DNA of the future

US gene judgment opens up biotech industry

A recent ruling by the US Supreme Court on gene patenting has huge implications for the biotechnology industry, healthcare and medicine. It will trigger a review of over 100,000 existing American patents. In a unanimous ruling, a nine-member bench has declared that a naturally occurring DNA (deoxyribonucleic acid) segment, or gene, cannot be patented. However, a patent can be granted for isolated forms of genes. The ruling was in a high-profile case filed against the biotechnology company Myriad Genetics by the Association for Molecular Pathology (AMP), a not-for-profit scientific association.

The human genome contains over 20,000 genes. About 40 per cent of these have already been patented. Those patents are now "half-invalid". In the natural condition, genes are "mixed" together. They may be isolated and synthesised by various processes. The natural form is known as genetic DNA, or gDNA. The isolated, synthetic form is called complementary DNA, or cDNA. The court ruling held: "A naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated, but that cDNA is patent-eligible because it is not naturally occurring. Separating a gene from its surrounding genetic material is not an act of invention." A patent covering cDNA is thus, in effect, a process patent. A different process that isolates the same gene can work around the patent. Earlier US practice allowed patenting of both the cDNA and the gDNA, thus giving the patent holder a 20-year monopoly on all research into that gene.

"Rollbacks" on existing gDNA patents may have several effects. The earlier practice offered greater incentive for research because the patent holder could recoup profits over a long period. That moat has been lowered. The AMP and the majority of the academic establishment argue that sweeping patents effectively halt further research into a specific gene and allow patent holders to make exorbitant profits. The AMP declared the ruling was "a great step forward for the field of molecular pathology, for genomic science, and most importantly, for patients". Myriad Genetics' charges were considered particularly egregious, which is why it was targeted. Myriad was awarded nine patents in 1996 on the related BRCA1 and BRCA2 genes. Mutations in these two genes trigger breast cancer. Myriad charges $4,300 for gene-screening tests for those two genes. (Actress Angelina Jolie took those tests before opting for her mastectomies.) By comparison, the entire human genome can now be sequenced for around $1,000. Limited DNA mapping kits are available off the shelf for $100. Researchers in John Hopkins and Yale claim they can provide free tests for mutations in BRCA1 and BRCA2 now that the patent is annulled.

Apart from holding to the basic premise that patents should not cover natural substances or natural laws, the court's decision may have been influenced by academic opinion, as well as a declaration from the US Department of Justice that it does not support the patenting of naturally occurring genes. On balance, the ruling should provide for a more rational development of the biotechnology industry and lead to lower healthcare costs as well as faster medical breakthroughs.