A Billion-Dollar Question

By Samini Thiruchelvam

Genetic diseases and disorders which are caused by faulty genes in cells are debilitating and worsen the quality of life of a patient. But what if you could return the faulty genes to normalcy as easily as fixing your profile picture with Photoshop? Or even create a designer baby with desired features? A gene-editing tool known as clustered regularly-interspaced short palindromic repeats (CRISPR) opened up the possibility of achieving such tasks that seemed to be improbable in the past.

CRISPR is, in fact, part of bacterial immune system, which stores the DNA of viruses that attack bacteria, so that during a reoccurring attack, the bacteria can recognise the virus and defeat it. This defence system is assisted by CRISPR-associated proteins (Cas) that cuts the DNA of viruses and destroys them. This ability to recognise and precisely snip DNA is what makes CRISPR appealing as this system can be utilised for cutting faulty genes in the human body and replacing them with normal genes.

CRISPR is not the first gene-editing tool known to public as it has its predecessors – zinc finger nucleases and transcription activator-like effector nuclease (TALENS). However, CRISPR is much more time-efficient and simpler to use, resulting in a multi-billion dollar business.

Of course, it is a no-brainer that the inventors of CRISPR would rush to the patent office and file a patent application to obtain exclusive rights to the invention and to protect it from potential copycats. But it would be obvious to many researchers that, while you are working day and night, slaving in chemical-infused laboratories, it is very much possible that another person on the other side of the world could be working on the exact same research! Consider the situation where both of you file a patent application for same invention – which side would the patent office take when granting exclusive rights?

This is the exact scenario faced by Jennifer Doudna’s lab from UC Berkeley and Feng Zhang’s lab at the Broad Institute and Massachusetts Institute of Technology, both claiming to be the rightful owners of CRISPR technology.

Here is what happened: Doudna filed an application at the Unites States Patent and Trademark Office (USPTO) on 15th March 2013 and Zhang filed his application 7 months later, on 15th October 2013. However, Zhang requested for accelerated examination at USPTO and had his patent granted on 15th April 2015. Meanwhile, Doudna faced some technical issues regarding the ownership of the patent application and at the time of writing this article, her US patent application is still pending.

So now we have two inventors claiming to have invented same invention. Who is the rightful owner who will successfully claim exclusivity of the invention and possibly win a Nobel Prize?!

First-to-file vs. First-to-invent

In such cases, there are two type of systems used to determine the rightful patent owner. The first is the first-to-file system, where the person to file a patent application first wins the battle. This is a straightforward rule and is easy to determine. The winner of the race to the patent office owns the patent rights.

It is not as simple as that when following first-to-invent system. The US was one of the countries that followed this system but changed to the first-to-file system on 16th March 2013. In the present case, both Doudna’s and Zhang’s applications will follow the rule of first-to-invent as both applications claim priority from applications filed prior to 16th March 2013. In the US, under this system, the first person to invent has legal rights over the invention and it is determined by an expensive and time-consuming proceeding called interference.

When Doudna’s team discovered that Zhang had obtained a number of patents related to CRISPR, they requested for an interference proceeding at USPTO in April 2015. The request was successful and interference was declared by USPTO Patent Trial and Appeal Board (PTAB) early this year. This proceeding will determine the first inventor by taking into account testimonies, research records, test data and other evidences submitted by both parties. Here, Zhang, as the “junior party” – having filed the patent application later than Doudna – has the burden of proving that he is first to invent the subject matter.

A final decision will be delivered by the PTAB. We can certainly expect the losing party to file an appeal, considering this is one of the more significant discoveries in biotechnology field in this decade.

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