The CRISPR Patent War - Everything You Need To Know

The CRISPR Patent War – Everything You Need To Know

Millions of people suffer from devastating genetic disorders like cancer, sickle cell anemia, cystic fibrosis, muscular dystrophy, Huntington’s disease and many more. Can you imagine the pain and suffering that could be avoided if these diseases could simply be cured by rewriting the genetic code of patients? That is how promising the CRISPR-Cas9 gene-editing technology is!

One of the hottest developments in recent years has been the CRISPR gene editing process. CRISPR stands for “clustered regularly interspaced short palindromic repeats” and it’s a way to delete or insert certain genes, or even chemically repair DNA. Its possible applications are arguably endless and there’s a lot of current research happening in chemistry departments all over the world. But there’s one factor some might be missing, and that is the legal side of CRISPR.

The US Patent Office is currently conducting hearings on a CRISPR Patent War – a dispute between the University of California and the Broad Institute at Harvard and MIT. Two biochemists at UC Berkeley filed a patent for the process in 2012 and published their work showcasing their process. Feng Zhang from the Broad Institute was also working

on CRISPR and filed a patent after the Berkeley team but he paid to have the US Patent Office expedite his review (which is legal) and thus was issued the first CRISPR patent. The debate has become the definition of CRISPR. The Patent Office has said it’s specific to eukaryotes, cells in plants animals and humans, which Zhang’s work involved. The Berkeley team’s work involved prokaryotes, which are only in bacteria and do not have the potential applications that eukaryotes do. The debate between the two uses of CRISPR could shape the future of technology. A patent dispute of this magnitude is likely to affect research globally.

CRISPR in a very short period of time became one of the most exciting scientific breakthroughs in today’s world. If we look back at the early days of CRISPR discovery, we come to know, that neither Francisco Mihika nor Philipp Horvath had the setup to undertake groundbreaking research. They were merely going about doing routine tasks as part of their jobs or investigating something that just caught the eye. The truth is breakthroughs are most of the times the summation of countless small discoveries. Even you might be working on any small but crucial discovery right now; the manuscript that you write for journals may be picked up someone somewhere in the scientific community to eventually build upon it.

Multiple discoveries about CRISPR were made by many scientists throughout the years and the reason why CRISPR can grow so fast today is that each discovery was communicated to everyone effectively through journals and publications. The scientific community shares one another’s knowledge, successes and failures and science advances as a whole. While Collective progression is an excellent way to accelerate scientific development, it does cause a unique problem – in the discovery of CRISPR it is exactly because so many scientists participated in CRISPR’s development with each having made significant contributions it is impossible to pinpoint a particular person and declare he or she discovered CRISPR. That is the problem that has been unfolding in recent years as scientists scramble to claim patent rights to CRISPR.

Many scientists consider their work to be the significant milestone in CRISPR’s discovery but so many important discoveries were made based on previous discoveries which were based on even earlier discoveries. Instead of a single scientist discovery of CRISPR, the situation is more of a group of scientists in the discovery of CRISPR. This makes it extremely difficult to conclude who should have the patent rights for CRISPR! Since the technology has so much potential, whoever owns the rights to the process will likely have a billion dollar asset in their pocket.

The CRISPR Patent History

The CRISPR mechanism was first published in the year December 1987 by Amemura, Ishino, Makino, Nakata, Shinagawa, Takase, Wachi at Osaka University.

On 18 Jan 2000, more clustered repeats of DNA were identified in other bacteria and archaea, termed as Short Regularly Spaced Repeats (SRSR) by Mojica, Diez-Villasenor, Soria, Juez at the University of Alicante and University Miguel Hernandez. The term CRISPR-Cas9 was published for the first time by Mojica, Jansen, Embden, Gaastra, Schouls at Utrecht University in the year March 2002.

Later Jennifer Doudna and Jillian Banfield started investigating CRISPR at the University of California Berkeley Regulators debate about what restrictions should be enforced with CRISPR/Cas9, the technology that has become the subject of a major patent dispute.

Dupont had filed the first application to patent the technology in March 2007 (WO/2007/025097). The patent application covers the use of technology to develop phage-resistant bacterial strains for food production, feeds, personal care products, cosmetics, and veterinary products. Since then, patents have been filed by 3 heavily financed Biotechnology start-up companies and half a dozen universities.

UC Berkeley vs MIT – CRISPR Patent War

In the US, 2 major competing patent claims have been filed. One on 25 May 2015, grounded in the work led by Jennifer Doudna at the University of California, Berkeley, and Emmanuelle Charpentier, originally at the University of Vienna and presently at the Helmholtz Centre for Infectious Research in Germany. The application has 155 claims and covers numerous applications for a variety of cell types (US Patent Application No. PCT/US2013/032589).

The second was filed for the work of Feng Zhang by MIT-Harvard Broad Institute on 12 December 2012 which focused on the use of CRISPR/Cas9 for genome editing in eukaryotic cells. A fast-track status was given and the patent was granted on 15 April 2014 (US Patent No. 8,697,359). Charpentier and the UC and Vienna filed a challenge to the patent with the US Patent and Trademark Office, in April 2015. Four years after it entered into a legal battle with the Broad Institute due to a crossover between patents filed by the two parties, the University of California (UC) will soon gain its third patent on the gene-editing technology known as CRISPR.

The US Patent and Trademark Office at Alexandria Virginia, Vienna has had hearings about the CRISPR Cas 9 patent interference, with attorneys representing the University of California on one side and the Broad Institute of MIT and Harvard on the other side just give their case for why they should hold the CRISPR patent. This is a genome editing technology that people have said will change the world. CRISPR potentially can engineer super crops, snip out genetic diseases from humans and even make designer animal models for research. Billions of dollars are at stake now, according to experts. The litigious timeline starts way back in May 2012 when a group of biochemist and molecular biologists including Jennifer Doudna and Emmanuelle Charpentier filed their first CRISPR patent.

