A Practical Primer For Patenting Genes Amid Myriad Uncertainties

Since the courts have long held that products of nature are patentable once isolated or manipulated by man, the District Court decision of Judge Sweet in the "Myriad" case¹ that isolated or manipulated genes are not patentable and the subsequent appeal of that decision to the Court of Appeals for the Federal Circuit (CAFC) ² has prompted considerable legal debate. While the CAFC should issue its decision shortly, there is every expectation that the Myriad case will be appealed to the Supreme Court, further prolonging current uncertainties as to the patentability of isolated and manipulated genes. Given this uncertainty, those who seek or hold patents directed to isolated or recombinant nucleic acids should adopt strategies to protect their intellectual property irrespective of what the courts ultimately decide.