On April 4, 2014, Chief ALJ Charles E. Bullock issued the public version of Order No. 17 (dated March 14, 2014) in Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903). In the Order, ALJ Bullock granted Complainant BTG International Inc.’s (“BTG”) motion to compel Respondents Laboratorios Silanes, S.A. de C.V., Instituto Bioclon, S.A. de C.V., and Rare Disease Therapeutics, Inc. (collectively, “Silanes”) to produce samples of the accused snake antivenom compositions.
According to the Order, BTG asserted that Silanes had failed to comply with a Request for Production (“RFP”) that sought ten samples of each composition of snake antivenom manufactured, imported, offered for sale, sold for importation into the U.S., or sold or offered for sale after importation into the U.S. after January 1, 2010. BTG argued that FDA regulations did not prevent importation of the samples. BTG further argued that the safe harbor provision of 35 U.S.C. § 271(e)(1) could not be used to refuse production of samples that were being held within the U.S. BTG also argued that the production of the requested samples would not be an infringing importation because the samples would only be used for testing purposes in the investigation.
Silanes opposed the motion. In particular, Silanes argued that the RFP at issue was overbroad, that the requested samples would need to be imported from Mexico and that this was unduly burdensome, and that BTG had failed to articulate any reason why it needed to test the samples, as Silanes had already provided BTG with the accused products’ molecular compositions and other test results.
The Commission Investigative Staff (“OUII”) supported BTG’s motion. OUII argued that Silanes had failed to show that the samples were outside the scope of the RFP and had failed to cite any specific statute or FDA regulation that prevented importation of the samples. OUII further argued that BTG has the right to perform its own testing and should not be forced to rely on the test results provided by Silanes.
After considering the arguments, ALJ Bullock determined to grant BTG’s motion. The ALJ ordered Silanes to produce samples responsive to the RFP within ten days of BTG’s identifying a person who could lawfully accept the samples. ALJ Bullock further ordered that BTG and Silanes should each bear half of the total cost of producing the samples.