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The United States District Court for the Southern District of New York faced a difficult question at the intersection of law and biotechnology last month: can one patent nature? On Monday, March 29, United States District Court Judge Robert W. Sweet said no, and invalidated seven patents related to the BRCA1 and BRCA2 genes, the mutations of which are associated with both breast and ovarian cancers.
Mark Skolnic, the founder of Myriad Genetics (Myriad), patented the BRCA1 and BRCA2 genes in the 1990s. In May of last year, the American Civil Liberties Union (ACLU), a number of breast cancer awareness groups, and other scientific organizations filed a class action suit against Myriad, which still holds the patents to the cancer-linked genes.
Lawyers for the ACLU argued that genes are a product of nature, and thus should not be subject to patenting, and that the patents would hinder scientific progress in the area of genetic technology. Judge Sweet agreed, stating that the patents were improperly granted because Myriad did not invent or create the BRCA1 and BRCA2 genes. Myriad plans to appeal.
What’s the big deal if we can’t patent genes, one might ask? Now that the BRCA1 and BRCA2 genes are not subject to a patent, competitors may enter the market and offer genetic testing for these genes for a much lower price. For instance, Myriad charges roughly $3,000 to analyze these genes, whereas Canadian companies offer the same gene analysis for a mere $1,000.
While competition and lower prices for consumers sound a lot like “apple pie and motherhood,” there are also some not-so-great consequences to consider. Without these patents, how are researchers supposed to raise the enormous amount of capital necessary to advance their studies? Mega-industries have been built on the patent trade, and with patents for over twenty percent of all human genes, these mega-industries should be bracing themselves for a mega-fall.
So it seems that we are at a standstill. Either we do not allow any gene patents, and funding for genetic research enters a death spiral, or we allow gene patents, and patients are prohibited from benefiting from genetic discoveries. One thing is for sure: there is a long and litigious road ahead for Myriad and the ACLU, with legal minds projecting the case to make its way to the Supreme Court.
– Lauren Sibyl Bair
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