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