The Proper Scope of DNA (or "Gene") Patent Claims

By Kevin E. Noonan --

One thing has become abundantly clear in the public debate about the patent-eligibility of isolated human DNA.  That something is that there is a great deal of uninformed opinion extant, predominantly by well-educated people with scientific backgrounds, who believe wholeheartedly that patenting genes is pernicious because it has or will inhibit medical science and progress in the diagnosis or treatment of disease.  But that doesn't appear to be the situation to those with a background in biotechnology patent law, and so exploring why the two groups have come to such diametrically opposite conclusions may be informative.

And, before we start, let's agree that we won't waste time accusing each other of being motivated by "hidden biases" or "self interest."  Precious few doctors, hospitals, or medical societies have called for the practice of human genetic diagnostic methods to be performed free of charge, and it is well to remember that patenting, for all its arcane minutiae, is relatively straightforward.  Protecting intellectual property in other ways, such as by trade secret, requires a great deal more cleverness, and patent lawyers are particularly adept at being clever (if you doubt this, ask Justice Breyer).

We begin, as we must, with the claims ("The name of the game is the claim," as Judge Rich famously noted).  For most "gene patents," the claims have a canonical format, constructed over the last generation by the U.S. Patent and Trademark Office, on the one hand (who have been generally parsimonious in what is permitted to be patented, accusations by gene patent opponents to the contrary) and by patent applicants, who generally want claims that can be defended in a court of law when asserted against an infringer.  These claims have the format:

An isolated (human) nucleic acid (or DNA molecule or gene (specified by name), encoding an amino acid sequence identified by SEQ ID NO: X.

(The portions of this claim in parentheses are optional, used in some cases but not necessary to properly recite the claimed subject matter.)  Certain features of this claim merit further discussion.  First, the Office has required the term "isolated" to be in the claim, for at least two reasons.  First, under Diamond v. Chakrabarty, the claimed DNA must show "the hand of man" and be "markedly different."  That standard was established during times where isolating a human gene was truly analogous to finding a needle in a haystack, where the needle was made of hay.  While not based on a "sweat of the brow" requirement, the necessity for the "hand of man" was more evident during those times than (perhaps) it is now, when the entirety of the human genome exists (representationally at least) in computer databases worldwide.  Second, a DNA molecule was required to be isolated so that the claim would not encompass ("read on" in patent geek speak) the molecule as it exists in nature.  This is not a question, necessarily, of patent eligibility, but rather of novelty; the gene in nature is not novel until is isolated.  This reasoning can be seen in early cases, such as Wood-Paper Patent, 90 U.S. 566 (1874), and Cochrane v. Badische Anilin Soda Fabrik, 111 U.S. 293 (1884).  In the former case, the Supreme Court stated its reasoning for finding the claimed cellulose-based paper as follows:

It [the isolated cellulose] may have been in existence and in common use before the new means of obtaining it was invented, and possibly before it was known that it could be extracted from the subject to which the new process is applied.  . . .  If, then, the Watt & Burgess patent for a product is sustainable it must be because the product claimed, namely, "a pulp suitable for the manufacture of paper, made from wood or other vegetable substances," was unknown prior to their alleged invention.  But we think it is shown satisfactorily that it had been produced and used in the manufacture of paper long before 1853, the year in which the original patent of Watt & Burgess was dated.

Similarly, in the Cochrane case the Court said:

According to the description in [the patents in suit], and the evidence, the article produced by the process described was the alizarine of madder, having the chemical formula C₁₄H₈O₄.  It was an old article.  While a new process for producing it was patentable, the product itself could not be patented, even though it was a product made artificially for the first time, in contradistinction to being eliminated from the madder root.  Calling it artificial alizarine did not make it a new composition of matter, and patentable as such, by reason of its having been prepared artificially, for the first time, from anthracine, if it was set forth as alizarine, a well-known substance.  Wood Paper Patent, 23 Wall. 566, 593.  There was therefore no foundation for reissue No. 4,321, for the product, because, on the description given, no patent for the product could have been taken out originally.

