Latest in the § 101 Saga: Sequenom Requests En Banc Rehearing, Indicating Biomedical Research Will Be Stymied Otherwise
Posted in Litigation, Patents

Arguing that its invalidated diagnostic patent claims were “collateral damage in what is properly a war on frivolously broad claims directed to things like correlation tables and actual strands of human DNA,” on August 13, 2015, Sequenom petitioned the Federal Circuit for an en banc review of its June 12 holding in Ariosa Diagnostics, Inc. v. Sequenom, Inc. In that strikingly sweeping decision, a Federal Circuit panel invalidated U.S. Patent 6,258,540 (the ’540 patent) as being directed to ineligible subject matter. Sequenom now warns that the panel decision “reads recent Supreme Court precedent to create an existential threat to patent protection for an array of meritorious inventions” beyond those in the personalized medicine and diagnostics industries:

If this Court does not step in and draw this line, the panel’s rule threatens to swallow many more meritorious inventions along with this one. The core of nearly every major innovation is the discovery of a fact about the natural world that motivates inventors to combine existing techniques to achieve new practical results.

Sequenom predicts that two negative consequences will stem from the panel’s decision. First, researchers will be encouraged to keep their fundamental discoveries secret as long as possible, stymieing the progress and development of medical innovations. Second, the uncertainty engendered by the panel’s test will discourage investment, as “neither scientists nor venture capitalists will see much to gain in basic biomedical research.”

Background of the Federal Circuit Panel Holding

The inventors of the ’540 patent discovered that cell-free fetal DNA (cffDNA) was circulating in the blood of pregnant mothers and employed this knowledge to create maternal blood tests for fetal genetic traits and abnormalities. Claim 1 of the ’540 patent recites:

A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

While conceding that the discovery underlying the ’540 patent was indeed ground-breaking, the panel nevertheless held that the claims failed the two-step Mayo framework under the Supreme Court’s holding in Mayo v Prometheus. First, the invention was found to be directed to a patent-ineligible concept, reasoning that the method “begins and ends with naturally occurring phenomenon” (cffDNA in maternal blood and paternally inherited cffDNA). At step two, the panel examined whether the claims recite elements that amount to ‘significantly more’ than the judicial exception to ‘transform’ it into a patent eligible concept. Relying on Mayo, the panel stated that “for process claims that encompass natural phenomenon, the process steps are the additional features that must be new and useful.” Since the intrinsic record indicated that the ‘amplifying’ and ‘detecting’ steps were well-understood in the art, they did not ‘transform’ the method claims into patent-eligible subject matter. The panel majority drew a parallel between the ’540 patent and the claimed methods in Mayo, which were found to be appending conventional steps to a natural law (and therefore insufficient to supply an ‘inventive concept’).

Judge Linn separately argued in a concurring opinion that Sequenom’s invention was nothing like the diagnostic in Mayo, as the latter claimed a set of steps that were already being performed by doctors. Nevertheless, he reluctantly joined the Court’s opinion because the “Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though here no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers.”

En Banc Request

Seeking an en banc rehearing now, Sequenom hopes that the full court will overturn the prior panel’s ruling. In its en banc petition, Sequenom argues that this case raises the following precedent-setting question:

Is a novel method patent-eligible under § 101 where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates her to apply a new combination of previously known techniques to the phenomenon; and (3) she thereby achieves a previously unknown and impossible result?

Sequenom argues that the panel’s ruling was inconsistent with the Diamond, Mayo, and Myriad decisions. The petitioner noted that according to Diamond, “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.” Sequenom argues that the panel ignored the instruction of Diamond to consider the claims as a whole when determining the subject matter eligibility of process claims. Further, the fact that it was a discovery of a natural phenomenon that motivated the novel combination of steps should not foreclose patentability. Sequenom contends that the panel’s ruling leads to an absurd result: a researcher can patent a useful diagnostic that combines existing techniques only if he does not understand the natural phenomena underlying it.

Next, Sequenom also argues that Mayo in fact reaffirmed the holding of Diamond that a new combination of steps was patentable, even if the core of the invention was directed to a judicial exception and the individual steps were known. Sequenom echoes the arguments made by Judge Linn distinguishing the ’540 invention from the Mayo diagnostic claims. Finally, according to Sequenom, while the Myriad Court foreclosed claiming a natural phenomenon itself, the Supreme Court opinion also stated that, “as the first party with knowledge of [a natural phenomenon], Myriad was in an excellent position to claim applications of that knowledge.”

Sequenom concludes by arguing an en banc review would be the perfect opportunity for the Court to establish a “principled line in this difficult area that is consistent with Supreme Court precedent, continues to reject patents that purport to claim natural phenomena, and yet protects truly meritorious patents” from becoming innocent casualties in the § 101 battle. As the § 101 area remains an unsettled area of law, patent applicants and patent holders should be cognizant of continuous developments and adjust their strategies in real time.

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