Genus-Species; Doctrine of Equivalents; and Patentable Subject Matter

By Dennis Crouch

For many, the most interesting aspect of this case comes at the end in Judge Dyk’s dissent. Dyk makes the case that genes should not be patentable. 

* * * *

Intervet Inc. v. Merial Limited (Fed. Cir. 2010)

In 2006, Intervet filed a complaint against Merial — asking the DC District Court for a declaratory judgment that Intervet’s Porcine Circovirus vaccine (PCV-2) did not infringe Merial’s gene patent.  Merial’s patent claims both the isolated DNA molecule of PCV-2 and a vector that contains the DNA.  The application includes a listing of several different sequences that all fall within the PCV-2 category. 

Although Intervet also uses a PCV-2 vector. The DJ plaintiff argues that its DNA molecule is different from the one described and deposited by Merial. The district court agreed — holding that the Intervet product was only 99.7% homologous to the closest deposited sequence and therefore outside of the literal claim scope. The district court also applied prosecution history estoppel to rejected Merial’s claims of infringement under the doctrine of equivalents (DOE). On appeal, the Federal Circuit reversed on both claim construction and DOE.

Genus Not Limited to Examples: The asserted claim includes a limitation of a “PCV-2” DNA molecule. The District Court limited that term to cover only the DNA sequences that were deposited with the PTO. On appeal, the Federal Circuit rejected that construction as overly limiting. Rather, the appellate panel held that the deposited sequences serve as a representative sample of PCV-2 DNA sequences. “Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Here, the deposited strains are representative species of the larger ‘type II’ genus, where the genus is identified and claimed as the invention.” In describing its invention, the specification noted that the PCV-2 desposited sequences had a 96% homology and that the invention did not cover PCV-1 sequences that at most shared 76% homology with the deposited sequences.  Taking those quantitative limits from the specification, the Federal Circuit ruled that the claimed PCV-2 molecule should be construed as being “about 96% or more homologous with the … sequences disclosed in the present specification, and about 76% or less homologous with the [disclosed PCV-1] sequence.”

What is Equivalents are Surrendered by a Narrowing Amendment: An accused infringer may still be liable even though its product does not literally infringe every element of an asserted patent claim.  Under the doctrine of equivalents (DOE), a patentee may be able to provie infringement by showing that one or more elements of the accused product are equivalent to elements in the claim.  Under the limiting doctrine of prosecution history estoppel (PHE), a patentee will ordinarly be estopped from claiming DOE over a claim element that was narrowed during prosecution. (A narrowing amendment made for purposes related to patentability creates a rebuttable presumption that estoppel applies.)

Here, one of Merial’s original claims was directed to a markush group of open reading frames (ORFs) that had been described in the specification as “ORFs 1–13.”  In an initial rejection, the examiner suggested that the limitation could refer to ORFs of non-PCV-2 molecules. Although the patentee argued that the claim was clear, it still added the limitation that the claimed ORFs were PCV-2 ORFs.  The Federal Circuit held that this was a narrowing amendment substantially related to patentability. That narrowing amendment therefore created a presumption that the patentee had surrendered all equivalents that relate to non-PCV-2 ORFs. The district court erred, however, in holding that this narrowing amendment would estopp the the patentee from asserting that the claims cover a non-claimed PCV-2 ORF as an equivalent. “Such a draconian preclusion would be beyond a fair interpretation of what was surrendered. The rationale for the amendment was to narrow the claimed universe of ORFs down to those of PCV-2, and bore only a tangential relation to the question of which DNA sequences are and are not properly characterized as PCV-2.”

Dissenting-in-part, Judge Dyk discussed his argument that the claims directed toward the isolated form of a naturally occurring gene are likely unpatentable under 35 U.S.C. § 101.

[T]he isolated DNA claim raises “substantial issues of patentable subject matter under 35 U.S.C. § 101. . . . Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules. Although we have upheld the validity of several gene patents, none of our cases directly addresses the question of whether such patents encompass patentable subject matter under 35 U.S.C. § 101. . . .

I think that such patents do in fact raise serious questions of patentable subject matter. The Supreme Court’s recent decision in Bilski v. Kappos has reaffirmed that “laws of nature, physical phenomena, and abstract ideas” are not patentable. No. 08-964, slip op. at 5 (U.S. June 28, 2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, see Bilski, slip op. at 13, so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public. Thus, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” Chakrabarty, 447 U.S. at 309. These aspects are properly conceptualized as representing a public domain, “free toall men and reserved exclusively to none.” Id. (quoting Funk Bros., 333 U.S. at 130) (quotation mark omitted).

In Funk Brothers, the Court considered the patentability of a mixture of several naturally-occurring species of bacteria. 333 U.S. at 128-31. The patented product was a mixture of bacteria used in agricultural processes, enabling plants to draw nitrogen from the air and convert it for usage. The inventor discovered that certain strains of the bacteria were effective in combination with one another, and contrary to existing assump-tions, did not exert mutually inhibitive effects on each other. The Court held that the invention was not pat-entable subject matter. Id. at 131. The inventor “did not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.” Id. at 130. The Court furthermore noted:

The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of na-ture has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the applica-tion of the law of nature to a new and useful end.

Id.

In Chakrabarty, the Court considered whether a human-made microorganism is patentable subject matter under section 101. 447 U.S. at 305. The microorganism in question was a bacterium that had been genetically engineered to break down crude oil. In concluding that the man-made bacteria was patentable, the Court observed that the claim “is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter.” Id. at 309. The Court went on to distinguish Funk Brothers on the ground that the Chakrabarty bacterium possessed “markedly different characteristics from any found in nature. . . . His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” Id. at 310 (em-phasis added).

Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with “markedly different characteristics from any found in nature.” It is far from clear that an “isolated” DNA sequence is qualita-tively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

 

 

76 thoughts on “Genus-Species; Doctrine of Equivalents; and Patentable Subject Matter

  1. Look for the issue raised by Judge Dyk to start working its way up to the SCOTUS (maybe in Myriad?). Though it’s hard to imagine the Justices completely invalidating gene patents, considering how much patent litigation and the biotech industry have relied on them in recent years. I’d like to see what kind of test they’ll devise to determine the validity of gene patents. This could get interesting.

