EAST TROY, Wis., April 6, 2016 /PRNewswire/ -- Wisconsin manufacturer Cytophil, Inc. today filed suit against Merz North America, Inc. and German parent company Merz Pharma GmbH & Co. KGaA, alleging false patent marking, monopolization of markets for implantable medical devices, and commercial disparagement.
Cytophil asserts that the Merz companies are artificially raising market barriers and prices by their conduct in United States markets for injectable vocal fold medialization systems. The case involves U.S. Food & Drug Administration (FDA) approved products for augmentation of injured or deformed vocal chords, also useful in aesthetic applications.
Cytophil, with its Renú® Gel and Renú® Voice products, is a relatively new entrant and direct competitor to Merz in the relevant markets. Merz's products at issue are under Merz's Prolaryn™ and Radiesse® product lines which Cytophil says account for more than a 98% market share. Both Cytophil and Merz manufacture in Wisconsin, although Merz's headquarters are in Germany and North Carolina.
Merz's conduct alleged to violate federal antitrust law, patent law and common law is occurring in the face of stiff price competition from Cytophil's Renú® products, which sell for a fraction of Merz's prices, according to Charles Milo, Cytophil's Chief Business Officer.
Central to Cytophil's allegations are Merz's assertions of exclusive rights under a patent, U.S. Patent No. 6,537,574, claiming a method using a "soft tissue augmentation material" containing "permanent" ceramic particles.
The complaint, filed in U.S. federal court in Milwaukee, states that Merz is knowingly misleading the public and disadvantaging competitors by asserting that the patent covers Prolaryn™ and Radiesse® line products that do not contain any ceramic particles, and others which lack the "permanent" particles of the patent.
Merz's gel-only products are falsely marked "Protected by U.S. Patent 6,537,574," as are Merz's particle-bearing products, which are described as "non-permanent" in Merz statements to the FDA, according to the complaint.
Cytophil's false marking allegations point in part to the patent's description of the required particles as "permanent" and non-resorbable, contrasting sharply with Merz's public statements describing its particles as "non-permanent" and wholly absorbed by the body.
Merz has described Cytophil's Renú® Voice as identical to the Merz products it calls "non-permanent." But despite this, Merz filed an infringement suit against Cytophil last year for "inducing" use of Renú® Voice by physicians. Cytophil's complaint filed today calls that suit a "sham" undertaken by Merz to "suppress, foreclose and destroy existing and foreseeable lawful competition," given Merz's knowledge that use of Renú® Voice does not infringe the patent.
Cytophil's lawsuit demands a jury trial and seeks an award of treble damages. It also seeks preliminary and permanent injunctions barring Merz from marking its Prolaryn™ and Radiesse® products with any reference to U.S. Patent No. 6,537,574.
Cytophil is represented by Jansson Munger McKinley & Kirby Ltd.
Radiesse® and Prolaryn™ are trademarks of Merz North America, Inc.
The case is captioned as Cytophil, Inc. v. Merz North America, Inc. and Merz Pharma GmbH & Co. KGaA, Civ. No. 2:16-cv-00423 in the United States District Court for the Eastern District of Wisconsin, Milwaukee Division.
About RegenScientific – Cytophil, Inc.:
RegenScientific, a wholly-owned business unit of Cytophil, Inc., is dedicated to providing physicians and patients with high-quality, safe, efficacious, and cost-effective soft tissue augmentation implants. The company has CE-Mark for its Renú® Soft Tissue Volumizing Filler for lipoatrophy, vocal fold insufficiency, and soft tissue augmentation in Europe. The company has FDA 510k clearances for its Renú® Gel and Renú® Voice otolaryngology products indicated for vocal fold injection augmentation. Renú® is a registered trademark of Cytophil, Inc. REGENSCIENTIFIC™ and the REGENSCIENTIFIC logo are trademarks of Cytophil, Inc.
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SOURCE Cytophil, Inc.