When a child dies of brain disease at Children’s Hospital of Orange County, Philip H. Schwartz meets with the parents, explains his research and asks them to donate their child’s brain to his quest for a cure.
“These are not easy conversations to have,” he said. “There are expectations by parents that if they allow us to do that to their child, it will serve a useful purpose.”
But for three years, the cells derived from many of those children’s brains have been suspended in limbo, frozen in Thermos bottles. The nonprofit Southern California hospital has shut down the research, intimidated by a patent claim from the Palo Alto biotech company StemCells. The company’s co-founder is esteemed Stanford stem cell scientist Dr. Irving Weissman, one of the world’s most passionate advocates for giving scientists access to a field entangled by politics, ethics — and now money.
The standoff over Schwartz’s 50 cell cultures illustrates how the commercialization of stem-cell science is creating roadblocks to this red-hot field, even while spurring much-needed investment. It’s a classic clash between business and science, and similar battles are being waged over access to embryonic stem cells, genes, biotech tools and other scientific discoveries.
“The landscape is messy,” said Gregory D. Graff, a patent expert at Colorado State University. “It is a complex situation where you have research interests intermingling with commercial interests. They are both legitimate purposes, but can be in conflict with each other.”
Schwartz, who spoke at length last year to the Mercury News, is no longer publicly discussing the dispute but stood by his previous unpublished interview.
With his research stymied, “all the money has shifted from the lab to the lawyers,” said Schwartz, who said he believes the cells may hold deep secrets to such devastating conditions as autism, brain cancer and neurological disease.
The dispute comes down to access to a technique that Schwartz helped develop at the Salk Institute but the institute failed to patent. StemCells did.
In January 2007, the company sent Schwartz a letter saying it owned rights to the technology that he used to extract the cells at his Neural Stem Cell Repository. The hospital attorneys told him to halt his research and stop shipping the cells to dozens of other academic scientists, who also are conducting brain research.
“It’s a disservice to families who allowed us to” use their children’s brains, he said. “It’s hard to talk about without getting angry.
“There’s been a stranglehold put on the field because of this. The access to the science community to cells like this for basic scientific study is virtually nil,” he said.
Weissman has had little to say about this dispute. In an e-mail to the Mercury News, he wrote that StemCells “has been prompt and diligent in discussing the issues” with the hospital, but referred further questions to company attorneys, saying “they know the situation, and I do not.”
Negotiations are still inching forward, and the two sides have stayed out of court. Neither the hospital nor the company would offer official comment.
Weissman, the director of the Stem Cell Biology and Regenerative Medicine Institute at Stanford, is a champion of stem-cell science, expounding to legislators and laymen alike the promise of stem cells for treating disease and why it is wrong to restrict their use for ideological reasons. With a formidable team of scientists, the goal of StemCells is to transplant healthy cells into damaged brains, offering relief and recovery.
Schwartz said his nonprofit hospital has no intention of commercializing its discoveries or stealing profits from StemCells.
“We’re a small clinical institution whose primary purpose is caring for kids,” he said. “We’re unwilling to risk this mission by bumping heads with StemCells Inc.”
The U.S. Patent Act permits exclusive control of any “process, machine, manufacturer, or composition of matter” to a patent holder. StemCells holds exclusive rights to 55 U.S. patents and 200 non-U.S. patents and has launched clinical trials of treatments for several novel brain diseases. It is the leading private company in the neural stem cell field.
Patents can stimulate research because they attract private capital investment and assure investors that a company’s products are protected, experts say.
“Research and development is very expensive and there are a lot of failures — and the successes need to support the experimental trials, and the failures, so we can have successful and safe products on the market for everyone,” said patent attorney Antoinette Konski of the Palo Alto law firm Foley & Lardner. Once the 20-year patent expires, the public has full access to it, she added.
But others say exemptions should be made for universities and nonprofit research teams. This noncommercial research can enhance the value of a company’s patent if new discoveries are made, they say.
UC San Francisco and Stanford University require no license from academics to use their patent inventions and materials for noncommercial research purposes, according to Joel Kirschbaum of UCSF’s Office of Technology Management and Katharine Ku of Stanford’s Office of Technology Licensing.
“Behavior like this is repulsive and unacceptable, and the leadership of the company should be called to task,” said Dan Ravicher, executive director of the Public Patent Foundation, a nonprofit group that urges limits on patent protections in life sciences.
John Simpson of the Los Angeles-based Consumer Watchdog, who is closely watching the case, called it “an egregious assertion of overreaching patent rights. Even if StemCells Inc. can technically assert the patent, I think it is wrongheaded for them to do it. You don’t want to freeze that sort of research.”
The roots of the conflict go back several years. While at Salk Institute, Schwartz created a new application out of an existing technique: deriving neural stem cells from post-mortem brains, then growing them in culture. At the same time, StemCells was doing similar things.
Neural stem cells, the immature precursors to brain cells, offer huge insights. They allow researchers a way to study cells as they grow and look for ways to interrupt diseases.
“You can create the battle in a culture dish,” said Schwartz, saying it could also benefit research into diseases like Alzheimer’s and Parkinson’s. “Autism — we don’t even have a blood test. We don’t understand what it is. In metabolic diseases that affect the brain, what is the sequence of events? What kills them?
“These cells can be used to help us get an idea.”
Contact Lisa M. Krieger at 408-920-5565.