Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense of Patent

Posted: July 7, 2012 at 8:13 am

SAN DIEGO, July 6, 2012 /PRNewswire/ -- Sequenom, Inc. (SQNM), a life sciences company providing innovative genetic analysis solutions, today confirmed that the United States District Court for the Northern District of California has denied a motion by Sequenom for a preliminary injunction against Ariosa Diagnostics.

"While obviously a disappointing preliminary outcome in our efforts to enforce an issued US patent against infringement, yesterday's decision is by no means a final ruling on the infringement or the validity of the '540 patent, but is one step in a long process to enforce our patent and protect our proprietary rights in the non-invasive prenatal testing marketplace," said Harry F. Hixson, Jr., Ph.D., Chairman and CEO, Sequenom, Inc.

Earlier this year, Sequenom filed the motion against Ariosa (formerly Aria) Diagnostics to stop the company from making, using, selling or offering for sale, importing or exporting, infringing tests for detecting fetal chromosomal aneuploidy, such as Ariosa's Harmony Prenatal Test, pending the ultimate resolution of the litigation.

Sequenom's request for preliminary injunctive relief followed its counterclaims filed in the lawsuit in the United States District Court for the Northern District of California, which allege that Ariosa is infringing U.S. Patent No. 6,258,540 ("'540 patent"). The case is ongoing and Sequenom will be seeking a full trial on the merits of its claims and all relief, including damages and a permanent injunction against Ariosa.

Using circulating cell free fetal nucleic acid as the analyte, as covered in the issued '540 patent, Sequenom Center for Molecular Medicine (Sequenom CMM) was the first fully certified clinical diagnostic laboratory to develop, fully validate in a major clinical study and bring to market a high precision non-invasive prenatal diagnostics laboratory developed test (LDT) for chromosomal aneuploidy. Sequenom CMM's MaterniT21 PLUS LDT detects a genetic chromosomal anomaly known as Trisomy 21, the most common cause of Down syndrome, as well as trisomies 18 and 13, in single, twin or triplet pregnancies. MaterniT21 PLUS is available as a testing service to physicians through Sequenom CMM.

About SequenomSequenom, Inc. (SQNM) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.

About Sequenom Center for Molecular MedicineSequenom Center for Molecular Medicine (Sequenom CMM) has two CAP accredited and CLIA-certified molecular diagnostics reference laboratories dedicated to the development and commercialization of laboratory developed tests for prenatal and eye conditions and diseases. Utilizing innovative proprietary technologies, Sequenom CMM provides test results that can be used as tools by clinicians in managing patient care. Testing services are available only upon request to physicians. Sequenom CMM works closely with key opinion leaders and experts in obstetrics, retinal care and genetics. Sequenom CMM scientists use a variety of sophisticated and cutting-edge methodologies in the development and validation of tests. Sequenom CMM is changing the landscape in genetic diagnostics. Visit http://www.scmmlab.com for more information on laboratory testing services.

Forward-Looking StatementsExcept for the historical information contained herein, the matters set forth in this press release, including statements regarding the process to enforce Sequenom's patent and protect its rights, that Sequenom will be seeking a full trial on the merits of its claims and all relief, including damages and a permanent injunction, the ultimate resolution of the litigation, Sequenom's commitment to improving healthcare through revolutionary genetic analysis solutions, and Sequenom CMM's dedication to the development and commercialization of laboratory developed tests and changing the landscape in genetic diagnostics, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with ongoing patent litigation, Sequenom's ability to develop and commercialize new technologies and products, particularly new technologies such as prenatal and other diagnostics and laboratory developed tests, Sequenom's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory developed tests, obtaining or maintaining regulatory approvals, ongoing litigation, and other risks detailed from time to time in Sequenom, Inc.'s most recent Annual Report on Securities and Exchange Commission Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom, Inc. undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

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Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense of Patent

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