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

March 23, 2020 marked the tenth anniversary of the enactment of the Biologics Price Competition and Innovation Act (BPCIA), which provided the approval pathway for biosimilar products. While it was five years before the first biosimilar—Sandoz’s Zarxio—was introduced in the United States, we now have twenty-six approvals and seventeen biosimilars on the market. With the steep increase in biologic drugs, presently accounting for 50% of sales within the pharmaceutical market, the pace of biosimilar development and approvals is increasing. Indeed, we now have multiple biosimilars competing in the same categories (e.g., five biosimilars of cancer immunotherapy drug Herceptin and six of autoimmune treatment Humira) and this occurrence will certainly reoccur.

Since BPCIA enactment, there have been numerous litigations and post-grant reviews relating to the patent portfolios of reference product sponsors (RPS). These disputes have served to clarify Continue Reading Ten Years Into the BPCIA—How Will Immunotherapy Biologics Fare?

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