The same rationale explains why isolated DNA claims cannot be read to encompass the genes in chromosomal DNA "isolated" from cells (but otherwise unchanged); Frederich Mieschner "isolated" DNA to this level of purification in the 1880's and thus, any such interpretation of the term "isolated" in isolated DNA claims would render them unpatentable for lack of novelty.

Another feature of the representative claim set forth above is that, to infringe, it requires that the entire amino acid coding sequence be produced.  The reason for this limitation stems from the purpose of such claims from the dawn of the biotechnology age: to be able to produce a protein having therapeutic or other beneficial uses.  If an isolated gene was to be used to produce erythropoietin, or tissue plasminogen activator, or interferon, or insulin, or blood clotting factors VIII or IX, or any of the other patented human genes, it needed to be full-length or otherwise a truncated fragment would be produced that, even if it retained biological activity could perhaps differ in biological half-life, immunogenicity, or other important properties.

One more claim feature should be mentioned, which is present in almost all but the earliest-filed claims: the nucleic acid is claimed in terms of the protein that it encodes.  This represents a compromise, because although the claim thus encompasses any nucleic acid that encodes a specific protein, the claim encompasses only those DNA molecules that have the specifically recited, identified sequence.  Accordingly, literal infringement does not lie even if there are conservative amino acid substitutions, meaning that a Valine to Isoleucine substitution (a difference of a single methylene group, -CH₂-) in a molecule having hundreds of amino acids does not infringe.  In addition, the scope of these claims is further limited by Federal Circuit case law and PTO reactions to it, resulting in claims to unspecified "conservative" substitutions being held unpatentable under 35 U.S.C. § 112, first paragraph.

There are several consequences of these considerations regarding these claims.  First, the claims are only infringed if someone without authorization makes, uses, sells, offers to sell or imports an isolated nucleic acid encoding the specified amino acid sequence.  Typically, a "gene patent" identifies a cell or tissue source (and, frequently, identifies a plurality of cell or tissue sources as part of its characterization of a gene) that natively expresses the gene.  Thus, anyone who uses such a cell or tissue source to study the gene without isolating it will not infringe.  Second, portions of the gene can be isolated, sequenced, and characterized and not infringe, and such portions can be changed and then introduced into the gene to produce another gene that does not infringe.  (The patentability of primers and probes selected from the gene sequence are not considered here; their patentability, rather than patent eligibility, has been called into question by others; see "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims").  Third, the gene product (typically, a protein) can be isolated from the cell and studied without infringement, as can antibodies raised against the gene product.  These antibodies can be used to detect under- or over-expression of the gene in cell or tissue sources for diagnostic purposes, and mutant forms of the gene product associated with disease can also be produced.  All without infringing the gene claim.

Fourth, the sequence itself can be identified in individuals and compared to wildtype or disease-associated mutations without infringing unless the entire DNA is isolated intact (something that is unnecessary and unduly burdensome to do; portions can be sequenced and the entire sequence aligned in a computer).  This is because (ACLU arguments to the contrary) the DNA sequence information is not protected by the patent claim.  (Again, whether there can be crafted a valid method claim for making a diagnosis is not within the scope of this discussion; indeed, challenging the "gene" claims while eschewing a challenge to Myriad's several remaining method claims smacks of cynicism in an attempt to garner the most publicity rather than a honest effort to obtain genetic BRCA diagnostic testing for those women who cannot afford it.)  This is also the reason why "whole genome sequencing" and other present or future genetic diagnostic methods are unaffected by the isolated DNA claims:  practice of these diagnostic methods do not infringe the DNA claims.

