Patents, Public Interest and Common-sense
Genius, not discovery, has been ruled the determining factor in registering patents in the field of human genetics. Eight thousand US patents for gene sequences have been rendered potentially invalid by a recent US Supreme Court decision holding that "a naturally occurring DNA segment is a product of nature and not patent eligible" simply because a research team has isolated it.
The implications are profound, but may represent a welcome check to a pattern of patent registration excess which marked the last quarter of the twentieth century and the first decade of this century.
Back in 1984-5 I was working on my LLM thesis Patents and the Public Interest: Aspects of the Law of Compulsory Licensing at the University of Toronto. It involved, in part, sifting through the vast quantities of submissions to the Eastman Commission on the topic of pharmaceutical compulsory licensing, then legal in Canada. More generally, it led me to consider what, precisely, the patent system was for.
An analysis stretching back before the French Revolution and encompassing three separate continents, left me with an uneasy sense that patent systems are in constant danger of assuming lives of their own. If the system is not kept under stringent, evidence-based review, research becomes shaped not by its usefulness to society or even its presumed profitability, but by whether one can get a patent for it.
That concern deepened over the next decades. The USPTO in particular seemed to be pushing the boundaries of patentability, opening the doors for a wide range of software and business method patents of dubious validity. Many of these did not seem to offer the necessary incentive to innovation. Indeed, blanket patenting strategies by large organisations, patent "trolling" and low benchmarks for inventiveness applied by patent offices actually operated as a brake on innovation, particularly by SMEs, since fear of patent litigation inhibited them.
The nadir was probably reached with US Patent US 6368227 B1 Method of swinging on a swing. This patent was filed in 2000 by a Mid-West patent attorney in an attempt to show his small daughter how the system worked. In fact, it managed to prove to the wider intellectual property community that it didn't.
Concerns were intensified as gene sequences were patented, threatening to put diagnostic processes into the hands of monopolists and greatly increase the costs of medical treatment. The 13 June 2013 US Supreme Court decision in Association for Molecular Pathology et al. v. Myriad Genetics Inc, et al. would appear to have put a much-needed check on the process.
The Court held that
"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."
The case concerned the BRCA1 and BRCA2 genes, whose role in causing breast cancer was recently highlighted when Angelina Jolie announced she had undergone a preventative double mastectomy on discovery of a BRCA1 mutation which put her chances of developing the disease at 87%. In a frank and moving op-ed in the New York Times, Ms Jolie not only set out her own experiences, but drew attention to the role played by overly restrictive patent rules in inhibiting treatment for women without Ms Jolie's wealth:
"Breast cancer alone kills some 458,000 people each year, according to the World Health Organization, mainly in low- and middle-income countries. It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women."
The Supreme Court's decision may have gone some way towards making that hope a reality. In an interview in the New Statesman, Mary-Clare King, the geneticist who discovered the BRCA1 and BRCA2 genes applauded the Supreme Court ruling as a victory for common-sense.
The ruling was careful to draw a distinction between what was unpatentable and sequences which — being artificially created — could be patented. But, hopefully, the door has been opened for a push-back against overly-broad patents, returning us closer to the position outlined by Kahn J. in the Supreme Court in Israel, back in 1974:
"There exist grave reasons against the creation of a monopoly by a patent in respect of medical treatment. We are confronted here by saving human live or alleviating human suffering, and one should take great care lest the freedom of action of those who treat, caused by patents, should affect human life or health."
—Wellcome Foundation v. Plantex Ltd ( RPC 524 at p. 539)
The main image used for this article is: 'DNA Purification' and was used under the terms detailed at the above link on the date this article was first published.