Court Report: Special Edition

    By Kevin E. Noonan --

Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, Myriad Genetics et al.
09-cv-04515-RWS; filed May 12, 2009 in the District Court for the Southern District of New York

Earlier today, a group of patients, physicians, academic researchers and medical societies filed suit in the Southern District of New York against the U.S. Patent and Trademark Office and Myriad Genetics, among others, over several patents claiming human BRCA1 and BRC2 genes and methods for detecting mutations in these genes to diagnose a predisposition to breast and ovarian cancer.  The causes of action asserted in the complaint are that patent claims directed to isolated nucleic acids are not patentable subject matter as being products of nature contrary to 35 U.S.C. § 101 and Article 1, Section 8, Clause 8 of the Constitution, and violations of free speech under the 1st Amendment and due process violations of the 14th Amendment.  The lawsuit was filed by American Civil Liberties Union (ACLU) lawyers and that perennial antipatent litigant, Daniel Ravitcher from the Public Patent Foundation (PubPat).  (In homage to Donald Chisum, it would be more accurate to call it the Public No-Patent Foundation.)  Details of the complaint, the parties, the patents, the politics, and the prospects for the suit will be presented in future Patent Docs posts -- in particular, we will be addressing "issues" with the complaint in a future post.  We wish to thank a Patent Docs reader for bringing this case to our attention.  The complaint can be viewed here.

Comments

[EG]

Kevin,

More silliness from organizations (ACLU and PatPub) who appear to have nothing better to do than to make it even more difficult to keep American research and innovation here and to create American jobs in an awful economy. Once more the Crichton/Becerra illogic rears its ugly head, and will hopefully be chopped off quickly by a district court judge who has the sense to realize that this suit is "frivolous rhetorical nonsense" that the plantiffs should have known better not to file.

[Keep It Real]

US Patent 5,612,179

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:

a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and

b) analyzing the amplified DNA sequence to detect the allele.

Here's where the rubber meets the road. Is there a Ph.D. patent attorney alive who is not directly invested in the validity of this patent claim who believes that it is valid? I have yet to meet one.

[Kevin E. Noonan]

Dear Keep:

One of the first things we'll do is go over all the claims and post on them.

The complaint does not focus on your issue, of course; for plaintiffs and their politically-motivated counsel, genes are per se unpatentable. That is not my position, as you no doubt know.

But while on first blush the claim you cited appears broad, the claim Myriad would assert is undoubtedly the dependent claim that recites specific primers that identify a specific exon from BRCA1 or BRCA2, and (perhaps) differentially amplifies the mutant (disease-associated) allele. Assuming that the inventors were the first to identify the mutation and the correlation between its presense and breast or ovarian cancer risk, for me the question becomes: why would such a claim not be patentable? I know what plaintiffs think; what say you?

Thanks for the comment.

[6]

I don't know the science and all, but it has always troubled me how genes that were pre-existing are able to be patented. I mean sure we give patents for discoveries, but not for naturally occuring objects that are discovered.

btw I tried to get into the science of the Kubin case a bit the other day but to little avail, my attention became distracted after awhile.

[Donald Zuhn]

6:

It's really fairly simple: a DNA sequence that is recited in a claim does not exist in nature. For example, a gene that exists naturally within an organism's genome must be recited as being "isolated" in order to satisfy 35 U.S.C. 101 (i.e., specify patentable subject matter). In addition, in higher organisms, genes exist within the genome as a collection of exons and introns. Before the gene sequence is transcribed into mRNA, which will then be translated into a protein, the introns are first removed. The DNA version of the mRNA transcript is the sequence that would be most useful to an applicant, and a claim reciting such a sequence would not (and could not) cover a naturally-occurring sequence.

Don

[Amy]

MSNBC has posted an article today which is poorly written and skews the issues to inflame the public. According to MSNBC, patent attorneys are "sweating bullets today" due to this suit. Ahh, quality journalism! Check out the readers comments and votes against gene patents. Very grim.

[Kevin E. Noonan]

Dear 6:

I couldn't say it better myself than my colleague Dr. Zuhn. But let me say it in a way that requires no scientific acumen.

