24 Jun 2013, Sheetal Sukhija, BioSpectrum
As of 2013, about 3,000-to-5,000 patents on human genes have been granted in the US. The obvious reason why patenting of human genes stirs a raging controversy every time that it comes to light is because it seems odd to patent an universal entity like a gene.
A closer look at the time when patenting began would reveal many cases where calls for prohibition against patenting certain subject matter have led to controversy. Most often than not, the allegations in such cases are that the patents pose a threat to biomedical research and public health.
It was in December 1980 that the first patent on a recombinant DNA method was granted. The patent, shared by Stanford University and the University of California, laid the groundwork for using cells to produce useful proteins and turning them into valuable drugs.
In the US alone, an estimated 47,000 patents making various claims on DNA or RNA have been granted. It was in the mid-1990s when DNA-related patents recorded maximum growth.
Case I - Diamond v Chakrabarty
This case was fought between petitioner Ms Sidney Diamond, commissioner of Patents and Trademarks, US, vs respondents Mr Ananda Chakrabarty and others, from 1972-to-1980. The bone of contention in the case was ‘Whether genetically modified organisms be patented?'
In 1972, genetic engineer Mr Ananda Mohan Chakrabarty working at the University of Illinois College of Medicine, US, filed a patent on a bacterium, that was capable of breaking down crude oil. Mr Chakrabarty had proposed that the invention was novel and potentially useful in cleaning up oil spills. The US Patent and Trademark Office rejected the application claiming that living things, as products of nature and not artifice, could not be patented. Mr Chakrabarty appealed and the decision was reversed by the Court of Customs and Patent Appeals. Ms Sidney Diamond, commissioner of Patents and Trademarks, asked the US Supreme Court to consider the case.
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.
Case III - LabCorp v Metabolite
This case was fought during 2000-to-2009 and the fight was ‘Whether a patent can be allotted on co-rrelational relationship in a medical test result?' In the 1980s, research scientists at University Patents (UPI), US, discovered that high levels of the amino acid homocysteine in the body are correlated with dangerously low levels of two B vitamins. UPI filed for a patent, seeking to license both the method of testing for the amino acid, and the correlation of the amino acid levels with B vitamin levels. UPI's successor licensed Metabolite Laboratories, which in 1992 sub-licensed the patent to Laboratory Corporation of America Holdings (LabCorp). When in 1998, LabCorp started using another company's test and stopped paying Metabolite royalties, Metabolite sued.
A jury found LabCorp guilty of patent infringement and breach of contract and awarded damages to Metabolite. In an appeal to the Circuit Court of Appeals for the Federal Circuit, LabCorp argued that the patent was invalid. Natural phenomena themselves are not patentable, but new applications of them normally are. LabCorp argued that Metabolite had impermissibly patented a relationship that already existed in nature. The Federal Circuit rejected that argument, however, ruling that Metabolite could patent its discovery of the correlation and that any association of homocysteine levels with B vitamin deficiency could constitute patent infringement. LabCorp appealed its case to the Supreme Court. The Court dismissed the writ of certiorari as improvidently granted. The decision of the Federal Circuit was left in place, as if the Supreme Court had never agreed to hear the case at all.