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« "Colbert Report" Enters Gene Patenting Fray | Main | Court Report »

April 18, 2010

Comments

Kevin, you're right on: with economics, it's all about the assumptions one uses. Economics likes to cloak itself in scientific clothing, but it's not science, since there's no lab and no way to the control the variables. So you can still get to the "right" answer based on the wrong assumptions you make. Your answer just won't reflect the real world.

Here, it's hard to assert that in Prof. Stiglitz lacks functional gray matter, but his op-ed piece suggests that he must be one the stupidest smart people on the planet. That, or he simply hasn't done the research to understand what patents protect (and what they don't protect), how long that protection remains in place, and the quid quo pro of disclosure. He certainly seems to have turned a blind eye to the growth in the biotech industry that resulted from Bayh-Dole.

There's a law school at Columbia. The academically honest thing for Prof. Stiglitz to do before he next opines on patent matters would be to spend time there taking some courses in patent law.

Kevin,

Thanks once again for pointing out how the propoents for banning gene patenting, as well as the medai simply rely on credentials (Nobel prize) of "smart people" (Professor Stiglitz) who know nothing about the subject they're talking about (impact of gene patenting). That's why it is important for folks like you who know what they're talking about to point out why the "amateurs" don't, even in the face of being criticized and demonized for it. My hat is off to you for being brave enough to point out the rhetorical nonsense (again) of those who are distorting the facts, science, and law, but are unwilling to acknowledge that there is another (and more accurate) side to this story. Believe me, I've already been "demonized" for daring to suggest that the ACLU and 60 Minutes have grossly distorted and misrepresented the facts, science, and law this gene patent debate. Do continue the good fight!

Hear, hear! Please keep up this valuable public service.
By the way, there was a segment on NPR last Friday about the multiple antibiotic-resistant bacteria problem (MRSA) and some discussion about how drug companies are apparently not pursuing new antibiotics that might be useful against them. It wasn't part of the discussion, but I wonder whether this is because many antibiotics have common structure to the point where any "new" antibiotics would probably be deemed obvious under KSR and therefore nonpatentable. Also, haven't at least several pharma executives stated publicly that they will not invest in technology unless there is good patent coverage? It would be great to have a collection of such statements. People certainly say this sort of thing when they look at investing in our company, and it's easier to cite such a quote than it is to try to explain this complicated science to non-scientists.

Thank you, Kevin, for not only pointing out the errors of the common misconceptions surrounding this debate, but also, and I'd say more importantly, for educating the public on the reality of gene patents and patent law in general. It is one thing to be critical of the nay-sayers, but it is far better to explain why the flaws in their arguments are incorrect, based on facts and evidence. Or at least attempt it. I have been following this debate since the case was filed against Myriad, and have had many personal discussions on this topic with various people, only to discover how little they knew of the patent system, what was actually asserted in the lawsuit, and how patents affect the economy in a practical sense. While not everyone is open to learning, thanks for being a constant voice in the pro-gene patent side of the debate. It is not easy, but it is appreciated!

"Partially true, with regard to companies -- it should come as no surprise that patents prevent competing commercial activity. "

If only it were an invention Kev. It's really more of a derivation... Now, I know, I know, patent attorneys have been stretching the term invention for quite awhile now, but that doesn't really make it any more right to do than the first day they started such a practice.

JH,

Thanks for sharing your empirical experience. What you've seen here isn't uncommon, as the popular media is particularly bad at distorting what the facts, science, and law are on this issue. Also, the forces attempting to ban gene patenting, including the ACLU, are "fanning the flames" here in a way that grossly distorts, and only acknowledges, one side of this debate. The use of so-called "experts" with impressive creditionals but with no real knowledge of what they're talking about when it comes to the gene patent controversy is one very distressing tactic being used by the forces against gene patenting. That use is also highly dangerous in swaying the public that is otherwise ignorant based on emotion (not reason) to accept as "gospel" what are often deliberately distorted views of the facts, science, and law.

