January 2006--Hopkins’ famed molecular biologist Daniel Nathans was once asked whether he and colleague Hamilton Smith had considered seeking patents for their discoveries on restriction enzymes that would earn them the 1978 Nobel Prize.
“Had we done that,” Nathans responded in an interview published in a book after his 1999 death, “the School would’ve made a lot of money, but neither Ham Smith nor I was thinking in those terms in the early 1970s.”
Putting their discoveries into the public domain, Nathans and Smith helped to revolutionize biotechnology by allowing scientists to build on their work, cleaving DNA without first getting permission or signing licensing agreements.
“If Hopkins were a less than scrupulous institution,” notes Vice Dean for Research Chi Dang, “we could have slowed down the entire biotechnology field.”
Times have changed greatly. In the same interview, conducted in the 1990s, Nathans said he would have “absolutely” considered patent protections if he had made the discovery then. Encouraged by the Bayh-Dole Act of 1980, universities now actively apply for patents for inventions and partner with corporations to bring those advances to the marketplace. Intellectual property protections are recognized, overall, as a good thing for scientific endeavor. But can patents sometimes hinder progress? When a “foundational” discovery is essential to advance research in an emerging field, should universities and scientists forego financial gain and share more openly?
A dispute involving stem cell research highlights these issues: the U.S. Patent and Trademark Office issued a preliminary ruling that three patents held by the University of Wisconsin should be overturned. Led by biologist James Thomson, the Wisconsin researchers had developed a process to grow embryonic stem cells outside the body on a bed of other tissues. The patents cover not just the process of deriving stem cell lines, but the cells themselves.
The Wisconsin Alumni Research Fund (WARF), which holds the patents, charges the University little for the cell lines—$500 per line per researcher. WARF relaxed its policies to allow companies to sponsor university research without a license. Companies still need licenses to develop products for the marketplace or bring the research into corporate labs.
Even with the new rules, Dang says the patents have hamstrung scientists at Hopkins and elsewhere. Licensing agreements often limit how researchers can manipulate the cells. And the Wisconsin group, he adds, can also claim intellectual property rights to new lines created elsewhere through its derivation method. Hopkins cancer researcher Elias Zambidis, for example, wants to cultivate stem cell lines from embryos containing disease-triggering genes. He says these cells might provide new understanding of the pathology of diseases.
“The research is my main priority,” Zambidis says, “but it would be disappointing to come up with a new stem cell line and find out that somebody else owned it.”
The patent restrictions have also made it more difficult to attract corporate funding, says Hopkins neurologist Douglas Kerr. He led a team that showed how paralyzed rats could partially regain motor function when embryonic mouse stem cells, derived by the patented process, were injected into their damaged spinal cords. His recipe for turning stem cells into motor neurons holds hope for human spinal cord injuries and diseases such as ALS.
Despite the work’s promise, it’s difficult to find corporate partners, Kerr says, because WARF could demand royalties from any therapy developed from a partnership.
He hopes the ruling on the Wisconsin issue will reverse that. In its decision, the patent office agreed with two nonprofit organizations which argued that the advances, essentially, weren’t innovative enough and were built on years of work by the research community.
The ruling is only a recommendation, and it could be years before there’s a final determination. Meanwhile, the patents remain valid. “It’s business as usual” with the Wisconsin group, says Sigrid Volko, a portfolio manager in the University’s technology transfer office.
Volko says that despite the hurdles, companies and intellectual property-holders can often find solutions when there’s money to be made. Deals may involve multiple layers of patents. “University patent holders know that to exclude others entirely from using or developing their technologies serves neither their own best interests nor those of the public at large,” she observes.
Dang, who directs Hopkins’ Institute for Cell Engineering, says the Wisconsin patents will ultimately be a non-issue, allowing researchers to work freely with the cell lines.
“Universities have to be enlightened enough to know that at some point the public good is better served by their not being greedy,” says Dang. “I think it’s got to be handled case by case, and you have to use very good judgment about what institutions do with certain discoveries.”
– Jamie Manfuso
Reaping the fruits of research