Bard Peripheral Vascular v. W.L. Gore & Associates — Federal Circuit Affirms $371M Enhanced Damages for Willful Infringement of Vascular Graft Patent

Case
Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc.
Court
U.S. Court of Appeals for the Federal Circuit
Date Decided
June 14, 2012
Docket No.
No. 2010-1510
Judge(s)
Judge Lourie wrote for the court; multiple concurrences
Topics
Willful infringement, enhanced damages, joint inventorship, vascular graft patents, ePTFE, medical device patents

Background

The dispute traced back to the early 1970s and one of the most important advances in vascular surgery: the development of prosthetic blood vessel grafts made from expanded polytetrafluoroethylene (ePTFE), a highly porous form of PTFE (the material in non-stick cookware). Dr. Robert Goldfarb, a surgeon, received U.S. Patent No. 6,436,135 covering vascular prostheses made from ePTFE. The patent application was filed in 1974, but due to a complex prosecution history, the patent did not issue until 2002.

W.L. Gore & Associates, Inc. (the maker of Gore-Tex®) had long manufactured ePTFE vascular grafts and disputed whether its own employee had jointly invented the technology, which would have entitled Gore to co-ownership rights and a defense against infringement. After a nearly decade-long litigation, a jury found that Gore had willfully infringed the ‘135 patent and awarded $371 million in enhanced damages, plus attorneys’ fees, costs, and an ongoing royalty. The district court upheld the verdict and Gore appealed.

The Court’s Holding

The Federal Circuit affirmed. On the inventorship question, the court found substantial evidence that Gore’s employee — who had supplied ePTFE tubes to Goldfarb for testing — had not made an inventive contribution to the critical aspects of the claimed invention. The employee provided the material for testing; it was Goldfarb who had the specific insight about how to fabricate ePTFE into a successful vascular graft and who reduced that conception to practice. Supplying materials for another’s experiments, without contributing to the conception of the claimed invention, does not make a person a joint inventor.

On willfulness, the court applied the post-Seagate objective-recklessness standard. Gore’s multi-decade copying of Goldfarb’s patented approach, combined with its failure to identify and rely upon a good-faith non-infringement position, supported the jury’s finding of willfulness. The court upheld the full enhanced damages award as within the district court’s discretion under 35 U.S.C. § 284.

Key Takeaways

  • Joint inventorship requires actual contribution to the conception of the claimed invention — supplying materials for an inventor’s experiments does not create joint inventor status.
  • Willful infringement following decades of copying, without a good-faith defense, supports substantial enhancement of damages under § 284.
  • Even patents that take decades to issue (here, 28 years from application to issuance) can be valid and enforceable if prosecution was pursued in good faith and not abandoned.
  • The case illustrates that medical device patent disputes involving foundational technologies can result in some of the largest damage awards in patent history.

Why It Matters

Bard v. Gore is one of the landmark patent cases of the early 2010s, both for the size of the damages award and for the decades-long scope of the dispute. The case resolved a fundamental factual and legal contest about who had the critical insight that led to a life-saving medical technology — a technology that had saved millions of lives through coronary bypass and peripheral vascular surgery.

The case has lasting significance on several points: the standards for joint inventorship (contribution to conception, not merely execution); the durability of willfulness findings through appeal under the Seagate objective-recklessness test; and the availability of substantial enhanced damages for decades of knowing infringement. For medical device companies, the ruling is a sobering reminder that pioneer technology patents, even those with unusual prosecution histories, can impose enormous liability on companies that copy patented technology without establishing a credible legal defense.

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