UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NORTH CAROLINA Civil Action No.:

Transcription

1 MERZ NORTH AMERICA, INC., UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NORTH CAROLINA Civil Action No.: v. CYTOPHIL, INC., d/b/a REGENSCIENTIFIC, Plaintiff, COMPLAINT (Jury Trial Demanded) Defendant. Plaintiff Merz North America, Inc. ( Merz ), a North Carolina corporation, states its Complaint for Patent Infringement against Defendant Cytophil, Inc., d/b/a Regenscientific ( Cytophil or Defendant ) as follows: PARTIES 1. Merz is a corporation formed under the laws of the State of North Carolina, having a principal place of business at 6501 Six Forks Road, Raleigh, North Carolina Upon information and belief, Cytophil is a corporation formed under the laws of the state of Delaware, having a principal place of business of 2485 Corporate Circle, Suite 2, East Troy, Wisconsin Upon information and belief, Regenscientific is the sales and marketing arm of Cytophil, Inc., is co-located in Cytophil s offices at 2485 Corporate Circle, Suite 2, East Troy, Wisconsin 53120, and is not a separate legal entity from Cytophil. JURISDICTION AND VENUE 4. This is an action for patent infringement pursuant to 35 U.S.C. 1 et seq. 5. The Court has subject matter jurisdiction for the pleaded claims pursuant to 28 U.S.C and 1338(a). 1 Case 5:15-cv H Document 1 Filed 06/18/15 Page 1 of 8

2 6. This Court has personal jurisdiction over Defendant consistent with the principles of the U.S. Constitution and N.C. Gen. Stat in that Defendant, either directly or through its agents and as further described in the Factual Background below, regularly and continuously transact business and enter into contracts to supply goods and services in the State of North Carolina in general and in this District in particular. Upon information and belief, Defendant has committed specific acts of infringements complained of herein in the State of North Carolina and in this District. 7. Venue is proper in this District pursuant to 28 U.S.C. 1391(b), (c), and (d), and 1400(b). FACTUAL BACKGROUND 8. Merz is the owner, by assignment, of all right, title, and interest in and to United States Patent No. 6,537,574 ( the 574 patent ), entitled Soft Tissue Augmentation Material. Mr. William G. Hubbard is the named inventor on the 574 patent. See Exhibit A. 9. The 574 patent was duly and lawfully issued by the United States Patent and Trademark Office on March 25, The 574 patent issued from Application No. 08/159,071 ( the 071 application ). 11. The 071 application is a continuation of Application No. 07/999,411, which was a continuation-in-part of Application No. 07/833, The 574 patent claims, among other things, a method for soft tissue augmentation comprising the introduction at a desired site in a mammal of a material that comprises a matrix of rounded, substantially spherical and biocompatible finely divided ceramic particles. 13. Merz is a specialty healthcare company that develops and commercializes innovative, high-quality treatment solutions in aesthetics, dermatology, and neurosciences in the 2 Case 5:15-cv H Document 1 Filed 06/18/15 Page 2 of 8

3 U.S. Merz is a market-leading innovator and manufactures a number of medical device and pharmaceutical products, including two product lines that practice the invention of the 574 patent: Prolaryn Plus, a vocal fold implant, and Radiesse, a volumizing dermal filler for augmentation of the face and hands. Both Prolaryn Plus and Radiesse have been approved by the U.S. FDA for their respective uses. 14. Merz previously referred to its Prolaryn Plus product as Radiesse Voice, and accordingly filed a Section 510(k) premarket notification with the FDA describing its Radiesse Voice product. 15. Upon information and belief, Cytophil is the manufacturer of Renú Voice products, which are injectable implants consisting of calcium hydroxylapatite microparticles suspended in a gel carrier. 16. Upon information and belief, as a named inventor of the 574 patent, coupled with his involvement in the prosecution of the patent application that led to the 574 patent, Mr. Hubbard had knowledge of the 574 patent since it issued on March 25, Upon information and belief, Mr. Hubbard founded Cytophil in 2004 and has operated as Cytophil s President and/or Chief Executive Officer since its founding in Accordingly, upon information and belief, Mr. Hubbard and Cytophil have had knowledge of the 574 patent since at least On February 22, 2013, the FDA cleared Cytophil s Section 510(k) premarket notification of intent to market a Calcium Hydroxylapatite Vocal Fold Implant (K121795). See Exhibit B. 18. In its 510(k), Cytophil identified Merz s Radiesse Laryngeal Implant as the predicate device, stating that Cytophil s vocal fold implant product was identical chemically and physically to Merz s Radiesse product. See Exhibit B. 3 Case 5:15-cv H Document 1 Filed 06/18/15 Page 3 of 8

4 19. Cytophil s 510(k) also states that its product comprises calcium hydroxylapatite particles ranging in size from 25 to 45 µm that are blended into an aqueous gel including glycerin and sodium carboxymethylcellulose. See Exhibit B. 20. Upon information and belief, the calcium hydroxylapatite particles in Cytophil s Renú Voice product are substantially spherical and rounded in shape. 21. Upon information and belief, Cytophil markets and sells its Renú Voice product, the product described in its 510(k) notification and listed on Regenscientific s website through the Vocal Fold Filler link on the Products tab, nationally through Regenscientific, which sells the product at least to physicians. Through the Regenscientific publicly-available website, Defendant states: RENÚ Voice is an injectable implant consisting of synthetic Calcium Hydroxylapatite (CaHA) microparticles, which have diameters in the range of 25 to 45 µm, suspended in an aqueous hydro gel carrier. These CaHA microparticles have proven biocompatible and safe while providing long-term augmentation lasting up to 24 months. See Exhibit C. 22. Mr. Charles Milo was previously the Director of Marketing at Bioform, Inc., Merz s predecessor-in-interest, and then at Merz for the Radiesse Laryngeal Implant, 23. Upon information and belief, Mr. Milo joined Cytophil in January 2015 and now holds the position of Chief Business Officer at Regenscientific Cytophil, Inc. 24. Upon information and belief, Defendant has used and continues to use the preexisting relationships with physicians throughout the country, in North Carolina, and this judicial District that Mr. Milo previously developed during his employment with Bioform and Merz to market, offer for sale, and sell Renú Voice products to these same physicians and their medical practice groups. 4 Case 5:15-cv H Document 1 Filed 06/18/15 Page 4 of 8