The question remains what experiments will be impeded by the existence of claims to isolated human DNA.  (It should be mentioned that there are more than 8,000 scientific research papers published in the BRCA genes since the grant dates of the patents.)  Clinical testing may be one type, where a population is to be assessed for the prevalence of BRCA gene mutations, for example.  Here, there are questions of whether the testing will be performed for free or whether the patients will be charged; it is difficult to defend a "study" where the research subjects pay for the privilege.  But even in cases where there is a need for such a study it seems that countervailing practices should be able to reduce if not eliminate any negative effects of a gene patent claim.  As discussed above, large-scale sequencing can be performed without incurring patent infringement liability as to the isolated DNA claims.  Also, scientific research typically requires specialized reagents and services that are supported by grant monies.  For example, there was a time when restriction endonucleases were not readily available but could be isolated from the particular bacteria that produced them, and lambda phage packaging extracts were routinely (albeit laboriously) produced from complementary cultures of mutant phage (one making the packaging protein but defective phage heads, the other making intact phage heads but not the packaging protein).  The advent of commercially available preparations of more and more restriction enzymes and highly effective packaging extracts made these homemade efforts obsolete; similarly, engaging the patentee to perform the genetic testing would eliminate any risk of patent infringement liability as well as gaining for the project the reliability that such testing services provide.

Thus, there seems to be little empirical support for the contentions that "gene patents" are inhibiting research, despite the allegations from former Acting Solicitor General Neal Katyal, at this year's BIO conference, that his two weeks with NIH scientists convinced him (and, it seems, the rest of the Department of Justice) that gene patents raised such a "clear and present danger."  However, because no one is infallible (here or at the NIH), it is possible that there are such instances or circumstances that have been overlooked.  If so, please let us know.  If not, perhaps it is time for those who argue without basis that gene patents do not "promote the progress" to make their arguments honestly, based on (legitimate) moral, religious, or political grounds.  There is nothing to be ashamed of in making these types of arguments; but if that is the basis for principled opposition to patenting human DNA then perhaps the issues can be addressed in ways that can foster a solution rather than (as in so many things) mere partisanship.  We welcome a response.

Comments

[EG]

Kevin,

Nice, thoughtful article on this subject without the hyperbole and rhetorical nonsense we hear too often. Like you I'm fine with "legitimate" debate on this subject.

[Arthur Gershman]

See:
http://www.aclu.org/files/assets/2010.12.08_-_Southern_Baptist_Convention_Amicus_Brief.PDF
and click on my name below and see particularly "The Kosher GoldFish."

[6]

In this thread Kev reiterates that which we all already know, and have known for some time, and gleefully sidesteps the only issue currently facing the claims what so ever.

"Second, portions of the gene can be isolated, sequenced, and characterized and not infringe, and such portions can be "

We know.

"Third, the gene product (typically, a protein) can be isolated from the cell and studied without infringement"

That is your opinion, which may not be shared by Myriad.

"Fourth, the sequence itself can be identified in individuals and compared to wildtype or disease-associated mutations without infringing unless the entire DNA is isolated intact (something that is unnecessary and unduly burdensome to do; portions can be sequenced and the entire sequence aligned in a computer). "

Nobody cares :(

"(It should be mentioned that there are more than 8,000 scientific research papers published in the BRCA genes since the grant dates of the patents.)"

I thought you said 80k last time.

"Thus, there seems to be little empirical support for the contentions that "gene patents" are inhibiting research,"

Nobody cares :(

But when will Kev get around to telling us something new? Like, for instance, how the claims do not in fact preempt all substantial uses of the whole naturally occuring gene (save possibly for research). I will be glad to read about it when he gets around to that.

[Kevin E. Noonan]

Thanks, 6. However, a few points:

First, the purpose of the post is to elicit responses from working scientists regarding their perceptions on how gene patents inhibit their work. This is because many amici, and the plaintiffs, argue that these patents do just that. As you have already conceded, you know nothing about this.

Second, in order to determine whether the claims "unduly preempt" uses of a product of nature, we need to know what the public cannot do once they are patented. It is important to remember that the Supreme Court didn't say "preempt, it said "unduly preempt," because all claims preempt to some degree.

Finally, you have not (and I dare say cannot) define what is encompassed by "all substantial uses of the whole naturally occurring gene." First, your caveat (save possibly for research) disqualifies a great deal of substantial non-infringing use. Second, you have not defined any substantial uses to which the patented gene cannot be used in a non-infringing way.

I say this kindly, 6: you were purported to be in law school. Make a legal argument that isn't merely a restatement of the conclusion and we can have a productive discussion. Otherwuse, it's just self-aggrandizing noise and I'm sure we both have better things to do.

