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Dr. Sherine Tawfiq believed she had designed a medical device that would revolutionize hernia treatment in women. Now, Tawfiq is suing medtronic, A global leader in medical devices, the company is accused of stealing its patented design.
Tofig, a Beverly Hills surgeon with more than 22 years of experience, says she found that a significant number of hernia patients with postoperative complications were women — and that most mesh designs on the market were designed primarily to fit male anatomy.
In 2016, it applied for an international patent to protect a new design aimed at improving outcomes for patients.
In a lawsuit filed in the U.S. District Court in Delaware on Tuesday, the latest in a series of patent challenges against Medtronic, Tofig accuses the medical device company of stealing its design after the two parties met in 2015 and signed a reciprocal nondisclosure agreement. In 2016, Tofig says she visited Medtronic's manufacturing site in France to discuss potential collaborations and its patent-pending product.
In May 2017, Medtronic filed its own hernia mesh patent for a product that Tofig says closely resembles its design.
“I was expecting a publicly traded company to have a more ethical approach to this, and that's not what I encountered,” Tawfiq said in an interview with CNBC.
Patented Towfigh mesh designs.
US District Court in Delaware
Tawfiq files a lawsuit to obtain damages in an unspecified amount.
A Medtronic spokesperson said in a statement to CNBC that the company is reviewing Tawfiq's complaint.
“Medtronic believes in its innovations and has a long history of respecting the intellectual property rights of other innovators,” the spokesperson wrote.
Tawfik says she followed up several times with Medtronic over several years, but didn't make much progress. In an email cited in the 2019 lawsuit, Tawfik expressed concern that Medtronic's new mesh design “completely mirrors” its pending patent. A company representative responded to Tawfik, saying that Medtronic “is not going the route you described to us in your patent.”
Tofig says that after raising her concerns further, Medtronic offered her a job as chief medical director for the company's hernia division, but she declined.
In 2020, a local Medtronic sales representative reached out to her and provided her with a premarket sample of the company's new hernia mesh product. Tofig described the product as nearly identical to its patent-pending design.
“I couldn’t talk,” Tawfiq told CNBC. “I saw the actual product in my hands for the first time and I turned pale.”
Premarket sample of Medtronic hernia mesh product.
Source: US District Court for the State of Delaware
In October 2019, an international patent was approved for Tawfiq. In May 2020, Medtronic launched its new hernia mesh product, Dextile.
This is not the first time Medtronic has faced allegations of patent infringement. In 2014, Dr. Mark Barry sued the company, alleging that Medtronic infringed two of his patents intended to correct spinal problems. A federal judge found that Medtronic “recklessly copied” Barry's technology and awarded him $23.5 million.
In the same year, Medtronic agreed to pay more than $1 billion to settle patent claims with Edwards Lifesciences over allegations that Medtronic's CoreValve product infringed its transcatheter heart valve patent.
More recently, in 2020, Colibri Heart Valve filed a lawsuit against Medtronic, alleging that the company's devices infringed its patent related to heart valve replacements for patients with heart disease. Medtronic was ordered to pay $106.5 million.
— CNBC's Scott Zamost and Agne Tolokaite contributed to this report.