  2. Lionel I refer to the public policy against profiting from patenting an isolated DNA sequence by extorting money from researchers actually using that information to produce gene therapies and new pharmaceuticals. That’s where the real value and money is.

    Your policy is already recognized in existing law which provides a safe harbor for infringers who are using the claimed compositions in research that is likely to be part of an FDA submission in the future.

    If I discover a new strain of bacteria growing in the rain forest can I patent it as such in an effectively unmodified form?

    What do you mean “as such”? You mean an “isolated bacterial cell of species x”? You likely could not patent it as the prior existence of an “isolated” cell identical to the claimed cell would be deemed inherent (depending, of course, on how the term “isolated” is defined. On the other hand, if you could show that the cell likely never previously existed without the presence of two other related but different species and you identified culture conditions which allowed the cell to grow without those two other cells, then you could claim a composition comprising the “isolated strain” and the culture.

  3. Malcolm,

    By the way, the ability to reproduce DNA in the lab is an extremely valuable contribution and I am all for patents on the processes and methodologies involved. Just not the sequences themselves.

  4. Malcolm,

    I refer to the public policy against profiting from patenting an isolated DNA sequence by extorting money from researchers actually using that information to produce gene therapies and new pharmaceuticals. That’s where the real value and money is.

    If I discover a new strain of bacteria growing in the rain forest can I patent it as such in an effectively unmodified form?

  5. Hans, in a sense you are right, but in a sense you are wrong. The point is that the investigator of the bird virus did exactly the same thing as did the investigator of the pig virus. He isolated the bird virus, and then, presumably, developed a vaccine for it. He did not use any part of the prior disclosure by the isolator of the pig virus. It was only by sheer happenstance that the two viruses turned out to have the same effective DNA.

    Now with the above facts clearly in mind, please read the Supreme Court case of Boyden vs. Westinghouse Power Brake, a case dating from the 1880s. This is the first case involving functional claiming in the area of apparatus. The accused brake perform the same emergency stopping function as did the patent brake, but did so in an entirely different way than the patented brake. Yet the accused brake literally infringed the claim.

    While later, in Halliburton, the Supreme Court would simply hold invalid apparatus claims functional at the point of novelty, here they developed the rule that functional apparatus claims should be construed to cover the corresponding structure as described in the specification, and equivalents thereof, to confine the scope of the claim to the scope of the invention.

    The Supreme Court is continuously concerned with the scope of claims. They are concerned that claims be confined to the scope of the invention disclosed and enabled. Thus it is not clear to me just how the isolator of a pig virus is entitled to claim not only the pig virus, all but all other viruses for all other animals in the animal Kingdom that happened to use the same effective DNA as the does the pig virus. But that is exactly what the claim to the isolated DNA does.

  6. I am confused Ned. How are you “using” the isolated viral DNA? You’ve simply discovered that the sequence of the bird virus is the same as the sequence of the pig virus. Now if you want to use the isolated DNA to make a vaccine for the bird then you’d be infringing. Are you suggesting that mere possession of a bird that is infected with a virus whose sequence is identical to PCV-2 is an infringement?

  7. Hans, and I think you just illustrated the vice in patenting the isolated DNA per se. It preempts all uses of the DNA, known or unknown. This effectively is a patent on the DNA itself, a thing which is product of nature and legally in the public domain.

  8. Ned, unless I’m missing something, your patent would be invalid under 102 if the sequence is identical to the previously published sequence. All you’ve really discovered is that the virus infects birds as well as pigs.

  9. “More to the point”

    The only “point” here is that the examining corps doesn’t apply the law correctly any more than I play professional baseball.

    “but the rubber hits the road when you have to talk to professional peers in real life.”

    I espouse exactly what I say here irl. I have many times actually.

    “Put your money where your mouth is. Convince your peers to stop issuing ‘bogus’ patents. ”

    I have convinced more than 3 examiners to not issue beauregard claims, at all. I have widely spread the word about Miyazaki and its applicability. I fought the accounting trick known as the new count system in public, in full view of my AU and many outside it. I publicly espoused nearly the exact principles expressed in KSR before KSR came out. I have raised many other issues within my own cases and convinced my spe on the issues. What exactly do you think I should do? Have a weekly meeting with Davy K? Arrange meetings with each AU one at a time to explain to them that, o, wait, they’ve been doing things wrong for years now?

    No, it is the job of the courts to settle this nonsense. And I’m not on the Fed Circ just yet.

  10. Assume that I discover that a virus in birds cause certain diseases and patent its isolated DNA.

    What if it is genetically identical to PCV-2? Is there an infringement?

  11. Wait, wait, a whole section of the examining corps doing the wrong thing in examination somehow proves me wrong? I’ve only been here 3 years or so and the whole of the examining corps has been misapplying the law the entire time I’ve been here. Less now than before though.

    Yes. They’ve been there longer than you (3 years?!), they know the subject matter intimately (you’re electrical; if you’ve had more than an intro course in biology, do tell), and no matter how smart you believe you are, it’s a pretty safe bet that there’s several that are smarter.

    More to the point, you can claim anything you want here — nobody bothers to put their real reputation on the line in here anymore (and then, why should I) — but the rubber hits the road when you have to talk to professional peers in real life. Put your money where your mouth is. Convince your peers to stop issuing ‘bogus’ patents. Of course, they may decide that you’re a loon…

  12. Pharma Patents, Myriad’s test does not utilize “patented genes.” It’s an exon-amplification and sequencing test. Genomic DNA is amplified with various primer pairs that sit right outside the exons. The amplified segment (exon + a little bit of intron/non-coding sequence upstream and downstream) is sequenced, and the sequence is compared to a reference sequence to determine the existence of causative/correlative mutations.

    As far as I know, Myriad does not own or control any patents claiming any of the specific primers utilized. And if it did, I would love to be the party against whom Myriad asserted such patents.

    In theory, someone could perform a BRACAnalysis-type test by sequencing a cDNA that had been reverse transcribed from mRNA from tissue in which the gene is expressed, but this would never happen in practice.

    The claims that Myriad relies on to protect its test are the method claims, which are justifiably in deep trouble. All this hubbub about “gene patents” is just silly. Notwithstanding Judge Sweet and Judge Dyk’s opinions on the issue, true gene patents are in no danger of being prohibited.

