Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

By Jacqueline Wright Bonilla, PhD, JD. Ms. Bonilla is a partner at Foley & Lardner and filed an amicus brief supporting Myriad's position.

In entering the fray of this discussion, I note that I, along with two of my colleagues at Foley & Lardner LLP, submitted an amicus brief in the AMP v. PTO (a/k/a ACLU v. Myriad) "gene patenting" case on behalf of our clients Rosetta Genomics and George Mason University. In addition to our brief, other colleagues at our firm submitted a different amicus brief on behalf of a different client, Alnylam Pharmaceuticals. Both briefs, along with Myriad's brief and a number of other amicus briefs filed last week, support a reversal of the district court opinion as it pertains to "isolated DNA" composition claims. These briefs agree that such claims are patent eligible under current law, and should continue to meet the threshold of 35 U.S.C. § 101 as a matter of policy and social considerations. We are sensitive to dire consequence to biotech innovation in the face of a possible alternative outcome.

As it turns out, however, while such briefs agree on patent eligibility of "isolated DNA" claims, a number of briefs differ in viewpoints regarding applicable law, and even which cases are relevant versus not. As such, a reading of just the briefs filed with the Federal Circuit so far—even without considering the ACLU brief yet to be filed, much less amicus briefs filed in support of the ACLU's position—underscores a point worth mentioning.

The point is this: reasonable minds can differ on an interpretation of what constitutes relevant case law and how it should be interpreted in this case. This point is often missed in the hubbub we see in the press. For instance, many have commented on the amicus brief filed by the Department of Justice last week. Some have accused the DOJ of misreading the law entirely and attempting to eviscerate biotechnology innovation altogether. Such viewpoints misread the point of the DOJ brief, in my opinion.

Look what the DOJ brief actually says. It argues that the district court got it wrong in certain important respects. As stated in the DOJ brief:

… the district court erroneously cast doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA. Such compositions—e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as "'human-made inventions'" eligible for patent protection under section 101. [] The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the '282 patent, that are directed solely to cDNAs.

DOJ brief, pages 9-10 (citations omitted). As part of this discussion, the DOJ likewise agrees with our position that claims directed to recombinant vectors comprising any isolated DNA—even DNA having a sequence exactly as it exists in nature—constitutes patentable subject matter. See DOJ brief, page 16, discussing claim 8 of the '282 patent. Thus, unlike the district court opinion, the DOJ proposal does not throw the entire biotech baby out with the bath water.

That said, it appears that the DOJ may cut off a hand of the biotech baby. It argues that "isolated DNA" comprising a sequence from genomic DNA as it exists in a body does not constitute patentable subject matter. The DOJ brief (pages 10-11) argues that the "chemical structure of native human genes is a product of nature," even "when that structure is 'isolated' from its natural environment."

This position presents a slippery slope of considerable concern to those affiliated with biotech innovators responsible for actually getting medical products to patients. For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, "human made" inventions. These products simply do not exist without human intervention. Thus, how does one successfully distinguish what is really "human made"? Moreover, human involvement is needed to identify valuable isolated nucleic acid molecules, such as DNA vaccines, PCR probes, interfering or micro RNA, etc., and then isolate them. When exactly is the human involvement sufficient to meet § 101? An additional slippery slope in the DOJ position is that many non-nucleotide compositions also exist as "products of nature" in a human body or other natural physical state. These compositions include many valuable small molecule pharmaceuticals, proteins, antibodies, just to name a few. Such compositions could likewise be subject to the same legal reasoning propagated in the DOJ brief. In other words, the fallout of the DOJ's position has wide-sweeping implications, even if not as flabbergastingly debilitating as the district court opinion.

This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law. The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations. The courts will consider case law, of course, but in reality may only apply it after the fact. I also believe that any precedential decision issued here, either way, will necessarily have at least some negative fallout. In fact, the patent system itself intends negative fallout to some people by virtue of granting a right to exclude others for a limited time. Thus, keeping the ideals of patent law in mind, it will be critical for courts to choose a course of action that provides the most amount of good, while causing the least amount of collateral damage. In other words, forget all the clever legal mumbo-jumbo—what do we want to happen here for the better collective good?

My understanding of the patent system is that it exists for the very purpose of stimulating innovation, as well as public disclosure of that innovation. As discussed at length in our amicus brief (and by others), abolishing patent eligibility of genetic inventions—not to mention inventions in other areas of health and medicine potentially impacted by a decision here—will have more of a dampening effect on research, development and innovation than any patent right could ever have.

My hope is that courts will remain ever conscious of slippery slopes created by any one interpretation of the law and application of science. No one wins if we inappropriately dampen incentives for innovators to discover, apply and provide innovation to the benefit of humans.

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259 thoughts on “Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

  1. TINLA, you just made a great argument for the application of Benson to the present case. Benson requires that that claim preempt all practical uses, which is what you said he Myriad claim actually does.

    Earlier, I said I did not know the answer to that question which prevented me from forming the legal conclusion. But, TINLA, you now have supplied the necessary factual basis to draw the legal conclusion.

  2. Gottschalk v. Benson, 409 U.S. 63 (1972)

    Posted by: Friends of Douglas and Stevens

    Sorry, but you misunderstand Benson. That was a process claim, and the thing “preempted” was a “mathematical algorithm,” which was stated to fall under the category of “abstract idea,” not “natural phenomenon.”

    The preemption of the “abstract idea” is preemption of all uses of the “abstract idea,” whether by man or otherwise. But, as Malcolm has pointed out, the claim to the “isolated gene” does not preempt all uses of the “wild gene,” as can be seen in the use by nature of the gene to express biological characteristics in nature. In other words, the claim to the “isolated gene,” to the extent that it preempts uses of the “wild gene,” only preempts uses by man of that gene. Accordingly, the claim to the “isolated gene” is not a claim to the gene itself.

  3. “Your molecule cannot exist without all those other atoms that you chose to try and ignore.”

    There you have it. Skepticism by one of obvious skill in the art. That proves that isolating DNA is non-obvious.

  4. And, what you are really saying –since the molecule will react with differently depending on the atoms you are refusing to acknowledge–is that functionally you only care about the sequence of nucleotides since you plan on using them to determine markers.

    You absolutely refuse to see the similarities between you claim to only a sequence of nucleotides which ignores so much else about the molecule and implicitly is claiming a function and a Beauregard claim.

  5. Yes, IANAE, but the difference is that a windshield wiper can exist without the car. Your molecule cannot exist without all those other atoms that you chose to try and ignore.

    If you ever become intellectually honest you will confront this issue.

  6. When has “preemption” ever been applied with respect to a composition of matter or article of manufacture, on the basis that a “natural phenomenon” is preempted?

    Gottschalk v. Benson, 409 U.S. 63 (1972)

  7. Ned: “For example how would one prove infringement of such claim? Would one compare the structures of two DNA strings? Or would one prove that the two DNA strings encoded for the claimed protein?”

    One would sequence the infringing DNA, and then show (possibly using Wikipedia) that the sequence codes for the claimed protein. Probably the only reason the DNA was claimed in terms of the protein in the first place is because it’s a much easier (and equally definite) way to account for degeneracy in the DNA code. The key here is the direct two-way correspondence between structure and function, which you don’t get with software because software doesn’t always use the same code.

    But that’s something you’d probably only claim if you were after the utility of synthesizing the protein. Presumably if you were using your DNA as a diagnostic tool to detect its complement in vivo, you’d want/need to specify the DNA sequence directly.

    Ned: “Suppose for example I isolated DNA that coded not only for the claimed protein, but also coded for several other proteins not claimed. (I assume that one could do this by adding in other DNA sequences separated by the required ending or separation structures.) Obviously, such a DNA structure would not have the same structure as the DNA that encodes only for the claimed protein. But, I would contend, that it would still be an infringement because the structure in fact encoded the protein claimed. That is all that is required to infringe.”

    That depends on the exact wording of the claim. If you claim a sequence of nucleotides, the claim is no less infringed by adding more nucleotides to the end of the claimed sequence. Much like if you claim an intermittent windshield wiper your claim is no less infringed by adding a car on the end.

  8. RE the “preemption” argument endorsed by Ned and 6.

    When has “preemption” ever been applied with respect to a composition of matter or article of manufacture, on the basis that a “natural phenomenon” is preempted? Is there any basis for thinking that “preemption” applies to anything other than process claims that preempt all uses of abstract ideas?

  9. Personally, I am tired of the hand-waiving and poor legal arguments on this blog, wherein the mere “I said so” is taken as persuasive. It is not.

    Let’s start with Malcolm Mooney giving the explicit statement that functional language is an appropriate way of claiming structural differences, that he at the same time claims he has done (and led) dozens of times and yet still holds that Beauregard claims are somehow illegal. And let’s have this simple statement unencumbered with provisios of being applied to a particular art unit, or couched in similar weasel words.

    I am asking for just a little integrity here.

