Rachel Elsby and Dianne Elderkin Quoted in IAM on Federal Circuit Section 101 Ruling

IAM has quoted Akin Gump intellectual property partners Rachel Elsby and Dianne Elderkin in the article “New CAFC Section 101 ruling creates pathway for protecting diagnostic-related methods,” which reports on a ruling by the U.S. Court of Appeals for the Federal Circuit that some diagnostic-related methods may be eligible for U.S. patent protection. The decision overturned a lower court ruling that invalidated patents for methods of preparing fractions of DNA for use in diagnosis.

According to IAM, the appellate decision upholds previous findings that diagnostic methods are directed to laws of nature and are therefore ineligible for protection. It remains to be seen, though, the article says, how significant the ruling is for beleaguered diagnostics innovators.

This has put the ball back in the Federal Circuit’s court, said Elsby and Elderkin. “The fact that the opinion speaks so directly to what the case is about (methods of preparation) and what it is not about (diagnostic methods and methods and treatment),” they said, “is an indicator that the court is trying to bring more certainty to Section 101 in the life sciences.”

If the judgment survives challenge, Elsby and Elderkin added, its precedent will only cover a relatively narrow range of diagnostics-related inventions. The two warn against undermining the holding of the case “by seeking broad ‘method of preparation’ claims that could be seen to broadly pre-empt a wide array of laboratory methods.” Such claims, they said, would “undoubtedly receive great scrutiny from the courts, and could bring about a reversal of course” in similar cases.