Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, “At this point, diagnostics are really not patentable.” Watch the five-minute video to understand why he believes this.

Joe Hage: Hey, it’s Joe, I’m here with Gavin Bogle, and you have your own intellectual property firm.

Gavin Bogle: Right, I’m a partner in a small firm named Magyar and Bogle at http://MagyarBogleOhara.com.

Joe: You spoke today at http://peds2040.org and you said something that really caught my attention. You said, “At this point, diagnostics are really not patentable.”

Gavin: Right.

Joe: What did you mean?

Gavin: Well, under a recent case, The Mayo Clinic vs. Prometheus, the Supreme Court of the United States said the diagnostics at issue in that case are basically an application of natural phenomena or the use of a natural phenomenon.

And, therefore, not patentable. It just does not constitute patentable subject matter. And in that case, it was actually the use of a diagnostic to alter the treatment regime a doctor would use and they found, in that case, that was not patentable.

So where we are today, I think, is pretty clear… I have a very hard time picturing the in-vitro diagnostic that would actually be patentable. I’m always open to innovative people coming up with novel solutions but if you’re measuring an analyte that occurs in the person even as the result of a disease and comparing it to its normal state, that’s a natural state and not patentable.

The lower courts all have to follow that.

And it’s not actually that new. It’s a couple of years now. And the inability to patent anything that’s a natural phenomenon or, basically, uses a natural phenomenon without a significant transformation of that natural phenomenon – and I am simplifying here, you have to understand – but anything that doesn’t provide a significant transformation, other than applying intellectual thought to it, is not patentable.

Joe: Let me take it to an easy extreme. I have a blood pressure cuff. I am measuring someone’s vitals.

Gavin: Right.

Joe: Not patentable?

Gavin: Well, the cuff itself might be [patentable]. The machine that you have might be. But the test of relating the pressure to some disease wouldn’t be.

I think about in-vitro diagnostics where you [attempt to] discover the relationship between an analyte and a disease. And that relationship is not patentable. Even if it’s new and novel and not obvious.

Joe: Have you, since Prometheus, seen a shift in the amount of investor or entrepreneurial energy in diagnostic innovation?

Gavin: I’m not sure, you know, I don’t have a good sense of overall. I think that if there hasn’t been, there certainly will be a shift. No question.

The Prometheus case was a great example where Mayo wanted to use the diagnostic and Prometheus wanted to sell the diagnostic. There was a difference between the buyer and the seller. The buyer wants it to be cheap and the seller wants it to be proprietary.

Joe: For those of us who don’t know, what did Prometheus do as a result of this loss?

Gavin: Well, it’s still a company that goes on, they have lots of diagnostic tests and most hospitals and purchasers want to buy the test rather than make it themselves so there’s always going to be a marketplace and it’s always going to be… the end result is the market and marketing is going to lead to sales.

Joe: And I recall you having said, “At this point, marketing is a better defense than a patent for the diagnostic space.”

Gavin: Well, except for the example you use where you have a machine that you build, and it’s a new, a novel, and unobvious machine that does something that nobody else does, I can imagine there are lots of ways of patenting that machine. It’s the intellectual input that’s not patentable.

Joe: Very interesting.

Gavin: Some would say the intellectual input is the real heart of these inventions but patent is going the other way.

Joe: Gavin Bogle, thank you very much.

Gavin: Thanks.

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Gary Baker, Esq., MT
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Gavin speaks well on his feet.

Yes, natural correlations are not patentable. But, as he suggests, the correlations can be a part of a claim that also includes an inventive way to use the correlation, particularly if combined with an device uniquely tailored to using the correlation.

Maria Qadri
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Is this limited to in-vitro diagnostics or does it extend to devices like clinical decision support system and/or algorithms in such devices? In the future, should we design and protect them as trade secrets?

Sean Kelly
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How about US Patent #7,149,756 A, Dec 2006. Isn’t that a patent on a diagnosis process ?

Bernard Chaudoir
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This does seem strange. The point of the Patent system should be to protect novel thought; any device is typically a collection of more or less unoriginal materials and parts. It’s the design and use (the thought) that adds value and innovation.