Drug Reimportation Comes to the ITC as a Gray Market Trademark Complaint
The German pharmaceutical company Merck Group (EMD Serono in the United States) filed a Section 337 complaint at the ITC on March 11 seeking a general exclusion order against imports of In Vitro Fertilization Products, and Components Thereof, and Products Containing the Same. The allegations in the complaint revolve around a prescription drug importation scheme in which Turkish pharmacies are selling various brand-name fertility drugs to Americans through a website called fastivf.com. Merck Group claims these are gray market imports that infringe its registered U.S. trademark.
Although much less common than patent cases, trademark infringement is the most frequent complaint asserted in non-patent-based Section 337 investigations at the ITC. And of the twelve trademark complaints the ITC has received since 2017, three of those have involved gray market imports (genuine goods meant for foreign markets but not authorized for sale in the United States). This IVF Products complaint, however, is the first time (as far as I know) that someone has used Section 337 to challenge a drug reimportation scheme as gray-market trademark infringement.
In addition to its trademark claim, the complainant in this case is also alleging that respondents violated the Lanham Act by making false and misleading claims about the drugs they sell. This can form the basis of a Section 337 violation under subsection (a)(1)(A) which broadly prohibits all “unfair methods of competition and unfair acts in the importation of articles . . . the threat or effect of which is . . . to destroy or substantially injure an industry in the United States.”
The false advertising allegation focuses on the website’s claims that the complainant’s foreign-market drugs are “the same” as its U.S.-market products (which Merck Group denies on the grounds that they are sold through different supply chains and have different packaging) and that they are “legal,” (which they are not because they have different packaging and distribution methods than the FDA-approved U.S. market version). Curiously, the complaint also accuses respondents of misleading consumers when the website refers to Turkey as “European.”
