Gene Patenting; or Patenting Life

NextBookIts Patenting 101 — Patents are available for newly isolated DNA when the isolated gene is new and useful.  DNA fits well within the statutory categories of both a manufacture and a composition of matter.  And, although most genetic structures are derived from those found in nature, the isolated form is certainly ‘made by man.’

Michael Crichton agrees that genes are being patented, but argues that such patents are really really bad. Read here from today’s NYTimes Op-Ed.

YOU, or someone you love, may die because of a gene patent that should never have been granted in the first place. Sound far-fetched? Unfortunately, it’s only too real. . . .

Fortunately, two congressmen want to make the full benefit of the decoded genome available to us all. Last Friday, Xavier Becerra, a Democrat of California, and Dave Weldon, a Republican of Florida, sponsored the Genomic Research and Accessibility Act, to ban the practice of patenting genes found in nature. Mr. Becerra has been careful to say the bill does not hamper invention, but rather promotes it. He’s right. This bill will fuel innovation, and return our common genetic heritage to us. It deserves our support.

As the debate heats-up, Kevin Noonan is emerging as the backstop:

Writers like Dr. Crichton (particularly academics, who should know better) have created a “new vitalism;” in this philosophy DNA is “different” and patenting DNA should be prohibited.  One problem with their position is its intellectual dishonesty: as Dr. Crichton does here, they accuse gene patentees of having ownership rights to “your” DNA (the DNA in the cells of a person’s body).  This is nonsense, since anyone familiar with this space or any other truthful description of DNA patenting knows that patented DNA must be “isolated” or “isolated and purified.”  In short, no one has ownership rights over “your” DNA (or mine, or Dr. Crichton’s).

Read Noonan’s dissection of Crichton’s piece at PatentDocs.

35 thoughts on “Gene Patenting; or Patenting Life

  1. Michael Crichton spoke on this issue at the “Who Owns Your Genes” conference, hosted by Chicago-Kent College of Law on May 21 (see link to whoownsyourbody.org ). Crichton confessed at this conference that he cannot by himself change anything, but he views his role as some combination of gatekeeper and cheerleader. Essentially, he wants to get as many people from all interested perspectives to engage in thoughtful discourse about the pros and cons of patenting genes.

    This is not to say that he is neutral on the issue–he is strongly opposed to gene patents. I think the underlying goal of his book is to start the discussion (albeit from a perspective that is on one end of the spectrum!).

    From his comments at this conference, I would say that he is primarily concerned with the ramifications of private control over a human gene, and not necessarily with the ownership of the patent rights per se. The conference focused on ethical problems that have popped up as a result of private ownership of gene patents, not on the technicalities of the patent law (in fact, this was completely absent from the conference discussions…). As far as the USPTO itself, I think Crichton’s concern is primarily that the office began issuing gene patents without very much public discussion on the ethical issues that may spring from the exculsionary rights that accompany patent protection over a human gene. My impression was that he feels the USPTO (and patent practitioners by association) are patenting human genes without any consideration for the ethics involved.

    Crichton’s comments at the conference were well-reasoned and reflect a deep understanding of the patent process and how private companies use patents to further the bottom line, sometimes at the expense of an individual’s medical care.

    I am about 2/3 of the way through “Next” and find it entertaining and thought-provoking. As a patent practitioner, though, I’m not as concerned that the USPTO is the most institutionally competent group to address Crichton’s ethical concerns. This is an issue that I think Congress is better equipped to address as they can hold hearings to gather expert advice and gauge the public’s temperature on legislation designed to limit a gene patent owner’s exclusionary rights.

  2. As a nurse with extensive experience in the Neonatal ICU for 16 years…I have first hand experience with genetic variations. The fact that a corporation can own the exclusive rights to any part of normal or abnormal gene sequences is abhorent at best. What are we thinking? Has the almighty dollar superseded our limited brains. Cynthia Thompson

  3. The real problem? The patents are overbroad.

    Interpreted as a process patent, a gene patent should only cover one method of isolation. Instead, they purport to cover many, including uninvented ones.

