The CRISPR-Cas9 Trilogy, CRISPR 101 Part II: Who do we have to thank?

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March 30, 2016

2:12 PM

Last week, we explored the mechanics of the CRISPR-Cas9 breakthrough. In this second installment, I present unfortunately unique patent issuance for this technology.

To recap, the CRISPR-Cas9 is a genomic system for making incredibly efficient and exact edits to the genetic code of, imaginably, all organisms (basically, anything with a genome). It was first discovered in bacteria as a component of immune function by team of astute scientists at UC Berkeley led by Jennifer Doudna in cahoots with Emmanuelle Chapbecbe;c. This team then looked beyond its role in bacteria and hypothesized that this editing process could take place in higher organisms. They proceeded to successfully reproduce it using genomic material in a test tube. With this development, researchers all over the world postulated that the CRISPR-Cas9 system, with its profound ability to remove, replace, or edit the genome with laser-beam specificity, would usher in a new era for genomics-based medical treatments, bioengineering, and basic science research the world over.

In this second installment, I present unfortunately unique patent issuance for this technology.

With so many predicted applications of this new technology, patent ownership of CRISPR-Cas9 pays out initially in hundreds of millions of dollars. Not to mention the subsequent royalties to be incurred over a lifetime, and reasonably, beyond. Additionally, there is the Nobel Prize as the likely cherry on top.

Unfortunately, the jury is still out on who gets to claim this patent, one which will certainly solidify the legacy of the researcher to whom it is granted.

From the outset, it doesn’t take someone with a thorough knowledge of patent law to realize that with so much at stake, any ambiguity over who has the rights to this patent spells cutthroat, competitive, horrifically contentious legal proceedings from now until kingdom come.

Unfortunately, there was a lot of ambiguity surrounding the patent issuance for CRISPR-Cas9. Not just ambiguity, but what seems like flagrant opportunism exacerbated by a pretty unfair application process for patent ownership.

So, where is the ambiguity? Up until now the most recurring name in this report is Jennifer Doudna, the Berkeley researcher who observed the CRISPR-Cas9 system in bacteria and then reproduced it in a test tube, challenging the world to perform it in a higher-level organism. Who is trying to assume patent ownership from her?

Who is trying to assume patent ownership from her?

Well, if you were to look up the CRISPR-Cas9 patent now, you would read that Feng Zhang of MIT has current ownership.

The alignment of events that granted Feng Zhang the patent are pretty unbelievable. On May 25th, 2012, Doudna filed a patent application for CRISPR-Cas9. Zhang, after performing CRISPR-Cas9 editing in a mammalian cell, filed for a patent application on December 12th, 2012. Here is the ambiguous part: Zhang elected to subject his application to an expedited review process, so the patent was granted to Zhang in April of 2014.

The wholly upsetting caveat of this sequence is that the United States Trade and Patent Office (USTPO) originally designated rightful ownership of a patent to the party which obtained patent approval first. In this way, Zhang would be viewed as the legal owner of the CRISPR-Cas9 patent. However, the USTPO changed this policy to shift rightful ownership to the party that filed their application first, and did so the day after Doudna filed her application. Conceivably, Doudna, her team, and basically everyone involved with/following the CRISPR-Cas9 quagmire could have saved a years-long headache if Doudna has waited 24 hours to file her application.

As of March 9th,a patent interference proceeding began concerning the rights to the CRISPR-Cas9 patent, which is presided over by three judges from the USTPO. You might have been able to deduce Doudna’s argument for ownership by now: she maintains that her observation and subsequent reproduction of the CRISPR-Cas9 system qualifies her as the “first” to pioneer this system, and that Zhang’s reproduction of the system in a mammalian cell was simply the natural next step that could not have occurred without her work serving as its foundation. Zhang argues that if this was the obvious next step, why didn’t her team do it first? Additionally, Zhang’s version of the CRISPR-Cas9 system has the capability to actually edit DNA (as in cut it and put it back together) whereas Doudna’s demonstration only cut the genome at a directed site. 

Zhang argues that if this was the obvious next step, why didn’t her team do it first?

So if you’re a gambling individual, you might be asking: who should I put my money on? (First of all, this case is likely to drag on for years, so only bet on it if you can be patient). In light of the USTPO’s shift in emphasis to the first to file party, Doudna’s team is granted “senior” status in this investigation. That makes Zhang’s team the “junior” party, and in patent legal proceedings the junior party bears the burden of proof, so Doudna’s team has the advantage in that respect. Zhang’s team has to submit proof that they arrived at their conclusions originally and before Doudna’s file application. Generally, the rules seemed stacked against Zhang, however, he is certainly within his right to file an appeal after Doudna’s likely victory.

This is forecasted to be an, understandably, unusually bitter patent war. To put the winner’s spoils in context: Columbia University recently patented a method to insert new proteins into experimental cells to the tune of $790 million. For Doudna, a payout like this would not only enhance future of her work but also that of her sponsoring institution, UC Berkeley, considering the strain of Berkeley’s sizeable debt. 

To put the winner’s spoils in context: Columbia University recently patented a method to insert new proteins into experimental cells to the tune of $790 million.

On a broader scope, this case will be a meaningful one to follow because it brings to light a few key schisms in the research community. First, many are pointing to this as a case of gender discrimination in the sciences; how it is so typical to undermine the contributions of women to the body scientific. I do not look forward to to potentially offensive rhetoric of the discussions of surrounding this particular aspect of the debate but I am looking forward to this issue being on display for a larger audience. Second, right now it is unclear how this legal battle will affect patients that could potentially benefit from this technology, and it will be a telling case study of how the economics of scientific discovery could potentially determine the health outcomes of sick individuals.

In next week’s final installment, I’ll take a more zoomed-out perspective of the implications of CRIPSR-Cas9, in a discussion regarding the ethical conundrum we’re in now that we’re charge of our own genetic material.

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