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C5 Medical Werks LLC v. GmbH

United States District Court, D. Colorado

January 5, 2017

C5 MEDICAL WERKS, LLC and COORSTEK MEDICAL, LLC, Plaintiffs and Counter-Defendants,
CERAMTEC GMBH, Defendant and Counter-Plaintiff.


          R. Brooke Jackson United States District Judge.

         This case was tried to the Court from August 29, 2016 to September 8, 2016 and from October 3, 2016 to October 5, 2016.


         A. The Parties.

         1. Defendant/counter-plaintiff CeramTec GmbH (“CeramTec”) is a company that produces pink-colored ceramic hip implant components sold under the name BIOLOX Delta. See Trial Tr. 619:1-10; DX-399. CeramTec sells these products to Original Equipment Manufacturers (“OEMs”). DX-1095. OEMs incorporate BIOLOX Delta products into hip implant systems that the OEMs in turn sell to hospitals for use by surgeons in orthopedic surgeries. Id.; Tr. 1618:19-1619:3. CeramTec currently controls roughly 95% of the ceramic hip implant market in the United States. Tr. 1617:21-25.

         2. Plaintiff/counter-defendant C5 Medical Werks, LLC (“C5”), which later became CoorsTek Medical, LLC (“CoorsTek”), was founded in 2005 to produce ceramic products, including ceramic hip implant components, for sale in the orthopedic market.[1] Tr.149:19- 151:25, 153:3-17, 213:9-15.

         B. Timeline of Events.

         3. On July 2, 1996 CeramTec applied for a utility patent on a ceramic cutting tool. DX-423 at 1. This application asserted that CeramTec had solved a pre-existing problem with certain ceramic composites known as zirconia-toughened alumina or “ZTA” ceramics whereby the introduction of zirconium used to toughen the material caused a drop in the material's hardness. See Tr. 657:16-658:5; PX-190 (Applicant's April 15, 1997 Response to Patent Office). CeramTec claimed that through the introduction of chromium in a specific molar ratio with other components of ZTA ceramics, namely zirconium dioxide, Tr. 657:19-25; see also PX 190 at 216, it could achieve hardness scores for ZTA ceramics that had never been achieved with corresponding zirconium dioxide contents, Tr: 657:19-658:8; PX-190 at 216. Hardness is an important characteristic of ceramic materials because it affects the ceramic's wear properties, which influence performance.[2] Tr. 219:12-16, 643:25-644:13.

         4. Although an existing patent already taught the use of chromium in ZTA ceramics, see Tr. 656:20-657:7 (describing the “Ekstrom” patent), the Patent Office issued CeramTec a patent on November 3, 1998 (the ‘816 patent). DX-423 (the ‘816 patent). CeramTec overcame a contrary office action based in part on the company's insistence that it had discovered that a small and specific ratio of chromium improved ZTA ceramic hardness values dramatically. Tr. 656:20-659:10; DX-423; PX-190.

         5. Around the same time that it obtained the ‘816 patent, CeramTec developed BIOLOX Delta. See DDX-1017; Tr. 1016:20-1017:15; 1018:20-23. In producing BIOLOX Delta, which is a ZTA ceramic product, CeramTec practices at least claim 3 of the ‘816 patent. ECF No. 247 at 2, ¶4 (joint pretrial stipulations). The chromium added to BIOLOX Delta gives it a light pink color. DX-228; DX-281.

         6. In the early 2000s, CeramTec began to market BIOLOX products commercially. DDX-1017.

         7. In September of 2002 CeramTec obtained another patent for ZTA ceramics (the ‘957 patent). PX-142. Like the ‘816 patent, the ‘957 patent claimed the use of chromium in ZTA ceramics. PX-142 (the ‘957 patent), claims 1-4 and at 4:37-56, 5:12-51, 7:14-27. Echoing the ‘816 patent, the ‘957 patent also explained that the introduction of chromium in a specific ratio with zirconium counteracted a drop in hardness. PX-142 at 5:41-44 (“[T]he chromium addition counteracts any drop in the hardness values when the proportion of zirconium dioxide rises.”). CeramTec does not specifically practice the ‘957 patent in producing BIOLOX Delta products. Tr. 394:4-10. This patent is still in force today.

         8. CeramTec owns an additional patent on ZTA ceramics (the ‘970 patent) and a pending patent application (U.S. Patent Publ. No. 2012/0142237 or the ‘554 Appl.) that similarly teach the use of chromium to improve the properties of ceramic materials. PX-550 (the ‘970 patent), claims 1 and 20; PX-551 (the ‘554 Appl.), claim 8; Tr. 1136:16-24.