  13. slapfest plot twist:

    As 6 beats down on Malcolm in Malcolm’s own backyard, Malcolm deflects the discussion to anti-software and 6 becomes mesmerized (oooh, shiney object). 6 posts three times in a row, trying to find his way back to a dominant position (very unfamiliar ground for him).

  14. “Thanks, 6, I can finally take a vacation now.”

    Actually I was just kidding, so no vacation just yet.

    “Don’t “we” worry that socialized medicine will limit the cutting-edge healthcare that we are used to?”

    I don’t know about you but I’m not particularly worried about that what so ever. I’m still not sure how you think that “socialized medicine”, where everyone is assured to be able to buy you guy’s product might limit your cutting edge health system.

  15. “Will they be rescinding notices of allowance, ”

    Nah, not worth the trouble.

    “So long as isolated DNA patents continue to be issued, you’ll continue to be proven wrong.”

    Wait, wait, a whole section of the examining corps doing the wrong thing in examination somehow proves me wrong? I’ve only been here 3 years or so and the whole of the examining corps has been misapplying the law the entire time I’ve been here. Less now than before though.

  16. “Contrast this with, oh, I don’t know, Beauregard claims, which does the exact opposite: uses a completely illogical interpretation of existing law to justify the patenting of inventions that requires relatively ZERO risk and relatively ZERO financial investment to conceive and reduce to practice, such that legions of patent attorneys and agents themselves were inspired to join in the game and, in the process, complete dxck up the USPTO’s ability to do its job.”

    Their day is coming MM. Their day is coming. I keep trying to force that day, but attorneys have no spine for this kind of thing in my AU. A simple objection to the drawings is probably what is really fing with them, I include one of those in each of those kinds of cases, to date, I’ve not received any backtalk :(

  17. Malcolm, the exception you’re talking about (35 USC 271(e)(1)) lets competitors develop new therapies, but not market them – it only applies to would-be infringing acts “solely for purposes reasonably related to” obtaining FDA approval.

    I’m aware of that. It remains an important exception regardless and weakens the rights of owners of these sorts of patents (particularly) in favor of a policy of promoting research into therapeutics. That was my point.

  18. Malcolm, the exception you’re talking about (35 USC 271(e)(1)) lets competitors develop new therapies, but not market them – it only applies to would-be infringing acts “solely for purposes reasonably related to” obtaining FDA approval. The intention was to let generics get through the FDA approval process before the patent expired, so that once the patent expires the generics can hit the shelves.

    So, in the ACLU case, competitor labs can’t use the patented genes in their own tests without Myriad’s permission or until the Myriad patent expires, but they probalby could go through the steps required to get FDA approval for their tests, so that once the patent expires they are ready to enter the market.

  19. Psuedonym, I just got back from the 1630 groups and the TC director’s office. They’ve agreed to stop issuing isolated gene patents.

    Will they be rescinding notices of allowance, or will I have to wait until the end of the year to rerun that search that demonstrates the lie? So long as isolated DNA patents continue to be issued, you’ll continue to be proven wrong.

  20. PharmaP I think the public is generally OK with the use of patents to prevent commercial competition, but gets uneasy about preventing “research,” etc. Of course, that’s a question of enforcement – just because a patent owner could enforce a patent against a researcher doesn’t mean that they will.

    Even more to the point: legislators and courts have

      already

    enacted laws creating exceptions for would-be infringers who use patented inventions in the course of developing clinical therapies. In other words, the rights of patentees of these sorts of patents has already been weakened in accord with a public policy of developing therapies.

    And now the ACLU wants a judge to create a massive new class of ineligible subject matter based on misrepresented facts and a completely illogical interpretation of existing law?

    Contrast this with, oh, I don’t know, Beauregard claims, which does the exact opposite: uses a completely illogical interpretation of existing law to justify the patenting of inventions that requires relatively ZERO risk and relatively ZERO financial investment to conceive and reduce to practice, such that legions of patent attorneys and agents themselves were inspired to join in the game and, in the process, complete dxck up the USPTO’s ability to do its job.

    Q: Why isn’t AI on this thread throwing a shxtfit?

  21. Thanks, 6, I can finally take a vacation now.

    Smashmouth, 101 is not jurisdictional, otherwise the court wouldn’t have tha authority to invalidate a claim under 101. The Supreme Court did say that it was a “threshold” issue, but in King Pharmaceuticals this week, the Fed. Cir. decided not to reach a 101 issue when it could invalidate a claim under 102, so go figure.

    Ned, I can’t speak for Malcolm, but an isolated DNA claim doesn’t impact any uses of naturally ocurring DNA because the scope of the claims just doesn’t reach naturally occurring DNA. If I patent an isolated human gene, I can’t sue you for infringement (because your body is making or using naturally occuring DNA), no matter what the ACLU says. On the other hand, my patent could prevent others from making, using or selling isolated DNA for any reason.

    I think the public is generally OK with the use of patents to prevent commercial competition, but gets uneasy about preventing “research,” etc. Of course, that’s a question of enforcement – just because a patent owner could enforce a patent against a researcher doesn’t mean that they will. People do license patents. This “gut reaction” also ignores the fact that even researchers must get funding from somewhere, and universities get their own patents and/or enter into joint patenting agreements (or licenses) with commerical entities.

    Now I’m agreeing with Malcolm’s last post above. The whole patent system is based on the notion that granting patents encourages “progress.” I haven’t seen any justification for second-guessing the wisdom of our Founding Fathers and pulling the plug on patents in an entire field that promises the next breakthroughs in medical diagnostics and therapeutics.

    Don’t “we” worry that socialized medicine will limit the cutting-edge healthcare that we are used to? But at the same time “we” want to “socialize” the fruits of genetic research so that it is “free” for everyone? We can’t have it both ways.

  22. Psuedonym, I just got back from the 1630 groups and the TC director’s office. They’ve agreed to stop issuing isolated gene patents.

  23. Lionel Question 1: is my patent still valid?” No.

    Public policy weighs in favor of invalidating your patent.

    I assume you are referring to the policy of discouraging innovators from isolating, testing and identifying useful nucleic acid polymers with sequences that exist in “nature”, a labor-intensive process requiring substantial amounts of investment $$ to proceed, and one which has yielded extraordinarily beneficial therapeutic, diagnostic and research tools.