Would you say that penicillin, or any other new, useful and non-obvious antibiotic, would be patentable subject matter if isolated from a culture of bacteria or yeast? (The answer has always been yes, but I want you to think about the comparison.) How about a N-U-NO chemical obtained from crude oil? OK, now how about a human protein isolated from urine (EPO)? Blood (Clotting Factor VIII)? Tissue (human growth hormone)?

If you are OK with these examples, we are halfway there: they are all "pre-existing" chemical compounds that were "discovered" not "invented" (provided that invented must = constructed, which isn't in the statute).

So how does this related to DNA? DNA in a cell is no different that any of these other things in terms of being pre-existing, etc. However, the thing that most people don't understand is how close the analogy is to isolating a particular molecule from a complex chemical mixture (which is a characteristic of all my examples) to isolating a particular DNA molecule, i.e. a gene. The DNA you want is buried in about a million-fold excess of DNA you don't want, and so the task of isolating it is every bit as difficult (if not more so), than isolating the molecules I mentioned before.

Now,there is a consistent position to be taken that nothing chemical can be patented unless it is a completely new chemical compound, newly synethsized by man. I disagree with that position, but it is consistent. What isn't consistent is saying somehow that patenting genes is bad while all the rest of my examples are OK. Just doesn't wash.

And, if it makes you sleep better at night, no one will ever knock on your door and ask for a royalty for using "your" DNA. No one wants it (I have earlier posts that explain why; no one wants mine, either), and no one can charge you for it.

Hope this (and Dr. Zuhn's earlier comment) help.

[Kevin E. Noonan]

Dear Amy:

We can expect this type of thing from the popular press. Fortunately, the public's attention span is so short it won't register by Friday, and with any luck the suit will be kicked for lack of standing in any event.

Thanks for the comment, and the heads-up.

[Keep It Real]

"why would such a claim not be patentable? I know what plaintiffs think; what say you"

Kevin, I don't have a problem with a claim for identifying a newly discovered mutation that is closely linked to breast cancer.

But I do have a problem with the claim I posted. And I believe that Myriad is among hundreds of companies that has licensed that claim and passes the costs of that license onto consumers of its patented BRCA1 test.

[CNS]

Dear Keep,
Myriad hasn't licensed "that claim" -- they've licensed the entire patent. I suspect that if the claim you posted didn't exist, Myriad would nevertheless be in the same position they are presently in because of the narrower BRCA-specific claims. In other words, they probably don't even need the broad claim -- the narrower ones cover their diagnostic test just the same (and are likely stronger, as Kevin notes).

[EG]

Kevin,

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.)

[TTO voice]

Kevin, if there is a "villain" in this piece, it may be the University of Utah, which apparently failed to include a limit to the period of exclusivity in their license to Myriad, enabling Myriad to have a strangehold on what became an important test. However, this exclusivity may have been needed to sign a deal, without which the test might not have been commercially available (and no benefit accrued to any of the parties).

[Dileep P. Vangasseri]

Dear Keep and Kevin,

Though the wider issue is on patenting of genes itself and not on this patent per se:

In US Patent 5,612,179, I do not see any dependent claim directed toward detection of allelic variations of BRCA1 or BRCA2. I assume Myriad was interested in the general method claims of this patent, which they could employ for identification of the presence of genetic variations (particularly intron variations) in BRCA gene family. I assume Myriad may have specific patents on diagnostic correlation of allelic variation of BRCA with breast cancer. Myriad must have been interested in the second independent claim of this patent:

A method for detection of at least one allele of a multi-allelic genetic locus comprising:

a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said allele and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
b) analyzing said amplified DNA sequence to determine the presence of a genetic variation in said amplified sequence to detect the allele.

[Baltazar]

Myraid may survive this challenge on legal grounds, but the public as a whole will lose. If innovation is inaccessible to those that really need it, then there is no purpose to invent.

"Perhaps the ACLU lawsuit, as unlikely to succeed as I think it is, will achieve its goal by reminding the emerging world of genetic medicine that, as Benjamin Franklin understood when he refused to patent his lightning rod, service to humanity is part of the duty of those who invent and innovate." Arthur Caplan, Ph.D., is director of the Center for Bioethics at the University of Pennsylvania.

