Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010) (Judge Sweet)
In a powerful move away from standard thoughts on patentability standards, the district court for the Southern District of New York has held that Myriad's patents claiming "isolated DNA" do not qualify as patentable subject matter under 35 USC 101.
The claims-in-suit directed to "isolated DNA" containing human BRCA1/2 gene sequences reflect the USPTO's practice of granting patents on DNA sequences so long as those sequences are claimed in the form of "isolated DNA." THis practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character. Many, however, including scientists in the field of molecular biology and genomics, have considered this practice a "lawyer's trick" that circumvents the prohibitions on the direct patenting of DNA in our bodies but which, in practice, reaches the same result. The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in an "isolated" form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to "isolated DNA" containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 USC 101.
Similarly, because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subjct matter under Section 101.
This decision is the result of an action brought by a coalition of scientists and public interest groups in 2009. The group challenged Myriad's breast cancer gene patents as violating both the patent laws and the US Constitution.
The Federal Circuit is likely to reverse this decision — opening the door to an important Supreme Court showdown.
I have here a bottle of Xanax. Please explain where this compound is found in nature.
Sheesh.
Why is a polynucleotide different from all other molecules?
Judge Sweet happened to issue this decision on March 29th, just a few hours before this year’s Passover Seder, when Jews traditionally ask “Why is this night different from all other nights?”
His answer to the question posed above is “because it contains biological information.”
Okay, that’s nice, but is that a scientific distinction that should support the statutory unpatentability of a novel and nonobvious polynucleotide, while allowing patentability of other natural products such as adrenaline, Taxol and tetracycline?
I guess it would be if you accept as science that there’s a Higher Power that wrote the “information” into the genome. [Compare Richard Dawkins on The God Delusion with Robert J. Sawyer’s novel Calculating God.]
But didn’t a federal judge hold in 2005 after a lengthy trial that “Intelligent Design is not science”? And, oh yes, wasn’t that conclusion vigorously spearheaded by …. the ACLU? link to en.wikipedia.org
Hmmm.
For some more on this, see my posting at link to elman.com
This one almost slipped by, but IANAE is absolutely right again.
Of course, this is obvious to us who are as good as Michael Jordan, but the rest of you can join RWA at teh snobbery festival and drink tea together wishing you were as good as you like to think that you are.
I think Sweet hit upon the right characterization of the appropriate test.
There’s a big difference between “this invention is patent-eligible because it is markedly different from anything found in nature” and “the minimal standard for patent-eligible subject matter is that it be markedly different from anything found in nature”.
It’s like the difference between “Michael Jordan is a good basketball player” and “you have to be as good as Michael Jordan to be considered a good basketball player”.
Ned said:
“WER, did Diamond v. Chakrabarty hold that an “engineered” composition of matter that was identical with, and indistinguishable from, that found in nature to be patentable?”
No. The Court in that case would have no reason to make such a holding, as the bacterium in question was engineered to do something it did not normally do.
Here’s a description of the Chakrabarty invention from the opinion:
“This human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. Because of this property, which is possessed by no naturally occurring bacteria, Chakrabarty’s invention is believed to have significant value for the treatment of oil spills.”
The issue was whether a living organism (i.e., a microorganism) was patentable subject matter under 101, and that was the holding. The rationale:
“Judged in this light, respondent’s micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter — a product of human ingenuity “having a distinctive name, character [and] use.””
The Court was careful to distinguish Funk, and that’s where the “markedly different characteristics” phrase was used:
“Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature, and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.”
I think Sweet hit upon the right characterization of the appropriate test. The decision is most vulnerable to attack, I think, based upon the factual determination of whether the claimed DNA meets this text. I have been reading MM’s technical discussion on this point with great interest….
TINLA IANYL
The “experimental use” exception is not that broad, as you’ve discovered. See Duke Univ. v. Madey. It’s always been narrow, but universities have somehow always thought themselves to occupy some moral high ground that made them exempt. They don’t, but the PR hit and the samll dollars involved, plus the difficulty of detecting infringement usually makes them a poor target for an infringement suit.
Wait, I may have spoken too soon. It looks like there was some case law that came alomg and changed things a bit, so the exception does nto reach back to cover activity trying to develop new drugs or tests, but only to seek FDA approval for a generic version of an existing drug prior to expiration of the patent. The same case law also says Universties aren’t protected under the experimental use exception becaeu the research is perfromed in furtherence of theior legitimate business, which is teaching students. So I may have to mea culpa. I’ll get back to you.
For what is worse then disincentivizing further research into alternative tests? It is disincentivizing the kind of research that resulted in the original test.
Worse still is disincentivizing the treatment or cure because someone has a patent on the test.
I’m no biotech expert, but I question whether we’re giving a prize for reaching the finish line, or merely letting someone put up a barrier as he passes the first checkpoint along the way.
That’s why I said it makes researchers immune. 271(e) is an experimental use exception. But running test procedures as part of research sounds like experimental use to me.
If they had the data they needed, then they should have stopped testing. If not, then they should not have backed down in the face of a baseless threat.
In either event, what they should not have done, and what I resent them doing, is whipping the scientific community into a furor in a misleading manner that counts on people misunderstanding the law to try and change the law in a way that will, in turn, disincentivize groundbreaking research by removing the promise of a dominant patent in the field.
For what is worse then disincentivizing further research into alternative tests? It is disincentivizing the kind of research that resulted in the original test. Preventing patents on isolated genes disincentivizes that kind of research, when others can capitalize on that hard work to more cheaply develop a competing test by capitalizing on the hard work and resource expenditure of the original researchers.
TINLA IANYL
271(e)(1) doesn’t make universities immune. They have to be doing research to generate data for FDA approval. Here the universities were essentially running test procedures as part academic research not directed to FDA approval. Indeed, in some cases the testing was almost for profit in nature.
Lurking less: 287(c) probably does not let doctors off the hook. Read the definition of “medical activity” in the statute:
2) For the purposes of this subsection:
(A) the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include
(i) the use of a patented machine, manufacture, or composition of matter in violation of such patent,
(ii) the practice of a patented use of a composition of matter in violation of such patent, or
(iii) the practice of a process in violation of a biotechnology patent.