    As a product patent, the “isolated gene” is arguably a valid product — but only insofar as any chemical is patentable as a product. If the gene is isolated by trivial, standard methods, it’s a product but not an invention.

  4. “But if you simply go in and dig out a mutation that occurs in the chlorine pump membrane proteins of 5% of the Cystic Fibrosis patients – that’s not an invention, it’s a discovery, and it should not be patentable.

    (snip)

    If finding and purifying genes is inventive, then do tell the thought the PhD lab rat has at the moment of invention. If you can’t then you should recognize you are wrong”.

    You have painted your argument far too broadly. Eg. “if you *simply* go in and dig out a mutation” – what if it isn’t simple? You seem to be arguing all gene discoveries are ipso factor obvious.

    Which isn’t even a 101 objection, but let’s let that pass.

    This is a proposition, rather than a fact, and one which sounds inherently unlikley – why should discovering genes be any easier than discovering other things? Discoveries are after all, explicitly patentable, so arguing they shouldn’t be isn’t going to cut much wood.

    It is hornbook patent law that having made a discovery, the way to go about implementing as a technological invention may be obvious, but that doesn’t bar the patent on the discovery being found wanting for lack of inventive step, if the discovery itself wasn’t obvious.

    E.g. I discover a “cure for cancer” – in this case wonder molecule X – which I have isolated from some organism. It is trivial to then use this discovery as an actual medicine by isolating and giving it to a patient. Way should I not get a patent on the isolated molecule (which is unnatural, it doesn’t occur isolated, but as part of say a poisonous bile residue in nature), assuming the discovery was not trivial – ie. the discovery was not “obvious”?

    If you want to convince me *All* genes can’t be patented ipso factor, I will want a good reason why my (non-gene) wonder molecule X can’t be patented.

    Saying blankly that finding and purifying genes, without qualification, isn’t inventive won’t cut the mustard. Now some such activity won’t be inventive; that I’ll grant you. Eg. if you strongly suspect that a certain disease is gennetically determined from other work, and maybe even located in approximatly location Y, then finding the gene is likely (but not necessarily) to be trivial; purifying it quite possible too (but again, maybe not). But these are fact dependent questions, are they not?

    Some of time, finding a gene will not be easy at all, and may involve inventive activity. or are you saying searching for something can never be inventive? Because that’s what it looks like to me.

    Regards, Luke

  5. Dear Gideon:

    At least you are logically consistent.

    Lincomycin: U.S. Patent No. 3,086,912
    EPO: U.S. Patent No. 4,677,195
    Gaucher’s: U.S. Patent No. 6,451,600

    Vitamins and lubricants are harder to find, since the patents tend to be very old. I will look at my copy of Patents: Bubblewrap, Bottlecaps, Barbed Wire, and Other Ingenious Inventions tomorrow.

    But you see the point – patents on products isolated from nature have always been patentable. And I haven’t even mentioned Louis Pasteur’s yeast patent from the 1800′s.

    Thanks for the comment

  6. Kevin -

    The last of these is not different from the rest.

    Do you have patent cites for any of them? I think that they are all equally unpatentable. That is, from a philosophical perspective. From a practical perspective, of course genes are currently patentable.

    The can of worms the Office has opened with genes, of course, is why shorter sequences are not patentable. Why isn’t a 45 nucleotide segment of cDNA that was found using reverse transcriptase in an RNA slurry from a heat shocked cell patentable if a gene is?

    The answer is, OF COURSE IT IS! – if the gene is.

    The reason the PTO doesn’t want to give it is because a 45 bp sequence gives you extremely broad coverage that likely covers many know homologues. So what does the PTO do? They argue utility! Hah!!! What morons! Utility!

    For the sake of all that is holy, why would a fortune 100 company spend 500,000 in legal fees for something that had no utility? Hah!

    But that is what the gene exception did – it opened up a can of worms.

