Monday, February 1, 2016

CRISPR: Ground-breaking  technology faces off with old laws at the USPTO

Originally published by Rita Handrich.

CRISPRThose of us who work in patent litigation are used to strange bedfellows, but this is irony at its best. You may have heard about CRISPR as it’s been all over the media with hopes and promises and endless controversy. Essentially, it is a way to edit the genome to remove hereditary diseases caused by mutated genes. Here is a nice CRISPR primer from Gizmodo.

The emergence of CRISPR has caused multiple concerns about “designer babies” and what happens if the CRISPR operator snips a bit too much out of someone’s DNA. The international symposium on CRISPR (held in December, 2015) concluded they need to be open to studying the issue further. “

The symposium final statement asserts that germline gene editing for human reproduction — that is, genetically altering sperm, eggs, or embryos and initiating a pregnancy with them — has not been shown to be safe or effective, and that for now “it would be irresponsible to proceed.” Nor should any such effort be made, it says, until “there is broad societal consensus about the appropriateness of the proposed application.”

If you are still wanting clarity on how all this works, you can also watch this 4 minute video explaining CRISPR from MIT.

In the meantime, there is a big fight going on as to just who invented CRISPR. A well-regarded scientist recently wrote an article on the history of CRISPR and has been attacked for trying to cut women out of the picture as well as not disclosing conflicts of interest. The invention has been tied up for years as researchers argue about who got to the USPTO first. Now, like King Solomon and his decision to cut the baby in half so each “mother” could have part of it, the USPTO has decided they will decide using an “interference law” already expired but in place at the time the patents were filed. Here’s what WIRED magazine says in the article:

The US Patent Office will resolve a dispute over one of the hottest biotech breakthrough of the decade, the genome-editing technology Crispr/Cas9, through an arcane proceeding that technically should no longer exist. Because the disputed patents date back to just before a new law took effect in 2013, the patent office will work out who gets credit for inventing Crispr via a so-called interference proceeding—probably one of the last such proceedings ever.

It is the sort of dilemma we can imagine causing high distress for mock jurors. Here is technology that could result in removing inherited and often deadly disease from ever developing. On the other hand, there are those who insist this technology will result in “designer babies” and that scientists cannot be trusted to behave ethically around such hot-button (and financially lucrative) issues. These are case themes that would result in strong feelings all the way around. Yet, there was collaboration amongst the scientists and we think our mock jurors would say they should simply share the wealth. And then there are those who are adamantly opposed to ownership of genetic technology…

Even in dry and often esoteric and confusing cases, ultimately the story is always about people. In this case it is the scientists on both sides of this dispute, and their respective compelling personal stories. This is one we will continue to follow, and we encourage you to follow the links in this post and educate yourself on the hope and the drama this high-tech invention is prompting.

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