Favorable Outcome for BTG in Snake Antivenom ITC Investigation

Wolf Greenfield recently secured a favorable settlement for our long-time client BTG plc, manufacturer of CroFab® rattlesnake antivenom, in a complex investigation before the International Trade Commission (ITC). The settlement prevents the accused infringers from entering the market until 2018 and requires favorable royalty payments from that point until BTG’s patent expires in 2028. It also requires them to move to terminate their inter partes review (IPR) of BTG’s patent. This successful outcome was the result of Wolf Greenfield’s long-running and multidisciplinary strategy to protect BTG’s pioneering intellectual property and preserve its market-leading position.

Wolf Greenfield attorneys worked to obtain patent protection for BTG’s CroFab since 1996. We overcame numerous obstacles during the patent prosecution process, which involved multiple appeals to the U.S. Patent and Trademark Office’s Board of Patent Appeals and Interferences along with a further appeal to the U.S. Court of Appeals for the Federal Circuit and a subsequent civil action filed with the U.S. District Court for the District of Columbia. Working with the client and numerous experts, we ultimately secured a critical patent for BTG in November 2011.

In October 2013, BTG filed a complaint with the ITC asserting that several foreign biotechnology companies and their U.S. partners had begun to violate BTG’s hard-won patent rights by importing and selling snake antivenoms. These products threatened BTG’s market share.

The ITC agreed to launch an investigation, which began in November 2014 and spanned 10 furiously-paced months of intense patent litigation. Wolf Greenfield assembled a multidisciplinary team that included attorneys experienced in ITC litigation and IPRs along with professionals intimately familiar with the relevant technology.

Our team secured a string of pre-trial victories, including a favorable claim construction decision. We also achieved success on several key discovery motions, including compelling key discovery from the defendants while at the same time defeating over a dozen different procedural and substantive motions that the defendants filed, including several motions for summary judgment. Our team also efficiently surmounted numerous other discovery obstacles that the defendants—represented by a much larger group of lawyers—sought to place in BTG’s path.

Given the strength of the case that our team developed, the ITC’s Office of Unfair Import Investigations (OUII) filed a pretrial brief that agreed with BTG as to all essential issues. In particular, the OUII attorneys concluded that the defendants were infringing BTG’s patent, that none of the defendants’ invalidity defenses should prevail, and that BTG had established the “domestic industry” necessary for an exclusion order.

These successes positioned BTG favorably for settlement negotiations on the eve of trial in August 2014. As a result, BTG achieved a resolution that secured its market-leading position, removed a validity challenge to BTG’s patent, and ensured favorable compensation once the defendants eventually do enter the market.

The ITC recently approved the settlement.

The Wolf Greenfield team included Greg Corbett, Michael Siekman, Allen Rugg, Chelsea Loughran, Charlie Steenburg, John Strand, Tobias Brambrink, Alex Ewing, Turhan Sarwar, Brett Morrison, and Libbie DiMarco.