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« IPO Sends Letter to Senate Leaders in Support of Defend Trade Secrets Act | Main | PTAB Update -- The Constitutionality Edition »

December 02, 2015


What a bunch of wimps.

Hey Kevin:

Sigh. How many amicus also (strongly) suggested that the Ariosa panel decision was wrongly decided?

What is particularly galling is how Dyk accepts the "framework" set forth by Mayo and Alice v. CLS Bank as being "an essential ingredient to a healthy patent system, allowing the invalidation of improperly issued and highly anticompetitive patents without the need for protracted and expensive litigation." How Dyk can say that with a straight face, and still believe that the "rule of law" (i.e., the express language of the statute, as expressed in 35 USC 101) is being obeyed escapes me.

I also place the blame for all this nonsense squarely at the feet of the Royal Nine. May be Congress will finally listen to those amicus when diagnostic methods become "invisible" because they are kept strictly trade secrets.

Hey EG:

The Senate just released a report in which it criticized Gilead for keeping the price of its Hep C treatment high so that it could - gasp! - realize high profits. You know, profits: revenues above and beyond the revenues that offset the costs of the R&D and clinical trials that got the drug to market in the first place, revenues that get plowed back into additional research and, occasionally, get paid out to shareholders as dividends. Ooh, that evil pharma company!

I share your sentiments, but I wouldn't hold my breath on Congress stepping in and fixing anything in this area any time soon.

The statement of:

"indicating once again an unwillingness by the Court to confront (or take the lead on) important issues for patent law in the face of Supreme Court disapproval."

is far less a sign of "wimpiness" as Curious George may put it, and far more a sign of natural conditioning brought upon the court created (in substantial part) to bring order to patent law BY the overbearing brow beating of the Supreme Court.

I am reminded of the story of monkeys in a cage, being fire-hosed when they reach for a hanging bunch of bananas. Once "trained," new monkeys are introduced one at a time and it is the previous monkeys that "train" the new ones not to reach for the bananas.

Eventually all the monkeys are not from the originally fire-hosed monkeys and they don't know why they should not reach for the bananas, only that they don't dare reach for them - nor let anyone reach for them.

When we have reached the state of such "conditioning" that a primary purpose of having this court established can no longer reach its mandate, it is time to SERIOUSLY consider disbanding the court and trying something else (going back to the original arrangement should be considered - but it is doubtful that such will suffice).

Hey Dan,

I'm not "holding my breath on Congress," but it's the only way this mess created by an overzealous and overreaching Royal Nine can be fixed. If Big Pharma would get behind such a fix and push hard, it might actually happen, especially if it is pointed out that the only "realistic" options without such a fix are: (1) keep all such diagnostic methods as trade secrets; or (2) spend no R&D on such diagnostic methods, and thus they're not developed. Either of options (1) and (2) will lead to slower development of such diagnostic methods. It would especially cause serious angst in the university tech transfer community which cannot choose option (1) and might reluctantly choose option (2) (or diminish support of academic research on diagnostic methods) because there's no hope to get commercialization of such diagnostic methods by businesses.

It is disappointing to find so few of the serious questions raised in this appeal addressed by the court e.g. the relationship between new utility or new result and eligibility under Section 101.

However, the opinions are almost an open invitation for the Supremes to take the case.

"The opinions are almost an open invitation for the Supremes to take the case."


I wish that were true. But the Royal Nine seems to enjoy keeping us "mere mortals" in the dark and continually "hiding the pea" as to how a medical diagnostic method can reach the patent-eligibility zone. If you sense that I give the Royal Nine a "Vote of No Confidence" on this question, you would be correct.

All the amici in this case seem to have in common a position that this discovery itself was a great scientific breakthrough. But was it, since most patent cases ended on 101 grounds do not ever get to 103 issues?
Here is one 103 allegation made in a Patently-O comment on this case. I have no idea is valid or not, but readers of this blog can: At the time the subject patent application was filed (March 4, 1997)?, was there really no POSITA hypothesis that fetal DNA might be floating around in the mother’s blood and that the fetal DNA could be selectively amplified by focusing on the paternally inherited portion of its DNA?
It was alleged in this comment that both parts of that hypothesis were proven at least as early as a hotlinked 1993 paper entitled: "Isolating fetal cells from maternal blood. Advances in prenatal diagnosis through molecular technology." Is that true?

Here is the cite to the alleged prior art article, which is noting earlier work:
JAMA. 1993 Nov 17;270(19):2357-61.
"Isolating fetal cells from maternal blood. Advances in prenatal diagnosis through molecular technology."
Simpson JL1, Elias S.

Paul: There are some practical implications to this even if the paper stands for the proposition that people knew there were fetal cells in maternal blood. For example, 1 mL of blood contains 7 million white blood cells. Separation methods exist to separate white blood cells from red blood cells and plasma, but I don't know of any physical method for separating fetal cells from maternal white blood cells. (Detecting fetal cells is different from separating them, and you can't do the analysis without separating.)

So while it is possible that there are ways to do such separation, what the inventors discovered was that nature had done the work for us, in that fetal DNA was contained in the plasma/serum. Separating the cellular from acellular components of blood has been understood for a very long time, so that you could do the analysis for fetal DNA in ways you couldn't do the analysis for fetal cells.

And the "Shazam" factor is that not only did no one know fetal DNA was in plasma but plasma was routinely discarded when performing analyses like looking at the mother's white blood cell count.

I don't think the paper affects the patentability assessment.

Kevin: "fetal DNA was contained in the plasma/serum."

Right. Maternal DNA is also in that serum. As everyone knew, you could distinguish between maternal DNA and fetal DNA by probing paternal sequences in the fetal DNA.

Maternal DNA is in maternal serum because maternal cells are floating around in maternal serum. Where you find cells, you find broken cells and where you find broken cells you find DNA. Where you find DNA, you can apply PCR to detect it. All this was known. It was so well known that people were contemplating taking dinosaur DNA from fossilized insect stomachs.

What wasn't well-known is what were the exact isolation and reaction conditions needed to get a reliable result that you could market commercially. The answer to that question isn't anywhere near the asserted claims which do nothing more than recite a discovery and state "detect it using conventional tools."

Is your position is that without that kind of extraordinary claim breadth nobody is going to discover and disclose valuable information anymore, then you just come out and say it, Kevin! Ideally you'd have some evidence to back you up on that remarkable assertion. One problem for you, of course, is that nobody doubts that had this "discovery" not been made by these alleged "discoverers" it would surely have been made by someone else shortly thereafter. Likewise everyone is keenly aware of how patentees will behave if the gates are left wide open to the type of claims you seem to favor. See, e.g., Prometheus and Myriad.

There's also this from the Abstract of Steele et al. (1996) http://www.ncbi.nlm.nih.gov/pubmed/8934032

"PCR has been shown to be a powerful tool in allowing amplification and identification of very small amounts of fetal DNA. However, this is limited to cases in which a specific and unique gene from the father is sought. ... It remains to be determined whether testing maternal blood for fetal cells **or DNA** will be used as a screening tool, similar to the maternal serum screening currently in use, or whether the accuracy can be improved to a level such that the techniques can be used diagnostically. Although there are many questions that remain unanswered at this time, the outlook for noninvasive prenatal genetic testing in the future is optimistic."

Sure doesn't sound like "teaching away" to me.

MM: we would be having a different conversation if the claims were invalidated under Sec. 103.

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