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Home/Legal & Regulatory and Reimbursement/Spine Patent Infringement Costs DePuy Synthes $12M
Legal & Regulatory and Reimbursement

Spine Patent Infringement Costs DePuy Synthes $12M

December 27, 2022 1 min read Premium comments

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Spine Patent Infringement Costs DePuy Synthes $12M
SYNFIX Evolution System / Courtesy of DePuy Synthes
Secondary#depuysynthes#rsbspine#johnson&johnson

A jury in the United States District Court for the District of Delaware has found in favor of RSB Spine, LLC in a patent infringement claim against DePuy Synthes Sales, Inc. and DePuy Synthes Products, Inc. in the amount of $12 million.

RSB Spine claimed that a number of DePuy products infringed on its patents. These products included the following: Zero-P VA Spacer, Zero-P Spacer, Zero-P Natural Plate, and Synfix Evolution System.

According to RSB Spine’s Amended Complaint, the Zero-P VA Spacer is a “stand-alone implant for use in cervical interbody fusion, combining the functionality of a cervical interbody spacer and benefits of an anterior cervical plate.”

The Zero-P Spacer is a “stand-alone anterior cervical body fusion device designed to combine the functionality and benefits of a cervical interbody spacer and an anterior cervical plate.” The Zero-P Natural Plate is “designed for use with an allograft spacer that offers structural support and fusion potential.” The Synfix Evolution System is “designed for standalone ALIF surgery.”

RSB Spine was successful in its claim that the above products infringed on U.S. Patent Number 9,713,537 (‘537 Patent). The ‘537 Patent Abstract states as follows: “A bone stabilization plate system. The bone stabilization plate system includes a base plate configured to fit primarily between an anterior portion of a first bone’s lip osteophyte and an anterior portion of a second, adjacent bone’s lip osteophyte. The bone stabilization plate system includes a plurality of bone screws configured to fit in respective bone screw holes in the base plate to secure the base plate.” RSB Spine’s InterPlate products incorporate the ‘537 Patent.

In a counterclaim, DePuy claimed that the ‘537 Patent was invalid. The jury found that DePuy did not show that the ‘537 Patent was invalid. DePuy Synthes is the Orthopaedics Company of Johnson & Johnson.

Based in Cleveland, Ohio, RSB Spine was formed in 2001 as R&B Surgical Solutions. John A. Redmond and Robert S. Bray, Jr., M.D. founded the company to create and market spinal implant products. RSB Spine is still active today, selling its products through a master distributor, Paradigm BioDevices.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

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?

8
JT
James Thornton, MDSpine Fellow · HSS

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.

5
RP
R. PatelSports Medicine · Stanford

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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