People (lots of) vs. The Breast Cancer Gene Patents

Assn for Medical Pathology v. USPTO & Myriad & the Directors of the University of Utah Research Foundation (S.D.N.Y. 2009)

A host of medical organizations, researchers, and cancer patients have filed a Section 1983 action against the USPTO, Myriad Genetics, and the University of Utah Research Foundation (via its directors) demanding that the BRCA gene patents be declared invalid as unpatentable under 35 USC Section 101.

"Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article I, section 8 of the Constitution and 35 U.S.C. Section 101."

In addition, the suit alleges that the patents are unconstitutional under the First and Fourteenth Amendments to the US Constitution.

Myriad's patents allow the company to maintain a monopoly in the US over genetic testing for human BRCA1 and BRCA2 genes - markers for breast cancer. Claim 1 is directed to "an isolated DNA coding for BRCA1 polypeptide." (The patent defines the amino acid sequence of the polypeptide).

PubPat and the ACLU are serving as attorneys for the plaintiffs.

Notes:

• Read the Complaint: BRCA1 complaint.pdf
• NYTimes Article
• ACLU Blogs Here (with pictures of the plaintiffs).
• The gene patenting debate has been interesting - emphasis here on has been. The genome has been mapped and sequences published. Very few new patents claiming isolated human genes are being filed. The ones already patented will expire within the next decade -- most of them will expire before being put to any practical use.  
• Caplan of CNN Says "Lawyers who work on patents in the pharmaceutical and biotechnology industries are sweating bullets today." This is good, because the US is currently suffering under a bullet shortage.
• On May 6, PubPat filed two other lawsuits.
• PubPat v. Cumberland Packing (alleging false marking of its Sweet n Low sugar packets).
• PubPat v. Iovate (alleging false marking of Xenadrine).

Comments

[Kevin R.]

Thanks for posting the complaint. I have been waiting to see the "causes of action" in this document since this morning...

“102. Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article 1, section 8, clause 8 of the United States Constitution and 35 U.S.C. § 101.

103. All of the challenged claims represent patents on abstract ideas or basic human knowledge and/or thought and as such are unconstitutional under the First and Fourteenth Amendments to the United States Constitution.”

[6]

Noonan should eat this up here shortly.

[James]

Imagine patenting a fish that you discovered (not created) in Caribbean waters. Patenting discovered genes is a scientific equivalent.

[Michael L. Slonecker]

Perhaps a "nit" to some, but I am trying to decipher the phrase "...are invalid under Article I, section 8 of the Constitution AND (emphasis mine) 35 U.S.C. Section 101."

An interesting "factoid" is the names of the "owners" of these patents. One is the USG. Another is a foundation created by the University of Utah, obviously for the purpose of exploiting work performed by the research arm of the university. In this case it preliminarily appears that the research work was performed under a USG grant.

[me]

Imagine if the BRCA1 gene were not patented, would it have been discovered? Would the removal of diagnostic tests like this remove pharma from doing the basic research required?

Patent create incentive, without it folks will move to higher productivity areas and MORE people will die because of a lack of a cure. The academics have benn TERRIBLE about really moving research forward beyond a certain point, both in the agricultural and pahrmaceutical biotechnology areas - and pahrma and VC will not promote these discoveries through the regulatory hurdles without proper incentive - WE NEED GENE PATENTS!!!!!

[me]

James-

You would be right if that is what happened, but it is not. The gene is not patentable subject matter under 101 in the fish, it is patentable only if it isolated by man and the Office is moving toward requiring knowledge of function and use. You are simply incorrect.

[James]

@'me' - I was speaking from a scientific perspective, clearly not a legal one.

@'me' - Pharma did not 'discover' BRCA1. Do we need gene patents? Perhaps. Do we need patents on genes that already exist in nature? No.

[Ignorant computer guy]

Wasn't there something like this a few years ago with the gene for Canavan disease? Can someone give a summary of what happened there?

[fisher ames]

When the ACLU singles you out, you must be doing something right.

[James]

@zimmer - Except in this case, where the company in question is simply exercising dubious monopoly rights to screw cancer patients.

[Ronald J Riley]

I am surprised that ACLU is associating with an outfit of second raters like PubPat. I also doubt that PubPat is really representing the public. I think that they are probably funded by big software interests who want to undermine the patent system so that they can take more liberties with others inventions.

If PubPat was really interested in the public's interest they would be funding research directly and offering significant compensation to those who produce discoveries.

I think that it is time for the Professional Inventors Alliance to produce a list of anti-patent rights organizations to guide successful inventors in their charitable activities. I am sure that ACLU would support our First Amendment rights in this matter. :)

Inventors produce jobs and drive the creation of businesses which enjoy much higher profit margins than can be generated reselling low margin commodities produced in low wage nations. I submit that America cannot maintain our high standard of living except with invention driven business activities.

Anyone who thinks otherwise is a fool, and there most certainly is no shortage of fools, especially in the software profession.

While I was a hardware engineer working at the leading edge of microprocessor implementation in the early days, I have also worked from raw coding to high level languages and PLC (automation), CNC, process, etc. Today software engineers who lack any hardware engineering expertise are ill equipped to understand that inventions can and are implemented in either or both areas.

Their ignorance of the underlying issues does not stop them from having strong feelings of inadequacy when they discover that reinventing something by recoding it in a marginally different way leaves them in the unfortunate position of being second rate or worse. Their mob mentality does not change this unfortunate fact of life.

Ronald J. Riley,

Speaking only on my own behalf.
Affiliations:
President - www.PIAUSA.org - RJR at PIAUSA.org
Executive Director - www.InventorEd.org - RJR at InvEd.org
Senior Fellow - www.PatentPolicy.org
President - Alliance for American Innovation
Caretaker of Intellectual Property Creators on behalf of deceased founder Paul Heckel
Washington, DC
Direct (810) 597-0194 / (202) 318-1595 - 9 am to 8 pm EST.

Posted by: Ronald J Riley |

[Malcolm Mooney]

"Imagine if the BRCA1 gene were not patented, would it have been discovered"

Yes.

This has been another edition of ...

[Malcolm Mooney]

"I also doubt that PubPat is really representing the public. I think that they are probably funded by big software interests who want to undermine the patent system so that they can take more liberties with others inventions."

Reason #56432 why nobody takes Ron Riley seriously.

[fisher ames]

"@zimmer - Except in this case, where the company in question is simply exercising dubious monopoly rights to screw cancer patients."

brother, you dance with the one who brung you. I sympathize with these patients who can't get their health insurance companies to pony up. BUT, the yet undeveloped diagnostic test(s) needed for many many other devastating diseases out there will not emerge from a hippie commune.

[restriction/election]

(I know that this is off-topic.)