    In any case, please cite the patent. I am unaware of any patents, other than gene patents, that allow you to claim discoveries. Please disabuse me, as I love to learn.

  7. Gideon:

    Go back to my answer to Stephen. Here it is – tell me where you think the logic breaks down.

    I isolate a petrochemical with excellent lubrication qualities. It is used in very expensive machinery so I can charge a lot of money for it.

    I isolate Vitamin B12 from beef muscle, and use it as a cure for anemia. I charge a lot of money for it, because anemia kills people.

    I isolate a new drug, penicillin, from a mixture of naturally-produced chemicals made by a mold. I use it to cure, among other things, syphillis, which otherwise killed people. I charge a lot of money for it.

    I isolate erythropoeitin from urine and use it for kidney dialysis patients, who otherwise die of anemia. I charge a lot of money for it.

    I isolate a gene responsible for Gaucher’s disease, a lipid storage disease, and use the gene to make the missing protein. It is efficiently gobbled up by macrophages in the affected children’s blood, which cures the disease. I charge a lot of money for it.

    Now, if you can come up with a logical position why the last of these is different from the rest, I’d like to hear it. And if your problem is that inventors get to charge a lot of money for cures for fatal diseases, then I think you have a bigger problem than with the patent system.

    And, by the way, the law restricting physicians from being sued for infringing medical methods patents doesn’t preclude from liability companies that sell the physicians the specialized tools used to do so, and teach them how to do the procedures. In addition, the law specifically excludes pharmaceuticals.

    Thanks for the comment.

  8. Okay I went back and read more

    “But if you simply go in and dig out a mutation that occurs in the chlorine pump membrane proteins of 5% of the Cystic Fibrosis patients – that’s not an invention, it’s a discovery, and it should not be patentable.”

    I agree that the fact of nature should not be patentable. But a concrete method of exploiting an aspect of that previously unrealized fact should be patentable. That is the essence of invention.

    According to your logic, the airplane that I built from natural materials (e.g., balsa wood) isn’t patentable because, after I put those materials together, I merely “discovered” that those materials can fly.

  9. “On the patent level, the Company hasn’t invented a thing. If going after and finding an existing molecule and “purifying” it was an invention, then Boyle would have been entitled to a patent on atmospheric oxygen.”

    I stopped reading after that. Had Boyle isolated and purified a significant amount of oxygen, he might have been entitled to a patent on a container for delivering same.

    I have no issue with the PTO taking the position that isolating and purifying a nucleic acid (or complement or siRNA or whatever) that was previously sequenced and known is obvious. No problems there.

    But I do have a problem with declaring such chemicals to be unpatentable subject matter per se, just because Michael Crichton wrote a scary story about it.

    I’m still wanting to know: what lobby bought this California congressperson???? How could a representative of California support such a bill????

  10. Someone wrote that my opinion that “genes should not be patented, period” was based on emotion.

    On the contrary.

    It’s really ridiculously simple.

    Let me try it this way . . .

    1. I’m talking about genes here. OK? If you don’t know what that word means, then look it up.

    2. The issue is the following . . . Company A decides it wants to investigate disease X. It finds that disease X is caused by an excess of molecule Q. It further finds that enzyme Z is responsible for removing Q from affected cells. It spends 2 billion dollars determining that gene T with nucleotide sequence GGAATTCC. . . is the gene that encodes enzyme Z.

    3. The claim that Company A is allowed is “a purified nucleic acid having the sequence GGAATTCC . . . ”

    This is flat out wrong, on at least two levels.

    On the patent level, the Company hasn’t invented a thing. If going after and finding an existing molecule and “purifying” it was an invention, then Boyle would have been entitled to a patent on atmospheric oxygen.

    Sure, a lot of work went into finding the gene and isolating it. So what? The standard is not “work,” it is invention.

    Frankly the charge that this is an emotional position is silly. It fits perfectly with all of patent case law and statute prior to the first gene patent. It is the gene patent that is the aberation, not my protest.

