Conformis Continues Litigations Against Patient-Specific Medical Technologies

| Christy LeaSabing Lee

On June 3, 2021, Conformis continued its patent enforcement efforts involving patient-specific technologies by filing suit against Bodyhub and Exactech in the Middle District of Florida.

In a first complaint, filed against Exactech, Conformis accused Exactech’s Vantage® Total Ankle System of infringing U.S. Patent Nos. 8,460,304, 9,295,482, 8,623,026, 9,326,780, and 9,186,161. According to the complaint, the infringing products include 3D-printed tibia and talar cutting guides and the associated ankle implants.

In a second complaint, filed against both Bodycad and Exactech, Conformis accused the two companies of infringing U.S. Patent Nos. 8,974,539, 9,387,079, 7,799,077, 8,077,950, 8,638,998, and 9,180,015. The accused products include Bodycad’s Reflex UniTM unicondylar knee replacement and software, for replacing a single compartment of an arthritic knee, and Bodycad’s Fine OsteotomyTM patient-specific surgical guide and plate, for a knee osteotomy procedure where either the tibia or femur is cut and then reshaped to relieve pressure on the knee joint. According to an exclusive distribution agreement announced November 24, 2020, Exactech will be the U.S. distributor for Bodycad’s Reflex Uni system under the name Truliant Reflex Uni, with limited market availability in early 2021 and a full release by the end of 2021.

These two lawsuits continue Conformis’s history of enforcing patents from its portfolio of over 200 issued patents. U.S. Patent Nos. 8,460,304, 9,295,482, 8,623,026, 9,326,780, and 9,186,161, from the first complaint against Exactech, have been asserted by Conformis in prior litigations, but U.S. Patent Nos. 8,974,539, 9,387,079, 7,799,077, 8,077,950, 8,638,998, and 9,180,015, from the second complaint against Bodycad and Exactech, are being asserted for the first time. These newly asserted patents include claims directed to patient-specific implants, which differ from patents asserted in prior suits which included claims directed to systems comprising patient-specific instruments and off-the-shelf implants.

The prior litigations include cases filed against large orthopedic companies such as Depuy Synthes, Wright Medical Technology, Medacta, Smith + Nephew and Zimmer Biomet. The litigations against Depuy Synthes, Wright Medical Technology and Medacta are active, while the litigations against Smith + Nephew and Zimmer Biomet were settled according to press releases issued on September 17, 2018 and May 28, 2020. Several of the Conformis patents have also been challenged in inter partes review proceedings before the USPTO Patent Trial and Appeal Board.