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« Venture Funding in Life Sciences Sector Drops 9% in Second Quarter | Main | Grants for Funding University Technology Transfer Introduced in Congress »

July 23, 2012

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I wonder whether Mr. Castanias had read Watson's brief. Was it a good strategy to call attention to Dr. Watson?

"[T]he Federal Circuit spent a generation under the leadership of Judge Rich, and Judge Markey, and all the other Chiefs and other judges, in fulfilling its mandate of being the court that understands technology and patent law and thus is in the best position to interpret that law and apply it to the cases before it. It should continue to do so."

Kevin,

Amen to that.

While I would personally agree with that "Amen" EG, there appear to be plenty of people who do not share that view of the expansive benefits of patents, and (selectively, for different arts) would find that those like Rich and Markey illegally expanded the purview of patents.

I am skeptical that merely invoking the names of Rich and Markey will sway those that are fundamentally opposed to (the perception of) Rich and Markey. Preaching to the choir will not aid in the act of conversion.

Dear Arthur:

I think the reference was intentional - his point being that the gene claims are not infringed by whole genome sequencing, something Judge Bryson thought when he wrote his opinion the last time.

Kevin, you seem to think that a patent monopoly is the only possible incentive for producing a drug. Why do you think that? There's no evidence for that belief.

Moreover, products and laws of nature are necessarily part of the commons (which is no tragedy, I'd say), as established by the Supreme Court, but once you move sufficiently downstream, say to where some product becomes something that is now the result only of man's design and intention, then we'd both agree it should be eligible under 101.

In Myriad, if the plaintiffs ultimately prevail, it will not mean the end of life-saving research, as the BRCA genes were being closed in on by numerous research groups, largely publicly-funded, at the time of their discovery, and someone would have produced tests capable of screening for those genes, patents or not, because there was a market. Competition would have meant reasonable prices for those tests, and less-inflated medical costs putting pressure on insurance premiums. That's how the free market works. I don't see the point of worrying so much over ceding some ground back to the scientific commons. It would be just.

Seriously, David? In my experience, patent protection is the only incentive to produce a drug today. Perhaps that was not the case before the thalidomide disaster, when it did not cost hundreds of millions of dollars to get FDA approval and when Jonas Salk could test his vaccine on the residents of the local home for retarded children, but not today.

Products of nature are not a Supreme Court recognized exception, no matter how long anyone on your side of the argument makes that claim. But to make the discussion concrete, tell me which of the three penicillin claims you think satisfy 101.

Your ex post facto analysis of what would have happened with the BRCA genes ignores the investment in the methods and infrastructure that enable Myriad to have a track record of never making a mistake. What gets lost is that, today, these patents are unnecessary for Myriad's business. But at the time they were necessary for the investment to set up the tedious, redundant methods of quality control, genetic counseling and insurance reimbursement. That effort would not have occurred without a reasonable ROI, which the patents provided. And heaven forbid having research scientists, or worse clinicians, trying to provide these services - not only isn't it what they do well, it isn't what they should be doing.

At the end of the analysis, I think doing it "your way" would result in fewer genetic tests and those that did exist would be monopolized by the big corporations, who would be able to out compete small companies and steal inventions made by university and other publicly funded scientists. Which is what happened before Bayh-Dole. I don't see making the choices you make, for the reasons you espouse, to be compelling enough to suffer those consequences.

So we will continue to differ. Thanks for the comments. Hope you are well (your daughter is growing up too fast!)

Hey Kev, did you like the part in the oral args where the one party noted that Myriad had yet to offer a single use for the whole unisolated gene at issue that would not infringe? Wonder where they got that arg from? Hmmmm, seems like it popped up somewhere nearby to this thread, perhaps where an anon discussed it with a certain Kev. More later on your points you raised in your post.

"by saying that preemption is a proxy for whether there is an invention."

It is only a proxy if you're a person with an underdeveloped mind :(

"Here, his point was that there was a great deal of human ingenuity involved"

And nobody cared.

"Mr. Castanias agreed that this would not be patent-eligible but because it is not an invention, being just a new way to make an old thing. "

Since when is a new way to make an old thing necessarily not patent eligible?