    Or are you referring to some other policy? If so, please explain.

  24. mutating its sequence.”

    I will agree categorically with you that his per se is patentable subject matter.

    But that is not what we are talking about, is it?

    I actually have no idea what you’re talking about, Ned.

    I’m talking about eligible subject matter under 101. There is no logical argument that will justify classifying one “isolated” 1500 residue nucleic acid polymer as ineligible subject matter but an otherwise identical nucleic acid polymer comprising a single additional residue or single mutated residue or single chemically modified residue as eligible subject matter.

    Patentable under 102 or 103? Totally different set of issues.

  25. I just read Judge Dyk’s dissent in INTERVET v. MERIAL. In my entire life, I have read at least 2,000 cases from the Federal Circuit. I have never encountered an opinion containing writing so bizarre and devoid in reason and sense, as Judge Dyk’s dissent. This dissent is a product of impulse, or whatever. Another person in this comment string (see above) characterized Judge Dyk’s dissent as a “rant.” I agree.

    Another reviewer made the comment, “public policy weighs in favor of invalidating your patent.” But note, it is rare or never the case that “public policy” is used as a criterion for assessing patentability. If you want “public policy” to be used as a criterion for patentability, you need to write a letter to your congressman, and have your policy concern be written into law, as part of title 35 of the United States Code.

  26. Malcolm wrote: “Let’s say I have a piece of isolated DNA from a bacteria and I engineer it (mutating its sequence) so that the protein it encodes is new and something much more powerful than the native gene.”

    Perfectly patentable. The mere recreation of the DNA sequence in the laboratory should notn be (other than as a product by process or process patent).

    “After I get my patent on the isolated mutated nucleic acid (including a claim to an artificial chromosome encoding the gene) someone discovers a related population of bacteria. The genome of this newly discovered bacteria is sequenced and lo and behold the gene in this bacteria has the same sequence as my mutated gene.

    Question 1: is my patent still valid?” No.

    Public policy weighs in favor of invalidating your patent. Is this what would actually happen today? Maybe not as patents are being granted on simple isolated gene sequences. However, there are strong arguments against removing things from the public domain as you would have here. Not to mention that it’s a basic violation of 101. Just because you were ignorant of the existence of something does not mean you deserve to keep your patent.

  27. “Frankly, I don’t understand why Judge Dyk went off on a rant that the claimed subject matter was patent-ineligible under 35 USC 101. As the majority pointed out, this issue was never raised by the district court, or even in the appeal briefs. This issue is obviously a “bee in [Dyk's] bonnet.”

    Posted by: EG | Aug 06, 2010 at 08:11 AM”

    Not saying I agree with Judge Dyk in this case, but I think there’s a simple explanation to your question–subject matter eligibility under s101 is essentially a jurisdictional issue, so it can be raised at any time, and an appellate court may raise it sua sponte.

  28. “Despite the stature of William O. Douglas, the Kalo v Funk decision is an example of a decision that was just on the facts being given for the wrong legal reasons, thereby creating a minefield of disinformation for subsequent practitioners.”

    Paul,

    You got that very right. I wrote a law review article just after I got out of law school in 1977 on the patent-eligibility of microorganisms and this case and Douglas’s reasoning were blasted by me as rhetorical nonsense.

    Malcolm,

    Well stated views. In one of those rare moments we agree.

    Frankly, I don’t understand why Judge Dyk went off on a rant that the claimed subject matter was patent-ineligible under 35 USC 101. As the majority pointed out, this issue was never raised by the district court, or even in the appeal briefs. This issue is obviously a “bee in [Dyk's] bonnet.”

  29. 6,

    If you feel so strongly about this, then I suggest that you zip on down to the 1630 groups and tell them to knock off granting all those clearly invalid patents:

    link to patft.uspto.gov

    Better yet, call the TC director at 571-272-0600 or -0700 and lecture him on his incompetency like you lecture us here.

  30. One or two typos in my last paragraph. I should have said:

    and the evils that it in fact addressed are now covered by enablement, written description and the depository requirements.

  31. Despite the stature of William O. Douglas, the Kalo v Funk decision is an example of a decision that was just on the facts being given for the wrong legal reasons, thereby creating a minefield of disinformation for subsequent practitioners.

    As usual, to understand the decision it is necessary to read the patent in issue. The invention as claimed was:

    “An inoculant for leguminous plants comprising a plurality of selected mutually noninhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.”

    The specification said nothing about the particular strains that were mutually non-inhibitive, and this was decades before the requirement for the requirement to deposit such strains in a depository institution as a condition of patentability. There was undoubtedly ingenuity in hypothesizing that a suitable combination of strains existed and then finding the particular strains that would work, but this was not what the claimed invention was about. In modern terminology it was a “reach-through” claim unsupported by any detailed description and therefore lacking written description and enablement on the principles set out in the University of Rochester case.

    Judge Douglas rightly smelled a rat, but unfortunately it was the wrong rat. As he said in his opinion:

    “There is, of course, an advantage in the combination. The farmer need not buy six different packages for six different crops. He can buy one package and use it for any or all of his crops of leguminous plants. And, as respondent says, the packages of mixed inoculants also hold advantages for the dealers and manufacturers by reducing inventory problems and the like. But a product must be more than new and useful to be patented; it must also satisfy the requirements of invention or discovery.”

    A modern student of patent law, knowledgeable about the origins of and the reasons for the patent system, can only regard this language as bizarre. The industrial revolution was based on the substitution of the work of man by the work of industrial machines and mechanical ingenuity, and here we see a vehicle for reducing the work by inocculant manufacturers and farmers in the growing of crops. Ample scope for finding new result and invention.

    Kalo, along with the A & P case and indeed the Cuno v Automatic devices decision was one of a sequence of unsatisfactory decisions from the Supreme Court that led to the passage of 35 USC 103. It is worth searching in the name Giles S Rich for the history of his contribution to the drafting of 35 USC 103 following the decision in A & P in particular, and the many papers that he wrote on the subject of 35 USC 103.

    Kalo is one of the old and unsatisfactory decisions that were overruled by statute by the passage of 35 USC 103. It is not a decision that sets any useful precedent or rule that should be carried forward, and the evil that it in fact addressed are not covered by enablement, written description and the depository requirements. Judge Dyk is on shaky ground in seeking to revive Kalo – an isolated substance is of great value. How many human lives were saved by isolated quinine?

