While Europe has experienced more turmoil in recent years over the patenting of genetically modified organisms, a specialist on patent systems told a seminar audience at AAAS that the United States also is likely to see a steady increase in challenges to biotech patents as advocacy groups raise broad questions about the role of the public in science and technology policy-making.
Shobita Parthasarathy, co-director of the Science, Technology and Public Policy Program at the University of Michigan's Ford School of Public Policy, is completing a comparative study on the history and future of the U.S. and European patent systems. Established originally to deal with claims of novelty for industrial objects, processes and designs, the patent offices have come under intense scrutiny in an age when patents are being awarded for the mouse as well as the mousetrap.
Are there limits to knowledge and innovation that should not be crossed? Should scientists be able to patent not only animal life but also segments of the human genetic blueprint? What about animal-human hybrids called chimeras? And who should make these decisions? Parthasarathy argues that patent systems have been slow to adapt to the new intellectual landscape where questions that formerly might be pondered by philosophers now are being tossed at patent examiners, legislative bodies, and courts.
Parthasarathy spoke 5 May at the latest in a series of seminars at AAAS on contemporary issues in science, technology and policy. The series is organized by the Chemical Heritage Foundation's Center for Contemporary History and Policy  and the AAAS Archives .
A new patent era began in the 1970s with a landmark U.S. case brought by microbiologist Ananda Chakrabarty of the General Electric Co. He had genetically engineered a bacterium capable of breaking down components of crude oil, potentially useful in treatment of oil spills. His application was initially rejected and Chakrabarty's fight to patent a living organism went all the way to the Supreme Court, which ruled 5-4 in his favor in 1980. The Court noted in its majority opinion that "anything under the sun that is made by man" was patentable subject matter.
Since then, thousands of patents have been awarded on living organisms and their components such as cell lines, tissues and genes. And there have been dozens of legal challenges—not only by industrial competitors, but also by citizens and governments—here and abroad to biotech patents, a trend that Parthasarathy believes will only intensify.
"These are interesting times for the global patent system," Parthasarathy said. "There are a wide variety of new kinds of actors trying to engage with the system." Where once the parties mostly were inventors, corporate lawyers, universities, farmers, and others with an economic stake in a successful patent, now they include social activists who are questioning the very foundations of the patent system, she said.
At the heart of debates over patents on genetically engineered organisms and other biotech developments, she said, is controversy over what kinds of information, expertise, and reasoning policy-makers need when deciding what constitutes a patentable invention.
The controversy reflects a larger debate on how technological advances, in general, should be weighed in a democratic society, Parthasarathy said. When critics raise questions about new developments in biotechnology, she said, the reaction often has been: "They just don't understand the science." But, in fact, some of those critics have been asking the policy-makers to consider other factors, such as ethics and traditional ways of knowing, when deciding whether to grant patents for novel crops or organisms.
Parthasarathy noted that South American shamans were among those protesting at the U.S. Patent and Trademark Office (USPTO) in 1999 when it reconsidered a patent on an Amazonian plant considered sacred by the indigenous tribes. The patent ultimately was disallowed on narrow, technical grounds. Activists complained that the USPTO had failed to grapple with larger issues such as whether traditional knowledge by indigenous peoples should be considered part of what patent examiners call "prior art."
In her work, Parthasarathy is using a case study approach, with archival research and extensive interviews with patent examiners, government officials, activists, lawyers, and others in the United States and Europe. She has completed her field work and is writing a book on her findings.
Historically, the U.S. Patent and Trademark Office is much older than its European counterpart. It was established in 1836 as a legal certification system focused on the economic benefit of novel inventions. The European Patent Office (EPO), proposed in the aftermath of World War II as Europe was developing a common market, was formally established in 1973. In the European system, too, patents were inextricably linked to economic growth, Parthasarathy said.
There is a judicial process within the EPO to deal with disputes, and the office is considered stronger than its American counterpart, which lacks substantive rule-making authority of its own and is governed by the Congress and the courts. The European system also offers more explicit authority for outside groups to challenge patents on moral as well as technical grounds. Article 53 of the European Patent Convention says that patents shall not be granted for inventions whose publication or exploitation would be contrary to "ordre public," a French term for morality.
