In the ACLU v. Myriad case, the ACLU has alleged that the patents involved in the case cover genes found in nature. This statement is so patently (pun intended) false, that the ACLU either purposely deceived the court or is guilty of gross negligence about the facts plead in the case. As Gene points out in his post, Fired up: Challenging the Constitutionality of the Patent Act none of the claims in question cover genes found in nature. These claims are directed to screening, identifying, and isolating the BRCA1/2 genetic sequences. This is not a claim to the gene itself, but methods of screening, identifying and isolating the genes, which are processes not found in nature. This is no different than a patent having claims for screening, identifying or isolating gold. Gold is found in nature, but methods for screening, identifying, or isolating gold are not found in nature and are definitely patentable subject matter. The ACLU either purposely deceived the court when they stated “The patents cover the human genes themselves”, paragraphs 3-4, 55-67, & 102 of the complaint, or showed gross negligence about the facts pleaded in their complaint.
The ACLU used this purposeful deceit to argue that the Myriad patents violate the First Amendment of the Constitution. The court’s ruling that the ACLU’s complaint provides sufficient facts to support the allegation that the Myriad patents violate the First Amendment do not stand up to even the most cursory statutory analysis. The First Amendment states (with emphasis added):
Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.
The highlighted portions are the parts of the First Amendment in contention in this case. The ACLU plead that the patenting of human genes violates the First Amendment of the Constitution. Even if you believe ACLU’s pleading that the claims of the patents cover human genes, this is insufficient to support a claim that the patents violate the First Amendment. In order for the ACLU’s pleading to support a First Amendment claim, they must plead that Congress passed a law abridging freedom of speech or the press. Unless the ACLU is claiming that patent law violates the First Amendment, this claim is frivolous. An individual patent cannot violate the First Amendment, since it is not a law made by Congress.
Even if the ACLU had plead that Congress passed a law abridging speech or the press, such a pleading would not be plausible on its face. The rights provided with a patent are defined in 35 USC 154 (a)(1), which states (with emphasis added):
Every patent shall contain a short title of the invention and a grant to the patentee, his heirs or assigns, of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States, and, if the invention is a process, of the right to exclude others from using, offering for sale or selling throughout the United States, or importing into the United States, products made by that process, referring to the specification for the particulars thereof.
The key portions of the statute are highlighted. The right to exclude others from making, using, offering for sale, selling or importing an invention, has nothing to do with speech or the press. It is clear that Congress did not pass a law abridging the freedom of speech or the press by the enactment of the patent statute.
The ACLU also alleges that the Myriad patents violate the 14th Amendment to the Constitution, which reads (with emphasis added):
All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws.
Representatives shall be apportioned among the several States according to their respective numbers, counting the whole number of persons in each State, excluding Indians not taxed. But when the right to vote at any election for the choice of electors for President and Vice-President of the United States, Representatives in Congress, the Executive and Judicial officers of a State, or the members of the Legislature thereof, is denied to any of the male inhabitants of such State, being twenty-one years of age,* and citizens of the United States, or in any way abridged, except for participation in rebellion, or other crime, the basis of representation therein shall be reduced in the proportion which the number of such male citizens shall bear to the whole number of male citizens twenty-one years of age in such State.
No person shall be a Senator or Representative in Congress, or elector of President and Vice-President, or hold any office, civil or military, under the United States, or under any State, who, having previously taken an oath, as a member of Congress, or as an officer of the United States, or as a member of any State legislature, or as an executive or judicial officer of any State, to support the Constitution of the United States, shall have engaged in insurrection or rebellion against the same, or given aid or comfort to the enemies thereof. But Congress may by a vote of two-thirds of each House, remove such disability.
The validity of the public debt of the United States, authorized by law, including debts incurred for payment of pensions and bounties for services in suppressing insurrection or rebellion, shall not be questioned. But neither the United States nor any State shall assume or pay any debt or obligation incurred in aid of insurrection or rebellion against the United States, or any claim for the loss or emancipation of any slave; but all such debts, obligations and claims shall be held illegal and void.
The Congress shall have the power to enforce, by appropriate legislation, the provisions of this article.