"It has been a consistent theme of the ACLU and their friends that Myriad has somehow hijacked an individual's genes, when the fact is that gene patents do nothing of the sort."

Kev, you know I've been thinking about this supposed "misstatement". And it seems to me like there are a lot of intelligent human beings who are making this argument. Indeed, even several of them who are not ignorant of the facts and the law. So this leads me to believe that the parties may be talking past one another. That is, they are not presenting their viewpoint in a manner in which you are able to understand, and your side is not presenting your viewpoint in a manner which they understand. Or at least the former.

So, to that end, I decided to think on the matter a bit more and see if I could try to better understand what the ACLU et al. are actually trying to say, even though maybe they're not presenting it so well.

Allow me to bounce this off of you right fast, and no response needed if you already got this much from what they're saying.

It seems to me that there is a good chance that when ACLU et al. refer to owning someone's genes they may not be talking about direct ownership, but rather an indirect ownership. For instance, if I as an individual own land, but another person owns the right to exclude use of that land (or an isolated section of that land) in a particular fashion (mining, farming perhaps?) then my ownership is diminished and not complete ownership. Another person has partial ownership over my land in a manner of speaking.

Is this not directly analogous to my owning my genes and yet Myriad owning the right to exclude me from using my genes in, for instance, a breast cancer test? Is my ownership not diminished while another indirectly "owns" the right to use my genes (by excluding me from doing so unless I take a license)?

Just bear with me and see what you think. Two fairly simple questions are presented by someone who is not really in the know about ownership.

"It seems to me that there is a good chance that when ACLU et al. refer to owning someone's genes they may not be talking about direct ownership, but rather an indirect ownership."

6,

I can almost guarantee that the ACLU is representing (or more accurately misrepresenting) that Myriad, through its patents, is trying to own your genes. What the ACLU has done is "legal grandstanding" at its worst. The ACLU's complaint so deliberatly misrepresents what Myriad's patents cover that I and others feel it should be sanctioned under FRCP 11. That Judge Sweet bought into this drivel doesn't make it any less offensive to factual and scientific accuracy, as well as proper legal construction of what these patent claims cover.

Kevin,
I'm a biotech patent attorney who greatly appreciates your blog and your defense of IP needed for innovation in the industry. But the more I think about the Myriad claims, the more I think that the ACLU picked the right defendant and patents to attack in order to establish bad law.

The Myriad '282 defines "isolated" as follows: "An 'isolated' or 'substantially pure' nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins. The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems."

I think due to this broad definition of "isolated" and the presumption of validity, another diagnostic company would be risking infringement simply by developing a diagnostic test that involved obtaining a DNA sample from a breast cancer patient in the BRCA1 population.

I think the act of simply preparing a DNA sample for testing from a BRCA1 patient for another test could be considered to infringe '282 claim 1 because during the sample preparation process it is likely that the patient's BRCA1 DNA, as well as the other "design-around" sequence being analyzed, would be substantially separated from its naturally occurring environment.

In short, any DNA sample preparation method for diagnostic test of a breast cancer patient in the BRCA1 population is likely to result in an "isolated DNA" reading on the '282 claim 1 at some point.

Maybe the defendant could win SJ of non-infringement with the right claim construction, but that would likely be a coin flip, and I wouldn't want to be before a jury in a Utah Dist. Ct. where Myriad is based.

If an FTO analysis based on this construction of "isolated" informed the risk analysis of decision makers in any potential design-around diagnostic test company it could have prevented their decision to pursue their innovation.

Ultimately, I think the problem here is an old one, overbroad claims issuing to that should be invalid, but who is willing to risk challenging them.

Unfortunately, I fear these bad claims have allowed the ACLU to pursue a strong case that could establish bad law.

Dear Just:

I agree that the ACLU picked a "good" defendant, for a variety of reasons (sympathetic nature of at least some of the plaintiffs, an aggressive patent-enforcing strategy by Myriad, and the complexity of the technology). And while I think there are certainly claims that may be more or less overbroad, I think the claims such as Claim 1 of the '282 patent are relatively straightforward and consistent with other gene patenting claims.