I seem to remember that there was a relatively recent case (or maybe it was an article) which held that if you had been prosecuting multiple inventions in an application for some time that it was improper for an examiner to issue a restriction/election requirement later, late in the prosecution. Can anyone help me? Thanks

[Seth Waxwoman]

Even if the gene sequence is unpatentable, aren't the other claims to the method of detecting it still patentable? Aren't those detecting claims what the plaintiffs really want to invalidate - they want the test for free (or from other sources besides the pantentee)? I'm not sure what this suit actually achieves for those sufferring from breast cancer, besides an angry patentee that they still have to deal with for the gene test.

[6]

"I seem to remember that there was a relatively recent case (or maybe it was an article) which held that if you had been prosecuting multiple inventions in an application for some time that it was improper for an examiner to issue a restriction/election requirement later, late in the prosecution. Can anyone help me? Thanks"

That would have to be a lot of time, like maybe 4+ years without any final action? It's standard practice to send out a restriction at any time, barring some unreasonable amount of time spent stalling with 2nd, 3rd, 4th, 5th etc... action non-f's. And I certainly do not recall any case (esp on PO) that had to do with that being improper. Though, like I say, after an exceedingly long period of time it would be. That's "policy", not "regulation" or "law" or "MPEP guidance".

Remember, if you sent in an RCE the whole case is born anew and you'll be without grounds of complaint. Well, you can complain, but the spe may or may not take pity on you. I have seen this happen personally sans complaint. They send in 2nd RCE and decide to add in some claims "to the same invention(s)" and I restrict them right the frak outta there. Although, my cases haven't been being worked on for more than 2 years since I started them all myself.

[Imagine patenting a drug compound that you found in Yew bark]

The argument that the patentees did not 'invent' but merely 'discovered' BRCA1 and BRCA2 is a red herring so long as Diamond v. Chakrabarty is good law.

To the best of my knowledge, the patents do not claim BRCA1 and BRCA2 as it exists within a human cell - i.e., as chromosomal DNA. Nor do they claim BRCA1 and BRCA2 as fragments within a genetic "soup" created from digestion or biological decay. These forms are naturally occurring, but are useless for laboratory genetic research.

Instead, the patents claim an isolated sequence of genetic material. That isolated sequence was invented -- it does not occur in either the body or in nature -- and was created by human beings through the modification, separation, and/or assembly of DNA. That isolated sequence is also useful by itself for genetic testing and the like.

Accordingly, the Jeremiad that these patents claim something that exists in nature is simply bad rhetoric. The plaintiff's take on patentability is only true if you disregard significant limitations within the claims, and it pretends that those limitations have no significance when they quite clearly do.

BTW: The plaintiffs can consider themselves lucky if their First Amendment argument gets off the ground. Nothing in the patents prevents the plaintiffs from thinking or speaking about the BRCA1 and BRCA2 genes, and there is no legal basis for protecting "research activities" to any greater extent than "commercial activities" under the First Amendment. Medical research by and large is commerce. Genetic testing is commerce, period. There had better be one hell of an argument in the ACLU's briefs, because this has all the hallmarks of a pro se complaint filed by the man-on-the-street.

[6]

"Can someone"

Canavan.

Patent.

"I'm feeling lucky".

http://canavanfoundation.org/news/11-00_parentssue.php

Try that out with your next claim you write for some client k?

[6]

"That isolated sequence was invented -- it does not occur in either the body or in nature -- and was created by human beings through the modification, separation, and/or assembly of DNA. "

So are you saying that it's 100% certain that these isolated genes do not exist inside my body right now? Or is it 100% certain that they do exist inside my body right now? Or, finally, is there some chance that they exist or do not exist inside my body right now?

[Malcolm Mooney]

6 "So are you saying that it's 100% certain that these isolated genes do not exist inside my body right now?"

Yes.

This has been another edition of ...

[Malcolm Mooney]

For what it's worth, I am not at all sure that these well-intentioned folks expect to win this battle. As with Jeremy Rifkin and his "manimal" application, sometimes cases are filed just to bring some attention to a cause with loftier goals.

Frankly, there are far worse patents than these out there, worse both in terms of their validity and their scope. I don't know how PubPat picks their battles but they appear to be based mainly on press coverage and not necessarily on the likelihood of success. Of course, there may be some weaknesses in Myriad's public relations and/or legal departments that PubPat is privy to that we are not.

[fish bones]

ACLU (of which I am a very long time member) should focus its resources on actual "civil liberties" issues in my opinion.

[Frank_B]

"Instead, the patents claim an isolated sequence of genetic material. That isolated sequence was invented -- it does not occur in either the body or in nature -- and was created by human beings through the modification, separation, and/or assembly of DNA. That isolated sequence is also useful by itself for genetic testing and the like."

Ding!

6: no, he's not saying that you don't have these genes in your body. He's saying that you don't have a serum of this isolated and purified gene in your body. This isn't a new concept either. Compare Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y. 1911) (L. Hand), where a patent for purified adrenalin was granted even though it obviously occurs in nature. The gene must be isolated in order to be diagnostically useful, and it does not occur isolated in nature.

This suit really pisses me off. These patents will all be expired soon anyway, and any hindrance in research will be the genes with no known use (others are deterred from researching those), but genes that are identified will be and are researched further.

[curious]

the patentee is going to kill all of those cancer patients because of his patent -- great anti-patent public relations suit

[6]

Well that's what I thought, and if those are the kinds of claims they've limited themselves to then I don't see why the plaintiffs have been given press for this. All press is good press and the press should restrain themselves from blatant political propagandizing.

Next up: 6 sues state of texas for killing people because the death penalty is cruel and thus violates the constitution.

Didn't we settle this concept awhile back at the USSC? Did nobody settle the gene patent thing yet?

[Yeah]

They forgot to argue that a gene is merely functional descriptive material which, when executed by a cell, causes the cell to produce a protein.

Also, the whole "purified serum" thing is like Beauregard for biochemists.

[Malcolm Mooney]

CNN jumps into the fray

http://www.cnn.com/2009/HEALTH/05/13/genes.patent.myriad/index.html

"If a company wants to patent the purified form of an antibiotic that exists in nature in a fungus, no one challenges that, Silver said. Plant DNA, as well as human DNA, can be synthesized in a laboratory. Distinguishing this case from a patented human gene that is useful in diagnostics would require the ethical argument that the human genome is sacred -- and even then, things get murky, considering that about 25 percent of human genes are shared by chimpanzees, he said."

Chimpanzees are certainly sacred. From what I've gathered, they are also very tasty.

[Ronald J Riley]

"the patentee is going to kill all of those cancer patients because of his patent -- great anti-patent public relations suit"

Without the invention nature would still have killed all those patients. The public wants the inventions but do not want to pay for the research upfront or pay for the invention after the fact. Where are subsequent inventions going to come from?

I know, from Malcolm Malarkey, a fountain of inventions. Next thing you know Malarkey will surpass the greatest inventor of our times, Jerry Lemelson www.Lemelson.org. Not only was Lemelson a great inventor but he was also a great patent warrior who taught many a corporate stooge like Malarkey a lesson or two.

