Board of Regents & TissueGen v. Boston Scientific: $42M Stent Patent Verdict
The University of Texas System and TissueGen sued Boston Scientific over biodegradable polymer scaffold technology embedded in its SYNERGY BP Stents. After a bifurcated jury trial, plaintiffs secured a $42 million damages award plus $7.4M in pre-judgment interest on US Patent No. 6,596,296 — a case that ran for over six years before final judgment.
A $42M university patent win over Boston Scientific’s SYNERGY stents
Filed in March 2018 in the District of Delaware, this infringement action pitted two university-affiliated plaintiffs — the Board of Regents of the University of Texas System and TissueGen, Inc. — against Boston Scientific Corporation, a global medical device leader. The asserted patent, US6596296, covers biodegradable polymer scaffold technology, and the accused product is Boston Scientific’s SYNERGY BP Stent, a bioabsorbable polymer everolimus-eluting coronary stent. A second patent, US7033603, was also listed among the patents involved.
The case proceeded to a bifurcated trial beginning January 25, 2023, with the jury returning unanimous verdicts in both phases by January 31, 2023. The jury found Boston Scientific liable for direct infringement and induced infringement of claims 1, 11, 17, and 26 of the ‘296 patent, and upheld the validity of those claims. The jury rejected willful infringement, meaning enhanced damages were not awarded. Final judgment, entered June 28, 2024 after resolution of post-trial motions, set damages at $42,000,000 with $7,436,328 in pre-judgment interest and post-judgment interest accruing at 4.87%.
The six-year-plus duration from filing to final judgment reflects the complexity typical of high-stakes medical device patent disputes, particularly those involving bifurcated trials and extensive post-trial motion practice. The rejection of willful infringement suggests the jury did not find Boston Scientific’s conduct egregious enough to warrant treble damages, which likely limited the overall exposure from what could have been a significantly larger award. Attorneys’ fees motions under 35 U.S.C. § 285 remain outstanding pending appeal, leaving the total cost burden unresolved from the public record.
Filing to Judgment on the merits for Plaintiff in 2299 days
2,299 days — over six years from filing to final judgment, well above the median federal patent case duration
Jury verdict and judgment: what the $42M ruling means for both parties
Bifurcated trial delivered a split but plaintiff-favourable verdict
The court structured proceedings as a two-phase bifurcated trial. The jury found direct and induced infringement on claims 1, 11, 17, and 26 of US6596296, and upheld validity — the two core battlegrounds in patent disputes. The rejection of willful infringement is legally significant: without it, treble damages under 35 U.S.C. § 284 were unavailable, capping recovery at compensatory damages only. Final judgment followed post-trial motion practice resolved in June 2024.
Judgment on merits — plaintiffPlaintiffs secure $49.4M total award with validity confirmed
Board of Regents and TissueGen emerge with a $42M compensatory damages award, $7.4M in pre-judgment interest, and ongoing post-judgment interest at 4.87%. Critically, the jury upheld validity of the asserted claims — defeating Boston Scientific’s invalidity challenge — which preserves the ‘296 patent’s enforceability for any future infringement actions. The ruling also confirmed induced infringement, broadening the scope of actionable conduct beyond direct manufacturing.
Validity upheld; $42M awardedBoston Scientific escapes treble damages but faces $49.4M liability
Boston Scientific successfully avoided a willful infringement finding, which prevented enhanced damages that could have tripled the $42M base award to over $120M. However, the company faces the full compensatory award plus interest, and attorneys’ fees exposure under § 285 remains open pending appeal. The SYNERGY BP Stent — a commercially significant product — was found to infringe, creating ongoing implications for product strategy and potential design-around obligations going forward.
No willfulness; $42M+ liability remainsUniversity-held biodegradable polymer patents carry real enforcement weight
This verdict signals that university-originated patents covering bioabsorbable polymer scaffold technology can sustain multi-decade enforcement campaigns against major medical device OEMs. With the ‘296 patent’s validity confirmed and claims 1, 11, 17, and 26 found infringed, competitors deploying similar biodegradable polymer stent coatings face heightened FTO risk. The deferred § 285 fees question also suggests further cost exposure for Boston Scientific — and a cautionary signal for defendants in complex medical device cases.
