04 July 2016
ByAppeared in BioNews 858
A federal appeals court had ruled in June last year that Sequenom's MaterniT21 test – a non-invasive test to detect a third copy of chromosome 21 from the fetus in the blood of a pregnant woman – was not patent eligible, upholding a previous decision on the matter.
Sequenom's president and chief executive officer, Dr Dirk van den Boom, said the company was disappointed with the decision by the Supreme Court.
'We believe that the Supreme Court missed an ideal opportunity to clarify patent eligibility criteria, not only to protect the significant investments made by Sequenom but also by other innovative organisations to advance the standard of patient care and treatment,' he said, adding: 'We fear this decision will discourage such investments in the future.'
Sequenom's '540 patent has been at the centre of a number of lawsuits since 2012, when the company entered a patent battle with competing companies Ariosa and Natera.
In 2013, the US District Court for the Northern District of California found that the '540 patent was not valid because it described a natural phenomenon – the presence of fetal DNA in the mother's blood – which is non-patentable under rules set out by the Supreme Court in 2012. Natural phenomena and 'abstract ideas', like mathematical formulae and drug metabolites in the blood, are excluded from patent protection.
The company appealed, but the decision that the test was not sufficiently 'inventive' to be patentable was upheld by a US federal appeals court in June 2015. The court held that Sequenom had not done anything more than use traditional methods to describe a natural phenomenon (see BioNews 807).
The company then appealed again asking the court of appeals to rehear arguments on the patentability of the test, but the court said that it remained bound by the Supreme Court’s decision in Mayo v Prometheus to determine the claims as non-patentable (see BioNews 831).
Sequenom therefore petitioned the Supreme Court to clarify language about patent eligibility. Despite support from pharmaceutical companies, the Coalition for 21st Century Medicine, the Biotechnology Innovation Organization, and several law professors and law associations, the Supreme Court denied Sequenom's petition.
The company said the decision will have little impact of its business as it has been operating under the invalidity ruling since 2013. Sequenom still holds valid and enforceable patents over the test, which can detect Down's syndrome before a baby is born (see BioNews 630), with claims equivalent to those of the '540 patent in Europe, Japan, Hong Kong, Canada and Australia.
Sequenom has said it will not pursue further appeal opportunities in the USA.