Today, independent inventors are handing out many more attitude adjustments to members of the Piracy & Fairness Coalition members. Adding insult to injury is that Patent Deform is dieing a bloody death once again. It seems that Malarkey and all the other corporate stooges are mostly hot air.

Just in case no one noticed, I don't take all the Malarkey from Malcolm Mooney very seriously and once again inventors are having the last laugh.

Boy is the anti-trust game going to be fun :) All those fairness types are going to be buying personal lube in staggering volumes.

Ronald J. Riley,

Speaking only on my own behalf.
Affiliations:
President - www.PIAUSA.org - RJR at PIAUSA.org
Executive Director - www.InventorEd.org - RJR at InvEd.org
Senior Fellow - www.PatentPolicy.org
President - Alliance for American Innovation
Caretaker of Intellectual Property Creators on behalf of deceased founder Paul Heckel
Washington, DC
Direct (810) 597-0194 / (202) 318-1595 - 9 am to 8 pm EST.

[broje]

@ James:

Most medecines exist in nature first and then people patent a use of it. Think of Penecillen. It was a bread mold that turned out to be useful as an antibiotic. The active ingredients in almost all medecines come from nature, and were not synthesized so much as isolated as to particular uses. Letting people patent the use that they discover for something that exists in nature is old hat and to be encouraged, and that holds true for genes as well.

But I do balk, on some level, at letting people patent the gene in such a way that they control it for all purposes, including research to determine other uses. I mean, with such a patent, the patent holder, if they so desire, can prohibit others from performing research to discover, and patent, additional uses.

But I still have mixed feelings about it. If someone isolates the gene for the first time in such a way that they have a tool that makes it possible to perform research regarding uses of the gene, but have not discovered a use for the gene, should they be prohibited from patenting that tool? It is a tough call.

Maybe there should be some kind of prohibition on letting a patentee have an injunction to prevent research. But patents for uses could be abused too. Imagine a patentee that has the cure for cancer but refuses to let anyone have it. Now imagine charging so much for it that certain classes of people, who tend to be financially disadvantaged, cannot afford it. If you make the cure for cancer into the test for cancer risk, then we arrive at the present situation.

I am not sure what the answer is. But what seems clear to me is that preventing patenting of new uses for things that exist in nature is not the way to go. It seems more appropriate to sue the government for failing to have nationalized health care.

[Malcolm Mooney]

"They forgot to argue that a gene is merely functional descriptive material which, when executed by a cell, causes the cell to produce a protein."

LOL. A better analogy would be a claim to "A software program comprising a gene sequence on a computer-readable medium, wherein said program, when executed by a specialized computer, causes said computer to display a sequence consisting of SEQ ID NO 1 on a display terminal."

If SEQ ID NO 1 is novel and useful, then *yawn* why shouldn't this be *yawn* patentable? Do we really want the Chinese to steal our genes?

[Malcolm Mooney]

"I mean, with such a patent, the patent holder, if they so desire, can prohibit others from performing research to discover, and patent, additional uses"

If the research is related to a future FDA submission, there already is an exception and the exception has been interpreted quite broadly by the Supremes.

[Malcolm Mooney]

broje "It seems more appropriate to sue the government for failing to have nationalized health care."

Or to force the government to exercise it's march-in rights, assuming that government grant money was used to develop the test.

But as I alluded to above, I think this about the optics and, at least in part, about trying to get the media and the public's attention focused on the cost of health care. And it appears to have worked for the moment. You'll note that the public's love for patents is directly proportional to its understanding of the patent statutes. Then again, those statutes were ignored by the PTO and applicants for years so why should anyone be surprised?

[6]

I don't want the chinese to be a stealin' on ma genes! :(

[Pacific Reporter]

"the patents are unconstitutional under the First and Fourteenth Amendments to the US Constitution"? WTF? This case is out of control.

[James]

broje: "Imagine a patentee that has the cure for cancer but refuses to let anyone have it. ... If you make the cure for cancer into the test for cancer risk, then we arrive at the present situation."

So this is a very common circumstance. Consider imatinib (Gleevec), for example. It effectively cures chronic myelogenous leukemia (CML).

I accept that this molecule is patented. Even if it came from a plant without any modification whatsoever, I would accept this patent (from a moral perspective).

On the other hand, *human* genes and gene products (proteins, microRNA, protein-catalysis-byproducts, etc) are fundamentally different from all other genes and gene products. The difference is this: all humans are already have each of these human genes (genomic deletions notwithstanding).

In other words, I *can* accept that a company would prevent me from making use of imatinib, as there is no imatinib naturally in my body. But I cannot accept that a company would try to deny me the 'use' of BRCA2. Indeed, without this crucial DNA repair gene, you and I would be developing cancer (not only breast or ovarian) at a far higher rate. We use it all the time, though we are not consciously aware. To be fair, the patent is for the isolated BRCA2, so let me address that specifically:

There is no difference between the BRCA2 gene in vitro or in vivo. The base pairs are unchanged. The sequence is unchanged. The only difference is that the material around it has been cut out. Now, if this company had developed the device for splicing out the surrounding material (actual inventor: Daniel Nathans), I could accept such a patent. But to patent the actual splice itself? This is simply a patent on information. You may patent a device that manipulates information (e.g., a sequencing machine). As far as I care, you may patent a technique that is used to access (e.g., a test) or create (e.g., a drug) information. But this patent goes a step beyond, and concerns the information itself. As such, it should not stand.

[curious]

James: Where in the claims at issue are the "information itself" which you refer to?

[Malcolm Mooney]

James "this patent goes a step beyond, and concerns the information itself."

James, let's kick it up a notch, mkay? Which patent is "this" patent and which claim are you referring to?

I'm not saying that certain claims in the patents referred to in the complaint are *not* invalid under 101/Bilski. I'm just wondering what the hxll you're talking about.

[James]

@curious, @Malcolm Mooney:

In patent #5747282, these are the claims that I am referring to:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

3. The isolated DNA of claim 1 which contains BRCA1 regulatory sequences.

4. The isolated DNA of claim 2 which contains BRCA1 regulatory sequences.

These claims are for isolated DNA of a specific sequence. (Note: there are methods claims further down in the patent, and I do not dispute those *per se*.)

Again, I see no issue, in theory, with denying people access to these sequences by patenting the methods or tools necessary to access this information. But to claim that, no matter how I extract these sequences from my body, dozens of variations of the BRCA sequences are covered under your patent? An absurd notion.

[anon]

"I'm not saying that certain claims in the patents referred to in the complaint are *not* invalid under 101/Bilski. I'm just wondering what the hxll you're talking about.

Posted by: Malcolm Mooney | May 13, 2009 at 09:25 PM"

Dear Biotech,

We feel your pain.

