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« Round One Goes to the ACLU | Main | Director Kappos Testifies before House Subcommittee Regarding USPTO Budget »

March 30, 2010

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Comments

Whether to enforce a patent claim is a business decision. To spend the money necessary to litigate a claim, there must be a monetary reward (i.e. lost profit or royalty stream).

In the case of academic researchers, and especially those at state institutions who may enjoy 11th amendment immunity, why would Myriad waste their resources to pursue legal action when the monetary return is not worth the expenditure?

Kevin,

Good article. And thanks for addressing the important question: is Myriad's patented technology novel (and if it is) unobvious over the prior art?

Judge Sweet's opinion yesterday in invalidating Myriad's patents under 35 USC 101 amounts to a judicial enactment of the Becerra bill. That's "judicial activism" at its worst. We don't need that if we're to have any respect for our judicial system.

Judicial activism with hootzpah!

As Professor Andrew Chin showed, there's a way of defeating all oligonucleotide claims regardless of the outcome of the Myriad litigation -- just put the sequences on a CD-ROM and deposit it in a library. http://unclaw.com/chin/scholarship/artfulpriorart.pdf

I'll never understand why you feel compelled to defend Myriad's greed, Kevin. They filed on a lot of garbage. Deal with it.

"Thus, the results set forth in this paper were almost completely unexpected when approached from the outlook of the person of skill in the art in 1994."

Really? I have no idea how you reach this conclusion. Note that there is no reason that searching the database circa 1994 for sequences that anticipate or render this claim obvious would need to be limited to deposited *human* sequences.

The claim was a bad joke when it was filed and it stinks now. It was plainly overreaching when it was filed. What I would like to know is: why did Myriad stop there? They should have filed claim 6 on "antibodies that bind to proteins encoded by claim 5." And then claim 7: "A DNA encoding an antibody of claim 5." Etc. etc. Maybe Myriad just ran out of paper?

Also, is it just me, or is claim 5 broader than claim 1, from which it depends? Is that not a problem?

"I'll never understand why you feel compelled to defend Myriad's greed, Kevin."

KIR,

Why do you assume that Kevin is defending Myria's "greed"? The fact is both the ACLU, as well as Judge Sweet, are resorting to "judicial activism." What the ACLU and Judge Sweet wanted was in the Becerra bill which didn't pass. Why is it now right for them to grossly distort the patent law precedent, as well as mischaracterizing what Myriad's patents cover?


The fact is Sweet's decision is going to be trounced by the Federal Circuit. That's not because of "judicial fiat," but by following the patent law precedent, as well as construing Myriad's claims properly (which don't cover the genes and are not simply a "product of nature"). If you don't believe me, then just wait to see how Sweet's decision is handled by the Federal Circuit (and be prepared for a judicial version of a verbal "blood bath").

In fact, as I pointed out above, I'm perfectly fine if Myriad's patents go down because they lack novelty or are obvious over the prior art. In other words, judge the claimed invention on the merits, not based on some "moral imperative" that ignores, distorts, and mischaracterizes the relevant facts, as well as the relevant patent law precedent.

Dear Keep:

"No one wants an invalid patent. The in terrorem effect of such a patent is greatly exaggerated, particularly when its invalidity is so easily demonstrated. Here, these claims, as well as similar claims in other patents, turn out to be sufficiently overbroad as to be easily invalidated. It is unlikely that the University of Utah, the National Institutes of Health, or Myriad Genetics (all owners of this patent) wanted this result."

So on this list of malfeasors we need to include the NIH and the University of Utah, correct? I think my explanation is more likely, that we know a lot more now than we did in 1994 and that information has consequences. (Of course, it would be interesting to look at claims for patents having been filed post-2000 to see how many of them have oligo claims).

And you noticed that your hypothetical claims are not in the patent, so you should give them credit for limited overreaching (which has come back to bite them after all). On the other hand, your comment on claim 5 versus claim 1 is right on.

If we have time maybe we will look at how many universities filed such oligo claims in the 1990s.