Elevated FTO risk in bioabsorbable stentsFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Board of Regents | Individual | University of Texas System and TissueGen, Inc. — holders of US6596296 (biodegradable polymer stent technology)Search in Eureka ↗ |
| Co-Plaintiff | Tissuegen, Inc. | Company | Search in Eureka ↗ |
| Defendant | Boston Scientific Corp. | Company | Boston Scientific Corp. — global medical device manufacturer; maker of SYNERGY BP bioabsorbable polymer stentsSearch in Eureka ↗ |
| Plaintiff counsel | Alex Q. Jacobs | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff counsel | Chijioke E. Offor | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff counsel | Corey M. Lipschutz | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff counsel | Michael W. Shore | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff counsel | Samuel E. Joyner | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff counsel | Stamatios Stamoulis | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff counsel | William D. Ellerman | Attorney | Counsel for Board of RegentsSearch in Eureka ↗ |
| Plaintiff law firm | Stamoulis & Weinblatt LLC | Law Firm | Representing Board of RegentsSearch in Eureka ↗ |
| Defendant counsel | Brian E. Farnan | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Chad M. Drown | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Christopher J. Burrell | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | David J.F. Gross | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Doowon Chung | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Edmond Ahadome | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Elliot Choi | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Evan J. Kline-Wedeen | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Jacob M. Bass | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | James R. Ferguson | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | John E. Nilsson | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Karen L. Pascale | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Katherine S. Razavi | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Lauren J.F. Barta | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Matthew M. Wolf | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Melissa A. Anyetei | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Michael J. Farnan | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Michael J. Word | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Michael P. Kahn | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Nicholas M. Nyemah | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Nirvani Chethana Perera | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Rachel J. Elsby | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Rebecca L. Neubauer | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant counsel | Timothy E. Grimsrud | Attorney | Counsel for Boston Scientific Corp.Search in Eureka ↗ |
| Defendant law firm | Farnan LLP | Law Firm | Representing Boston Scientific Corp.Search in Eureka ↗ |
| Defendant law firm | Young, Conaway, Stargatt & Taylor LLP | Law Firm | Representing Boston Scientific Corp.Search in Eureka ↗ |
| Presiding judge | Judge Gregory B. Williams | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The June 28, 2024 judgment is notable for its precision: it separately enumerates findings on direct infringement, induced infringement, willfulness, validity, and damages — each claim-specific to claims 1, 11, 17, and 26 of US6596296. The explicit rejection of willful infringement and enhanced damages, entered in Boston Scientific’s favour, caps recovery at compensatory levels. The deferred attorneys’ fees mechanism, tied to the appellate timeline, suggests the court anticipates a likely appeal — meaning the $49.4M total (damages plus pre-judgment interest) may not represent the final financial resolution of this dispute.
US6596296 — Biodegradable Polymer Scaffold Technology for Drug-Eluting Stents
US6596296 (application no. US09/632457) covers biodegradable polymer scaffold technology used in drug-eluting coronary stents — specifically, bioabsorbable polymer matrices that carry and release therapeutic agents as the polymer degrades in vivo. The patent, originating from the University of Texas System and commercialised through TissueGen, represents a foundational claim in the bioabsorbable polymer stent space. Claims 1, 11, 17, and 26 were specifically found infringed and valid in this proceeding. US7033603 (US10/428901) was also asserted, covering related biodegradable polymer stent compositions and methods.
The SYNERGY BP Stent — Boston Scientific’s bioabsorbable polymer everolimus-eluting platform — became the accused embodiment, reflecting how commercially significant second-generation drug-eluting stent designs can implicate earlier foundational polymer patents. For competitors developing bioabsorbable polymer-coated stents, transcatheter heart valves, or vascular scaffolds, this verdict elevates the FTO priority of the ‘296 and ‘603 patent families. The validity confirmation makes these patents harder to design around via IPR or invalidity arguments that Boston Scientific presumably already advanced.
Should you run an FTO against US6596296 and US7033603?
Any medical device company developing bioabsorbable or biodegradable polymer-coated stents, vascular scaffolds, or drug-eluting implants should treat US6596296 and US7033603 as high-priority FTO targets following this verdict. The claims found infringed — 1, 11, 17, and 26 of the ‘296 patent — survived a full validity challenge at trial, making them robust against standard prior art arguments. R&D teams engineering next-generation bioabsorbable polymer coatings or new drug-eluting stent platforms should conduct claim mapping before product launch.
