No Trade Dress Protection For Pink Ceramic Hip Implant Components

The U.S. District Court for the District of Colorado recently denied a manufacturer of ceramic medical products trade dress protection for the color pink for its ceramic hip-implant components.

CeramTec sells ceramic hip-implant components made of zirconia-toughened aluminia (ZTA), under the name BIOLOX Delta.  Hardness is an important characteristic of such components because it impacts wear and performance.  In 1998, CeramTec obtained a utility patent that disclosed a combination of chromium and zirconium dioxide to achieve hardness scores for ZTA ceramics that had never been obtained before.  The chromium gives BIOLOX Delta its light pink color.

In 2009, C5 Medical Werks, LLC introduced a competing ceramic hip component product containing chromium and that was also pink.  After CeramTec sent C5 a cease-and-desist letter alleging infringement of CeramTec’s trade dress rights in the color pink, C5 filed a declaratory judgment action.

CeramTec had the burden of proving that the pink color in BIOLOX Delta was non-functional.  To do so, CeramTec had to show that the pink color was not essential to the use or purpose of the component and that it did not affect the cost or quality of the component.  CeramTec failed this test.

First, CeramTec’s utility patent showed that chromium is an essential component of BIOLOX Delta.  The patent’s disclosure of a specific molar ratio of chromium to produce harder ZTA ceramics was “strong evidence” of chromium’s functionality.  Further, both the patent and the patent’s prosecution history showed that the addition of chromium solved an existing problem in ZTA ceramics—a drop in hardness due to zirconium dioxide, which is used to toughen ceramic composites—and was “the reason the device works.”  According to the Court, CeramTec’s patent alone was sufficient to deny CeramTec trade dress protection.

Second, substantial evidence showed that chromium affects the quality of BIOLOX Delta, including two other CeramTec patents that similarly showed the benefits of using chromium in ZTA ceramics.  Though CeramTec did not practice these patents in producing BIOTEC Delta, they showed that up until this litigation, CeramTec’s stated position was that chromium affected the quality of ZTA ceramics by increasing their hardness.  Additionally, CeramTec made six FDA filings, published research, and distributed training and marketing materials all stating that chromium “affects the quality” of BIOLOX Delta by making it harder.

The Court rejected CeramTec’s two counter-arguments.  CeramTec attempted to distinguish between chromium and its pink color, arguing that while chromium may be a functional feature of BIOLOX Detla, the color is not.  The Court disagreed.  Unlike the pink color of Corning Fiberglass insulation, chromium’s pink color is not an arbitrary design flourish, but rather the natural byproduct of the chromium used in the production of BIOLOX Delta.  “If CeramTec is correct that the general appearance of a functional feature can be distinguished from the underlying functional object,” the Court reasoned, “then the ‘orange’ color of orange juice can be distinguished from the orange fruit used to make it.”

CeramTec also argued that “the science now suggests that chromium does not increase hardness and therefore that chromium is actually a non-functional component of BIOLOX Delta.”  In making this argument,  CeramTec relied on a questionable white paper published by a CeramTec manager roughly eight months after C5 had filed suit.  Also, CeramTec’s new position on chromium contradicted the vast majority of evidence in the case, including CeramTec’s own patent.  Even if science conclusively showed that chromium in BIOLOX Delta does not increase hardness, the Court held that CeramTec was estopped from denying chromium’s functionality based on its prior position to the contrary.

The case is C5 Medical Werks, LLC v. CeramTec GmbH, Case No. 14-cv-00643-RBJ.