As we were putting the finishing touches on this issue, and its cover story devoted to gene patenting, the US Supreme Court ruled on a related matter — the case of Stanford University versus Roche Molecular Systems. This case hinged on which group researcher Mark Holodniy gave patent rights for his PCR-based HIV test and on the interpretation of the 1980 Bayh-Dole Act. Holodniy signed an agreement with Stanford saying, "I agree to assign" future patents to the school, while his agreement with Cetus — whose PCR assets were bought by Roche — said "I do hereby assign" future patents to the company. Stanford argued that Holodniy developed the patented process with federal funding and that, under the Bayh-Dole Act, those patent rights belonged to the university. The Supreme Court disagreed, and found for Roche. Chief Justice John Roberts wrote in the majority opinion that Stanford's interpretation "assumes that Congress subtly set aside two centuries of patent law."
Patent law can be complex and nuanced. For this month's cover story, Christie Rizk sifts through that labyrinthine world to understand what makes something patentable and how the practice of gene patenting affects biotech, the academic research community, and patients. She speaks with lawyers for both Myriad Genetics and the American Civil Liberties Union to get a handle on each side's arguments on the BRCA gene patent case — which a Federal Circuit Court is slated to rule on soon and which may advance to the Supreme Court — as well as with experts from other areas of biotech and diagnostic development. Whichever way the court rules, Christie finds that it might bring some resolution to the field, though there will still be questions to answer.
Also in the news is an outbreak of E. coli that has Europe on edge. Public health experts have yet to track down the cause, but as they do so, researchers are sequencing and assembling the strain that caused it. In a feature story in this issue, Tracy Vence reports on this and other genomic epidemiology-based disease outbreak investigations.