Tag Archives: patent

articles, March 2017

Harder, Better, Stronger, Faster through CRISPR?

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After a year-long intense and bitter dispute over the rights to patent use of CRISPR-Cas9 gene editing technology in mammalian cells, the US patent office ruled in February that “there is no interference” and that the patent belongs to the Broad Institute. Needless to say, effects of this verdict extended beyond the emotions of the scientists locked in the dispute, as the shares for Editas Medicine, established by Feng Zhang from the Broad, saw a 29% jump by the close of trading. What does this mean for other biotech companies looking to harness the power of this novel technology? It would mean that they can only license the use of Broad’s patents if Editas passes on a specific disease-related application since Zhang holds the patent for application of CRISPR for disease applications. However, this does not mean that Doudna and Charpentier, the two heavyweights from the losing side of this patent battle, are going to miss out on benefitting from their discoveries. UC Berkeley has already filed patent for application of CRISPR technology on all cells, which the Broad is not contesting. Biotechs who had invested in obtaining patents through UC Berkeley may actually be able to benefit regardless of the loss in the patent fight.

The promise of CRISPR-Cas9 in disease applications, while still in its nascent stages, is a real possibility. CRISPR has yet to enter human clinical trials en masse for such purposes, although last week a team of Chinese scientists reported successful editing of normal human embryos. This hasn’t deterred popular science news outlets from speculating whether the era of designer babies is finally within sight. This may have been compounded by the recent release of a report by an international committee convened by the U.S. National Academy of Sciences and the National Academy of Medicine that cautiously suggests germline editing of human embryos sometime in the future, albeit “only for compelling reasons and under strict oversight”. The panel also suggested that the genome editing can only be undertaken after much more research on its risks and benefits. This report appears to be a cautious first step towards unlocking the so far forbidden zone of germline editing, and a move away from the moratorium previously established in December 2015 by an international group of leading scientists.

Does this imply, then, that Gattaca or similar engineered societies are upon us? It is a possibility that heritable diseases may one day be cured, but scientists warn us that engineering complex traits such as intelligence are still a pipe dream. These utopian societies are based on the fantasy of engineering the human species to be “harder, better, stronger, faster”; however, they completely ignore the scientific evidence that such adjectives usually are applied to traits that require reciprocity between the genetics and the environment. While genetics play a part, the environment of the individual, along with other factors such as diet, lifestyle and socioeconomic status heavily influence such traits. Even making small changes in the genome has been a challenge, as shown by the efforts to “fix” the mitochondrial genome of babies using the three parent approach.

The question then becomes whether we can engineer designer babies or not, but rather should we be doing such a thing. It would help to note that this obsession with making human beings “better” is rooted in eugenics and racial supremacy, and history is rife with such examples. What the futurists or people who propagate such ideas are missing out on is that evolutionary changes are not meant to make any species more “efficient” as is understood in technological vernacular, but rather help the organism adapt better to the changing environment. This understanding perhaps would help shed more light on the role of the environment and pull us out of our obsession with genetic determinism. Maybe if we ARE to build better human beings, we should start by fixing our environmental problems, such as pollution, climate change, deforestation, the threat of extinction to a large variety of organisms, etc. The promise of genetic engineering should not blind us to what is more important at the moment. Like they say – “one bird in hand is better than two in the bush” and if we don’t do our part to save the environment, we won’t have any bushes or birds left.

articles, October 2016

CRISPR Interference Battle: Still Duking It Out?

At the moment in the USPTO office, a fierce battle is occurring between two scientific teams over patent rights associated with core CRISPR/Cas technology. On one side of the dispute is Jennifer Doudna’s team from UC Berkeley. On the other side is Feng Zhang’s team from the Broad Institute of MIT and Harvard. Both teams were the first labs to demonstrate that the Cas9 enzyme can be directed to cut specific sites in isolated DNA. It will be intriguing to find out who is finally the victor of this contentious debate.

The story of the patent dispute has been lengthy and drawn-out. Jennifer Doudna’s team first filed for patent rights over CRISPR/Cas technology back in May of 2012. Feng Zhang’s team subsequently filed their patent application in December of that same year. Interestingly, Zhang’s team beat Doudna’s team to the punch over patent rights because in October of 2013 they submitted their application for expedited review. Expedited review required the Broad to undergo “accelerate examination,” where they were required to respond quicker to questions asked by the USPTO office. Due to the expedited reviewing process, the patent was ultimately granted to Zhang’s team in April of 2014. Shortly after this event, eleven other CRISPR-related patent applications were  filed by the Broad Institute. To counter-attack the Broad’s prompt monopoly over CRISPR-related patents, Doudna’s team requested a patent interference against all CRISPR-related patents filed by the Broad. The USPTO office finally declared the patent interference in January of 2016.