@ Moonpie for: “Here’s an experiment: find some tissue ‘in nature’ containing some dead smallpox and inject it into your body. Wait a couple weeks and let us know what happens. Then expose yourself to some ‘live’ smallpox vaccine.”
I’m not feeling so good.
Thomas,
Congress passed a law, 35 U.S.C. 271(e)(1), that makes researchers in this area immune to patent infringement. The argument that Universities can’t perform research does not hold water. There is no ethical issue in that regard. What you are saying cannot be entirely correct.
On the other hand, the problem for Universities is that the Universities will find it more difficult to license their patents on successful results of that research. Their licensees most likely will also have to obtain a license from Myriad, so long as the patent claim to the isolated DNA is in force. So, with diminished prospects of obtaining licensees, the profit motive is diminished for Universities, and the motivation to expend resources on the research is reduced.
So, make no mistake. The motives of the Universities are not so pure. It’s greed, plain and simple. We used to live in a world in which the Universities performed research and published results and dedicated the knowledge to the public domain. They still have the capability to do that. They just don’t want to do that anymore.
The result in this case should not be surprising in view of the facts. Research universities studying breast cancer issues were threatened by Myriad and, in fact, stopped their breast cancer research. There is an ethical issue here that screams for social responsibility and justice for the cause of unfettered medical inquiry into a devastating illness. While the District Court’s opinion may seem overly broad, I do not think that the overall result will be reversed. That overall result is one that most Americans would support.
“I am impressed with one Malcolm Mooney. Kudos.”
Wait, is NAL trying to make IANAE jealous?
(Or is that Cranky? Or is this some type of incestuous thing, since IANAE is Malcolm, and Malcom is Cranky?)
I need a scorecard – NAL, can you get me a scorecard?
Re the novel properties of isolated DNA: try to do a BRCA assay with unisolated DNA. Go ahead – you won’t infringe! Not working for you? Could it have something to do with the “isolated” part?
Judge Sweet relies heavily on old cases (noted by Ted in post #3), and he doesn’t care to read them too closely. Take the 1948 Funk Bros. case, holding a combination of bacterial strains to be unpatentable subject matter. Sweet relies on the what, but ignores the why: “Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.” Does that really describe an isolated DNA sequence, used as a probe or primer?
Sweet repeately cites American Fruit (1931), which held unpatentable an article of nature (oranges) to which another article of nature (borax) had been added: “Addition of borax … does not produce from the raw material an article for use which possesses a new or distinctive form, quality, or property. The added substance only protects the natural article … There is no change in the name, appearance, or general character of the fruit. It remains a fresh orange, fit only for the same beneficial uses as theretofore.” Again, hardly descriptive of an isolated DNA molecule.
The CAFC will make short work of this decision.
I ask myself, how in the world did we ever agree to let doctors off the hook?
Posted by: Ned Heller | Apr 02, 2010 at 02:13 PM
In the U.S., doctors are off the hook based on 35 USC 287(c). That section was added due to Pallin v. Singer, 1995 U.S. Dist. LEXIS 20824, 36 U.S.P.Q.2d 1050 (D.Vt. 1995), if you want to take a look.
Nobody Asked
Read the opinion. The ACLU is not a plaintiff. They are the public interest law firm representing the plaintiffs. The plaintiffs have standing. Their law firm does not need standing.
Jim: As for the proposition that a physical embodiment of information is unpatentable, let’s hope Judge Sweet never gets hold of a Beauregard claim
Truly, because in contrast to DNA, there is zero relationship between the structure of the computer-readable medium and the utility-imparting “information” recited in the Beauregard claim.
The solution is in a clever design-around, competing technology, or legislation that curbs the scope of such claims (preferably without killing off the motivation to develop diagnostic DNA assays).
Or the government could exercise its so-called “march-in rights,” created by those evil socialists Bob Dole and Evan Bayh, but as yet never exercised.
From the point of view of a chemist, the DNA is not “isolated” or “purified” from nature — it’s chemically altered, cut out of the cell’s much longer DNA. Chemical bonds have been broken, the molecular weight reduced by orders of magnitude. It’s no longer associated with the regulatory regions that control expression in vivo. GF’s observation is on target: the isolated DNA in question is altered from its natural state to a greater degree than, say, isolated penicillin. Calling it “isolated” is hardly a “lawyer’s trick.”
(As for the proposition that a physical embodiment of information is unpatentable, let’s hope Judge Sweet never gets hold of a Beauregard claim.)
No question in my mind that the CAFC will shred this decision. If Myriad’s hegemony (and $5,000 price tag) over detecting BRCA genes in patients is a bad thing for society, the solution isn’t likely to be found in a courtroom. The solution is in a clever design-around, competing technology, or legislation that curbs the scope of such claims (preferably without killing off the motivation to develop diagnostic DNA assays).
Malcolm: Brian has stated that the ‘utility’ is for diagnosing disease. Is that the utility you are going to use? I don’t see this ‘utility’ mentioned in Myriad’s composition claims, at least not the ones I’ve looked at recently.
Well, detecting mutations that associated w/ increased risk of disease, yes, but still, interesting point. I think I am probably inferring too much about the Myriad claims from Judge Sweet. Myriad seems to have separated many of their isolated DNA claims from their method claims in separate patents, although one of the BRCA1 gene patents in question (282) also claims “A kit for detecting mutations in the BRCA1 gene”. Not sure if that qualifies for what Malcolm is saying. My understanding of all this may have improved, but it’s still quite poor…
Hans, you and I seem to agree that the novelty is in the use of the information in some form of treatment. That should be claimed. But, as you said, since doctors are immune, treatment claims are valueless.
I ask myself, how in the world did we ever agree to let doctors off the hook? At the time, I had some influence in various organizations considering the advisability of the proposed exclusion. I said nothing.
Good point, Malcolm. The utility is not actually claimed (it is in the “infer” claim). So, I amend my point to the “disclosed” utility.
Now, if the novel utility was somehow claimed, that should end the discussion.
Ned:
the Feds will have to hold that isolated DNA that encodes the same proteins as natural DNA is materially different in order to overturn Sweet. I think this test should focus on the claimed utility, and not on irrelevant structures that have do not affect the utility one way or the other.
