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CRISPR Lawsuit: The Biggest Gene Patent Pre-Suit of All Time Hit PTAB

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By Jonathan R. Tung, Esq. on March 14, 2016 4:13 PM

At first hearing, you might have thought that Crispr was some sort of new age snack. But it just happens to be probably the biggest giant leap forward in biotech and bioengineering in recent history of medicine. Crispr could be the key to hacking genes in ways that scientists could previously only fantasize about.

Sounds like there's a lot of money to be made? Yeah, we'd say so.

CRISPR

Clustered Regularly-Interspaced Short Palindromic Repeats (aka, CRISPR or Crispr) represents the cutting edge in advancements in gene-editing and splicing. In very layman's terms, Crispr exploits the process by which biological immune systems make fight against viral infections in order to make "edits" to DNA sequences.

Crispr technology became most visible to the public when the germlines of human embryos were successfully modified using the technology back in 2015. In China, where some of the first applications to human biological material were made, no authority gave the green light to move forward. A short while later, UK authorities granted limited authority for doctors to study human embryos by making gene edits and then later discarding them -- hoping to allay ethical fears.

But there have been less controversial applications of the technology, too. It had been successfully applied to halt HIV growth in human cells.

Crispr Meets PTAB

Last week saw the opening of formal proceedings before the Patent Trial and Appeals Board in Virginia, principally to determine which of two scientists -- bioengineer Feng Zheng or biologist Jennifer Doudna -- owns the intellectual property rights to certain key sections to some applications of the technology.

In March of 2013, UC Berkeley's Doudna filed an application for 155 claims related to Crispr. But in October of 2013, MIT's Dr. Zhang submitted his own application for Crispr-related claims to the PTO and was somehow able to obtain a faster review. In 2014, the USPTO granted him a patent covering claims relating to plant and animal cells. Doudna, challenged Zhang's patent claiming that his patent infringed on her submitted claims that were still undergoing review.

Meanwhile, coincident with the Zhang-Doudna conflict, the USPTO made a change in its system that recognized priority in those applicants who submitted their patent applications before others. Previously, the USPTO would grant patents to those applicants who could prove that they were the first to come up with an idea, even if they were not the first to apply for the patent.

The issue at bar, essentially, is whether the old rules can be applied to Zhang, who filed after Doudna.

Years in the Making

The interlocutory stage opened last week, but lawyers for both sides anticipate that the review process could take years. PTAB will first collect the evidence and see whether or not the case can move forward -- another very involved and lengthy process.

The loser at this stage still will have the option to appeal to the U.S. Court of Appeals for the Federal Circuit and that too could take years. Dr. Doudna didn't seem particularly perturbed by the prospect of a lengthy legal process. "Whenever you have an important technology come along, there are multiple claims ... We are probably looking at years," she said.

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