Latha Jishnu: Your genes? Not on your life!

It is a landmark case by any standard. In a first of its kind, a motley group of interests — from cancer patients and civil liberties activists to clinic pathologists and researchers — have challenged the gene patents granted to a US biopharmaceutical company. A fortnight ago, they sued Myriad Genetics of Salt Lake City, the University of Utah Research Foundation, which is Myriad’s research associate and co-owners of the gene patents, and the US Patent and Trademark Office on a fundamental issue: The right to patent genes.

The case, filed in the New York federal court, has had the effect of an explosive thrown into a protected enclave where everyone thought they were sitting pretty. Legal experts, academics, the wide community of patent lawyers and commentators — all with entrenched views — and not to forget the industry are in a tizzy over the case. This is the first time that gene patents have been challenged in such a fundamental way although such patents have been granted for two decades. Myriad’s patents, for genetic testing for breast and ovarian cancer disposition in women, are almost 15 years old.

 

Moved by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, the plaintiffs are claiming that the patenting of genes limits research and the free flow of information and, consequently, violates the First Amendment. At the heart of this unusual case is Genae Girard, a 39-year-old from Austin, Texas, who was diagnosed with breast cancer in 2006. Girard also took a test to find out if her genes put her at risk of ovarian cancer, too. The tests done by Myriad came back positive. Naturally, she wanted a second opinion, but discovered that there could be no other opinion since the company held the patents for BRCA1 and BRCA2, the genes associated with hereditary breast and ovarian cancers. The ACLU suit seeks the revocation of seven patents covering the BRCA1 and BRCA2 gene tests.

Experts appear to be fairly evenly decided on the merits of the case but few are willing to bet on a successful outcome to the challenge because of the large number of gene patents that have already been granted. Besides, the Myriad case raises a complex web of issues from ethics to over-pricing. A serious complaint is that the monopoly granted to Myriad allows it to charge an exorbitant amount ($2,400 to $3,000 per test) that is not covered by public healthcare. Critics have also slammed the company for ethical issues over its advertising which, according to some analysts, could be misleading and frighten all women into taking the tests.

Myriad’s BRCA1 and BRCA2 patents on unmodified human breast cancer genes have been controversial from the beginning. In the US, other laboratories offering such tests at a hugely-discounted rate were threatened with lawsuits. In Canada’s province of Ontario, large-scale tests were conducted by the public health authorities who simply chose to ignore the threats made by Myriad and the US ambassador who warned Canada that it could face trade sanctions! Canadians got their results far quicker from their own laboratories and they were charged just a third of Myriad’s rates.

However, the biggest setback to Myriad came in Europe which said all women at risk of such hereditary cancer should be offered the tests and not just those who could afford to pay for it. So hospitals began flouting the patents. Then in 2004, in an unprecedented move, the European Patent Office (EPO) revoked Myriad’s patents because it said Myriad had not invented anything new and did not meet the criterion of ‘inventiveness’, one of the essential conditions for securing a patent, even if it had figured out the composition of key genetic sequences. In short, all that the company had done was to discover something already existing in nature.

Gene patenting ignores a looming crisis. Already, about 20 per cent of the human genome, involving thousands of individual genes, has been patented. This has serious implications for the future since the understanding of diseases has changed radically. Earlier, scientists believed that single genes were responsible for complex diseases but over the years they have discovered that complex diseases can be the result of 50 or even 100 genes in interaction with each other. With each gene protected by patents, researchers will find it difficult to cut through the thicket of patents and licence-fee arrangements which could cost huge sums. This could force universities and individuals to abandon research.

But companies like Myriad argue that the patents are an important way of rewarding them for their investment in research and development. Whose arguments will win the day is not clear yet. One hopes the Indian authorities are keeping tabs on this case. For the patent office, it is important to keep in mind the EPO’s definition of inventiveness; for the health authorities, the Canadian and European focus on universal access to tests should serve as an example. After all, our genes belong to us, right?