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Home/Legal & Regulatory and Reimbursement/Patent Fight Continues: Extremity Medical vs Fusion Orthopedics
Legal & Regulatory and Reimbursement

Patent Fight Continues: Extremity Medical vs Fusion Orthopedics

January 4, 2024 2 min read Premium comments

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Patent Fight Continues: Extremity Medical vs Fusion Orthopedics
Source: Unsplash and Komang Gita Krishna Murti
#fusionorthopedicsSecondary#extremitymedical#ptab#uspto

The patent fight is heating up between Extremity Medical, LLC and Fusion Orthopedics, LLC.

In a recent press release, Fusion Orthopedics is claiming a victory over Extremity Medical. This alleged victory comes from the United States Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board’s (PTAB) most recent ruling in the patent dispute. The PTAB has ruled against Extremity Medical and has instituted an inter partes review of the patent at issue.

The patent at issue is U.S. Patent No. 11,298,166 (‘166 patent) for intraosseous intramedullary fixation assembly and method of use. There is parallel litigation involving the patent and the two parties in United States District Court for the District of Arizona. For OTW’s original coverage of the litigation, see “Patent Fight: Extremity Medical vs Fusion Orthopedics.”

According to the patent document itself, the ‘166 patent for an intramedullary assembly for intraosseous bone fusion includes a “lag screw member and a tapered screw member.”

Also, per the ‘166 patent document, “The lag screw member includes a first elongated body, where the first elongated body includes a first threaded portion at a first end and a bulbous portion at a second end. The tapered screw member is coupled to the lag screw member, and the tapered screw member includes a second elongated body, where the second elongated body includes a second threaded portion at a third end, and an opening at a fourth end.”

According to the USPTO website, inter partes review is a “new trial proceeding conducted at the Board to review the patentability of one or more claims in a patent only on a ground that could be raised under §§ 102 or 103, and only on the basis of prior art consisting of patents or printed publications.”

Here, the PTAB granted the petition by Fusion Orthopedics for an inter partes review of claims 1–15 of the ’166 patent. This means that per the PTAB order there will be a new trial to review the patentability of claims 1–15 of the ’166 patent. The proceedings must statutorily be completed within a year. However, the proceedings may be extended for good cause by six months and may also be terminated by settlement.

We are tuned in to this case so more to come, for sure.

React:

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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