In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) held that domestic industry products do not need to be commercially available to satisfy section 337’s domestic industry requirement.
In Certain Strontium-Rubidium Radioisotope Infusion Systems, Inv. No. 337-TA-1110, Complainant Bracco Diagnostics Inc. (“Bracco”) sued Respondents Jubilant DraxImage Inc. of Quebec, Canada, Jubilant Pharma Limited of Singapore, and Jubilant Life Sciences of Uttar Pradesh, India (collectively “Jubilant”) at the ITC alleging infringement of patents related to strontium-rubidium elution and infusion systems used in positron emission tomography for cardiac imaging.
Complainants at the ITC are required to satisfy the ITC’s “domestic industry requirement,” which has an economic prong and a technical prong. To satisfy this, complainants must prove that an industry in “articles protected by the patent, copyright, trademark, mask work, or design concerned, exists or is in the process of being established.” 19 U.S.C. § 1337(a)(2). Bracco argued that its Model 1700 system satisfies the domestic industry requirement—even though it does not have FDA approval yet and is not commercially available. In contrast, Respondents and the ITC’s Staff argued that the Model 1700 could not satisfy the domestic industry requirement until it received FDA approval and was thereby commercially available. The Respondents and Staff also argued that because the device lacked FDA approval, the continued existence of the domestic industry is uncertain, as the FDA might never approve the device.
ALJ Cheney disagreed with Respondents and Staff and ruled that Commission precedent illustrates that the commercial availability of a patented article is not necessary to show that a domestic industry exists or that an industry is in the process of being established. With respect to the issue of whether the domestic industry would exist in the future, he ruled that domestic industry is assessed at the time of filing and that accordingly it is irrelevant if the product is approved by the FDA or will exist in the future. He noted that the future of any industry is speculative. ALJ Cheney further found that any uncertainty about the domestic industry’s continued existence can be addressed by including reporting requirements in the remedy.
Although ALJ Cheney found that all of the asserted claims were obvious in light of the prior art, this determination is noteworthy for its discussion of the domestic industry. ALJ Cheney’s finding that domestic industry products do not need to be commercially available may be helpful to patentees in the future. His suggestion to include reporting requirements in the remedy may also help patentees whose industries are dwindling—and whose industries are developing.