Mr. Castinas argues himself in circles.

"The inventors defined this as the BRCA1 gene"

Finally someone defines it.

"which required an enormous amount of inventive effort"

Again, nobody cared.

"making it very unlike a tree trunk"

That's interesting, I'm not 100% sure that anyone has ever extended the effort to define where the trunk of a given specific tree truly ends and the roots begin down to a micro-cellular level. I bet it would take a lot of manpower to do that. Guess tree trunks will be patent eligible when they do it right?

"Mr. Castanias started well,"

If that is "starting well" where you come from then I could have started "awesomely" very easily.

"But then Mr. Castanias and the bench spent what everyone recognized was a few unfruitful minutes discussing whether claim 20 was properly before the Court. "

Yes, what a waste of time that whole bunch of malarky was that you posted the other day.

"Mr. Hansen, during his argument, was happy to provide the Court with Lockheed Martin Corp. v. Space Systems/Loral, Inc. for authority to the contrary"

Because Mr. Hansen was the only attorney other than the gov that knows what the frak is up in the case.

"which is not surprising"

It surprised me that a roomful of patent greats couldn't parse simple language in a simple claim.

"Again, Mr. Hansen came to the rescue"

Because again, he's the only one that understand what is going on. Everyone else apparently took the day off because they know the case is headed to the supremes so that the supremes can overrule Moore.

"Mr. Hansen (at right) began his argument by noting what he called the "stunning breadth" of the composition of matter claims,"

In other words, Mr. Hansen started off awesomely.

"udge Lourie interrupted by noting that breadth is properly a concern under Section 112 and not Section 101 of the Patent Act."

In other words, Judge Lourie is unfamiliar with Prometheus and BFDB.

""law of nature"/"product of nature""

I prefer to think of what they call products of nature as "natural phenomena" since natural products are simply phenomena. But whatever floats your fancy.

"Judge Moore noted that his breadth argument undercut his preemption argument, because if preemption the issue, breadth is irrelevant under Mayo."

Because Judge Moore doesn't understand Mayo as I believe she just got through demonstrating the other day in a decision. Poor Judge Moore, just begging for the Supremes to spell it out for her.

"She indicated that preemption is a "bright line prohibition" and thus this argument is "a waste of time and space.""

Can't wait till this case gets back from the Supremes and she eats those clueless words and I get to lol.

"Wisely, Mr. Hansen took the opportunity to move on to claim 20. "

I disagree, it appears to me that claim 20 will probably pass, at least until I further study what it is actually attempting to preempt. I may have posted on this awhile back.

"Reality check: it would have been impossible to produce a recombinant (or "transformed") cell comprising a cancer-causing BRCA gene variant until such a gene was isolated by Myriad."

And nobody cares Kev. :(

"falsely negated the inventiveness of the BRCA transformed cell"

The preemption doctrine is not about "negating" the "inventiveness". It is about noting if such subject matter has been judicially exempt. If he was using this as his basis, which I forget if he actually did or not, he is mistaken.

"and moreover, with anything -- "salt, sugar, water, oil" as opposed to the non-naturally occurring drug in Mayo"

Yeah, there might be a natural phenom/law at the heart of the claim that I'm just not seeing atm and which they haven't spelled out yet. It may well be preempt.

""if all you did was to put PenG next to bacterium and tested and it worked better than water, then that isn't patentable"

That is a much better argument than what he started out with re: claim 20.

"a "concern" in Mayo regarding the extent to which claims preclude public access to a product of nature"

Aka the basis of the preemption doctrine for the last 50+ years.

"unitary Executive"

Even while we have a substantial number of intellectually deficient people spouting off about the preemption doctrine that they do not understand in the USPTO.

"Ms. Patterson raised Bilski as an example of where "thousands" of patents had been invalidated and said that the "settled expectations" provided "no reason to alter how a court looks at Section 101," asking the Court to make general (and preclusive) rules on patent eligibility."

Obviously. As if the lawl on 101 should bend to the PTO misapplying it.

