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January 19, 2010

Comments

Kevin,

The PTO's memorandum in support of its motion meticulously (and accurately) points out the absurdity of the ACLU's position on the constitutional claims. If only Judge Sweet would listen and simply dismiss this nonsensical lawsuit.

It is clear that the plaintiffs have raised constitutional issues, but it is equally clear those are not the only issues that concern the USPTO. The case could also turn on claims structure, and intricacies such as the meaning of "isolated" DNA, the breadth of claims, and the structure of claims that the examiner has scored as "dependent," but are actually expansions that have been granted in some of these BRCA patents and many others pertinent to DNA diagnostics. Those issues are about examination practice at USPTO as well as prosecution and claim structured by patent applicants.

Citing the Syntex case about re-examination may not be very persuasive in this case, which is not about re-examination. Judge Sweet is likely to notice that difference. And the assertions that patent claims are only about chemicals and not information are on thin ice, given the combination of structural claims and method claims that in effect bar any way to derive the information. This may be good law or bad, but it is certainly not a settled matter, and this is, to my knowledge, the first case that has gotten before a judge that bears on diagnostic use, which is basically about extracting information from DNA samples (as opposed to using DNA molecules to make a valuable therapeutic).

Seems likely that Myriad will have some patent claims at the end of the day, but those claims might be considerably narrower in scope than the ones granted by the USPTO, if the European opposition process is any guide.

Why would the European opposition process be any type of guide in a US application/US Constitutional setting?

Dear Bob:

The ACLU may have raised constitutional questions, but I think the PTO’s point is that’s rather like Mortimer raising demons in Act III, scene i of Henry IV, Part I. Whether the issues are properly raised remains to be seen – the Office doesn’t think so, and it may be that the Supreme Court thinks this challenge is more like Eldred than not.

At the risk of once again repeating myself, no matter what the merits of the case against the patent-eligibility of genetic diagnostic claims, that isn’t what the ACLU et al. are asking for – they want all gene patenting claims to be banned. We can’t talk about the case without recognizing that, as a strategic and publicity matter the ACLU chose to “go for it” rather than taking a more limited approach.

Of course, your point about the deficiencies of the claims at issue on patentability – rather than patent-eligibility – grounds is also the Office’s point, and their brief does not get to the merits of those issues. Indeed, the Office’s position is that the plaintiffs only reach their constitutional issues if the court decides that the claims were properly granted under the various sections of the patent statute. Thus the “Catch-22” in the Office’s argument.

I think the Syntex case was merely cited for the proposition that private litigants cannot hale the Office into court based on whether a particular patent is properly granted or not – the remedy is against the patentee, not the Office. And I doubt very much that the Judge will notice or take the government to task for the quote.

Also, I wouldn’t look to the EPO as a guide – different law, different standards (and when it comes to biotech, different outcomes).

Thanks for the comment.

"Thus the “Catch-22” in the Office’s argument."

That's not really a "catch-22" :( I know why you're saying it is, and I know they want it to be. But it isn't one since even if it was "properly" issued under the patent act, that doesn't necessarily mean a portion of the patent act isn't unconstitutional as the office applied it and is still applying it. It might also force an interpretation of the patent act that would leave the act valid, but the court would order it be interpreted differently than the office has been. As such, the PTO shouldn't get off scott free at this point.

Dear 6:

I meant a procedural Catch 22 (which was what the original Catch 22 was). There are two possibilities: either the Office properly granted the patents under the relevant portions of the statute (101, 102, 103, 112, i.e. based on patentability) or it did not. If not, then the court should stop right there, according to the PTO, because there is a principle in US law that a court should avoid constitutional issues if possible. However, if the court finds that the PTO granted the patents properly under the statute, then it can look to the constitutional issues - that the PTO has granted a patent that does not qualify for patent-eligibility, either because DNA isn't patent-eligible subject matter or because the patents impinge a citizen's free speech rights under the First Amendment.

Now, it's easy to mix these up because the Supreme Court talks about whether something is patentable when they are considering whether it is patent-eligible. But the Office's point is sound with regard to review: since the patent-eligibility question impacts the Constitution, the court should avoid reaching it if it can.

Which is the Catch-22. In order for the plaintiffs to reach the constitutional issues (which is what they want, because they are not content with invalidating just these patents), the Office says the court has to find that the claimed subject matter is patentable - not something the ACLU wants to happen.

Thanks for the comment.

"I meant a procedural Catch 22 (which was what the original Catch 22 was). There are two possibilities: either the Office properly granted the patents under the relevant portions of the statute (101, 102, 103, 112, i.e. based on patentability) or it did not. If not, then the court should stop right there, according to the PTO, because there is a principle in US law that a court should avoid constitutional issues if possible. However, if the court finds that the PTO granted the patents properly under the statute, then it can look to the constitutional issues - that the PTO has granted a patent that does not qualify for patent-eligibility, either because DNA isn't patent-eligible subject matter or because the patents impinge a citizen's free speech rights under the First Amendment."