I assumed that the highlighted portions are the parts of the 14th Amendment the ACLU alleges were violated by the Myriad patents. No other sections of the Amendment appear to be even remotely related to this case. The ACLU’s complaint does not specifically allege nor plead facts sufficient to show that a State made or enforced a law that abridges the privileges or immunities of citizens of the United States or deprived any person of life, liberty, or property, without due process of law or denied equal protection to anyone. Since the actions of one of the States are not involved in this case, it would be impossible for the complaint to plead a cause of action under this clause of the 14th Amendment. Patent law is federal, it is evident on its face that the 14th Amendment cause of action fails. The fact that the court did not even explore this issue, shows a complete lack of objectivity.
The ACLU should be hit with rule 11 sanctions for bringing this obviously frivolous lawsuit. They either purposely lied about the contents of the claims in the Myriad patents or were grossly negligent with regard to the facts in this case. Their pleading is not sufficient to state a First Amendment case, since they did not plead that Congress passed a law abridging speech. Even if they had a sufficient pleading, it is a matter of basic statutory analysis to show that rights conferred with a patent do not abridge speech or the press. The 14th Amendment cause of action also fails, since the only portions that can possibly be relevant to the present case deal with actions of the States. Patent law is federal law not State law. The obvious errors by the court calls into question its objectivity in this case.
About the Author
Dale B. Halling is a patent attorney and the author of The Decline and Fall of the American Entrepreneur: How Little Known Laws and Regulations are Killing Innovation, due to be release in January 2010.
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35 comments so far.
Disability InsuranceDecember 2, 2009 03:01 pm
Great post Dale, thanks for sharing. I think that this is just another case of the ACLU being negligent and evasive to get their agenda across. I find it amazing that others have yet to catch on to this and don’t see it as a huge issue.
brojeNovember 25, 2009 10:58 am
As for the gold analogy, if the first person to discover gold then sought to patent something as broad as perceiving, extracting, and using gold, then I think there might be a good faith argument that the claims preempt the discovery itself, instead of claiming one of plural practical applications of the discovery.
On that basis, perhaps the ACLU is making the same kind of argument regarding the claimed process with regard to the genes. I really don’t know. But that seems to be the issue that some people are trying to get at, and others are either missing or avoiding.
The blanket statement of the issue whether the patents cover the gene itself does seem to be overreaching, without further explanation of the rule that is the preemption doctrine, at least a brief analysis, and how it migh be possible to draw that conclusion. But an issue like this one deserves more in depth analysis, rather than a simplistic observation that the claim is directed to a process, and not to a gene sequence.
Just visitingNovember 23, 2009 12:32 pm
“no, Scrappy, because a request for reexamination under 35 U.S.C. 303(a) will not get to the underlying, colorable constitutional questions.”
You think a court will address the alleged “underlying, colorable constitutional questions” when statutory mechanisms for determining whether or not the claim is patentable or not already exist?
You cannot even reach your alleged constitutional questions until you address the patent question (i.e., what is being claimed), which is a question of claim construction. The Federal Circuit will eventually take on any case involving an issue of claim construction, so no matter what happens on this level, this case dies at the Federal Circuit. I hope you don’t harbor any hopes that SCOTUS will overturn the Federal Circuit’s/USPTO’s clam construction of the term “isolated DNA coding,” which is the only way this case will turn out any differently. If, by some remote chance, SCOTUS does happen to overturn the claim construction, then the patent gets invalidated under 102, and your constitutional issues never get addressed.
A big f’ing waste of time and money. Of course, all of this could be done for publicity purposes only with no expectation of winning the case. If so, then Rule 11 sanctions are definitely warranted.
Dale B. HallingNovember 23, 2009 12:28 pm
An isolated gene is not found in nature. It is found as part of a chromosome and is inside a human cell. Myriad did not file for a patent on isolated version of any gene it filed for a gene that indicates a propensity to breast cancer. Myriad would not be entitled to a patent for an isolated a random gene. Your analogy to a Raven’s liver is exactly this situation of a patent to a random isolated gene, since you have provided not utility for having isolated a Ravens’s liver. Thus, under 35 USC 101 it is not patentable. But, clearly an isolated gene that shows a propensity to breast cancer is useful and is not found in nature.
By the way, it appears that it would be simple to design around the isolated BRCA1 gene, since we know the genes next to the BRCA1 gene. By isolating part of the adjacent genes with the BRCA1 gene you should avoid the claim that Mr. Koepsell is so concerned about. While I am not an expert on genetics, this would appear to be fairly easy to accomplish.
