Agricultural groups explore impact of ruling

Agricultural biotechnology companies were confident that they had been spared too harsh a blow in Thursday’s Supreme Court ruling that natural human and plant genes cannot be patented.

Makers of genetically modified seeds and other altered plant materials believe their products have been changed enough to fall outside the judges’ definition of “products of nature”.

“Nothing about this particular decision terrifies us as a member of the ag biotechnology community,” said Greg Ikonen, senior vice-president of corporate development at Mendel Biotechnology in California.

“At least for now, a transgenic plant, a new plant that would then be higher yielding or have greater drought resistance or provide a higher level of nutrition, like golden rice, would still be patentable,” he said.

The justices examined a case involving two breast cancer genes that had been isolated by Myriad Genetics and used in a $3,000 genetic test for breast cancer. The justices ruled that those two genes, BRCA1 and BRCA2, and other naturally occurring DNA strands could not be patented because they occurred naturally and were not human-made.

The ruling was narrow, however, and allowed companies to maintain patents around the creation of synthetic or complementary DNA, known as cDNA.

Monsanto, one of the largest producers of high-yielding seeds, said it believed the court’s decision would have “no impact” on its business.

Several attorneys said that under the limited ruling, most agricultural biotechnology would still be protected, mainly because they probably have diverse patent portfolios that cover the various aspects of their products, including the method used to isolate a gene or enzyme, and its application.

“Most companies should have fallback positions in terms of their patent claims,” said Lisa Haile, co-chair of DLA Piper’s global life sciences group.

Most plant genes were discovered long ago and the industry has already moved on to creating more advanced technologies, Mr Ikonen said. However, the social and political climate around genetically modified organisms and chemical pesticides has pushed some companies to look for more naturally occurring organisms to work with, like microbes, he added.

Thursday’s decision could create some grey area around these organisms, even the combination of natural organisms. That could be a disincentive for researchers who sometimes go to great lengths to discover and isolate some of them.

“A researcher who goes to the bottom of the ocean or the edge of a volcano to find organisms that can withstand extreme temperatures and conditions, if that researcher then tries to simply patent the genome, that’s probably not going to be patentable after today,” said Michael Bennett, a professor at Northeastern University School of Law.

Such organisms have a variety of uses, from food production to waste treatment to industrial manufacturing. There are naturally occurring oil-eating bacteria that helped clean up the BP oil spill in the Gulf of Mexico, for example.

Courtenay Brinckerhoff, a partner at Foley & Lardner, said companies that use these materials should review their patent portfolios, prepare to confront some potential new competitors and review their legal position in light of several recent legal decisions, not just the Myriad case.

“It’s never crystal clear until you have the actual same facts decided,” she said.

Such uncertainty could have a chilling effect on entrepreneurs and scientists, Mr Ikonen said. The Myriad decision, in combination with other recent rulings on genetic patents, “has a lot of people concerned that the threshold of patentability and return on hundreds of millions of dollars in investment is getting harder and harder”, he said.