'Bionanotechnology from Theory to Practice' is a short online, course providing an interdisciplinary and up-to-date overview of the rapidly developing area of bionanotechnology
Page URL: https://www.bionews.org.uk/page_93348

Personalised medicine patents disputed at US Supreme Court

19 December 2011
Appeared in BioNews 638

A patent for a diagnostic test is currently under consideration by the US Supreme Court. The eventual decision may have profound implications for the burgeoning personalised medicine industry which often relies on DNA tests to guide physicians in choosing tailored therapies for patients.

In the current case, the Mayo Clinic, based in Minnesota, is challenging a patent held by Swiss-based, Nestlé-owned Prometheus Laboratories in an intellectual property spat that has been going on for seven years. The test under consideration helps doctors determine the optimum individual dosage of the drug thiopurine, used to treat autoimmune illnesses, such as Crohn's disease and lupus. After the patient has been given thiopurine, a blood sample is taken to measure the number of metabolites, and the results compared against predetermined ranges – the doctor can then decide whether to alter the dose of the drug.

The Mayo Clinic previously used Prometheus' test but developed their own allegedly more accurate test in 2004 and Prometheus Laboratories sued the Mayo Clinic for breaching their patent protection. However, a federal court judge ruled that the original Prometheus patent was invalid, on grounds that it was based on a natural phenomenon and mental processes, neither of which is patentable. The decision was overturned by the US Court of Appeals, leading the Mayo Clinic to the present appeal to the Supreme Court.

The legal issue is, in the words of Justice Stephen Breyer of the Supreme Court: 'What has to be added to a law of nature to make it a patentable process?' And by extension, has Prometheus Laboratories successfully done that?

Fellow Supreme Court Justice Elena Kagan thinks not: 'This is not a treatment protocol, it's not a treatment regimen… All you have done is pointed out a set of facts that exist in the world [...] and are claiming protection for something that anybody can try to make use of in any way, and you are saying, "You have to pay us"'.

Representing Prometheus Laboratories, Mr Richard Bress, said: 'The idea that we are not novel because people took some of the same steps along the way to invention that we actually succeeded in is wrong'. Furthermore, argued Bress, 'the court has never suggested that there is an extra-statutory limitation that prevents patents on developing useful information, even if they have a mental step at the end'.

The Obama administration openly supports Mayo Clinic's position. Solicitor General Donald Verrilli stated: 'You can't get a patent by tacking a mental step onto an utterly conventional process for administering drugs and testing their effects'.

This case is about more than the determining the boundaries of the legal test for a medical patent, and ascertaining whether those conditions have been met by Prometheus. There are broader concerns around the impact on innovation in personalised medicine and the possible creation of market and knowledge monopolies. Mr Stephen Shapiro, representing Mayo Clinic, argued that Prometheus' patent was so wide as to prevent a patient seeking a 'second opinion…[using] a better metabolite test with more accurate numbers' from the Mayo Clinic.

The case was heard by a full Supreme Court, who will deliver their ruling next year.
Fight over human genes patents goes to the US Supreme Court
ABC News |  8 December 2011
Justices consider 'personal medicine' patent issue
Associated Press |  8 December 2011
Medical Patents Before Court
Wall Street Journal |  8 December 2011
Supreme Court has hard time finding an easy test for patents on medical processes
Washington Post |  8 December 2011
Supreme Court takes a look at medical patents
Forbes |  8 December 2011
20 May 2013 - by Dr James Heather 
The US medicines regulator, the Food and Drug Administration, has approved a genetic test to help doctors select suitable lung cancer patients to be treated with the drug erlotinib...
20 August 2012 - by Dr Sarah Spain 
In the latest instalment of a highly contested case, the US Federal Circuit Court of Appeals in Washington DC upheld Myriad Genetics' right to patent two genes, BRCA1 and BRCA2,which are associated with the risk of breast and ovarian cancer....
6 June 2012 - by Ruth Saunders 
23andMe, a personal genomics company, announced last week that it had been successfully awarded a patent for a gene variant which appears to protect against a high-risk mutation for Parkinson's disease...
23 January 2012 - by Ayesha Ahmad 
Myriad Genetics, a leading US molecular diagnostic company, has been granted exclusive rights to an analysis of the RAD51C gene. Mutations of the gene have been associated with an increased risk for hereditary breast and ovarian cancer and the company now hopes to develop a commercial test for RAD51C....
14 November 2011 - by Dr Louisa Petchey 
A new genetic test that will help to tailor drugs to cancer patients' individual tumours has been successfully trialled in the US...
14 November 2011 - by Martin Turner 
In what appears to be the end of a long running legal saga, a ruling by the UK's Supreme Court has found in favour of a patent for a gene and the protein sequence it encodes. Lawyers say that the ruling will make it easier to patent discoveries which do not have a clear demonstrated application, a result that will largely please the private bioscience industry but may alarm many who believe that human genes should not be patentable....
22 August 2011 - by Nishat Hyder 
The NHS may be at risk of being sued over patent infringement, says a new report published by the Human Genetics Commission (HGC), the UK Government's genetics advisory body...
19 April 2010 - by Harriet Vickers 
Researchers examining gene patents used in diagnostic tests say these can block competition and slow innovation, rather than spur development of new technologies for assessing the risk of genetic diseases...
to add a Comment.

By posting a comment you agree to abide by the BioNews terms and conditions

Syndicate this story - click here to enquire about using this story.