[Kevin E. Noonan]

Dear Arthur:

I could not find the Kosher GoldFish reference which is too bad - sounds like an interesting contradiction in terms.

Unfortunately, the Baptists' brief doesn't help, because I cannot (and don't intend to) argue about religious beliefs. I am happy when they are expressly enunciated as such, however.

For the record, I also think it amusing when people bring up Mr. Moore's hairy cell leukemia. This is because I am sure that he would have (and probably did) pay for the doctors to get it out of his body. But I agree that patients should be made aware that whatever a doctor removes from their bodies is no longer "theirs."

The post is intended to deal with PTO practice that is frankly amoral, because it must be so under the First Amendment. The government cannot be imposing the Baptists', or any other groups religious values on the rest of us.

And to reiterate, no gene patent owner owns anything of yours or mine. Ironically, it is likely that isolating your BRCA genes would not infringe Myriad's claims: remember that your gene would need to encode the same amino acid sequence that is recited in Myriad's patent, and the prevalence of "neutral" sequence variation in the human population is high enough to make infringement unlikely.

Thanks for the comment.

[6]

"Finally, you have not (and I dare say cannot) define what is encompassed by "all substantial uses of the whole naturally occurring gene."

Which is the beauty of it Kev, I don't have to. I can let other people do the grunt work, if there even is any. :) Obviously I have to do it in my cases, but this isn't my case, saweeet :)

"Second, you have not defined any substantial uses to which the patented gene cannot be used in a non-infringing way."

Sure I can, you told me about it long ago, and MM just got done telling me about it a few days ago. But I don't strictly need to, all that really technically needs to be put on the record already has been by Mr. Hanson.

"First, your caveat (save possibly for research) disqualifies a great deal of substantial non-infringing use."

That is correct. But, then again, you could research every last single one of the judicially exempt subject matter that has been held to be preempt in other cases. So I will set it to the side, just as they always do, and always will do. And there is a good reason why. But I bet you can't guess it, even though it is the law and you are a lawyer.

I'm sorry though that I'm not prepared to reiterate the "legal argument" in its full splendor for you yet again Kev, as I have made it many dozen times by now and it already exists on this record. And you will see that it already exists here shortly.

But in any case, gl getting researchers that don't know enough to respond to respond. :)

[Arthur Gershman]

Dear Kevin,
I am a littke confused. In your original post you state: "...perhaps it is time for those who argue without basis that gene patents do not 'promote the progress' to make their arguments honestly, based on (legitimate) moral, religious, or political grounds."
It sounded like you were aiming at my point of view.
Yet in your response to my comment you state: "Unfortunately, the Baptists' brief doesn't help, because I cannot (and don't intend to) argue about religious beliefs."
Sp there's that.
Then, the Kosher Goldfish website is at www.koshergoldfish.com. It is also the top search result when you google "Kosher Goldfish."
Respectfully,

[Kevin E. Noonan]

Dear Arthur:

Sorry, didn't mean to be confusing. My point is that I would like to eliminate (by the existence of no concrete examples) the basis for the anti-gene patenting position that gene patents inhibit research per the Supreme Court's Mayo decision. Once accomplished we can have a moral/religious debate. But let's doff the sheep's clothing about research first; masking a religious debate in the guise of a scientific one is dishonest. The Baptists generally were not dishonest in making their religious-based arguments.

Thanks for giving me the opportunity to clarify.

[Skeptical]

"perhaps the issues can be addressed in ways that can foster a solution rather than (as in so many things) mere partisanship"

This may overlook the fact that "solutions" based on patisanship are desired by some.

Some WANT solutions that ban patents that are nothing more than EFFECTIVELY claiming a Product of Nature. And make no mistake, the judicial exception does include Products of Nature, as there is no other way to read the phrase "Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter." These examples of natural phenomena are clearly things or products of nature and they are examples that range from the simple to the complex, indicating that the breadth of this exception is broad.

The key is to come up with a solution that conquers the partisanship because that partisanship is not going away.

To me, the key is to focus on the "markedly different" clause - otherwise known as the "change in kind" clause.

This is a proper legal foundation (rather than "hope" or "but the industry will be decimated" type of arguments).