  10. There gonna need a bus. Hal you will be the first on. So now we know it’s Tamai. and the PTO is just saying. he is an inventor LOLOL. And because of that he can no longer work at the USPTO. LOL . now bring it on. And Gene you say Novena. you don’t know what a good catholic is. i wouldn’t even qualify you as an agnostic. That was clearly a great idea. to bad you failed.

  11. All will notice that the rust brains did not respond to my questions. Silence = my victory.

    Bozos.

    And, MM, so cute the way you abstract and say “structural differences.” So, the atoms are different they just don’t count in your book as “structural differences.” About as clever as as a pig claiming he is rice grain to get out of being roasted.

    Face it. You lose, again.

  12. Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein? — Ned Heller

    Ned Heller, let’s say you find some wild rice on the ground. No, that cannot be patented. Now, lets say instead that you find that same rice afixed to the rice plant. Now, if you isolate that rice … bingo! Patent city.

    Lets say you discover that such rice can be within a variation set and you still get what you want. So you list these variations in a table (Table I). The patent claim? Here is it:

    I claim:

    1. An isolated rice, comprising: rice from Table I.

    Please respect my invention. Thank you.

  13. Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein?

    Ned Heller, let’s say you find some wild rice on the ground. No, that cannot be patented. Now, lets say you find that same rice afixed to the rice plant. Now, if you isolate that rice … bingo! Patent city (assuming you get one of them there DNA patent examiners).

    Lets say you discover that such rice can be within a variation set and you still get what you want. So you list these variations in a table (Table I). The patent claim? Here is it:

    I claim:

    1. An isolated rice, comprising: rice from Table I.

    Please respect my invention. Thank you.

  14. Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein? — Ned Heller

    Ned Heller, let’s say you find some wild rice on the ground. No, that cannot be patented. Now, lets say you find that same rice afixed to the rice plant. Now, if you isolate that rice … bingo! Patent city (assuming you get one of them there DNA patent examiners).

    Lets say you discover that such rice can be within a variation set and you still get what you want. So you list these variations in a table (Table I). The patent claim? Here is it:

    I claim:

    1. An isolated rice, comprising: rice from Table I.

    Please respect my invention. Thank you.

  15. If this so called Patently O Court of Law was allowed, and the Judge maybe was told it would be fair, and it wasn’t, because whay I say is not recorded and filtered on other Computers . And the whole year was a tyrannical lying Joke. The Houston we have an even bigger problem. This is AWWEEESSSOOOMMEEEEEEEE!

  16. please understand that Malcolm will simply move the goalpost and start beating on some other strawman that he knows little or nothing about.

    Fixed. Sunshine, Iza be waiting for your earnest reply to Malcolm Bafoonery.

    A nice, short, quick sentence will set him straight, won’t it.

    C’mon, a single sentence – even you can plainly state a truth that you believe in, cantcha?

  17. Malcolm and IANAE, I never said that one could not determine the molecular sequence being claimed. I just don’t think that is relevant at all.

    For example how would one prove infringement of such claim? Would one compare the structures of two DNA strings? Or would one prove that the two DNA strings encoded for the claimed protein?

    Suppose for example I isolated DNA that coded not only for the claimed protein, but also coded for several other proteins not claimed. (I assume that one could do this by adding in other DNA sequences separated by the required ending or separation structures.) Obviously, such a DNA structure would not have the same structure as the DNA that encodes only for the claimed protein. But, I would contend, that it would still be an infringement because the structure in fact encoded the protein claimed. That is all that is required to infringe.

    Do you agree?

  18. >>For the time being, I’m having fun satisfying >>myself that NWPA’s isolated gene arguments are >>(1) even more damning of Beauregard claims, >>and (2) trivially refuted using high school >>biology and Wikipedia.

    So, you are asserting then that the isolated gene is being claimed with each atom of the molecule being part of the claim?

    Is that right wise guy?

  19. please understand that NWPA will simply move the goalpost and start beating on some other strawman that he knows little or nothing about.

    Trust me on this.

    Posted by: Malcolm Mooney | Nov 09, 2010 at 04:02 PM

    ________

    Well, Mooney I think we can all trust you are the king of strawmen.

  20. MM >>sequences and structure

    I never said they didn’t define a structure. I said that all the atoms and all the structure was not defined for the molecule that is being claimed. So, you are claiming a molecule by only partially specifying the molecule structure. Why is that? Why do you think you can not specify all the atoms and yet demand that the exact sequence of 1′s and 0′s be specified.

    >>You need me to explain to you how software works?
    You ran from this.

    >>If you know of any other atoms that are >>missing, now’s the time to show off your >>immense knowledge of this art.
    Yeah, what atoms are at the end of the sequence of nucleotides? (as one example).

    You still didn’t answer the question why machines were claimed functionally.

    Of course the Bearegard claims structure. You just can’t understand it. Or more likely chose not to understand it.

  21. “Trust me on this.”

    As soon as you learn to stop arguing with ping.

    For the time being, I’m having fun satisfying myself that NWPA’s isolated gene arguments are (1) even more damning of Beauregard claims, and (2) trivially refuted using high school biology and Wikipedia.

    He can move the goalposts and declare victory all he wants, and it doesn’t bother me one bit. Serious business, this internets thing.

  22. “>>Still printed matter
    This has been asserted and blow up a hundred times.”

    Nobody has ever shown that the printed matter on a computer-readable medium is functionally related to the medium. You always hand-wave about the function of the computer that is sold separately. The medium is just that – a medium. An inert substrate. It functions exactly the same no matter what code is on it.

    “Would you say that a gear depends on the material used so that it has no structure until you specify the material?”

    Of course not, because a gear is defined by its geometry, and its geometry does the same thing no matter what machine you put it in, for any reasonable choice of materials that would commend themselves to a person of skill in the art.

    Ones and zeros can be implemented in a variety of structural ways, depending on the medium – presence vel non of transistors, stored charge on transistors, stored charge on capacitors, orientation of magnetic dipoles, holes in a punch card, order of nucleotides… The code does not even come close to defining the structure.

    Also, try running PC software on a Mac, and you’ll see that the order of the ones and zeros doesn’t define the function or vice versa. And you don’t need to be skilled in the art to know that, either.

    “Just how do you explain that when you put that thing in a computer that the computer does some pretty amazing things, but without that thing the computer doesn’t do much of anything?”

    You need me to explain to you how software works?

    If you put food in a human, that human can do some pretty amazing things. If you don’t put any food in, the human doesn’t do much of anything. That’s a pretty solid demonstration of the utility of the food, but not of the patentability of the plate that supports the food. Now, if you’d invented the Krebs cycle, you’d really have something there.

    “You do not specify all the atoms. And you know it. Your isolated DNA has lots of atoms that are unspecified because you cuoldn’t specify the aotms without making it trivial to design around the claim.”

    Isolated DNA is described as a series of nucleotides. Each of those nucleotides is composed of a very well-known arrangement of atoms, and connected in a very well-known way. Put together, those nucleotides account for all the atoms in the isolated DNA.

    If you know of any other atoms that are missing, now’s the time to show off your immense knowledge of this art.

  23. IANAE, assuming you do manage to teach NWPA the basics of molecular biology and the direct relationship between sequences and structure (hint: you won’t succeed), please understand that NWPA will simply move the goalpost and start beating on some other strawman that he knows little or nothing about.

    Trust me on this.

  24. OK. So, I’ll sum up your argument as: Change issues.

    >>Still printed matter
    This has been asserted and blow up a hundred times.

    >>because the structure of 1′s and 0′s depends on the medium
    Would you say that a gear depends on the material used so that it has no structure until you specify the material?

    Why does the following matter? Does that mean that a gear has no utility until you know which machine it is going to be used in?
    >>until you know what computer is doing the >>reading.

    Just how do you explain that when you put that thing in a computer that the computer does some pretty amazing things, but without that thing the computer doesn’t do much of anything?

    You do not specify all the atoms. And you know it. Your isolated DNA has lots of atoms that are unspecified because you cuoldn’t specify the aotms without making it trivial to design around the claim.

    Sheesh. This is a joke.

  25. Sorry to disappoint you, NWPA. I can tell you desperately wanted to have a grown-up conversation about patents.

    Hey, is this the question you wanted answered?

    “what if one did specific all those 1′s and 0′s? What would happen?”

    Because I answered that one already. They’re still printed matter, they’re still not claimed structurally (because the “structure” of ones and zeros depends on the medium), and they still have no recognizable utility (or, if you prefer, any arbitrary utility you care to define) until you know what computer is doing the reading.

  26. >>does specify ALL the atoms

    It does not specify all the atoms. False.

    You did not answer the questions that were put to you, so you are a rust brain. Admittedly, I threw in some name calling and silliness, but there were substantive questions that you did not answer. Tou never do. Instead: Yapping.

  27. “Rust brain: the fact that those 1′s and 0′s bother you so much means you are not one of ordinary skill in the art.”