What is the “claimed utility” Ned? Please identify. And then explain how I can use the DNA in its natural state — in a cell, in a human body, bundled up in chromatin with billions of other nucleic acids, proteins, and other chemicals — for this purpose. If there is no ‘material difference’ between the DNA in its natural state and the claimed DNA, then it should be easy to explain.
Brian has stated that the ‘utility’ is for diagnosing disease. Is that the utility you are going to use? I don’t see this ‘utility’ mentioned in Myriad’s composition claims, at least not the ones I’ve looked at recently.
Ned: The question becomes whether the engineered composition is materially different. That is the question addressed by Sweet.
If this test is correct, and I think it is, then the Feds will have to hold that isolated DNA that encodes the same proteins as natural DNA is materially different in order to overturn Sweet. I think this test should focus on the claimed utility, and not on irrelevant structures that have do not affect the utility one way or the other.
Ned, this is essentially what I’ve been trying to figure out, whether or not the test needs to focus on the claimed utility, so thanks! Although I would say that it’s not necessarily the protein encoding per se, but the sequence information, whether it’s encoding a protein, a splice site, stop codon, or something like that.
So I think I understand Sweet’s argument ok, but it will be interesting to see if he gets “slapped down” by the feds, as Malcolm thinks. Whether this is being properly handled under current law is still a bit beyond me, but I think I’ll be able to understand the Feds decision, when it comes.
Thanks to Malcolm and everyone else for educating me. And glad I helped, Ned – I figured I was just freeloading…
” although seems to be arguing this only applies to DNA.”
He says this because of what the art says.
I’m trying to view this from the perspective of law, but it occurs to me that as a scientist, I would never think of DNA this way – isolated or not. Structure and function are inexorably linked. Judge Sweet seems to have proclaimed that with respect to DNA, they can be treated differently under the law, although seems to be arguing this only applies to DNA.
Ned, re your 11:05 am post: go back to my original comment and you’ll see that I corrected my erroneous statement immediately afterwards. Good catch, though.
Ned, in the U.S. you can patent a new use for an old compound in the form of a method. In the case of a therapeutic, such a patent, called a method of treatment patent, isn’t particularly valuable, because instead of suing the manufacturer of the drug for direct infringement, you have to sue for indirect infringement (can’t sue the doctor, because he/she has immunity). Other countries do not permit this. Practitioners in these countries tried to get around this prohibition with what became known as a “Swiss-type” claim. Instead of claiming a method of treatment, you would claim “use of drug x in the manufacture of a medicament for the treatment of y.” But the EPO’s Enlarged Board of Apppeal just killed this claiming strategy last month.
I was struck by someone early in this thread that said the reason one patents the pre-existing composition of matter per se when one discovers a use for it, is that a later discoverer of a different use could be selling the composition, perhaps for a different use, and it would be difficult to show contributory infringement if the patent had to be limited to the discovered use.
I find this rational bizzare. In Mayo, a researcher was accused of infringement for ordering the very same tests, but for a different purpose unrelated to the novel therapy. This illustrates, dramatically, the vice in the claims.
I submit that one cannot patent an old composition (think gold) simply because one finds a new use for it. Ditto if I am the first discoverer.
So, when I then say that instead of patenting the composition, I patent the engineered composition, should that end the conversation.
Not really, at least according to Sweet and I think according to the Supremes in Chakrabarty. The question becomes whether the engineered composition is materially different. That is the question addressed by Sweet.
If this test is correct, and I think it is, then the Feds will have to hold that isolated DNA that encodes the same proteins as natural DNA is materially different in order to overturn Sweet. I think this test should focus on the claimed utility, and not on irrelevant structures that have do not affect the utility one way or the other.
Brian, thanks for your help on this.
Nature is an awfully big place.
Bucky balls are found in nature.
All the transuranics are found in nature–at some diminishing small concentration somewhere.
If you define your vessel small enough (say, the size of a single molecule), every organic molecule is found at high concentrations in nature.
If you accept the judge’s reasoning, all compositions of matter are not patentable subject matter.
WER said,
“What is interesting is that the “markedly different characteristics from any found in nature” language is from Diamond v. Chakrabarty. Sweet’s decision is not contrary to that decision.
What we have is a continuum between “as found in nature” (i.e., nonpatentable) and the genetically-engineered (i.e., patentable). Where along that continuum do you draw the line? Removal from the natural state? Isolation? Purification? Modification?”
WER, did Diamond v. Chakrabarty hold that an “engineered” composition of matter that was identical with, and indistinguishable from, that found in nature to be patentable?
I think Sweet’s point was that isolated DNA is the same as natural DNA — and if it is, one cannot patent it per se. One has to patent it’s use, which is the discovery.
Malcolm said:
““Isolating” a sequence is just putting the information in a different place, encoded by a physically different set of atoms from the set you created it from.
If you are the first to discover that a chemical contains new, non-obvious and useful “information”, then you can patent that chemical and prevent others from creating that chemcial using a “physically different set of atoms.”
This cannot possibly be right. I find a new use for gold and I can patent gold?
Max, I think you got it. While I side with Kevin and Malcolm on the “isolated DNA” issue, there is a reason that the biotechnology industry is pushing for a data exclusivity period of at least 12 years for new biologics, even though the data exclusivity period for new pharmaceuticals is only 5 years. This judge is absolutely no dummy.
Readers, please excuse what follows. I am not a biotech-er and haven’t followed the thread properly. But I have just got through the decision, nearly to the end, and am so excited by Footnote 51 on page 123 that I want to share with you the following thought.
Judge Sweet finds a sui generis way for DNA. For him, it is not a member of the class “chemical compound” so none of the jurisprudence on chemical compounds, compositions, combinations, collocations and mere mixtures applies to it.
That leaves him free to dismiss the isolated DNA claims as claims directed to a carrier of information, rather than to a chemical compound. In handling the claims in this way, he puts no impediment in the way of future claims to any isolated compound except pieces of a genome.
It puts the jurisprudence in line with TRIPS, and with those who view with distaste claims to software and business methods.
Roll on Bilski, another Decision to be made on grounds of public policy.
PS. Can anybody tell me why Stratton is not entitled to be named as one of the inventors?
Brian wrote:
“The “isolated” DNA carries the same protein coding information as the native DNA, and it is the protein coding information that tells us whether or not a deleterious mutation is present. ”
No, that’s not true. It’s the reason why what used to be called “junk DNA” is no longer so-called. Protein-encoding is what genes do, but genes are not the sum total of DNA, and protein-encoding is not the sole province of genes (no matter how much this was thought 40 years ago).