David KoepsellNovember 23, 2009 11:18 am
no, Scrappy, because a request for reexamination under 35 U.S.C. 303(a) will not get to the underlying, colorable constitutional questions.
scrappyNovember 23, 2009 09:56 am
“Like most misguided attempts to show that claims are not patentable under 35 U.S.C. 101, these issues are best decided under 35 U.S.C. 102/103.”
I wonder if Mr. Koepsell agrees with that in his heart (“I think that it is obvious how to isolate both ravens’ livers and genes, given the fact that nature has conveniently defined their borders.”)
Just visitingNovember 23, 2009 09:21 am
“The claim construction analysis by Just Visiting is informative, because it sets forth a vital part of what the court must determine. Because this is a legitimate issue to inquire about, and to ask for the court’s involvement (because no govt. agency is beyond challenge), no rule 11 sanctions should issue. It’s a colorable claim, involving a real federal question.”
That’s the best you can do?
The claim construction issue had already been decided — by the USPTO dozens or hundreds of time (depending upon how many similar patents have had similar claims issued).
However, if you believe there is a claim construction issue that would raise a “a substantial new question of patentability,” then file for a request for reexamination under 35 U.S.C. 303(a).
Like most misguided attempts to show that claims are not patentable under 35 U.S.C. 101, these issues are best decided under 35 U.S.C. 102/103.
David KoepsellNovember 23, 2009 08:15 am
I think that it is obvious how to isolate both ravens’ livers and genes, given the fact that nature has conveniently defined their borders. I appreciate your help.
scrappyNovember 23, 2009 08:00 am
Mr. Koepsell, the fact that you know of such a thing called “ravens’ livers” means either 1) it is old (in isolation) and cannot be patented, 2) it is obvious how to isolate them and therefore cannot be patented, or 3) it is not obvious how to isolate them and you can therefore patent “isolated ravens’ livers.” That is the law.
I suspect your analogy does not hold, though, since I bet the gene(s) in question were not known, isolated or not… or if they were known, then 3) above would distinguish it from your 2) ravens’ livers analogy. It seems to me these are basic principles that (if you’re dabbling in this field) you should already understand. (If you don’t understand them already, then I suspect you can help the patent system exactly as much as our former Director Jon Dudas with zippo patent experience helped the patent system…. Yes, the saying holds, Mr. Koepsell, fool me once….)
David KoepsellNovember 23, 2009 07:47 am
then use the ravens’ liver example, if you prefer, which do not occur naturally in an isolated condition. Moreover, as I have pointed out many times, genes are isolated by promoter and stop-codons* and finding these is trivial (like finding the borders of a liver, once you know what part of the bird to poke around in)
p.s., glad you agree about this “major problem of the patent system.”
* In the standard genetic code, there are three stop codons: UAG (in RNA) / TAG (in DNA) (“amber”), UAA / TAA (“ochre”), and UGA / TGA (“opal” or “umber”) … The start codon is typically AUG (or ATG in DNA; this also encodes methionine)
scrappyNovember 23, 2009 07:34 am
“Otherwise, H2O, or adrenaline, could be monopolized by anyone inventing a single means of synthesizing them.”
Mr. Koepsell, you bring up (previously, and in your last comment, vis-a-vis adrenaline) what I consider to be a major problem with the patent system, but it has zip to do with freedom of speech. Gene is right.
[Actually, in practice, the problem can be much worse than you conjecture, because a claim to a product can cover (i.e., provide an exclusive right over) “improvements” that were impossible to implement at the time the patent was granted. Surely, an impossible improvement could not have been “invented” by the patentee, and obviously therefore should not be foreclosed by his patent, since it was not his “discovery,” per Article I Section 8 of the Constitution. Maybe this is the “written description” problem the court needs to address. Oh well, perhaps we have all our patent policy experts and academic rabble rousers focusing on red herrings like freedom of speech instead of real issues. It wouldn’t be the first time. But hopefully the Court will make it the last.]
P.S. Your H2O analogy has so many holes (and leaks so badly) that I could not even address it, since H2O occurs naturally in an isolated condition (that is, “isolated H2O” could never be patented under current law, no matter how it was synthesized; new distillation methods are patented all the time).
