18 June 2015Americas

BIO 2015: Picking apart the Federal Circuit’s Sequenom ruling

On day three of the BIO International Convention, LSIPR spoke to Kevin Noonan and Donald Zuhn, partners at law firm McDonnell Boehnen Hulbert & Berghoff and authors of the Patent Docs blog, about the possible impact of the Federal Circuit’s Ariosa v Sequenom decision on the life sciences industry.

The court affirmed unanimously that Sequenom’s patent covering the method of detecting foetal abnormalities in pregnant mothers is ineligible for protection because it applies to a “natural phenomenon”.

However, Judge Richard Linn notably said that although the patent covered a “breakthrough” technology and that he saw no reason for it to be deemed patent ineligible, he was bound by the patentability test set out in Mayo v Prometheus.

LSIPR: What are your thoughts on this case?

KN: The court seems to be under the impression that it has been commanded to do what it’s doing under the Supreme Court, and I think that that’s a mistake.

We need to get a good amicus brief together.

DZ: The problem is that there may be one or two justices who think the idea of breaking the claim down into its individual elements and determining whether this step is routine and conventional [is good practice, as Supreme Court justice Stephen Breyer taught in Mayo].

LSIPR: Do you envisage life sciences companies turning to trade secrets to protect their innovations?

KN: I wouldn’t say that we’re seeing more ... [but that life sciences companies] have no place left to go. I think that if Sequenom is not reversed, I don’t see anybody trying to file for a diagnostic patent—what would be the point?

DZ: We’re still getting patents allowed; we’re trying to implement Mayo and follow on decisions the best that we can. I have one client who has a test for melanoma. After Mayo, when they first approached us, I said you have two choices here you need to understand: choose wisely, and there are no guarantees either way.

You can keep your markers and your algorithms to yourself, and not tell anyone. Obviously publication is going to be a bit more difficult, and they’re very concerned with reimbursement. Or you can try to get a patent on it, but now that we’ve got Mayo, there are very difficult circumstances for diagnostic [methods] but we’ll do the best we can.

We can get you patent claims, but whether those claims will stand up, that’s the problem.

We have to make sure the client understands the options and the risks, and if they make a business decision to go with it then you do the best you can.

LSIPR: In practice, how would trade secrets work in the life sciences sector?

DZ: Pharma, biotech and high-tech are important sectors of our economy. If [innovative companies] don’t have the ability to do some investment recapture, to keep others out of the market, they are not going to do the innovation, or they’re going to keep it themselves.

Trade secrets are not bad—they’re different. A trade secret is not time limited—it’s unlimited protection. On the life sciences side you might eat up five, six, seven years of that if you get a patent, so you’re looking at 12, 13, 14 years of protection. It’s limited, and it’s open to everybody. So a limited patent monopoly has a trade off. You have to disclose your patent with sufficient detail to the public; trade secrets don’t have that.

Trade secrets have other downfalls: you have to keep them confidential and that’s really tough to do, and costs a lot of money. I have one client who has a process that could keep trade secret, and there’s only one person in the entire company who knows every detail of every single step. What they do is segment it out so there are groups that handle individual components.

The  2015 BIO International Convention is taking place in Philadelphia from June 15 to 18.

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