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?

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.

Previously, several district courts have split on whether a PTA-based extension of patent term is vulnerable to ODP. In 2021, two New Jersey district court decisions found Continue Reading Does the PTAB’s Recent Ex Parte Cellect Decision Signal Concern for the Valuable Patent Terms of Biopharmaceuticals?

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

The CRISPR-Cas9 gene editing system has revolutionized genetic engineering. Over the last decade, this technology has exploded at a breathtaking pace due to its simplicity, scalability, affordability and adaptability. Currently, the CRISPR-Cas9 system is employed in molecular biology laboratories all around the world and has been used to edit the genomes of a myriad of organisms from bacteria to yeasts to plants to mammals. This is particularly true in the cancer immunotherapy sphere, where the CRISPR-Cas9 system has been successfully used to genetically enhance different cancer-killing properties of human immune cells. Pickar-Oliver and Gersbach, 2019, Nature Reviews Molecular Cell Biology 20(8), 490-507.

Considering the potential application of the CRISPR-Cas9 system in the immunotherapy space, it is helpful to stay abreast of developments concerning the patenting of this technology. While there are a plethora of patents and patent applications relating to CRISPR, Continue Reading Talk in the Biotech Industry has Focused on the Broad Institute’s Big Win—But Will Continued Scientific Development Minimize Its Impact?

Immunotherapy treatments such as antibodies targeting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1) and PD-1 ligand1 (PD-L1) have shown promise in reactivating weakened immune cells to fight cancer. While these immunotherapies have had a dramatic impact in some cancer patients, the positive results only appear in a fraction of cases. The cost of treatment and potential for immune-related adverse events make it imperative that doctors have protocols to identify patient populations with an increased likelihood of successful outcomes with immunotherapy. This has led to a search for predictive biomarkers that may allow identification of such patients. Some have turned to artificial intelligence (AI) to scour data to identify common biomarkers or other covariates in patients successfully treated with immunotherapy.

AI has the capability of reviewing a staggering amount of patient data to identify recurring patterns of shared predictive factors that would elude unaided human capacity. Continue Reading Patent Considerations for Optimizing Immunotherapies with the Help of Artificial Intelligence

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