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« USPTO Proposes Changes to PTA and PTE Provisions | Main | C5 Freedom to Operate Forum »

April 07, 2011

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Kevin,

Nice report. I had listened to the portion of the oral argument up through Hansen (for the ACLU), but not Kaytal (for DOJ). From what I heard in the oral argument, Hansen appeared to be frustrated and flounder at times, sinking into the quicksand when it came to the dealing with "technology." From what I heard about Kaytal's argument, I've seen others have charaterized his response to Moore's question about 35 years of precedent for gene patents as being somewhat misleading with regard to the government's view (and whether the USPTO agreed with that view).

It was also unfortunate that so little oral argument time addressed the method claims. I still predict that the plaintiffs will lose on the standing issue, as well as the patent-eligibility issues, but you're right that this isn't the end. En banc and cert petitions are bound to come from the loser here.

"If the Federal Circuit reaches the substantive issues discussed herein, it is likely to be subject to en banc review, a petition for certiorari to the Supreme Court, or both. The case is far from over."

I hope Myriad loses, the ACLU wins completely, and review is denied by the fed and the USSC. And on that day, I shall futterwacken. Vigorously.

"From what I heard in the oral argument, Hansen appeared to be frustrated and flounder at times, sinking into the quicksand when it came to the dealing with "technology." "

If that's what you thought about Hansen you should have been there and listened to Mr. Castanias. I almost loled when he just threw up his hands and declared he was an english major.

"I still predict that the plaintiffs will lose on the standing issue"

Care to make a friendly wager? How's a thousand sound?

EG,

The merits will not be reached if the standing issue is the deciding factor. An appeal would only address that standing issue as well.

6,

Why do you feel so strongly that the standing issue favors the plaintiffs?

"Why do you feel so strongly that the standing issue favors the plaintiffs?"

If you were there you'd know why. I'm surprised you don't know why considering that you no doubt heard the recording.

They grilled Mr. Castanias like he was a hotdog.

Comparatively, they just felt that the evidence was a little weak for some of the plaintiffs, and were somewhat worried this might open the floodgates. The later indicates strongly to me a situation where they're just going to wave a judicial wand and make it all better by making up some standards. You should have a good eye for these kind of situations by now Kev.

Furthermore, Myriad practically threatened to sue them, if they do testing, right in the courtroom, even in the event that the plaintiff's win. That means that the 2nd prong which several thousand plaintiffs might have some difficulty in meeting, will likely be judicially glossed over.

And finally, and perhaps most dam mingly, these people are very much laboring under the thread of litigation as Judge Moore pointed out. That is as blatant as the nose on your face. That will win the day hands down on the second prong. Judge Moore is spoken for already. Bank on it. Her "concerns" are just that. Concerns. The fact that she can tell that there is an active threat of infringement to this day is dispositive of the issue regarding the foremost plaintiff regarding the standing issue.

All that said, I'm somewhat surprised that these people didn't just organize a massive political "sit in" infringement demonstration to kick this thing off. It would have garnered much more public support and attention. And standing wouldn't be an issue at all once Myriad sued.

Not to say that there isn't a chance that Lourie and Bryson could have a stroke while deciding the opinion, but the chances are astronomically low as I understand that they're in fairly good health.

If Kaytal really argued "that the same could be said for minerals such as lithium, which "exist as salts with covalent bonds," then he needs to go to a chemistry class where they distinguish between ionic bonds and covalent bonds. Last time I checked a salt is not formed by a "covalent bond." Good to know the arguments are based on fantasy rather than reality.

Thanks 6.

I think.

My schedule has been a bit busy of late and I have not heard the tapes. I am not much into predicting how many angels are dancing on the heads of judicial pins, so once the decision comes back, then I will look into the why's and wherefore's.

My question above was more to gauge your understanding of what "standing" means.

"The merits will not be reached if the standing issue is the deciding factor. An appeal would only address that standing issue as well."

Skeptical,

Point well taken. But there is the possibility that this panel might only partially overturn the lower court on the standing issue. That's what Judge Moore's line of questioning suggests.

6,

Normally, I don't pull "experience rank" but I will here. (I was in patent practice when the Chakrabarty decision came out and had even written a law review article on the "product of nature" doctrine prior to Chakrabarty.) I'm also going to qualify my argument on the standing issue.

You may have been at the oral argument but you also need to listen to the line of questioning by the panel judges, especially the questions posed by Judge Moore. From her line of questioning, Moore is obviously troubled by the "broad brush" the ACLU and Hansen tried to paint regarding the standing issue. Some of the plaintiffs may slip through on the standing issue (such as those plaintiffs who really planned to do competitive testing), but not all of them, such as the patients. Moore was pretty clear about that, meaning that at least some of the plaintiffs are going to flunk on the standing issue.

Regarding the "isolated" gene sequence issue, it's pretty clear Bryson as well as Lourie didn't buy into Hansen's "plucked from nature" argument. Remember that these aren't technically-challenged judges (who also happen to have technical clerks in addition to normal law clerks) that you can schmooze with such gibberish. And as Moore pointed out during her questioning of Kaytal, we're talking about 35 years of precedent by the USPTO (not the DOJ that Kaytal comes from) issuing patents on isolated gene sequences. (Kaytal likely damaged his credibility with this panel with his response to Moore's question.) Not to mention that you would have to overturn the Supreme Court's Chakrabarty decision, as well as the CCPA's binding precedent of In re Bergy. That's simply not going to happen with this Federal Circuit panel.