    The fact that you feel so threatened and defensive and resort to name-calling whenever anybody points out the obvious fundamental weaknesses of Beauregard claims means that you’re not one of ordinary skill in the art of lawyering. All you ever do is cling to your preconception that Beauregard claims are better than gene claims, despite the obvious analogies between them, for reasons you can’t even explain to yourself.

    “Why don’t you have to specify ALL (ALL!!!!!!!!!!!!!!! in your lingo) the atoms? ”

    The fact that you don’t realize a sequence listing does specify ALL the atoms means you are not one of ordinary skill in the art.

    And the fact that you use so many exclamation points means that you’re the sort of person who wears his underpants on his head.

  28. And why is it that when a machine is claimed made of rust (whoops iron) that each and every atom of the machine does not have to be claimed? Why is that huh? Yap. Yap. Yap.

    Why did they start claiming functions of machines? Can you answer that? If you can’t then it explains a lot. Yap. Yap. Yap.

    I see red dust coming out of your ears.

  29. I have a question: what if one did specific all those 1′s and 0′s? What would happen?

    And rusty brain, why is that your isolated molecule dingy can leave off all the atoms that may be hanging around? Why is that? Why don’t you have to specify ALL (ALL!!!!!!!!!!!!!!! in your lingo) the atoms?

    Rust boy stop the games. Yap no more and try to learn that you are nothing but a silly little rust brain.

  30. IANAE: endless yapping about Beauregard claims. Yap. Yap. Yap. Yap. Yap. Switch issues. Yap some more. Bully. Threaten. Yap. Change issues. Yap. Challenge. Yap. Run. Threaten. Yap.

    Rust brain: the fact that those 1′s and 0′s bother you so much means you are not one of ordinary skill in the art.

  31. “IANAE answers for Malcolm in the first person and Malcolm answers for IANAE in the first person.”

    Who asked you?

  32. The Bobsie Twins at work here – IANAE answers for Malcolm in the first person and Malcolm answers for IANAE in the first person.

    No wonder people think both are a joke.

  33. “Now let me get this straight, you are acknowledging that it is prefectly acceptable to claim distinguishing structure by functional claiming?”

    I just explained that, not two hours ago. It is perfectly acceptable to claim distinguishing structure by functional claiming when a person skilled in the art can readily determine all of the structures that can produce the claimed function from the functional language.

    Transcription and translation are reversible simple ciphers. It’s abundantly clear to even a person unskilled in the art but having access to Wikipedia which specific DNA sequences code for a particular amino acid sequence. You don’t even need the “reader” to know what the DNA codes for. The claim is both structural and definite.

    The claim is even more definite (if such a thing is possible) when the credible utility is for the sequence to detect its complement, because then you don’t even need to transcribe or translate the sequence to get the result. The function is the structure.

    Compare and contrast Beauregard claims. You can’t possibly know every bit string that produces the claimed function. The bit string stored on the medium doesn’t even make any sense without knowing what computer will be doing the reading.

    Even if you could account for every known computer language and every known operating system, you can’t account for later-invented languages or OSes, and you can’t account for all possible forms of encryption or compression. In fact, any prior art bit string can be made to infringe any Beauregard claim by suitably designing an encryption/compression algorithm or a new computer language. It’s impossible to know whether or not a Beauregard claim is infringed without producing the computer that generates the infringement.

  34. MB From one whose mantra has been “must distinguish by structure”, your evasion of this point is particularly glaring.

    Of course I haven’t evaded it. On the contrary, asked and answered dozens of times by myself and others

    Now let me get this straight, you are acknowledging that it is prefectly acceptable to claim distinguishing structure by functional claiming?

    You will pardon my skepticism and indulge me (and countless others) and provide a clear and unequivical express statement directly to this effect. Something short sweet and without any weasel addendums or adornments.

    This will be interesting, no – priceless to see.

  35. MD Has the court yet construed “isolated”?

    It’s often defined expressly in the specification, rendering the construction relatively straightforward.

  36. When ya started out I asked ya about the teleportation ya needed to match your analogy to what was goin on. Have ya “construed” that yet?

  37. Ned Still, the claim is functional. It is to DNA that encodes a specific protein. The protein is defined, not the DNA.

    As recognized by courts and the PTO, the nucleic acid coding for a specified protein sequence is immediately recognizable by the PHOSITA, given the well-known genetic code.

    IANAE explained this to you …. and it’s not the first time it’s been explained, Ned. More like the tenth. What is it with you?

  38. When we started out, I was likening “isolated” to photographing a selected yard of a thousand mile long strip of asphalt. But through the length of this not quite yet thousand part thread, I have gathered that, however wide the term “isolated” is, it is not wide enough to cover that.

    Or is it? Has the court yet construed “isolated”?

  39. So…

    Weza can claim the carbon molecule cause we can separate it?

    Also, your middle earth is showin as to what actually need be there for the computer arts, but it’s nice to see that at least ya aiint fightin the functional claim aspect like my pal Malcolm.

  40. Still, the claim is functional. It is to DNA that encodes a specific protein. The protein is defined, not the DNA.

    If the protein is defined, you know the sequence of the DNA, to within certain interchangeable codons that code for the same amino acid. Sure, it’s functional in that it’s a something-readable medium which, when read, produces a particular amino acid sequence, but unlike a Beauregard claim it can be unambiguously reverse-engineered to the exact sequence of zeros and ones. And twos and threes. And from there to the exact molecular structure.

    If you were in the mechanical arts and you claimed a female connector in terms of matingly engaging a specific standard and well-known male connector, is that a functional claim? Sure it is, but it’s also simple and unambiguous to deduce the actual structure necessarily implied by that function.

    Isolated simply says that the molecule being claimed is not in a specific location or combined with other molecules.

    The wild DNA is arranged in chromosomes, each of which is a single giant molecule. A small molecule consisting of a single isolated gene is very much a different physical structure, in the same way that a carbon atom isolated from aspirin is a different physical structure from aspirin. It’s not a question of sorting one type of molecules from another, it’s a whole different molecule.

    We can discuss whether it’s obvious or not to select out a particular piece of an existing aperiodic polymer as a stand-alone molecule (and that’s really the interesting discussion to have), but you can’t reasonably say it’s not a novel structure or that it’s not a structural claim.

  41. The filter to what I say is awesome from one to another. Do you really think I can’t and won’t hand deliver a letter to the poor District Court..What are you going to do ARREST ME. that will be AWESOME
    Dicks little sister.

  42. IANAE and Max, as always helpful. Still, the claim is functional. It is to DNA that encodes a specific protein. The protein is defined, not the DNA. All this talk about cutting, reading, etc., is irrelevant. All that matters in the end is that the DNA encode the protein. Not how, or when, etc.

    It is a given that the claim covers any DNA that encodes the protein. “Isolated” only excepts the wild DNA from infringement. It does not to me or to the government require any structure because the structure being claimed is instead defined by the functional requirements. Isolated simply says that the molecule being claimed is not in a specific location or combined with other molecules. But, in the end, this is does not change the structure being claimed as far as I can tell.

    The structure being claimed is any structure that encodes the specified protein. That structure is per se old.

  43. Lulz Malcolm, I see the answer is c) – whoops where’s the geometric factorin? Only dozens? for sure, I thought weza be in the hundreds.

  44. MB From one whose mantra has been “must distinguish by structure”, your evasion of this point is particularly glaring.

    Of course I haven’t evaded it. On the contrary, asked and answered dozens of times by myself and others. In fact, if you go back to the earlier threads on this subject, I’m quite sure you’ll find I was the first commenter to address the issue.

    Please learn to read.

  45. (Of course, I do have a utility for my stemless leaf, so let’s just avoid that non-sequitur altogether, shall we)

    Of course, we’ll avoid the central point of the discussion because it’s probably not relevant. We’ll also ignore what “non sequitur” means, apparently.

    Tell you what, if you actually have a credible utility for a stemless leaf, and you can show that it wasn’t obvious to a sane botanist to make the cut at the point where the leaf clearly begins, you can have your patent.

  46. I pluck a leaf from a tree, carefully at the base of the leaf rather than at the base of the stem, thereby changing its endpoint.

    I shall now run to the patent office to patent my new creation, a stemless leaf.

    (Of course, I do have a utility for my stemless leaf, so let’s just avoid that non-sequitur altogether, shall we)

  47. “Isolated” therefor is not structure. It is the absence of other structure.

    Isolated is structure when you’re talking about removing parts of a molecule. A DNA sequence that starts here and ends there is a different structure from a chromosome-sized molecule of DNA. It confers novelty, at least.

    How meaningful is the structure associated with isolation? That depends on how you look at it. Yes, the really important aspect is the gene sequence, and that may well be unchanged or trivially changed from the original chromosome. But another very important functional aspect of DNA is where you start and stop reading it. Some prokaryotes, if I recall, have overlapping genes so that the same DNA sequence, read from a different starting point, codes for one of two completely different functional proteins.

