Perhaps more confusing than making and using stem cells are the intellectual property rules governing such use. In addition to the licenses his company has attained from the Wisconsin Alumni Research Foundation, David Earp, patent counsel for Geron, said that his company had filed more than 300 patents covering a variety of areas: undifferentiated cells; differentiated cells; methods to scale, differentiate and process cells; and ways to grow cells without blood products and feeder layers.
Esther Kepplinger of the law firm Wilson Sonsini Goodrich & Rosati and Robin Feldman of the University of California Hastings College of the Law provided a stem cell–focused tutorial on what criteria a valid patent must establish and what areas a patent can cover. For instance, a patent can cover the cells themselves, the method of producing the cells or the use of cells in therapy or diagnosis.
Kepplinger, who oversaw the assessment of patents at the U.S. Patent and Trademark Office before joining the law firm, said that from what she’s seen, the patent office is rejecting more patents and claims have been getting narrower. She also said that because stem cell patents are likely to be of high public interest, they can receive extra scrutiny. Finally, she defended the existence of patents themselves: without them, she said, companies would not make the necessary investments to develop new products.
Aurora Plomer, of the University of Sheffield Law School, described what she considers a sort of drift of the European Patent Office’s directive declaring that uses of human embryos for industrial or commercial purposes are not patentable. The intention of the directive was to prevent fertility clinics from turning embryos into commodities. The interpretation of the directive to cover embryonic stem cells, products made from embryonic stem cells and products made with research using embryonic stem cells is highly flawed, she says.
Editor’s note: Students from the law and medical schools at Stanford University brought together an impressive group of world-class experts last week to discuss stem cell policy. I’ll describe some (very select) highlights over three blogs. Check the site for the Stanford Journal of Law Science & Policy over the next few weeks for powerpoints presentations and audiorecordings.