Further, the very fact that one can establish a "markedly different" or "different in kind" means that the claim is NOT EFFECTIVELY to the Product of Nature - that there is some critical difference. Also, in a nod to 6's preemption concerns, such a difference also menas that the product of nature is not preempted.

To me, any other attempt to work around the issues to come up with a non-partisan solution are doomed to failure. One cannot ignore the opponent and hope to win a legal argument.

[Kevin E. Noonan]

Dear Skeptical:

Actually, I can read the quoted sentence a little differently, wherein "a 'mere' mineral in the earth or new plant found in the wild" (or a leaf from a tree per Judge Dyk). What worries me is the broad interpretation that would preclude claims to a purified product of nature like an antibiotic, using the specious logic that it hasn't been "invented."

My comment on partisanship was based on my perception that the two sides of the debate are arguing past each other. I agree that the solution is to address what is actually claimed and the impact of those claims on research. This is because what resonates with most people (and, according to Mayo, the Supreme Court) is the charge that patenting DNA prevents progress and innovation, which is directly related to the scope of what is infringing (which is much more narrow than the ACLU and their friends would have us believe).

As for preemption, remember that Judge Moore considered that argument "a waste of time and space." But insofar as the Supreme Court is concerned, the recognition that the scope of any such preemption is not undue may be significant.

And while I agree that "decimating the industry" is not a legal argument, it should be effective in reminding the judiciary that their decisions are retroactive and should be rendered carefully.

Thanks for the comment.

[AAA JJ]

A couple topics ago, Keep It Real said to 6, "What is the "judicially excepted subject matter" being removed from the public domain by Myriad's composition claims? Let me guess: you don't know and you're hoping some judge is better at kicking up dust than you. Good luck with that."

Still waiting for his answer.

If he transferred to the Detroit office, he might, just might, be able to get into Cooley.

[Skeptical]

Dr. Noonan,

I might have slightly different views than you on the appropriateness of giving a patent for something that is merely isolated or purified.

If that isolation or purification is not enough to make a change that matters, the "markedly different" change - otherwise known as the "change in kind," then no patent SHOULD issue. And that is regardless of how much work is involved in isolating or purifying. We do not have a sweat of the brow patent system, and invention IS required for the patent right.

And let's not forget what is under consideration here from the Mayo v Prometheus GVR: "EFFECTIVELY." Just as in Mayo that did not do enough in a method setting, something in the composition of matter setting that is "not enough" will be found not eligible.

Personally, I do think the composition in the Myriad case has "done enough" and is "different in kind," but the legal hurdle still must be jumped over - there IS a Product of Nature judicial exception and that exception MUST be accounted for.

I am highly skeptical of anyone who would hand-wave the Product of Nature judicial exception away.

[Kevin E. Noonan]

Well, Skeptical, I don't see it that way - "laws of nature, natural phenomena and abstract ideas" are the three exceptions noted in every case, and the "mineral in the earth or new plant" is dicta - granted, Supreme Court dicta, but dicta nonetheless.

I think the changes in isolating and purifying naturally occurring substances are almost always sufficiently different from their natural state as to be patent eligible for policy reasons - would you rather have a compound isolated from a plant and put into a pill or have to chew leaves/bark/etc. See my penicillin example/hypothetical in the Myriad oral argument post.

As for Myriad's DNA claims, they suffer from the change in perspective - 20 years ago, isolating a gene was not only difficult but provided something otherwise unavailable - the ability to produce useful quantities of useful proteins. In addition, is your argument that we don't want to provide incentives for inventions that are difficult to achieve? (Although I agree that difficulty isn't necessary or sufficient, it should be considered.) On top of that, as set forth in this post there is little that the public is interested in that is precluded by patenting the DNA.

So we may differ, but at least deciding the case as I advocate avoids all the (perhaps) unintended consequences of a frank "product of nature" exclusion. Remember, "all we have is nature."

Thanks for the comment.

[Skeptical]

Dr. Noonan,

You are handwaving. The Product of Nature exception is more than dicta. It is a part of the three exceptions. It is simply understood that phenomena includes physical items.