    So why was this allowed? Very simple – because by granting patents on genes research is encouraged.

    I’m not saying that the resultant research and development is not a good result – I’m just saying that the result was reached through a clear abrogation of basic patent law precedent – that you cannot patent a discovered molecule or substance.

    The “purified” part was the spurious pretext offered to attempt to shoehorn this into existing patent law.

    By the way, the reference to Chakrabarty is also silly, and, again frankly, doesn’t say much for the writers legal skills.

    Chakra simply held that a Pseudomomas that had been engineered to contain and maintain an enzyme pathway that had never been in it before was patentable. Of course! Now THAT’S an invention! They actually had to think, “hmmm, let’s take that DNA from over there, do this to it, put it on a vector, transform the Pseudomonas, put selectable markers on it to make it stable, and then hope it eats oil.”

    That took a moment of inventive thought.

    What is the inventive thought when Company A says, “let’s find gene T?”

    Who’s the inventer there? The lab tech who “purifies” the gene into a DNA slurry? The head of the lab who first said, “let’s go find a gene that controls Q”? The guy who, 10 years earlier and who is now dead first identified Q? The guy who was sitting next to the automatic sequencer when the sequence came out?

    What a huge crock of s_____.

    If you are going to support the position that the sequence of genes that exist in all or most human beings are patentable, at least don’t try to pretend that this fits in with the requirement that something be “invented”.

    At least have the cajones to stand up and say “hey, it’s not an invention, and of course it would never have been patentable if the traditional rules were applied, but it’s a good public policy decision to use the Patent system to offer Corporations incentive to go mine human DNA.”

    That’s really your position, and if you find yourself resting on the “purify” language, man that is really sleeping in s____.

    Finally, to the person who incorrectly noted that the SC had “already” ruled on this, beyond your legal error, I note that the SC has ruled on many issues, and has ruled on many issues WRONGLY. Not the least of these was the recent New London decision.

    So even if the SC rules that genes are patentable subject matter, that will neither 1. Make genes inventions, purified or not, or 2. Make it right.

    Finally, to the person who discussed mutations and such things, I have no issue with the patenting of human constructs.

    That is, you create a new and useful DNA sequence, you should be able to protect it.

    But if you simply go in and dig out a mutation that occurs in the chlorine pump membrane proteins of 5% of the Cystic Fibrosis patients – that’s not an invention, it’s a discovery, and it should not be patentable.

    This, by the way, is not a difference of opinion. It’s a difference of the canards people set up to justify unjustifiable positions.

    Velcro – “I’ll create minute hooks and rings with plastic.”

    Deisel – “I’ll use compression to achieve ignition temperature and inject #2 fuel on the down stroke”

    Wrights – “We’ll use and airfoil and a motorized engine in a flexible frame to provide control”

    Genes? What? “Look, look! I found the gene responsible for . . . ”

    If finding and purifying genes is inventive, then do tell the thought the PhD lab rat has at the moment of invention. If you can’t then you should recognize you are wrong.

    Damn. Read it twice. It’s that good.

    And I waive all copyrights, so use what you want.

  11. Stephen:

    I think the distinction is that chemical elements are not patentable, but chemicals always have been. My point is that it is not just synthetic chemicals, but chemicals that have been extracted from “natural” sources. What is the difference between isolating Vitamin B12 from beef muscle and patenting it, with patenting isolated DNA? Or isolating lincomycin from a bacteria and patenting that? “Products of nature” is a nice term, but limited; the patent system protects invention, and many times in the past “invention” has meant isolating something from nature. My point is that there shouldn’t be a difference just because the subject matter is DNA. It is just as useful, and patentable, to extract a new chemical from crude oil (and can be as complex) as isolating a gene. And if it is permissible to isolate EPO from urine and obtain a patent, it should be permissible to patent DNA.