In 1988, researchers at Harvard University received a U.S. patent on a mouse that had been modified to be more susceptible to cancer. When the researchers applied for a similar patent in Europe, critics cited Article 53 in opposing the mouse patent. It was granted nonetheless but later narrowed significantly compared to the American patent.
In 1998, the European Parliament passed a biotechnology directive that further articulated the ordre public concept and mentioned processes that should not be patented for ethical reasons. They included cloning of human beings, use of human embryos for industrial and commercial purposes, and modifying the genetic identity of humans. The directive said human genes cannot be patented but the processes that lead to their discovery and isolation can be.
The directive also said patent officials should consult a European Union ethics panel when questions arise on the advisability of a patent application. Since the directive was passed, social activists have mounted many successful challenges in Europe against biotech patents, Parthasarathy said, including patents on stem cell lines and various genetically engineered plants.
The U.S. patent system, in philosophy, is quite similar to the European, Parthasarathy said. Both are technocratic institutions staffed by experts capable of assessing the complex, often highly specialized patent applications. The U.S. system is reasonably transparent and was meant to allow access and benefit for all, she said. But critics such as long-time biotechnology activist Jeremy Rifkin have argued that the system should give more weight to possible environmental, ethical, and health consequences of new biotech inventions. Rifkin's unsuccessful challenge of the Chakrabarty patent urged examiners to consider more than just the potential economic benefits of the engineered organism.
As the United States patent office moved forward from Chakrabarty, granting patents on mice and other higher organisms, Rifkin and others have continued to press their argument that there should be limits on what is patentable and that ethical considerations should be an integral part of the patent process.
In 1997, Rifkin and cellular biologist Stuart Newman applied for a patent on a human/animal chimera in order to force the Patent and Trademark Office to decide whether such organisms can be patented. By the USPTO's own rule, they argued, the patent should be granted. The application was denied in 1999. When asked by Rifkin and Newman for the legal basis for the denial, the USPTO initially cited the Thirteenth Amendment, which forbids slavery and ownership of human beings. It later cited the moral utility doctrine used originally to deny patents on gambling devices and early medical frauds. The office interpreted the utility doctrine as excluding inventions deemed to be "injurious to the well being, good policy, or good morals of society."
While the moral utility doctrine is not as explicit as the ordre public concept in European patent law, it showed that the U.S. patent office—like its European counterpart—is willing to set normative standards for biotechnology. However, because it has been so rarely invoked, it is difficult to predict when and why it might make an appearance in U.S. patent decisions, Parthasarathy said.
She also noted the congressional approval in 2003 of an amendment authored by U.S. Representative Dave Weldon (R-Florida) that prohibits the U.S. Patent and Trademark Office from issuing any patent "on claims directed to or encompassing a human organism." The USPTO backed the amendment, which it said provided unequivocal congressional backing for the agency's policy of refusing to grant patent containing claims that encompasses "any member of the species Homo sapiens at any stage of development," including a human embryo or human fetus.
"It's been fascinating for me to be aware of the similarities of critique" of the U.S. and European patent systems, Parthasarathy said. However, activists have had somewhat easier access to the European Patent Office, she said, perhaps because there is broader public concern in Europe about potential consequences of biotechnology.
There has been more "push-back," as she called it, in the U.S. patent office, which nonetheless has developed a data base of controversial patent applications to be flagged and monitored closely. The European Patent Office has created a similar data base, and also has devoted attention in its internal newsletters to protests over controversial biotech patent applications. The EPO also has held ethics seminars and has been grappling with the sorts of knowledge that it will need in the future to assess biotech patent applications.
"All technical institutions are facing increased attention and interest by the citizenry," Parthasarathy said. "It's not enough to just explain what we're doing and assume they'll go along." As the patent offices learn to deal with engaged citizens, she said, it should spur changes in the culture and functioning of the institutions. But more democratic participation in the process, she said, ultimately should lead to less controversy while still allowing worthwhile biotech patents to go forward.