To carry Malcolm’s analogy further, for IMO it’s a good one, you get the protein if the letters “bow” appear in the gene. But only to a first approximation – it’s a naive view, that is no longer valid.
There can be a bunch of exceptions that say “but not if situation X happens” and the rules for X are spelt out in DNA that is not covered by the relevant gene.
Thus the information content of the isolated DNA – make protein BOW – may be quite different from in its native setting (in which case it could be ‘make BOW unless X, Y or Z is true’).
(Not that it is a “may be”. Malcolm isn’t saying the information content is always different, I believe, since we don’t know enough about things to make that assertion yet.)
Cheers, Luke
I never thought I would be saying this, but I am impressed with one Malcolm Mooney.
Kudos.
Now if only the rest of the patent world were like this particular niche…
Mean Gene Except that the bat doesn’t have as it’s sole utility being useful for telling us what type of tree it came from.
Myriad’s claimed compositions also have more utility than “telling us where they came from.” If their only utility was to “tell us where they came from”, nobody would care about them.
And by the way, most of Myriad’s claimed compositions “come from” a DNA synthesizer, if I’m not mistaken.
I understand how the first person to isolate a gene may have had something patentable, but why would the next guy picking a different gene and isolating it be non-obvious?
“I understand how the first person to isolate a cancer-preventing compound from a hundred trillion other compounds may have had something patentable, but why would the next guy picking a different compound and isolating it be non-obvious?”
Brian The way it looks to me is that Myriad is claiming NOT to be claiming the BRCA1 gene as it exists in the cell, but because the protein coding information – the information being used to detect the presence of a mutation – has not changed, Judge Sweet is saying, yes you are.
Judge Sweet may be saying that and that’s why Judge Sweet is going to get slapped down because this “logic”, if followed in other contexts, will prevent a lot of useful compositions from being patented.
“but that’s like arguing that the “information content” of a baseball bat is “latent” in a tree trunk.”
Except that the bat doesn’t have as it’s sole utility being useful for telling us what type of tree it came from. I understand how the first person to isolate a gene may have had something patentable, but why would the next guy picking a different gene and isolating it be non-obvious? I admit I’m not a bio guy. Does the method for isolating one gene not work for any other genes?
It’s relevant because Myriad is NOT claiming the BRCA1 gene as it exists inside the cell.
The way it looks to me is that Myriad is claiming NOT to be claiming the BRCA1 gene as it exists in the cell, but because the protein coding information – the information being used to detect the presence of a mutation – has not changed, Judge Sweet is saying, yes you are.
But recognize that we are really talking about, at least in the composition claims, is structure, which can certainly be used to store “information”, but which is *properly* claimed and *properly* examined based on its structure.
Is this another way of saying that this argument is properly handled under the purview of non-obviousness? ‘Cause I can totally dig that…
I think I explained that: it’s the “information content” that determines how, when, and where any protein encoded by the series of nucleotides is to be expressed. You can argue that the “information content” of the “naturally occuring gene” is “latent” in relation to the information content of the “isolated gene” but that’s like arguing that the “information content” of a baseball bat is “latent” in a tree trunk. On some philosophical level, the argument might be correct, but it opens up a nasty can of worms in the patent context.
This is really not what I’m arguing – or, to be more accurate, the point I am trying to discuss. You’ve explained what you mean by “information content” above, but I’m not buying that it’s relevant to the argument that DNA carries certain biological information, and that this information is not in any way altered by the “isolation” that Myriad has done. This is the argument that I understand Judge Sweet to be making. (and to be fair, that I was making, and am now trying to avoid making)
More precisely, it is not the “how, when, and where any protein encoded by the series of nucleotides is to be expressed” that the claim of non-novelty seems to rest on, but the what – the protein itself. The “isolated” DNA carries the same protein coding information as the native DNA, and it is the protein coding information that tells us whether or not a deleterious mutation is present. The argument that is being made is that since this information is not changed by isolation and is not novel, then the isolate is not patentable. Now, this may not be a valid legal argument, but it does argue against deploying the “information content” of the “naturally occurring gene” as an argument in defense of the patent.
Brian See, this is where I think people like me are losing you. Precisely what information content are you referring to?
I think I explained that: it’s the “information content” that determines how, when, and where any protein encoded by the series of nucleotides is to be expressed. You can argue that the “information content” of the “naturally occuring gene” is “latent” in relation to the information content of the “isolated gene” but that’s like arguing that the “information content” of a baseball bat is “latent” in a tree trunk. On some philosophical level, the argument might be correct, but it opens up a nasty can of worms in the patent context.
Sure, the in vivo relationships of DNA can define how that DNA is expressed in the cell, but I still don’t understand why this is relevant to the Myriad case.
It’s relevant because Myriad is NOT claiming the BRCA1 gene as it exists inside the cell. It is claiming an isolated gene which is different because the “information content” of an isolated gene is different from the “information content” of the same gene in its natural setting, as you just admitted. But recognize that we are really talking about, at least in the composition claims, is structure, which can certainly be used to store “information”, but which is *properly* claimed and *properly* examined based on its structure.
Myriad is testing for mutations.
That’s right. But Myriad’s patent rights don’t cover the genomes of the people who have those mutations (or those who don’t have them). They do own rights to certain reagents and certain methods that can be used to detect those mutations. I suspect some of those rights were carelessly granted but the mere fact that they relate to the detection of mutations that occur naturally doesn’t mean that the patents are invalid, per se.
For what it’s worth (and not to change the subject) but I do believe that if a naturally occuring gene has been identified in the prior art (e.g., by the whole sequencing of a genome accompanied by a computerized analysis of the codon/promoters etc) then its subsequent patentability in isolated form (including expression vectors) should be precluded. Non-obvious methods of using that isolated gene or its protein product, if any — another matter entirely.
6: What if the novel printing press was not “markedly different” from the old one? Does the analysis change if the old one also occured in nature? What if the new printing press is the old printing press with a few (non-function critical?) bolts taken out?
You tell me, 6. You’re the Examiner. Seems to me these are factual questions of the sort that would preclude a one-size-fits-all conclusion of the sort proferred by Judge Sweet.