    The end points are also important for diagnostics, because you’re using the sequence to detect its complement. Too long, and you risk false negatives. Too short, and you risk false positives.

    Now, whether it’s obvious to start and end at a particular point, that’s a whole other debate. But it very much is a meaningful structural feature. Much more than, say, “on a disk”.

  48. I doubt that Mooney will reply. I had thought there was no doubt that, to the relevant PHOSITA, “isolated” delivers novelty and a structure that is not identical. Imagine a kernmantel climbing rope 30 meters long. Now imagine “isolating” a chunk of it, a long way from both ends, by marking it, then severing it from the long strand, without using heat. Examine the state of the braided fibers of the marked “isolated” section a) remote from the cut end and b) right next to the cut end. Are the fibers adjacent to the cut end spaced apart from each other by the same distance as the braid fibers remote from the cut end? The “isolated” section of the rope has a structure different from that of the section prior to isolation. The isolated section is a new and different thing with a different structure and different properties.

    And we haven’t even begun yet to look at electron field densities.

    As to my “marking” step, remember the old story about the expert with the stick of white chalk, who alone of all experts can overcome the factory shut-down simply by putting a white cross on the exact location in the giant machine where the fault is located?

  49. Here, the legal AND policy arguments in favor of patenting new and useful chemical compositions

    That’s the key, isn’t it – new – How new is it, if it is exactly like the item in nature (at least the claimed part)?

    And please tell those followers of this blog how structurally different the claimed molecule is different than the wild one. Ned Heller’s point about “isolated” not being a structural difference is on point, his point about that limitation being a functional one is on point.

    From one whose mantra has been “must distinguish by structure”, your evasion of this point is particularly glaring.

    Oh, which of Malcolm’s precious defenses will this board see?
    a)I don’t know what you are talking about
    b)I don’t want to answer
    c)I already told you – see I just told you again
    d)BIG COMPUTER BRAIN

  50. In addition, you’ll find policy arguments (in addition to legal arguments) against such patents.

    Haven’t seen any real legal arguments yet, only wishful thinking and policy wonking.

  51. patent litigation I’ve noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones

    And just to be clear, it’s not just “biotech proponents” that do this. At least with respect to methods of analyzing genetic information (e.g., for the purposes of making a diagnosis), I’m sure you can find many “software proponents” who can make a pro-patenting contention “based on policy arguments rather than on legal ones.”

    In addition, you’ll find policy arguments (in addition to legal arguments) against such patents.

    Here, the legal AND policy arguments in favor of patenting new and useful chemical compositions (and treating DNA like chemical compositions because, uh, that’s what they are) are more compelling than the policy arguments against such patents.

    The method claims may rest on shakier legal grounds, depending on how they are drafted.

  52. Although some gene patent proponents argue that this patent litigation is about legal precedent and reliance, I honestly think that this is one of those issues that is largely about one’s politics and policy. Whether or not human genes are legally patentable is a question rather like the “if a tree falls in the forest” hypo. I’ve noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones — perhaps because there is no real legal answer. That being the case, although I’d like to read a Supreme Court opinion deciding this issue, perhaps this is really one for Congress to deal with.

  53. Malcolm, now, let’s revist your testimony in the Therasense case.

    Right. Like I want to spend the next week and two pages of comments explaining why your characterizations of my earlier comments are wrong and/or irrelevant to this thread.

    No thanks.

  54. Ned A claim to an isolated leaf, i.e., the leaf outside the context of the tree, is a claim to the leaf per se. It is not defining new structure, just the absence of irrelevant structure.

    The tree is irrelevant to a tree’s leaf? Wow, you learn something new here every day.

  55. Malcolm, the cow or the test tube? You do seem to endorse the government’s analogy to the leaf and the tree. A claim to an isolated leaf, i.e., the leaf outside the context of the tree, is a claim to the leaf per se. It is not defining new structure, just the absence of irrelevant structure.

    The “active” structure of the wild and the isolated DNA is the structure being claimed. It is claimed not by a sequence, but by its function, the function being to encode or to express a certain protein where the protein is identified by its structure. The structure that does this, either wild or isolated, is IDENTICAL. Other structure that may be present in the wild, is not claimed. The word isolated means that it is not claimed.

    “Isolated” therefor is not structure. It is the absence of other structure. Recall our discussion of this issue in the “membrane” case (Therasense) where the absence of the membrane for use in whole blood was the claimed invention. There you were quite derisive IIRC in concluding that there was no invention in the absence of something and that the patent attorney advancing the thesis that it was not being entirely candid at best.

    These claims are almost like Beauregard claims. The real invention, if any, is the programmed machine. The Bearegard claims, by analogy, are to the isolated program.

    (Love these anologies.)

  56. Tell you what, when Anon restricts his shoveling to only dirt, we’ll resume our discussion of this metaphor.

  57. Anon: I was addressing your error as to even obtaining the second patent.

    I wasn’t even talking about the second patent in the first place. I’m impressed that you think you found an error in something I didn’t say. It’s somewhat akin to finding a hole right in the middle of a larger area that has no dirt.

    Ned: When anybody does this in a brief or other argument, I ALWAYS take to mean that this is done to hide a central weakness.

    What does it mean when both sides are doing it?

  58. could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein?

    Done this already many times. I’m sure you were there.

    Let’s put it this way Ned: other than the sequence of nucleotides, there are no other structural similarities between the isolated DNA and the DNA in the wild. Let’s take the gene encoding bovine insulin. Have you ever seen a cow before? That’s what the gene looks like “in the wild.”

    Now look at a tiny tube of water with an isolated nucleic acid encoding bovine insulin floating in it (hint: it looks just like a tiny tube of water). Now look at the cow. Do you see any structural differences between these two compositions?

    Yes, this is simplistic and somewhat silly but not nearly as simplistic and silly as the arguments in the district court’s opinion.

  59. BTW, IF this structural difference is discussed in any brief, just point me too it. IIRC, almost all the briefs in favor of patentability wave their hands at this point in their argument, frantically diverting attention to other issues like the value of such patents. When anybody does this in a brief or other argument, I ALWAYS take to mean that this is done to hide a central weakness.

  60. Malcolm, without being too cute, could you identify precisely what the structural differences are between an isolated DNA that ecodes a specific protein and the wild DNA that encodes the same protein?

  61. Anon Was anyone addressing you?

    LOL. Because you are really concerned about people jumping into conversations here. Hilarious.

    No one was discussing infringement

    As I noted upthread, MaxDrei was discussing infringement.

    You’re making this too easy, Anon.

  62. Ned What defines the structure of the molecules being claimed? “Isolated” or the protein encoded?

    Both, of course.

    The government brief says the latter.

    If so, the government is wrong. I’ve already noted that the government’s characterizations of the claims are misleading.

  63. Malcolm,

    MaxDrei asked the question, which in itself has no error. I took issue (or to use your words ragged on) the person who gave the answer with the error in it.

    Do you have a problem here? Was anyone addressing you? Do you have a problem with people posing questions, but not one with people giving errant answers? IANAE is perfectly capable of devising his own non-answer, and doesn’t need your cheerleading, as misplaced as it is.

    IANAE,

    Your comment at 12:38 PM only digs the hole deeper. You ask a question that you should have asked yourself prior to your first answer. No one was discussing infringement and it is perfectly known that patents on advancements of ideas do not give the second patentee any rights over the substance of the first patentee – I was addressing your error as to even obtaining the second patent. Trying to hide your error in cleverness is not very clever. Clearly you recognize your own error. Just admit to it instead of covering it up.

  64. Malcolm,

    What defines the structure of the molecules being claimed? “Isolated” or the protein encoded?

    The government brief says the latter.

    But this means, does it not, that the structure that encodes the protein in the isolated DNA is the SAME structure that encodes the protein in the wild DNA. (Other parts of the wild DNA that do other things are not part of the claimed structure.) In other words, the structure being claimed is identical to the structure of the wild DNA, not different as you have consistently claimed in these threads.

    That is why I suggest you are reading some structure into the claim that does not exist in fact.

    Turning to Max’s point that most new molecules are per se obvious, but they are patented to the first discover of an use. Others here have hotly contended, however, that one cannot patent a pre-existing molecule even if one were the first to discover a use for it. Per se structural novelty is the minimal requirement.

    The distinctiions are fine, and do not appear to make much sense. But let’s go with the flow.

    Given the simple fact that the “structure” being claimed in the present case is old, the majority view here would be that one cannot claim that structure even if one were to discover a new use for it.

    However, if the “structure” is new, man made, not old, one could patent the novel structure to the extent that one also finds a use for it.

    Now we understand the government brief. The structures claimed that are new, cDNA, or vectors, are entirely patentable subject matter. But structures that are old are not patentable even if one discovers a use for them.

