Patent Rights and Infringement Claims in Spine Surgery in the United States: A Primer for Neurosurgeons.

Abstract

Despite the importance of patent rights and the prevalence of patent infringement claims in spine surgery, no study to date has comprehensively assessed this topic. Therefore we investigated patent infringement claims in the United States within the field of spine surgery. We also provide neurosurgeons with a basic knowledge of patent law. A retrospective review of legal cases published on the legal databases Westlaw and LexisNexis was conducted without time constraints. Patent infringement cases in spine surgery involving medical device companies were included. Criminal cases, other intellectual property cases (eg, copyrights, trademarks), and patent-related litigation not explicitly involving infringement claims (eg, royalties disputes) were excluded. Case characteristics included verdict outcomes, party demographics, case location, case year, type of spinal device involved (eg, surgical implant), type of patent infringement, and legal outcome. Comparisons between plaintiff and defendant verdicts were performed using independent samples t -test or χ 2 test. Of the initial 468 screened cases, 35 met the final inclusion criteria. Cases ranged from 1996 to 2021. Verdict outcomes were split evenly between plaintiffs (49%) and defendants (51%), with most cases involving disputes about surgical implants (n = 25, 71%) between medical device companies (n=29, 83%). Among the 35 cases, there were a total of 55 patent infringement claims, with 35 direct, 8 indirect, and 12 willful infringement claims. Among the 6 (out of 17) plaintiff verdicts reporting 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 plaintiffs and defendants' verdict decisions. In addition to serving as a primer in patent law for neurosurgeons, our empirical analysis provides valuable insights into the complex legal environment surrounding technological innovation and intellectual property rights in spine surgery in the United States.