I think the “diagnostics community” needs to get its act together and deal with the situation then.
True enough. It won’t, though. There’s always somebody at the top who thinks they might soon be the beneficiary of one of these patents.
The “information content” of a defined series of nucleic acids is inextricably linked to its structure and that includes the structure of any nucleic acids and other molecules that are adjacent to the nucleic acids.
See, this is where I think people like me are losing you. Precisely what information content are you referring to? Sure, the in vivo relationships of DNA can define how that DNA is expressed in the cell, but I still don’t understand why this is relevant to the Myriad case. Myriad is testing for mutations. Mutations are changes in the base pair sequence, regardless of the presence of repressors or response elements or anything else that isn’t there in the tube containing the “isolated” DNA.
To (dangerously) extend your analogy, Myriad isn’t trying to tell people whether you should be using a violin bow or bowing to your master, it’s telling people that they’ve written “bog” instead of “bow” (or pub ogner).
Brian: however, it seems that a better way to think about it would be that they’ve received a patent so overly broad as to effectively rule out anyone else working with the sequence. Judge Sweet seems to have closed the loop for us here, handing down a finding that rules on what Myriad’s patents effectively are doing rather than what they specifically say. Thus, as you say, they are making new law.
Am I getting closer?
I think so. The problem here was not created by the law which allows one to patent novel and non-obivous isolated nucleic acids encoding genes, but by a patent office which was notoriously lax in its enforcement of the laws which prevent applicants from obtaining patents on overly broad composition claims or (in the case of some of Myriad’s method claims) claims which cover the mere act of thinking about information disclosed in a patent specification.
My understanding is that they have used the threat of litigation to prevent the development of tests – commercial and clinical tests, that is, not academic research – that would catch mutations that their test is known to miss, based upon their sequence claims. I can’t really document this for you, but it is generally held to be the case in the diagnostics community (they are one of a few companies who are considered better at defending their patents than they are at testing).
I think the “diagnostics community” needs to get its act together and deal with the situation then. There are a number of ways to invalidate annoying patents and even more ways to quiet an obnoxious barking dog.
“But this isn’t true. The “information content” of a defined series of nucleic acids is inextricably linked to its structure and that includes the structure of any nucleic acids and other molecules that are adjacent to the nucleic acids.”
Mhmmmmmmm. I think it is at this point where most people don’t understand how this could be true. If the introns (I think that was the term for the “nucleic acids and other molecules” or was amongst them) count towards the informational content then how is the cDNA truly representative of the BRCA 1/2? Seems to be logical that the only information you’re interested in is the part that is in the non-intron part, which is the same part as comprises the cDNA.
“The relationship of a defined DNA sequence to another sequence in a cell can determine whether the defined sequence can be expressed as a functional protein, or whether it is not expressed at all, or whether it is expressed as a different protein based on which particular nucleic acid in the defined sequence is used as the starting site for “translation” of the DNA.”
So the question is then, does the naturally occuring sequence with all the junk still in it behave in the same way as cDNA of the same sequence does in all (substantially all?) instances? The answer to this question determines whether or not the judge decided correctly. If yes, then he was right. If no, then there is a good chance he was wrong.
“But so what? Nobody would argue that a novel printing press is not patentable just because it prints pamphlets that are identical to previously known pamphlets, especially if the novel printing press can be used to print 10 or 100 or 1000 more such pamphlets in half the time.”
What if the novel printing press was not “markedly different” from the old one? Does the analysis change if the old one also occured in nature? What if the new printing press is the old printing press with a few (non-function critical?) bolts taken out?
I’m going to assume you didn’t purposely ask a question that you knew contained a false premise. That’s a real waste of time.
Sorry, you were the victim of a poorly edited paragraph, I meant to refer to my claim that only the sequence has utility, which I think I edited out there…
But I greatly appreciate your contribution here. I am coming away much better informed, and I hope I am not wasting your time.
Brian, the smart people at the PTO and the Federal Circuit are well aware of the ‘distinct characteristics’ of DNA. Search “MPEP” and “nucleic acid” and you’ll see what I mean. There is really nothing new here, except a bunch of people confused about the law (that would be you, sorry) rushing in to complain about it.
Fair enough, although to be fair, I’m not rushing in to complain so much as rushing in to ask if there was anything new here, and finding the discussion a bit confusing. So, asked and answered…
Absolutely.
Is Myriad’s “litigation strategy” to sue anyone who synthesizes BRCA1 or who studies the prevalence of particular mutations in BRCA1 in people with breast cancer? That was not my impression. If I’m wrong, let me know.
My understanding is that they have used the threat of litigation to prevent the development of tests – commercial and clinical tests, that is, not academic research – that would catch mutations that their test is known to miss, based upon their sequence claims. I can’t really document this for you, but it is generally held to be the case in the diagnostics community (they are one of a few companies who are considered better at defending their patents than they are at testing). It is certainly possible that these claims are overblown, but so far no one else has been able to offer tests for the mutations that Myriad’s test doesn’t cover.
In looking into this – and with your clarifications – I’m beginning re-evaluate my thinking about this. I think it seems to me, Judge Sweet, and plenty others (usually scientists) that Myriad’s patent claims essentially claim a patent on the gene sequence, which is neither novel nor non-obvious. In looking a little further into the actual patents, however, it seems that a better way to think about it would be that they’ve received a patent so overly broad as to effectively rule out anyone else working with the sequence. Judge Sweet seems to have closed the loop for us here, handing down a finding that rules on what Myriad’s patents effectively are doing rather than what they specifically say. Thus, as you say, they are making new law.
Am I getting closer?
By analogy (and I recognize the danger), you are essentially asserting that the “information content” of the letters “bow” is the same whether it is used in the sentence “Where is my violin bow” or in the sentence “Bow down to your master” or in the sentence “bow wow” (suggested by Fido).
I forgot to add: “The pub owner is drunk.”
Ned: Malcolm, et al. on the Sweet will be overturned side of the fence, it strikes me that Sweet is fundamentally correct if one makes the assumption that DNA is not patentable regardless of the discovery of a utility for the DNA information.
Confusing, Ned. Is that an assumption, or is it the conclusion of some argument that someone may or may not have already presented?
The isolated DNA does not change the information content of the DNA at all.