  12. Kevin:

    Thanks for your reply. I take your points: I am fully aware of the doctrinal position, but my post was intended to be normative, not prescriptive. What strikes me as odd about the gene patenting debate is that chemists have been isolating and purifying elements and compounds from nature for thousands of years yet it is only during the twentieth century have these molecules came to be regarded (in patent law, at any rate) as “artificial” rather than “natural” (apart from a period during the seventeenth and eighteenth centuries when chemists became concerned that the then dominant method of extraction of plant and animal materials – distillation – transformed the resulting products). Did man conceive or create the structure or properties of these compounds? No, they’re simply products of evolution. What is inventive is the use of these compounds in medical treatment, but, of course, it was not possible to protect methods of medical treatment in the vast majority of countries until well into the twentieth century (or medicinal substances, for that matter), and where they could be claimed – namely, the US – the protection afforded by these claims was regarded as ineffectual, because no robust system of contributory infringement existed, or because it was ethically questionable, not to mention politically inexpedient, to sue the primary infringers – the patients themselves.

    As for Chakrabarty (which has nothing to do with isolation and purification), I seem to recall the majority stating that a new mineral found in the earth is not patentable. I struggle to see how this is reconcilable with the isolation and purification doctrine, unless one reads into it the additional gloss that the mineral is found in its impure state and/or has no discernibly useful qualities at the time of its discovery.

  13. I’m not terribly well-informed on the subject, but one relevant precedent is notably missing from this discussion.

    Patent law prevents enforcement medical procedure patents.

    Why? To ensure that an inventor is not able to prevent physicians from using the best available medical knowledge in their practice.

    The analogy to this discussion should be clear: while the public has an interest in funding being provided for researchers to study the human genome (patents are one way to provide this), the public also has an interest in valuable medical advances progressing from the experimental stage to the common procedure stage without paying massive economic rents in the process.

    Those in favor of patenting genes seem to think a gene patent holder would never hold the world ransom for extraordinary license fees, in a predatory manner reminiscent of so-called patent trolls in other areas. When some Big Pharma company has the answer to a major flu epidemic and they use their patent rights to extract a windfall from the public, is this an acceptable consequence?

    Rather than debate about *whether* genes should be patented, it seems a more useful discussion to discuss the *undesirable consequences* we anticipate from each position on gene patentability, and devise a strategy that mitigates the downside of each position.

    Unless, of course, y’all just enjoy nay-saying each other. ;-)

  14. Stephen:

    Factually incorrect. For example, is it your position that Fleming could not have patented penicillin after purifying it from the host of other compounds produced by the mold in Mr. Florey’s coat? Or that a chemist could not patent a new chemical compound isolated from crude oil? If it is, you are simply wrong.

    In fact, a “gene” is one piece of DNA encoding a protein that is found amongst at least a million other pieces of DNA, and the act of isolating a gene has been a Herculean task. Just look at the history of how economically-important genes like EPO were isolated. The only reason it got “easier” was that scientists went the other way – sequence the whole human genome and look for the open reading frames, then sort it out. But the fact that it has gotten technically easier to do does not make the end product – the gene – unpatentable, provided it fulfills the statutory requirements of utility, novelty and non-obviousness. The “isolated and purified” requirement is not mere verbiage, despite that Congressman Becerra thinks – it reflects the “hand of man” required for patentability according to Diamond v. Chakrabarty.

    On another point, it is better not to change the native sequence once you’ve cloned it, since you want the protein produced to be as close to the human protein as possible. This maximizes the likelihood that the protein will function, be properly regulated and not be antigenic.

  15. I would suggest that if “the public is not well educated in this field” it is because patent lawyers have failed to make out a convincing case for how “purified” genes are (ontologically) distinct from “crude”, naturally-occurring versions. Simply to suggest that a “purified” gene is an invention because it does not appear in that form in nature is disingenuous and, in my opinion, does patent law a great disservice. Indeed, the entire history of chemistry is a denial of that proposition. What renders a gene artifactual, and, hence, patentable, is the necessity of altering its structure to obtain expression of a protein in E. coli or some such (the paradigmatic type of gene patent – of course, they take many other forms). The only novel property the purified gene has over its “crude”, natural form is its ability to be used in this way. That is why they are – and should be – patentable, not because they do not appear in that form in nature.