"Difficulty" is not a legal requirement under the patent law. It is a canard, like "patents should be given only for those items that otherwise would cost too much to develop." Or like "patents should only be given to those inventions that show a flash of genius." Such canards are beneath you.

As to the "all we have is nature" comment, I would reply that what is in the warehouse of nature belongs to all men (sound familiar?). It is what Man does with what nature provides that is important (the concept of invention should be ringing in your ears). Do enough (echo of Prometheus) and you can earn a patent.

[Kevin E. Noonan]

Dear Skeptical:

As I said, we will have to disagree. However, I submit that in In re Bergy, there was no question that the isolated preparation of lincomycin was patent eligible, it was the purified culture of the bacteria that made it. So I think we have a great deal of revisionism about whether any court has ever said that a product of nature was patent ineligible. Handwaving goes both ways.

Thanks for the comment.

[Kevin E. Noonan]

But what is really frightening is that the Supreme Court thinks it knows what is "enough" to warrant patent protection.

[Skeptical]

Dr Noonan,

Perhaps you misunderstand me. I do not say that "purified" cannot be patent eligible (so your example does not carry the point you think it does). What must happen with the purification (or isolation, etc), is that a change in kind must be effected. No change in kind, no patent. Simple and straight forward.

As to your second comment, I would modify it slightly:

But what is really frightening is that the Supreme Court keeps it secret what is "enough" to warrant patent protection.

[Kevin E. Noonan]

Dear Skeptical:

I agree with the sentiment regarding the Supreme Court, but what makes you think they know the "secret"?

I guess it depends on what you mean by a "change in kind." Hypothetical: I discover a molecule produced in human beings that controls blood pressure. It is the perfect blood pressure regulator. Keeping in mind that how I make it is not relevant to patent eligibility, would you consider a claim to the isolated compound, atom-for-atom the same as what occurs in the body, to be patent eligible? If not, what would make it changed "enough" to satisfy you?

[Skeptical]

Dr. Noonan,

Thank you for the dialogue. I appreciate your time and your thoguhts.

If I understand your blood pressure regulator molecule hypothetical example, you want to claim something that exists in nature with the only change being that you removed it from the body.

This is not patent eligible because there is NO change in kind.

What would make it changed "enough" to satisfy me would be a change in kind, or to use the legal language reflected in Chakrabarty, a change that is "markedly different." What that ACTUAL change would be for your specific example is difficult to see as what you WANT is already there in nature - what you WANT is already in the warehouse belonging to all men. You WANT what you may not have. Such simply is not the type of discovery that patent law covers. You have discovered no more than what nature provides and have not done anything inventive with it. You are no better off than Prometheus - you have merely switched enumerated category.

It is not in the fact pattern of your example, but perhaps by isolating and purifying you can (or do) induce a change that is markedly different or a change in kind (as I alluded to, this to me seems the best chance for Myriad).

Perhaps a question or two would help with the answer. Let's say you obtain the patent on the blood pressure regulator molecule. Does your patent cover that molecule inside the body? Let's say you obtain the patent on the ISOLATED blood pressure regulator molecule. Does your patent EFFECTIVELY cover that molecule inside the body? If the molecule cannot be used by man without the ability to take it out of the body, then you have transgressed against the right of man to use the warehouse of nature freely. You have EFFECTIVELY claimed the molecule in the body even though you only claim an isolated vesion.

There is nothing magical about "isolated." In fact, your example (without more) shows that "isolated" can easily fail to bring something out of the warehouse of nature that belongs to all men freely.

Do you see the problem? If isolation does not make a change in kind, then that step is like the beginning steps in Prometheus, and like Prometheus, the claimed item will fail a Patent Eligibility review.

As to the Supreme Court, my pun falls short of its intended mark. I was attempting sarcasm in that the Court is only too willing to say "not enough" or "its abstract (in the case of Bilski)" but refuses to share (or define) a way of reaching that point. Much like your question of "what would make it changed 'enough' to satisfy me?" in fact. My answer would be that the claim must show enough invention so that it differentiates and does not cover (or does not effectiely cover) what belongs to all men. In your whole molecule example, since what you want in already in nature as you want it, it is doubtful - at least to me - that there would be ANY change that is enough to make it patent eligible, as any change enough to differentiate would likely change what you claim to NOT be the molecule you want. The sad but true result is that not every thing is patent eligible (and by thing, I mean phenomena of nature, which whether you like it or not, does include physical things, like crystals (the simple), like plants (the complex), and yes, like molecules (the in between)).

