Showing all posts written by Arash Pia
Jury Verdict Against Boston Scientific for $42 Million For Infringement of Patent on Biodegradable Drug-Releasing Implant
On January 31st, 2023, a jury awarded $42 million to medical device company TissueGen in a patent infringement case against Boston Scientific for infringement of U.S. Patent No. 6,596,296, titled “Biodegradable Drug-Releasing Implant.” The ’296 patent relates to a drug releasing biodegradable fiber implant which allows for controlled delivery of therapeutic agents.
The verdict comes after a five-year long dispute between the parties. The Board of Regents of the University of Texas System and TissueGen sued Boston Scientific for infringement of the ’296 patent in November 2017. TissueGen received an exclusive license to the ’296 patent from the University of Texas in 2003.
TissueGen’s infringement case concerned Boston Scientific’s SYNERGY™ technology. Boston Scientific reportedly previously received FDA approval for its SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System in 2015. The SYNERGY™ system is alleged to be absorbed shortly after drug elution is complete at three months to eliminate the long-term polymer exposure.
In the first phase of the trial, the jury found that the patent at issue was valid and that Boston Scientific had infringed the patent. In the second phase of the trial, the jury further found that Boston Scientific’s infringement was willful and awarded the plaintiffs $42 million in lost royalties.
Dr. Kevin Nelson, the founder of TissueGen, had allegedly met the Boston Scientific executives in a symposium in 2009 where he told them about the patented technology. Dr. Nelson is a named inventor on the ’296 patent and is reported to have invented the technology while he was an employee of the University of Texas.
TissueGen is a medical device company that reportedly has a portfolio of patents on drug delivery technology. It was founded in 2000. Boston Scientific is a worldwide medical device company founded in 1979. Boston Scientific recently announced that it generated net sales of $3.242 billion during the fourth quarter of 2022.
FDA Publishes New Monkeypox and Medical Devices Web Page
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.
The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.
Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.
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