In Snake Antivenom ITC Investigation, a Multidisciplinary Team Proves Potent
In a complex biologics investigation before the U.S. International Trade Commission, Sterne Kessler clinched a positive outcome for Instituto Bioclon, a snake antivenom manufacturer based in Mexico, and for its licensee Laboratorios Silanes.
Bioclon was in Phase III clinical testing for its antivenom, and had applied for FDA licensing to import its biologic drug into the U.S. – under a pending biologics license application (BLA). In an effort to block Bioclon's and Silanes’ entry into the U.S. market, BTG Plc, the owner of a U.S. patent for snake antivenom, initiated an ITC investigation for alleged unfair acts of importation, claiming that Bioclon and Silanes were infringing its patent rights. One of the remedies requested by BTG was an exclusion order directed to Bioclon/Silanes to prevent future importation of their competing product.
Our response was to assemble a team of experienced ITC litigators, top biotechnology patent attorneys, and inter partes review specialists. This combination proved to be successful for our clients, and the investigation settled the day before trial was scheduled to begin. Moreover, the investigation settled without an exclusion order, giving the licensee Silanes the ability to enter the US antivenom market in the future.
Though the matter concluded via settlement, it is significant because the resolution included a payment of $6,000,000 in legal fees from BTG to Bioclon, which the ITC did not find objectionable.
This investigation is also noteworthy because it was only the second matter relating to biologics that the ITC has addressed in its history. And given the explosive growth predicted in the biologics space, we are expecting more ITC and IPR matters in the coming years.
Ultimately, it was not snake charming that won the day, but a careful defense at the ITC, as well as the strategic use of an aggressive inter partes review before the USPTO, that resulted in a favorable settlement.