  16. Marc, Read “Next”

    From the publisher: “In an ambitious effort to show what’s wrong with the U.S.’s current handling of gene patents and with the laws governing human tissues, the author interweaves many plot strands, one involving a California researcher, Henry Kendall, who has mixed human and chimp DNA while working at NIH.”

  17. In reading Crichton’s op ed, all I could think of is why now is he reviving this decade old debate. The only answer I could fathom was that he perhaps may be writing a new novel where this issue plays out.

  18. Mark:

    The PTO lists over 17,000 publushed patent applications having the terms “nucleic acid” and “encoding” in the claims. Not a scientific survey, but browsing through the claims it looks like most include what I would call “gene patenting.”

    And keep in mind, those are the pending, published applications. Many groups have priority rights to applications filed over the past 5-10 years for other gene sequences.

    Having said that, I think it unlikely that all human gene sequences will be patented before the 20 years from initial filing limit, but it’s hard to guess how many will be. As someone else posted, the PTO is limiting patenting of many gene sequences by requiring knowledge of specific utility (not by homology with known related genes) at the filing date, and many genes that were part of the gene patenting flood following the Human Genome Project probably can’t meet that standard. But that’s another subject.

    Kevin

  19. Does anyone know if the Becerra bill would be retroactive? If so, there will be some serious takings arguments. If not, I wonder how much it accomplishes. Are there a lot of new human gene patents being applied for, as opposed to patents still in force and applications already in the pipeline?

  20. I wonder how many patented mutated genes do or did actually exist in nature because of evolution.

    There are likely things that undergo evolution that are also (patently) novel. But how can we determine what these things are? Nobody may be able to prove prior existence of the mutated worms that I breed, but the anticipating prior art may have died out two million years ago. Likewise, I may carry a mutated gene that someone has just patented.

    Novel or not, are things that undergo evolution unobvious? Does not the mechanism of evolution suggest that many of these inventions would come about naturally and without any inventive effort, if not next Tuesday then in ten thousand years or so?

    A machine on the other hand, is very unlikely to be spontaneously created by a bunch of rocks that slide down the side of a mountain. Even a simple machine like a crowbar, is very unlikely to just evolve.

    I doubt that the anti-gene-patent people get as obtusely philosophical as I have above, as evidenced by the sensationalist, and frankly misleading, nature of Crichton’s article. It also seems to me that methods of manufacturing or concentrating genes should be patentable.

  21. Aside the issues presented in the “article,” was anyone stunned at how poorly researched it was? “You, or someone you love, MAY die because of a gene patent that SHOULD NEVER have been granted in the first place.” How? Which gene? “Because of A misinterpreted statute…” Which statute? If that’s not sensationalism without fact, I don’t know what is.

  22. Someone earlier did comment that what is being patented (recombinant DNA) is not found in nature. The public is not well educated in this field and cannot not distinguish the actual DNA composition in our body with that being synthetically produced, and when you have people like Dr. Crichton making comments like he did, the whole topic gets misrepresented. I am bit surprised that Dr. Crichton did make those comments. He is a MD and didn’t he go to Harvard?

  23. We must not forget that nowadays, although patents protect inventions, they essentially serve innovation, in that way that they guarrantee a possible return on investment to inventors/companies spending resources in R&D and developping new products for the civil society. Genes have become a new area of research because of their potential to cure genetic diseases, and to identify new medicines. Developing a pharmaceutical product, be it a gene or a chemical compound, in order to bring it to the market, takes years and millions $US. Who can afford spending such amount of money without the guarantee that it will possibly at least get this money back ? Likely nobody. This is one reason why genes shall be patented, at least if one goal of the society is to cure more and more human diseases.

  24. ” And the debate is important because it has consequences, bad ones, for innovation and invention.”