Thanks for the comment.

KN: "So on this list of malfeasors we need to include the NIH and the University of Utah, correct?"

If they were involved in the prosecution: yes. And shame on the PTO for allowing such claims to issue. Maybe it was all the Ecstacy the kids were taking back then. On the other hand, they still issue a lot of nutty stuff but much less in the 1600 art unit, as far as I can tell.

"And you noticed that your hypothetical claims are not in the patent, so you should give them credit for limited overreaching"

Very funny.

Are you suggesting that a claim can be overbroad today, in view of what's known today, but not be overbroad when filed in 1994? That has some curious consequences.

In any event, the fact that "any particular 15-mer" was expected to occur about 3 times in a random 3 Gbase genome doesn't quite get to the point: you have to multiply those 3 random occurrences by the 1.6 million 15-mers encompassed by claim 1. With roughly 5 million such 15mers scattered through the genome, it was a mathematical certainty (even in 1994) that a large fraction of known gene sequences would contain at least one of them. What was missing in 1994 wasn't knowledge -- what was missing was the computing power to do the search (Examiner Martinell's excellent point.) Claim 5 was clearly invalid, even in 1994.

Claim 1 is where the action is. How does one claim a gene, without leaving room for design-arounds, if this decision is upheld? Perhaps we should pay more attention to ensuring that the compositions and combinations actually used in diagnostic methods are well-claimed.

Dear James:

What I was trying to counter was the implication that the patentees intentionally overreached. I think that the claim was much more reasonable in 1994 when less was known about the structure of the human genome.

I know there are 1.6 million 15-mers, but the thought was that each 15-mer would be present no more than 3 times (admittedly, the math works better for a 16-mer). I think it was not a mathematical certainty that any particular 15-mer would be detected in the genome anywhere other than in the BRCA1 gene; as it turns out, it is a biological reality that such oligos are found hundreds of thousands of times in chromosomal DNA from a chromosome without any related BRCA sequences.

In any event, claim 5 was invalidated, and in view of the data in the Kepler paper it is likely that these types of oligo claim would be valid only if such a search was performed and the uniqueness of the sequence confirmed.

Thanks for the comment.

"[i]t was not a mathematical certainty that any particular 15-mer would be detected in the genome anywhere other than in the BRCA1 gene..."

You are correct. But it was 1.6 million times more likely that *at least one* of the 15-mers of claim 5 would be detected in another gene.

Whether the applicants *intentionally* overreached depends on whether or not they appreciated the difference, and on that score I'm in agreement with your conclusion. This was overreaching beyond sec. 112, and deep into sec. 102 territory -- and who intentionally files a claim guaranteed to be anticipated? (Indeed, we might be arguing different points - you're making a 112 argument, which I'm countering with the probability of a 102 issue.) At any rate, given its other problems, I think we can agree that not a lot of thought went into claim 5.

The PTO doesn't (yet) have the computing power to deliver a yes-or-no 102 verdict on such claims. They can do the statistics, but can an examiner reject a claim under 102 based on a 99.99% probability of anticipation? How many nines before a claim can be denied under 102? How many nines justify a 112 rejection?

"Are you suggesting that a claim can be overbroad today, in view of what's known today, but not be overbroad when filed in 1994? That has some curious consequences."

The only thing curious about it is that examination in this area has apparently been a joke for over 15 years.

"and who intentionally files a claim guaranteed to be anticipated? "

Quite a few applicants in my art.

"How many nines before a claim can be denied under 102? "

I think you need a bar over the nines before you can deny under 102. As you well know, .9bar=1.

http://en.wikipedia.org/wiki/0.999...

"They can do the statistics, but can an examiner reject a claim under 102 based on a 99.99% probability of anticipation?"

Don't forget about obviousness. If you've ever tried to argue that an oligonucleotide of say, 30 nucleotides, which overlaps with another oligonucleotide by 28 bases is "non-obvious", you'll appreciate that it's not easy.

And it shouldn't be easy.

Dear Keep:

Agreed.

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