Dive Brief:

• The U.S. International Trade Commission is investigating whether Intuitive Surgical is violating the Tariff Act by importing certain reload cartridges for laparoscopic surgical staplers. 

• The ITC voted to start the investigation after receiving a complaint from Johnson & Johnson’s Ethicon subsidiary that the cartridges imported from Mexico infringe its patents. 

• Ethicon wants the ITC to order U.S. Customs and Border Protection to stop the cartridges from entering the country and issue a cease and desist notice to Intuitive regarding its practices.

Dive Insight:

The ITC investigation opens another front in the fight between Ethicon and Intuitive. Ethicon filed patent infringement complaints against Intuitive in U.S. courts in 2017 and 2018, arguing the robotic surgery specialist’s EndoWrist and SureForm staplers and instruments used in laparascopic surgery infringe its intellectual property. The trials are set for October 2019 and October 2020.

But J&J unit Ethicon is now hoping ITC will block imports of the allegedly infringing reload cartridges used in Intuitive’s devices under Section 337 of the Tariff Act. 

Intuitive secured FDA clearance for its EndoWrist stapler and reloads in 2012. The clearance marked an escalation of Intuitive’s intrusion onto turf dominated by large competitors. In the annual report published months after the EndoWrist clearance, Intuitive warned investors that the introduction of staplers and other robotically controlled products exposed it to "greater competition from larger and well established companies such as Ethicon." The warning was absent from earlier reports. 

A spokesperson for Intuitive declined to answer questions about the case, stating the company does not comment on pending legal proceedings.

The ITC historically takes less than 15 months to complete Section 337 investigations, although it warns that the rising complexity of cases and workload of judges has resulted in a "substantial number" of probes taking longer in recent years. If the ITC takes up to 15 months to complete the investigation, at least one of the patent infringement trials may have already taken place.

The law empowers the ITC to order border agents to exclude infringing articles from a specific firm, in this case reload cartridges imported by Intuitive. Ethicon is pushing for that outcome, which would hamper Intutive, an emerging competitor to its surgical stapler business.