But this isn’t true. The “information content” of a defined series of nucleic acids is inextricably linked to its structure and that includes the structure of any nucleic acids and other molecules that are adjacent to the nucleic acids.
There is an entire subfield of biology devoted to the study of gene silencing, where the “information content” of nucleic acids is hidden due to the position of the DNA in the chromosome, or the timing of its synthesis.
The relationship of a defined DNA sequence to another sequence in a cell can determine whether the defined sequence can be expressed as a functional protein, or whether it is not expressed at all, or whether it is expressed as a different protein based on which particular nucleic acid in the defined sequence is used as the starting site for “translation” of the DNA.
By analogy (and I recognize the danger), you are essentially asserting that the “information content” of the letters “bow” is the same whether it is used in the sentence “Where is my violin bow” or in the sentence “Bow down to your master” or in the sentence “bow wow” (suggested by Fido).
Now it is true that in Myriad’s case their claims cover an isolated gene that could be used to produce a BRCA1 gene product that has the same sequence as the BRCA1 gene product produced in the cell. But so what? Nobody would argue that a novel printing press is not patentable just because it prints pamphlets that are identical to previously known pamphlets, especially if the novel printing press can be used to print 10 or 100 or 1000 more such pamphlets in half the time.
How do you tell a male chromosome from a female chromosome? – Pull down their Jeans… bad, I know.
I’m interested in seeing how this plays out with Venture Capital backed biotechs who’s IP is completely wrapped around a family or cluster of genes and related pathways…
Malcolm, et al. on the Sweet will be overturned side of the fence, it strikes me that Sweet is fundamentally correct if one makes the assumption that DNA is not patentable regardless of the discovery of a utility for the DNA information. The isolated DNA does not change the information content of the DNA at all.
We have discussed whether there is an patent exception to patenting DNA per se as opposed to its use in a new process or method. I think the there is. DNA, like a law of nature, exists and is not made by man. In this sense, it is not and cannot ever be “new.” This is why the law requires one to patent its use, not the preexisting DNA itself.
This case has all the earmarks of a case that will soon find itself before the Supreme Court regardless of what the Federal Circuit does. I say this because of the importance of the subject matter to the nation.
With regard to the gene claims, there are two steps to consider.
First, what standard or test do you use for the natural product exception? Looking to several SCOTUS decisions, including Diamond v. Chakrabarty, Judge Sweet determined (as paraphrased by me) that the appropriate test was whether the invention had “markedly different characteristics” from the natural product (i.e. had a new or distinctive form, quality, or property). Mere purification of a natural material would not make the purified product patentable unless it resulted in properties and characteristics that were different in kind from those of the known product rather than in degree.
This is arguably supported by the cases, although as EG posts above, reasonable legal minds can disagree. This case is going to require digging into some obscure SCOTUS opinions.
What is interesting is that the “markedly different characteristics from any found in nature” language is from Diamond v. Chakrabarty. Sweet’s decision is not contrary to that decision.
What we have is a continuum between “as found in nature” (i.e., nonpatentable) and the genetically-engineered (i.e., patentable). Where along that continuum do you draw the line? Removal from the natural state? Isolation? Purification? Modification?
The second step then is to apply whatever test you come up with to the claims in question. This requires a factual analysis of what is meant by “isolated” DNA, etc.
With regard to the method claims, Judge Sweet correctly applied applicable law (Bilski). We all know that Bilski is on appeal to SCOTUS, of course, but based upon the justices comments during oral argument, does anyone really think that they’re going to make it easier to get a method claim? While the machine-or-transformation test may soon be moot, I don’t think the method claims in question will survive whatever the justices come up with in Bilski.
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So what happens now to Gene Patents? do they just sit while this is overturned or not?
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Depends on whether or not they are litigated in Judge Sweet’s Courtroom.
So what happens now to Gene Patents? do they just sit while this is overturned or not?
“I think a lot of the criticism of these types of claims is fueled by poor understanding of the relevant laws.”
“There is really nothing new here, except a bunch of people confused about the law (that would be you, sorry) rushing in to complain about it.”
From the department of redundancy department.
Brian I realize I worded that strongly, but I did it purposely.
I’m going to assume you didn’t purposely ask a question that you knew contained a false premise. That’s a real waste of time.
Brian: It occurs to me to ask, however, if the fact that Judge Sweet seems to have thrown down a gauntlet here with respect to how DNA is treated in the law is a big deal in patent law? The Judge asserts that DNA is “distinct in its essential characteristics from any other chemical found in nature.” Setting aside for the moment the glaring omission of RNA, is there any chance that DNA will be understood as having distinct characteristics which necessitate different treatment under the law from epinephrine or digitalis etc.?
Brian, the smart people at the PTO and the Federal Circuit are well aware of the ‘distinct characteristics’ of DNA. Search “MPEP” and “nucleic acid” and you’ll see what I mean. There is really nothing new here, except a bunch of people confused about the law (that would be you, sorry) rushing in to complain about it.
Wow! Is Myriad claiming they’ve changed the hydrogen-bonding properties of DNA?
No.
Do they have previously unknown base pairings?
Depends on what you mean by “previously unknown base pairings.” My understanding is that Myriad believes that it was the first to synthesize and describe certain chemical compositions that could be used to diagnose and study breast cancer in humans. The law doesn’t require that a composition needs to change our understanding of fundamental chemical principles in order to be patentable. It just requires that the compositions are new, useful and non-obvious.
If Myriad were relying on the hydrogen-bonding properties of their molecule, then wouldn’t others be able to come along and offer other tests using the hydrogen-bonding properties of other molecules that match BRCA mutations that increase the risk of breast cancer but weren’t discovered by Myriad and are currently not offered by Mryiad?
Absolutely.
Myriad’s business model and their litigation strategy (i.e. they won’t let other BRCA tests be developed)
If that is an accurate statement of Myriad’s “litigation strategy” then Myriad will likely see more of its claims invalidated as it tries to stretch the scope of those claims beyond what is supported.
Is Myriad’s “litigation strategy” to sue anyone who synthesizes BRCA1 or who studies the prevalence of particular mutations in BRCA1 in people with breast cancer? That was not my impression. If I’m wrong, let me know.
