Updated on 24 June 2013
The verdict of the case was that the US Patent and Trademark Office (PTO) rejected claims to a genetically engineered bacterium on the grounds that living organisms are not patentable. The Supreme Court disagreed, deciding that a patent may be obtained on ‘anything under the sun that is made by man.' The Supreme Court decision revolutionized the biotechnology industry and opened the floodgates for protection of biotechnology related inventions. Post the verdict, thousands of patents have been issued, hundreds of new companies have been formed, development of thousands of bioengineered plants and food products has taken place.
Case II - Mayo v Prometheus
This case, which was fought between 2004-to-2012, dealt with a bone of contention of ‘Whether an application of a law of nature to a known structure or process deserve patent protection?' In the limelight were tests that measured the levels of metabolites produced by the body after a person takes thiopurine drugs, which are typically used to treat Crohn's disease and other inflammatory bowel conditions. Knowing those levels helps doctors assess how well a patient is responding to thiopurine treatment. The drug dosage may be modified depending on whether the metabolite levels are too high or low.
Prometheus Laboratories had been the exclusive licensee of these patents and sold diagnostic kits based on them. Mayo Collaborative Services bought these kits untile 2004 and then decided to offer its own diagnostic tests to its clients at Mayo and worldwide. In June 2004, Prometheus sued Mayo for infringement in the Southern District Court of California, US. In March 2008, the district court held the patents invalid.
In a unanimous decision on March 20, 2012, the court called the correlation between the naturally-produced metabolites and therapeutic efficacy and toxicity to be an un-patentable ‘natural law'. The court struck down Prometheus' patent claims on methods of determining metabolite levels in the body to dose thiopurine drugs for stomach disorders. The bench clarified that claims directed to a method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug, were not patent eligible subject matter.
The Supreme Court emphasized that an application of a law of nature to a known structure or process may deserve patent protection. However, in order to transform a law of nature into something worthy of a patent, the applicant must do more than simply state the law of nature while adding the words 'apply it'. Following the case several diagnostics tests were rendered non-patentable.