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)
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.
The issue for the Supreme Court’s review if certiorari is granted is the standard for assessing enablement for broadly drafted claims to a functionally defined genus covering potentially many thousands (if not millions) of compositions when only a relatively few working embodiments are disclosed in the specification. Amgen’s petition argues that
Continue Reading Amgen Inc. v. Sanofi: Does the Supreme Court’s Call for the Solicitor General’s Views Signal an Intention to Resolve Important Enablement Questions for Genus Claims?
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.
These results are good news from a clinical perspective. They also provide good news from a patent protection perspective because
Continue Reading Antibody Combinations in Immunotherapy Offer New Opportunities for Innovators to Strengthen IP Protections
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?