By Miriam Swedlow

On March 21, 2016, Sequenom, Inc. asked the Supreme Court to review a decision from the Federal Circuit Court of Appeals that rendered invalid the company’s patent directed towards detecting paternally inherited cell-free fetal DNA (cffDNA) in a pregnant woman’s blood.

In 1996, two doctors discovered the presence of cffDNA in maternal plasma and serum. Once discovered, the doctors used established laboratory techniques to separate and amplify the genetic material to identify paternally inherited DNA and perform genetic diagnostic tests on it. Sequenom, Inc. commercialized the method as its MaterniT21 prenatal diagnostic test. Utilizing the test allows pregnant women to screen for many prenatal defects without having to undergo dangerous and invasive procedures into the uterus.

In 2001 the doctors obtained a patent for their method of finding this paternally inherited cffDNA. In response to patent infringement allegations, a district court held Sequenom’s patent invalid because (1) it was not patent eligible subject matter and (2) the claimed processes posed a risk of preempting a natural phenomenon.

On June 12, 2015 the U.S. Court of Appeals for the Federal Circuit upheld the district court’s ruling. The court’s analysis explained that it was bound by Supreme Court precedent in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which established a framework for distinguishing patent eligibility for claims involving laws of nature, natural phenomena, and abstract ideas. Because Sequenom’s patent was directed to cffDNA, a natural phenomena, it met the first part of the Mayo test.

Next, the Federal Circuit applied the second step, looking for an “inventive concept” in the elements of the claim that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [natural phenomena] itself.” The court concluded that Sequenom’s patent used methods that were well-understood and broadly used for amplifying and detecting the paternally inherited cffDNA at the time of the patent application.

The Federal Circuit’s decision did not sit well within the life science world and indeed, the Federal Circuit itself seemed unhappy with the outcome. Judge Linn’s concurrence begins by explaining that he join’s the opinion “only because I am bound by the sweeping language of the test set out in Mayo” and ends by concluding “[b]ut for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”

Although the court rejected a rehearing en banc, the opinion echoes this criticism of Mayo’s precedent. Acknowledging that the initial panel correctly applied Supreme Court precedent, Judge Lourie opined, “it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on the grounds that they only claim a natural phenomenon plus conventional steps.”

Despite the near unanimous criticism of Mayo’s scope, it is uncertain whether Supreme Court review would result in a favorable outcome for Sequenom. Judge Dyk’s concurrence in the denial for rehearing lays out the failings of the current Mayo test, suggesting an approach that permits a narrow scope of patents based on new discoveries. But he goes on to say that regardless of changes to Mayo, Sequenom’s patent will fail not because it lacks inventive concept, but because it is overbroad. Plus, there still is the issue of preemption, which the Federal Circuit did not address. In the end, this may be the right issue—with the wrong case.

Image source: fullcirclehealthcareinc.com.