37 C.F.R. § 1.801
Biological material
For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. 101, the term biological material shall include material that is capable of self-replication either directly or indirectly. Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles and other non-living material existing in and reproducible from a living cell may be deposited by deposit of the host cell capable of reproducing the non-living material.
Notes of Decisions
Cited in 2
cases (1 in the last 5 years), 2002–2024 · leading case: Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013 (Fed. Cir. 2002).
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013 (Fed. Cir. 2002). “37 C.F.R §§ 1.801 — 1.809. Those regulations provide inter alia that “[wjhere an invention is, or relies on, a biological material, the disclosure may in- *1028 elude reference to a deposit of such biological material.”
Corteva Agriscience LLC v. Inari Agric., Inc. (D. Del. 2024). ““37 CFR § 1.801 does not attempt to identify what biological material either needs to be or may be deposited to comply with the requirements of 35 U.”
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