  65. Oops, sorry, I should have written “prima facie” obvious. I did not intend it to be a blanket, “per se”, exclusion. See, I’m not an academic, just an anonymous hobby scribbler.

    IANAE forgive me that I can’t hold in my head all our previous discussions. Perhaps we have already rehearsed the point I will now make.

    Obviousness in Europe is decided as of the date of constructive reduction to practice ie the day the inventor reports the invention to the Patent Office. When is it in America? Might it be the date of conception and, if so, might that be the explanation of our different mindsets here? Thinking on, is this going to be just one more intellectual challenge, if ever “harmonisation” comes, between US patent law and that of the rest of the world?

  66. I’ll come clean IANAE: I’m in a 101 thread on a 103 point.

    Shall we split the difference and talk about 102?

    A new molecule, per se, is obvious. Thus, what makes a “new” molecule “non-obvious” is the “technical effect” it delivers.

    You already know where I stand on that sort of thing. Nothing you discover about your invention after the fact should have any relevance to whether it was obvious to make that invention when you did. If a molecule was obvious before it had a use, now it’s obvious-but-useful, which is still undeserving of a patent.

    These are the sort of problems we run into when we start declaring whole classes of otherwise meritorious inventions “per se obvious”. We have to start making exceptions to the obviousness determination based on factors other than obviousness, and then we have no way of filtering out the inventions that actually are obvious.

  67. I’ll come clean IANAE: I’m in a 101 thread on a 103 point.

    What I cannot get out of my mind is EPO thinking that the scope of protection should be commensurate with the contribution to the art, and EPO thinking on obviousness (which sets what the “contribution” is). A new molecule, per se, is obvious. Thus, what makes a “new” molecule “non-obvious” is the “technical effect” it delivers. In engineering, the only claim that gets through to issue is the one that delivers the very technical effect that is relied upon for patentability. In chemistry though, once you show the effect, you get a 20 year monopoly for the molecule as such, which without the effect would be found obvious. If it is discovered that medication containing a dose of molecule X can cure disease Y then the claim should be directed to the medication (not the molecule per se).

    I’m angling for a Grand Unifying Theory to reconcile EPO obviousness law in chemistry with its obviousness law in engineering. But my discussion with you is leading me to think that I am seeing difficulties where none exist, and that the EPO Technical Boards of Appeal have already got there.

  68. another Anon loser:

    It is obvious that a patent to a device does not cover uses undisclosed, as method patents are available for novel uses of the device after the initial patent.

    Instead of ragging on IANAE, perhaps you should take it up with MaxDrei. It was he who asked: “is it right that the original “inventor” of aspirin or AZT can monopolise also the later unrelated use, totally unenvisioned by the original inventor?”

  69. I do not recall owners of use claims being unable to enforce them.

    Max, I would be very surprised if it were common to discover a second, completely independent use for a drug during its patent term. If there is only one known use, it doesn’t take much to prove on a balance of probabilities that any prescription or ingestion of that drug is for that one use. However, if the claims are drafted such that the off-label use is non-infringing, and the parties involved are aware of the patent, I can imagine that it would be very difficult to find evidence of how many times the drug was prescribed specifically for the patented use. I suspect you may be assessing the risk based on a low probability of it occurring, which is not necessarily indicative of how much it costs when it does occur or whether that’s a result we want to have.

    Besides which, I’m more concerned with the principle than with whether the practical effects are large or small, particularly when we can agree on what the qualitative effects would be. If you invent a thing, you should be entitled to claim the thing, and your claim should be assertable during its term against any making, using, or selling of the thing. I see no reason why that rule should change based on what sort of thing has been invented.

  70. as method patents are available for novel uses of the device after the initial patent.

    Speaking of being obtuse, do you really need to be reminded that the same device or method can be both patentable and infringing?

  71. IANAE,

    Grow up and stop taking so much delight in being obtuse.

    It is obvious that a patent to a device does not cover uses undisclosed, as method patents are available for novel uses of the device after the initial patent.

  72. IANAE you write:

    “If you give the original inventor protection only for his disclosed utility, you run the risk that an off-label utility could render his patent virtually worthless. He’d have to show that everyone taking the drug was taking it for his claimed utility, and possibly even that the drug was effective in producing that utility in that patient.”

    but I’m having a hard time seeing much risk. If (as you say) there is only in very rare cases any more than the one disclosed utility, then what could anybody legitimately be doing commercially with Molecule X if not using it for its only known utility?

    When it comes to the burden of proving infringement, the standard that applies is the usual civil law “balance of probability” is it not? Thinking about litigating claims to medicaments, is there really going to be the practical difficulty you apprehend?

    30 years of practice with “Use” claims has done something in Europe to etch away at the prejudice against “purpose limited” composition claims. I do not recall owners of use claims being unable to enforce them.

    In engineering, in reality, meaningful claims to devices are more or less “purpose limited”. Think how a Patent Office classifies the subject matter of device claims? Field of use? Is this the same as with claims to molecules per se? Only asking.

  73. I am not following your correlation between molecules and the mechanical arts.

    My “correlation” is that the same rules should apply to all arts unless there’s a very good reason why the rules ought to be different. Claims to structure should cover the structure per se in all arts. Claims to printed matter on a prior art substrate should be treated the same in all arts. Equal under the law, and all that.

    If inventing a new and useful device allows you to claim the device structurally and capture any instance of the same device as an infringement, why not for the inventor of a new drug or a new gene?

    Are you implying that the mechanical arts patents on the device also covers undisclosed uses of that device?

    Doesn’t it? The patent covers the device sitting in a room, even if it’s not being used at all. Making or selling, without more, is an act of infringement. On what legal basis does that device escape infringement merely by being put to an undisclosed use?

  74. IANAE,

    I am not following your correlation between molecules and the mechanical arts.

    Are you implying that the mechanical arts patents on the device also covers undisclosed uses of that device?

  75. I had supposed that, apart from rare genetically pre-ordained diseases like the sickle cell thing, every gene was involved in everything.

    Genes code for proteins, and proteins have very complex structures that generally can perform only one highly specific task. I think there are some isolated examples of different enzymes having the same sequence but different folding, which would give one gene two functions.

    If you want to know what genes do, look what goes wrong when they break. Sickle cell anemia appears to affect only hemoglobin, and nothing else in the body except in its reliance on hemoglobin making its regular deliveries.

    Of course, this is all just armchair genetics, but doesn’t it feel correct?

    Tell me, is it right that the original “inventor” of aspirin or AZT can monopolise also the later unrelated use, totally unenvisioned by the original inventor? If so, why?

    Good question. Maybe they should get some benefit from it, if they’re the ones who gave the public this useful molecule in the first place. The second utility would not have been discovered without the prior existence of the molecule.

    If you give the original inventor protection only for his disclosed utility, you run the risk that an off-label utility could render his patent virtually worthless. He’d have to show that everyone taking the drug was taking it for his claimed utility, and possibly even that the drug was effective in producing that utility in that patient.

    In the mechanical arts, when you invent a new device that has a utility, you claim the device. Nobody has a problem with that, because the device is the invention. You gave the world that device, and the patent is your reward.

  76. IANAE, you’ve got me there, when you ask:

    “…how many genes really affect the human body in more than one fundamental way? Very few, I imagine.”

    I had never imagined that a chunk of the naturally occurring DNA molecule affects the human body in one (and one only) fundamental way. There was me, supposing (to be frank) exactly the opposite. I had supposed that, apart from rare genetically pre-ordained diseases like the sickle cell thing, every gene was involved in everything. I had thought this to be the reason why all the hype about sequencing the genome has now dissipated. But, as I say, I’m not a biochemist. Anybody here who can say more?

    Tell me, is it right that the original “inventor” of aspirin or AZT can monopolise also the later unrelated use, totally unenvisioned by the original inventor? If so, why?

  77. MaxDrei: Suppose the new molecule X is a “classic” organic “small” molecule that delivers a pharmaceutical effect. It doesn’t matter whether the inventor gets absolute protection for all uses of the molecule, or just the use revealed by the written description in the app as filed. This because the only use there is ever going to be is the use found in that written description. So, keep it simple, give her a claim to “Molecule X” per se. No harm done.

    Max, I’m not a chemist either, but aspirin is a pretty classic case of a patentable small molecule that is very slightly changed from a naturally-occurring compound having pretty much the same utility, that was later found to have other uses.

    I believe thalidomide and AZT have also been put to uses beyond those envisioned by the inventor of the compound.

    Sure, those are isolated cases and most drugs are only ever put to the one use, but how many genes really affect the human body in more than one fundamental way? Very few, I imagine. Unless there’s some science to the correlation between hair color and certain essential brain chemicals.

  78. sarah, what is dumbfounding is how you do not see that Mikey wants your invention too. Just ask him if he is the inventor of your concept and he will tell you. Do you really find such skulduggery entertaining?

