of immunology itself.
Our “new” collective vocabulary around COVID-19—on the lips of government officials, policy makers, and scientists and doctors—is necessarily forward looking (to a new treatment, for a new virus) even as it evokes the discoveries and methodologies of more than a century ago in the work of the forebears of modern immunology. Today’s search for a “magic bullet” to selectively target and neutralize the coronavirus finds its roots at the turn of the twentieth century in the “magic bullet” that Paul Ehrlich envisioned in his theory of antibody production; and the use of “convalescent plasma therapy” to treat COVID-19 patients with serum from patients who have already recovered is a present-day extension of the rabbit-to-mouse serotherapy for tetanus first demonstrated in 1890 by Emil Behring and Shibasaburo Kitasato. Above all is the tireless experimentation taking place in dozens of laboratories to develop a vaccine against the coronavirus, almost 225 years after Edward Jenner reported that deliberate exposure to the cowpox virus, “vaccinia,” provided protection against smallpox infection. (It is fitting, then, that the Jenner Institute at Oxford University has one of the first vaccines in human trials.)
The pandemic has already fundamentally transformed the public discourse on drug discovery, preventative medicine, and disease diagnostics. It will undoubtedly also have lasting downstream effects on immunotherapy innovations, as well as on the legal mechanisms to protect them. Immunotherapy is now moving faster than it ever has, and SARS-CoV-2 has added urgency to the advancements in the field. This will naturally present new opportunities for intellectual property procurement and enforcement (although some have questioned whether companies should be patenting during the pandemic, and legislation has been introduced to suspend the terms of patents covering coronavirus therapies until the end of the national emergency); but it will also create new pressure points as the rapidity of innovation, and the practical realities of publicizing new coronavirus drugs and treatments as they emerge, may outpace the ability of companies to perfect the underlying patent rights. Moreover, as antibodies and vaccines to SARS-CoV-2 and related treatments begin to be patented and work their way into legal proceedings, they will add to and clarify a developing body of law, with corresponding effects on immunotherapy patenting as a whole.
A blog focusing on immunotherapy and IP law is more relevant and necessary today than ever before. Mayer Brown’s launch of Immuno-Innovation in these extraordinary times will contribute to the ongoing and important conversations about the critical intellectual property components of these life-savings therapies.