The question whether “isolated DNA” is different from DNA in nature simply turns on what “isolated” means in this context. According to the Glossary of Judicial Claim Construction from Pub Pat, caselaw indicates that it means separated from the other DNA and present in higher concentration, but does not require purifying. I don’t know for sure, but I think that means more than just restricted at cites to either side of the DNA sequence, so as to separate it from other parts of the sequence, or produced from the protein, as might occur in nature. My understanding of that part is a bit shaky, since I am not a biotech practitioner. It does seem to mean that the amount of that DNA sequence is in much higher concentration in the sample than occurs in nature. So, I think we must be talking about a PCR product here. I don’t think I see another interpretation. The Pub Pat Glossaries are available here:
link to pubpat.org
If it is the case that the isolated sequence is really a claim to the PCR product, and if they only disclosed PCR, and if someone came up with another way of achieving the isolated product, then there might be a written descrioption issue that would invalidate the claim.
I don’t think it is correct that the patentee can phohibit development of other types of tests. Didn’t Congress pass a law specifically immunizing researches from infringement of these tyopes of claims. I think a lot of the criticism of these types of claims is fueled by poor understanding of the relevant laws.
Ned: Isolation is apparently necessary for identification of what the DNA is and, if I understand this correctly, isolated DNA is different from naturally occurring DNA in a number of physical ways. Right?
Well, this is where I have a hard time. Basically, my answer is no, not really, but I understand why in the context of IP you might want the answer to be yes. So I can accept that isolated DNA can be considered as being “different” from native. What I hear and read, however, are a lot of explanations that use these various differences to elide the fact that Myriad seems to have patented a sequence of DNA base pairs which is not at all novel.
MM: Really? They aren’t relying on the hydrogen-bonding properties of their claimed molecules?
Wow! Is Myriad claiming they’ve changed the hydrogen-bonding properties of DNA? Do they have previously unknown base pairings? I realize I worded that strongly, but I did it purposely. It boils down to this: No sequence, no test. If Myriad had found a way to alter the hydrogen-bonding properties (or any other property) that allowed them to detect BRCA mutations, then we wouldn’t be having this discussion.
Let me try and clarify by asking a question. If Myriad were relying on the hydrogen-bonding properties of their molecule, then wouldn’t others be able to come along and offer other tests using the hydrogen-bonding properties of other molecules that match BRCA mutations that increase the risk of breast cancer but weren’t discovered by Myriad and are currently not offered by Mryiad?
Both Myriad’s business model and their litigation strategy (i.e. they won’t let other BRCA tests be developed) suggest that their IP claim is, as Judge Sweet said, about DNA as “the physical embodiment of biological information”, rather than any other physical characteristic that “isolated” DNA has been argued to have.
That being said, your clarification has been very helpful here, so thank you! Even coming at this from a scientific perspective, which I have, I can now see how, even if you accept what I’m saying, this can (should?) be dealt with as a matter of obviousness and not composition – win!
It occurs to me to ask, however, if the fact that Judge Sweet seems to have thrown down a gauntlet here with respect to how DNA is treated in the law is a big deal in patent law? The Judge asserts that DNA is “distinct in its essential characteristics from any other chemical found in nature.” Setting aside for the moment the glaring omission of RNA, is there any chance that DNA will be understood as having distinct characteristics which necessitate different treatment under the law from epinephrine or digitalis etc.?
Brian
What I don’t understand is why the fact that none of those properties has anything to do with the utility for which Myriad uses their patent(s) is critical to the validity of those patent(s).
I tried to parse this but I failed, Brian. Sorry.
I will tell you that the law allows a composition claim to be invalidated as obvious even if the prior art suggests a different use for the claimed composition than that taught by the patentee. But for whatever reason, Judge Sweet chose to not to deal with obviousness and instead created his own law. Not a wise move.
Myriad is in the business of telling women whether or not the BRCA genes in their bodies carry some of the known mutations that increase their risk of breast cancer. In this capacity, it is the sequence information, and no other aspect of the molecule, that allows them to do this.
Really? They aren’t relying on the hydrogen-bonding properties of their claimed molecules?
“All that other excremental baloney… makes a focused discussion of any particular legal issue… that much more difficult.”
I guess there is a reason they say bad facts make bad law.
6: Actually MM, the patentdocs just posted a page about how at least some of the claims at issue are actually anticipated by some database we had in 1994. At least I think that’s what the article is saying.
6, I’ve read it. I’ve said before (many times) that a lot of Myriad’s claims are junkk. They don’t even try to claim a novel gene-encoding nucleic acid composition, but rather seem to be drawn to groups of billions or trillions of oligos that encode for peptide fragments of the protein encoded by those genes. Those claims are crxp and should never have been issued by the PTO in the first place.
All that other excremental baloney in Myriad’s patents makes a focused discussion of any particular legal issue (e.g., “can you patent an isolated newly discovered gene”) that much more difficult.
“What is being claimed is an isolated chemical composition that has properties which differ from those found in any known “natural” composition.”
Actually MM, the patentdocs just posted a page about how at least some of the claims at issue are actually anticipated by some database we had in 1994. At least I think that’s what the article is saying.
“Well then maybe a law could be enacted to make the generic maker pay a fee or a tax. Like a license to the company that made it in the beginning? So then they could get there money back that way?”
Ummm… they can license the patent.
“They discovered…”
cue to AI to recite the Constitution’s Article 8 (once again).
Myriad didn’t invent a new process for isolating genes or wasn’t the first to synthesize cDNA, were they? If not, why would isolating a specific gene be non-obvious? They discovered a correlation that existed in nature. Laudable, but not patentable. Why should they then be allowed to own the corresponding cDNA copy of the gene? As many others have said, the only utility of the proxy is for its direct link to the actual naturally occurring gene.
Pick a gene, any gene, patent it, and camp it. If you’re lucky, some correlation between that gene and something of note exists, and when somebody discovers it, you could become rich! DNA campers – the updated version of WWW domain name campers.
The comment about good luck cancer patients couldn’t be further form the truth.
Research is completly stifled by gene patents as the monopoly granted is way too broad and strangles any form of competition at birth.
Drug companies are there to make as much money as possible, the fact that they’ve managed to massage the system into getting these patents in the 1st place just shows easy it is given enough money and influence to get patents through no matter what thier validity.