"In his rebuttal time, Mr. Castanias clarified the language of claim 20 and disputed Mr. Hansen's allegations that the transformed cell was something Myriad "got of the shelf, like a test tube." "

In other words, he misunderstood Mr. Hansen's allegation that the cell that was to be used in the transformation was something that Myriad got off the shelf. Mr. Hansen didn't say, and didn't mean, that the cell, already with the gene inside it, was got off the shelf. He meant the base cell, pre-implantation with the gene, was got off the shelf. In other words, Mr. Hansen, who knows what the frak is going on again runs circles around the "legal greats" in the room.

"e also attacked the government's argument as establishing "no principled line" for making the distinction between patent eligibility and ineligibility, and said that Chakrabarty draws the line."

Obviously incorrect, preemption draws a clear line, and Chakrabarty is in complete accord with that line.

"He also distinguished his earlier remarks as not being a "sweat of the brow analysis" for patent eligibility but being the product of "work and inventive judgment.""

In other words, it isn't a sweat of the brow argument, it is a needlessly complicated version of a "sweat of the mind" argument.

" Mr. Castanias ended with his most persuasive argument: that Chakrabarty is the answer and Mayo doesn't change it."

He's right of course, but unfortunately that answer is not the one he wants. Lulz.

Now for your commentary Kev:

"The danger in AMP's preemption argument, and even more so in the government's argument, is something hinted at in the now-vacated Federal Circuit majority opinion."

I like that you finally recognize what their actual argument is. Aka the same one I've been drilling into you for years.

"That is the argument, expressed frankly by the government, that merely isolating something from nature was "not enough" to render it patent eligible."

Nothing save for a failure to preempt a judicial exception is "enough" Kev. :(

"Another is the failure to discuss the inseparable impact on what is claimed and how it is claimed."

The draftsman's art was discussed at length in Prom Kev. Why reopen old ground?

"what of the patent-eligibility of penicillin"

Remind me what penicillin is made of and I will help you out.


"Philosophically (while we are talking general principles), the government's position that claims should not be allowed that will preempt a "product of nature" is a good way to create a "tragedy of the commons," because there is no incentive to identify, isolate/extract, test, and produce a drug from a naturally occurring source if its source precludes patent eligibility."

Sure there is, you can still patent the drugs and other true inventions. Nothing is stopping you from doing that. You just don't understand the preemption analysis Kev :(


"does not recognize is that there is a good reason to make the distinction"

The recognize the distinction. The distinction just happens to not be material. Sorry bro.

A few notes on the end:

"Patenting a natural law restricts development of any future application of that law during the lifetime of the patent, whereas patenting a chemical compound from nature is limited to that compound."

I think you meant to say:

Patenting a natural law restricts development of any future application of that law during the lifetime of the patent, whereas patenting a chemical compound from nature is limited to restricting development and exploiting any future application of that compound.

"Indeed, it has always been the case that "the public" is free to find new uses for compounds made by others and to patent them, which the original product patentee cannot practice without a license."

I think you meant to say:

Indeed, it has always been the case that "the public" is free to find new uses for compounds made by others and to patent them, which the original product patentee cannot practice without a license, although that person who patented the new use also must pay a fee to the original patentee in order to exploit their new use, or perhaps get an injunction issued against them.

"Thus, product patents by their nature do not have the breadth of method patent claims and do not raise the same issues due to the specificity of what is claimed in a composition of matter claim."

I think you meant to say:

Thus, product patents by their nature in some cases have a much wider breadth than many method patent claims and thus do not raise the exact same issues, although perhaps raising even larger issues, due to the specificity, or not, of what is claimed in a composition of matter claim.

"No matter how the Federal Circuit decides this case, what is at stake is a larger principle."

Amen. Let us all hope and pray that the preemption doctrine prevails against these folks.

Poor strategy to cite Dr. Watson. Overall, Castanias did NOT do well. Fortunately for him, the oral argument doesn't matter in deciding the case. The judges have already decided based on the briefs.

