UPDATED: ITC blocks Chinese imports of rice-derived rHSA products after ALJ review
Commission overturns one ALJ finding but affirms all others, agreeing that Wuhan Healthgen infringed Ventria's rice seed patent | Dispute concerns recombinant human proteins derived from genetically engineered rice.
The US International Trade Commission ( ITC) has affirmed with modifications an administrative law judge’s (ALJ’s) finding that products made by a Chinese company infringe a patent belonging to Ventria Bioscience.
In its opinion made public on October 11, the Commission affirmed that Wuhan Healthgen Biotechnology's clinical-grade products infringed Ventria's patent, but reversed the ALJ's finding that its medium-grade (cell culture) products also infringed.
The dispute concerns plant-derived recombinant human serum albumins (rHSA) and related products, expressed by genetically engineered rice developed by Ventria.
The rice seeds produce either human serum albumin, contained in blood, or lactoferrin, an iron-binding protein found, for example, in human milk. The albumins, or proteins, are extracted for use in the therapeutic and medical fields.
Healthgen was found to have used the proteins in its rHSA products, sold under the brand name OsrHSA, which it imported to the US from China. Healthgen’s OsrHSA is supplied as ‘medium grade’ and ‘culture grade’ powder; and a ‘clinical grade’ powder and liquid.
Initial complaint
In January 2021, the ITC launched an investigation into Healthgen following a complaint filed by Ventria the month before alleging infringement of its US patents 10,618,951 (‘951) and 8,609,416 (‘416).
The ALJ received a briefing and subsequently held a Markman (pre-trial) hearing in May 2021, issuing a Markman Order in August 2021; the ‘416 patent was dropped following a number of evidentiary hearings later that year.
After a week-long trial in April 2022, Administrative Law Judge MaryJoan McNamara found that the patent in question (US patent no. 10,618,951 or ’951) violated section 337 of the Tariff Act of 1930. The ITC subsequently set out to review this finding two months later.
Meanwhile, in August, the US Patent and Trademark Office ( USPTO) denied a request by Healthgen for an inter partes review of the patent.
Following its review, the ITC issued a limited exclusion order and cease-and-desist orders in September 2022 banning Healthgen, along with US-based firms ScienCell Research Laboratories, Aspira Scientific, eEnzyme—distributors of Healthgen’s rice-derived albumin products—from importing the albumins and related products into the US.
Of these four respondents, only Healthgen participated in the investigation. ScienCell, Aspira, and eEnzyme were found in default.
‘Impure’ products
In the ITC's conclusion this month, while affirming that all of Healthgen’s clinical-grade products infringe Ventria’s patent, it overturned the ALJ’s finding that Healthgen’s medium-grade products infringe, stating that they were “very impure”.
The purity level of the products is defined by a requirement of 2% or more aggregated albumin, and future imports by Healthgen must each be shown to be non-infringing by this requirement, regardless of whether the imports are labelled as “medium grade” or “culture grade.”
Ventria said that this outcome was a "win for American innovation and American manufacturing".
“Ventria Bioscience is pleased the ITC found Wuhan Healthgen in violation of US trade law," the company said in a statement.
“The ITC affirmed the validity of the ’951 patent, affirmed that Ventria satisfies the domestic-industry requirement, and has excluded Wuhan Healthgen’s infringing products from the US market (in addition to imposing orders against Healthgen’s distributors for concealing the Chinese origin of these products).
“Regarding the ITC’s finding that one Wuhan Healthgen product does not infringe, that was specifically based on the conclusion that such product is “very impure”—hardly a victory for Wuhan Healthgen, and a result that should concern users of Healthgen’s rHSA.”
But a spokesperson from Finnegan, which represented Wuhan Healthgen, said: “This is an important victory for Healthgen and customers of rHSA products, who have generally viewed Healthgen’s product as superior to Ventria’s.
“Ventria apparently felt threatened by Healthgen’s superior product, and decided to bring various legal actions and make spurious allegations against Healthgen rather than competing in the marketplace.
“Healthgen appreciates the Commission’s review and reliance on the testing data (especially Ventria’s own in-house testing data) to find Healthgen’s medium-grade products do not infringe.”
This article was updated on Friday, October 21 to clarify aspects of the case.
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