Opinie: Patent op kankergenen funest voor patiënten

Borstkankeronderzoek stagneert in de VS doordat kankergenen het intellectuele eigendom zijn van slechts één bedrijf. Hoe is het mogelijk dat genen gepatenteerd kunnen worden, vraagt de Delftse filosoof dr. David Koepsell zich af. In onderstaand opiniestuk (in het Engels) trekt hij fel van leer tegen de Amerikaanse Patent and Trade Office en het bedrijf Myriad, dat zich de genen heeft toegeëigend.

Gene patents hinder research and hurt patients

Perhaps you, like many, were recently shocked to learn that Myriad, a biomedical company, holds a patent on two forms of the gene that is associated with breast cancer. This patent not only protects Myriad’s genetic screening test, which helps predict whether one will get breast cancer, but it also prevents other companies from developing similar tests. Unfortunately, patents may also prevent basic research. Myriad used their patent to try to shut down breast cancer research being done at Yale University. In The U.S., they can do this as that research necessarily involved making copies of the genes that they now monopolize with their patents, and unlike Europe, there is no research exception.

The American Civil Liberties Union (a U.S. civil rights NGO) recently sued Myriad on behalf of those researchers and cancer victims. While the European Patent Office does not allow claims on gene sequences, they recently reversed their 2004 decision denying Myriad’s patent in Europe, and the test to be patented. Does this indicate a trend by which Europe may eventually allow gene patents?

Patents have been granted for unmodified human genes for the last decade. This is because Craig Venter’s company, Celera, began patenting genes in the 1990s. Other companies quickly followed. The Human Genome Project was publicly-funded and produced basic scientific knowledge in the public domain, but Celera began patenting genes. The U.S. Patent and Trademark Office accepted Celera’s strained legal interpretation of cases that made owning engineered life forms possible. Now, more than 20% of human genes are patented, including genes for several diseases like breast cancer.

Einstein worked in a patent office, yet he never applied for a patent on the theory of relativity. It wasn’t his invention after all. Nor are the unmodified genes for which countless patents have already been granted the inventions of the patent holders, although we should be grateful for these discoveries, and industry will doubtless make useful, patentable inventions based upon these discoveries.

New chemical products, which might be composed of well-known chemicals that cannot receive patents, may be patentable as new compositions of matter not otherwise found in nature. Similarly, new combinations of genes could be patentable. But genes identified as causing diseases, or associated with propensities toward diseases, should not be owned by anyone.

Laws of nature should not be patented, this was settled by the U.S. Supreme Court in Gottschalk v. Benson in 1972, when the court held that a patent was not available for a mathematical formula because "the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." Simply put, mathematics depicts laws of nature. Genes are akin to gravity or mathematical truths: they are the products of nature itself. There is no sense in which the laws of mathematics or the strings of base pairs in unmodified human genes are new, only their applications through specific technologies may be inventive.

The ACLU's case is based on sound legal precedent, just as the decade-long practice of patenting unmodified gene sequence is not. The PTO has made mistakes before, but none that has so directly impaired science that might otherwise benefit the public. This lawsuit, much of which centers around the public status of scientific knowledge, and the intended role of patents, is a long overdue and welcome defense of the free pursuit of knowledge and science. Let’s hope that a win for the ACLU will help prevent a similar trend in Europe. Myriad’s patents affect scientists and those suffering from breast cancer, making research difficult, and detection unduly expensive.

David Koepsell is the author of Who Owns You?: The Corporate Gold Rush to Patent Your Genes (Wiley-Blackwell 2009). He has a law degree and a PhD in philosophy from the University of Buffalo, and teaches Ethics and Technology at the Delft University of Technology in the Netherlands. He has a blog tracking this case at http://whoownsyou-drkoepsell.blogspot.com/