You're free to express your opinion about this oral argument (as am I). But Kevin has previously warned you about how much you know about biotech (and Hansen should have taken that cue as well). I also suggest you need to be careful about opining on legal issues like these which others much more experienced know more about than you. Just some friendly advice.

d-
You are correct.
Glad to see that someone else knows a little chemistry around here.
I just wish that everyone involved with this case did.

Dear d:

Surprisingly, the lithium-carbon bond has substantial covalent character, and even lithium halides are not quite as "ionic" as you might think. The theory is that the small size of the lithium nucleus has something to do with the character of the bonding, and the nuclear strong force is somehow implicated. (That's the extent of what I know about it; until I looked it up I thought the same thing about the type of bonds in lithium.)

Which explains why the DOJ chose lithium (in addition to its having been discovered in 1818, relatively late in history but not as late as some other true metals which would form ionic bonds). It's a pity that all that erudition is squandered on such an artificial, unscientific and unsound argument

Thanks for the comment.

"It's a pity that all that erudition is squandered on such an artificial, unscientific and unsound argument."

Kevin,

Thoroughly agree (and even I who was a chemistry major undergrad was unaware of the potentially "covalent" character of lithium). I wish we would just focus on technology at issue, and not other, extraneous examples or analogies. I've got the same problem with Justice Breyer and his inane "raccoon invention" comment during oral argument in KSR International. Or Justice Scalia's inane comment about "horse whispering" in Bilski.

Dear Kevin:

I think you give the DOJ too much credit in their analysis, but thanks for the lesson. Maybe if he had given that level of detail I would believe that they knew that. What amazes me in all of this, and doesn't appear to be discussed, is that no one knew the BRCA gene and its mutation giving risk to the cancer until the genetic analysis had been done. This was a big deal and has probably saved numerous lives for people who have had to make the difficult, yet necessary, decisions to have their breats and/or ovaries removed because of the presence of the mutated gene. Therefore, regardless of the "isolated" debate, to render the diagnosis claims invalid as well would be a horrible outcome. I won't go down the slippery slope argument that none of these discoveries would be made without patents, but it will take longer without the financial incentive. I can't figure out what the ACLU really wants, the rewards of science without rewarding those that figure it all out. For the courts and lawyers to say that it was "easy" to figure out the BRCA gene is laughable. If it were that easy then we would have all the genetic links to all the diseases out there. Last time I checked we haven't done that yet. Anyway, just my two thoughts on how ridiculous this case is and how the big picture seems to get lost by the over simplification of what was actually done by the University of Utah and Myriad.

" Good to know the arguments are based on fantasy rather than reality."

Trust me, nearly the entirety of the arguments from both sides were based on complete fantasies.

"Moore was pretty clear about that, meaning that at least some of the plaintiffs are going to flunk on the standing issue."
I agree entirely that some of the 1.5 thousand plaintiffs will likely not have standing. But it won't matter because it only takes 1.
And I also agree that I lack much technical understanding of the science involved. However, I will hang my hat with the gov's position, at the least, that if it exists in nature then it isn't patentable. And mere isolation isn't going to do it. CDNA etc. might be fine, it might not be, and the method claims are a whole other ballpark.
So just to be clear, as to the merits, I will hang my hat with the gov on the isolated DNA claims. As to CDNA etc. I have no carefully decided opinion but feel confident that there is a way to invalidate them under 101 as well even if these guys don't do it in this case though there is a great chance that there isn't. And the method claims I also will have no definitive opinion on except in so far as I will say that if they encompass substantially all uses of an abstract idea or natural phenomena (such as natural DNA, isolated or not) then they fail 101. I will also say that at least some of the method claims appear to encompass an abstract idea of comparing.
As to whether or not we're undoing 35 years of PTO practice I see that as largely irrelevant. If people can't be bothered to challenge it in court then administrative agencies do the best they can. Now that they have had to review the situation, they came down as expressed by the gov. Also, the fact that our web team is slow in changing guidelines is also irrelevant. We're the gov. we move slow.
Besides, I thought stare decisis refers mainly to judicial opinions that must be respected, not to administrative interpretations of the statute they are tasked with enforcing. And a mere 35 years is not enough to have made the common understanding into a long standing interpretation by "everyone" so to speak.

Brown vs. Topeka Bd of Education reversed more than a hundred years of unjust precedent, and cost millions, leading to rioting and strife as it was slowly implemented ... but it was Just. Let's hope the courts continue to slouch toward justice.

Myriad is much more than this year's hot patent litigation case (i.e., this year's successor to Bilski). It's critical for the courts to get this one right. I hope the Justices of the SCOTUS are already doing their research, so they'll be proficient on the details when this case finally reaches them.
http://online.wsj.com/article/SB10001424052748703806304576245064194577624.html#ixzz1Ikhfbier

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