Genomic manipulation

Does commerce always prevail over logic or the larger interests of mankind when patents are at stake? Decidedly so in the US, where patenting tends to run amok, especially by the software and pharmaceutical industries. Cases relating to these two sectors clog the courts, and, despite several attempts by the politicians and the software industry to reform the patent system, these efforts have come to naught in the US Congress. Judges invariably uphold the sanctity of patents even if they are out of their depth when dealing with such complex issues as gene patents.

One would have thought after the world’s leading authority on genomics had sent it lucid arguments on why human genes should not be patented, the court would have taken note of these issues. However, the US Court of Appeals for the Federal Circuit that is hearing the Myriad Genetics case appears not to have understood the import of the amicus curiae brief filed by the legendary James D Watson, discoverer of the double helix structure of DNA and Nobel Laureate.

In one of the most awaited patent decisions the world over, the appeals court once again upheld the right of Myriad to patent two genes linked to breast cancer after the Supreme Court asked it to review its controversial decision.

There was a dissenting opinion in the three-judge bench which said ‘isolated genes’ could be patented. Myriad is the licence of the patents for BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancers and are held by the University of Utah. In fact, Watson had said pointedly that judges and lawyers misunderstand scientific research when they contend that patent protection is necessary to encourage scientists to discover human genes. ‘A scientist does not – and should not – expect to obtain a legal monopoly controlling the information encoded by human genes. And the average scientist should not expect a windfall simply for revealing the sequence of DNA bases that encode various genes. Research on human genes is one of those rare endeavours which should be – and is done – with the understanding that, although inventions based on those genes may later be commercialised, the genes themselves are to be employed for the maximum benefits of humankind.’

Two years ago, John Sulston, who led the UK branch of the Human Genome Project, had warned that such patents would come in the way of research. He had urged scientists and lawmakers to resist attempts by companies and individuals to patent human genes since the attempt was only to monopolise all the tools for genomic manipulation. His concern was that scientists still have to explain much of the genetic basis of most diseases. Earlier, ‘it took 13 years to sequence the first genome but now we sequence several human genomes every few days.’

The American Civil Liberties Union (ACLU) argued that patents on human genes were a violation of the First Amendment and patent law because genes are products of nature, but the majority court opinion held that ‘on the limited questions before us, we conclude that the composition claims and the screening claim involving growing a transformed host cell meet the standards for patent eligibility, while the claimed methods for ‘analysing’ or ‘comparing’ do not’.

In his dissent, Judge William Bryson used his leaf analogy  again, contending that a gene isolated from the human body cannot be patented any more than a naturally grown leaf plucked from a tree could become patentable. ‘Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet, prematurely plucking the leaf would not turn it into a human-made invention.’ But the other two judges contended that ‘snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.’

The court has yet to write finis to the case. Dennis Crouch, associate professor of law at the University of Missouri School of Law, writes that there is ‘a strong possibility of either an en banc rehearing by the full 12-member Federal Circuit and/or a grant of certiorari by the US Supreme Court.’ There is a chance the views of Watson and Sulston may yet prevail.

On arrangement with Down to Earth magazine