On 27 June 2016, the US Supreme Court denied a petition to review the decision of a lower court that invalidated Sequenom’s patent to a test for detecting fetal genetic material. This decision has left patent protection in the field of diagnostic biotechnology in the US in a state of limbo. Companies and researchers face little certainty in obtaining protection for novel biological diagnostic techniques or the ability to enforce existing patents. The Sequenom matter is also active in the Australian Federal Court, as discussed below.
The Sequenom patent family relates to a detection method performed on a sample of maternal serum or plasma from a pregnant female. The method involves detecting the presence of a nucleic acid of foetal origin in the sample. The invention enables non-invasive prenatal diagnosis including, for example, sex determination, blood typing and other genotyping, and detection of pre-eclampsia in the mother. The method allows detection and diagnosis in early pregnancy and avoids dangerous, invasive techniques that can potentially be harmful to both the mother and the fetus.
History of the US Case
In June 2015, the US Federal Circuit1 affirmed a lower court’s finding that the US Sequenom patent was not directed to patent-eligible subject matter and was thus invalid. The decision of the lower court was based on the Supreme Court’s decision in Mayo Collaborative v Prometheus Labs 2, where it was found that a newly discovered law of nature is itself unpatentable and the application of that newly discovered law is also normally unpatentable, if the application merely relies upon elements already known in the art.
On 21 March 2016, Sequenom filed a petition for the US Supreme Court to review the decision of the lower court. The petition raised the question of whether 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.
However, on 27 June 2016, despite support from pharmaceutical companies, the Coalition for 21st Century Medicine, the Biotechnology Innovation Organization, and a number of law professors and law associations, the Supreme Court denied Sequenom’s petition. Sequenom have since stated that they will not pursue any further appeal opportunities for review of their patent in the US.
The Australian Sequenom Case
Infringement proceedings in relation to the equivalent Australian patent have been initiated in the Federal Court of Australia3. On 7 June 2016, Sequenom filed suit against Sonic Healthcare, Australian Clinical Labs and Ariosa Diagnostics, Inc. The suit accuses Sonic Healthcare and Australian Clinical Labs of infringing Australian Patent 727,919, by their use of the Harmony™ NIPT test supplied by Ariosa. Sequenom is seeking all available remedies, including damages (or an account of profits) and orders of restraint. A directions and interlocutory hearing was set to be held on 24 June 2016 but was adjourned pre-hearing, and the costs of the case management hearing and the Applicant’s interlocutory application were reserved. The proceeding is listed for further directions at 9:30am on 9 September 2016.
It not yet clear what impact the US decision, which occurred subsequent to Sequenom initiating suit in Australia, will have on their pursuit of the Australian case. We will report here on any further developments in Australia as they arise.
This article was written by Dr. Rosemary Manhire-Heath
If you have any specific enquiries about this decision, please contact Debra Tulloch or Paul Jones.
Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015)
Mayo Collaborative v Prometheus Labs
Sequenom, Inc v Ariosa Diagnostics, Inc & Or VID611/2016