Sincerely,
Software

[James]

Other choice quotes from the patent itself:

"More specifically, [a] the present invention relates to germline mutations in the BRCA1 gene and [b] their use in the diagnosis of predisposition to breast and ovarian cancer."

[a] being the line in which they admit that they are trying to patent the actual human sequence (not simply the isolated sequence), and [b] being the line where they admit that they believe they are patenting the information content.

[Patently O Action News Team]

Mooney:
"Chimpanzees are certainly sacred. From what I've gathered, they are also very tasty."

Breaking Headline: Malcolm Mooney Considering Cannibalism

Full details at 11

[Malcolm Mooney]

James: "But to claim that, no matter how I extract these sequences from my body, dozens of variations of the BRCA sequences are covered under your patent?"

Well, the fact is that no matter how you extract the sequences from a person with a BRCA1 gene, the sequences are highly likely to be identical to the claimed sequence, unless you are really bad at extracting them. I tentatively question whether you are ranting above your comprehension level, James.

With respect to those particular claims, what seems odd to me is that the claims appear to literally cover entire chromosomes comprising the gene. If that's the case, the claims would be anticipated because human chromosomes were isolated prior to the filing date.

But it most likely isn't the case because the specification (or, less favorably, the prosecution history) probably includes a definition of "isolated" that precludes such a broad construction.

"Again, I see no issue, in theory, with denying people access to these sequences by patenting the methods or tools necessary to access this information. "

Ironically, that is where the Supreme Court, the Federal Circuit and I all agree that there are serious issues, "in theory." And my initial reading of the complaint suggests that there may be a few claims in Myriad's collection of patents that suffer from what we prefer to call a "LabCorp" problem.

[Malcolm Mooney]

James "a] being the line in which they admit that they are trying to patent the actual human sequence (not simply the isolated sequence), and [b] being the line where they admit that they believe they are patenting the information content."

Okay, so it's clear that James lacks an understanding of basic patent law and posseses, at best, a high school or low level collegiate education in biology. That's fine. Nothing wrong with that. We'll proceed accordingly.

If we follow your faulty logic, James, we'd have to conclude that someone who filed a patent in 2008 on a method for identifying oil deposits was trying to patent the earth. Do you get it?

Please pour yourself a beer and hang in the chill out room for a few hours.

[James]

@Malcolm - I believe lawyers would call your approach ad hominem. As I've admitted elsewhere, I have no background in patents (or law). However, your attack on my knowledge of science, and human biology in general, is completely off-base.

Just as I hope to learn about the lawyers' view of these patents, I will gladly teach (or re-teach, if you've had any in the past) the relevant biology, as well.

[PatentLawNewbie]

Forgive me for my complete lack of knowledge in this scientific area.

The argument/law is, an "isolated DNA coding for a BRCA1 polypeptide" is patentable, since this DNA coding is never in nature in isolated form. Is this right? So a claim to the "DNA coding for a BRCA1 polypetide ..." would not be patentable since that is in nature (everyone's body).

I see James's argument and am not sure which argument I think is correct.

From a policy perspective, I'm not sure if allowing genes to be patented is a good idea. Would this have been invented (isolated, I guess) without patents? Yet, now with it patented, it has to the potential to completely stop research on the gene for 20 years (outside of the patentee or assignee). 20 years is a lifetime in this type of research I imagine. Perhaps there could be a carve-out exception for research (but what's the point if the research can't be put into use to save lives?).

I think I might be with James. The inventor here isolated the gene, so he should be able to patent that method, and uses for it, etc. But the gene already existed. But I can be convinced otherwise; plus I'm likely completely misconstruing the law/arguments.

[SST]

"But I do balk, on some level, at letting people patent the gene in such a way that they control it for all purposes, including research to determine other uses. I mean, with such a patent, the patent holder, if they so desire, can prohibit others from performing research to discover, and patent, additional uses."

Whether there should be a research exemption beyond those that already exist has been often debated. However, that is a completely different issue than whether isolated biological molecules (human or otherwise) should be patentable. In addition to the existing research exemptions, there is often a de facto research exemption. In other words, even when research technically infringes a patent, the patent holder almost never cares unless real money is being lost. For example, who has ever heard of big, bad pharma suing a research university for infringing the pharma co's patent by performing academic research? Anyone?

The reality is that nobody ever bother to sue universities (or others) for performing basic research, because the damages are minimal if anything. Certainly not enough to justify the expense of patent litigation. BTW, Madey v. Duke doesn't count because the underlying issues in that case mainly involved employment law and personal grievances (i.e. Madey was mad at Duke because they forced him out but kept his laser).

[Malcolm Mooney]

PLNewbie "The argument/law is, an "isolated DNA coding for a BRCA1 polypeptide" is patentable, since this DNA coding is never in nature in isolated form. Is this right?"

Almost. The correct statement is: before the invention of the isolated gene by the named inventors on the patent, it did not occur in nature. After the BRCA1 gene was first isolated (by the inventors) and disclosed, the isolated DNA could no longer be patented by anyone else except the inventors because as far as patent law (and science, for that matter) is concerned the laboratory is just as natural as the ocean.

"a claim to the "DNA coding for a BRCA1 polypetide ..." would not be patentable since that is in nature (everyone's body)."

That is correct.

[Michael L. Slonecker]

Perhaps I have missed something in my reading of the complaint, but I am stymied trying to determine if any of the plaintiffs have standing to pursue a declaratory judgment action. While each plaintiff has an "interest" in the subject matter embraced by these patents, I do not see any allegations in the complaint that rise to the level of any plaintiff having a reasonable apprehension that he/she/it is likely to be sued.

[James]

@Michael - Forgive me if I am misunderstanding your comment, but I was operating under the belief that the patent had been used at least 9 times to stop some of the plaintiffs from performing research and patient care with regards to the BRCA genes.

[GP]

The PTO/courts screwed up a long time ago allowing patents on genes.

An "isolated dna sequence" that occurs in nature is not an invention. That's simple.

+1 for big business.
0 for common sense.

Par for the course for U.S. patent law over the last decade and more.

[Malcolm Mooney]

"An "isolated dna sequence" that occurs in nature is not an invention. That's simple."

Right. Same with anything made of wood. How can it be an invention just because you isolated it from a tree trunk or branch using well-known carving techniques? That's simple.

[James]

@Mooney - that's a poor analogy; essentially, a straw-man.

To analogize with a *carving* is inappropriate, because creative effort is put into carving, even if you're using the tools of the day. At the very least, a carved piece of wood (even if done poorly) hardly resembles the tree from which it was cut.

Imagine that these folks had isolated the BRCA DNA and then used it to create some gene with similar, but distinct, functionality. That would be an interesting innovation - something I would consider worthy of a patent.

On the other hand, what these folks did was simply patent the lowest trunk on the tree. Now, by law, they couldn't patent it when it was still attached to the tree, so they simply removed it by commonly known means. They believe that, since the trunk is now separated from the tree, they can own the patent it. Is it useful? Sure. But it is not new, nor is it non-obvious.