As such, I think that there are many ways to identify a mutant sequence that do not infringe this claim. PCR amplifying and sequencing a select portion is one example. I don't know how Myriad performs its tests, but I think it unlikely that they isolate the entire gene from every patient. But I could be wrong.

Thanks for the comment.

Dear 6:

I understand their argument - don't worry. But to address yours, we need to separate the gene claims from the diagnostic method claims. As I said upthread, I don't think it is necessary to isolate a gene to perform the kinds of mutation detection testing that Myriad does. So there is no occasion for an individual to have part of "her" property controlled by anyone - no one owns your genes, period.

Now, if we are talking about a diagnostic test, then the argument is a little different. There, the question (for me) is a patent one - you can say "no!" to diagnostic tests (as Justices Breyer, Souter and Stevens did in Metabolite), but what is the outcome? No patent protection, no incentive to disclose (note that I didn't say "invent" or "innovate" or "commercialize" - in this case disclosure is the key). Arranging the system to discourage disclosure is a bad idea, in my opinion - as I have said at length elsewhere.

But thanks for the effort to try to bridge the divide.

Finally, with regard to your opinion that I should get to the gym, do you really want my trainer to have to get medieval on your ass?:

http://www.nbc.com/American_Gladiators/images/bios/large/venom.jpg

(No joke)

Thanks.

I was amused by the authors' view that a patent was not warranted because the gene was "already there." I daresay the esteemed professors would appreciate the invention more if they lost their car keys and needed help finding them, despite the fact that the keys were "already there".

Intellectuals, including Nobel Prize winners, have no business medling in the affairs of practical people.

Just and Kevin:

Myriad performs its test by amplifying the exons with specific primers and sequencing the amplicons. Claim 1 of the '282 patent does not prevent anyone from doing this. There are some fragment claims which may be infringed by certain primers (e.g., sometimes when an exon is large, you have to break it up and this requires using primers that hybridize to coding sequence). But the principal claims that Myriad relies on to prevent others from performing a BRACAnalysis-type test are the claims directed to methods for identifying mutations. Everyone is up in arms about Judge Sweet's decision with respect to the composition claims, but it's not the composition claims that really protect the test (other than possibly the fragment claims mentioned). His decision on the method claims is basically in line with the S.D. Cal.'s decision in Prometheus v. Mayo (reversed by the CAFC panel in an utterly incomprehensible decision) and the Breyer/Stevens/Souter's dissent from the dismissal of cert. in LabCorp v. Metabolite.

Gary and Kevin,
I agree that Myriad's diagnostic method claims based on detecting BRCA1 are the ones that it should rely on to exclude any diagnostic company competitors. The political problem for the biotech industry is that the "isolated DNA" claims are the focus here. I think that these claims have overbreadth problems and raise a lot of fundamental issues regarding the scope of IP rights on natural occurring compositions. Politically, we should probably take a more measured approach and not stake too much on them. If this goes up to the S. Ct. or to the legislature there's potentially a lot more to be lost.

To further clarify what I see as the overbreadth problem that I think can be used by ACLU (and others) to argue that "isolated gene" patents go too far...

Any DNA diagnostic test starts with a tissue (or blood) sample that has to be pre-treated (homogeneized/cells lysed/spun/perhaps some DNA cleavage) before the PCR amplification step. I think this pre-treatment results in a sample containing an "isolated BRCA1 gene" under the Myriad patent's definition (and probably many other such patent's use the same definition). This sample containing an "isolated BRCA1 gene" would exist even before the BRCA1 specific primers are added - i.e., even if another sequence besides BRCA1 is being tested. Consequently, I think it would be difficult if not impossible for a Myriad competitor to design a DNA-sequence based diagnostic test for breast cancer patients that does not result in "isolated BRCA1 gene" in the patient DNA sample.