PatSnap Eureka’s FTO Search Agent can cross-reference your device’s polymer composition, degradation mechanism, and drug-release profile against the claim language of US6596296 and related family members in minutes. Eureka’s citation graph also surfaces continuation and divisional applications that may extend coverage beyond the asserted patents — a critical check before commercialising any bioabsorbable polymer stent product. Use Eureka to monitor TissueGen and the Board of Regents’ broader patent portfolio for further enforcement activity in this technology domain.
Run a freedom-to-operate analysis on US6596296B1 to assess your product’s exposure
Run FTO in Eureka →Similar biodegradable polymer stent patent cases in Delaware and beyond
Cases involving biodegradable polymer stent and drug-eluting device patents in the Delaware District Court and related federal venues.
Related patent case — similar technology
Comparable case in the same technology domain. Patent holder and defendant reached resolution after proceedings.
SettledRelated infringement action — same court
Comparable SYNERGY BP Stents-adjacent infringement action. Patent enforcement dynamics analysed in depth.
Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedBoard of Regents’s broader IP enforcement history
Board of Regents’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat this verdict signals for the medical device IP landscape
A $42M jury award in Delaware on biodegradable polymer stent patents reshapes enforcement calculus for the entire bioabsorbable device sector.
University patent holders can sustain major verdicts against device OEMs
The Board of Regents and TissueGen’s success demonstrates that university technology transfer offices and their spinouts can prosecute complex, multi-year patent campaigns against well-resourced defendants like Boston Scientific. The $42M award — plus interest — validates the model of asserting foundational polymer scaffold patents against commercial embodiments.
Bifurcated trials can limit damages while confirming infringement
The split verdict — infringement confirmed, willfulness rejected — is a common pattern in bifurcated medical device trials. Defendants should note that avoiding willfulness does not eliminate substantial compensatory exposure. Patent holders asserting biomedical polymer patents should build willfulness records early in prosecution and pre-suit correspondence.
§ 285 fee motion outcome could reshape the total cost of this dispute
Attorneys’ fees under 35 U.S.C. § 285 are deferred until after appeal, meaning Boston Scientific’s total outlay remains uncapped in the public record. An ‘exceptional case’ finding on fees — possible given the scope of litigation — could add tens of millions to the defendant’s burden. In-house teams should model this tail risk in any comparable dispute.
Induced infringement finding extends liability beyond the manufacturing act
The jury’s induced infringement verdict on the SYNERGY BP Stent suggests that downstream promotion, labelling, or clinical guidance around the stent’s biodegradable properties contributed to liability. Device companies should audit IFUs, marketing materials, and physician training content for any language that could be read as inducing use of patented methods or compositions.
Regents v Boston — key questions answered
The jury found Boston Scientific liable for direct and induced infringement of claims 1, 11, 17, and 26 of US6596296 and upheld the patent’s validity. The court entered judgment for plaintiffs awarding $42,000,000 in damages plus $7,436,328 in pre-judgment interest. Willful infringement was not found, so enhanced damages were not awarded.
The SYNERGY BP Stent — Boston Scientific’s bioabsorbable polymer everolimus-eluting coronary stent — was the accused product. The jury found both direct and induced infringement of four claims of US6596296, which covers biodegradable polymer scaffold technology used in drug-eluting stents.
The verdict form entered judgment in Boston Scientific’s favour on the willful infringement question. While the public record does not specify the jury’s precise reasoning, willfulness typically requires showing that the defendant knew of the patent and deliberately disregarded an objectively high risk of infringement. Rejection of willfulness prevented treble damages under 35 U.S.C. § 284, capping recovery at compensatory damages.
The case was filed on March 13, 2018 and final judgment was entered on June 28, 2024 — a duration of 2,299 days (approximately 6.3 years). The trial itself began January 25, 2023, with jury verdicts returned January 31, 2023. Post-trial motions were resolved by June 5, 2024 before final judgment was entered.
Yes. The June 28, 2024 judgment expressly deferred any motions for costs and attorneys’ fees — including under 35 U.S.C. § 285 — until 14 days after the appeal deadline expires or 14 days after issuance of any appellate mandate. This means the total financial exposure for Boston Scientific remains unresolved pending any appeal.
Assess your FTO exposure in bioabsorbable polymer stent technology
This $42M verdict confirms that foundational biodegradable polymer stent patents carry serious enforcement risk. Use PatSnap Eureka to run a freedom-to-operate analysis against US6596296 and monitor the TissueGen portfolio for new enforcement activity before your next product launch.
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