  32. “mutating its sequence.”

    I will agree categorically with you that his per se is patentable subject matter.

    But that is not what we are talking about, is it? If it is, then we have no disagreement.

  33. Ned unless isolated bark has a utility different from bark, I don’t understand how it is patentable under Supreme Court authority.

    As regards eligible subject matter I think the answer is: of course it’s eligible subject matter. As to whether it’s patentable under 102 or 103: depends. Did the tree ever shed its bark? Did anyone ever chop the tree apart and notice pieces of bark lying around and maybe use the pieces to start a fire or something? Or line a canoe?

    The effective part of bark (the mysterious compound) is in both.

    So what? Let’s say I have a piece of isolated DNA from a bacteria and I engineer it (mutating its sequence) so that the protein it encodes is new and something much more powerful than the native gene.

    After I get my patent on the isolated mutated nucleic acid (including a claim to an artificial chromosome encoding the gene) someone discovers a related population of bacteria. The genome of this newly discovered bacteria is sequenced and lo and behold the gene in this bacteria has the same sequence as my mutated gene.

    Question 1: is my patent still valid? Answer: of course.

    Question 2: if during the course of sequencing the genome of this organism, the company manufactures an artificial chromosome encoding the gene that I’ve claimed, do they infringe my patent? Answer: yes, in the same way that Exxon would infringe my oil composition patent if Exxon happened to produce it as a stable, detectable intermediate during its refining process.

    Malcolm, you contend that the utility of isolated DNA is the same as that of naturally occurring DNA.

    Where did I contend that, Ned? A large fraction of naturally occurring DNA has no utility (or at least no known utility) in its “natural” state. The DNA can be deleted entirely from the chromosome without any detectable change in the organism’s viability or behavior. But that same useless piece of DNA, when isolated, could have great utility to people. How does this obvious, high school level fact square up with the ACLU’s kindergarten level arguments?

  34. Pharma, I am still a bit confused by Malcolm’s response to my point that claiming the isolated DNA (compound, gene, bark, mineral, bacterium, ….) does not wholly preempt all practicable uses of the naturally occurring DNA. It does, of course, if there is no other way known to practicably use that naturally occurring DNA.

    This somewhat conflicts with his OP that isolating the DNA allows dramatically different uses than naturally occurring DNA — as if its genetic sequence was not the pith and essence of its utility.

    Back to the bark. I have no problem patenting the use of the rare bark for medicinal purpose. This was the discovery after all. I assume such a claim would encompass the use of both bark and isolated bark for the medicinal purpose. But, unless isolated bark has a utility different from bark, I don’t understand how it is patentable under Supreme Court authority. The effective part of bark (the mysterious compound) is in both.

    Ditto, DNA.

  35. Why am I surprised that I agree with Malcom Mooney’s first post?

    Ned, if I discover that a certain compound in bark that has been ingested for medicinal (or recreational!) reasons has the desired effect, I can patent the isolated compond (if its otherwise novel) and a method of using the isolated compound for the same medicinal reasons.

    I have promoted the progress of the useful arts by identifying the active compound, and for disclosing that discovery to the world I get my 20 yrs patent term.

    Didn’t the “mineral” case confound 101 and 102?

  36. Malcolm, help me understand your point. I think you said that if an isolated DNA has utility X, one can still use the naturally occurring DNA for utility X.

    So, I discover that the bark of a rare tree has a medicinal property. I find that if I subject the bark to a known isolation process to enhance the medicinal properties of barks in predictable ways, I can enhance this property.

    Since I cannot claim the bark, can I claim the isolated bark. Is this patentable?

    Under Diamond v. C, it seems to me that the utility must be new, i.e., have markedly different characteristics. If the utility is the same, how can there be markedly different characteristics?

    Take steel. It’s utility is different from iron in a number of significant ways. Thus I can claim steel as a composition or article of manufacture if I am the first to discover the secret of steel.

    But, Malcolm, you contend that the utility of isolated DNA is the same as that of naturally occurring DNA. This is where you lose me.

  37. “That’s still not isolated.”

    That doesn’t matter. And the reason why it doesn’t matter has been explained to you, but you’re still not understanding it. Or, rather, you’re choosing to pretend not to understand to try to create confusion to avoid mass invalidity. Perhaps of your personal claims.

    Here, lets have a simplistic example of the situation:
    You claim a cookie jar filled with cookies, including a brown cookie (natural law-naturally occuring part of a gene). Brown cookies happen to pretty much only be useful in cookie jars. (this is an example to demonstrate scope, play along). The USSC states that there shall be no claiming of brown cookies. Your claim preempts all uses (as defined for this example) of brown cookies. That is, it is, in effect, directly preemptive of all uses of brown cookies (along with other things, including cookie jars filled with cookies including a brown cookie), which you were forbidden to preempt. Your claim is disallowed even though you didn’t directly claim the brown cookie. Why? Because your claim got substantially all of the uses of brown cookies which is in practical effect no different than allowing a claim to brown cookies in the first place.

    The scope issue combined with the preemption issue is what is wrong here.

    Perhaps Ned can give you a link to the primer I wrote him.

    “Not really. Why don’t you actually identify it for us.”

    Allow me to amend my statement, it is readily apparent to one of ordinary skill what information per se an isolated gene carries. I personally have not looked into the matter, nor do I wish to, since I personally couldn’t care less if the information is preempt, I would rely on other grounds. That is simply what the court stated and what the expert testimony seems to support.

    “Molecular modeling on a POWERFUL COMPUTER BRAIN (shout-out to Mooney!). A useful application of DNA information not preempted by a claim to isolated DNA. Search versus shotgun-sequenced personal genome. A useful application of DNA information not preempted by a claim to isolated DNA. Need I go on?”

    I thought about that one myself, but I’m not too sure if that would be encompassed by the claim or not. Making a model of something is kind of using it, it would thus seem like your use might still infringe the claim.

    Regardless, the fact that one use, or even a few, might survive will not save the claim. There may have been one or two uses that wasn’t preempt by Benson’s claim as well that nobody could think of at the time, but that wouldn’t have saved the claim. The fact is, the overwhelming majority of uses are preempt, seemingly all those within the Useful Arts, and seemingly all those in the field of bio rather than, for instance computer bio. And that is enough to do the invalidity waltz all over yo claim. See Flook. F, f, f, field o’ use limitations.