[Kevin E. Noonan]

OK, Skeptical, maybe we are getting somewhere. If you recall, in my Myriad post I listed three penicillin clams:

1. Penicilin
2. A isolated and purified penicillin preparation having a specific activity of at least 100 IU per mg and having a bactericidal activity efffective to kill at least 10 million bacteria.
3. A pharmaceutical composition comprising a therapeutically effective amount of penicillin and a pharmaceutically acceptable diliuent or carrier.

Now, claim 1 above is your hypo - it reads on the product of nature per se, and thus would not be patent eligible (although it would also not be novel, which is a less subjective way of invalidating it). Claim 3 should be patent eligible even under your criteria, because it has been"markedly changed" (into a drug); even the Supreme Court in Mayo recognized that clams to drug formulations should be patent eligible.

My question to you is, what about claim 2? Why or why not?

[Skeptical]

Asked and answered Dr. Noonan.

Admittedly, as I have disclosed before, this is not my area of expertise, and to the specific answer I cannot tell you if claim 2 is still EFFECTIVELY covering a Product of Nature.

If it does, then no patent.
If it does not, then patent eligible.

The why/why not is universal. The specific yes/no depends on what the claim effectively is and what the corresponding Product of Nature is.

Also, please do not attempt the "novelty is less subjective" goalpost moving argument. The legal argument, like it or not, is 101, and the judicial exception is NOT a time dependent (novelty//before) bar.

[Kevin E. Noonan]

Well, Skeptical, I am having the same problem with you as I have with 6 (no offense intended). I don't remember much from my Jesuit teachers in logic and rhetoric, but I do remember that it isn't an argument when you merely reiterate the conclusion. I still don't know what "effectively" covering a product of nature means. (I don't blame you; the Supreme Court doesn't know, either).

But remember the point here is to determine whether one of the logical premises of plaintiffs' argument (and the government's; curious, don't you think?), that claims to isolated DNA unduly preempt the naturally occurring product is factually accurate. If so, it should be easy to enumerate the ways in which the public's right to the treasure trove of the natural world has been unduly reduced.

As for subjective versus objective, both are "legal;" as we discussed up thread, the Supreme Court is not sharing the secret of its subjective view (the "we know it when we see it" test). This means that whether a claim satisfies 101 will depend on the subjective judgment of a PTO examiner, a district court judge, the Federal Circuit or the Supreme Court. In my opinion, it is better where possible to employ principles of novelty instead.

We may be at a point where the Supreme Court holds that subjectivity is the standard for composition of matter claims; if we were sure there would be nothing to discuss. But seeing as Justice Breyer based his Mayo decision on undue preemption, it seems reasonable to ask for evidence in the case of isolated DNA.

I am still waiting (from anyone, not just you).

Thanks for the discussion.

[Skeptical]

Dr. Noonan,

First, let me thank you for your continuing our conversation. I really do think we agree more than we disagree, and that exploring the boundary where we disagree is beneficial (at least it is to me).

With that said, I must add that respectfully, you ask for answers and then complain that you don’t get them even after answers are provided. You say that you do not see the argument when you close your eyes to that argument. For some reason you label the answers as “conclusions” and say you are not satisfied. I think you are not satisfied because you are not getting what you want (even though you are getting answers and not just conclusions).

I gave you what you asked for. If you want something else, then perhaps you should rephrase the question.

The argument of “What must happen with the purification (or isolation, etc), is that a change in kind must be effected. No change in kind, no patent. Simple and straight forward.” Is not a conclusion as you would paint it. You say “I guess it depends on what you mean by a ‘change in kind.’ “ I would answer that no, it is not a guess; and yes, “change in kind” is exactly what the argument is.