         9. In April of 2004 CeramTec made two submissions to the Food & Drug Administration (“FDA”) in which the company represented that the addition of chromium in its composite material counteracts a drop in hardness caused by an increasing amount of zirconia. See PX-79 at 6; PX-86 at 6.

         10. In 2006 CeramTec produced research that suggested that chromium did not increase hardness. Tr. 1100:18-1101:4. CeramTec refers to this as its first “data point” that chromium might actually be a non-functional component of BIOLOX Delta. See id.

         11. However, despite that research and a few additional studies in the late 2000s that reached similar results, see PX-554, the company did not change its public stance that chromium increased hardness. On the contrary, it maintained its position that chromium increased hardness in additional submissions to the FDA in September 2008, October 2008, February 2012, October 2012, and June of 2013. PX-79; PX-86; PX-87 at 26-27; PX-22 at 6; PX-82; PX-88; PX-84 at 26; PX-166 at 34. CeramTec also reiterated this stance, as well as the fact that chromium turned the product pink, in numerous training materials for its customers, research articles, and marketing campaigns spanning this same time period. See, e.g., Tr. 1151:4-14, 2029:1-9 (referencing an e-mail chain involving the marketing “story” of chromium increasing hardness that CeramTec adopted); DX-215 (e-mail chain); Tr. 223:4-231:1; PX-429 (Summary of CeramTec presentations); PX-40 (Training Guide); PX-129 (Research).

         12. In 2009 C5 entered the ceramic hip component market and began to compete with CeramTec with two products of its own: (1) Cerasurf-p, a ceramic product that like BIOLOX Delta contains chromium and is pink; and (2) Cerasurf-w, a white ceramic product that does not contain chromium. DX-517; DX-090 at 91; DX-90 at 118; DX-517; Tr. 297:4-12; DX-519 at 9; DX-065. Initially, C5's internal testing revealed no difference in hardness or strength between Cerasurf-p, which contains chromium, and Cerasurf-w, which does not. See DX-527. Nevertheless, additional testing C5 conducted eventually showed statistically significant evidence that its pink material was harder than its white material. See, e.g., Tr. 1307:11-12, 1941:3-20. While the Cerasurf-p product looks identical to CeramTec's BIOLOX Delta product aside from the companies' logos engraved on these products, C5 claims that it carefully designed its product so that it did not infringe on CeramTec's ‘816 patent. Tr. 923:1-13; Tr. 239:3-13.

         13. Although BIOLOX Delta controlled the vast majority of the ceramic hip implant market at this time, CeramTec soon grew concerned when C5 entered the market. See PX-44 at 62; PX-68 at 2. The company subsequently took three actions to preserve its market share. First, on April 9, 2013 CeramTec filed an application with the United States Patent and Trademark Office (“USPTO”) seeking trade dress protection on the pink color of chromium in BIOLOX Delta on the principal register. DX-156; DX-157. In response to questions, CeramTec asserted that the color pink was not a functional component of BIOLOX Delta. See DX-156 at 56-57, 65-66; DX-157 at 53-54, 61-62. It informed the USPTO that “[t]he color pink is not a natural byproduct of the manufacture of implants generally, supported by the fact that none of Applicant's competitors create pink implants.” DX-156 at 56 (¶II.7), DX-157-53 (¶II.7) (emphasis added). It added that the color pink is a result of CeramTec's proprietary manufacturing process. Id. Significantly, however, the response did not explain that the color pink was a natural byproduct of the chromium in CeramTec's implants or that CeramTec had for many years claimed that the chromium was a functional component of its BIOLOX Delta products. Id. The USPTO nevertheless rejected CeramTec's application because it found that CeramTec had not acquired secondary meaning or distinctiveness, which is necessary in order to register a color as trade dress. DX-156 at 29-30; DX-157 at 29-30.

         14. Second, having been rejected by the USPTO, CeramTec obtained U.S. Supplemental Trademark Registration Nos. 4, 319, 095 and 4, 319, 096 (the ‘095 and ‘096 registrations) for the pink color of chromium in hip implants. DX157 at 6; DX156 at 7.

         15. Third, on November 20, 2013 CeramTec sent a cease and desist letter to C5 asserting that Cerasurf-p infringed on the ‘816 patent. PX-558 at 24-44. This became moot when the ‘816 patent expired that same year.

         16. On March 3, 2014 C5 took the offensive, initiating this lawsuit against CeramTec. ECF No. 1 (Complaint).[3] In its initial Complaint, C5 sought to cancel CeramTec's ‘095 and ‘096 registrations and to obtain several other rulings regarding C5's rights to manufacture and market Cerasurf-p. Id. at ¶¶78-106.

         17. CeramTec answered C5's Complaint on September 25, 2014 with numerous affirmative defenses and counterclaims of its own, asserting among other things that Cerasurf-p infringed on CeramTec's ...

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