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« USPTO to Release Revised Subject Matter Eligibility Guidance | Main | Impact of Interim Guidance on Business Method and Software Claims »

December 16, 2014


The USPTO issues new Guidance and then two days later the CAFC decides Myriad v. Ambry. I guess that the good news for the PTO is that the new Guidance holds up pretty well under the new decision. The bad news for patent applicants and biotech investors is that today's decision makes it that much harder to write a claim sufficient to justify investment in developing diagnostic tools for genetic diseases.


Greg beat me to it. The DNA primers were problematical in view of Myriad, but the reasoning applied by Dyk & Company (Utah/Myriad couldn't have drawn much worse of a Federal Circuit panel) to the screening method claims puts the patent-eligibility of any medical diagnostic in jeopardy. Thanks again Royal Nine for your nonsensical reasoning in Mayo, Myriad, and Alice!

EG: "the reasoning applied by Dyk & Company (Utah/Myriad couldn't have drawn much worse of a Federal Circuit panel) to the screening method claims puts the patent-eligibility of any medical diagnostic in jeopardy."

It certainly puts the patentability of using old generically described information gathering methods to gather information about "new" (but obvious) targets in jeopardy.

But innovative diagnostic methods are just as eligible for patenting as they always were.

As it should be.

"I guess that the good news for the PTO is that the new Guidance holds up pretty well under the new decision."

What does the new guidance say about a claim reciting a "new" (but ineligible) genomic sequence and nothing other than a reference to an old conventional "vector" or some hand-waved "heterologous" nucleic acid?

I don't think those claims "hold up pretty well" under this new decision (to the extent they ever "held up pretty well").

The point made crystal clear by this decision (which some have great difficult acknowledging, although it was quite clear long before Mayo made it perfectly clear) is that you can't protect ineligible subject matter with a patent by salting your claim with obvious, conventional subject matter. If you could do that, then the point of declaring the subject matter ineligible in the first place would be rendered moot.

if "but obvious," why then the wrong statute?

Of course there are plenty of companies in the diagnostic testing space (Myriad was suing some) who don't necessarily rely on patented sequences as part of their business plan. The work of identifying disease causing sequences will also continue, both in universities and private industry because the Costa continue to drop and there is a market for testing.

Yes, Jan, but why would anyone disclose the diagnostic marker? There are many diagnostically relevant needles in the genomic haystack and if I find one I can't protect I might try to hide it (obviously not part of the university model).

Thanks for the comment.

If they find it during basic research at a university, for instance, they need to publish and have others verify or falsify. Not all such research is to make profits.

If scientists find a diagnostic marker during basic research at a university, they could arrange to sell it to a company that could use it in a diagnostic method kept as a trade secret. I am not aware of any legal requirement for scientists to publish their work.

Any discussion on universities, "publications," innovation, and the intersection of the patent world would not be complete without a reference to the thundering success of the Bayh-Dole act and the outright success of turning on the Lincoln-esqe fuel of interest.

Please take note, Jan.

They could, but that won't get them tenure or promotion. Publication is the currency of academia.

Well, Jan, let's think about your profit statement. First, not one of the competitors is performing these tests for free or even at cost, so they are concerned with profit. Second, not one of the Myriad plaintiffs (not the breast cancer patients) wanted to perform the tests for free or at cost, so they were concerned with profit, too. Even the academics are concerned with "profit," if we consider that to include the benefits that derive (some of them monetary in nature) from making these discoveries.

And if the world had worked the way the ACLU seems to think it should, then Myriad would not have patented any of this and what do you think would have happened? I don't think it would have been free or there would have been widespread availability of the technology, for reasons I have set forth at length in earlier posts. For very Adam Smith reasons Myriad used patent exclusivity to do just what it was intended to do - protect a nascent industry as it was being established and now, having done so, permit the public to freely use the technology once the patents have expired.

Thanks for the comments.

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