[Saddlepack maker]

Dear Baltazar,

Your, and Dr. Caplan's, suggestion of donating inventions to society is naive. If this were to occur, who would pay for the clinical and preclinical trials needed to secure FDA approval? And who would do so if unable to make a profit?

[6]

"OK, now how about a human protein isolated from urine (EPO)? Blood (Clotting Factor VIII)? Tissue (human growth hormone)?"

Idk about them either kev. I mean, it's a protein that my body makes, where's the invention? The invention was in the method of obtaining the protein and perhaps in the machine to do it it seems to me.

There is a trend in today's patenting circles where everything is filed on whether or not it was the invention. That is to say when a new device is created people file method claims. When a new method is created people file product and apparatus claims. They want to get the whole tamale so to speak with their IP. Unfortunately this leads to things being claimed that never were, and never will be the invention.

Nowhere is this more plain in the case from the early 1900's that first allowed method claims to be distinguished in terms of the structure on which they were being performed. Like simply claiming a method comprising: providing a bicycle that comprises reflectors on it's wheels, rather than claiming a method comprising: providing a bicycle with wheels, and providing reflectors on the wheels. This is a simplistic example, but it leads to complicated issues in other examples. Issues that wouldn't exist if method claims were not distinguishable by the structures on which they were acting, as they originally were. I'm not disputing that the method of the first claim is not a new method. However, that is a concern under U.S.C 103, not a concern directed to the manner in which we presume claims are to distinguish themselves from the prior art as a matter of form. Sure, form shouldn't top substance, but in these instances the form dictates substance all too often.

It boils down to whether or not the patent system was intended to protect inventions or whether or not it was intended to protect claims. I believe we have shifted the balance too far through judicial activism in changing the fundamentals of the system over the years. Years long forgotten by those now alive for the most part, and disregarded when the issue is brought up. That is, until the issue is brought up in real life in formal interviews. Then attorneys take a much more balanced view of the merits of the discussion.

To be sure, I have little problem with allowing method claims to distinguish in terms of structure. The problem I have with it is the problems it creates, both in prosecution and then later on down the line. (As an aside I also have a problem with allowing people to claim a device as a method where the method says nothing more than basically "provide the device" because that is ridiculous and plainly not the intent of having separate statutory classes) Problems which seem closely mirrored by allowing folks to claim the proteins and genes my body is busy making. It just simply doesn't seem to be what you invented, whether or not you're claiming it, and whether or not it passes 112/102/103.

Setting all that aside and getting back to the genes, I understand where you guys are coming from about the DNA not being isolated. And on the surface I agree with you and everything was cool. Then, over at PO, the issue of the degenerate nature of genes came up where the poster asserts that it is assured that the gene has been isolated naturally by degeneration. Then other posters said that he was stretching the word "isolated" to cover things it really shouldn't ivo the spec and in normal usage of the term throughout the art as a whole. Nobody has, as of yet, brought to my attention a satisfactory construction of "isolated" that would prevent the previous poster from stretching it to cover the degenerate state.

[Kevin E. Noonan]

Dear 6:

In the words of a famous football announcer, "Whoa, Nelly" - slow down, 6, let's take this one at a time.

It is very important, in my view, to forget whether something is patentable - in terms of 101 (utility), 102, 103 and 112 - when we discuss this issue. As Judge Rich said, there are many things that are not patentable that are patent-eligible. That's the question.

The second thing is that Congress does not have the power to grant patents as a reward for a job well done. The power is granted to promote the progress etc. So that raises the question: what promotes the progress? If I discover a method to produce a pure protein, whether it's from a bacteria, or a cow, or a human, then I have invented the "pure" (or "isolated") protein. That isn't just semantics - the protein inside the cow does no one but the cow any good. If I can't get a patent on my purified protein, why should I bother? Even better, I can just invent the method to purify the protein and keep it as a trade secret.

For biotechnology, the benefits are even greater, and I'll use one simple example. For years, Eli Lilly (and others) produced insulin from goats and sheep and cows, etc. It worked pretty well to control diabetes, and especially in the past when diabetics died young it was good enough.

But Lilly can now produce human insulin using recombinant DNA and you know what? It works a lot better, including avoiding immunological responses that have become more and more important as diabetics lived longer and longer. Doesn't that sound like something we want to promote?