Dear Kevin,

Thanks, Amelia is amazing, a wonderful natural phenomenon :)

We agree that regulations have skewed the R&D cycle and market in drugs, but disagree about the relative roles of which regulations need changing, I think. I believe the current system skews R&D toward blockbusters, away from important but less profitable niches, and leads to mainly incremental changes in popular, boutique drugs (like anti-depressants). Contrast this with the early days of chemotherapy agents where, impelled by private foundation and govt. funding, numerous agents were rather rapidly discovered and tested. Albeit, the current testing regime is admittedly very awkward and probably inefficient (and maybe not helpful or necessary)

Regarding genetic tests, the space appears now to mainly occupied by the big players anyway, so your argument about allowing smaller players in seems not to be borne out by the evidence. Of course, my evidence is based only upon my quick scan, I'd be interested to see if in fact patents have opened up that market to entrepreneurs who have thus been able to compete against the big guys. Can you show me some figures on this?

We both know that Myriad's ROI was accomplished long, long ago for BRCA, and despite promises to lower the costs of testing to $300, they never did, instead using insurance to pay their high fees of $3000, costing everyone extra in the process through higher premiums.

Finally "natural phenomena" are explicitly excluded from patents (under Chakrabarthy), and that includes products of nature and processes of nature, both of which are natural AND phenomena (something, fact or occurrence, that is observable by the senses). Unless you have a specific definition of a phenomenon that somehow excludes products, but that would be a non-standard definition.

Anyway, best to you and yours, and at least we both agree that Myriad is set for, at best, a Pyrrhic victory if they prevail, and that will mean SCOTUS will likely doom everyone else for the cost of Myriad's bullheadedness.

as ever,
David

As a friendly reminder to everyone, the ONLY claims that would prevent others from determining whether a person carries a mutation are the now invalidated method claims (invalidated by the Federal Circuit, and NOT appealed by Myriad -- and don't forget about the 9-0 Prometheus v. Mayo decision) and possibly the cDNA fragment claims, which are certainly invalid anyway in view of prior art. It's really kind of amazing that Myriad even pressed on. If anyone launches a test that is performed the way Myriad currently performs its test, Myriad will not sue for patent infringement. The only problem is that Myriad has a database of mutations and clinical data that the world does not entirely know about (I say "not entirely" because Myriad used to publish this stuff, but stopped doing so back in 2004 I believe). So if a third party runs the test and discovers a variant, it will be at a disadvantage in terms of identifying the variant as disease-causing or not. This disadvantage should dissipate over time, but it could take awhile. I just wonder what Myriad truly hoped to gain by pressing on.

David,

Myriad may be "bullheaded" on this issue, but that is their choice, as it is your choice (and right) to disagree with me and Kevin on the patent-eligibility of Myriad's claimed isolated DNA sequence.

As far as the "product of nature" doctrine, I would be careful how you rely on that doctrine. Everything on this God-given earth could be considered a "product of nature." The question is whether there's a "difference in kind rather than degree," and that's not always easy to determine.

An example of this is the Pacific Yew, the bark of which contains taxol. You can't chew on the bark of the Pacific Yew and get the anti-cancer benefits of taxol. Instead, you have to extract the taxol and get it into a form that will provide the therapeutic anti-cancer benefit (see Kevin's claim 3); that's what is patent-eligible, not taxol per se (that's Kevin's claim 1).

I wrote a law review article (13 Richmond Law Review 247-78) on the patent-eligibility of microorganisms over 30 years ago (not long after I graduated from law school) involved in the cases of In re Bergy and Diamond v. Chakrabarty which required me to do extensive research on the so-called "product of nature" doctrine (so-called because it wasn't clear if the doctrine really existed, other than in dicta). What I discoverd from doing my legal research is that the doctrine is very murky and difficult to apply. In fact, many of the so-called "product of nature" doctrine cases are actually efforts to patent what were "old" compounds and compositions, thus lacking novelty.

What I found usually matters is whether the properties of the isolated entity (or the structure of the isolated entity itself) are truly different from the native source. If they are, the isolated entity is usually deemed patent-eligible. And if Myriad's claimed isolated DNA sequence is different in structure and/or properties as Myriad asserts it is, then this claimed isolated DNA sequence is patent-eligible, even in view of the "product of nature" doctrine. In this regard, I would suggest reading Professor Holman's amicus brief which expertly explains the technology (and law) involved, and why it's patent-eligible.