[Ironsides]

The analogy between pharmaceutical R & D and Myriad is not very tight. R & D companies have to do long expensive clinical trials and face much uncertainty regarding their investment. Myriad did not have to do clinical trials, they charge a lot of money and the tests are based on an underlying genetic discrimination since the majority of the problem is due to the Askenazi Jewish founder mutations. If you are Askenazi or have Askenazi blood, then you gotta poney about the 3000

The Myriad patents might be used to stop other people from developing other types of test for BRCA1 associated cancer risk based on the BRCA1 gene/protein. Generally, pharmaceutical patents (and law 271e) allow others to develop drugs for the same disease. That is to say, most pharma patents do not preempt development of new drugs against the same target or indication, whereas here the DNA patent preempts others from developing news tests for the disease.

[Maybe they should have hired patent lawyers instead of the ACLU]

Setting aside the established doctrine (which obviously the district court here will not be able to do), isolated natural compound patents create an incentive for researchers to go through the expensive process of searching for, purifying, identifying, and testing new (to us) natural compounds. Why would we want to reduce the incentive to speedily bring these compounds to market? Especially considering how quickly we humans are destroying rare species and the places that they live. I would think that we should be flying into action, not putting the brakes on, finding these natural compounds. Gene patenting, as some commenters have pointed out, is not making a big impact and won't be around for long. Heck, I don't understand at all why a test for BRCA1 polymorphisms would need to infringe composition claims on isolated gene sequences.

[Mark Nowotarski]

@ James

Thank you for posting the claims. What I find interesting about claim 1 is that it reads on an enormous number of nucleic sequences. The nuclear code is degenerate (stop snickering Malcolm…you too #6). See http://en.wikipedia.org/wiki/Genetic_code#Degeneracy_of_the_genetic_code

That means that there are multiple codons (sets of 3 nucleic acids) that code for the same amino acid. That means that claim 1 reads on artificial nucleic acid sequences, not just the one found in nature.

How does that impact the argument that the inventors are trying to patent a naturally occuring substance?

[What's a Metaphor]

James,

Do you mean lowest limb? Removing the trunk from a tree seems like a lot more work to do than removing a limb from a tree...

[EG]

The suit filed by the ACLU et al., to the extent it relates to the unconstitutionality of patenting isolated genes, human or otherwise, won't fly. The unconstitutionality counts should be dismissed either by a FRCP 12(b)(6) motion for failure to state a claim for which relief can be granted or motion for summary judgment. In fact, the ACLU et al. should be sanctioned under FRCP 11 for including in their Complaint such frivolous counts. The plaintiffs may have a cause of action under violation of lack of consent or breach of contract, but suggesting the unconstitutionality of Myriad getting patents on the isolated gene goes way over the line.

This suit is very similar to 4 other suits I'm aware of involving tissue ownership rights, the most recent of which is Catalona v. Washing Univ. in the 8th Circuit. The courts have ruled all ruled against the patient (or in the case of Catalona, against the doctor who collected the tissue specimens) on the tissue ownership rights issue.

In the earliest case I'm aware of, the 1990 case of Moore v. Regents of University of California, the university obtained a patent on the cell line based on tissue of a patient. The Supreme Court of California (certainly not a conservative court) ruled against the patient's claim of ownership of the patented cell line on a theory of conversion. (The Court did say that the patient might have a valid cause of action for breach of fiduciary duty and lack of informed consent.)

[Imagine patenting a drug compound that you found in a sea sponge]

"An 'isolated dna sequence' that occurs in nature is not an invention. That's simple."

Demonstrate how the ISOLATED DNA sequence occurrs in nature. Not as chromosomal DNA. Not as a compenent of a mixture of cleaved chromosomal DNA. After all, that's simple, right?

This is the sort of common sense that I see in Office Actions every day. Ignore whatever word inconveniently contradicts the conclusion that you want to draw, because otherwise you'd have spend more than 5 minutes constructing a rebuttal argument, and that'd be work.

[Nice Llama]

A *purified form* of the gene gets around 101 (provided that it is useful) and 102. This is the same issue as the EPO line of cases.

In this situation, 103 will depend on whether the gene was difficult to isolate, requiring more than routine purification techniques.

[MaxDrei]

For the sake of all those non-patent practitioners who have joined us on this thread, I want to raise an "old chestnut" namely whether "Molecule X" can ever be a valid patent claim. In many jurisdictions, it is thought that the scope of protection awarded to the inventor should be commensurate with the scale of the "contribution" to the art that the invention has brought. Thus, when after long research it turns out that Molecule X is good against Disease Y, give the researchers a monopoly over use of X to treat Y, for sure, but why should those researchers be given a 20 year monopoly for any use of Molecule X whatsoever, such as using it as a friction-reducing additive in motor fuel? I know that the Applicant has to show "utility" but that doesn't restrict to a particular use the absolute substance protection of a claim that reads "Molecule X" does it? The utility issue is up for resolution currently, in Europe, in the "Human Genome Science" case, but I don't think any court in Europe has yet come round to the idea of going back half a century, and banning "absolut Stoffschutz" type claims. But with the current outcry about IPR pushing the boundaries more and more, into areas that didn't ought to be patented, maybe the time is right for the courts to do a bit of pushing back?.

[anon]

James if you think what has been patented here "exists in nature" then go and get us one. Or better still, get half a dozen of them to prove your point.

Oh wait, you can't.

Sloppy language, sloppy thinking and emotions running high. That's what this is about.

[Lionel Hutz]

Good, I hope this is the beginning of the end for "isolated" gene patents. It's ridiculous that they were ever allowed.

[Lionel Hutz]

"If a company wants to patent the purified form of an antibiotic that exists in nature in a fungus, no one challenges that, Silver said."

I challenge that. I know it's accepted, but it has always violated the spirit of 101. There is no invention involved, just work.

[Dave]

Can someone familiar with the field of DNA please distinguish these claims from those at issue in In re Fisher, 421 F.3d 1365, wherein the court concluded that ESTs claimed by Fisher lacked specific and substantial utility, and thus were not patentable under 101?

[order of the coitus]

This suit will be dismissed in short order -- the issues are not justiciable. In fact, the plaintiffs may even be sanctioned for filing it.

I don't think the suit is even necessary if the goal is to permit others to offer a test to analyze these genes for the presence of mutation. With respect to the composition claims, I haven't looked at them in detail, but it seems that a BRACAnalysis-style test would either not infringe such claims, or could be easily modified to avoid such claims (sequencing technology has come a long way, baby). As for the method claims, these are dead under Bilski, and will further be crushed when the Federal Circuit decides Prometheus v. Mayo.

