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 assessed after PTA is applied to a patent, meaning that PTA does not protect a patent from ODP.
Scott McMurry, PhD, is counsel in Mayer Brown's New York office, member of the Intellectual Property and Life Sciences practice. He is a trained organic chemist and Registered Patent Attorney. He regularly advises clients in all aspects of IP issues, focusing on patent litigation and due diligence in mergers and acquisitions, including the largest biopharmaceutical reverse merger to date. He frequently counsels clients on the intersection of IP and regulatory issues for biologic and small molecule drugs.
Scott also brings extensive experience in all manner of patent litigations and pharmaceutical technology. He has successfully defended market-leading blockbuster products in Hatch-Waxman litigation, inter partes reviews and ITC investigations, and has extensive experience in patent strategy and global portfolio development for large cap pharmaceutical companies and research universities. Prior to law school, Scott performed drug discovery research in medicinal chemistry at a global pharmaceutical company.
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?
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