The Morphing Patent Problem

We’ve certainly learned a lot about stem cell technology recently. Late this summer, my friend George, a prominent stem cell researcher, could hardly get any work done he was so busy explaining stem cell lineages-hepatocytes, myocytes, osteoblasts-to the eager journalists and TV news crews camped in his lab.

It’s still too early to tell, but we all can probably learn an important lesson about patents from the stem cell debate as well. In case you missed it, just as President George W. Bush decided to let federally funded researchers study those human embryonic stem cell lines already in existence, the public learned that a little-known private firm-Menlo Park, CA-based Geron-held a proprietary lock on them so tight that federal funding might be nearly moot. The situation was so dire a National Institutes of Health team scurried off to “negotiate” (read beg) for access to the sought-after stem cell lines.

How in the world is one company able to “own” such critical technology? Especially given that much of the work behind Geron’s position-led by developmental biologist James Thomson at the University of Wisconsin-Madison-was done at a public university?

Well, it’s a tragedy of errors.

First, the federal government deserves blame for dragging its feet in funding human embryonic stem cell research to begin with. Its politically motivated reluctance to get into this area left the door wide open for Geron to demand an exclusive license to the technology when it helped underwrite Thomson’s early research in 1995. (While federal funding for embryonic stem cell research was banned from 1996 until the NIH issued new guidelines last year, Geron helped keep the field alive [see “The Troubled Hunt for the Ultimate Cell,” TR July/August 1998].)

Second, we need to scrutinize the role played by an outfit called the Wisconsin Alumni Research Foundation (WARF), which guards the university’s commercial interests in such matters. Most universities have similar technology licensing operations. And in this case, the Wisconsin foundation brilliantly performed its core job: securing a phenomenally broad patent on human-embryo stem cell research and on the stem cell lines themselves-and then inking the exclusive deal with Geron. The problem is that this private group was accountable to no one as the public guardian of a vital monopoly.

These problems were compounded by President Bush’s hairsplitting decision to allow research only on existing human embryonic stem cell lines. In so doing, Bush unwittingly strengthened Geron’s hand. Because the number of cell lines has now been limited, researchers will be all the more at the whim of WARF and Geron for the next two decades while their patent remains in force. Not surprisingly, the company’s stock rose to a six-month high on the strength of its position.

But the situation gets even worse.

The Wisconsin foundation holds patents on not only the five original cell lines developed by Thomson but also the laboratory methods used to produce them. In a press release, a Wisconsin spokesperson said virtually all other embryonic cell lines now in existence fall under the Thomson patent. As a result, Geron can arguably lay claim to the results of any federally funded research involving any cell types developed from the precious stem cell lines originally created by Thomson.

Perhaps the biggest lesson of all, though, surrounds the chronic myopia of the U.S. Patent and Trademark Office in awarding such needlessly all-encompassing patents as it has in this field. By now, if you have followed the stem cell story you undoubtedly know that human embryonic stem cells are undifferentiated cells taken from fertilized embryos that can morph into virtually any of the more than 200 cell types in the human body. In theory, these undifferentiated cells grown in culture could provide an unlimited source of specific, clinically important specialized cells to treat diseases such as Parkinson’s and Alzheimer’s, or even provide replacements for damaged or diseased bone, muscle, liver or blood cells.

What’s really scary about this, as it relates to patents, is that some patents are a lot like embryonic stem cells-so broad and undifferentiated they can be seen to apply to virtually any research problem in a given area. To borrow from the stem cell lexicon, these patents are pluripotent, or totipotent. They can morph into almost any application they wish to.

The problem with broad patents on such embryonic technology is clear: they wind up blocking the path for other, more specific patents seeking to bring innovations to market. The patent office vitally needs to learn to distinguish between these kinds of embryonic research tools and marketable inventions more akin to the differentiated cells that perform specific jobs in the body.

As legal scholars have documented in other high-tech areas, overly broad patents lead to the paradoxical result that fewer useful products are developed, because they shut other researchers and inventors out of the action. This is likely what will happen with stem cells. That outcome, desired by no one, would be the biggest-and sorriest-lesson of this debate.