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August 18, 2015


Nice job by Sequenom setting forth the real implications of the panel decision if upheld.

Regardless of the grant or not of an en banc hearing at the CAFC, this one is eventually headed to a request for cert at the SCOTUS.


Agree with your assessment that Sequenom did a very good job in its petition for rehearing en banc. But the core problem is the nonsensical reasoning in Mayo, as well as in Myriad. As even Lourie's panel opinion notes, the Royal Nine has created this mess and without any guidance, expects the Federal Circuit to clean it up. If medical diagnostics cannot be patented in this case, we've got a huge problem with how Our Judicial Mount Olympus absurdly approaches patent-eligibility, one which I'm sure Big Pharma will "scream" to Congress about.

Agreed. This was a horrible decision so happy to see they are requesting a rehearing.

No question the end-game is a petition for cert: counsel for Sequenom is noted SCOTUS advocate Tom Goldstein of Goldstein & Russell, PC.

Has anyone else noticed that the product of the amplification step is not cffDNA as defined in the opinion ("non-cellular foetal DNA that circulates freely in the blood stream of a pregnant woman") because in amplified short sequence form it is synthetic material not foetal material and does not in that short sequence form circulate in the maternal bloodstream?

Mr. Cole,

Do you really think that quantity alone (your the amount has been amplified) suffices to create a difference in kind rather than one merely of degree?

Maybe the Fed. Cir. should leave the case as is. Judge Linn is correct, the problem lies in the incorrect test articulated in Mayo, and we can't get any 101 reform done if the Fed. Cir. tries to limit the application of Mayo.

"But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible."

Mayo and Myriad are easily dealt with on an ongoing basis because the Guidance gives us plenty of clues for conveying eligibility in things as simple as increased stability. However, our issued patents do not have the benefit of the guidance, and we can't have every patentee with invalid DNA and diagnostic claims go all the way through appeal.

PTO actions have already been affected by the proposed implications in Sequenom's petition. I had a similar case that examiner said on the phone he was finally going to allow, but instead he issued another 101 rejection because the Sequenom decision is forcing them to reject essentially all diagnostic methods.

One quote from the petition sums the panel decision perfectly: "This is absurd"

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