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CRISPR-Cas9: After oral argument, Broad likely to prevail—but is it failure of the patent system?

Zachary Silbersher

On April 30, the Federal Circuit convened oral argument in the highly-watched patent case between UC and Broad over the interference proceeding covering patents for CRISPR-Cas9.  (An overview of the case and the respective arguments were published in an earlier post.)  The hotly-contested argument suggests the Court is leaning towards Broad, but raises deeper questions about whether this is a success or failure for the patent system.

Two issues loomed over the proceeding.  The first was the contemporaneous statements made by UC’s inventors that, despite their own discoveries, the likelihood of success implementing CRISPR-Cas9 in eukaryotic cells remained unpredictable.  UC’s counsel attempted to argue that the Patent Office afforded these statements too much weight.  He cited to caselaw from the Federal Circuit purportedly holding that an inventor’s statements have been overlooked in the past.  Yet, the Honorable Kimberly A. Moore shot back.  She explained that the question before this Court is whether the Patent Office decision was supported by substantial evidence.  And the contemporaneous statements of the inventors are evidence, which in total, support the Patent Office’s decision.  On this issue, Judge Moore was fairly adamant that UC has not done enough to show that the Patent Office’s decision should be reversed. 

The second issue concerned whether the Patent Office applied the correct legal standard.  This issue consumed a larger portion of the hearing, and the questioning was driven by the Honorable Sharon Prost as well as Judge Moore.  On this issue, Chief Judge Prost telegraphed considerably more sympathy for UC’s position.  She outwardly questioned some of the legal principles relied upon by the Patent Office, and even suggested one was “something [she] had not heard before.”  Yet, in sum, Chief Judge Prost's questioning appeared more in the vein of untangling precisely what the Patent Office did, rather than necessarily telegraphing that the Patent Office got it wrong. 

The issue teed-up was this:  UC appears to have discovered the minimal and sufficient components of using a CRISPR-Cas9 system in any environment—eukaryotes, prokaryotes and outside of cells.  That discovery was published in Jinek 2012.  Yet, UC did not conduct studies showing that the system actually worked in eukaryotes until much later.  (Eukaryotes are the goldmine of CRISPR-Cas9 because they encompass plant and animal cells, i.e., medicine, agriculture and limitless potential for gene-editing.)  Instead, Broad was the first to publish and patent successfully implementing CRISPR-Cas9 in eukarytoes.   

At the oral argument, Chief Judge Prost attempted to untangle whether the Patent Office had applied the correct legal standard, which is another way of saying whether it had asked the right question.  Because if the wrong question was asked, then the answer itself (that Broad’s patents are not an obvious derivation of UC’s patents) may be in jeopardy.  At its most basic, the Court appeared to suggest that the right question is whether UC’s work in Jinek 2012 created a reasonable expectation that implementing CRISPR-Cas9 in eukaryotes would be successful.

Yet, even after Jinek 2012, there was doubt among the scientific community whether implementing the system in eukaryotes would actually work.  Indeed, UC’s inventors publicly expressed doubts, and UC’s own litigation expert published an article explaining those doubts.  Those doubts were borne out by prior examples.  Transferring systems from prokaryotes (bacteria, single-celled, i.e., very simple environments) to eukaryotes (plant/animal cells, multi-cellular organisms, i.e., very complex environments) had proven difficult in the past.  Each time it had worked had required innovative and non-conventional techniques.  Thus, the purported consensus among scientists after UC published its work was that, although there was great excitement and promise that the CRISPR-Cas9 system could be used in eukaryotes, there remained doubt whether it would work.

Turns out, it did work.  Multiple research groups quickly showed that UC’s CRISPR-Cas9 system could be easily implemented in eukaryotes.  And more importantly, they each used routine, conventional techniques to do so.  No special or unique innovations were required to make the transition.  The reason that Broad has staked a claim to patents covering CRISPR-Cas9 in eukaryotes is because it was the first to publish and file the patents successfully showing CRISPR-Cas9 in eukaryotes--not necessarily because it developed innovative techniques to do so.

During the oral argument, UC’s counsel strenuously argued that UC’s work clearly showed that there was a reasonable expectation of success in eukaryotes.  Indeed, six groups quickly showed that CRISPR-Cas9 works in eukaryotes.  And they did so using routine and conventional techniques.  This, UC’s counsel emphasized, is the best evidence that scientists at the time thought implementing the CRISPR-Cas9 system in eukaryotes would work without further innovation.  This was the best evidence, he argued, that persons of skill believed making the jump to eukaryotes would require nothing more than routine and conventional techniques.  And that, in sum, was the best evidence that Broad’s patents were an obvious derivation of UC’s invention. 

