August 7, 2020

The Niche

Knoepfler lab stem cell blog

Myriad SCOTUS Decision: Can you have a gene patent?

Can a gene be patented? Gene patent
Can you get a gene patent? What about stem cells?

Should a company be able to have a gene patent and more generally and practically speaking can genes be patented?

Patent and IP issues always raise a myriad of questions so what about a patent case on a company called Myriad? Complicated, right?

If genes in their natural form cannot be patented, does that mean that potentially very valuable cell types including stem cells also cannot be patented?

It’s a timely question to ask because the Supreme Court of the United States (SCOTUS) ruled yesterday that genes in their natural form cannot be patented.

Jon Rowley, very much on the ball, first asked the question yesterday on Twitter (see below) and it got me thinking more about the implications.

Jon Rowley Tweet

The SCOTUS case Association for Molecular Pathology v. Myriad Genetics drew much attention because of the  major implications of a ruling either way. Here’s a nice piece on the arguments from the Stanford Law Blog for background.

SCOTUS ruled unanimously against Myriad, handing the company (and indirectly many other companies) a major, albeit expected defeat.

The focus was on Myriad’s intellectual property (IP) rights to two genes that are powerful markers for breast and ovarian cancer: BRCA1 and BRCA2. The BRACAnalysis test sold by Myriad to a quarter of a million women a year is extremely expensive at around $3,000 a pop. Analysts predict the price will go way down now, making it more accessible to women and likely saving many lives.

This is one very positive outcome of the decision, but some in the biomedical field are asking whether the ruling also might have the negative outcome of discouraging innovation. Thousands of other patents are effectively nullified and there will be a boost of competition in many areas.

Why did SCOTUS rule this way?

Justice Clarence Thomas provides the rationale in his write up:

“Myriad did not create anything,” Thomas said. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” 

In effect, SCOTUS reasoned, “Genes already exist so you cannot patent them. You didn’t invent them.”

What are the implications for other biological products and patents?

What about stem cells?

There are thousands of patents on stem cells, many related to naturally occurring stem cells that researchers and companies did not invent.

Does this SCOTUS ruling in effect challenge the IP rights to certain kinds of stem cells?

Thomas’ particular choice of words resonates here: separating that gene from its surrounding genetic material is not an act of invention

Does that mean that separating specific stem cells from their surrounding cellular material is not an act of innovation?

A definite maybe.

As a result, could stem cell patents be invalidated too in the future?

It is quite possible.

In fact in Europe, patents on embryonic stem cell research are banned, a decision that scientists are challenging and questioning. Strangely, the rationale of the European Court for its ruling remains unclear to this day I think even to the Court itself. I think its a bad ruling.

Back here to the US and the SCOTUS ruling’s implications for the stem cell field, there is a striking paradox here for many in the stem cell field hoping to make money off of stem cell patents.

On the one hand, a major argument made by for-profit stem cell clinics is that the stem cells that they transplant into patients are naturally occurring things (even when propagated in the lab in culture) that are not more than minimally manipulated so they should not be regulated as drugs. They want the FDA off their backs.

On the other hand, in many cases the same group of folks wants patent rights to their stem cell products. They claim unique, inventive ways of producing a distinct stem cell product and they naturally want protection from competitors taking away what they perceive as their own innovation.

But you cannot have your cake and eat it too.

If your company prepares a unique stem cell product that is not simply some naturally occurring thing (as Justice Thomas indicated) it seems by definition that it is very likely to be more than minimally manipulated and hence subject to FDA regulation as a 351 drug. If your stem cell product, however, is indeed not substantially different than endogenous stem cells and you think it should be regulated as a 361 non-drug biological product, then it seems a much bigger hurdle to then also claim IP and hence patent rights to it.

There’s the rub. To be clear, I’m not against patenting stem cells, but stem cell companies that claim both minimal manipulation and patent rights may be dreaming if they think they can pull off both in the long run. Maybe they can, but the Myriad ruling raises doubts in my mind.

It will be fascinating to see how this area develops in the coming years.

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