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Biotechnology

CRISPR gene editing wins Japan patent case

Ruling for US lab has potential to raise costs for drug and food development

A technician works with genome samples at a lab of the Chinese biotech company Sinogene, which specializes in dog cloning.   © Reuters

TOKYO -- A Japanese court ruled Tuesday in favor of a patent application by a U.S. institute on the breakthrough CRISPR-Cas9 gene-editing technique, in a win for a technology embroiled in intellectual property disputes worldwide.

If the ruling is upheld, drugmakers and other companies would be required to pay license fees to use the technique for commercial purposes.

Makiko Takabe, chief judge of the Intellectual Property High Court, rejected the Japan Patent Office's decision on one of two applications made by the Broad Institute, part of the Massachusetts Institute of Technology and Harvard University.

The patent office denied both applications in 2017, citing existing patents related to the technology. But Takabe said CRISPR-Cas9's contribution to more efficient genome editing was not covered by those patents. The court upheld the office's decision in rejecting the second application.

Several leading research institutions, including Broad and the University of California, have filed for patents around the world related to CRISPR-Cas9. The method, which lets users edit genetic material more easily compared with older systems, is applied in a wide range of fields from medical treatments to agriculture.

But ongoing legal battles leave the field in flux. Questions also remain as to the ethical limits of gene editing.

For now, Japan's latest ruling "means commercial users of gene-editing technology will need to obtain licenses from many patent holders," said Kazuo Makino, a lawyer who specializes in high-tech patents. Pharmaceutical and food companies could face more hurdles and costs in product development.

"The ruling gives Broad Institute and the University of California a strong claim over the technology in Japan, like they have in the U.S.," said Taro Isshiki, a lawyer experienced with U.S. intellectual property law.

When multiple entities share patents on a key technology, they can form a pool in which users obtain all necessary licenses at a lower cost. Takabe's ruling could accelerate the Broad Institute's push to create a pool for CRISPR-Cas9. But not all patent holders are committed to the idea.

Others say the ruling actually makes it easier for companies to avoid paying license fees. Broad Institute's U.S. patent covers the technology's use on a wide range of animal and plant cells. But the Japanese patent is much more limited because of preexisting patents in the area.

"From a business perspective, the ruling comes close to a loss for the Broad Institute," said Kazunori Hashimoto at Centcrest IP Attorneys.

Broad Institute has applied for several other patents in Japan.

"We could see more court cases in Japan," said Tomoji Mashimo, a University of Tokyo researcher who uses genome-editing technology.

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