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« Court Report | Main | Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court »

March 18, 2014

Comments

Kevin,

Nice article and astute comments about how these USPTO guidelines not only overreach, but misinterpret Myriad and Mayo, and are contrary to controlling precedent such as In re Bergy (which I know well have written a law review on living subject matter/product of nature controversy in this case not long after graduating from law school). For example, Paul Cole in his article posted on IPWatchdog has pointed to the mind-boggling example in these guidelines involving the hypothetical Amazonian cherry tree/amazonic acid (a pretty clear analogy to the Pacific Yew tree bark/Taxol in "real life"). The Federal Circuit should pound these guidelines to rubble (and hopefully Our Judicial Mount Olympus will shut up and stay out this situation), but unfortunately our clients will be paying the cost for this USPTO foolishness.

Kevin,
I agree entirely. Regarding "professional association" involvement, I direct you to the amicus brief submitted by the Boston Patent Law Association to the Supreme Court in Myriad. The chief focus of this brief is on the impact of the decision on other natural products such as antibiotics.
Leslie Meyer-Leon

Kevin, thanks for the well-reasoned article. Incidentally, we have already been getting rejections for claims directed to cDNA despite the favorable mention in Myriad.

1) Does anyone think that these Guidelines have been written to deliberately take the Myriad and Mayo holdings to their logical extremes, in order to highlight that they are inconsistent with years of prior holdings, settled expectations of businesses and USPTO practice, and thereby to force a resolution outside the USPTO?

2) What will likely be the route of quickest/most effective resolution? CAFC/SCOTUS? Or corrective legislation clarifying 101?

3) Is a legislative clarification of 101 narrowing the scope of patent ineligibility doomed by countervailing interests of the software/computer industry?

4) Is judicial review likely to uphold this sweeping expansion of the scope of patent-ineligible subject matter?

Dear Leslie:

I am happy to include the Boston PLA with the ranks of those who have filed amicus briefs. But I think that if we are to prevail we need more; the "other side," mostly doctors who use their white coats to justify theft, have a strong backer in Justice Breyer and base their arguments on emotion, prejudice against property rights and a loosely defined argument that "everybody knows" patenting things like genes is just wrong. The argument needs to be made by industry that no one is going to spend $500 million to commercialize the next cutting edge technology without some ability to produce a return on that investment.

Which is why the article focuses at the end on jobs - it seems to be the only thing that gives the Supreme Court pause (read Bilski) and motivates Congress to act (even when it does so in ways that don't help).

Thanks for the comment.

Dear Chase:

Why am I not surprised?

Thanks for the comment.

" Incidentally, we have already been getting rejections for claims directed to cDNA despite the favorable mention in Myriad."

Just because you call a molecule a "cDNA" doesn't mean that it's eligible. Nor does the fact that you isolated it as a cDNA. What matters for eligibility purposes is the sequence of the molecule you are claiming. The Supreme Court was clear about that.

Without seeing the rejections, it's hard to know whether it's your claims that are the problem, or the Examiner's interpretation of the art and law. But again: a "cDNA molecule" is not per se eligible. It all depends on the relationship of the claimed sequence to all sequences found in nature and/or in the prior art.

Kevin: "The response from the patenting and biotech communities has been appropriately Apocalyptic"

As a member of this community who works with many other members, I can tell you that none of us saw anything remotely resembling an "apocalypse" in the Myriad decision, nor do we see anything in these guidelines.

The vast majority of the most innovative companies out there are not in the business of identifying or claiming merely isolated compounds, whether those compounds are DNA or any other molecules. Did some companies get caught up in the Myriad meat grinder. Sure. There's nothing apocalyptic about that.

Most people in biotech community that I know were very glad to see Myriad's claims go up in smoke. Much more of a celebratory event than an "apocalypse."

Try to keep calm, Kevin.

Well, Diana, I have little faith in the ability of Congress to provide a fix, in the face of the massive amounts of money that is being spent to kill patenting. I used to have faith in the CAFC, but they are like a dog that has been beaten - not much fight left in enough of the judges to stand up to SCOTUS, and as long as Justice Breyer is on the Court (and the rest of the so-called "business" Justices worry more about rewarding the unworthy than promoting progress) we will be stuck with this kind of thing.

Maybe the next Administration will be less influenced by politics and more realistic when it comes to patenting. But I doubt it.

Thanks for the comment.

Quite right, Tobias, but I wouldn't presume that was the basis for the Office's rejection.

On another note, I am always fascinated by the pseudonyms readers choose to use when providing their comments on the blog. Is there a literary or other reference I am missing in your choice, or is it just an idiosyncrasy of yours?

Thanks for the comment.

Kevin: "no one is going to spend $500 million to commercialize the next cutting edge technology without some ability to produce a return on that investment."

(1) What in the world does this have to do with the Myriad decision?