You left out the part about the constitutional basis of the patent act tho Kev. But let's ignore that for now.

Yes, I understand what you're saying, but I don't see that as proper since the court has been presented now with both issues and they are both legitimate. The hearing on the constitutional issue shouldn't be a different hearing than on the patent act one.

See, you seem to be acting like the consideration of the issues should progress from one to the next in "separate phases" if you will, and that seems a bit bogus. The court can consider both issues all at once, one trial, but only reach the constitutional issue in its decision if the other doesn't pan out.

I'm sure there's probably something I'm missing, but that just seems stu pid to let them off now only to have to drag them back in later. Especially having seen cases with this similar issue where the court wanted to avoid the issue of the constitutional challenge.

One of the cases I've seen was especially relevant since the court threw out the old interpretation of a law so that the guy got off and the case was then dismissed, or he was ruled not guilty, and then the constitutional challenge was never ruled upon in the decision. Still it was heard at oral arguments in the trial. Then of course the VA legislature corrected the law to mean what it should have said in the first place the next year, and I got hauled in on the same issue. I should have fought that case, but I kept missing the court date or the date to reply to get a court date. Which I also found stu pid. They're going to make me reply in writing to EVEN GET MY DAY IN COURT? W T F? Just how much nonsense do I have to go through to make an argument? I don't reply in "(hand) writing" to anything. Frakin snail mail. I don't have envelopes, stamps, good paper, or any of the rest of that nonsense.

All you old people make the legal system too difficult and unweildy for the people, especially people of my generation.

On the other hand, when I do subject myself to considerable bothersome activity to fight the system it goes pretty well. At least you guys did get that part right.

It only took me 4 hrs of trying to look up the statute I was accused of breaking to find the one sentence I needed to read and print to have the case well taken care of in one instance.

ONLY 4 HOURS. ONE SENTENCE.

Kev if you ever get into public office I want you to get this nonsense under control. You should go for it, there's nobody else hardly running. Who knows? You might take pres.

"Which is the Catch-22. In order for the plaintiffs to reach the constitutional issues (which is what they want, because they are not content with invalidating just these patents), the Office says the court has to find that the claimed subject matter is patentable - not something the ACLU wants to happen."

But that doesn't mean the office should be let out of the trial. The court is still going to reach the issue in its decision if the first one falls through. These guys must have some bogus "procedure" rule that I'm not privy to. Because like I said, in the other cases I've seen, they argued the constitutional ground at the same trial and the court would have considered it in the same opinion if it needed to.

Sorry, 6, for not getting back to you sooner.

The Office is saying, look judge, before you get to the part of the complaint that implicates us you need to decide that we (the PTO) properly applied the statutes and the law in granting the patents in the first place. But even if you decide that we have, the constitutional arguments plaintiffs have made are wrong and we (the PTO) deserve judgment as a matter of law.

Most of the brief is taken up with (the PTO's) arguments that plaintiffs are wrong in claiming that patenting genes is outside the scope of Art. I, sec. 8, cl. 8 and also wrong that there is any First Amendment violation. Assuming the PTO is correct, there is no reason for the court to keep them in the case, because in the only part of the case that implicates the PTO plaintiffs deserve to lose.

Now, you may disagree with the substance of these arguments, and if the judge disagrees he will deny the motion. But if the PTO is correct then there is no reason for them to remain in the case. Again, a purely procedural issue based on the underlying law.

Thanks for the comment. I would be interest in any insight you may have about what Examiners think should hap


Oh a JMOL, I gotcha kev, thanks man.

What I think is that some of the issued claims are alright and there is certainly no constitutional issue, but there are some claims which I'm not too sure about. Probably more of a job for 101 or 103 than anything though. I also think that most people don't even understand the claims well enough to comment. Myself being pretty much included in the later catagory. You guys explaining what was going on in a different thread was helpful, but I just don't think I'm seeing how all the pieces fit. Specifically, how the arguments against the claims fit into what is happening in the science. And the science is probably still shaky for me.

However, whatever happens in the case, something needs to be done about not being able to get a 2nd opinion outside of the patent holding company, whether it be the patent holding company licensing it to someone so they can do the test or whatever other solution happens.


If the definitions of "Science" and "Arts" have changed (essentially flipped) since the Patent Act was drafted, the current 35 USC needs to be modified for modern times. The Patent Act, the Constitution, and the Bible are all arbitrary documents (to begin with) that need to be modified with the times.

I solemnly believe this issue of DNA/gene patents should not be settled on precedence, because DNA is different from what's precedence - is a chemical, but is not. Could be "man-made" i.e. isolated, but is not really man-made. 35 USC needs to be completely re-hauled at least for biotechnology patents.

My two cents.

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