    “It is the naturally occuring structure that is having all it’s uses preempt by your claim.

    Not naturally occurring. As mentioned elsewhere, all composition claims preempt all uses of the claimed composition. You really need to check the preemption caselaw — it does not apply to physical structures.”

    As I have explained to you, and which you very well know, it is both the naturally occuring and the “not naturally occuring” versions that are being preempt in your claim. Or substantially preempt, take your pick, I don’t care which way you choose for your claim to die.

    Oh, and I’ve checked the caselaw, and it sure as f will apply to claims other than methods. The issue just so happens to pop up in that context most often. But with the advent of structures that preempt information like isolated DNA and certain computer embodiments a man’s gotta do what a man’s gotta do. Newman on the other hand will dissent, as usual.

    “As mentioned elsewhere, all composition claims preempt all uses of the claimed composition.”

    But do they also preempt all, or substantially all, uses of a naturally occuring composition? No, they do not. But yours happen to.

    In any event, I’m through discussing it with you man, you’re plainly not very well caught up in the conversation that has been going on for months and you’re just dragging up the same ol’ straw mans that have been put to rest many, many times beyond count. My kill count on straw mans is like hundreds of thousands by now. Like literally, my gun is so hot that it is hard to hold.

  38. I have to say that I’m in substantial agreement with the counter-argument that when these things are decomposing it is, as a practical matter, inherent that it will have been formed naturally at some point in history, or would be formed naturally as humanity progresses through time. If not inherent in the natural process itself, it is implicitly taught to be occuring in the natural process in the text books describing such decay. Take your pick, I don’t really care which it actually is.

    That’s still not isolated. That’s a molecule in a soup of similar molecules and other organic #&*!. DNA has even been intentionally subdivided six ways from Sunday by restriction enzymes and the like. That’s still not isolated.

    It is quite apparent what information per se an isolated gene claim “carries”, i.e. that a claim to will preempt the use of.

    Not really. Why don’t you actually identify it for us.

    Or that it represents it and that a claim thereto substantially preempts all known (and probably possible) useful applications of that information

    Molecular modeling on a POWERFUL COMPUTER BRAIN (shout-out to Mooney!). A useful application of DNA information not preempted by a claim to isolated DNA. Search versus shotgun-sequenced personal genome. A useful application of DNA information not preempted by a claim to isolated DNA. Need I go on?

    It is the naturally occuring structure that is having all it’s uses preempt by your claim.

    Not naturally occurring. As mentioned elsewhere, all composition claims preempt all uses of the claimed composition. You really need to check the preemption caselaw — it does not apply to physical structures.

  39. Malcolm,

    *snort* Yes, there is that. Considering I have an appeal in progress where that is the central issue, I should have put that proviso in there myself.

  40. As a general matter, one cannot claim an old composition upon discovering a (new) use for it. So, even if the “isolated” gene could be put to use, that is practically what is happening with these gene patents, not so?

    How is the isolated nucleotide polymer an old composition? Where does that polymer exist without the surrounding chromosome or, more specifically, the adjacent nucleotide polymer sections representing junk DNA and/or other genes? Does the existence of a molecule render “old” any molecule that you can derive from it by removing one or more atoms? Are you not veering dangerously close to 102/103 considerations rather than the text of 101?

    I would be comfortable if one were patenting the use of a gene to do something new. Patenting the gene itself preempts all uses of the gene, discovered or undiscovered.

    Patenting any composition of matter preempts all uses of that composition of matter, discovered or undiscovered. Patenting the isolated gene preempts all uses of the isolated gene. It does nothing to prevent uses of the gene where it is not isolated. Respirate. Procreate. Clone yourself. Stick the chromosome in a bacterium. Stick a 500 kbase sequence that happends to include BRCA1 on a pin and sell it on eBay. Isolated means isolated.

  41. “Every machine and molecule “carries” information concerning its own construction,”

    O rly? What information does, the machine here carry?

    link to google.com

    I double dog dare ya to go ahead and tell me what information it “carries”. Go ahead, I’m waiting. It looks to me like the claim doesnt’ preempt the use of any information per se.

    On the other hand, it is quite apparent what information per se an isolated gene claim “carries”, i.e. that a claim to will preempt the use of. And it isn’t just the information that relates to its own construction if I do recall correctly.

    Guys, no matter how much you want to apply this to all inventions it simply doesn’t work. You’re playing semantic games and ignoring precedents and their reasonings rather than simply facing what exactly it is you’re trying to patent. And the USSC will see through your transparent attempts to do so quite easily if history is any guide.

    “The patenting of isolated genes wholly preempts all uses of the naturally occurring gene and therefor effectively is a patent on the gene itself.”

    Not the naturally occuring gene Ned, the naturally occuring relevant portion of the the gene. MM will tear you a new one and then claim that he sent you back to the drawing board if you’re careless with your words.

    He might even then throw out the ol’ canard that we just saw on this site, and had previously seen on the Docs where it is stated that nobody has proven that the relevant portion exists by itself in nature. I have to say that I’m in substantial agreement with the counter-argument that when these things are decomposing it is, as a practical matter, inherent that it will have been formed naturally at some point in history, or would be formed naturally as humanity progresses through time. If not inherent in the natural process itself, it is implicitly taught to be occuring in the natural process in the text books describing such decay. Take your pick, I don’t really care which it actually is.

    I doubt a court would allow such a determination to rest on such a thing anyway.

    “you must explicitly or implicitly make the leap that DNA is information,”

    Or that it represents it and that a claim thereto substantially preempts all known (and probably possible) useful applications of that information :( Either way, I won’t stop you from going either route. Up to you.

    It is really too bad you have a hard time comprehending the DC decision. At least if you understood it you might could mount an effective argument against it.

    Regardless, the real issue probably isn’t the “information”, it is the naturally occuring structure that is having all it’s uses preempt by your claim. And even should the Fed’s rule the information problem to not be a problem, I wouldn’t be a bit surprised to see the decision go down a similar path at the DC as what I’ve described to you.

