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Canadian MDx Firm ArcticDx Takes Sequenom to Court over Patent Fight

NEW YORK (GenomeWeb News) – Canadian molecular diagnostics company ArcticDx has sued Sequenom alleging patent infringement and has asked a federal court find that it and its subsidiaries do not infringe patents held by Sequenom.

The lawsuit filed in US District Court, Eastern District of Texas Marshall Division, is the latest in a flurry of lawsuits filed against and/or by Sequenom. Unlike other recent litigation involving Verinata, Natera, and Aria Diagnostics, though, ArcticDx's litigation pertains not to pre-natal testing but adult macular degeneration testing technology.

A Sequenom spokeswoman declined to comment on ArcticDx's litigation.

In its complaint, ArcticDx, based in Toronto, claims Sequenom and its Sequenom Center for Molecular Medicine subsidiary infringe US Patent No. 8,114,592. Specifically, it is asking the court to find that Sequenom's RetnaGene test — a laboratory developed test for evaluating a patient's risk of developing choroidal neovascularization — infringes the patent.

ArcticDx is further asking the court to find that its Macula Risk products and activities do not infringe on five patents held by Sequenom: US Patent Nos. 8,053,190; 7,867,727; 7,695,909; 7,351,524; and 8,088,579.

The '592 patent was issued about two weeks ago and ArcticDx holds an exclusive license to it. In its complaint, the company alleges Sequenom and SCMM "practices at least one of the claims" of the patent. It presented as proof that Sequenom was aware of ArcticDx's rights to the patent a remark made by Ron Lindsay, Sequenom's executive vice president of R&D, during the firm's third-quarter 2010 earnings conference call in which he recognized ArcticDx as a competitor and said that "there's probably some IP issues there."

ArcticDx has asked the court to find that Sequenom knowingly and willfully infringed the '592 patent and asked it to issue a preliminary and permanent injunction against the San Diego-based firm from further infringement. It is seeking triple damages.

In addition, the company has asked the court to preempt Sequenom from suing it for patent infringement on the five patents to which Sequenom holds rights.

ArcticDx's legal action follows separate letters sent by Sequenom's lawyer in December to Greg Hines, president and CEO of ArcticDx, and to Michael Salem, president and CEO of National Jewish Health, which was planning to offer ArcticDx's adult macular degeneration test services. In the letters, Michael Malecek, Sequenom's lawyer, stated that his client held the rights to the '190, '727,' 909, '524 patents. He also referenced the patent application to the '579 patent in his letters. The patent was issued after Malecek sent his letters.

The letter to Hines "purported to provide 'notice' to ArcticDx of [Sequenom's patents] and requested that ArcticDx 'discontinue any diagnostic activities that you may be currently engaging in which are covered by [the patents],'" AcrticDx said in its complaint. Further, it threatened that "Sequenom may seek all damages owed to it for any infringement'" of the patents.

ArcticDx's lawyer responded with a letter to Malecek saying his letters did not provide a claim chart or infringement analysis and noted that the letter to Salem was an attempt to interfere with ArcticDx's business relationship with National Jewish Health.

Arthur Renaud, ArcticDx's lawyer, demanded Malecek retract his letters to both Hines and to Salem, which Malecek has not done.

ArcticDx's complaint also points to Sequenom's recent litigation against Verinata, Natera, and Aria "to stop perceived competitors from lawfully commercializing their own intellectual property."

"Based on Sequenom's correspondence and litigious history, and its failure to respond to Mr. Renaud's letter, [ArcticDx] has formed a reasonable belief that Sequenom will employ the same litigation tactics in an attempt to eliminate lawful competition" from ArcticDx, the company said.

ArcticDx has asked the court to find that its Macula Risk products and activities do not infringe any of the five patents and that the claims of each of the patents are invalid.

The Macula Risk test was launched in Canada in 2007 and in the US in 2010. Hines told GenomeWeb Daily News in 2010 that it planned to file with the US Food and Drug Administration in mid-2011 for regulatory clearance of the test.

Brent Zanke, chairman and CMO of ArcticDx, told GWDN today that the company has submitted a pre-IDE application to FDA for Macula Risk and anticipates completing its submission to the agency in the third quarter of this year.

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