‘Product of nature’ doctrine could help fight gene patents

CHAPEL HILL — People troubled by the fact that the United States government has granted patents on genes and is likely to continue may find new hope through a legal argument being made by a University of North Carolina at Chapel Hill patent expert and a Philadelphia law student.

Dr. John M. Conley, William Rand Kenan, Jr. professor of law at UNC, and Dr. Roberte Makowski, a former agricultural biologist now studying law at Villanova University, say opponents of such patents have not taken advantage of the long-standing “product of nature” doctrine.

They offer their opinions on biotechnology patents in the current issue of the Journal of the Patent & Trademark Office Society, the principal publication for patent attorneys.

“I’ve taught patent law for most of the past 20 years, and during that time, my course has increasingly concerned genetic and other biotechnology patents,” Conley said. “The first time you expose law students or lawyers without any background in the topic to the idea that you can actually patent genes, they all have the same reaction — ‘You’ve got to be kidding! You can’t do that.'”

Conley assures them that he — or anyone else — can.

“You can’t patent genes inside the body, they have to be isolated outside it, and in most instances, the patented genes have nonfunctional regions excised from them,” he said. “What are ultimately patented are versions of DNA sequences in the genes as they exist outside the body, but they are still genes we’re talking about and also proteins and cell lines. It’s not just the new uses to which you can put genes such as gene therapy that are patentable.”

Widespread concern exists about the ethics, economics and long-term effects of biotechnology patents, Conley said. Opponents have had difficulty, however, finding a legal hook to hang their concerns on, and the courts have rebuffed them repeatedly.

“People who look at this from an economic perspective say it seems inefficient and counterproductive to let others monopolize genes, proteins, etc. before the full range of uses you can put them to can be known,” he said. “It seems like you will have a blocking effect on future progress. Many other people are saying such patents are just wrong and ought to be limited.”

The courts, including the U.S. Supreme Court, have understood but not accepted those arguments, Conley said, because they say existing laws appear to allow such patents. Likewise, members of Congress have expressed reservations, but nothing has changed.

An issue that seems to have been glossed over in the court cases is how some biotechnology patents have been granted in the face of the more than century-old “product of nature” doctrine, he said. Just as it sounds, that essentially flat rule is that one cannot patent naturally occurring products.

“We examined the history of the ‘product of nature’ doctrine and the cases where it was applied and concluded that the patent community generally has skated right past this without really pausing to think about it or to use it,” the UNC professor said. “These cases assume that anything that’s outside the body is not a product of nature and that there’s enough difference to get past the doctrine.

The most famous related Supreme Court case, in which a scientist named Ananda M. Chakrabarty persuaded the court in 1980 that he should be issued a patent, was not a good one for testing the doctrine as a legal barrier since Chakrabarty inserted new DNA into a bacterium to create a species that had never existed before, he said.

“Based on our research, we believe that this doctrine is still out there and that the issue needs to be argued more vigorously by those who oppose certain kinds of biotechnology patents,” Conley said. “We think it may be a hook people who want to slow the whole process down can use to their advantage. Every other hook they have tried so far has not worked.”

Conley said the huge biotechnology industry is doing good things, particularly in medicine, and he is no fanatic in opposing biotechnology patents.

“The problem here is the unknown,” he said. “For example, patents have been issued on so-called BRCA genes that in some cases are thought to cause breast cancer or predispose some people to breast cancer. If I have a patent on such a gene, I can effectively block all research on that gene because anyone who wants to do research on it has to come to me for a license, which I might choose not to give them.

“Given the enormous and as yet poorly understood potential for genetics in medicine, it seems to me troubling very early in the game to allow these enormous blocking patents way upstream.”

Reopening such questions is worthwhile because of a tradition in U.S. intellectual property law that issues many thought to be resolved have been re-examined and sometimes reversed or modified considerably, Conley said.