“What I don’t understand is why the fact that none of those properties has anything to do with the utility for which Myriad uses their patent(s) is critical to the validity of those patent(s)
per chance one needs to read teh claim as a whole?
There’s a fascinating take on this at the Skeptic’s Health Journal, sort of provides some of the background to the debate, if interested you can read on it here, link to healthjournalclub.blogspot.com
Ok, Dr. Patent,
Please explain to me how the ACLU has standing? Are they anticipating a suit as an infringer which would warrant a DJ action, which is what Medimmune is about.
Or, can standing be granted to them because of public policy grounds, like in the present case?
Please enlighten me on the concept of how a party who will never be subjected to an infringement suit has standing?
Well then maybe a law could be enacted to make the generic maker pay a fee or a tax. Like a license to the company that made it in the beginning? So then they could get there money back that way?
People who think that there is a standing issue here either (1) haven’t read the opinion, (2) don’t understand what standing is, or (3) don’t understand what the Supreme Court’s Medimmune decision did to the law regarding DJ jurisdiction.
Most likely all of the above.
Sarah,
Without patents, drug company R&D stops because it and the clinical testing that are needed to get FDA approval are so expensive. Without the patent, as soon as a new drug is sold, a generic company figures out what it is and starts competing. The original company never makes enough money to recover their investment. Since everyone knows this before the r&d starts, it never gets started.
Brian, you make a good point about the “differences” being related to the utility. I believe at least in Parke-Davis, the differences were directly related to the utility. Unpurified adrenaline did not have the same utility as purified adrenaline.
Isolation is apparently necessary for identification of what the DNA is and, if I understand this correctly, isolated DNA is different from naturally occurring DNA in a number of physical ways. Right?
Brian, in quoting MM:
“If you are the first to discover a chemical containing new, non-obvious and useful “information”, then you can patent that chemical…”
you alight upon the point of most sensitivity.
Why does the inventor get to monopolise the compound, per se, for 20 years or more? Why not give out monopolies limited to the specific utility? Wouldn’t then the scope of protection be more commensurate with the magnitude of the inventor’s contribution to the art?
This is a public policy matter. Europe still gives protection for the compound, per se. But with the EPO’s “Problem and Solution Approach” to obviousness, it would be easy to cut the scope back to the particular utility, using the obviousness tool (ie, the compound, per se, is obvious).
Hey, MM, thanks for responding.
I understand that what is being claimed is an isolated chemical composition that has properties which differ from those found in any known “natural” composition. What I don’t understand is why the fact that none of those properties has anything to do with the utility for which Myriad uses their patent(s) is critical to the validity of those patent(s). It is the sequence, and only the sequence that has utility here. Several commenters have pointed out differences (it’s a salt, it’s not associated w/ any proteins, it can be put into a vector, etc.), but Myriad is not in the business of using DNA as salts or in plasmids or anything else that the “isolation” of the BRCA1&2 genes conceivably imparts. Myriad is in the business of telling women whether or not the BRCA genes in their bodies carry some of the known mutations that increase their risk of breast cancer. In this capacity, it is the sequence information, and no other aspect of the molecule, that allows them to do this. As you say, “If you are the first to discover a chemical containing new, non-obvious and useful “information”, then you can patent that chemical…” Fine, but so far no one here (or anywhere else I’ve read) has produced a compelling argument that the “information” contained in the BRCA1 gene “isolate” is new. It’s not. It’s the same information that is in the women who are worried about their risk of breast cancer – it has to be, or the test would not be able to tell us what it is designed to tell us. This is pretty much what judge Sweet says, and while I am pretty firm on the reason why the good judge is right, I am interested in why he/she may not be right as a matter of law.
So no, I don’t understand why kids are grounded when they take the car for a drive without permission, as I am not fully aware of the rules these kids are bound by in regards to driving the car. I’m not really interested if they get grounded or not, I’m more interested to know how well (or not) the rules are consistent with sensible parenting.
The issue that is scary here is that Judge Sweet has allowed parties to challenge a patent without being a party to a suit. So, I guess the ACLU or other party can challenge any patent without using the procedures that already exist (3rd party reexamination). Just sue the USPTO and the owner of the patent in a Federal Court.
I would love to read a decision from the Fed Cir on the standing issue, or even the Supreme Court.
A correction …
I wrote : If you are the first to discover that a chemical contains new, non-obvious and useful “information”, then you can patent that chemical and prevent others from creating that chemcial using a “physically different set of atoms.”
Should be: If you are the first to discover a chemical containing new, non-obvious and useful “information,” then you can patent that chemical and prevent others from creating that chemical using a “physically different set of atoms.”
Brian: If the BRCA1 and 2 gene sequences didn’t exist in nature, they would have zero utility.
The sequence information is not what is being claimed. What is being claimed is an isolated chemical composition that has properties which differ from those found in any known “natural” composition. Are some properties similar? Yes, but so what?
“Isolating” a sequence is just putting the information in a different place, encoded by a physically different set of atoms from the set you created it from.
If you are the first to discover that a chemical contains new, non-obvious and useful “information”, then you can patent that chemical and prevent others from creating that chemcial using a “physically different set of atoms.”
If doing that makes it fundamentally different, then I’m going to argue that all my old Napster mp3s are “isolated”.
Okay. I’m going to refer to my phone as a chicken. Now what?
I think that if the law were to hold that “Myriad’s “isolated” BRCA1 and BRCA2 gene sequences are also “novel” as they don’t exist in nature”, then the law would be fundamentally in error.
The word “novel” accurately describes something that did not previously exist. Useful compositions that did not previously exist and which are properly claimed (by describing their structure in terms that are understood by those skilled in the art) are patentable. I don’t think this is a “fundamental error” in the law, as the law has proven useful for encouraging the development of new and useful compositions of matter. Perhaps there are policy reasons that you disagree with the way that the law enables patents to be obtained on nucleic acid sequences. That’s a great issue for Congress to tackle (although I’d rather see other reforms take place first).
if Sweet’s opinion is likely to be reversed, I’m trying to figure out why…
Unfortunately, Sweet’s opinion is likely to be reversed for reasons that have little to do with whether the claimed compositions and methods are “novel” or not. Do you understand why kids are grounded when they take the car for a drive without permission? If so, then you should be able to understand why Sweet is likely to be reversed.