CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology has been making waves in the biotechnology and IP fields since it’s discovery in 2012, but what is CRISPR and why is there a legal storm surrounding it?
To explain why this technology is making waves, we first have to define what it is…
CRISPR -CAS9: a genome editing tool which is far more accurate whilst also being cheaper and faster than any previous technique. It consists of two core molecular components that work together to introduce a controlled mutation (or change) into a DNA strand.
CAS9: an enzyme that cuts can cut DNA at a specific site so sections of DNA can be inserted into or removed from the original strand.
Guide RNA (gRNA): a section of designed RNA located within a larger RNA segment. The larger segment binds to the DNA strand and the guide RNA directs the CAS0 enzyme to the correct part of the strand. Combining guide RNA with the enzyme in this way ensures that Cas9 cuts the correct part of the DNA strand to allow an insertion or deletion.
So, why is this technology important?
This technology is by its very nature controversial. On the one hand advocates of the technology claim that it has the potential to eradicate many common genetic diseases within a generation. Detractors, on the other, warn of the dangers of human genome editing, and the resulting ethical debate has followed the technique since, including the recent claim by a Chinese doctor to have used the technique on a pair of twins.
This explains the excitement among biotechnology experts and the public, but why is CRISPR of such interest to lawyers and IP professionals?
The birth of the technique and the ownership of rights is as important a topic as the uses to which it might eventually be put: a robust legal battle has been underway almost from the beginning between University of California Berkley who submitted their patent application first in 2012, and Harvard’s Broad institute, whose application published first due to their paying for an expedited examination (an option UC Berkley did not choose to apply to their own application).
The fight has flowed back and forth between the two organisations over the years, but a recent decision by the USPTO may have altered the situation. The American Patent Office (USPTO) has revealed that they have completed their examination of a key application from UCB, announcing the claims laid out in the document are likely to be accepted:
“We are pleased the patent application is now allowed and that the issued patent will encompass the use of CRISPR-Cas9 technology in any cellular or non-cellular environment.” Said Eldora Ellison, Lead patent strategist on CRISPR matters for the University of California in an online statement
Following the USPTO’s ruling, what are the likely next steps? With both organisations having outlaid large sums already in patent litigation, the cost is likely to spiral upwards for infringement proceedings if an agreement cannot be reached.
The technology has the potential to solve a number of modern issues, reducing the impact of genetic disease or producing new crop strains that can thrive in collapsing soils. However, innovation cannot thrive if companies are unsure who to pay for the licence, especially as backing the wrong side may result in a company being in breach.
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