The Federal Circuit has issued a unanimous precedential decision holding that a patent whose term was extended through Patent Term Adjustment (“PTA”) can be invalidated for obviousness-type double patenting (“ODP”), affirming the PTAB’s Ex Parte Cellect decision that we discussed in a previous post. The Court agreed with the PTAB that ODP should be
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During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 2 of 2)
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
During a Public Health Emergency Should Patents Covering Vaccine Development Be Treated as Standard Essential Patents? (Part 1 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.
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?
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
Does the PTAB’s Recent Ex Parte Cellect Decision Signal Concern for the Valuable Patent Terms of Biopharmaceuticals?
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
Antibody Combinations in Immunotherapy Offer New Opportunities for Innovators to Strengthen IP Protections
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
Talk in the Biotech Industry has Focused on the Broad Institute’s Big Win—But Will Continued Scientific Development Minimize Its Impact?
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
Patent Considerations for Optimizing Immunotherapies with the Help of Artificial Intelligence
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.
Immuno-Innovation: A Welcome to Readers of Mayer Brown’s Newest Blog, and an Inaugural Post from Our Home Office Outposts During the Pandemic
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),
Ten Years Into the BPCIA—How Will Immunotherapy Biologics Fare?
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
