Patrick Sweeney, M.D. via his company Spinal Generations, LLC is suing DePuy Synthes, a subsidiary of Johnson & Johnson, for patent infringement related to a surgical screw he developed for fractured bones.
Patrick Sweeney, M.D. Sues DePuy Synthes for Patent Infringement
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Dr. Sweeney is a retired orthopedic surgeon. The lawsuit claims in 2002 Dr. Sweeney invented a surgical screw used to repair fractured bones.
Dr. Sweeney has nine patents related to the screw in the United States. Per court documents, the invention is also patented in Europe. Dr. Sweeney purportedly assigned his patents to Spinal Generations. Spinal Generations then purportedly licensed the patents to another company that Dr. Sweeney owns, Flow-FX. The screw and insert are called the “Flow-Nail” and “Flow-Screw.”
Spinal Generations claims that in 2014-2015 Dr. Sweeney met with DePuy Synthes about the potential for a partnership for the patented invention. It was during a meeting between Dr. Sweeney and DePuy Synthes executives that Spinal Generations asserts Dr. Sweeney showed DePuy Synthes the Flow-Nail design. During the meeting Spinal Generations also claims that Dr. Sweeney “repeatedly stressed that his product was protected by issued patents.”
DePuy Synthes did not partner with Dr. Sweeney. However, Spinal Generations alleges that just two years after the purported meeting, DePuy Synthes introduced its TFNA product. A product Spinal Generations claims is “virtually indistinguishable from the Flow Nail product that Dr. Sweeney had presented to them.”
According to court documents, “Dr. Sweeney’s novel design contains a hollow cavity disposed inside the screw shaft with pre-designed openings at points along the shaft. It also includes a ‘cannulated, fenestrated insert’ with a hollow cavity and openings that goes inside the screw.” The screw and insert “allow a surgeon to deliver a precise amount of medicine, including binding agents and other fillers such as cement, into exact locations around the fracture, to maximize the effectiveness of the repair to the injured bone.”
The lawsuit was filed earlier this month (October 2022) in the United States District Court of Delaware. The lawsuit lists the following as defendants: DePuy Synthes, Inc., Synthes USA, LLC, and Synthes USA Products, LLC. Spinal Generations is requesting a jury trial. DePuy Synthes has not yet filed a response.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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