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Myriad Genetics breast cancer gene patent ruling sent back to lower court

2 April 2012
Appeared in BioNews 651

The US Supreme Court has ordered that the two gene patents held by Myriad Genetics be sent back to the US Court of Appeals for the Federal Circuit, to be re-examined.

Myriad Genetics has held patents for two genes, BRCA1 and BRCA2, since 1994. Mutations in these genes are associated with increased risk of breast and ovarian cancers, and the patents give the company exclusive rights to test for them. The test, called BRACAnalysis, costs around $3,000 per patient.

In 2009, the Public Patent Foundation, American Civil Liberties Union and the Association for Molecular Pathology filed a lawsuit against Myriad genetics, claiming that the patents violate patent law as they cover natural phenomena, and restrict scientific research and patients' access to medical care.

In 2010 a federal judge in New York ruled that genes cannot be patented, but this was overturned in July 2011 by the Court of Appeals, who also ruled that Myriad's technique for screening potential therapies was patentable.

The latest instalment of this long-running case came on 26 March, following a contradictory decision in a related case, where the Supreme Court denied Nestlé's Prometheus Laboratories' patents of biomarkers that help calibrate drug dosage. Justice Stephen Breyer wrote that inventors must do more than 'recite a law of nature and then add the instruction "apply the law"'.

'A unanimous Supreme Court has now undeniably declared that a trivial noninventive transformation' is insufficient for a patent, Daniel Ravicher, executive director of the Public Patent Foundation and co-counsel in the lawsuit, told the New York Times. He said that, as isolating DNA is a trivial, well-understood process, this new ruling contradicts the appellate court's decision to uphold Myriad's patents.

However, others doubt it will have that much influence, as the Myriad patents involve both composition-of-matter and process claims, while the Prometheus case only involves process claims.

According to an interview with Reuters, Junaid Husain, a research analyst for Dougherty & Co, said the choice to send the case back to the Appeal Court to be reheard could delay the verdict by another 'two to three years, keeping the BRACAnalysis franchise safe from competition'. This may explain why shares in Myriad rose over three percent following the decision.

The case is the Association for Molecular Pathology vs. Myriad Genetics, No. 11-725.

Courts to Re-Examine Gene Patents
The Scientist |  28 March 2012
Justices Send Back Gene Case
New York Times |  26 March 2012
Lawyers Offer Predictions for Myriad, Diagnostic Field Based on Supreme Court’s Decision Against Prometheus
GEN |  26 March 2012
Myriad gene patent ruling sent back to lower court
Reuters |  26 March 2012
Myriad Patents Get New Review
Wall Street Journal |  26 March 2012
Myriad’s Human-Gene Patent Rehearing Ordered by High Court
Bloomberg |  26 March 2012
17 June 2013 - by Dr Sarah Spain 
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18 February 2013 - by Matthew Thomas 
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5 November 2012 - by Antony Starza-Allen 
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1 October 2012 - by Ruth Saunders 
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20 August 2012 - by Dr Sarah Spain 
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23 January 2012 - by Ayesha Ahmad 
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8 November 2010 - by Dr Nadeem Shaikh 
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14 June 2010 - by MacKenna Roberts 
The Australian Federal Court in Sydney is considering groundbreaking legal action of whether private companies can obtain patents on human genes....
6 April 2010 - by Dr Vivienne Raper 
A US judge has invalidated a genetic testing company's patents on two breast cancer genes...
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