  79. This is what i now know
    I know KT was denied Registered status.
    Iknow JS was fired.
    I know DT is also in the mess. And of course the great RL moved so he could be the Man.
    I also know the little pimp squeek, shouldn’t have claimed to file one thing and then filed another instead. Because no matter what hw says… he haf to have had designs when he lied to me and told me to get lost after he took me for a another needless financial ride. And then line his pockets.
    And then goes the third. broken Record by now. It’s skipping da duc her da duck her duck her da duck her. Do you know that Record, Ducher? I even know that phone number.

  80. sarah,

    it’s not who i am that’s important – it’s who you think i am, when i am not that person that is important. I am not thinking of me – i am thinking of you.

    As for Mikey, I can’t tell you how many times I have to deal with people who with their three grandfathers have invented everything, yet can’t invent a legal way to protect themselves and only want to blame everyone else and say that everyone else doesn’t understand anything. He’s not even original in his psychosis. When he stops whining and actually does something to make his grandfathers even remotely proud of him, then he maybe he have a be otch to pe otch. Until then, he wastes more of his valuable time whining and his grandfathers spin more quickly in their graves.

  81. 6 The utility requirement is not at issue here

    And that’s just one of the reasons why this case is a loser with a capital ‘L’, 6.

    Bank it.

  82. You all had better get used to it. you won’t win. DNA is found in nature. Squeeze Oranges make Orange juice. Squeeze Lemons make Lemonade. Move a DNA sequence make it different. Stack large Pancake small Pancake. Switch it all. Stack em large then all small.It’s still a stack of Pancakes.

  83. Kev just told me several uses for wild DNA MM. Seems like there is plenty of utility for them. Not that it matters. The utility requirement is not at issue here, nor does it impact the inquiry into whether or not a judicial exception is applicable to a given claim.

  84. Fisher fan,

    No matter the outcome of this case/argument, all of those could have been patented for their use (e.g., as a hormone therapy, lowering blood pressure, etc).

    Seems like the scope of protection should go with the scope of the invention.

  85. 6 I’m pretty sure that they were addressing EST’s in In Re Fisher MM.

    Me, too. Congrats, 6! You can read.

    I do not recall them stating that wild DNA had no uses.

    I don’t recall them saying that the moon isn’t made of green cheese.

    I also do not recall them stating that a claim to the same DNA then having been isolated did not preempt all (or nearly all) uses of the wild DNA.

    I don’t recall them stating that Ronald Reagan invented the electric bong.

    I think we’re pretty much on the same page. But you should educate yourself on the utility requirement of 101, as applied in In re Fisher.

  86. We prosecutors…

    We good prosecutors don’t jump directly into 102/103′s from 101.

    one step at a time WCG – make sure that first step isn’t into the path of an oncoming semi.

  87. ping,

    “The rest of your 9:24 post is nonsensicle and ya seem to be caught up in semantics. “removing the isolated DNA…isolating the isolated” – um, this is a bit redundant as the process of removing is what creates the state of isolated – how ya goin to isolate the isolated? Do ya always include extra words in your mechanical or electrical claims?”

    We prosecutors of patent applications argue over semantics, it’s what removes a 101 issue while retaining issues of 102, 103, and 112.

    By analogies, I see these issues. One issue is a claim of oxygen v. versus a claim of isolating oxygen from water. Another issue is a claim for a polypeptide coding as being akin to a claim of a formula and not the use of such formula to do something else.

    Too simple? Analogies not on point?

  88. Okay, but wouldn’t it take it out of § 101? and make moot the patentability issue?

    Not sure just what your question is here WCG. Are you saying that to avoid the 101 issue that the inventor should still try to get a patent on something old (the method) in order to get around the 101? That would be like avoiding the oncoming bus by stepping out of the way of the bus and into the way of the oncoming semi.

    The rest of your 9:24 post is nonsensicle and ya seem to be caught up in semantics. “removing the isolated DNA…isolating the isolated” – um, this is a bit redundant as the process of removing is what creates the state of isolated – how ya goin to isolate the isolated? Do ya always include extra words in your mechanical or electrical claims?

  89. From the p. 23 of the rosetta genetics brief:

    “…the human body never, at any time, produces ‘isolated DNA.’”

    I don’t see an element in the claims that recites “removing the isolated DNA having sequence No. _____”, “isolating the isolated DNA having sequence No. _____”, etc….

    If the claims included and recited in such elements, then it should take resolve the § 101 issue, shouldn’t it? Why can’t patent attorneys/agents include such elements when drafting the claims?

    The molecular structure of each isolated DNA appears in nature and is not man-made. It seems to me that the man-made invention lies in isolating (or producing) the naturally-occuring molecule (or some other atomic structure if my biotech terms-of-art are incorrect).

  90. ping,

    A bit more of a response from me.

    “Easy – because the Method is old.”

    Okay, but wouldn’t adding these elements to the claim it take it out of § 101? and make moot the patentability issue?

  91. ping,

    “Easy – because the Method is old.”

    Okay, but wouldn’t it take it out of § 101? and make moot the patentability issue?

  92. If this is the case, why not claim the method (system, etc…) of isolating the isolated DNA molecule drawn to the specific sequence and not the isolated DNA itself?

    Easy – because the Method is old.

  93. From the commentator’s comments:

    “For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, “human made” inventions. These products simply do not exist without human intervention.”

    If this is the case, why not claim the method (system, etc…) of isolating the isolated DNA molecule drawn to the specific sequence and not the isolated DNA itself? By analogy, this is akin to claiming a method of generating an electrical signal and not the signal itself.

    If one could present the issue using a mechanical or electrical analogy, it would help many to understand the issue. Is there no analogy?

  94. Sarah, if I were you I would not worry. The writer of this piece surmised that the court will decide it on public policy considerations, and the United States Constitution has some nice words which suggest to me that public policy should be to promote the general welfare.

    It’s week-end now. I’m looking forward to an answer next week to my point, that a middle position is possible, between Y) absolute protection for all future uses of any enabled, useful, DNA fragment of DNA found in nature, and N) prohibiting its patentability, namely, M) limit the substance claims to the substantial utility enabled in the written description of the application.

    In the context of small molecules, it is a very old debate.

  95. Have any of you ever.. I mean ever thought about all the Countries out there trying to find Cures? And what they will do when they find it? Do you think Medicine is expensive now? And only the Rich and Insured are sure to be protected. Look at it this way, there is plenty of money out there to find the cure. Because that in itself is expensive enough without some drug company or some Country holding it over the heads of people that need it. This way the Drug Companies still make their money. License the formula. But make it affordable for all the companys that produce it, including a lowered Generic type. And all people hopefully will benefit. Think of it as a step up for everybody. Invent something that doesn’t control a persons quality of life. Invent something to make life easier. Making drugs for a better life should be for everyone. Not a payment to stay alive ONLY if you can afford it. And if you think making a better healthy life for all is Socialism, you’re all missing the Train.

  96. I’m pretty sure that they were addressing EST’s in In Re Fisher MM. I do not recall them stating that wild DNA had no uses. I also do not recall them stating that a claim to the same DNA then having been isolated did not preempt all (or nearly all) uses of the wild DNA.

  97. DOJ,

    Here are some drugs which DOJ presumably doesn’t think should be patentable under 101 (some or all may be anticipated or obvious now, but not when they were discovered).

    vinblastine sulfate (derived from periwinkle).
    Digitalis — leaves of Digitalis purpurea
    Reserpine – sedative from tropical shrubs
    Taxol – Cancer drug from yew trees
    Magainins – antibiotic from african frogs
    Captopril – Blood pressure med from vipers
    Premarin – hormone therapy from horse urine
    TM601 – anti-cancer drug from scorpions

    All of these are “isolated” from plant or animal sources. The only difference between these and DNA is that the DNA is even more changed, since it is in much smaller pieces than those found in nature, while these compounds are otherwise unchanged, except for being purified.

  98. Ned,

    Deuel is dead. KSR killed it and Kubin drove the nails into the coffin.

    Fisher is the central case here, and Fisher clearly implies that some isolated DNAs have utility while others don’t.

    Fisher says:

    Congress did not intend for these practical implications to affect the determination of whether an invention satisfies the requirements set forth in 35 U.S.C. §§ 101, 102, 103, and 112. They are public policy considerations which are more appropriately directed to Congress as the legislative branch of government, rather than this court as a judicial body responsible simply for interpreting and applying statutory law. Under Title 35, an applicant is entitled to a patent if his invention is new, useful, nonobvious, and his application adequately describes the claimed invention, teaches others how to make and use the claimed invention, and discloses the best mode for practicing the claimed invention. What is more, when Congress enacted § 101, it indicated that “anything under the sun that is made by man” constitutes potential subject matter for a patent. S. Rep. No. 82-1979, at 7 (1985). Policy reasons aside, because we conclude that the utility requirement of § 101 is not met, we hold that Fisher is not entitled to a patent for the five claimed ESTs.