David KoepsellNovember 23, 2009 07:19 am
Great, so you undermine Dale’s interpretation of the BRCA1 and 2 patents by showing that the patent applies to the product, just as Myriad’s does (whereas he seems to keep claiming it is a method patent and doesn’t apply to the genes themselves). The logical problem with both of these is shown by my H2O analogy. I still haven’t heard a satisfactory response to this problem, since, if I understand Dale’s argument correctly, my patent on a new process for synthesizing water would not cover the product, but just the process. If it covers the product, then that spells trouble, doesn’t it? How could such a patent, on H2O, ever be enforced? Again, with adrenaline, supposing the patent really covered the product, and not just the process, would that preclude others from developing alternate means of synthesizing the identical, naturally-occurring adrenaline? Or let’s suppose I am a competitor, and I extract, rather than synthesize, adrenaline and seek to market it. Have I infringed the patent? It seems like terrible precedent to hang one’s hat upon, as it logically implies all sorts of ridiculous scenarios (e.g. the H2O example).
scrappyNovember 23, 2009 06:26 am
“I also think that the seminal case involving synthetic adrenaline is erroneously interpreted if it is read as covering the product as well as the method.”
Claim 1 of U.S. 730,176:
1. A substance possessing the herein-described physiological characteristics and reactions of the suprarenal glands in a stable and concentrated form, and practically free from inert and associated gland-tissue.
Sounds like your views (and the ACLU’s views) have nothing (nada, zip) to do with freedom of speech (since they apply equally to adrenaline and to genes), though that is a convenient noble sounding claim to “use” in support of your cause. (P.S. In case it isn’t clear to you, you devalue “freedom of speech” by misusing it for your own “high-minded” purposes. Like the folks who write off or twist the Constitution whenever it’s convenient to advance their agenda. Please just say you don’t think an isolated raven’s liver is a “new article of manufacture”. You can even quote the claims of U.S. 753,177. That would be a valid opinion, even if the weight of the evidence opposes it.)
David KoepsellNovember 23, 2009 02:31 am
It is the regulation that makes the mere isolation of a gene sufficient for patentability that is directly at issue in this case. We differ on the logic of this practice, and we obviously will continue to do so. I argue that it is analogous to granting a patent on raven’s livers to the first person to isolate a raven’s liver from the rest of the raven. I would concede that one could get a patent for a unique method of isolating raven’s livers, but could not get a valid claim to the raven’s liver itself. You are more liberal in your analysis, and see that as sufficient for patentability of ravens’ livers as well as the process. I also think that the seminal case involving synthetic adrenaline is erroneously interpreted if it is read as covering the product as well as the method. Presumably, had someone developed an entirely different manner of synthesizing adrenaline (a work-around), then that would not have infringed the patent. My water example points out the logical failure of reading such claims as covering the product, since, assuming there are multiple ways of synthesizing naturally-occurring compounds, the patent could never cover the compound itself, but only the synthetic version in conjunction with its method of production. Otherwise, H2O, or adrenaline, could be monopolized by anyone inventing a single means of synthesizing them.
Dale suggests that the claims at issue, which are product claims, should be read as method claims because of the totality of the patent, yet this is not how Myriad has enforced those claims, as they have stopped researchers, who were replicating the genes at issue in ways that were not circumscribed by the totality of the Myriad patent, and have claimed to be able to monopolize the gene sequence itself. Myriad has brought this on because of how they have chosen to enforce what they view as their rights under the patent.
The claim construction analysis by Just Visiting is informative, because it sets forth a vital part of what the court must determine. Because this is a legitimate issue to inquire about, and to ask for the court’s involvement (because no govt. agency is beyond challenge), no rule 11 sanctions should issue. It’s a colorable claim, involving a real federal question.
Just visitingNovember 22, 2009 05:27 pm
Sometimes, the likes of David cause us to forget our own training as patent attorneys.
A proper examination of the language “[a]n isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2” first requires a claim construction of the terms at issue. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1567-68 (Fed. Cir. 1987) (In making a patentability determination, analysis must begin with the question, “what is the invention claimed?” since “[c]laim interpretation, . . . will normally control the remainder of the decisional process”)
Under Gene’s claim construction, the isolated DNA coding is not found in nature.
Under David’s claim construction, the isolated DNA coding is found in nature. For example, David writes “[t]hese segments are isolated in those strings by a promoter and stop codon, these tell the mRNA when to start transcribing and when to stop transcribing proteins.”
