Two academic amici -- Robert Cook-Deegan (at right), Research Professor and Director, Center for Public Genomics at Duke University, and Christopher Holman, Ph.D. (Molecular Biology) (below left), Associate Professor of Law, University of Missouri – Kansas City School of Law -- filed a brief in the AMP v. USPTO (Myriad) appeal that rebuts many of the distorted (albeit emotionally effective) arguments made by plaintiffs and their supporters (specifically, the ACLU and PubPat) against patent-eligibility for human genes.
Earlier this year, we wrote about the situation with a petition to the National Institute of Health (NIH) to let other companies produce Fabrazyme, a drug that treats Fabry disease. Fabry disease is an enzyme deficiency that can create very serious problems in those who have it -- including kidney failure and heart attacks. Genzyme holds the patent on Fabrazyme, but has a problem: it can't produce enough of the drug. That means people die. A group of Fabry patients petitioned the NIH to see if other companies could be allowed to produce just a little more Fabrazyme. They didn't ask to break the patent. All they wanted was to let others make the drug, and pay Genzyme a royalty. On top of this, it's worth noting that the key research for the development for Fabrazyme wasn't actually done by Genzyme, but was done by the Mount Sinai School of Medicine and was financed with taxpayer money from the NIH.
The European Union and India said on Friday they had resolved a dispute over generic drugs in which was referred to the World Trade Organisation last year. Indian Trade and Industry Minister Anand Sharma told Reuters the EU's trade chief, Karel De Gucht, had told Indian negotiators during an EU-India summit that the issue had been resolved, and De Gucht confirmed the agreement.
"This is a great breakthrough which will of course lead to a suspension of WTO procedings. So the dispute is over," said Sharma.
India and Brazil brought a case to the WTO in 2009 saying that the EU was wrongly stopping and inspecting shipments of generic drugs in transit. While the EU and India have settled, the EU must still negotiate with Brazil.
The European Patent Office Enlarged Board of Appeal yesterday gave its decision on the so-called “broccoli” and “tomato” cases, and excluded “essentially biological processes for the production of plans (or animals)” from patentability.
The Board concluded that “while technical devices or means, such as genetic markers, may themselves be patentable inventions, their use does not make an essentially biological process patentable.”