IP rights offer innovators the exclusive right to exploit their innovations while recovering their expenditures, by providing IP owners with the ability to stop others from commercializing infringing products. During a public health crisis such as the COVID-19 pandemic, where time is of the essence, these competing interests rose to the forefront, as the patent community grappled with the question: how do we effectively balance respecting an owner’s IP rights with promoting the research and commercialization of life-saving vaccines in an expedited way? In the rush to develop COVID-19 vaccines, the patent community balanced these competing interests via patent pledges. However, in the face of other public health challenges even well before the COVID-19 pandemic, several alternative approaches were also proposed by others, including the pooling of Standard Essential Patents (SEPs).Continue Reading During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 2 of 2)

More than two years into the COVID-19 pandemic, we have a clearer picture of how the patent community responded to the rush to develop COVID-19 vaccines: patent pledges.  Patent pledges are voluntary, public commitments that a patent holder makes to refrain from exercising some or all of its patent rights, including suing for patent infringement.  Prior examples of patent pledges can be found in the automotive industry (e.g., electric vehicle makers Tesla and Toyota), the software industry (e.g., IBM and Google relating to open-source code), and in the biotechnology industry (e.g., Monsanto relating to genetically modified seeds and Myriad’s pledge not to assert its DNA patents against academic researchers).  In the midst of the COVID-19 pandemic, many patent holders pledged not to enforce patents needed for vaccine development, the frontline immunotherapy for combating COVID-19.  By April 2020, the Open COVID Pledge platform had been formed, allowing for the large-scale pledging not to enforce COVID-19 vaccine-related patents until the end of the pandemic, as declared by WHO, or January 1, 2023 (likely to be extended).Continue Reading During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 1 of 2)

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
Continue Reading Immuno-Innovation: A Welcome to Readers of Mayer Brown’s Newest Blog, and an Inaugural Post from Our Home Office Outposts During the Pandemic

Antibody-based serology tests and PCR tests for coronavirus are being approved at a breakneck pace by the U.S. Food and Drug Administration under newly relaxed guidelines. As recently as May 8th, the FDA issued an emergency approval for another serology test for coronavirus antibodies, an immunofluorescent sandwich assay necessarily developed in under six months. https://www.fda.gov/media/137886/download. Scientists also just reported the identification of neutralizing antibodies that are unique to SARS-CoV-2, which may trigger a flood of new diagnostic tests. https://www.nature.com/articles/s41586-020-2380-z. Diagnostic tests have proven difficult to patent under
Continue Reading A Glimmer of Light for Immunotherapy Diagnostic Method Patents