It is readily apparent that the “polypeptide having the amino acid sequence set forth in SEQ ID NO:2” is found in nature because it has been identified as a mutation that correlates with an increased risk of breast cancer. We can assume that this particular amino acid sequence has been around for quite some time – otherwise the correlation would not have been identified.
Claim construction is viewed the lens on one skilled in the art – which I am not. However, I do know that if David’s claim construction is correct, then 102 art would have abounded (perhaps on an inherency argument), and this patent would have never survived examination. The fact that it has survived examination under 102 leads me to believe that the claim construction of “isolated DNA coding” is different than what David is proffering.
There is a piece of well-known case law that states “[t]hat which infringes if later, anticipates if earlier.” Peters v. Active Mfg., 21 F. 319 (W.D.Ohio 1884) (affirmed and quoted in 129 U.S. 530 (1889)).
If a human body infringes the claim, then a human body would also anticipate the claim. Since human bodies have had this particular amino acid sequence and did not anticipate the claims, then human bodies (with this particular amino acid sequence) would not infringe the claim. Since a human body cannot infringe the claim, the arguments of the ACLU, David Koepsell et al., all disappear like a bad dream after one awakes.
BTW – Gene … for all my kidding aside on your political leanings, IMHO, the ACLU deserves to be sanctioned for the reasons you discussed above.
scrappyNovember 22, 2009 04:04 pm
I know nothing about gene patents… but I do know it was Justice Learned Hand that ruled on the “isolated” adrenaline patent, in favor of patentability. And why would we think any current judge would rule better? Are they genetics experts? Or are the parties’ advocates more eloquent, or the parties more altruistic? Or are the waters just more tainted by the $$$ that are at stake and the special interests that are being trumpeted through noble claims?
It seems to me, Mr. Koepsell, that that fact alone (Hand’s less “tainted” 1911 ruling) puts your opposition in quite good company. (For every Einstein, there are a billion folks who think they are, and those folks are destined to spend their lives convincing, or more often, trying to convince, us.)
It also seems to me that Justice Hand’s being an ardent and relentless supporter of free speech should, in light of his decision, evidence the falsity of the ACLU’s motives and intentions.
“I cannot stop without calling attention to the extraordinary condition of the law which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions as these. The inordinate expense of time is the least of the resulting evils, for only a trained chemist is really capable of passing upon such facts — e.g., in this case, the chemical character of Von Furth’s so-called ‘zinc compound,’ or the presence of inactive organic substances. . . . How long we shall continue to blunder along without the aid of unpartisan and authoritative scientific assistance in the administration of justice no one knows, but all fair persons not conventionalized by provincial legal habits of mind ought, I should think, unite to effect some such advance.”
Judge Learned Hand in Parke-Davis & Co. v. H. K. Mulford Co., 189 F. 95, 115.
Gene QuinnNovember 22, 2009 02:22 pm
It is clear that you do not understand patent law and you refuse to accept reality despite me and others pointing out the error of your analysis. Why do you refuse to accept clear and unambiguous statements aimed to educate you about the law? Why is it that you continue to propagate lies?
Each of these claims includes the word “isolated.” Isolation does not naturally occur. Under US patent laws these claims are clearly patentable and will remain patentable because there is human intervention. Why is this so hard for you to accept? Just because you do not like the law doesn’t mean it is not the law.
Really, please explain why you refuse to acknowledge the truth? This is becoming like a Monty Python skit where the character refuses to accept clear reality.
David KoepsellNovember 22, 2009 01:48 pm
No, Dale, that’s not the relevant claim. Had you read my blog (the link is above if you click my name), you’d see the claims, but I’ll reproduce them here:
the link is here: http://www.patents4life.com/US5747282.pdf
“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.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.”
These are not method claims, they are product claims on the nucleotide sequences themselves.
The gold analogy does hold, as does the water analogy, since in each case, it would be ludicrous to grant a patent on the underlying product, even if the new methods of extraction were patentable. That’s not what’s going on here. They have claimed exclusive control over a naturally-occurring gene sequence, and it prohibits any replication of those genes in labs, which the ACLU claims violates fundamental liberties.
Dale B. HallingNovember 22, 2009 11:38 am
But, this is intellectual dishonest, the patent is in not on PCR replication and it is not on the gene itself. It is on the combination of using PCR to detect the gene and knowing that the gene is responsible for breast cancer.