I agree that everyone in genomics/biotech/diagnostics industry drafts and prosecutes this type of "isolated DNA" claim (I've drafted many) and all biotech patent attorneys know that recitation of "isolated DNA" is acceptable and required. But until this case, I had not considered how broad the reach of "isolated DNA" could be in the context of diagnostic testing - and how this reach could appear to the lay public.

Hypothetical S.Ct. or Congressional questioning:
"So Myriad you contend that your claim doesn't cover the BRCA1 gene when it's inside a BRCA1 patient's body - only when it's "isolated." But under the terms of your patent isn't the BRCA1 effectively "isolated" as soon as the BRCA1 leaves a patient's body and is prepared for DNA testing - even if the test is for another different cancer gene? How can a competing diagnostic company hope to commercialize an alternative to your BRCA1 test when it can't even prepare a patient sample for DNA testing with infringing your claim? How can a patient ever expect to get an independent second opinion it there is only one test it can use and one company providing it?"

IMO - It might be better off for the biotech industry to give up on some "isolated gene" claims and fall back to the clearly patentable subject matter of e.g., diagnostic method claims reciting hybridization and detection steps. It will be much worse if the industry fights to the death on "isolated gene" claims and then Congress passes more severely limiting any diagnostic test based on a human gene sequence.

Dear Gary and Just:

I think that, despite the "definition" in the specification, there is no way what a court could construe the composition of matter claims to read on a gene in a DNA prep from a cell - if only because if that were the scope the claims would be anticipated by any DNA prep ever made from a mammalian cell - right back to nuclein as discovered in pus by Frederich Miescher in 1871.

I think there is much more risk in the diagnostic method claims, depending on what the Supreme Court decides in the Bilski case. Once that comes down, we will know where the problems are.

Thanks for the comments.

Kevin,

Very astute thought about the impact of Bilski on Sweet's ruling regarding the method claims. In fact, Sweet pretty much staked his ruling in this regard to the Federal Circuit's holding in Bilski, even though it's a virtual certainty that SCOTUS will overturn (or greatly limit) the "machine or transformation" test. That Sweet would do so seems very ill-advised and virtually ensures that his ruling will be overturned by the Federal Circuit as the SCOTUS ruling in Bilski is almost certain to come out before the Federal Circuit hears the appeal of Sweet's ruling. If possible, it would have served judicial economy better to have postponed the ruling in AMP v. USPTO until after SCOTUS ruled in Bilski.

Suppose Myriad didn't appeal at all. The last post from Just seems to suggest exactly this: Get rid of the "bad facts" and avoid the "bad law."

Dear crelboyne:

My sentiments exactly.

Thanks for the comment.

Simply stated, I agree the claims allowed in the Myriad case are too broad with regard to the definition of "isolated" and with regard to the sequence description relative to the 15-mer. Those claims shouldn't have passed muster in the PTO and as a result this patent is vulnerable to the court ruling that it received. I don't know (I'm not a lawyer) if on appeal the patent can be restored with more appropriate claims or deletion/modification of some claims but that would make more sense to me.

Kevin,
To reiterate what others have said, thanks for continuing to fight the good fight on this issue. Please keep it up.
Also, maybe you're already doing this, but if not, please expand your comments/arguments beyond this blog and into forums more often read by the general public (letters to the editors of newspapers and magazines, e.g., the WSJ, online comments on 60 Minutes' website, etc.). Yours is one of the clearest, most comprehensible voices out there on "our" side of this issue, and it would greatly benefit everyone if it was as widely heard as possible.
Thanks again.

Contrary to your supposition that disclosure is a great benefit of the patent system, the fact is that the rate of scientific advance in this field is such that over the next 15 years plus whatever would be disclosed would be discovered independently by other researchers.
It's not like the devilishly difficult formula for Coca-Cola, which has been protected by Coke's trade secrecy for over a century.
Patents impede innovation, period, and give rise to monopoly rents. They benefit lawyers and a small group of shareholders, at the expense of everyone else. This is true no less for gene patents than for every other type of patent.

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