CRISPR: Tech Transfer and the battle for IP Commercialization

University Technology Transfer Offices (TTO) often come in for criticism. Commentators are quick to accuse them of being too slow to commercialize important new innovations, of failing to bring in enough funding from licensing and grants to make money for their universities.

On other fronts, they stand accused of being too commercial, too focussed on generating revenue – at the expense of the education system’s mission of working towards the public good, and potentially even skewing the incentives of academics and their research.

It seems that TTOs are damned if they do, and damned if they don’t. Despite the criticisms levelled at Tech Transfer, it’s hard to argue that their mission –  bringing innovations from laboratories and research offices of universities into the real world, to solve real-world problems, is an important one. And, when done effectively it can not only lead to commercial success, but can change the world.

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Genetic Engineering – An Academic Innovation

Genetic modification, or genetic engineering, is the process of changing the DNA of an organism such as a bacterium, plant or animal. The very first successful genetically engineered organism was developed in 1973, as a collaboration between Herbert Boyer at the University of San Francisco and Stanley Cohen at Stanford university. Their work on recombinant DNA technology demonstrated that DNA molecules could be cloned, for example to encode antibiotic resistance from one strain of bacteria into another.

Herbert_Boyer_and_Stanley_Cohen.jpgHerbert Boyer and Stanley Cohen

The First GM Patent

The first patent for a genetically modified organism was granted in 1980, after the US Supreme Court determined in favour of Anand Chakrabarty, a scientist working for General Electric. In the Diamond v.Chakrabarty case, the court voted to allow a patent on a genetically modified strain of bacterium that was capable of breaking down crude oil.

Researchers and commercial organisations were quick to acknowledge the potential of genetic engineering, initiating and investing in a wide range of projects spanning applications such as crop development for agriculture, pharmaceuticals, and even modifying animal and human DNA.

Replicating Genes, Replicating Success

Despite the scale of interest and investment into GM research, for a long time the success stories were limited, but many of those early success stories were borne of university research. For example, researchers at Cornell University were credited with saving the Hawaiian papaya industry when they were able to genetically engineer a Rainbow papaya after the papaya growing industry on the island was devastated by the ring-spot virus.

Dolly the sheep, the first mammal to be cloned using somatic cell nuclear transfer, was the result of a successful collaboration between the University of Edinburgh and biotechnology company PPL therapeutics. But while the experiment was initially successful, the project was marred by the fact that Dolly didn’t live to a normal life expectancy.

dollythesheep_Ian_Wilmut.jpgEmbryologist Sir Ian Wilmut with Dolly the Sheep

The problem was that genetic modification was just too expensive and unreliable. Methods improved in 2002 when biologists discovered a technique enabling them to delete or replace specific genes using enzymes called zinc-finger nucleases. The next generation method used enzymes named TALENS. But it wasn’t till 2012 that researchers at The University of California, Berkeley, made a breakthrough discovery in genetic engineering that university and commercial projects really exploded.

The Commercialization of CRISPR-Cas9

CRISPR, or clustered regularly interspaced short palindromic repeats is a gene editing technique which makes it cheap, easy, and fast to slice and move genes around, in any living organism.

Discovered by Professor Jennifer Doudna and her colleagues, the technique not only speeds up previously tedious laboratory processes but creates new possibilities for medical treatments, therapies, and diagnostic processes.

“These are monumental moments in the history of biomedical research,” said genetic researcher David Baltimore. “They don't happen every day.”

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CRISPR has already attracted hundreds of millions of dollars of investment from VCs and pharmaceutical companies and as the graph above shows, there has been an explosion in patenting activity from both academic and corporate institutions. This is a real indicator that the technology has been successfully taken from the world of academia to commercialization. However, the core patents for the technique are at the centre of a heated dispute between researchers at UC Berkeley and The Broad Institute (affiliated with MIT and Harvard).

The value of the disputed patents which protect the process are estimated to be worth a figure in the billions of dollars. Unfortunately, it looks likely that tech transfer’s biggest success story will also be the reason for its biggest law suit.

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