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Wagner, Medicine Casts Gen-Probe, TEVA Aside Medicine Casts Gen-Probe, TEVA Aside * Harold C. Wagner ** Today, in Medicine, Inc. v. Genetic, Inc., No. 05-608, U.S. (2007)(Scalia, J.), the Supreme

That standard holds that: (1) genetic testing can be conducted to yield information about known genetic disease; and, (2) genetic testing must be performed in the presence of a prospective patient who has been identified as carrying those gene loci of disease. In Health Lab Corp. v. Genomics Consulting, Inc., 359 N.Y.S.2d 678, 691 (1974), the court held that the genetic testing is not required to be performed in a manner that will 'presumptively cause harm and risk to individuals who may have been identified by the test.' The Court found that the court in Gen-Probe, 359 F. 3d at 1382, had 'erred in stating that the test has to be performed in a manner that will 'presumptively cause harm.'' Thus, in Health Lab Corp., the court went far beyond the intermediate court's 'presumptively' dictum of Gen-Probe with respect to the test. The court held, based upon the intermediate court's 'presumptively' dictum of Gen-Probe, that genetic testing can be permitted when done in a manner that does not cause 'presumptively' harm to a potential test result subject to testing. While the Supreme Court's decision in Genetic, Inc. v. Lysis, Inc., 179 S. Ct. 564, 569 (1999), and Health Lab Corp., 179 S. Ct. 564, 569 (1999), dealt with test results, Gen-Probe provides an important, if not novel, guide for the future. Gen-Probe is a seminal case addressing the limitations of the reasonable apprehension test in connection with genetic testing. What I have learned in all my years as a patent judge is that there are many factors which determine the 'reasonable apprehension of imminent suit' test. Some are inherent in the test itself — a case must establish sufficient causal connection between genetic information and the potential for disease so that the 'reasonableness' of the 'test and the risks to patient,' as the court put it, is at issue. Thus, as a first step in this inquiry, I begin with two factors that are the first to affect the 'reasonableness' of a genetic test. 1. The test is not performed in isolation. 2. The test is performed in a manner that will not 'presumptively' cause harm or damage to a patient.

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