Historically, a patent interference has been a procedure to resolve disputes between two parties over who was the “first to invent.” However, in March of 2013 the USPTO altered the patent system from “first to invent” to “first to file.” Under these new rules, Doudna’s team would have won the CRISPR patent rights because the team was the “first to file” their patent. But since both parties filed their patents before March 2013, the interference procedure defaults under the outdated “first to invent” rules.

The “first to invent” rule has blurred the lines of who is the true proprietor of the patent rights. For over nine months, both parties have been providing evidence claiming they were the “first to invent.” The Broad asserts that Zhang’s team was the first group to demonstrate that CRISPR/Cas technology has applications in editing genes in mammalian cells. They argue that Doudna’s team only described using CRISPR/Cas in bacteria, not in eukaryotes. This distinction is important because some of CRISPR’s most lucrative, future applications will be in gene editing therapies for human diseases. Doudna’s team countered the Broad’s argument by claiming that although her team only demonstrated the use of the technology in bacteria, transferring the technique to mammalian cells was “obvious” and any “person of ordinary skill,” such as a postdoc, could have made that inference. This observation is also important because one of the hallmarks of patentability is that an invention cannot be obvious to a person of ordinary skill. Doudna’s team asserts that the obviousness of the Broad’s patent would make it invalid. The Broad subsequently counter-argued that the shift from bacteria to mammalian cells was “anything but obvious.” This type of back-and-forth between the USPTO, UC Berkeley, and the Broad has been continuing for the last nine months and updated details of the case can be viewed on the Broad’s CRISPR Patent Interference Updates webpage (reference is listed below).

Patent interference cases can last up to two years before appealing to the Federal Circuit. Due to the intense, ongoing clash between the two academic teams, attorneys expect the end date of the CRISPR patent interference case to be sometime in 2017. However, a recent twist in events may close the case completely by the end of this year. This past week, UC Berkeley attorneys submitted a 2013 dated email to the USPTO office. This email was from Feng Zhang to Jennifer Doudna describing his team’s first, published CRISPR paper and mentioning that he has been “very inspired” by her team’s work. This is enough evidence to imply that Zhang’s team had adapted from Doudna’s team’s work and that Zhang’s team was not the “first to invent” the CRISPR/Cas technology. The Broad understands that it’s difficult to counter this piece of evidence. Since the submission of this email, the Broad has asked patent officials to remove four CRISPR-related patents from the interference case in hopes that they can demonstrate novelty of the patents in other ways that are separate from the initial Zhang team’s CRISPR patent. If the Broad can separate these patents from the interference case, then both UC Berkeley and the Broad can walk away with some intellectual property. We will see in the forthcoming weeks how the case plays out.

Although intellectual property was at stake for the two scientific teams, the interference case has been rather unusual in nature. Why has the fight been so bitter and acrimonious? One explanation could be that it’s not the academic institutions that are footing the legal bill for the case but the biotechnology companies that are relying on licensing the patent. Both Doudna and Zhang have started up genome editing companies and if one of those companies has proprietary rights over the CRISPR/Cas technology, that company can collect huge royalties from patent licensing. Perhaps another reason why the dispute has been rancorous is because Doudna and Zhang have their eyes set on a Nobel Prize. CRISPR/Cas technology is revolutionizing the way we do basic science research, the way we treat diseases, and the way we practice agriculture. For these reasons it’s very likely that the scientists behind the technology will receive a Nobel Prize. Regardless of the outcome of the patent interference, the scientific community is certain of one thing: CRISPR has definitely made its mark in patent law history.

References:

  1. CRISPR Patent Interference Updates. Retrieved from https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-patent-interference-updates
  2. Begley, S. (2016, August 16). CRISPR patent fight: The legal bills are soaring. Retrieved from https://www.statnews.com/2016/08/16/crispr-patent-fight-legal-bills-soaring/
  3. Cohen, J. (2016, October 5). Dramatic twists could upend patent battle over CRISPR genome-editing method. Retrieved from http://www.sciencemag.org/news/2016/10/dramatic-twists-could-upend-patent-battle-over-crispr-genome-editing-method
  4. McCall, A. (2016, June 5). The CRISPR Clash: Who owns the groundbreaking, DNA altering technique? Retrieved from http://www.ipwatchdog.com/2016/06/05/crispr-clash-dna-technology/id=69650/
  5. Ledford, H. (2016, September 21). The Titanic clash over CRISPR patents turns ugly. Retrieved from http://www.nature.com/news/titanic-clash-over-crispr-patents-turns-ugly-1.20631