Stem cell research, though promising as an approach to treating diseases ranging from Type I diabetes to Parkinson's disease, has a long way to go before something shows up on the Food and Drug Administration's doorstep claiming to be a cure for a disease. Most of the advances breathlessly reported in the daily press are basic science insights or suggestive animal experiments. No one has conducted the successful animal safety test that would allow researchers to inject an experimental therapy derived from stem cells in humans.
That's why yesterday's announcement by the Patent and Trademark Office that it was voiding three seminal patents in the field previously awarded to James Thompson of the University of Wisconsin is good news for patients. Thompson was the first to isolate human embryonic stem cells, and in that discovery's wake, his university claimed all subsequent uses of the technology.
While, as this New York Times report points out, the university promises to litigate the decision, the PTO decision marks a welcome turning point in the battle against the unnecessary and unproductive privatization of mankind's quest to understand the natural universe.
Since passage of the Bayh-Dole Act in 1980, scientists receiving government funding have been encouraged to patent their discoveries if they were commercially viable. The patent fever set off by the law extended to virtually any research conducted at universities, whether publicly or privately financed. Because of U.S. government restrictions on funding embryonic stem cell research, Thompson's research was funded by Geron Corp., which ultimately received an exclusive license to the most promising uses of Thompson's discovery.
But that didn't stop the Wisconsin Alumni Research Foundation, which manages patents for the university, from charging private firms $100,000 and academic and non-profit institutions $5,000 every time they wanted to use the Thompson stem cell lines. This aggressive posture set the tone for the entire field, and encouraged other researchers to patent their discoveries.
This profusion of patent applications, what economists call a patent thicket, will inevitably retard the pace of research as researchers scramble to secure the necessary licenses and material transfer agreements. A British survey several years ago identified nearly 18,000 patents and patent applications in the stem cell field.
There are ways for researchers to collaborate in this aggressive intellectual property environment. In an article that appeared in PLoS Medicine a year ago, I proposed a patent pool for the stem cell field as a possible path through the patent thicket.
But another way to cut down the underbrush is by eliminating those patents that are most appropriately considered scientific discoveries about the workings of the natural universe. For something to receive a patent, it has to be a previously unknown invention that reflects the hand of man. Discovering human embryonic stem cells, which have been around since man first walked the earth, is more like Isaac Newton discovering gravity than the Wright Brothers building the first airplane.
The Public Patent Foundation and the California Foundation for Taxpayer and Consumer Rights, which challenged the Thompson patents, have provided a valuable service for the entire science community. Unfortunately, the PTO ruling relied on the traditional tenets of patent law. The examiners, upon reexamination, claimed the patent was obvious based on previous papers that had appeared in the literature. Obviousness and previous publication are cause for rejecting a patent application.
WARF's top officer immediately restaked their claim on those grounds. "It is inconceivable to us that Dr. Thomson's discovery, which Science magazine heralded as one of the greatest scientific discoveries in history, would be found to not be worthy of a patent," said Carl E. Gulbrandsen, the managing director of WARF.
In a bygone era, "one of the greatest scientific discoveries in history" would have gladly been shared with all mankind, not seen as a building block of academic alchemy that would turn basic science into gold. Basic science that may ultimately lead to useful products should be free and open to all who would build those useful products. Its inventors should not be allowed to become toll collectors on the road to innovation. Hopefully, the PTO decision yesterday is the first step on the road back to a reasonable standard for establishing where basic science ends and commercial invention begins.