Finally, no one wants your DNA, your EPO or anything else your body is busy producing (at least not in a commercial sense). And anyone who spouts that gene patenting is the equivalent of having an ownership right to "their" DNA is using rhetoric when they can't use logic to win an argument.

Thanks for the comment.

[Kevin E. Noonan]

Dear Baltazar:

Easy for Dr. Caplan to say. Is it more ethical to configure society so that the test not be made in the first place, or to maximize the incentives that there is a test, under circumstances of limited periods of exclusivity? Myriad (and Utah) could have kept all this as a trade secret, and the where would society be?

Thanks for the comment.

[6]

"If I can't get a patent on my purified protein, why should I bother?"

Because you can patent your method of purifying the protein. That's why. You could also protect the machine you created to do so.

Is that not plenty of an incentive? Is it not, specifically, what you invented? Then you performed your method, perhaps with your machine, and whallah, you were rewarded with an item that was already in existance that you had to use a special method to acquire.

The analogy with a tree over on PO comes to mind.

There is a whole tree in nature. But wait, you claim just the trunk of the tree, separate from the rest of the tree because you took an axe and chopped off the trunk from the tree (presume we've pulled the whole tree out of the ground beforehand for best imaginings of the situation). In reality the trunk was already in existance. What really did you invent? Perhaps you invented the method of chopping off trunks from trees. Perhaps you invented chopping off 2 feet long trunks from trees. Perhaps you inveted chopping off 2 feet long ash trunks from trees. Who knows? But one thing is certain. The tree trunk was there all along.

I had forgotten to mention above, the issue here is that you might be distinguishing a structure in terms of a method step ("isolated" being shorthand reference to the isolating method step constantly(?) being performed upon the gene, and being the sole differentiator from the prior art gene. In other words saying "isolated gene" is equivalent to saying "gene which is currently being, or has previously been isolated"). That is probably part of the issue here. And you know what happens when you're distinguishing a product in terms of method steps. Product by process. And you don't want that.

Bottom line, most of these claim types (isolated genes, beauregards, etc. etc.) that people take issue with are the result of courts allowing bad claim drafting techniques years ago and us paying the price for it (in terms of time spent arguing) today. The system was never created for such abominations of claim drafting and it should never have had them shoehorned in. Product by processes included.

And I am constantly astounded by modern attorneys lacking the insight into the history of the law enough to see this issue and how it came about. They just presume that everything is hunky dorey and that the fundamental (and perhaps improper for some circumstances) changes to the system as have occured have no ramifications as to the improperness of the claims resulting from the claim drafting practices of today. When you confront them with the issue and they see it clearly they start to catch the drift. I've yet to confront many attorneys with the issue clearly online, but irl they're pretty receptive. One app has already died because of these issues in my cases, there are still others pending death. I mean, I feel kind of sorry for them, but they were the ones that elected a stat class which may not properly be distinguished in the terms in which they have tried to distinguish it. This is an especial killer of product by process claims. Usually people in my art draft them by mistake and don't realize they've even done it until you bring it up. Sometimes it's my boss that realizes it is a product by process after I thought the claim was ready to go. That is, it slips right on past me sometimes.

"Doesn't that sound like something we want to promote?"

Yes, yes it does. So there is no reason we would not allow them the claims on the methods and apparatii used. And, perhaps in the recombinant gene scenario there is an actual new gene being created and thus perhaps it is patentable. Idk.

Perhaps you could explain why a really broad claim on the method/apparatii of isolating these genes (which we presume they're entitled to under current law) is not enough to protect these inventions Kev.

The answer, it seems to me like, is that it would be sufficient to protect these inventions, and would be very much so proper and statutory. The answer also seems to be that the structure claims are overkill and are part of the newer drafting concerns that should never (imo) have been.

[Baltazar]

Dear Kevin,

I would agree that it is better to maximize the incentives that there be a test. Sure, Myriad could have operated with a trade secret but they wouldn't because someone else would come along, "discover" the brac genes and get a patent. So society still ends up with the benefit of a test. I don't buy the argument that Myriad's patent is a result of a "flash of genius" as findng a gene is more tedious work than anything else. So if it was not Myriad, it would have been someone else.