The notion that patents provide the necessary incentive for the development and commercialization of diagnostic tests is nonsense. It's not like it takes 10 years and $100M to get a test commercialized. Obviously it takes some time and money, but so does opening your own coffee shop. Remember, the overwhelming majority of discoveries which underlie diagnostic tests were and are made by researchers at non-profit entities like government labs and universities. These folks won't care if patents aren't available for this stuff.

[Paul F. Morgan]

As with the above commentator Michael L. Slonecker, I wondered how some of the parties here have valid standing to pursue a declaratory judgment action, even under the new and looser Sup. Ct. MedImmune decision standards as further expanded by the CAFC in SanDisk v. STM (2007).
Also, considering how long human gene patenting has been so highly controversial, and all the thousands of [wasted taxpayer money?] patents originally filed by NIA etc., it would be amazing if this is the first actual judicial challenge to it. Is it?
Let's also hope the issue gets decided, if it does, on 35 USC 101, as I fear it might drag in and confuse 103 obviousness law for anything else "isolated" [and/or] "purified" from any of the billions of chemicals naturally existing buried in plants and animals, even if [in those other cases] there was no incentive or clue to do so, or even if the particular isolation or purification itself was unobvious?
For years, 3d world politicians have been making largely uncontradicted [even as to patent law lies] anti-American political "hay", even at WIPO, by claiming that U.S. companies are "stealing" and patenting their native plants and native [folk] medicines.

[Mike]

Design around?
Not that hard with a gene patent, although these are pretty broad (maybe not completely enabled). They have a really good patent team and the claims are very well written. US5710001 claim 19 and US5753441 claim 20 are actually more problematic than Claim 1 in these patents (claims listed below).

Design-around options: FISH-hybridization, genomic sequencing THROUGH the BRCA genes (not within the BRCA genes), newer techniques of genomic analysis, government research exemption(if Myriad was funded by US grants?) or SIMPLY send samples to Iceland, India or Australia for testing (probably cheaper than a Wal-mart anyway).

With the logic presented in their case, all pharmaceutical companies should be government owned, there should be NO pharmaceutical patents, the government should sponsor all pharmaceutical research and the government should hand out the drugs. Not actually a bad option BUT you have to choose one or the other - Private companies and patents or Government owned medical care. You can't pick and choose based on your needs. Tell someone going through cancer treatment that Taxol (which is now available as a generic) or Alimta (patented) is not required for their treatment because of costs. Costs of research and production affect all tests and treatments available to date. Thus either design around or pay for the test if required.

Better options to invalidate the patent would be to argue obviousness or anticipation based on Hall, et al., "Linkage of early-onset familial breast cancer to chromosome 17q21" Science 250 (4988), 1684-1689 (1990).

But this isn't about patent validity, the ACLU merely hates gene patents. Aren't they a little late to be entering the ring now, after billions of dollars and thousands of genomic patents have issued. Leave it alone and help these people work around this patent OR change the whole US medical care system. Don't whine and hand pick your annoyances with the system.

Wishing everyone the best, and hoping those with or at risk of cancer lead a long and healthy life.

Best wishes to all,

Mike

PATENT CLAIMS:
US5710001 <http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=US5710001>
Claim 1: A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

19. A method for detecting an alteration in a BRCA1 gene from a tumor sample from a human subject, said alteration selected from the group consisting of the alterations set forth in Tables 11 and 12, which comprises analyzing a BRCA1 gene or BRCA1 RNA isolated from said tumor sample or analyzing a BRCA1 cDNA made from mRNA isolated from said tumor sample for the presence of said alteration.

26. A method for screening a tumor sample from a human subject for the presence of a somatic alteration in a BRCA1 gene in said tumor which comprises comparing BRCA1 polypeptide from said tumor sample from said subject to BRCA1 polypeptide from a nontumor sample from said subject to analyze for a difference between the polypeptides, wherein said comparing is performed by (i) detecting either a full length polypeptide or a truncated polypeptide in each sample or (ii) contacting an antibody which specifically binds to either an epitope of an altered BRCA1 polypeptide or an epitope of a wild-type BRCA1 polypeptide to the BRCA1 polypeptide from each sample and detecting antibody binding, wherein a difference between the BRCA1 polypeptide from said tumor sample from the BRCA1 polypeptide from said nontumor sample indicates the presence of a somatic alteration in the BRCA1 gene in said tumor sample.

US5753441 <http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=US5753441>
1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

20. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 11 and 12 which comprises analyzing a sequence of the BRCA1 gene or BRCA1 RNA from a human sample or analyzing the sequence of BRCA1 CDNA made from mRNA from said sample.

27. A method for screening for a germline alteration in a BRCA1 gene in a human subject which comprises analyzing a BRCA1 polypeptide from a tissue sample from said subject for an altered BRCA1 polypeptide by (i) detecting either a full length BRCA1 polypeptide or a truncated BRCA1 polypeptide or (ii) contacting an antibody which specifically binds to an epitope of an altered BRCA1 polypeptide to the BRCA1 polypeptide from said sample and detecting bound antibody, wherein the presence of a truncated protein or bound antibody indicates the presence of a germline alteration in the BRCA1 gene.

37. A kit for screening for an alteration in a BRCA1 gene in a human subject which comprises at least one antibody (i) which specifically binds to wild-type BRCA1 polypeptide but not a truncated BRCA1 polypeptide or (ii) which specifically binds to an epitope of an altered BRCA1 polypeptide.

US6033857 <http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=US6033857>
1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

5. A method for detecting a mutation in a neoplastic lesion at the BRCA2 gene in a human subject which comprises comparing the sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from a lesion of said subject with the sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a mutation at the BRCA2 gene of the neoplastic lesion.

8. A method for confirming the lack of a BRCA2 mutation in a neoplastic lesion from a human subject which comprises comparing the sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from a lesion of said subject with the sequence of the wild-type BRCA2 gene or the sequence of its RNA, wherein the presence of the wild-type sequence in the tissue sample indicates the lack of a mutation at the BRCA2 gene.

[Erstwhile Surveyor]

"PubPat and the ACLU are serving as attorneys for the plaintiffs."

What you really mean is:
"A host of medical organizations, researchers, and cancer patients are serving as plaintiffs for the attorneys."

If not running afoul of the posting rules of this board, I would like to have a survey of the regular commenters in a yes/no answer to the following question: Do you favor the grant of patent rights to cover the isolated and/or purified form of any naturally-occurring substance?"

Without offering any explanations, analysis, hypotheticals, conditionals, and so on. For whatever reason--legal, policy, moral, whatever.

My own answer is NO.

[Erstwhile Respondent]

Erstwhile Surveyor--

No.

[Just an ordinary inventor(TM) (©¿®)™]

Yes.

[inviting body punches]

Surveyor--No.

As an aside, can anybody point to the earliest known US decision of a higher court that determined that an isolated or purified form of something occurring naturally was patentable?

I assume that it would have been a refined metal, or something of that sort.