5 25. Physicians who use Defendant s Renú Voice product perform a method of soft tissue augmentation that includes introducing at a patient s vocal fold a material comprising a matrix of rounded, substantially spherical, biocompatible, substantially non-resorbable, finely divided ceramic particles close to or in contact with each other, wherein the particles have a size distribution in the range of 15 µm to 150 µm. These ceramic particles in the Renú Voice product are comprised of calcium hydroxylapatite. 26. Instructions for Use ( IFUs ) for Renú Voice are publicly available through at least Regenscientific s website at CMCHA-Vocal-Fold-Implant-IFU-Attachment-01.pdf. See Exhibit D. The IFUs include directions for use stating that physicians should inject the Renú Voice product either percutaneously or orally. 27. Upon information and belief, physicians throughout the country, in North Carolina, and in this judicial District have used Renú Voice to treat vocal folds in need of soft tissue augmentation. COUNT I PATENT INFRINGEMENT (U.S. Patent No. 6,537,574) 28. Merz repeats and realleges each and every allegation of paragraphs 1 through 27 as though fully set forth herein. 29. Upon information and belief, physicians throughout the country, in North Carolina, and in this judicial District have directly infringed and continue to infringe the 574 patent in violation of 35 U.S.C. 271, literally and/or under the doctrine of equivalents, by, without limitation, using Renú Voice for implantation and soft tissue augmentation in violation of at least Claim 1 of the 574 patent. 5 Case 5:15-cv H Document 1 Filed 06/18/15 Page 5 of 8

6 30. Upon information and belief, Defendant has acted with knowledge of the 574 patent or willful blindness to the existence of the 574 patent in making, using, offering to sell, and selling Renú Voice to physicians in this judicial District with a specific intent to induce infringement of the 574 patent. 31. Upon information and belief, Defendant has had knowledge of Merz s Radiesse Laryngeal Implant since at least February 22, 2013, the date that Cytophil filed the 510(k). See Exhibit B. 32. Upon information and belief, Defendant provides or otherwise makes available the IFUs for Renú Voice to physicians with the intent that physicians implant Renú Voice into patients in accordance with the IFUs and with the intent that such implantation will infringe at least Claim 1 of the 574 patent. By providing its Renú Voice product with its IFUs, upon information and belief, Defendant specifically intends to induce physicians to introduce at a desired site in the patient material comprising a matrix of rounded, substantially spherical nonresorbable, finely divided ceramic particles close to or in contact with each other, said particles have a size distribution in the range of 15 µm to 150 µm. 33. Defendant has committed the acts of infringement complained of herein without the consent or authorization of Merz and in derogation of 35 U.S.C Merz has been and will continue to be damaged by Defendant s infringement of the 574 patent. 35. Merz is entitled to damages from Defendant, pursuant to 35 U.S.C. 284 and injunctive relief pursuant to 35 U.S.C. 283, for Defendant s infringement of the 574 patent. 36. Defendant s infringement has been and continues to be willful, intentional, and with knowledge of the existence of the 574 Patent and Merz s general patent rights. Merz is thus 6 Case 5:15-cv H Document 1 Filed 06/18/15 Page 6 of 8

7 entitled to enhanced damages pursuant to 35 U.S.C. 284, and attorneys fees and other expenses of litigation pursuant to 35 U.S.C DEMAND FOR JURY TRIAL 37. Plaintiff demands a trial by jury on all disputed issues so triable. PRAYER FOR RELIEF WHEREFORE, Plaintiff prays for the entry of a judgment: Holding that Defendant has infringed one or more claims of the 574 patent; In favor of Merz, and against Defendant, that Defendant s infringement of one or more claims of the 574 patent has been and continues to be willful; Awarding Merz all available damages pursuant to 35 U.S.C. 284 for Defendant s willful infringement of the 574 patent; Awarding Merz enhanced damages pursuant to 35 U.S.C. 284, and attorneys fees and other expenses of litigation pursuant to 35 U.S.C. 285; Awarding Merz interest and costs to the extent permitted by law; Permanently enjoining Defendant from any further acts of infringement of the 574 patent; and Awarding such other and further relief as this Court may deem just and proper. This the 18th day of June, /s/ Lance A. Lawson Peter D. Siddoway (N.C. Bar No ) Lance A. Lawson (N.C. Bar No ) Anthony P. DeRosa (N.C. Bar No ) MYERS BIGEL SIBLEY & SAJOVEC, P.A Parklake Avenue, Suite 600 Raleigh, North Carolina (telephone) 7 Case 5:15-cv H Document 1 Filed 06/18/15 Page 7 of 8

8 (facsimile) Attorneys for Plaintiff Merz North America, Inc. 8 Case 5:15-cv H Document 1 Filed 06/18/15 Page 8 of 8