    “Nobody would plausibly argue that in patenting the circuit you’ve also patented the description of the circuit.”

    I’m not arguing that here. You’re just too blind to see it :( And that is too bad.

  42. Ned,

    Look at pp. 564-570 of link to fdli.org. The isolated DNA is useful as a probe when, for example, it is radiolabeled or bound to an assay chip. I’m sure that there are other methods which also make use of the actual isolated molecule to physically detect whether that sequence is present in a diagnostic sample or not.

  43. Every machine and molecule “carries” information concerning its own construction, so that a claim to physical object is equally validly a patent on information using that logic.

    The can of worms I was referring to above.

    And remember: all valid, properly issued claims to isolated genes are grounded in structure that is readily apparent and unambiguous to those skilled in the art, in contrast to the essential structure that is completley absent from the description of every Beauregard composition.

  44. DNA carries information, and therefore a claim to such is a patent on that information rather than a composition of matter, to paraphrase a certain district court judge.

    Which is demonstrably false. The information carried by DNA can be represented in many other forms, including the nucleic acid sequence abstraction (GAATTCTC…), RNA forms, protein forms (which admittedly do not precisely represent the nucleic acid sequence) and, for that matter, a scale-model LEGO structure.

    No, 6, what I wrote was intentional and quite correct. To get from information is not patentable to DNA is not patentable, you must explicitly or implicitly make the leap that DNA is information, rather than a carrier of such. Every machine and molecule “carries” information concerning its own construction, so that a claim to physical object is equally validly a patent on information using that logic. A physical model of the electric circuit you’re examining is no different than DNA in this sense. It can be self-describing, it can be abstracted in SPICE, and it can be made in LEGO. Nobody would plausibly argue that in patenting the circuit you’ve also patented the description of the circuit. But you’re willing to buy that with DNA due to some form of exceptionalism. Name it and we’ll tear that apart as well.

  45. The patenting of isolated genes wholly preempts all uses of the naturally occurring gene

    False.

    A patent on the isolated gene does not prevent the use of an isolated cell containing the gene in its natural state, even if the cell itself is recombinant (e.g., an isolated human stem cell comprising the gene).

    Back to the drawing board.

  46. Yet another, I’m not totally with you yet. All you have said in your post is that the isolation determines the existence of the gene in the person. (I believe you are speaking here of Myriad.) The isolated gene is not actually physically used for any purpose in any otherwise patentable process. One can almost say Myriad can be resolved on the basis of lack of utility.

    As a general matter, one cannot claim an old composition upon discovering a (new) use for it. So, even if the “isolated” gene could be put to use, that is practically what is happening with these gene patents, not so? I would be comfortable if one were patenting the use of a gene to do something new. Patenting the gene itself preempts all uses of the gene, discovered or undiscovered.

    6, we did have a discussion of “wholly preempt” outside the context of mathematical algorithms. I believe we have here a live candidate for the doctrine. The patenting of isolated genes wholly preempts all uses of the naturally occurring gene and therefor effectively is a patent on the gene itself.

  47. “(DNA carries information, and therefore is information rather than a composition of matter, to paraphrase a certain district court judge)”

    Try:

    DNA carries information, and therefore a claim to such is a patent on that information rather than a composition of matter, to paraphrase a certain district court judge.

    Then you’ll be a little closer to what was held. And it is a DC’s way to apply 101, not avoid anything.

  48. “leaves do not occur in nature in their isolated form.”
    worries me a bit. Is that true, especially in the autumn?

    It’s true over on this side of the ocean, Max. What on earth happens to your trees in autumn?

  49. with the resultant product being a highly selective chemical indicator of the risk for cancer, whereas the product occurring in nature is not.

    Mixed up the vaccine up with the Myriad product. Non-infectious stimulant of the immune system.

  50. A judge expressing his opinion on what the LAW IS is not what they’re concerned about.

    But a judge expressing his opinion that the LAW IS hopelessly ambiguous concerning the line between a product of nature and a non-natural composition of matter is…

    I certainly see the difference. It’s as clear as a sheet of lead.

    Artificially isolated/concentrated/transmogrified chemicals are not “abstract ideas, laws of nature, or natural phenomena,” they’re compositions of matter expressly made patentable by 35 USC 101 (“invents or discovers”) so long as they are new and useful and satisfy the conditions and requirements of the rest of Title 35. Subject matter exceptionalism (DNA carries information, and therefore is information rather than a composition of matter, to paraphrase a certain district court judge) is a laggard’s way to avoid a proper 102/103 analysis.

    The claims are not to whole DNA, in vivo DNA, or any recognizable part of a person or animal. For all the discussion of water and leaves being thrown about, the patents claim a macromolecule that, albeit a fragment of a larger macromolecule, has not been shown to exist in nature as that fragment, and is itself new and useful once separated from the whole. With due respect to Judge Dyk, if “in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with markedly different characteristics from any found in nature,” then perhaps the first thing one should look at is that 99% of the product occurring in nature has been omitted, with the resultant product being a highly selective chemical indicator of the risk for cancer, whereas the product occurring in nature is not.

  51. “If so, that was a mistake. It happens.”

    So then you would encourage them to go ahead and use language that does include such compositions? Perhaps “natural compositions”? I’d be behind that, they should clarify what they meant.

    “If the Supreme Court wants to get that ridiculously metaphysical, then let’s just admit that everything in the universe is found “in nature,”"

    Things in my art are definitely not found in nature. They’re found only in the lab/factory before they’re sold. Kind of like, o wait, a lot of other things we refer to as things belonging to the Useful Arts. Furthermore, claims thereto do not preempt practically or fully all uses of anything found in nature.

    “Well, so is the suggestion that a mineral is a “law of nature.” ”

    I don’t know, they are just using it as a figure of speech MM, cut them some slack.

    “And then a scientist determines how to grow the “isolated” leaves in tissue culture?”

    I see no problem with him growing said leaves, he just can’t patent them. Boo hoo? Cry me a river? That’s kind of what you get when you’re attempting to make something that is already found in nature. You’re not inventing, save perhaps for the method of growth of the leaves, and perhaps any machines/compounds needed to do such. And to be honest, those advances in the Useful Arts are all that likely should be patentable in that situation.