[Night Writer Patent Attorney]

Erstwhile Surveyor: YES

[fisher ames]

Comrade Surveyor: DA.

[Pharmer]

Is anyone having a problem with the complaint link? I would like to read it. Any other place it is posted?

[anon]

I submit that if the Universe is infinite, everything already exists in nature. I just solved the backlog problem. Go home, you are fired. We don't need many patent attorneys now.

[Mike]

Erstwhile Surveyor: YES (with Utility)

PS. Fisher is directed to EST's or random pieces of DNA without any utility. They don't know what protein they encode, if they have a function, if they are associated with a disease, etc. It's like throwing rocks into a pile and saying "I claim anything useful in there."

[FROM PAGE 1: Codon degeneracy is not a reason to invalidate patents, it is known that more than 1 codon (3 DNA/RNA nucleic acids) can encode 1 amino acid. It is known, predictable and charts are available to translate the information, it does not change what is claimed .]

[Malcolm Mooney]

"Good, I hope this is the beginning of the end for "isolated" gene patents. It's ridiculous that they were ever allowed."

In re Kubin will have infinitely more impact on your fantasy than this photo opportunity.

Also, the number of players who are rely on patents to isolated naturally occurring genes is microscopic. Nobody really cares. I don't believe that Myriad would care, really, if the claims to those isolated genes were tanked.

[Malcolm Mooney]

"Do you favor the grant of patent rights to cover the isolated and/or purified form of any naturally-occurring substance"

Of course, if it's a useful, non-obvious substance.

But I don't think you really understand what you are asking.

[curious]

Erstwhile Surveyor--

Yes.

[James]

anon said, "James if you think what has been patented here "exists in nature" then go and get us one. Or better still, get half a dozen of them to prove your point. Oh wait, you can't. Sloppy language, sloppy thinking and emotions running high. That's what this is about."

Anon, this is what one might call "my day job." So yes, I can easily do this. I understand that this sounds difficult to you. Law sounds difficult to me, but presumably, as your day job, it's not all that hard to you. Likewise, the molecular biology being discussed here is still trivial for people in the field, just as it was back when these patents were filed.

Also, for those of you not familiar with molecular biology - there is a process called apoptosis, wherein a cell is triggered to destroy itself. During this process, specific enzymes are given access to chromosomal DNA, making initially stochastic (effectively random) cuts that, over time, lead to total degradation of all chromosomes. As this process has occurred to trillions of trillions of cells, it is a statistical certainty that the BRCA genes have existed in nature in form as these isolated genes under consideration here.

This is not an argument that I would even bother making if left to my own devices; it's merely a response to the understandably unfamiliar poster named 'Imagine patenting a drug compound that you found in a sea sponge'.

[Erstwhile Surveyor]

Preliminary survey results:

Yes - 6
No - 3

Malcolm--yes, I do understand what it is that I am asking, although in hindsight I would have worded the question slightly differently, asking if people believed whether or not such things should be deemed patentable subject-matter, for whatever reason.

But I think that the question, as posed, is comprehensible and answerable by regular commenters on this site.

Of course you had to post a conditional which is necessarily implied in the answer of every competent respondent. How inelegant.

Thanks to all for the responses, I'll keep the tally going.

[James]

Back to the Fisher case - this was already partially addressed by Mike. Basically, (1) it was an unknown sequence of DNA, and therefore the "invention lacks a specific and substantial utility and that the '643 application does not enable one of ordinary skill in the art to use the invention".

"Somewhere between having no knowledge (the present circumstances) and having complete knowledge of the gene and its role in the plant's development lies the line between `utility' and `substantial utility.' We need not draw the line or further define it in this case because the facts in this case represent the lowest end of the spectrum, i.e., an insubstantial use." ( http://bulk.resource.org/courts.gov/c/F3/421/421.F3d.1365.04-1465.html )

Presumably, the current case will help refine this spectrum.

[Genius no. 43]

The first amendment is about speech. How is futzing in a laboratory with genie stuff speech?

The activists of this world treat the first amendment like a nose of wax-- The have made it so the Congress can have the FEC fine you for speech advocating for a politician at the wrong time; but now they want to say Congress can't provide property rights in physical activity because that is speech. Nutcases on steroids.

[Malcolm Mooney]

James "it is a statistical certainty that the BRCA genes have existed in nature in form as these isolated genes under consideration here."

James, please go www.USPTO.gov. Find the patent search page. Find one of these Myriad patents that claims an isolated DNA. Then search the specification for a definition of the word "isolated." Then reconsider what you wrote.

Thanks.

[Genius no. 43]

"Yet, now with it patented, it has to the potential to completely stop research on the gene for 20 years (outside of the patentee or assignee). "

Not with the state of the law as it exists today. If the patentee is not researching, the courts won't issue him an injunction to stop infringers from researching. See eBay case: http://www.patentlyo.com/patent/2006/05/supreme_court_v.html
'

[Inviting Body Punches]

Here are some crude thoughts on this subject, at the policy level:

I think that it would be helpful to separate isolated natural substances into at least 2 separate classes:

Class 1 - the bulk intrinsic properties of a multiplicity of the atoms or molecules differ from those of the individual atom or molecule

Class 2 - the bulk intrinsic properties of a multiplity of the atoms or molecules DO NOT differ from those of the individual atom or molecule

(note that I omit mixtures from the discussion, because I assume that the "base unit" of any mixture is that combination that exhibits the properties of the mixture, as such--i.e. no difference))

Take the case of, say, an elemental metal. In bulk, they can form a useable material with strength, ductility, melting point, toughness, and so on--properties that the individual atoms do not possess.

How about an isolated DNA sequence? Used in some sort of lab assay or other procedure? If the assay or procedure relied upon bulk properties that differed from the discrete molecular properties, then patentable for that specific utility.

If assay instead measures response on the molecular level rather than on the bulk level, then utility only exists at whatever threshold number of atoms/molecules is required to produce a particular result by the assay or procedure--then patentable for that specific utility, but only down to that threshold number of basic units.

Please be kind, I am talking out of my a$$. I have realized that this kind of analysis would result in a utility-limited patentability, sort of what MaxDrei was getting at on an earlier post.

[Lisa]

An NIH committee recently released a draft report on the impact of gene patents on genetic diagnostic testing (the public comment period ends tomorrow):
http://oba.od.nih.gov/SACGHS/sacghs_public_comments.html

Interestingly, they conclude that in contrast with pharmaceutical pricing, diagnostic tests offered by US companies with exclusive licensing rights are often comparably priced to those without a monopoly, even for Myriad’s BRCA testing. The committee also concluded that “patents covering genetic tests . . . do not appear to be causing wide or lasting barriers to patient or clinical access.”

