By CRG staff - interview with Daniel Ravicher, Public Patent Foundation

Daniel Ravicher, JD, is a Lecturer in Law at Benjamin N. Cardozo School of Law at Yeshiva University and Executive Director of the Public Patent Foundation, a plaintiff in the Myriad case.


How far back does the debate about life patents date?

There has been a debate about what should be patent eligible subject matter for centuries. It's a constant debate. When new technology comes to the forefront, the debate then gets mapped onto that technology; so when we have biotech, or genetic sequencing, or nanotech, or software, we get all these new questions about where should patents play a role in that new field. But the issue of what should be patentable isn't a new issue whatsoever-it's as old as our country.

Why do you think it has taken this long for a serious challenge to gene patents to emerge?

I don't know, but maybe there haven't been parties motivated enough to actually bring the challenge, since there had not been enough financial impact yet. We brought this case not from financial motivation, but because we were motivated to serve a public good. There have been other gene patent cases, but most of the time they were between parties that both have gene patents-so neither side actually wants to allege that all gene patents are invalid, they just want to accuse the other one of having undeserved patents for obviousness or some other lack of scientific merit.


At times there can be a certain 'yuck factor' in the way that gene patents are portrayed, whether purposely or not, especially when it is framed as companies owning our bodies. Do you think that thinking misses the point, or is there something to it?

Well, what's in our bodies or not in our bodies is not a clear demarcation. The law says you can't patent something that is effectively nature, and the only use of genes isolated from the body is that they exactly replicate the genes in our body, or else they don't tell us anything about us.


It seems the legal issue primarily revolves around whether an isolated DNA molecule is markedly different from its counterpart as it appears in nature-

That's the legal test set forth in Chakraborty, yes.


Do you think that test makes the most sense?

Yes, there has to be some border between what is patentable and what is not. The purpose of patents is to encourage progress, to make the world a better place-not just to patent the world as you find it. What makes something better is making a significant, substantial change, to take what God or nature has given us and actually do something with it. I think that test makes sense as a policy point and as a legal marker, because it's an adjective that has a little bit of fuzziness to it, which allows it to be custom-tailored in appropriate circumstances.


You and others have said that most gene patents are not being enforced in a way that is harmful to the public since they are being widely licensed. Is there a legal distinction between companies that are reasonable or unreasonable in the way that they manage their patents?

The difference is that if a company is aggressively asserting its patents, it can be subject to a declaratory judgment lawsuit like we filed against Myriad; if a company isn't being that aggressive, there is no case or controversy that would support a lawsuit. So if a company has patents but are not asserting them against anyone, they don't have to run the risk of being sued in court like we sued Myriad. There is a legal distinction between these two categories of actors.


Is there a test for that distinction, or is it another fuzzy boundary?

It's a fuzzy boundary, which the Supreme Court said it prefers in this area of the law. In their Bilski decision, in their KSR decision-in many decisions they've handed down, the lower court, the Federal Circuit Court of Appeals, which handles all patent appeals, has been trying to come up with hard and fast rules, objective "true-false" statements, and the Supreme Court has said that's not the way the law should be applied. The law should be flexible and considered case by case.


So would companies that are acting in a way that you might call "reasonable" have anything to worry about if the case against Myriad is successful?

Even Myriad itself doesn't have anything to worry about, really, for its business model. It said to its own investors that even if it loses the case, it's not going to lose its business model or revenue. We only challenged 15 claims out of a total of over 100 claims. Even if we win, Myriad is still going to be in business, they're still going to be processing tests-this is everything they said to their shareholders, that this isn't a financial risk to them. And we agree with that. Some parties have come in now and said, "If this decision is upheld it will ruin the entire biotechnology industry and planes will fall from the sky," and that's all just a bunch of crap. If Myriad itself is saying that it doesn't have anything financially at risk here, I don't understand how anyone else can allege that they have anything to risk here. Patents are like snowflakes: they're each different, and they all have to be individually analyzed. Our decision may or may not have some impact on the validity of other patents. Only time will tell.

If Myriad themselves are saying that they will be fine ... are they still driving the defense of this, or has it been taken over by other actors claiming to have something at stake?

No, they're still defending it, though I don't know why. But I haven't understood Myriad's behavior from day one, so that's not unusual.

One of the other aspects of the gene patent debate that comes up often is the pragmatic end, the argument that patents have an incentivizing effect on bringing these tests to market.

Patents have a greater chilling effect than incentivizing effect. Whatever you say patents can incentivize, I can say they chill. Some people say they incentivize investment; patents actually chill investment to a greater degree than they incentivize it. Some people say patents incentivize research and development; patents actually chill research and development, there's no exception for research from patent infringement. So the larger effect of most patents, which is proven by the empirical data which has been published and not refuted by the pro-patent side, is that patents have a negative economic effect, a drag on advancement of science.


Do you think this is the case across the board, beyond gene patents?

Yes, the empirical data says that in the vast majority of industries, perhaps excluding chemicals, patents have a net drag effect on development. They siphon money away from R&D into the pockets of lawyers.


I suppose this might be why many of the most vocal proponents of gene patents are patent lawyers.

They are the people who are financially incentivized to promote their system. You have to be skeptical of the patent attorneys who say the sky is going to fall and actually talk to the scientists, look at the real people, the businesses on the ground, who say everything is going to be fine. We can have a patent system which respects individual rights and research, but which also provides the protections that are necessary to create a net incentivizing effect on research and development.

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