Sequenom’s en banc bid boosted by support from US professors

A group of 23 law professors has urged the US Court of Appeals for the Federal Circuit to re-hear the Ariosa v Sequenom dispute en banc.

The group filed an amicus brief on August 27 that argued that the federal circuit was wrong to invalidate Sequenom’s patent, which covers a method of detecting the paternally inherited cell-free fetal DNA in maternal plasma in pregnant women.

In June, a three-judge panel invalidated the patent on the grounds that it covered a “natural phenomenon”.

Judge Jimmie Reyna, who wrote the 3-0 opinion, cited the US Supreme Court’s decision in Mayo v Prometheus in determining the patent covered “ conventional techniques” and was therefore ineligible for protection.

But the group of professors has argued that the decision was incorrect.

Among the signatories to the amicus brief were professors from the University of California, New York University School of Law and Texas A&M University School of Law.

“The panel decision exceeded the US Supreme Court’s section 101 jurisprudence in distinguishing patents claiming laws of nature, natural phenomena, and abstract ideas from patents claiming patent-eligible applications of these concepts.”

According to a study by the Diaceutics Group, which was cited in the brief, the cost to develop and commercialise diagnostic technology is between $50 and $75 million.

The amicus brief said: “The economics of innovative diagnostic tests reflect exactly the economic justification for the patent system: the cost of applying a genetic diagnostic test is relatively low, but the ex ante research and development cost is enormous and is not reflected in the marginal cost of the medical test itself.

“The panel decision ... disincentivises making the massive R&D investments required to create new innovation in the twenty-first century. This is neither hyperbole nor conjecture,” the group added.

The Biotechnology Industry Organization and the Pharmaceutical Research Manufacturers of America also backed Sequenom’s petition for an en banc hearing.

In a jointly filed amicus brief, filed on the same day as the professors’s brief, both organisations argued that the case is a chance for the federal circuit to end the “uncertainty” around the validity of biotechnology patents.

Last month, Sequenom requested an en banc hearing arguing that the panel “misinterprets Mayo” in judging the patent to be invalid.

As the decision stands, there is “an existential threat to patent protection for an array of meritorious inventions”, Sequenom said.