Dale B. HallingNovember 22, 2009 11:37 am
First of all let me assure you if you were right that the claims covered the gene’s themselves, Gene and I would completely agree with you. However, this is clearly not the case.
Below is the claim I assume you are discussing.
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 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
It is a method of detecting, it is not a patent on the gene itself.
“Myriad’s cease and desist letters were sent to those who were doing standard PCR replication of the genes for research, and Myriad doesn’t own a patent on PCR, nor were the researchers using Myriad’s kits to isolate the genes. Any scientist skilled in the art, once they know the sequence they are looking for, can isolate and replicate genes using off-the shelf technology. So, if the patents didn’t cover the genes themselves, by what right did Myriad seek to exclude others from replicating these genes through methods other than those they patented?”
Myriad is not sending cease and desist letter because others have the gene, it is because they are using the same technique for isolating the gene. Your will undoubtedly argue that PCR replication is well known and this is true. But, this is intellectual dishonest, the patent is in on PCR replication and it is not on the gene itself. It is on the combination of using PCR to detect the gene and knowing that the gene is responsible for breast cancer. Your “logic is the fallacious logic which leads to the conclusion that since each of the words in Lincoln’s ‘Gettysburg Address’ were individually old and well known at the time he used them, it would have been obvious for anyone of ordinary skill with a dictionary before him, to have written it.” In re Dailey and Eilers, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). For instance, if another inventor figured out another technique for detecting and isolating these genes, for instance an optical technique, then Myriad would not be sending out cease and desist letters (appropriately) to this group.
Isolated in nature: Gold can be found in relatively pure form in nature also, this does not stop someone from obtaining a patent on a method of detecting, isolation or refining gold. Once again you analogy fails.
Constitutional Argument: David it is clear that the only rights provided by patent law to the holder are making, using, selling, offering for sale, or importing. No regulation give the holder of a patent any other rights. These rights clearly do not violate the 1st amendment of the 14th amendment. You keep bringing up a general argument that may apply in other areas of law, such as environmental law, but clearly is inapplicable to patent law and that is basic patent law.
David KoepsellNovember 22, 2009 02:03 am
…as further evidence of the fact that the patent covers the gene and gene mutations themselves, Myriad’s cease and desist letters were sent to those who were doing standard PCR replication of the genes for research, and Myriad doesn’t own a patent on PCR, nor were the researchers using Myriad’s kits to isolate the genes. Any scientist skilled in the art, once they know the sequence they are looking for, can isolate and replicate genes using off-the shelf technology. So, if the patents didn’t cover the genes themselves, by what right did Myriad seek to exclude others from replicating these genes through methods other than those they patented?
David KoepsellNovember 22, 2009 01:37 am
Gene and Dale,
Once again, if YOU had read the claims, or my blog which quotes the claims verbatim and links to one of the patents at issue, you’d realize that the claims do cover naturally-occurring mutations to naturally-occurring genes. So the analogies to gold and water are appropriate. Click my name above for the link to my post which includes a link to the patent itself. Moreover, The PTO has issued guidelines, published in the Federal Register, and when a govt. agency institutes a reg, or acts in a way that is claimed to violate the Constitution, it can be challenged under the 14th amend. This is basic Constitutional law. Again, re: the isolation of the genes, I have pointed this out before, but you still fail to grasp this apparently. The genome is not just a long string of nucleotides, it has segments (we call genes) that code for proteins. These segments are isolated in those strings by a promoter and stop codon, these tell the mRNA when to start transcribing and when to stop transcribing proteins. The mRNA excludes, in the process, the introns, transcribing only the proteins. So, yes, nature had isolated the BRCA gene and its mutations long ago. Raven wings don’t isolate themselves. Or even more appropriate, Raven livers don;t isolate themselves. So, if I am the first human to isolate a raven’s liver, tell me, can I get a patent on raven livers, or just the process used to isolate them? In the case of the BRCA1 and 2 mutations, the claims, if you please read them in the patent, cover the string of nucleotides itself, and the only inventiveness involved is the isolation of that genes. So how does the gene differ from a raven’s liver?
I’m still trying to figure out this mystifying sentence from Dale: “It is irrelevant if the ACLU is alleging that patent regulations violate the First Amendment. The regulaiton do not change the rights of the holder of a patent and those rights clearly do not violate the First Amendment.”