    What’s strange is that I haven’t noticed that most people actually give a hoot about patenting of *useful* nucleic acid sequences, which begs the question: why is Michael Crichton writing opinion in the New York Times about this issue, why is the New York times printing his opinions, and why is a representative of **California** peddling this policy before Congress????

    I’m reminded of Frank Zappa’s infamous question, “Is this private action?” Who’s pulling the strings? Who’s paying the lobbyists here?

  25. This is the problem with this issue – some people believe genes should not be patented, period. There is little support in law or logic for this position, but there it is.

    Question: if I discovered a useful molecule made by a bacteria, should I be able to patent the molecule? The answer is, of course, since this is where many antibiotics were first isolated and patented.

    So how is that not a “product of nature?” And how is it any different from a gene? The short answer is that it is not. The longer answer is that the anti-gene patenting position is not legal or logical but moral or political or some other rationale. And the debate is important because it has consequences, bad ones, for innovation and invention.

  26. The last week or two on Patently-O have been good, but I am bothered by some of the language being bantered about in Crichton’s article and the Novek/peer-to-patent post (not to mention the patent and business community at large). It would seem that “invention” and “innovation” have been and continue to be used interchangeably. Patent law deals with invention and disclosure. Innovation deals with changing the way people (consumers/businesses) act. The two are different, and I think we are all wise to use the two terms carefully. I can’t claim credit for this – Lawrence Ebert wrote a good piece (in general, not specific to genes) on patent reform in the December 2006 issue of the Journal of the Patent and Trademark Office Society that got me thinking about this. Vol. 88, No. 12 p.1068. He also has some interesting calculations for those interested in the allowance rate post. Check it out . . . sorry if someone else posted something on it that I didn’t catch. Keep up the good work Dennis.

  27. “they are no more inventions than are the worms you find under the rock in the back yard”

    Of course, if I identify a worm in my backyard with a very desirable mutation that nobody predicted previously and clone it so I generate an isolated population of worms with that desirable mutation — a population which nobody can prove existed in nature previously — then I should be able to patent that population.

    No? Why not? The isolated population is novel and non-obvious, is it not?

    How does it differ from chipping a rock with a desirable, novel, and non-obvious shape out of mountain and claiming that rock with its desirable, novel and non-obvious shape?

    The US Supreme Court has already dealt with this issue.

    I’m curious: just how many isolated nucleic acids which are identical (sequence-wise) to “normal” human genes are patented?

  28. I disagree, Gideon. Genes should be patentable under the following circumstances:

    1) it is not found in nature, or

    2) the method of isolating it is new (and in this case, the method is patentable, not the gene itself).

    -Anon (Full disclosure: my firm doesn’t have a bio client… heh)

  29. Genes should not be patented. Period.

    You don’t “invent” a gene. You isolate it from a cellular slurry.

    If you applied the special exception given to genes to other discoverable molecules in nature, you’d have a mess.

    Genes were determined to be patentable as a nod to big business. Period.

    Also note that you will never get this opinion from any employee of a sizeable firm with at least one biotech client going after gene patents.

    The recent, and I think still pending, fight over DNA fragments is the fallout. If discovered genes are patentable, then discovered segments of genes should be patentable. The utility argument made by the PTO is laughable on its face. Pretty much, if every big biotech company is accumulating fragment information as fast as possible, then the utility is not in question.

    Classic unintended consequences.

    Repeat, genes should never have been patentable – they are no more inventions than are the worms you find under the rock in the back yard.

    Now that the can of worms has been opened, there will be some pain before it works itself out.

  30. Can someone explain to me why anyone should care about what Michael Crichton says about patent policy? Seriously. Once again, I am reminded of why I canceled my subscription to the New York Times.

    Second, while it’s true that there are bad “gene patents” out there, they are mostly in the area of method claims and mostly they were granted in the Glory Days near the top of that camel hump in the graph Dennis posted yesterday evening.

  31. The ironic thing, Dennis, is that you, or someone you love, might die of a disease because genes could not be patented.

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