A Patent Storm Brewing
Big name funders such as Bill Gates and Google Ventures are backing the startup, Editas Medicine, but that still might not be enough to stop a major wrench recently been thrown into the company’s plans to begin utilizing their innovative, if not controversial, gene-editing technology by 2017.

Jennifer Doudna leads just one of the two teams that are currently claiming credit for the discovery of what is being called ‘CRISPR’ gene editing. The patent fight that has ensued from the disagreement over the discovery of the technology could potentially be worth hundreds of millions, and if they lose, the vital patents held by Editas, surrounding its exclusive rights to the gene-editing technology, could effectively be rendered useless.

A Little Background on the Technology

The technology at the center of this escalating legal battle is formally known as “CRISPR/Cas9.” It delivers a method for cutting and pasting DNA inside the cells of living organisms. This includes humans, and while DNA alteration remains a controversial issue, the technique has already received support for its potential to cure deadly diseases and modify crops.

Although some would understandably balk at the idea of giving scientists the ability to “create genetically engineered designer babies,” Editas Medicine’s preliminary plan is to utilize the technology in humans, even as early as 2017, in order to correct a rare form of blindness.

While Doudna, from UC Berkeley, leads one team claiming credit for the discovery of the technology, Feng Zhang of MIT and the Broad Institute lead the other team. Although Doudna’s team filed the initial patent on CRISPR, Zhang’s team circumvented this filing by paying to fast track their own application. Ultimately, it was Zhang’s team that was awarded the patent.

“First to Invent” vs. “First to File”

Additional complications in this dispute have arisen due to a new law that took effect on March 16th, 2013. Initially, both patent applications were filed under what is now an outdated US law that granted patent rights to the “first to invent.” However, the system used by most other countries, that which took effect on the 16th of March 2013, changed this law to grant patent rights to the “first to file.”

A dispute of this kind is rare, and the Berkeley team has since filed an “interference proceeding,” which now leaves the decision of which company will receive the patent up to the court. Although Doudna’s team was first to file their patent application, and they did so just one day before the new “first to file” rule went into effect, Zhang’s team claims to be the “first to invent” the CRISPR technology.

If an appeals board agrees to approve this legal process, the decision will ultimately come down to whether the patent legally covers the use of CRISPR in DNA-editing, which is said to be the invention of Doudna and her team, or CRISPR’s specific use in cells that have a nucleus, which Zhang’s team believes it initially pioneered.

While it appears it’ll take some time for the courts to unravel this complex legal case, various big name investors will be watching all developments closely. For Zhang’s team, and the backers of Editas Medicine, it very well may be a nervous start to 2016.

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Posted by: DSR
Tuesday, March 1, 2016
Tag: Legal
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