ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS (Fed. Cir. 2011)
In a much anticipated decision, the Court of Appeals for the Federal Circuit has rejected the Southern District of New York’s court’s holding that could have rendered invalid all patents claiming isolated forms of naturally occurring DNA molecules. However, the decision is somewhat nuanced and will be appealed.
Judge Lourie drafted the opinion of the court that was joined in-part by the entire panel. Judge Moore drafted a concurring opinion that agrees with the conclusion that the isolated DNA is patentable but disagrees with Judge Lourie’s methodology for determining when an isolated compound is sufficiently “man made” to no longer be considered a natural phenomenon or product of nature. Judge Bryson concurred in part, but dissented on the issue of whether an isolated human DNA molecule should not be patentable. Judge Bryson writes:
We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic material a patentable invention. The court concludes that it does; I conclude that it does not.
Focusing here briefly on the majority opinion, the court made four specific holdings:
- Affirmed: The District Court properly had jurisdiction over the case;
- Reversed: The district court erred in holding that Myriad’s claims directed to isolated DNA were invalid;
- Affirmed: The district court properly held that Myriad’s claims directed to comparing or analyzing gene sequences were invalid; and
- Reversed: The district court erred in holding that Myriad’s claims directed to screening potential cancer therapeutics via changes in cell growth rates were invalid.
The result here is that Myriad’s BRCA Gene patents are somewhat damaged, but remain strong. The plaintiffs are likely to either request an en banc rehearing or immediately file a petition for a writ of certiorari with the Supreme Court. Myriad is likely to request a rehearing on the issue of subject matter jurisdiction.
[More to Come]
Documents: Read the 105 page decision here.