Judge Moore disagreed.  Rather emphatically.  She had an exchange with UC’s counsel within the final minute of the oral argument, which itself last over 40 minutes, where the entire patent fight between UC and Broad essentially came to a head.  Judge Moore flat out rejected UC’s principle point.  She explained that this is how science works.  When faced with a scientific challenge, you start with the easy routes, and when the easy routes don’t work, you move on and try to innovate.  But starting with the easy, well-trodden routes does not necessarily mean those conventional techniques will necessarily work.  Judge Moore stated:

“[T]hat’s how science works . . . . You start with the conventional techniques, and then when they don’t work, you spend the time, energy and money coming up with a new technique.  So, the fact that they started with the easiest, off-the-shelf stuff, doesn’t mean they thought it would work.  It means it was what was most readily and easily available to them at the time; the least cost and the least effort.  Let’s rule out the easy stuff first, before we spend the time and money designing around . . . . That’s what the [Patent Office] found . . . . and it’s hard for me to say there’s not substantial evidence for that in light of this record . . . .”

In sum, Judge Moore's remarks were a shot in the arm to one of UC’s principle arguments within this entire dispute.  In light of all the other evidence cited by the Patent Office suggesting that implementing CRISPR-Cas9 in eukaryotes would be unpredictable, Judge Moore literally stated that she believed that the Patent Office decision was supported by substantial evidence.  In other words, UC has not shown what it needs to gain reversal of the Patent Office’s interference decision.  It bears emphasis that it is relatively rare for Judges on a Federal Circuit panel to be so vocal about their view of the case during oral argument.  Admittedly, Judge Prost and the Honorable Alvin A. Schall were less forthcoming about their prospective opinion on the case, which means the outcome cannot be predicted with certainty.

If Broad prevails, is that the best result for the patent system?

As far as Federal Circuit arguments go, which can often be rote, difficult to parse, and rather boring, this argument’s denouement was an exception.  An exception within a patent fight that has itself caught the specter of the public’s attention more than most intellectual-property disputes.  Even the Apple v. Samsung patent battle, one of the most expensive in history, failed to convince the public that the fight was over something that was truly groundbreaking and revolutionary.  Yet, perhaps because the invention in this CRISPR case augurs something truly pioneering, it leaves some unsettling questions about whether justice will prevail.  Indeed, Judge Moore’s comments at the tail-end of the oral argument raise deeper questions about to whom the spoils of patented inventions should go. 

A few years ago, I had the opportunity to speak with a genetic-engineering scientist who is colleagues with some of UC’s inventors, and has worked with them personally.  Speaking generally about the CRISPR patent fight with Broad and the scientists from Harvard and MIT, this scientist told me that the consensus within the community is that UC’s team actually invented this stuff, and that UC should be awarded the patents.  The basis for that view, if the record of this case is accurate, is because the Broad team did not necessarily do anything innovative.  UC mapped out the sufficient components of a CRISPR-Cas9 system in eukaryotes, and Broad was simply the first team to successfully carry it out.  But Broad did so using conventional, off-the-shelf techniques that everybody else was aware of.  Indeed, what Broad itself did was obvious—they took the obvious route.  They were not compelled to innovate.  Instead, they were just the first one to publish.

In fact, Judge Moore acknowledged that Broad’s team used conventional techniques to successfully implement the CRISPR-Cas9 system in eukaryotes.  But the reason Broad will get the patents is because no one was really sure if those techniques would work.  There remained doubt within the community.  That doubt was born of prior precedent, which suggested that using conventional techniques to transition systems from bacteria to plant and animal cells had proven difficult in the past. 

Yet, what remains unsettling about this case is that, even if the consensus was that implementing CRISPR-Cas9 in eukaryotes was unpredictable, that does not change the fact that what Broad actually did was itself obvious.  Broad’s success didn’t require innovation.  Indeed, Broad did what everybody else did.  And it is unclear why the team that took the obvious route, the route that was apparent to everyone else, will gain the spoils of this revolutionary invention.  Soccer and basketball fans appreciate that, in some cases, the assist deserves more celebration than the goal itself.  As shown by this case, patent law may lack that capacity.  As explained in our prior post, if UC loses this case, the value its own patents will be greatly diminished, whereas Broad could corner the market on the key patents required for the CRISPR-Cas9 revolution. 

UC mapped out the system, but acknowledged that it may not necessarily work in eukaryotes.  But when Broad actually tried, it used obvious techniques to do so.  And yet despite UC’s discovery, the spoils of this discovery will go to Broad.  For doing something that was obvious to everyone else.  Putting aside all the legal mechanics and convoluted standards, is that fair?  Admittedly, the role of the Patent Office and the Federal Circuit is not to ask what is fair.  Their role is to apply the law, as it stands.  If Broad prevails, it will appear that both tribunals did just that, and did so correctly.  But even so, it deserves to be asked—should we be happy with this result?  For science, engineering and all the purported pretense of having a patent system in the first instance, did the law get the right result?  Is this a victory or failure for the patent system?