The thorny and unresolved question of whether life itself can be patented may come again before the U.S. Supreme Court, if it accepts a motion filed Friday by Santa Monica-based Consumer Watchdog. (H/T to David Jensen's California Stem Cell Report.)
The issue isn't a new one either for the consumer group or the court. Consumer Watchdog launched its challenge of a patent on human stem cells issued to the Wisconsin Alumni Research Foundation, or WARF, in 2006. Since then the battle has been waged before the U.S. Patent Office, which overturned the patent then reinstated a narrower version; and the U.S. Court of Appeals for the Federal Circuit, which hears patent appeals.
The group has challenged the patent on two grounds: first, that the work covered wasn't novel or original, and second, that the Supreme Court has ruled that a "product of nature" can't be patented.
That ruling came in 2013, in a case involving laboratory-isolated DNA. Even then, however, the court left the door open for patents of some biological products, notably "composite DNA," which is synthetically created in the lab.
The court's attempt to split hairs, so to speak, reflects its discomfort with the very question of where to draw the line on what sort of organisms can be patented.
As it happens, that question was placed before the court only indirectly by the Consumer Watchdog motion. The immediate issue is whether the organization had legal standing to appeal the patent office's ruling in the first place. The appeals court threw out its appeal last year on the grounds that it hadn't been injured by WARF's patent, normally a prerequisite for bringing a lawsuit in federal court.
Consumer Watchdog's lawyer, Daniel Ravicher at the Public Patent Foundation, says patent law explicitly allows parties that challenge a patent to appeal an adverse ruling to a higher court. He speculates that the appeals court raised the standing issue on its own last year because it was inclined to uphold the patent, and feared being overturned by the Supreme Court.
"This case is almost identical to the genes case," Ravicher says. His goal is for the Supreme Court to accept its motion and order the appeals court to reconsider the stem cell patent on its merits. If that happens, the underlying issue of the patentability of life is almost certain to land back in the Supreme Court's lap.
All this is happening, researchers say, because WARF made exceptionally broad claims for its patent rights and exercised them very aggressively. This is, in fact, WARF's business; the nonprofit foundation was formed in the 1920s to exploit a patent issued to a University of Wisconsin professor on fortifying food with vitamin D, which it promptly licensed to Quaker Oats. By 1930, the deal was producing $1,000 a day. WARF also owns the rights to the drug Warfarin, which is named after the foundation.
A stem cell patent was originally issued to Wisconsin's James Thomson in 1995 (two more followed later), covering his extraction of stem cells from human embryos. WARF at first maintained that the patents covered the use of any human embryonic stem cells, and even products eventually produced by research using them.
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Can scientists patent life? The question returns to the Supreme Court