(2) People will continue to donate money in all kinds of stuff that they want to see happen. Not everyone is a greedy capitalist who demands massive profits or any monetary profit at all in return for their "investment".

(3) People who might have invested in arrogant, self-entitled, greedy, money-grubbing companies like Myriad can invest in other companies who are less offensive and inclined to push the envelope of what can be patented at ever turn. That's a good thing.

(4) In a recession like the massive historical recession we are just now crawling out of, the government should be much more involved in funding basic and directed research and creating jobs for researchers where the fruits of that research can be enjoyed by the public (including companies).

(5) Generally speaking, Kevin, you have a bad habit of appearing to worry very deeply about insanely wealthy people and whether they are going to give your clients money, and very little else. The "argument" you seem to think is so important (above) really isn't going to be relevant or persuasive to the vast majority of people in this country, nor are they likely to buy the baloney that without insanely rich investors throwing their money at junk patents like Myriad's or Prometheus' or Bilski's or Alice's then technologcial progress will grind to a halt. You're fearmongering. You've got no evidence. All the evidence shows the exact opposite.

Kevin,

You might also ask those "white coats" how many doctors are willing to take on new Medicare patients. And why won't they take on those new Medicare patients? (Hint: it has do with insufficient pay for services provided, and I frankly don't blame them.)

As far as Breyer is concerned, what can you expect from a virulently anti-patent philosophy major? Breyer frankly has a lot of nerve to denigrate the "draftsman's art" (as well as making other snide remarks during oral argument in other patent cases) after writing that atrocious opinion in Mayo.

Dr. Noonan,

From the tone, the assumed familiarity and the assumption that the speaker speaks for a mass of the population out there, and the speech that strikes out "against rich people," I wonder if "Tobias" does not post under the pseudonym Malcolm Mooney or any of the other ever growing hoard of sockpuppets that "MM" uses (but claimed on another blog that he did not use and complained bitterly that such sockpuppets were 'the worst thing ever.")

"Tobias", perhaps you would be willing to confirm or deny this...?

(based on other outbreaks here, will we see such a response? I am...

Not to spend too much time on this (which has been discussed elsewhere), there is very little evidence that Myriad is the most profitable genetics diagnostic company or that what they have charged for their testing is out of line with other commercially available tests. The cost will go down over time, which it has, because that's what maturing technologies do.

And, remember that my retirement is secure no matter what SCOTUS or the CAFC does. There was a time when the Federal Circuit was succeeding in making patent law relatively straightforward, with the goal of providing certainty to investors and business people. This has been reversed, mostly by the Supreme Court but also by Congress, over the past decade. The more arcane the area of the law, and the more important it is to companies making a profit, the more those people as clients need lawyers and are willing to pay for them.

I preferred it the other way, but so be it.

As for the rest, my positions have been clearly laid out over the past 8 years or so on the blog.

Skeptical,

Presume that "Tobias T." is MM until proven otherwise. Very hard for this leopard to hide his spots.

To clarify, the 101 rejections we have gotten on cDNA have been maintained in cases where the cDNA is consistent with the description of eligible subject matter on pages 16-17 of the Myriad opinion, and where we submitted sequence information to the patent office to demonstrate that to the Examiner.

And as part of the biotech community myself, I completely agree with Kevin's take on this.

Diana--wasn't it supposedly high tech, generally anti-patent interests who helped push the AIA through, and who seem (I believe according to Hal Wegner) to be behind these PTO anti-patent initiatives? If that is correct, Congress would seem to be the last place to expect help. I hope the courts might eventually realize what a mess this explosion of misguided 101 doctrine is creating, and pull back on it.

Chase,

Would it be too much to hope for a Chakrabarty/Diehr response to the pattern of Benson/Flook type of rulings?

Alas, I remain...

Chase: "To clarify, the 101 rejections we have gotten on cDNA have been maintained in cases where the cDNA is consistent with the description of eligible subject matter on pages 16-17 of the Myriad opinion, and where we submitted sequence information to the patent office to demonstrate that to the Examiner"

If this is true and your "cDNA" sequence as claimed is non-identical to any DNA sequence in the prior art or in nature, it sounds as if you are just dealing with human error. That's never going to go away.

It has nothing do with the Supreme Court or the PTO guidelines, however. I'd love to see the actual file wrapper, in any case, if you are willing to share the application number.

Just for the record the same conclusion for much the same reason had been reached in my posting in the patents4life blog.

I think that the PTO overstepped, and I think that the Supreme Court was wrong in Prometheus and Myriad. But for present purposes, I'd be grateful if the PTO could avoid confusing the matter further by using the terms "significantly different" and "markedly different" interchangeably and without any attempt at definition. We know that a DNA sequence cloned from an organism is neither "significantly" or "markedly" different than the same DNA sequence prior to cloning (Myriad), but that's not much help. We are left to the mercy of the good judgment and interpretive skills of patent examiners until the Federal Circuit provides further guidance.

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