Boston Scientific found guilty of infringing on drug-eluting stent patent, fined $42M

Half a decade after it began, an intellectual property case between Boston Scientific and TissueGen has finally reached a verdict.

Boston Scientific was found guilty this week of infringing upon a patent that was awarded to the University of Texas system in 2003 and ultimately licensed to TissueGen. It concerns technology that TissueGen founder Kevin Nelson, Ph.D., developed while a faculty member at UT Arlington, designed to deliver drugs through an extruded fiber in an implanted vascular stent.

TissueGen’s biodegradable Elute drug-loaded fibers launched in 2013 and could be customized to deliver a variety of drugs and fit into a devicemaker’s existing materials.

In 2015, Boston Scientific landed FDA clearance for its own Synergy system, a drug-coated stent aimed at treating coronary artery disease. It was made of a polymer designed to slow the release of the drug across three months, after which both the polymer and drug coating would be fully absorbed into the body.

According to a Delaware jury’s verdict this week, the Synergy technology infringes upon TissueGen’s patent—and Boston Scientific should therefore pay $42 million in lost royalties to TissueGen and the University of Texas.

“Boston Scientific respectfully disagrees with the jury’s verdict and plans to appeal,” a company spokesperson said in a statement sent to Fierce Medtech.

TissueGen didn’t immediately respond to a request for comment, though Nelson told The Dallas Morning News that the fine represents only a “tiny sliver” of the profits Boston Scientific earned from sales of the Synergy stents. He added that an appeal could potentially “exhaust” TissueGen.

“TissueGen does not control what Boston Scientific does with its resources, which are endless by comparison to TissueGen,” Nelson, currently the chief scientific officer of the company, told the outlet. “If Boston Scientific respects the court who provided both sides a fair opportunity to present their cases and the citizens who took time from their lives to render a judgment, the recovery will be poured back into research at UT System and TissueGen to save lives and relieve suffering.”

The case began in late 2017 when TissueGen and UT filed a complaint in a Texas court claiming that Boston Scientific had infringed upon two patents licensed to TissueGen concerning drug-releasing biodegradable fibers. In the ensuing years, the second patent claim was thrown out and the case was moved to Delaware.

TissueGen alleged that Boston Scientific was fully aware of its IP claim. In court filings, the company claimed that Nelson had met with two Boston Scientific executives during the 2008 Transcatheter Cardiovascular Therapeutics Symposium, where he told them about the patented biodegradable drug-eluting stent technology and gauged the company’s interest in participating in TissueGen’s then-upcoming series A funding round. Nelson stayed in touch with the execs after the conference, per the court docs, and emailed one of them a presentation offering more information about the technology in 2009.

In filings of its own, while Boston Scientific admitted that its executives met with Nelson at the TCT conference and later continued their correspondence via email, it denied that its technology infringed the patented portions of TissueGen’s. The medtech giant rejected the patent claims in part based on the fact that the Synergy system doesn’t include a “biodegradable polymer fiber.”