On March 29, 2010, the U.S. District Court for the Southern District of New York issued a decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09 Civ.4515 (S.D.N.Y 2010), holding that several claims in patents drawn to isolated DNA sequences encoding the BRCA1 and BRCA2 genes, and methods of using those sequences to detect or screen for cancer, are invalid because the claims were not drawn to statutory subject matter under 35 U.S.C. §101. Although this decision has drawn a great deal of press, upon closer inspection, it should not affect well-counseled diagnostics companies.
Several particulars regarding this decision render it of limited importance. First, this decision was issued by a district court and, as such, is not binding precedent on either the U.S. Patent and Trademark Office (PTO) or any other court in the U.S. outside of the Southern District of New York. Additionally, of the claims invalidated, those drawn to isolated DNA are not relied upon by most diagnostics companies. Similarly, the method claims invalidated in this decision do not recite any machine, apparatus, or transformative step—limitations that post- Bilski claims typically contain. Furthermore, decisions by courts of appeal are likely to curtail the holding or modify the legal underpinnings of the decision. Therefore, in light of the limited precedential effect of this decision, the limited relevance of the claims that were invalidated, and the lengthy appeal process that will almost certainly follow this decision, diagnostics companies will typically be in the same legal position they were prior to this decision.
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