Straumann has won two important legal battles against DRS International, a maker of dental implants that has been claiming its components are compatible with, and equivalent to, Straumann originals.
Courts in Germany and Switzerland found that neither conformity nor scientific tests had been conducted to support the claims made by DRS International and ProImplant, its former Swiss distributor, about the company's Oktagon implant system, according to a press release from Straumann.
The District Court in Frankfurt also found that "combined use" (use of parts in combination with parts from third parties) was not stipulated in the CE Mark certification. As a result, the court ruled that the Oktagon implant system may neither be marketed nor sold by DRS for combination with system parts from other producers and that dentists must not use it in such a combination.
Because compatibility is not stipulated in the CE Mark certification, a second ruling by the court forbids DRS from further claiming that a combination of Oktagon with other systems could be guaranteed, according to Straumann. If a dentist or a laboratory mixes Oktagon or any components from other producers with Straumann components the Straumann guarantee is void. The court also prohibited DRS from advertising Oktagon as a "high-quality copy" of Straumann's Standard Plus implant.
In a separate action against ProImplant, the Appeals Court in Basel struck down ProImplant's claim that the Oktagon implant is a "bioequivalent generic." The court found that the terms "generic" and "bioequivalent," which are used for pharmaceuticals, had been improperly and misleadingly applied to dental implants.
"Dentists and patients have been misled into believing that lower-price imitations are the same as Straumann originals," said Beat Spalinger, president and CEO of Straumann, in the release. "They have also been hoodwinked by a misleading guarantee. Dental implants are not ‘generic' or ‘bioequivalent,' and it is illegal to label them as such. Look-alikes and copycats are not manufactured to our standards nor have they undergone the extensive clinical testing that Straumann implants and abutments receive. Most importantly, without proven conformity they must not be used in combination with other systems."
