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Board of Regents & TissueGen v. Boston Scientific | PatSnap
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Case ID1:18-cv-00392
FiledMar 2018
ClosedJun 2024
Patent Litigation

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.

Resolution time
2299days
2,299 days — over six years from filing to final judgment, well above the median federal patent case duration
Patents asserted
2
US6596296 and US7033603 — biodegradable polymer scaffold/stent technology patents
Outcome
Judgment on the merits for Plaintiff
Jury found direct and induced infringement of claims 1, 11, 17, and 26 of US6596296; validity upheld
Cost ruling
Costs Deferred
Attorneys’ fees and costs motions (incl. § 285) deferred until after appeal deadline or appellate mandate
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

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.

Case at a glance
Case no.1:18-cv-00392
CourtDelaware
JudgeGregory B. Williams
FiledMarch 13, 2018
ClosedJune 28, 2024
Duration2299 days
OutcomeJudgment on the merits for Plaintiff
Verdict causeInfringement Action
BasisJudgment on the merits for Plaintiff
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

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

Case timeline: Complaint filed MAR 13 2018, MAY–JUN — 2299 days total Horizontal timeline showing the three key events in Board of Regents v Boston Scientific Corp. from filing to resolution. Source: PACER, Delaware District Court. MAR 13 2018 Complaint filed Pre-trial proceedings JUN 28 2024 Judgment on the merits for Plaintiff 2299 DAYS TOTAL
Court ruling

Jury verdict and judgment: what the $42M ruling means for both parties

Legal mechanism

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 — plaintiff
Patent holder outcome

Plaintiffs 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 awarded
Defendant outcome

Boston 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 remains
Commercial implications

University-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 stents
Legal analysis based on PACER docket records for case 1:18-cv-00392 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBoard of RegentsIndividualUniversity of Texas System and TissueGen, Inc. — holders of US6596296 (biodegradable polymer stent technology)Search in Eureka ↗
Co-PlaintiffTissuegen, Inc.CompanySearch in Eureka ↗
DefendantBoston Scientific Corp.CompanyBoston Scientific Corp. — global medical device manufacturer; maker of SYNERGY BP bioabsorbable polymer stentsSearch in Eureka ↗
Plaintiff counselAlex Q. JacobsAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff counselChijioke E. OfforAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff counselCorey M. LipschutzAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff counselMichael W. ShoreAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff counselSamuel E. JoynerAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff counselStamatios StamoulisAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff counselWilliam D. EllermanAttorneyCounsel for Board of RegentsSearch in Eureka ↗
Plaintiff law firmStamoulis & Weinblatt LLCLaw FirmRepresenting Board of RegentsSearch in Eureka ↗
Defendant counselBrian E. FarnanAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselChad M. DrownAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselChristopher J. BurrellAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselDavid J.F. GrossAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselDoowon ChungAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselEdmond AhadomeAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselElliot ChoiAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselEvan J. Kline-WedeenAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselJacob M. BassAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselJames R. FergusonAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselJohn E. NilssonAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselKaren L. PascaleAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselKatherine S. RazaviAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselLauren J.F. BartaAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselMatthew M. WolfAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselMelissa A. AnyeteiAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselMichael J. FarnanAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselMichael J. WordAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselMichael P. KahnAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselNicholas M. NyemahAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselNirvani Chethana PereraAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselRachel J. ElsbyAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselRebecca L. NeubauerAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant counselTimothy E. GrimsrudAttorneyCounsel for Boston Scientific Corp.Search in Eureka ↗
Defendant law firmFarnan LLPLaw FirmRepresenting Boston Scientific Corp.Search in Eureka ↗
Defendant law firmYoung, Conaway, Stargatt & Taylor LLPLaw FirmRepresenting Boston Scientific Corp.Search in Eureka ↗
Presiding judgeJudge Gregory B. WilliamsJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“This 28th day of June 2024, the Court having held a bifurcated trial consisting of two phases that began on January 25, 2023, the jury having rendered unanimous verdicts for each trial phase on January 31, 2023 (see D.I. 332 (Phase 1); D.I. 334 (Phase 2)), and the Court having entered a Memorandum Opinion (D.I. 368) and Order (D.I. 369) resolving the parties’ post-trial motion on June 5, 2024, pursuant to Fed. R. Civ. P. 58(b), IT IS HEARBY ORDERED that: 1. Judgment is entered in favor of the Board of Regents, the University of Texas System, and TissueGen, Inc. ("Plaintiffs") and against Boston Scientific Corporation ("Defendant") with respect to direct infringement and induced infringement of claims 1, 11, 17, and 26 of U.S. Patent No. 6,596,296 (the "’296 patent"); 2. Judgment is entered in favor of the Defendant and against the Plaintiff with respect to no willful infringement of the ‘296 patent and no enhanced damages; 3. Judgment is entered in favor of Plaintiffs and against Defendant with respect to the validity of claims 1, 11, 17, and 26 of the ‘296 patent; Judgment is entered in favor of Plaintiffs and against Defendant for damages in the amount of $42,000,000.00 (forty-two million dollars) for direct and indirect infringement of the ‘296 patent, with pre-judgment interest in the amount of $7,436,328, and post-judgment interest to accrue, beginning February 15, 2023, at 4.87% computed daily and compounded annually. IT IS FURTHER ORDERED that the deadline for any party to move for costs and attorneys’ fees (including under 35 U.S.C. § 285) is extended to within fourteen (14) days after the time for appeal has expired or within fourteen (14) days after issuance of the mandate from the appellate court, and no party shall file any such motion before that time.”
Source: PACER Docket, Case 1:18-cv-00392, Delaware District Court

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.

PACER case 1:18-cv-00392 · Public docket record Explore in Eureka ↗
Patent at issue

US6596296 — Biodegradable Polymer Scaffold Technology for Drug-Eluting Stents

Publication No.US6596296B1
Application No.US09/632457
Patent details
ProductBiodegradable polymer scaffold coatings for drug-eluting coronary stents
Cited in actionMarch 13, 2018

Publication No.US7033603B2
Application No.US10/428901
Patent details
ProductBiodegradable polymer stent formulations and methods of use
Cited in actionMarch 13, 2018

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.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

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.

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Related litigation

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.

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Strategic implications

What 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.

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Full strategic analysis in PatSnap Eureka
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Frequently asked questions

Regents v Boston — key questions answered

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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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