Federal Circuit Upholds ITC Import Ban: Key Rulings on Storage Defense and Domestic Industry Requirements
Patent – Patently-O 2025-02-09
Summary:
by Dennis Crouch
The Federal Circuit has affirmed a US International Trade Commission (ITC) determination that Wuhan Healthgen violated Section 337 through importation of clinical-grade recombinant human serum albumin (rHSA) products that infringe Ventria Bioscience’s U.S. Patent No. 10,618,951. Wuhan Healthgen Biotechnology Corp. v. International Trade Commission, No. 2023-1389 (Fed. Cir. Feb. 7, 2025).
The patentee in the case – Ventria / ExpressTec – is a small biotech company operating out of Junction City Kansas. Their asserted patent is directed to a cell culture media containing rHSA produced via plants genetically modified to include the human genes. The albumin is basically a protein food for growing human cells in artificial laboratory environments. Traditionally, the albumin came from animal sources, such as blood serum, but the plant process has some easy to identify benefits. A key feature of the patented invention is monomer purity. Ideally, the albumin will be in monomer form as opposed to forming dimers or other aggregated groups, and Ventria’s patent particularly requires “less than 2% aggregated albumin.”
Wuhan Healthgen has been competing in the market by supplying its own version of the product exported from its Chinese production facilities and Ventria took action – in the ITC seeking a trade exclusion order of the infringing product.