  99. Ned I wonder whether you are reading into the claim structure that is not claimed?

    I’m not reading any claim, Ned. What claim should I be reading?

    You asked me what I thought about the passage from the DOJ brief. I answered the question and I was perfectly clear. Now you’re mumbling about what I may or may not be thinking? C’mon.

  100. However, Malcolm, the way I read it, the segment that “encodes” the protein identified in the claim is identical. Everything else in the wild DNA does other things and therefor not part of the claimed structure.

    I wonder whether you are reading into the claim structure that is not claimed?

  101. Ned, I think it’s very poorly written and misleading. As I noted above, a utility argument can be made that relates to the second sentence in the quoted passage from the brief. But the first sentence is basically stating that “The structure of the claimed composition is identical to the prior art, except for the parts where it’s not identical.” Seriously? This is an argument for subject matter ineligibility?

  102. Malcolm, you have said before there are structural differences between wild and isolated DNA. What do you make of this passage from page 31 of the Government’s brief:

    “The “pure” human BRCA1 polynucleotide claimed in the ’282 patent is structurally identical to the DNA segment that occurs in the human body, apart from the fact of its isolation itself. Indeed, the structural identity of the isolated gene in the wild-type gene is the very point of the patent.”

  103. Ned if the only way to determine whether a gene was present is to detect the proteins it expressed, and the only way to do that would be to first isolate them.

    Yes, if these assumptions were correct (they’re not) and the claim was broad enough to cover the isolated gene in the form which it appears momentarily in the machine, then you would have momentary infringement.

    I have no idea why you think this is important.

  104. Malcolm, I asked before in another thread, but I still don’t have an answer that I fully understand.

    Suppose I invent a machine that takes a sample, does some magic, and then lists the sequences of all the genes in the sample. Perhaps the sample could be one chromosome of interest.

    Would the magic part of such a machine infringe, even momentarily, a patent on one of the genes in isolated form? I suspect that would be the case if the only way to determine whether a gene was present is to detect the proteins it expressed, and the only way to do that would be to first isolate them.

  105. Fisher held that DNA was not obvious over known protein (given cloning) because the DNA that could encode the known protein was still not known to any degree of precision. It did NOT hold, AFAIK, that isolated DNA is not per se obvious over known wild DNA.

    Why are you addressing this to me and what is the relevance to the 101 issue that we are discussing? Seems like a non-sequitur and the last sentence is particularly absurd.

  106. Malcolm, Fisher held that DNA was not obvious over known protein (given cloning) because the DNA that could encode the known protein was still not known to any degree of precision. It did NOT hold, AFAIK, that isolated DNA is not per se obvious over known wild DNA.

  107. 6 I’m pretty sure that taking a person’s DNA, isolating it, and then having it available for testing is “meaningful”.

    I’m pretty sure that your argument was rejected by the Federal Circuit in In re Fisher.

  108. “Note the word “meaningful.”"

    Oh I did MM, and I’m pretty sure that taking a person’s DNA, isolating it, and then having it available for testing is “meaningful”. Or else what are we all sitting around arguing about?

    I’m pretty sure that you’re just making a better case for the ACLU.

  109. MM, go easy on me. Bear in mind that I’m not a chemist or a biotecher. I was merely thinking that the new small molecule in itself is hardly a ubiquitous research or diagnosis tool and that the likelihood that it also cures a disease unconnected with the one mentioned in its app’s written description is negligible, whereas the likelihood is (I suppose) that the isolated and claimed DNA fragment will be needed in the commercialisation of the later inventions of other American inventors.

  110. “The “wild” DNA has no meaningful use, ”

    Don’t they use it to make isolated DNA?

    Note the word “meaningful.” The wild DNA could also be used as a source of phosphorous when added to bird seed. Also not meaningful.

  111. The expansion could logically be found to preclude a finding of substantial utility where the only credible, disclosed utility of a claimed sequence at the time of filing is (1) to detect its complement or (2) to express a protein for the purpose of studying the protein’s activity or to generate antibodies against the protein. According to this theory, a disclosure that merely postulated that a protein encoded by the nucleic acid could be used for a therapeutic purpose would not suffice to meet the utility requirement.

    Just to be clear, according to this theory, downstream uses of information obtained from (1) (such as correlating the presence/absence of detection with a disease state) would not be sufficient to overcome the lack of utility. Myriad’s composition claims would therefore fail 101′s utility requirement.

  112. MD Suppose the new molecule X is a “classic” organic “small” molecule that delivers a pharmaceutical effect. It doesn’t matter whether the inventor gets absolute protection for all uses of the molecule, or just the use revealed by the written description in the app as filed. This because the only use there is ever going to be is the use found in that written description.

    Huh? How in heck can you or anyone else possibly know this?

  113. Rader’s dissent in In re Fisher (2005):

    In truth, I have some sympathy with the Patent Office’s dilemma.   The Office needs some tool to reject inventions that may advance the “useful arts” but not sufficiently to warrant the valuable exclusive right of a patent.   The Patent Office has seized upon this utility requirement to reject these research tools as contributing “insubstantially” to the advance of the useful arts.   The utility requirement is ill suited to that task, however, because it lacks any standard for assessing the state of the prior art and the contributions of the claimed advance.   The proper tool for assessing sufficient contribution to the useful arts is the obviousness requirement of 35 U.S.C. § 103.   Unfortunately this court has deprived the Patent Office of the obviousness requirement for genomic inventions.   See In re Deuel, 51 F.3d 1552 (Fed.Cir.1995);  Martin J. Adelman et al., Patent Law, 517 (West Group 1998) (commenting that scholars have been critical of Deuel, which “overly favored patent applicants in biotech by adopting an overly lax nonobviousness standard.” (citing Anita Varma & David Abraham, DNA Is Different:  Legal Obviousness and the Balance Between Biotech Inventors and the Market, 9 Harv. J.L. & Tech. 53 (1996)));  Philippe Ducor, The Federal Circuit and In re Deuel:  Does § 103 apply to Naturally Occurring DNA?, 77 J. Pat. & Trademark Off. Soc’y 871, 883 (Nov.1995) (“The Court of Appeals for the Federal Circuit could have formulated its opinion in only one sentence:  ’35 U.S.C. § 103 does not apply to newly retrieved natural DNA sequences.” ’);   Philippe Ducor, Recombinant Products and Nonobviousness:  A Typology, 13 Santa Clara Computer and High Tech. L.J. 1, 44-45 (Feb.1997) (“This amounts to a practical elimination of the requirement for nonobviousness for these products, even when all the information necessary to discover them is previously available.”);   see also over fifty additional articles critical of Deuel in the “Citing References” tab for Deuel on Westlaw.   Nonetheless, rather than distort the utility test, the Patent Office should seek ways to apply the correct test, the test used world wide for such assessments (other than in the United States), namely inventive step or obviousness.

  114. IANAE am somewhat bothered by gene patents to the extent that they protect the diagnosis at the expense of research on the treatment, but that’s a policy issue and I can’t think of a valid legal reason to disallow them on that basis. The strongest argument is probably that diagnosis is either abstract or not a credible utility, but I can’t formulate a legal reasoning I find convincing – particularly when the diagnostic utility is not part of the claim.

    I agree that the utility angle represents the strongest point of attack. In effect, you would need to expand the holding of In re Fisher, which held that expressed sequence tags (“ESTs”) were unpatentable under 101 as lacking a substantial and specific utility, where the only disclosed use of the ESTs was to bind to and/or detect the corresponding gene or messenger RNA, without any indication that the claimed ESTs were in any way exceptional when compared to any of the thousands of other ESTs in the genome (in Fisher, the ESTs were derived from the maize genome).

    The expansion could logically be found to preclude a finding of substantial utility where the only credible, disclosed utility of a claimed sequence at the time of filing is (1) to detect its complement or (2) to express a protein for the purpose of studying the protein’s activity or to generate antibodies against the protein. According to this theory, a disclosure that merely postulated that a protein encoded by the nucleic acid could be used for a therapeutic purpose would not suffice to meet the utility requirement.

  115. This is in reply to IANAE at 2.31pm.

    Suppose the new molecule X is a “classic” organic “small” molecule that delivers a pharmaceutical effect. It doesn’t matter whether the inventor gets absolute protection for all uses of the molecule, or just the use revealed by the written description in the app as filed. This because the only use there is ever going to be is the use found in that written description. So, keep it simple, give her a claim to “Molecule X” per se. No harm done.

    But what if “Molecule X” is a bit of DNA? Is it the same as with the pharmaceutical? Any harm done, if you allow claims to “Isolated DNA Fragment X” per se? What else might others want legitimately to do, with that DNA fragment?

    And on obviousness at the EPO, yes IANAE, because EPO-PSA necessarily toggles between the technical “features” of the claim in view and the technical “effects” delivered by that new combination of technical features, as the way to decide whether or not the claimed subject matter is obvious.

