Bard Peripheral Vascular, Inc. et al. v. W.L. Gore & Assoc., Inc.

Docket No. 2014-1114

January 13, 2015

Brief Summary: DC decision of willfulness affirmed as Gore’s defense regarding inventorship determined not to be susceptible to a reasonable conclusion of invalidity.

Summary: Gore appealed DC judgment of willful infringement of US 6,436,135 (originally filed in 1974 and issuing 28 years later) relating to prosthetic vascular grafts made of highly-expanded polytetrafluoroethylene (ePFTE, sold as “GoreTex”). This technology and claims have been previously discussed (Bard 1 and 2, FC 2012; Cooper I and 2 (FC 1998 and 2001)). This appeal results from the DC decision following remand after Bard II that Gore “as a ‘reasonable litigant,’ could not have ‘realistically expected’ its defenses to succeed”. Gore argued for dismissal on the grounds that neither the original inventor (who licensed the patent to Bard) or Bard’s subsidiary BPV did not have standing to sue because the rights were not properly transferred (no written instrument transferring to BPV what it contends was the virtual assignment from [inventor] to Bard Inc”). That argument was rejected because BPV only claimed it was an exclusive licensee, and “the grant of a license does not need to be in writing” (Waymark, FC 2003). Under Seagate, the patentee has the burden of showing “by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent” (“risk..was either known or so obvious it should have been known”) and “[t]he state of mind of the accused infringer is not relevant to this objective inquiry.” In re Seagate, FC 2007; see also Uniloc USA, FC 2011 (must determine whether infringer’s “position is susceptible to a reasonable conclusion of no infringement”); and, objective recklessness not found where “substantial question of validity or noninfringement found (SpineSolutions, FC 2010; DePuy Spine, FC 2009). Gore’s argument that its employee supplied the particular ePTFE tubing that [the ‘135 inventor] used in making [the] successful graft” and was therefore a joint inventor was rejected because “if an individual supplies a component essential to an invention, that is an insufficiently significant contribution if the component and the principles of its use were known in the prior art” (Hess, FC 1997). Here, “the invention at issue was not merely the use of ePTFE in vascular grafts” but the “specified dimensions of fibril length that are essential for a successful graft” which was not shown to be conceived of by Gore’s employee when he provided the tubing (noting that “many grafts that were made of ePTFE failed” and “[p]rior to the invention, [those of skill] in the art believed that pore size was the key parameter for success”). The opinion also explained that “[f]orty years have passed since [the inventor] filed for the patent at issue in this case” with “decades of prior proceedings [that] shaped what defenses Gore could raise once it was sued for infringement” and presented no new evidence which would have been required for it “to have stood a reasonable chance of prevailing.” Thus, the DC decision of willfulness (i.e., Gore’s defense not susceptible to a reasonable conclusion of invalidity (“[I]f anything, the evidence presented…further bolstered the plaintiff’s position.”)) was affirmed. Judge Hughes concurred but wrote that the full court should review the case under Highmark (US 2014) and Octane (US 2014) (“calling into question our two-part test for determining willfulness”). Judge Newman’s dissent argued “[t]he panel majority does not review the evidence and apply the law objectively; the court merely searches for and recites adverse evidence.”

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