According to Myriad Genetics, Inc., the U.S. Supreme Court should not grant review in Association for Molecular Pathology v. Myriad Genetics, Inc. Details about the Federal Circuit Court of Appeals decision on remand from the lawsuit’s previous sojourn before the U.S. Supreme Court appear in Issue 41 of this Bulletin. The American Civil Liberties Union (ACLU) has requested that the Court review the Federal Circuit’s decision.

Myriad contends that the ACLU has mischaracterized the issues and that the Federal Circuit relied on settled principles in deciding that certain isolated genetic material is patent eligible. According to its brief in opposition, the U.S. Patent and Trademark Office (PTO) “long ago determined that claims to ‘isolated’ molecules of DNA reflect human-made, patent-eligible inventions.

Thus, over the last 30 years it has issued thousands of patents directed to isolated DNA molecules—indeed, the challenged patents themselves began issuing 15 years ago. And the PTO has issued over 40,000 patents drawn to DNA-related subject matter.” Myriad also cites PTO’s guidelines on patenting DNA molecules to emphasize consistent industry practices based on those guidelines and on which “the investing and inventing communities have relied … to develop significant advancements in human, agricultural, and industrial products.”

According to Myriad, “This case is unworthy of certiorari because it concerns the application of settled law to particular facts. … The court’s decision is also consistent with the policy goal of the Patent Act, the considered judgment of the PTO, and longstanding practice. Further, the issues presented are unique and fact-bound, and in order to even reach the § 101 issues, the Court would have to take up antecedent jurisdictional questions and preempt percolation in the Federal Circuit, the appellate court statutorily vested with unifying and clarifying U.S. patent law.”