By: J. Gibson Lanier, Ph.D
Just when the patent prosecution community thought that, for better or worse, the standards relating to the subject matter eligibility of claims were set for examination, the standards have moved again following the Mayo/Alice decisions. On Thursday, the USPTO released its latest subject matter eligibility examination guidelines for 35 U.S.C. § 101, evidencing just how unworkable the Mayo/Alice test is from a practical standpoint. This iteration of guidelines for examination is the third such revision and provides new examples of what may be subject matter eligible for biotechnology patents, but does not provide additional examples or guidance for software and electrical engineering based patents. In the new examples, the USPTO has attempted to provide examples of situations where subject matter eligibility would be found. However, the examples used are so clear cut from the beginning as to border on useless. Moreover, some of the examples have already been noted by observers to be in error and many neglect to provide a holistic analysis of a claim in determining whether the claim is directed to the subject matter eligibility exception. It should be noted that just as with prior guidelines, this latest iteration is subject to review and comment, and thus, it is likely that the guidelines will change yet again.
Nevertheless, do not expect the dust to settle with respect to subject matter eligibility any time soon. Before the Supreme Court is a petition for writ of certiorari in Sequenon, Inc. v Ariosa Diagnostics, Inc. The technology for this case revolves around the discovery of cell-free fetal DNA (cffDNA) circulating in maternal plasma and its use in non-invasive diagnostic tests for genetic abnormalities. In its decision to invalidate the Sequenon claims for lack of subject matter eligibility, the Court of Appeals for the Federal Circuit indicated that despite recognizing the groundbreaking medical breakthrough, the court’s hands were tied by the Mayo/Alice Supreme Court decisions and test for subject matter eligibility. In particular, Judge Linn wrote in his concurring opinion that “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.”
In its petition for writ of certiorari, Sequenon is asking the Court to determine [w]hether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?
The petitioner argues that the Mayo framework is grossly overstated and actually makes new applications of knowledge about a natural product ineligible for patenting despite indications in Association for Molecular Pathology v Myriad Genetics 569 US _(2013) to the contrary. This petition has been supported by no less than 16 amicus briefs authored by a diverse array of concerned parties including law professors, large pharmaceutical companies, industry advocate organizations, non-profits, foreign counsel, university research institutes, and small biotech companies. The briefs collectively point to the misapplication of the Mayo test, the improper importation of novelty and inventiveness into the eligibility inquiry, and the damage to the biotechnology industry amongst many other reasons for taking up the petition. Given the extraordinary support the petition has received, it seems likely that the Supremes will take up this case. However, in doing so, it will be a while before a decision is rendered and even longer before the USPTO can provide a new set of approved guidelines based on any decision rendered. Of course, as the Court presently has a vacancy that is showing no signs of being filled until after the change in Presidential administrations, it is possible that 4-4 split decision could result and the present misery over subject matter eligibility would continue.
For more information on this topic, contact your Intellectual Property counsel at Smith, Gambrell & Russell, LLP.