I perceive the true issue in this case is not one of the anti-patent versus the patent-mongers. Patents are important. The issue really is one of making sure that patents actually benefit society as a whole, not just the very wealthy. Sure patent rights expire, but in the meantime do we get fair access to the test. I don't know what is the right balance to ensure incentives for innovators and accessibility to affordable treatment. This is partly market driven (or not when you have a limited monopoly) but as part of society, innovators surely must be motivated by something else than pure monetary profits.

That is the true issue here. People want companies to innovate. But people also want accessibility to that innovation.

As always, I enjoy your website.

[Baltazar]

Dear Saddlepack maker,

You are reading your bias into what I wrote rather than reading what I really wrote. I did not promote donating inventions to society. I offered the view that innovators must serve society. And service does not mean for free, either.

I am quite aware of the cost to innovate. And that is exactly the issue in this case: do people who need the test able to pay for it or even get one? And you know the answer to that question. So, the debate should be about dealing with cost of accessibility and innovation. Now, the ACLU and their partners chose to challenge the validity of the patent, which I am sure will survive. To that extend, this lawsuit is useless as it does not help to focus the debate where it should be.

[Kevin E. Noonan]

Dear 6:

Once again, we will agree to disagree. But I have three things to add, not to contradict you but to illuminate what's wrong with the plaintiffs' position.

First, method claims are not enough - they are almost impossible to police re: infringement and there is no basis in the statute for limiting compositions of naturally-occurring substances to method claims. Second, your position is contrary to 200 years of precedent in the chemical arts, and making the type of radical change you espouse is bad policy; if a court were to do it, the act would violate the principle of stare decisis. And third, the plaintiffs are not making your argument, that is that ALL naturally-occurring compositions are unpatentable (I disagree with you but it is a consistent position); they are making this special about DNA, and in my view that's also bad policy without foundation in the statute.

Finally, and I'm not trying to be a wiseguy about this, but I notice your comments are longer and more involved lately. Are you just interested in our topics (which would be good) or do you have less and less to do these days?

Thanks for participating in the discussion.

[Kevin E. Noonan]

Dear Baltazar:

I think you underestimate the difficulties in finding and validating the kind of test Myriad is doing. I also think you neglect to consider the source: Utah. The reason this work was possible is that the Mormon families in Utah happen to keep very detailed medical histories (at least with regard to cause of death), mostly in their bibles (i.e., The Book of Mormon), and so researchers looking at SNPs could correlate this data with the historical record. From Craig Venter's work we know that our individual genomes are chock full or variability - indeed, his calculations predict differences on the order of 4% (keeping in mind that human genomic DNA is supposed to differ on average by about 2% with chimpanzee DNA).

So I don't think "someone else would have come along" and I don't think we can predict that this will be so. More importantly, I think that the attitude will dry up private investment, leaving it to public monies to fund research. Without patent protection, there will be no way to maximize the likelihood that these discoveries (which will be published since they are made by university professors) will not be expropriated by corporations (foreign and domestic) that will give no return. And what makes you think things will be cheaper then?

What seems to concern you, and others in this debate, is that the plaintiffs have made an allegation that Myriad has been overly aggressive in defending its IP. Maybe - my reading of the complaint is that it overstates whatever facts they may have, since there are large avenues of research not foreclosed by any of the claims of the patents in suit. Remember, many of the named plaintiffs are professors and medical doctors, who in my experience don't like to be told by anyone that there is any limit on what they can do. So there may be a tendency for relatively minor restrictions to become major in their eyes. Not to mention the likelihood that they want to provide fee-for-services that DO infringe; why should they get to infringe these patents just because they want to? And if patient access is the standard, why stop with genes: why not permit branded drug companies to preclude generic competition?

None of these are easy questions, and as we will explore in future posts finding the answers are not made any easier when the arguments are mostly rhetoric. But that's how it's being played for now.

Thanks for the comment.

[Baltazar]

Dear Kevin,

Hopefully discovery will reveal whether such claims are indeed overstated. A patentee should be allowed to repeat the fruits of its labor. This is not the debate. The debate is what is reasonable action by patentee to exclude others and defend their rights. That is, what constitutes reasonable patient access.