By Eric Schweibenz
On October 30, 2013, BTG International Inc. of West Conshohocken, Pennsylvania (“BTG”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

The complaint alleges that the following entities (collectively, the “Proposed Respondents”) unlawfully import into the U.S., sell for importation, and/or sell within the U.S. after importation certain crotalid antivenom pharmaceutical compositions and products containing the same that infringe one or more claims of U.S. Patent No. 8,048,414 (the ‘414 patent):

  • Veteria Laboratories of Mexico

  • BioVeteria Life Sciences, LLC of Prescott, Arizona

  • Instituto Bioclon S.A. de C.V. of Mexico

  • Laboratorios Silanes SA de CV of Mexico

  • The Silanes Group of Mexico

  • Rare Disease Therapeutics, Inc. of Franklin, Tennessee

  • Accredo Health Group, Inc. of Memphis, Tennessee

According to the complaint, the ‘414 patent generally relates to a pharmaceutical composition and corresponding method for treating snakebite victims.  The claimed pharmaceutical composition includes a particular type of antibody fragments, known as “Fab” fragments.

In the complaint, BTG states that the Proposed Respondents import and sell products that infringe the ‘414 patent.  The complaint specifically refers to “Antivipmyn,” “Anavip,” and “Antivenin- Bothrops asper and Crotalus durissus” as infringing products.

Regarding domestic industry, BTG states that its CroFab and CroVet products practice certain claims of the ‘414 patent.  As to the economic prong, BTG states that it is a leading specialist pharmaceutical company with its principal offices in Pennsylvania.  According to the complaint, BTG and/or its predecessors have made significant investments within the U.S. in plant and equipment, significant employment of labor and capital in the U.S., and/or a substantial investment in the U.S. in the exploitation of the ‘414 patent, including research and development and engineering.  The complaint specifically refers to a BTG-owned snake farm in Utah, where BTG milks snakes to obtain the venom used to make its products that practice the ‘414 patent.

As to related litigation, BTG states that the ‘414 patent was involved in an appeal to the U.S. Court of Appeals for the Federal Circuit.  According to the complaint, this was an appeal from a final rejection of the claims of the ‘414 patent by an examiner of the U.S. Patent and Trademark Office.

With respect to potential remedy, BTG requests that the Commission issue a permanent limited exclusion order and permanent cease and desist orders directed at the Proposed Respondents and other entities associated with the Proposed Respondents.