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25 January 2019Americas

Fed Circuit upholds $23m win for spine surgeon against Medtronic

An appeals court has upheld a $23 million damages award for a spine surgeon, after a jury found that medical device company Medtronic had infringed two of his patents.

Yesterday, January 23, the US Court of Appeals for the Federal Circuit rejected Medtronic’s appeal to overturn an earlier ruling by the US District Court for the Eastern District of Texas, which said the company had infringed several claims in two of Mark Barry’s patents.

In November 2016, Barry was successful in his claim that Medtronic had infringed his patents (US numbers 7,670,358 and 8,361,121) for “methods and systems for correcting spinal column anomalies”.

The patents are for a tool Barry developed, in 2003, that allowed him to grab pedicle screws in vertebrae and move them during spine surgery. He used the tool in three surgeries in 2003, two in August and one in October.

Between August 2003 and January 2004, the patients returned to Barry three times for follow-up appointments.

In January 2004, three months after the October 2003 surgery, Barry felt confident his invention worked for its intended purpose and publicised it in a professional forum.

In 2016, Medtronic introduced its vertebral column manipulation (VCM) kit, which is used in conjunction with its CD Horizon Legacy and Solera spinal surgery systems. The systems consist of rods, hooks, and screws for implantation in the spine to correct the abnormal curvature.

Barry alleged that the combination infringes the ‘358 and ‘121 patents. He also said Medtronic induced surgeons to infringe the patents by training them how to use the VCM kit.

In its appeal to the Federal Circuit, Medtronic argued that the ‘358 patent was invalid under the “public use” bar because it had been in use more than one year before the patent application was filed.

Barry’s application was filed on December 30, 2004, which means it had to be in public use before December 30, 2003.

The Federal Circuit rejected Medtronic’s argument. It said the public use bar is triggered where, before the critical date, the invention is in public use and ready for patenting.

It concluded that Medtronic’s public use challenge fails on two grounds. First, the invention was not ready for patenting before December 30, 2003. Second, there was no “public use” except for the three surgeries, which it deemed an “experimental use” of the invention.

The court added there was “substantial evidence” which confirmed that Barry’s invention was not ready for publicising until January 2004, after he had carried out the final three-month follow-up from the October 2003 surgery.

Several experts confirmed that in order to evaluate the success of a spinal-deviation correction, the surgeon must evaluate the patient after some time has elapsed post-surgery, particularly once a patient can stand.

An expert for Barry told the court that “when the patient stands up, there are some changes that happen over time”.

He added that although “normally you can see the straightening” at the time of the surgery, “follow-up is absolutely required to determine that it lasts”, and the follow-up appointments allowed Barry to conclude that he had “a method that works”.

Medtronic’s final invalidity challenge claimed that Lawrence Lenke, a surgeon who works with Medtronic, had been developing a similar spine derotation project since 2002 and was a prior inventor.

The burden of proof fell on Medtronic to show that Lenke had used the invention before Barry.

The court said it sustained the jury’s finding that Lenke “did not reduce the claimed invention to practice” before Barry.

A reduction to practice is the step in the formation of an invention beyond its original conception.

Reduction to practice is carried out by either filing a patent for the invention or using the invention in practice for its intended purpose.

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More on this story

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