Genetic Editing

In a stunning defeat, the U.S. Patent and Trademark Office (USPTO) ruled definitively that the foundational patents for CRISPR genetic editing technology belong to the Broad Institute (Harvard & MIT).

This is an outcome that I have been predicting for years, and it has massive implications for the biotechnology industry. It is also a painful loss for the group affiliated with U.C. Berkeley, who tried every legal trick in the book in an attempt to wrest the priority position held by the Broad Institute with its CRISPR patents as applied to eukaryotic cells (those of plants, animals, and – of course – humans).

I’m happy to say that the facts prevailed. Scientist Feng Zhang of the Broad Institute was the first to use CRISPR with a guide RNA, and file patents for its application for eukaryotic cells.

Billions were at stake, which is why the team at U.C. Berkeley spent years attacking the Broad Institute. Here is what the rough timeline looked like:

  • 2016: U.C. Berkeley files a patent interference case petitioning to have Broad’s patents thrown out – the court denies the petition.

  • 2017: The USPTO rules that there is no patent interference at all, and the patents in question belong to the Broad Institute.

  • 2017: After the USPTO ruling, U.C. Berkeley appeals the decision.

  • 2018: The appeals court upholds the USPTO ruling, and the Broad Institute wins again.

  • 2018: U.C. Berkeley filed new patent applications that effectively claimed prior use of CRISPR technology in eukaryotic cells – this was essentially an attempt to rewrite history in an effort to make their case stronger.

  • 2020: The two scientists affiliated with U.C. Berkeley, Jennifer Doudna and Emmanuelle Charpentier, very oddly win the Nobel Prize in Chemistry – leaving Feng Zhang, the inventor of the foundational patents, with no award.

  • 2020: The Patent Trial and Appeal Board (PTAB) again rejects U.C. Berkeley’s arguments in their appeal, but announces that there will be a formal ruling on the priority of patents.

  • 2022: On Monday afternoon, the USPTO ruled definitively in favor of the Broad Institute.

It should have been over in 2017, but it dragged on for another six years. And the team at U.C. Berkeley is already clamoring about another appeal. Ridiculous. Time to move on and get to work on curing the 6,000 plus diseases caused by genetic mutations that can be cured using CRISPR technology… And this is why this is such a groundbreaking case. Literally, the cures to these diseases are within our grasp.

For the first time in human history, we actually have the toolkit to develop therapies – cures – for diseases for which there are no existing therapies. That’s what the industry should be focused on.

And now it can.

The problem over the last seven years was that the biotechnology industry didn’t know who to license CRISPR technology from.
U.C. Berkeley licensed its patents to two companies, Intellia Therapeutics and CRISPR Therapeutics. Both of those companies have been posturing and licensing those patents out to other players in the industry as if they would win their patent appeals.
Now, based on the USPTO ruling, those patent rights are invalidated.

Here’s the catch…. The Broad Institute comes out on top, and it gave an exclusive license to just one company, the company that was founded by Feng Zhang himself – Editas Medicine. That’s right, one single company has the exclusive license to the foundational patents for CRISPR genetic editing technology and its use of guide RNA. If any company wants to develop therapies and eventually commercialize those therapies based on CRISPR technology, there is only one place they can go to license the patents…

Game, set, match.

Authored By: Jeff Brown