Globus Medical Lawsuit: What You Need To Know

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Globus Medical Lawsuit

Synthes USA LLC accused spinal implant maker Globus Medical Lawsuit Inc. of infringing three intervertebral implant patents, asking the court to force the defendant to break its allegedly infringing products.

The Patent Wars

Globus Medical, headquartered in Luxembourg, makes the Spinal Juno, a minimally invasive, spinal implant for spinal stenosis. The company claims the patents that it is accused of infringing pertain to a “splintable intervertebral device,” and was issued in 2010, 2013 and 2016.

According to the patent citations, the products covered in Globus Medical’s suit have been sold since 2013. Synthes USA, based in Louisville, Ky., sells the Apex system, an outpatient surgical system. The Complaint and Forbearance Globus Medical, citing the quiet period under the NVIPA, said it will be unable to respond to Synthes USA’s legal complaint. (Globus Medical Lawsuit)

globus medical lawsuit
globus medical lawsuit

What is the Lawsuit All About?

After a failed attempt by the plaintiffs to have a jury determine the outcome of the case, the matter is now before a federal judge in Tampa, Fla. The lawsuit, filed May 24 in the U.S. District Court for the Middle District of Florida, is the latest battle between the two companies.

The defendants have filed a motion for summary judgment and are seeking the case to be dismissed, arguing that the three patents do not actually exist and are not enforceable, according to a report from Xconomy. According to Synthes’ complaint, the two companies have been trading in these types of interbody devices for over 30 years.

The Alleged Inventions (Globus Medical Lawsuit)

Three patents are being used to identify the alleged infringing products. The company claims: “Low-level sustained transperineal anterior fixation system. The low-level sustained transperineal anterior fixation system (or system) comprises a pair of instrumented fiberoptic probes and a soft instrumented fiberoptic probe tip assembly.

The instrumented fiberoptic probes communicate with an instrumentation unit contained within the soft instrumented fiberoptic probe tip assembly.” “All-tissue mastoidectomy. The all-tissue mastoidectomy is a surgical technique where the mastoid bone is removed from the skull base and the bone flap is returned to the skull base. The soft-tissue mastoidectomy is performed without surgical contact between the soft tissue and the skull base.

The Alleged Infringement

The lawsuit was filed in federal court on April 9, 2016, and it accused the American spine medical device manufacturer of infringing the patent on a “vertical linear guided instrument” (VLGI) and a “vertical linear guided internal fixation” (VLGI-i). These are the same devices that were found in a Globus-sponsored study to be substandard. In that study, five of 15 VLGI implants from the SystFLEX® line were found to be inadequately stent-free and unresponsive to patient movement.

Another five of 14 VLGI implants from the AvantiTrac® line were found to be substandard. The SystFLEX® line includes devices such as the Infinity Springtor® II and Intellis™ S™ Intramedullary Nucleus Abscess Screw System. The AvantiTrac® line includes the Atlas™ Intramedullary Nucleus Abscess Screw System.

The Effects of an Injunction

If granted, the injunction would prevent Globus from selling its intervertebral implants until the parties come to an agreement, the plaintiff stated. This would prevent Globus from using the infringing products, also known as the January 10, 2019, decision. However, the plaintiff said, it may not work.

The ruling of the court does not have an impact on the other lawsuit filed against Globus by Medtronic PLC and a separate group of Medtronic’s distributors in the U.S. for alleged infringement of Medtronic’s 1999 patent for the Mini-Hertz system of interbody technology. What Happens Now? The lawsuit filed by Synthes with the US District Court for the Middle District of Florida claims that Globus infringed the three patents and requested a restraining order. (Globus Medical Lawsuit)

Conclusion (Globus Medical Lawsuit)

It is clear to me that Globus has done nothing wrong. At the end of the day, the judge will decide if the allegedly infringing products are really infringing or not. I think that the judge will look at the entire patent (including only the claims that Globus is calling infringing) and decide that the alleged infringing products do not infringe upon the patent, even though Globus cannot prove in court that they are not infringing the patent, due to the lack of a sufficient legal “materiel” to substantiate the claimed infringement.

Additionally, the court may decide that the patent has no realistic chance to be valid under patent law. My recommendation to Globus is to just issue a license to their Asian distributor to produce these products. It is not worth fighting this out in court.

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