In a development that is likely to have far-reaching ramifications in the field of gene editing, the US Patent Trial and Appeals Board (PTAB) put to rest a thorny controversy surrounding the patenting of the CRISPR Cas-9 method of gene editing last week.
The verdict comes in the wake of a hotly contested battle between UC Berkeley and the Broad Institute at MIT and Harvard as to who owns the patents over this gene-editing technique.
In the paragraphs that will follow, I will analyze the factual background in which the PTAB delivered its verdict and thereafter grapple with the major implications of this development. I will finally conclude by noting how this development is emblematic of the manner in which patent rights over inventions that are of immense significance often become the subject matter of heated contestations and how such contestations call into question the fundamental character of the invention concerned.
As this article explains, a team at UC Berkeley filed their application for the registration of a patent over their iteration of the CRISPR genome-editing technique in May 2012. Pertinently, the Berkeley team had only figured out how to cut DNA in bacterial cells in test tube studies until that point. In December 2012, a team at the Broad Institute and MIT similarly filed their application for patenting their iteration of the CRISPR method which entailed the use of the method to cut the DNA of plant and animal cells. Even though the Broad Institute filed their application later, they were granted the patent first after paying the fee for a fast-track review while UC Berkeley’s application was not acted upon by the USPTO.
As a result, the Berkeley team argued that this constituted ‘interference’ – a term of art used to refer to an arcane procedure at the USPTO, as Professor Jacob Sherkow explains, which can be invoked by a party when it believes that another party is interfering with its right to obtain patent protection for its invention.
The PTAB was called upon to assess the legal tenability of this claim.
In its 51-page ruling, the Board rejected Berkely’s motion, holding that the grant of a patent to Broad Institute did not interfere with the Berkeley team’s right to claim patent protection for its invention.
As this article notes, the Board was called upon to answer two main questions: First, if they had been filed prior to Berkely’s claims, would Broad’s claims have constituted prior art? And second, did Berkeley’s claims anticipate Broad’s claims or render them obvious?
Since there was no serious debate about the fact that the answer to the first question was in the negative, the determination of the case turned on the second issue. More specifically, the Board had to decide if the technique developed by the Berkeley team would work in plant and animal cells, called eukaryotic cells, which is what Broad’s patent claimed to do.
In arriving at its conclusion that the Berkeley team had failed to demonstrate that there was a reasonable expectation that the technique would work in eukaryotic cells, the PTAB relied on statements by inventors from the Berkeley team that was indicative of their failure to make the technique work in plant and animal cells and was reflective of their belief that it was unlikely to work on them.
Holding that a patent over the genus does not necessarily translate into a patent over its species, the Board arrived at the conclusion that the Berkeley scientists had failed to demonstrate that their invention would make Broad’s invention obvious.
Implications of decision:
The upshot of the decision is that, while the Berkeley team’s patent, if granted, will cover the use of the technique on bacterial cells, patent rights relating to the use of the CRISPR method on plant and animal cells will belong to scientists at the Broad Institute.
the metaphor that has been used by Jennifer Doudna, the founder of the project that led to the Berkeley invention is that the decision means that the Berkeley team will have a patent over all tennis balls while the Broad team has a patent over green tennis balls. This does not appear to be very accurate, in light of the fact that both teams will have patent rights over the use of the technique in different kinds of cells.
The Berkeley team has two months to appeal against the PTAB’s ruling before the US Court of Appeals for the Federal Circuit.
However, as this Nature article notes, since the PTAB’s verdict explains at length how the application of the technique developed by the Berkeley team to eukaryotic cells would require an additional invention, which is set forth in the Broad patent, Berkeley’s appeal would stand on a weak legal footing.
Further, in light of the fact that it is a well settled principle that the determination as to whether there is a reasonable expectation of success in an obviousness determination is a factual one, as this article notes, the appellate court is unlikely to interfere with this determination.
It will also be interesting to see how legal battles pertaining to patent rights over CRISPR play out in other jurisdictions. As this article notes, the answer to this question in Europe will turn on the determination of whether the method developed by the Berkeley team provided a sufficient motivation for the use of the technique on eukaryotic cells – if it did, Berkeley will have patent rights over the same; if not, the rights will again be divided between Berkeley and Broad.
Further, in addition to Berkeley and Broad, there are multiple additional parties who also claim to have invented other facets of the CRISPR method, giving rise to further complications.
As commentators have noted, if both Berkeley and Broad continue to possess patent rights over the CRISPR Cas-9 gene editing technique, the cost of commercializing the technique will go up significantly, as a third party would have to obtain separate licenses from both parties.
Ascertaining What Constitutes the Invention: Concluding Thoughts
While at first blush this controversy may appear to turn on a technical distinction between the application of a gene-editing technique to bacterial cells vis-a-vis eukaryotic cells, at root, it is like most other contestations about the patent rights flowing from significant inventions. More specifically, the determination as to who owns the patent rights here turns on what constitutes the invention, as Mark Summerfield notes. If what constitutes the invention is merely the gene-editing technique, then Berkeley would undisputedly be the sole inventor; if the invention is construed as comprising the application of a gene-editing technique to plant and animal cells, then the Broad Institute would be regarded as the inventor.
In this sense, this dispute is like most other patent disputes, inasmuch as it flows from lack of clarity as to what constitutes the invention (readers interested in learning more about similar such disputes may want to read Shan’s instructive post) on the subject.
Take, for instance, the hotly contested issue relating to the true inventor of the telephone.
While few would have disputed the proposition that Alexander Graham Bell invented telephone, in 2002, the US Congress recognized Antonio Meucci as being the rightful bearer of this title. The rationale undergirding this determination is that Meucci was the first to discover a system for enabling communication of sound and Bell merely refined the system to facilitate transmission of human speech from one device to the other.
This battle also bears striking resemblance to the controversy surrounding the true inventor of email, which Inika covered here. As she notes in her post, the fundamental question that we have to answer in order to ascertain who is the true inventor of email is this: What exactly do we mean when we say email?
While Ray Tomlinson developed the transmission protocol that helped make email communication a reality, Ayyadurai was responsible for developing the user interface; while the latter’s invention was tailored to meet the needs of local networks, the former’s invention could be replicated more easily on a large scale.
In conclusion, if there is one lesson that this dispute teaches us, it is this: it is not possible or desirable to determine who the true and first inventor of any invention is without first ascertaining with precision what constitutes the invention.