  116. >>No, it indicates that there are a lot of >>people who desire a certain outcome and are >>willing to ignore the law and the facts to get >>there.

    This is exactly right. There are several issues here that should be sorted out, but I am afraid all these points of view are not equal. One must follow our patent law. Feeling good about your views is not enough.

  117. Ned question is rather does such a claim to isolated “preempt” in all meaningful uses of the wild DNA so as to effectively be a patent on the wild DNA?

    The “wild” DNA has no meaningful use, Ned. And a claim to an isolated nucleic acid sequence isn’t infringed by “wild” DNA so it can hardly be characterized as “effectively … a patent on the wild DNA.”

    As noted in my previous comment, a “reasonable” person can disagree with this, but he/she would be wrong. It has nothing to do with “policy” and/or “social issues/costs.”

  118. This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law.

    Who exactly is “simply asserting” these things? The “simple assertions” are in the district court judge’s opinion, in the ACLU’s briefs, and in Judge Dyk’s weirdo dissent. Sure, “reasonable” people can have different opinions, but there aren’t two equally “reasonable” interpretations of the law and facts competing here.

    The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

    No, it indicates that there are a lot of people who desire a certain outcome and are willing to ignore the law and the facts to get there.

    Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations.

    And throw the constitution out the window? Gosh, I hope not.

  119. “Unless of course Rader writes for the majority and his one-sentence opinion is that the claims are abstract. At least now when he does that he can cite Bilski.”

    Sounds very simple to me.

    “a de novo analysis of the legal rules regarding section 101 and possibly even a second look at the findings of fact.”

    That also sounds pretty simple to me. Shouldn’t take more than an hour or two. Three if you take a 45 minute break after the first hour or so.

    “Everything is simple to 6. When you’re not encumbered by pesky details like fact and law, life’s a breeze.”

    Your overencumbering yourself with concerns of fact and law in your practice is no reason for the rest of us to overencumber ourselves in making determinations for cases JD.

    Also, try not to be so bitter after getting taken for a ride w/respect to enablement the other day. It’s only like the 5th time I’ve one-upped you. Considering your background in toiletpaper holders you’re doing quite well to have only had me do so on such few occasions.

  120. ping, look at the replies I received to the question about whether the first person to disclover a use to a known compound obtain a patent on the compound (as opposed to the use). The answer was a flat no.

    Now, review your answer to Withheld. You essentially said the opposite. You essentially contended that the first to discover the use of wild DNA could patent the wild DNA rather than the use.

  121. “In order to constitute anticipatory prior art, a reference must identically disclose the claimed compound, but no utility need be disclosed by the reference. In re Schoenwald, 964 F.2d 1122 (Fed. Cir. 1992)…”no utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” 964 F.2d at 1124″

    At first glance, that seems surprising, but it makes sense… if prior art discloses a widget, but now how to use it, and you claim the widget… well, it’s not a new widget.

  122. Ned – double LOL on ya, agreeing with 6 (always a sign of a loose grip on reality) and then agreeing with Withheld.

    Ya really really need to brush up on the prosecution side, ancient one.

  123. Can the first person to discover a use for a known composition obtain a patent on the known composition?

    As ben said, the answer is no. Specifically, see MPEP 2122.

    “In order to constitute anticipatory prior art, a reference must identically disclose the claimed compound, but no utility need be disclosed by the reference. In re Schoenwald, 964 F.2d 1122 (Fed. Cir. 1992)…”no utility need be disclosed for a reference to be anticipatory of a claim to an old compound.” 964 F.2d at 1124″

  124. Withheld,

    You should be.

    Your application of logic is completely vacuous in the realm of patent law. Audit a class and achieve some minimal level of understanding before offering the comments as you have. The human intervention that is spoken of simply is not required to be in the claim, but merely pertains to the subject matter of the claim.

  125. I agree with 6. It is a given that isolated DNA is a human manufactured composition — presumptively eligible for that reason for patentability as an article of manufacture or as a compositon.

    The question is rather does such a claim to isolated “preempt” in all meaningful uses of the wild DNA so as to effectively be a patent on the wild DNA?

    Ask the right question and perhaps we will get the right answer.

    Obviously the briefs are all over the map because the focus is on all sorts of side issues, such as whether biotech is valuable, etc., and/or whether isolated is man made. No one can seriously argue these points, but they are substantially irrelevant.

  126. “These products simply do not exist without human intervention.”

    Politics does not belong in patent law.

    When you look at a typicaly isolated DNA claim and perform a 101 review on that claim, you cannot escape the conclusion that the claim does not meet 101. The human intervention conduct (method) is not clamied. The product is not claimed in connection with the human intervention process of creating it. So there is no relevance to the argument that “These products simply do not exist without human intervention” to any given isolated DNA claim.

    You would never get away with such claims in the electrical and mechanical art area and allowing isolated DNA claims to receive a 101 pass makes for inconsistent patent law with other art areas.

  127. Q: Can the first person to discover a use for a known composition obtain a patent on the known composition?

  128. The EPO uses its 103 provision to get some of the way towards accomplishing this public policy objective. New molecules are often found obvious, but less so when they deliver surprising or unexpected performance.

    Do you think that comes more naturally to an examiner applying a problem-solution approach to obviousness? That is to say, the molecule is less likely to be obvious if it solves a real problem in a really clever way, which represents a greater contribution to the art.

    Must it be a straight choice between no protection and full monopoly covering every use under the sun off the claimed fragment? Is there no compromise position?

    What of other arts? If one invents a new drug, or material, or even a new mechanical device, could we not ask the same question about the inventor’s entitlement to claim the product for all uses?

    I am somewhat bothered by gene patents to the extent that they protect the diagnosis at the expense of research on the treatment, but that’s a policy issue and I can’t think of a valid legal reason to disallow them on that basis. The strongest argument is probably that diagnosis is either abstract or not a credible utility, but I can’t formulate a legal reasoning I find convincing – particularly when the diagnostic utility is not part of the claim.

  129. Is there in the USA any appreciation that the scope of the patent monopoly awarded should be commensurate with the inventor’s contribution to the art? The EPO uses its 103 provision to get some of the way towards accomplishing this public policy objective. New molecules are often found obvious, but less so when they deliver surprising or unexpected performance. Claims on gene fragments per se put the floodlight on any claim that gives absolute protection for a molecule, even when its known utility is only one very special application.

    Some say an award of absolute protection, covering all uses of the new molecule, is too much to be commensurate with the inventor’s contribution. Must it be a straight choice between no protection and full monopoly covering every use under the sun off the claimed fragment? Is there no compromise position? I suspect it might interest the court, if there was one available.

  130. “The DC found that they did. It is a simple question as to whether or not they are right.

    It’s actually not that simple.”

    Everything is simple to 6. When you’re not encumbered by pesky details like fact and law, life’s a breeze.

    Lulz

  131. The DC found that they did. It is a simple question as to whether or not they are right.

    It’s actually not that simple. There are a lot of degrees of “right” here. Various parties are arguing in their briefs that different types of gene patents are valid or invalid. Besides, if the DC is even slightly wrong, the Circuit will have to substitute its own reasoning for or against these claims, which requires a de novo analysis of the legal rules regarding section 101 and possibly even a second look at the findings of fact.

    Unless of course Rader writes for the majority and his one-sentence opinion is that the claims are abstract. At least now when he does that he can cite Bilski.

  132. 103 is probably what should be used here.

    This.

    If the argument against (some?) gene patents is that they copy or remake what is already known, 101 is not the place for it.

  133. Psyki, I pretty much agree with you. Despite the writer’s attempt at a group hug, I think that patent law does not permit us to say that an isolated gene is not an invention just because a real gene was used as a template to form it.

    103 is probably what should be used here.

  134. It is ridiculous to call a molecule that is made in a lab by man a product of nature. In fact, the first gene cloning was a profound innovation and doubtless deserved patent protection. On the other hand virtually no one in the public supports “gene” patenting because it implicates the very core of their unique biological code and appears to be only one step removed from patenting human beings.

    There is an easy solution which I hope the CAFC will consider. If someone obtains the gene sequence from nature using routine procedures and clones the gene using routine procedures, then it seem likely that your “invention” is obvious under KSR.
    There is no need to split the baby. Genes can be patentable subject matter, but if all you do is copy the sequence from nature, then you probably don’t deserve a patent, not because it is a product of nature, but rather because it is entirely obvious.

    My 2cents.

    Psykl

  135. “all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, “human made” inventions. These products simply do not exist without human intervention.”

    I disagree. To synthesize DNA molecules as it existed in nature is COPY, REMAKE, is NOT INVENT.

  136. I can see you are a keeper of the faith o blessed Jacqueline.

    Btw, what “really matters” is not up for “reasonable people” to disagree or agree on. There are three exclusions to patentable subject matter that the courts need pay attention to. All that remains is to see if, factually speaking, isolated genes preempt anything in any of those. The DC found that they did. It is a simple question as to whether or not they are right.

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