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Sequenom Challenges the Scope of Patentable Subject Matter

Posted By Mark Peterson, Nov 12, 2015

Should patentable subject matter be expanded in order to encourage disclosure of discoveries such as Sequenom’s?

The Sequenom Center for Molecular Medicine, LLC recently created the MaterniT21 test. This test uses cell-free fetal DNA to assess medical conditions and the gender of unborn children. This test has been considered groundbreaking as it cheaper, faster, and safer than prior tests. The Royal Society lauded this discovery as a paradigm shift in non-invasive prenatal diagnosis. However, the Third Federal Circuit has denied Sequenom the benefit of a patent in the case Ariosa v. Sequenom.

The founding fathers abhorred monopolies. Only under the pre-tense of scientific progress were they to be tolerated, and so it was memorialized in the US Constitution. Secrets stifle scientific progress. So the quid pro quo of patent law is disclosure. Disclosure disseminates useful information that promotes innovation and the progress of science. Disclosure is the price that must be paid if the people are to suffer the monopoly that is an exclusive patent right.

Patent law has a broad goal of promoting science and the pre-requisite to obtainment is disclosure. The issue then is whether Sequenom’s research is the kind of research we want to promote and the kind of research we want disclosed to the public. The answer is a resounding “yes.” However, we should be cautious to preempt building blocks of human ingenuity.

Patent protection has the potential to impede rather than promote the progress of science. To avoid the obstruction of scientific progress, the building blocks of our intellectual infrastructure are not patentable. These un-patentable building blocks include abstract ideas, physical phenomena, and laws of nature. Sequenom’s MaterniT21 test rests on a discovery of a natural phenomenon, the existence of cell-free fetal DNA. Because of this, the federal circuit denied them the benefit of a patent.

Unfortunately, the willingness of courts to strike down patents under the sweeping scope of Mayo v. Prometheus may serve to stifle rather than promote innovation. Without the availability of even limited patents, the company that makes the next paradigm-shifting discovery may choose to follow the trade secret path to recoup research costs. In fact, without the offer of a patent they will be encouraged to follow this route. Thus, the court’s overzealous behavior of striking down patents may cause the very problem they seek to prevent, the limiting of access to important building blocks of scientific innovation.

A limited scope patent achieves the best of both worlds. It discourages the utilization of trade secrets and it encourages disclosure without significantly tying up building blocks of human ingenuity. Sequenom sought a method patent. This patent would only stop others from performing an identical genetic test. Thus, Sequenom’s patent would serve to recoup research costs while simultaneously serving as fuel for scientific innovation that could utilize the knowledge of the existence of cell-free fetal DNA in another way.

Patent law is immensely complex, and the current simple blanket rules do not do it justice. More structure and robust analysis is needed. Sequenom’s patent did not tie up building blocks of human ingenuity. It was the narrow kind of patent that could serve as an immense catalysis to further scientific progress. However, this is not even a consideration within the courtroom. Now is the time for the Supreme Court to reassess the rules pertaining to patentable subject matter, to ensure that the rules optimally meet the constitutional requirement of promoting scientific progress.