Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm’n
Authored by: Jeremy J. Gustrowsky
In a recent decision, the Federal Circuit affirmed the International Trade Commission’s (ITC) finding that Wuhan Healthgen Biotechnology Corp. infringed Ventria Bioscience Inc.’s U.S. Patent No. 10,618,951, which covers cell culture media containing recombinant human serum albumin (rHSA) produced in genetically modified plants. The case centered on whether Healthgen’s imported clinical grade rHSA products met the patent’s requirement of containing “less than 2% aggregated albumin,” and whether Ventria’s domestic activities were enough to establish a “domestic industry” under U.S. trade law.
The court agreed with the ITC that Healthgen’s products did, in fact, infringe the patent. The key evidence was laboratory data showing that Healthgen’s clinical grade rHSA contained at most 1.1% aggregated albumin—comfortably under the 2% threshold required by the patent. Healthgen argued that this measurement, taken in China shortly after manufacture, did not reflect the product’s condition upon arrival in the U.S., since aggregation could increase during shipping and storage. However, the court found no convincing evidence that aggregation would rise above 2% by the time of importation, and even Healthgen’s own later testing showed levels below the limit.
A crucial part of ITC proceedings is proving that a U.S. “domestic industry” exists for the patented product. Here, Ventria relied on its Optibumin product, arguing that all of its investments in plant, equipment, labor, and research for Optibumin occurred in the United States. The court found that even though the dollar amounts involved were relatively small, the investments were significant when compared to Optibumin’s revenue and were entirely domestic. The decision emphasized that there is no minimum dollar threshold for a domestic industry, and that smaller companies should not be denied protection simply because their investments are less than those of larger firms.
This ruling highlights that both technical and economic requirements must be met for a successful ITC action, but also that the law is flexible enough to protect innovative smaller businesses. For patent owners, it’s a reminder that clear technical evidence and thorough documentation of domestic activities can be key to enforcing rights at the border.