The United States Court of Appeals for the Federal Circuit held in a split decision that isolated BRCA 1/2 DNA molecules patented and used by Myriad Genetics Inc. for diagnosing increased breast and ovarian cancer risk are patentable. The Court also found that claims on methods of using the DNA to screen for cancer therapeutics were also patent eligible but held that diagnostic claims directed to "analyzing" and "comparing" DNA sequences are not.
The Court concluded that the isolated DNA molecules are eligible for patent protection and rejected the plaintiff's arguments that the isolated DNA molecules were naturally occurring material. Referring to the Supreme Court precedent of Diamond v. Chakrabarty, the majority noted that the distinction between a product of nature and a human-made intervention turns on a change in the claimed composition's identity compared with to what exists in nature. Applying this test to the isolated DNA in this case, the Court concluded that "the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different ─ have distinctive chemical identity and nature ─ from molecules that exists in nature".
In the second step of its analysis, the Court considered the method claims reciting a method of screening by "comparing" or "analyzing" BCRA sequences from a tumor sample to detect genetic mutations associated with a predisposition to cancer and concluded that these claims fail to satisfy the machine-or-transformation test set by the Supreme Court in Bilski. On the other hand, the method of screening potential cancer therapeutics was found patentable.
Comment: This much anticipated decision removes overhang over the thousands of patents claiming "isolated DNA" issued so far by the USPTO. However, the decision raises some issues with respect to patents covering diagnostic-related methods because they may be seen as merely claiming abstract mental processes. To ensure that patents directed to diagnostic methods satisfy the machine-or-transformation test, the claims should recite some form of manipulation like extraction, collection of a bodily sample or affirmative steps for obtaining a sequence to be analyzed.
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