Emerging technologies legal update: CRISPR – The genetic gold rush

What is CRISPR?

The CRISPR-Cas9 system is a powerful and versatile gene editing technique which is used to alter, substitute and disrupt selected genes, for example those genes which cause disease to be passed on or are otherwise undesirable. It originated from a natural genome editing system from bacteria and was subsequently adapted by scientists to facilitate numerous scientific breakthroughs.

How does it work?

The mechanics of the system are relatively simple. Cas9 is a protein which functions as a pair of “molecular scissors” used to cut up DNA strands. CRISPR (an abbreviation of “Clustered Regularly Interspaced Short Palindromic Repeats”) is a segment of the “guide DNA” which instructs Cas9 to cut at its complementary DNA sequence. Together, they form a search-and-snip complex capable of identifying and slicing into target sites in DNA with high levels of accuracy.

Scientists are able to use this mechanism by picking and choosing the type of DNA used to guide Cas9 so that it can cut at its target site within a cell. Once the DNA strands are cut, a new sequence of DNA can be injected into the cell and the cell’s natural DNA repair mechanism will be able to weave the new gene into the existing DNA.

CRISPR in a commercial setting

While commercial use of CRISPR is not particularly prevalent in the present day, it has been estimated to grow into a $US10 billion market by 20251. It has potential uses beyond the healthcare and pharmaceutical industries. For example, the CRISPR tool can be used in agriculture to accelerate development of agricultural products with fewer undesirable traits and increase crop yield. Alternatively, CRISPR could be used in the renewable energy industry to produce biofuel at higher rates with greater efficiency.

The CRISPR technology is still undergoing developments to increase its specificity and efficiency. Attempts have been made to re-engineer the Cas9 protein, create software to design and optimise the CRISPR “guide DNA” and improve the quality of assays detecting off-target effects of CRISPR.

Patents

In August 2018, IP Australia granted Merck Pty Ltd with a patent to protect its paired CRISPR nickase technology which purported to reduce the chances of off-target cutting so that only diseased genes are removed while not affecting healthy ones. We expect to see more patent applications in the near future relating to the CRISPR technology.

Legal clarity needed

Australia’s genetic modification laws may need to be amended to catch up with the rapid and broad application of CRISPR. Currently, the Gene Technology Act 2000 (Cth) (Act) defines GMOs broadly to include an organism that has been modified by gene technology, which would capture the CRISPR-Cas9 system. This is significant as GMOs are subject to heavy regulatory burdens under the Act and the Gene Technology Regulations 2001 (Cth) (Regulations). However, Regulations do provide GMO-status exemption for organisms modified without insertion of foreign nucleic acid. The CRISPR technology could arguably fall into this exemption when it is used to manipulate pre-existing genes within a cell.

Due to the lack of consensus in the interpretation of these legislative instruments, it is uncertain whether CRISPR-engineered products will be classified as GMOs or if they could fall within its exceptions.

In an effort to provide clarification on the above:

  • The Office of the Gene Technology Regulator conducted a technical review of the Regulations and proposed that certain amendments be made (Proposed Amendments); and
  • A review of the National Gene Technology Scheme was conducted by a collaboration of Commonwealth, State and Territory officials on behalf of all Australian governments, assisted by an independent Expert Advisory Panel.

The National Gene Technology Scheme has undergone its third review and the Ministers (Commonwealth, State and Territory Ministers responsible for gene technology) met on 11 October 2018. The Ministers endorsed the review report along with the 27 recommendations and agreed that the recommendations should be implemented in line with a forward action plan.  The Ministers also considered the Proposed Amendments, and are currently seeking further advice in relation to these.

Implications

We expect amendments to be made to the Act and/or the Regulations in the near future. The question though is how it will change. The scientific successes of CRISPR technology have contributed to a strong voice in favour of deregulation so that gene-excision is no longer classifiable as genetic modification. However, as the technology remains fairly new and its long-term effects are uncertain, a more cautious and pro-regulatory approach may be more suitable.

In the event that CRISPR-modified organisms are distinguished from GMOs and undergo deregulation, the technology is likely to continue advancing in Australia at a rapid pace and we will see its commercialisation in various industries. Conversely, if outcomes from the reviews press for regulation of CRISPR technology, it may stifle commercialisation of the technology in Australia.

How we can assist?

If you are interested in protecting your CRISPR inventions or other intellectual property, or if you have any queries on how the gene regulatory reforms might affect your business, please contact a member of our Intellectual Property team.

This article was written by Luke Dale, Partner.

Luke Dale

P +61 8 8205 0580

E lcdale@hwle.com.au


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  See page 22 of CitiGPS Report: https://ir.citi.com/uims9KeGQBxXr2JWqUOQjpNwL9HlVE9xT6rG0XYhQI%2BlmtfIYoLJ16k%2BJB%2FT48WZqbCUF2pDgc0%3D

Important Disclaimer: The material contained in this publication is of a general nature only and is based on the law as of the date of publication. It is not, nor is intended to be legal advice. If you wish to take any action based on the content of this publication we recommend that you seek professional advice.