    “On the other hand, a DNA polymer taken from its “natural” state in a human chromosome and recombinantly inserted into a bacterial expression vector would also certainly not meet the terms of Dyk’s hypo.”

    But a claim thereto might preempt the use of such a thing might’n it?

  52. Dyk It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

    It is such a terrible analogy for many reasons, including the obvious one that MD noted above. But I can’t resist.

    What if the “natural” plant is an arid species whose leaves only appear once every 5-10 years because the native plant is genetically programmed to produce leaves only during rare monsoons? And then a scientist determines how to grow the “isolated” leaves in tissue culture?

    Seems like it should work, although perhaps one might argue that such a leaf is not “merely” isolated and so doesn’t meet Dyk’s hypo.

    On the other hand, a DNA polymer taken from its “natural” state in a human chromosome and recombinantly inserted into a bacterial expression vector would also certainly not meet the terms of Dyk’s hypo.

  53. I think that the USSC used the term rather broadly even encompassing compositions that are found in nature.

    If so, that was a mistake. It happens.

    If the Supreme Court wants to get that ridiculously metaphysical, then let’s just admit that everything in the universe is found “in nature,” including those things that “The Designer” has seen fit to be subjected to modification by a certain organism found in nature, i.e., human beings.

    It’s appalling isn’t it? Well, so is the suggestion that a mineral is a “law of nature.”

  54. SCOTUS got it wrong in Funk Bros.; why can’t the CAFC ignore that decision just like it ignores its own earlier en banc decisions much of the time? We all know that precedent and stare decisis are for chumps anyway, right?

    And yeah, Dyk’s inability to distinguish a law of nature from a naturally vs. non-naturally occuring composition is scary.

  55. “There is a difference between a “law” of nature and a composition that is found in nature. ”

    How does a mineral found in the earth fit into your definition?

    I think that the USSC used the term rather broadly even encompassing compositions that are found in nature.

  56. “Oh wait! That won’t happen. It’s not the principle of impartiality that they want, but a specific outcome. Man, that would have been an embarrassing mistake.”

    A judge expressing his opinion on what the LAW IS is not what they’re concerned about.

  57. Have yet to read the Decision but this:

    “leaves do not occur in nature in their isolated form.”

    worries me a bit. Is that true, especially in the autumn?

  58. The dissent cites Chakrabary for the proposition that “a new plant found in the wild is not patentable subject matter.” That may be true but what has been missed in the dissent and (IMHO) in AMP v. Myriad so far is that 35 U.S.C. specifically allows patents on “newly found seedlings” as long as that newly found seedling has been asexually reproduced. 35 USC 161. That provision makes a subtle but real distinction between an asexaully reproduced newly found seedling and “a plant found in a uncultivated state.” Id. Asexaully reproduction is just cloning and that is what isolation and purification of DNA is. To the extent that our interpretation of 101 utility patents can be related to the subject matter of 161 plant patents, it seems Congress intended patents to cover similarly small, subtle changes between the uncultivated naturally DNA and cloned versions of that DNA. That analogy is good for biotech but the catch is that plant patents are very very narrow. They extend only to the asexually reproduced plant and its clones. Independent invention is an inherent defense for plant patents. In other words, relying on the analogy to plant patents (which I think makes alot of sense) allows these patents under 101 but it sharply limits the available claim scope to the deposited molecules and clones derived from them. It gives some protection (it prevents outright copying) yet it does very little to wall off others from similar isolation and purification and research.

  59. Dyk It is far from clear that an “isolated” DNA sequence is qualita-tively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question.

    Completely missing the issue here. There is a difference between a “law” of nature and a composition that is found in nature. A composition that is found in nature anticipates a claim to that composition. The point of the term isolated is to distinguish the composition from the natural composition and to indicate that the composition is “made by man.” If it has a substantial utility, it’s 101 subject matter unless it’s a sham composition attempting to claim a method or information itself. The latter argument might have some legs, but I have yet to see it articulated persuasively and it would open up a can of worms that would make Bilski seem utterly forgettable.

    More importantly (as I’ve noted before) at first glance the qualitative differences between an isolated DNA molecule and the same sequence of nucleotides sandwiched between a billion other molecules, typically chemically modified and surrounded by a relatively massive amount of proteins and lipids and other molecules, each of which has profound effects on the utility and properties of the non-isolated sequence, is extremely obvious to anyone who does not get sucked into the hippy dippy tarpit of misrepresentation, non-sequiturs and red herrings floated by the ACLU and their ilk. And the closer you look, the more obvious the differences become.

    It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

    Timmy needs to take a break from those leaves. They are affecting his brain.

  60. It’s not the principle of impartiality that they want, but a specific outcome. Man, that would have been an embarrassing mistake.

    lol

    I think maybe I just thought of a fairly decent analogy. It’s like an image of a face is analyzed and information about certain features is stored as another image that is sort of like a collage, and that new image is useful for performing image recognition to identify faces that have those features even though they are different in other aspects.

  61. The ACLU files a motion asking for Judge Dyk to recuse himself from AMP and ACLU v. USPTO and Myriad in 5… 4… 3…

    Oh wait! That won’t happen. It’s not the principle of impartiality that they want, but a specific outcome. Man, that would have been an embarrassing mistake.

  62. “I don’t think that’s an accurate analogy. The isolated DNA is composed of many parts of the natural DNA taken apart and put together in a different way than occurs in nature. The example of trying to patent a single leaf seems more analogous to trying to patent a single DNA snippet, not an isolated DNA sample. But I also have a hard time thinking of a truly accurate anology. The isolated DNA sample seems rather unique in the way it is different from what occurs in nature.”

    They really should stop using the term of the art “isolated”. Soooo many people get confused on this point. Even so, I’m still not 100% sure about these “isolated” fragments o DNA being patentable.

  63. “discussed his argument that the claims directed toward the isolated form of a naturally occurring gene are likely unpatentable under 35 U.S.C. § 101.”

    O sssssaaanap!

  64. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

    I don’t think that’s an accurate analogy. The isolated DNA is composed of many parts of the natural DNA taken apart and put together in a different way than occurs in nature. The example of trying to patent a single leaf seems more analogous to trying to patent a single DNA snippet, not an isolated DNA sample. But I also have a hard time thinking of a truly accurate anology. The isolated DNA sample seems rather unique in the way it is different from what occurs in nature.

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