Can you please clarify if you meant that an unconstitutional act by the government would not invalidate the privilege/right granted by that unconstitutional act? (see my comment #12 above)
Dale B. HallingNovember 21, 2009 03:02 pm
1) Gold: Perhaps you have not read the claims or do not understand how claims work in patent law. It is clear that the claims do not read on the genes by themselves.
2) Regulations: Perhaps you are unaware that the Patent Office does not have authority to pass regulations that effect substantive patent law. The only portion of patent law that could be of issue in this case is the rights provided by a patent, which are excluding others from making, selling, offering for sale and importing do not violate the First Amendment.
3) Raven’s wing: David do you know of anyone who isolated these genes before hand? Do you know of anyone who knew that these genes were the cause of breast cancer before the inventors? Are you suggesting that determining which genes caused breast cancer is the same as cutting off a ravens wing?
Your analogy fails since it ignores that no one knew which genes cause breast cancer. If the patent was just isolating any gene that has no other meaning, then your analogy might make sense. Your arguments fall into the group of arguments that attempt to isolate each element of the claim and say each element is known. All inventions are combinations of known elements (Conservation of matter and energy). It is the combination elements and the purpose of the invention that matters. Ignoring one of the elements, connections or purpose of the invention is intellectually dishonest if done on purpose.
4) Water: Again your analogy fails. The claims do not cover the genes by themselves. If you had read the claims, Gene’s article, my article, or the comments you would know that this was the case.
David KoepsellNovember 21, 2009 02:00 pm
While I’m at it, I wondered if the patent attorneys could answer these questions:
1) How is an “isolated raven’s wing” unlike an “isolated gene”?
2) If I invented a new way to synthesize water, and I included a claim for H2O in my patent for that new method of synthesis, would I get a patent on H2O, or just the new method of synthesizing it?
David KoepsellNovember 21, 2009 01:54 pm
“As clearly pointed out above, the same argument could be made with patents to refine gold. The argument does not change when genes are involved. Your argument has no basis in fact, law, or logic, unless you are arguing that we should not have a patent system.”
No. Only if the patent were on gold (the element) itself, as the method to refine it is man-made. Gold (the element) is not man-made, as the ACLU claims that the patented BRCA1 and 2 genes are not man-made.
“It is irrelevant if the ACLU is alleging that patent regulations violate the First Amendment. The regulaiton do not change the rights of the holder of a patent and those rights clearly do not violate the First Amendment.”
What? I don’t fully understand this sentence. Are you claiming that an unconstitutional act by the government would not invalidate the privilege/right granted by that unconstitutional act? So, for example, if a government regulation somehow made it lawful to own a slave, then if a court found that regulation unconstitutional, the slaveholder would still be entitled to hold the slave?
Dale B. HallingNovember 21, 2009 01:41 pm
It is irrelevant if the ACLU is alleging that patent regulations violate the First Amendment. The regulaiton do not change the rights of the holder of a patent and those rights clearly do not violate the First Amendment.
Dale B. HallingNovember 21, 2009 01:39 pm
As clearly pointed out above, the same argument could be made with patents to refine gold. The argument does not change when genes are involved. Your argument has no basis in fact, law, or logic, unless you are arguing that we should not have a patent system.
David KoepsellNovember 21, 2009 01:19 pm
BTW (completely off topic) when did the past tense of “to plead” become “plead,” anyway? I keep coming across this error in legal writing. I was always taught it was “pleaded” … a less well-accepted form is “pled” but we always steered our students away from that.
David KoepsellNovember 21, 2009 12:55 pm
They are challenging the implementation of patent law in the case of certain specific naturally-occurring genes, nothing more than that. The implementation is guided by the guidelines I have cited, and the guidelines as they are implemented in the case of BRCA 1 and 2 patents differ from their implementation in the case of patents on man-made things. The theory is that because these genes exist in nature, are unmodified by man, etc., they should be freely expressible and accessible by anyone (just as other laws of nature cannot be held exclusively by anyone, to the exclusion of expression or other use by others). When an action of the government interferes with one’s access to information about, and expression of, something which is a law of nature, then that act of the government has violated rights to free expression. As we know, SCOTUS has held a number of non-speech acts to be covered by the 1st Amendment. It’s a novel argument, no doubt, but certainly colorable.
