Pallin’s claim ran counter to everything Singer believes about his profession, Singer explains. “It would have been much easier to purchase Pallin’s license and let others worry about the problem,” he says. “But from the beginning, I knew I had to fight this as a matter of principle.”
Three years and more than half a million dollars later, Singer won a legal victory. But the victory did not help Singer establish the principle that medical knowledge cannot be patented. Singer won simply because he could document that he had performed the incision for one month prior to Pallin’s patent claim.
Singer’s assertion that medical procedures must be shared among practitioners did find a broader following, however-in Congress. Rep. Greg Ganske, R-Iowa, a plastic surgeon by training, sponsored a bill to ban patents on medical procedures, a policy followed by some 80 other industrialized nations. Ganske warned that if Congress didn’t act, people would one day hesitate to perform the Heimlich maneuver on a choking diner for fear someone might sue them for violating a patent.
But other than banning private patents on nuclear-weapons-related inventions during the Cold War, Congress has been loath to set limits on the robust U.S. patent system. During the 1996 congressional hearings, lawyers from the American Intellectual Property Law Association, the Intellectual Property Section of the American Bar Association, and the Biotechnology Industry Organization argued that the United States risks a “domino effect” that would squelch technological progress if it systematically excludes certain types of patents on policy grounds.
These parties argued that Rep. Ganske’s proposed bill would invite other countries to weaken their patent laws at a time when the United States is pushing these countries to toughen them. The move could embarrass the United States internationally or, worse, even put the nation out of compliance with the intellectual property treaty arrangements of the General Agreement on Tariffs and Trade (GATT) negotiations- arrangements the United States was working to bolster in the international community.
The final legislation, signed by President Clinton in the fall of 1996, sought a middle ground between the two arguments. It specified that doctors and researchers can receive patents on medical procedures, but they cannot sue to recover royalties from other medical practitioners who use the procedures. In other words, Pallin could seek a patent today, but could not sue Singer. And if Pallin won a patent today, the law would make it effectively worthless, little more than an empty professional accolade. Yet, the U.S. government still preserves Pallin’s right to claim ownership over his discovery.
The congressional compromise reflects a deep-seated national conflict on this issue. The medical-procedure patent law will curb some of the worst incursions of private ownership claims into the shared terrain of medical education. But increasingly, as bitter intellectual property fights like the Bogart-Kaiser case spread throughout the biomedical field, Congress’ actions may prove inadequate to address the emerging clash between private profit and the shared “infostructure” of medical education. The legislation will not stop all legal battles. For example, it does not apply retroactively to existing patent claims, which leaves thousands of actionable medical-procedure patents on the books.
More important, the law does little to address similar problems arising in high-tech biomedical research. The legislation focuses on medical procedures, so it does not explicitly cover the vast number of claims like Bogart’s that involve insights about the body’s functions that researchers and companies can use to create diagnostic tests or novel treatment approaches.
Indeed, just months before President Clinton signed the congressional law to limit the value of patent claims among medical practitioners, he signed legislation that actually expanded patent rights in biomedicine. That law gives explicit backing to what may be the broadest patent in medical history: on ex vivo human gene therapy.
In 1990, a team of researchers at the National Institutes of Health (NIH) made medical history when they employed a new technique called ex vivo human gene therapy to successfully treat two girls with a rare genetic disorder. In this type of gene therapy, doctors remove the cells from the patient and alter them in a lab, outside of the body. The medical team took the girls’ white blood cells, inserted an altered virus that would correct their genetic disorder, and reintroduced the corrected white blood cells into the girls’ bloodstreams.
With strong legal advice, three members of the team managed to parlay the experiment into a patent on all ex vivo human gene therapy. The claim is so broad that doctors around the country were shocked when the team won the patent. “Deep disbelief, I’d say that’s what most people feel about the breadth of the patent,” Joseph Glorioso, head of the department of molecular genetics and biochemistry at the University of Pittsburgh told the journal Nature. “This is analogous to giving someone a patent for heart transplants.”
Dusty Miller, a key member of the original human gene therapy team-who was not on the patent and who is now a researcher at the Fred Hutchinson Cancer Center in Seattle- says such a patent shouldn’t exist, or, at the very least, should be defined far more narrowly. As he put it, the patent amounts to “another big step toward the bizarre world where people stake claims to the natural processes of the human body.”
Complaints like Miller’s grew louder when the team sold the exclusive rights to this entire new and promising field of medicine to the highest bidder. Ultimately, after various corporate mergers and acquisitions, those rights landed in the patent portfolio of Swiss pharmaceutical giant Novartis. The patent, and Novartis’ control of it, has far-reaching effects. Novartis can exact royalties from anyone seeking to use the technology and, because of this, those treatments that come to market will likely cost more.
Another set of problems posed by such patents is typified by a bitter, ongoing case involving Baxter International. Baxter, a large pharmaceutical and health care firm, claims to own a broad license on the technology related to a particular antibody that can be used in bone-marrow transplants for patients with breast cancer and lymphoma, among other diseases. Even though no comparable Baxter product is yet on the market, the company has legally blocked a small competitor-a Bothell, Washington-based firm called CellPro-from marketing its own similar treatment while Baxter tries bringing its own version through the lengthy Food and Drug Administration (FDA) development and approval process. The problem is that Baxter’s action could deny cancer patients around the country a promising FDA-approved treatment.
Andrew Yeager, director of bone-marrow transplant programs at Emory University, where physicians have been using the CellPro treatment with some success as a last-ditch effort to save lives of children suffering from acute leukemia, lamented to the Seattle Times: “It’s unfortunate that these sorts of things in corporate America can threaten therapeutic clinical trials and potentially life-saving therapies.”
More than three dozen members of Congress, the American Cancer Society, several patient advocacy groups, former U.S. Senator Birch Bayh, Jr., and former Carter White House Counsel Lloyd Cutler made an appeal on CellPro’s behalf to Department of Health and Human Services chief Donna Shalala. They asked her to exercise the government’s right to intervene in patent disputes that stem from publicly funded research in “extraordinary cases” where the dispute threatens public health. “CellPro’s request is simple. While the court case is allowed to run its course, an FDA-approved product must remain on the market, available to any and all cancer patients who need it,” Bayh and Cutler wrote Shalala.
The government denied the request. NIH Director Harold Varmus, who made the ruling, said he was convinced the courts would insure no one was denied treatment. Varmus was undoubtedly swayed by the many equally influential voices arrayed against such action, such as Stanford University President Gerhard Casper. Casper wrote to Varmus that to intervene would set a precedent that “would pose a grave threat to university-industry partnerships” and even “put into jeopardy the kind of investments needed today to take medical discoveries through the lengthy processes necessary to bring them to the public.”