But even though they found that many genetic testing patent concerns are exaggerated, they also concluded that there is little BENEFIT to patents in genetic diagnostics. Unlike for drug development, developing genetic tests does not require expensive clinical trials and FDA approval. The committee found that “patents offer minor if any stimulus to the development of genetic diagnostics,” since academic scientists are motivated to research new genetic tests for non-monetary incentives, and many unpatented discoveries have been developed into tests.

So from a public policy perspective, balancing the desire to provide incentives for innovation with the desire to allow broad access to innovations that are important for public health, it seems like there is little reason to allow patents to be enforced against people performing genetic diagnostic tests. Though I think this would have to involve legislative reform, like the exemption to infringement for surgical procedures, rather than judicial invalidation of gene patents in general.

[Malcolm Mooney]

"Unlike for drug development, developing genetic tests does not require expensive clinical trials and FDA approval. The committee found that “patents offer minor if any stimulus to the development of genetic diagnostics,” since academic scientists are motivated to research new genetic tests for non-monetary incentives, and many unpatented discoveries have been developed into tests."

Not only academic scientists, but Big Pharma itself has plenty of "built-in" or "natural" motivations to develop genetic tests. In other fields, it's called "giving people a reason to buy your product."

The current industry fixation on diagnostic tests and patents arises because it is relatively cheap to develop them. The FDA has noted the tendency of companies to half-bake existing data to identify "correlations" that are then leveraged into crappy tests (and patents). It's all about $$$ and in 99% of cases has nothing to do with improving the health of human beings.

If you want to truly appreciate how deeply our country cares about health, look at the crap that kids get fed in public schools. And watch the rats that crawl out of the woodwork when you try to keep a company based in Georgia (a really healthy state - LOL) from selling its sugar water in school cafeterias.

[Validation]

"...diagnostic tests offered by US companies with exclusive licensing rights are often comparably priced to those without a monopoly, even for Myriad’s BRCA testing."

Huh? With what is a monopoly like Myriad's BRCA testing compared? Certainly not another BRCA test, as there is none.

And if you're comparing completely different tests having completely different aims, it would be difficult to validate the comparison.

[James]

@Lisa - precisely right.

[breadcrumbs]

James,

Do you mean Lisa's part about "Though I think this would have to involve legislative reform, like the exemption to infringement for surgical procedures, rather than judicial invalidation of gene patents in general."

(I think not, but you might be a bit more knowledgable about law than you let on)

[Chill, man]

Malcolm says that "It's all about $$$ and in 99% of cases has nothing to do with improving the health of human beings."

As to the first part--no s_it Sherlock! Of course it's about profits--it's called capitalism. Brilliant. I always wondered why the Patent Office was within the Department of Commerce.

As to the second part, that's just wrong, and surprisingly vehement and venomous, as is the rest of the post. Surprisingly, I feel for you. Something must have particularly set you off today.

[6]

"Also, for those of you not familiar with molecular biology - there is a process called apoptosis, wherein a cell is triggered to destroy itself. During this process, specific enzymes are given access to chromosomal DNA, making initially stochastic (effectively random) cuts that, over time, lead to total degradation of all chromosomes. As this process has occurred to trillions of trillions of cells, it is a statistical certainty that the BRCA genes have existed in nature in form as these isolated genes under consideration here"

Interesting, and likewise MM's response is interesting for what it implies. Perhaps you could give us an off the cuff definition MM to save me the time looking for something you are obviously familiar with?

Hutz brings up an interesting position but doesn't really support it.

[Imagine that a question was answered rather than dodged]

"Also, for those of you not familiar with molecular biology - there is a process called apoptosis, wherein a cell is triggered to destroy itself. During this process, specific enzymes are given access to chromosomal DNA, making initially stochastic (effectively random) cuts that, over time, lead to total degradation of all chromosomes. As this process has occurred to trillions of trillions of cells, it is a statistical certainty that the BRCA genes have existed in nature in form as these isolated genes under consideration here."

For those of us familiar with molecular biology, and who have twice acknowledged that an undifferentiated soup of DNA cleaved by decay and/or shotgun sequencing exists, we're wondering (1) how is the 'isolated' DNA sequence in that soup useful for genetic research and/or testing and (2) how that satisfies the meaning of the term isolated under either its ordinary meaning in the art or the meaning supplied in the patents.

You continue to use the term 'isolated,' but not with a meaning that any English speaker would recognize. Are you a USPTO examiner?

[Gideon Pope lives (but not for long)]

Come on Dennis, you can do better - MUCH BETTER - than this - -

"""""Same with anything made of wood. How can it be an invention just because you isolated it from a tree trunk or branch using well-known carving techniques? That's simple."""""

The analogy is horrid, of course, because carving can be an inventive process.

The reverse analogy would be isolating DNA and in the process modifying the DNA molecule.

To modify your analogy to make it work (better), isolating DNA is as inventive as cutting a log into boards.

The boards are "isolated" from the tree, and they have unique pattern and design.

In your MM world contrarian-for-the-sake-of-hits world, Dennis, the boards are each patentable.

Damn. I'm good.

[Genius no. 43]

Lisa's comments on the NiH report prompt two comments of my own.

"diagnostic tests offered by US companies with exclusive licensing rights are often comparably priced to those without a monopoly" as if to suggest in this context that patents are monopolies. PATENTS ARE NOT MONOPOLIES. Monopolies are defined with respect to a relevant market -- for most patents, there are alternatives that can be chosen to get commercially acceptable results, so the patented item is NOT monopolized.

"So from a public policy perspective, balancing the desire to provide incentives for innovation with the desire to allow broad access to innovations that are important for public health, it seems like there is little reason to allow patents to be enforced against people performing genetic diagnostic tests." Are we going to carve up the subject matter that might be patented to negate the power of the patent for such carved-out subject matter? Since I am a lawyer I can say goody, goody, goody, another lawyer's full employment act. As a citizen, the law should be clear and simple and predictable and this would negate all three.

[6]

"either its ordinary meaning in the art or the meaning supplied in the patents."

For fraks sakes could someone just take half a minute and put us all on the same page as to what those meanings could possibly reasonably be so that either their side can win or lose the whole discussion on whether or not the decaying issue is a valid one?

[Malcolm Mooney]

James needs to stop acting like a baby and do his homework if he wants to shake his stick at patent lawyers. He claims to have some scientific expertise (although probably less than your typical biotech patent attorney or agent). If so, he can use the web like a grown up. But I bet that he can't apologize like one.

[PatentLawNewbie]

Genius no. 43,

I don't think eBay is a satisfactory protection for researchers. Under eBay, it may indeed be difficult for a NPE to get an injunction. But NPEs can still get a reasonable royalty.

Other researchers, especially universities and professors, aren't going to want to risk this. Especially since you seem to be saying they should willfully infringe (treble damages and attorney fees).

An earlier commentator did state that many have advocated for a researcher exception, but that it isn't a big deal since no companies are out there suing researchers. Well if that's a case, it should be easy to pass such an amendment to the patent act. There shouldn't be any companies lobbying against it, right?