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)
Is the genus claim dead, or has its demise been greatly exaggerated? We may soon have the Supreme Court’s answer. On April 18, following eight years of patent infringement litigation between Amgen and Sanofi, including two trials and two Federal Circuit appeals, the Supreme Court called for the views of the Solicitor General (“SG”) on Amgen’s petition for a writ of certiorari after the Federal Circuit invalidated its asserted patent claims for failing to satisfy the enablement requirement. See Amgen Inc. v. Sanofi, 987 F. 3d 1080 (Fed. Cir. 2021). The subject patents are directed to a genus of antibodies defined not by their structure (e.g., amino acid sequence) but by their function—specifically, the ability of the antibodies to bind certain parts of the PCSK9 antigen. Although these antibodies are not per se immunotherapeutic—PCSK9 is a target for treating high cholesterol and does not implicate immune system modulation—the Supreme Court’s resolution of the enablement questions presented will certainly have consequences for patenting protein immunotherapies, particularly antibodies, where claims are frequently drawn to genus-type claims with limitations to binding of immunoregulatory antigen targets.
In a warning to patent owners, a patent whose term had been extended through Patent Term Adjustment (“PTA”) was recently found invalid for obviousness-type double patenting (“ODP”) by the U.S. Patent Trial and Appeal Board (“PTAB”). Ex Parte Cellect Patent Owner and Appellant, Appeal No. 2021-00503, 2021 WL 5755329 (PTAB, Dec. 1, 2021). This is particularly concerning for makers of biopharmaceuticals, especially immunotherapeutic proteins and other biologic drugs. The duration of the patents protecting these drugs is critical to their value, and the terms of these patents are often extended by PTA. Moreover, effective lifecycle management strategies for immunotherapeutics typically involve developing broad, independent patent portfolios (often covering new or extended medical indications), increasing the risk of generating potentially invalidating ODP art.
Companies have been exploring the potential to use combinations of various checkpoint inhibitors to enhance the treatment of patients with various cancers. The recent approval by the U.S. Food and Drug Administration of Bristol Myers Squibb’s Opdualag™ for the treatment of patients with unresectable or metastatic melanoma shows that such combinations offer new avenues for patients suffering from cancer. Opdualag™, a fixed-dose combination of the antibodies nivolumab (a programmed death-1 inhibitor) and relatlimab (a lymphocyte activation gene-3 inhibitor) formulated as a single intravenous injection, showed improved results compared to nivolumab monotherapy.
