On May 5, 2022, ALJ MaryJoan McNamara issued the public version (Part I, Part II) of her April 7, 2022 initial determination (“ID”) finding a violation of Section 337 in Certain Plant-Derived Recombinant Human Serum Albumins (“rHSA”) and Products Containing Same (Inv. No. 337-TA-1238).

By way of background, this investigation was instituted in January 2021 based on a December 2020 complaint filed by Ventria Bioscience Inc. of Junction City, Kansas (“Ventria”) alleging violations of Section 337 by Respondents Wuhan Healthgen Biotechnology Corp. of Wuhan, China (“Healthgen”); ScienCell Research Laboratories, Inc. of Carlsbad, California; Aspira Scientific, Inc. of Milpitas, California; and eEnzyme LLC of Gaithersburg, Maryland (collectively, “Respondents”) in the unlawful importation/sale of certain plant-derived rHSAs and products containing same that infringe U.S. Patent No. 10,618,951 (“the ’951 patent”) and U.S. Patent No. 8,609,416 (“the ’416 patent”), and through false designation of origin. The technology at issue involves albumin, a protein used extensively in cell culture due to its multiple binding sites that reversibly bind diverse ligands such as lipids, amino acids, hormones, and peptides. Cell culture, in turn, is used extensively in research development for studying cells, the function of cells, and for production of biological compounds, including therapeutic proteins used in vaccines. Of the four Respondents, only Healthgen participated in the investigation. By the time of the evidentiary hearing in November 2021, only the ’951 patent remained in the investigation.

According to the ID, ALJ McNamara determined that Healthgen’s rHSA product sold under the brand name OsrHSA infringed claims 1 and 11-13 of the ’951 patent, and that these claims were not shown to be invalid. The ID also found that Ventria’s Cellastim®, Exbumin®, Optibumin®, OptiPEAK®, OptiVERO®, and ITSE™+A products satisfied the technical industry prong of the domestic industry requirement for the ’951 patent, and that Ventria has satisfied the economic prong under Section 337(a)(3)(A), (B), and (C). Accordingly, the ALJ found a violation of Section 337 and recommended issuance of limited exclusion orders against Healthgen and the defaulting respondents, and that bond be set at 100%.