Patent infringement in spine surgery: a primer and review of reported legal claims brought in the United States in the past 30 years

Introduction: Advancements in medical devices remain a bedrock of spine surgery. Obtaining a patent on new inventions is an integral part of such technological development. However, innovation in medical technology often leads to conflict, which can manifest itself as patent litigation. Despite the high prevalence of patent litigation within the field of spine surgery, no study has comprehensively assessed the empirical data on claims for patent infringement involving spine surgery devices and products.

Methods: The online legal database Westlaw was queried for closed cases and settlements involving spine-related patent litigation. Cases included civil cases or settlements involving patent infringement claims pursuant to 35 U.S.C § 271. Other forms of intellectual property litigation (e.g., copyright violation), as well as contract royalties or licensing disputes were excluded. Case characteristics included verdict outcomes, party demographics, case location, case year, type of spinal device involved (e.g., surgical implant), type of patent infringement, and outcome.

Results: Of the initial 410 cases, ultimately 25 cases were included. Cases ranged from 1996 to 2021, with the majority of cases occurring between 2010 and 2022 (n=18, 72%). Thirteen states were included in our cohort, with California possessing the highest number of cases (n=12, 48%). Verdict outcomes were split evenly between plaintiff (48%) and defendants (52%), with the majority of cases involving spinal instrumentation disputes (n=18, 72%) between medical device companies (n=21, 84%). Among the 13 plaintiff verdicts, 6 (46%) included monetary damages, 1 resulted in permanent injunctive relief, and 1 ended with royalty agreements. Five (40%) plaintiff verdict outcomes were settled out of court, not reported, or unavailable in our database. Among the 6 plaintiff verdicts resulting in monetary damages, the median, inflation-adjusted award payout was $28,899,596 ($2,833,870 - $202,626,170). There were no significant differences in case characteristics, infringement subtypes, or award outcomes between plaintiff and verdict decisions.

Conclusion : In addition to serving as a primer in patent law to the general spine surgeon, our results provide a glimpse into the complex legal environment surrounding technological developments, new inventions, and intellectual property rights in spine surgery.