Anyway, that’s what I understand the theory of the case to be, but you should probably confer with the ACLU’s lawyers for a more accurate view of their theory. I am just an interested observer.
Gene QuinnNovember 21, 2009 12:02 pm
Unfortunately the ACLU is not challenging an agency regulation or agency action. They are challenging an Act of Congress saying that the granting of patents violates the First Amendment. It just so happens that what they are challenging has been reviewed by the Supreme Court countless times and none of the various Supreme Court panels have EVER held that patents violate the First Amendment. They also never will, and you know that, as you admitted elsewhere in comments.
I am also extremely curious to know why you think a ruling that gene patents violate the First Amendment by curbing thought would not apply to all patents. Of course it would. I know you understand that, I am just curious what contrived rationale you will articulate.
David KoepsellNovember 21, 2009 11:36 am
You should know that regulations (not merely laws) may violate the First Amendment and be thus held unconstitutional (see., e.g, EMILY’s List v. FEC). The patenting of genes under the current federal regulations, and the substance of those regulations, is presumably at issue. The guidelines at issue can be found at: [Docket No. 991027289–0263–02] Federal Register/Vol. 66, No. 4/Friday, January 5, 2001/Notices. I addressed my disagreements with the rest of your analysis many times before, so I won’t repeat them, but I wanted to just point out that minor error in your analysis regarding First Amendment challenges. A govt. agency can indeed be challenged for implementing a regulation contrary to the First Amendment, without the necessity for finding a law that has been passed.
Dale B. HallingNovember 21, 2009 11:26 am
Anon, the ACLU states that Myriad’s patent claims cover abstract ideas or DNA found in nature and therefore they are not patentable subject matter. The only logical conclusion for this assertion is that Myriad’s patent claims cover the genes themselves. If you are a patent attorney this should be apparent to you. If you are not a patent attorney, then I will explain this in more detail in the next paragraph.
If all the ACLU is suggesting is that the claims have elements that are found in nature, then the ACLU has deceived the court about the law and should be hit with rule 11 sanctions. Every invention is made of known items (Conservation of matter and energy) and at some level those items must start from elements found in nature. As my example shows, gold is found in nature, but processes for identifying or isolating gold are clearly patentable subject matter.
Bob, every patent is a combination of elements and connections. So your question is about everyone sequencing genes in the same way is misleading at best. Discovering which genes cause breast cancer was not done by everyone. Just because they use a technique that is known does not mean that claims are obvious. If you are a patent attorney, this should have been apparent to you. Note obviousness 35 USC 103 is not the question in the case, it is whether the patent claims are directed to statutory matter.
Myriad discovered which genes cause breast cancer and used this to develop methods for screening, identifying, or isolating. Since no one else knew which genes caused breast cancer, they could not have invented these methods.
AnonNovember 20, 2009 10:49 pm
I haven’t read the complaint recently, but based on the information you’ve provided, I fail to see how your characterization of the ACLU position (“the patents involved in the case cover genes found in nature”) is equivalent to the assertion you’ve quoted from the complaint (“[t]he patents cover the human genes themselves”).
bob johnsonNovember 20, 2009 09:07 pm
First I would like to say I know nothing about the subject. But I would like to find out a few things. Are you saying that anybody can go in and look at the DNA for the BRCA1/2 gene or do your patents prevent that? Doesn’t everybody sequence DNA the same way or is there a special way you sequence the DNA on the BRCA1/2 genes? Can other people do research on the BRCA1/2 genes or does your patents prevent that?
EGNovember 20, 2009 03:02 pm
I agree with you whole heartedly that the ACLU should be pasted with Rule 11 sanctions for these so-called “constitutional claims” they presented in the Complaint. And I said that when I first heard about this outlandish and farcical suit shortly after it was filed.
What the ACLU has done here goes far beyond “zealous advocacy.” As you correctly point out, the ACLU has completely misrepresented what the patent claims cover. Put differently, this goes beyond simply a “baseless” claim, and into the realm of deliberatetly misrepresenting the facts that this “baseless” claim relies upon.
Unfortunately, I’m afraid Judge Sweet is oblivious to the ACLU’s duplicity here because he’s either been duped by the ACLU or is complicit in accepting these misrepresentations. That he has allowed this suit to get beyond the Rule 12(b)(6) is outrageous.