That's my 2 cents which you are free to accept or disagree with as you choose. And yes, kids are wonderful to watch as the grow up (and it does seem they grow too fast for us to comprehend). Do enjoy each moment of Amelia's life. My two boys are now 22 and 24, and I still remember many moments from their early childhood. Do treasure them.

To Eric I would like to say, first of all mazel tov on his family, and then point out that I have similar fond memories of the infancy and childhood of my Simon, now 27 years old. In fact, it was in the delivery room that I first became truly aware of God's handiwork in our lives. This faith persists and convinces me that despite the accusation of Vitalism, a human being is distinguishable from a dog (ALDF v Quigg) or a microorganism. I rest my case.

Eric,

Thanks for that, I have read your article, and it does a good job of pointing out the positive law. I am concerned foremost with finding some ontological distinction that would justify the Court's exclusion of products of nature, making sense of that, and applying it in some rational way. I don't believe the positive law has done that, and because of that, I think there is injustice that requires fixing. I think that a rational border between the natural and the non-natural is where human design and intention combine, and think that justice is served if we limit patent-eligibility to only the non-natural. That's why I press on.

I echo Arthur's "mazel tov," and am enjoying every moment I can of this wonderful adventure. We're enjoying it so much, we may try to make another ;)

all my best,
David

I vaguely remember David, from another time when he escaped from the assylum. Although we rarely agree, I find his bloviations entertaining. In regards to his comment that Myriad's $3000 fee is high, this needs to be placed in context and not a launching pad to discredit Myriad which provided one of the few successes in personalized medicine. A group at Duke undertook a study and found that the BRCA test is not costly relative to other tests. There is a more systemic problem of transaction costs that raise medical costs, which is not Myriad's fault.

Randy, enduring your contempt and vituperations is a badge of honor. Hope all is well with you, seriously.

I'd also note that nowhere in my comment do I state that Myriad's test is "too" expensive, but I do note that the government's exclusive monopoly has allowed them to keep that price, despite their promises at one time to lower it, without the danger of free market competition to force their price closer to the actual costs.

Finally, I assume Randy's mis-spelling of "assylum" moreover was intended to be cute.

as ever,
David

David, I apologize for the misspelling. The perils of using a smart phone I suppose. I applaud your attempt to distract from the actual topic.

I do not accept the premise of the basic arguments you propose. Myriad has a legal patent and develops arguably the most successful diagnostic tool in personalized medicine. So, lets sue the hell out of them (over and over). Shouldn't your side be mad and follow up on the suit against the government for granting the patent and then failing to march in? Instead the government is submitting amicus for the plaintiffs and you are mad at Myriad. How does all of this make sense?

Randy, a couple of observations in response:

- I know you disagree with the basic premise that a govt-sponsored monopoly is not a free-market mechanism. Like many of Ayn Rand's followers, you have that blind spot.

- Who is suing "over and over?" The challenge to gene patents in this case is unique. Moreover, the original suit DID name the USPTO as a defendant.

- yes, I'm mad at the USPTO for granting a patent that I believe is not eligible. It's a shame the courts have to step in and set them straight, as I hope they do.

- I'm not "mad" at Myriad. I can hardly blame anyone who is given a govt-sponsored monopoly under the guise of the law for using it to their fullest extent to make as much profit as possible. I never claimed any moral duty otherwise. My entire argument has always been that the subject matter granted protection is outside the rational bounds of patent because it is a "phenomenon of nature." I do find it bothersome that Myriad had at one point claimed they would offer their tests for as little as $300 (Skolnick said this himself) and then never followed through. Nice bait and switch. But fair business, certainly.

- The DOJ is clearly at odds with the USPTO on this issue, but far be it from me to disagree with representatives of the government when they do take rational positions, as the DOJ has in this case.

It all makes perfect sense, when you don't distort my claims or arguments.

all my best,
David

I have studied Rand, but do not consider her a gospel. There are limitations to free markets, so we have a self regulating system resulting in
a trade off of a temporary monopoly in the US. Australia no longer honors the patent on the test. In the original law suit, the USPTO is a defendant, but seems to be out of the fire recently. So is whomever is the march in police. It is them that have dropped the ball regarding licensing and pricing. Can we agree in that?

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