A month later, they published their work in a scientific journal, thus officially kicking off the CRISPR craze. While Doudna and Charpentier are quickly rising to CRISPR fame so was Feng Zhang from the Broad Institute. Zhang filed his first CRISPR patent in December 2012, and then quickly published a paper famously demonstrating the first use of CRISPR and mouse in human cells. In a perfectly legal move, the Broad Institute paid to expedite the review of their patent and in April 2014, Zhang was the first to receive an approved patent for CRISPR mediated cell editing, even though he submitted his application after the Berkeley group. Berkeley countered by petitioning for a patent interference, which is a legal proceeding where federal patent court judges determine who made the invention first. The Patent Office did approve Berkeley’s petition but defining CRISPR as a system specifically used in eukaryotes; which are organisms whose chromosomes are found inside a nucleus; such as plants, animals and humans; Not to forget what experts think; that eukaryotes are where the major buck lies at.

Doudna and Charpentier’s patent had CRISPR technology used only in prokaryotes, such as bacteria. Attorneys argued that the judges would have messed over the understanding of the word eukaryote. They said that if CRISPR has worked for prokaryotes, it would obviously work in eukaryotes too. The UC patent even cited the potential for using CRISPR and cells dozens of times. Berkeley’s attorney in their exact words has said that “no special sauce required” to move CRISPR into eukaryotes. Doudna’s own words were turned against her, in a defend by the Broad Institute. She had told the press that she expected many frustrations moving CRISPR from prokaryotes to eukaryotes and that she was unsure if it would even work. Zhang’s patent specifically showed how to use CRISPR in eukaryotic cells. There’s a spectrum of possible outcomes from this hearing the simplest is that one side wins the other side loses.

CRISPR Patent War Possible Outcomes

The losing team is likely to appeal though and an appeal would take the case out of the hands of patent judges with molecular biology backgrounds and send it to federal circuit judges that are unlikely to have any science training at all which may be an unappealing prospect for CRISPR stakeholders. But if Broad institute gets to win this, Berkeley could still get its patent approved, just that it would only cover the prokaryotic uses of CRISPR which look way less lucrative.

Another possible outcome is a sort of tie. The judges declared that both sides filed patents for the same invention and this would kick off a second phase of the case where both sides will have to submit lab notebooks and testimonies to figure out who actually had first thought of the CRISPR technology. There is also a possibility that CRISPR or other gene editing tools will improve so much by the time that judges decide their decision will not really matter.

So, what lies ahead? That depends partly on the appetite of those bankrolling the fight. Neither the UCB nor the Broad Institute is directly paying for this battle. It is being funded by biotech companies instead, which have taken out licenses to the key intellectual property assets in each organization. They have already spent tens of millions of dollars and they are not even in the most expensive phase yet. The costs could easily shoot up to hundreds of millions if the two organizations start to sue each other on grounds of infringement of patent claims. If the companies involved aren’t certain about how large those fees will ultimately be, and who they will need to pay licensing fees to, this may stand in the way of a much-needed innovation. This ongoing uncertainty is a big problem for commercial applications of gene-editing.

Impact of CRISPR Patent War On Us!

Why should all these CRISPR Patent War matters to a layperson? Of course, it should! We all eat food medicine and get treatments which are products of Biotechnology. Considering that CRISPR’s immense potential for real-world applications such as possibly rectifying mutations that cause cancer and hence curing cancer without chemotherapy. So obviously, whoever manages to claim rights to CRISPR; will be able to control the direction of its development deployment and access to the public. Who knows maybe one day we will depend on medicine or treatments enabled by CRISPR.

So whether you will eventually pay $13.50 a pill for an essential drug or 750 dollars a pill will depend on who is granted the patent. Take, for example, the case of price increase of 5000 percent for Daraprim in 2015, a drug patented and FDA approved in 1953 and it becomes all too easy to see how grants on CRISPR in the 2020s now will affect you and your family’s medical treatments in the 2040s. This is what makes the result of this patent dispute so highly anticipated.

We are still in the developing days of CRISPR technology and there is a lot more to understand and work both in and out of the lab. With the patents, licensing CRISPR may become more straightforward or at least clearer and more organized.

The current atmosphere surrounding CRISPR IP rights may be having a lot of litigation and contention around the core patents. But, one thing is certain, that the pace of innovation to create new nucleases, new ways to edit and more predictability means that the future of these technologies certainly looks promising. The future still remains a little way off—the dust is still settling down.

About the Author
Ms. Urmimala Ray, one of the finest faculties at BioTecNika, loved and idealized by a lot of students. Her fluent narration, upgraded knowledge, and hardworking nature are most talked about. The above article is a result of her In-depth knowledge of CRISPR tech. She has been an ardent follower of all latest innovations in the field of Bioscience. You will get to listen to her talk about more such techniques in the future too. You can listen to her podcast on CRISPR Tech here.
Preety
Perfection is her hobby, Reliability is a synonym, Editing is her passion, Excellence is her Goal, Tactfulness is in her genes, Yellow is her Fav color. Preety is the name of the Professional on whom entire BioTecNika relies when it comes to its website. A Gold Medalist in Biotech from SRM University, Chennai with a 9.9 CGPA ( was awarded the Gold Medal by Honorable Prime Minister of India Shri Narendra Modi , as seen in the pic ), She decided to join forces with BioTecNika to ensure India's largest BioSciences Portal expands its reach to every city in India. She has redesigned the new avatar of BioTecNika from scratch and heads the most dynamic, vibrant and well informed Online Team at Biotecnika Info Labs Pvt Ltd