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Sequenom prenatal test patent ruled invalid by appeals court

22 June 2015
Appeared in BioNews 807

A US federal appeals court has upheld a ruling that Sequenom's prenatal MaterniT21 test is not sufficiently 'inventive' to be patentable.

Although the court agreed with the importance of Sequenom's science and that the MaterniT21 test was the first marketed non-invasive prenatal diagnostic test for fetal abnormalities such as Down's syndrome, it disagreed that it had done anything more than use traditional methods to consider a natural phenomenon. On this basis, there was nothing legally which could be patented.

Following previous landmark decisions, US patent courts must follow a two-step process when considering whether a 'discovery' is sufficient to be patented.

The first step is to decide if the subject of the patent is a mere discovery of natural phenomena (non-patentable) or an abstract idea arising out of a discovery (patentable). The second step is to consider whether there has been an 'inventive concept' which has transformed the abstract idea into a patentable invention.

The MaterniT21 test (reported in BioNews 630) uses Sequenom's discovery that the blood of expectant mothers contains paternally inherited cell-free fetal DNA (cffDNA) from the fetus. This was held to be a 'natural phenomenon' for step one of the legal test and thus non-patentable, even though Sequenom's discovery used parts of maternal blood samples that would traditionally have been discarded.

Moreover, the methods used for testing the cffDNA were described by the Court as being 'well-understood, conventional and routine' and thus not sufficiently 'inventive' to gain patent protection.

Critics of the decision have commented that the decision makes almost all biotechnology discoveries non-patentable. Professor Jeffrey Lefstin of University of Iowa College of Law argues in a blog that the court's approach means 'most biotechnology processes are patent-ineligible, because they consist of the conventional steps of transferring drops of fluid from one tube to another.'

Indeed, one of the three judges hearing the case, Circuit Judge Richard Linn, was also scathing about the result, stating that he agreed with the decision reached by the other judges 'only because I am bound by the sweeping language of the test set out in Mayo'. He added that the court decision resulted in 'excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.'

Dr Lisa Haile of law firm DLA Piper, told GenomeWeb said the ruling means that 'the door's open for competitors'.

Sequenom has stated that 'as a practical matter, the Company believes that the ruling has little business impact' and pointed to its equivalent patents issued in Europe, Japan, Hong Kong, Canada and Australia.

The company has not ruled out a further appeal.

Appeals Court Upholds Invalidity of Sequenom Patent
Genetic Engineering and Biotechnology News |  15 June 2015
Ariosa Diagnostics, Inc. v. Sequenom, Inc.
United States Court of Appeals for the Federal Circuit (opinion) |  12 June 2015
Ariosa Diagnostics, Inc. v. Sequenom, Inc. – Another Diagnostic Patent Meets its End
National Law Review |  15 June 2015
Guest Post by Prof. Lefstin: Ariosa v. Sequenom and the Path Ahead for Subject-Matter Eligibility
Patently-O (blog) |  14 June 2015
Prenatal DNA test patent invalid, U.S. appeals court says
Reuters |  12 June 2015
Sequenom Patent Invalidation May Have Ramifications for NIPT Field, Entire MDx Industry
GenomeWeb |  16 June 2015
27 November 2017 - by Dr Rachel Montgomery 
The UK Patents Court has ruled that two separate non-invasive prenatal tests infringe patents licensed by the US firm Illumina...
4 July 2016 - by Dr Özge Özkaya 
The US Supreme Court has declined to hear an appeal by the biotech company Sequenom against a ruling that its prenatal blood test was not patent eligible...
7 December 2015 - by Antony Starza-Allen 
The US federal court of appeals has declined to rehear arguments on the patentability of a prenatal blood test, saying that it remains bound by the Supreme Court to determine the claims as non-patentable...
20 July 2015 - by Ceri Durham 
Abnormal results from a non-invasive prenatal test for fetal chromosome abnormality may indicate the presence of previously undetected cancers in some mothers....
13 April 2015 - by Dr Ainsley Newson and Associate Professor Stacy Carter 
In March, Sequenom revealed that its MaterniT21 non-invasive prenatal test has detected potential cancer in some pregnant women. This is a good thing, right? Women in the prime of their lives receiving information that may catch a cancer early. But, we suggest, it is not this simple. ...
9 March 2015 - by Kirsty Oswald 
US company Sequenom has revealed that its prenatal blood test - MaterniT21 PLUS - has detected potential cancer in at least 40 expectant mothers since its launch three years ago...
24 October 2011 - by Julianna Photopoulos 
A new prenatal test that can detect Down's syndrome by using a sample of the mother's blood was launched in twenty US cities last Monday....
13 December 2010 - by Julianna Photopoulos 
Scientists have scanned the entire DNA of an unborn child from the mother's blood sample for the first time to safely check for genetic disorders...
12 May 2009 - by Ben Jones 
The effectiveness of a prenatal test for Down syndrome has been thrown into doubt after its developers, Sequenom, admitted that study data had been 'mishandled' by its employees. The company, which had been producing apparently strong results in house for its DNA and RNA blood testing products...
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