The more precise point to quibble over is the word “effectively.” That word is the dagger that can eliminate the handiwork of man, that can limit the eligibility of something even if that thing was made by man.

In essence, the court is saying that just because something IS made by man, that is not enough. Man can create but if the THING that man creates is not distinguishable ENOUGH from what nature creates, then the thing is not eligible for a patent. And the verb “create” may include “isolate,” “purify,” “extract,” or ANY other action by man. It is daunting to comprehend that what on first blush are the typical ACTITIVIES that usually suffice to denote invention simply may not be enough if the RESULT of those activities is not different enough than what nature herself provides. Cleary, this is a proper argument and not just a conclusion.

Moreover, you wish to only aim for a factual determination, and as I already mentioned, that particular factual determination is not within my bailiwick. But that does not mean that my arguments do not apply, that the logic I present does not apply and that the answers from that logic do not apply. They do. It does. It does. It is also the answer you do not want to hear. You state “If so, it should be easy to enumerate the ways in which the public's right to the treasure trove of the natural world has been unduly reduced.” And the answer )again) has already been given, but let me put it another way: The unduly reduced public right is the grant of the patent to an ineligible invention. You cannot give a patent right to some THING that nature effectively also provides. If there is no change in kind, the patent grant removes from all men the ability to use that item freely. In any way that the patent would be enforced, THAT way is an undue reduction.

It is that simple.

Regarding your aversion of 101. That is understandable. Patent Eligibility is a nuclear bomb compared to the sniper’s rifle of the rest of the patent law.

However….

Your quote of “We may be at a point where the Supreme Court holds that subjectivity is the standard for composition of matter claims” is misplaced and ignores what the courts have said repeatedly: the form of the claim will not matter for a 101 analysis - 101 applies regardless of the enumerated category and compositions of matter do not enjoy any privilege over any other enumerated category.

Your writings seem to indicate (and my apologies if it is my error of reading into your words something you do not intend) that you feel one enumerated category “is more equal” than other enumerated categories.

I sense uncertainty in your position and perhaps that is why your questioning does not seem quite focused (or at least you are not satisfied with the answers you have been given). I am not sure by your words whether or not you fully embrace my statement that “things” are covered under the judicial exception, that there is a Product of Nature exception. I think the statements by the court are incontrovertible, and your points in your post of 8/3 11:25 AM and 4:10 PM are just wishful thinking. You may choose to disagree, as is your prerogative, just as closing your eyes and chanting “it is not so” over and over again is your prerogative, and I think the effectiveness of the two would be on par.

I think you play a bit of a strawman in painting the “subjective versus objective” picture. I do “get” that you prefer not to use 101. But your desire does not change what the legal issue actually is. The legal issue IS 101. Saying “both (subjective and objective) are ‘legal’ ” is a non-sequitur. You cannot switch the legal argument under consideration just because you do not want the court to be looking at composition of matter claims under 101.

I think the idea that 101 being applied to THIS enumerated category frightens you. The prospect of deeming ineligible a discovery because it does not “do enough” IS frightening. The thought that activity alone is not enough to achieve patent eligibility IS frightening. But no more so than any other art unit has ever faced, and for that matter, that any other of the enumerated categories have ever faced.
I think you improperly discount the logic that I have provided and labeled it a conclusion. I think you do this because you have not accepted that logic (and the conclusions that that logic will bring). You are still looking for the answer you WANT to hear. Sorry Dr. Noonan, but you will not hear that answer because the judicial exception does cover things (such is NOT dicta), and the coverage is not a ver batim coverage (just as in Mayo, for whose claims the Supreme Court acknowledged WERE more than a law of nature alone).

Notwithstanding the answers that you have been given, I too am somewhat less than satisfied with the “logic” that the Court has used in its 101 jurisprudence (I wonder if my Jesuit teachers and your Jesuit teachers would agree that the Court has failed in its explications). As I indicated several times, the Court has NOT provided a brightline roadmap to figure out JUST HOW MUCH is enough (or just how much is not abstract), but that does not mean that the answer is not before you. It is. The lack of specificity is not fatal to the answer (and yes, it is an answer). All that the lack of specificity means is that the law will need to be applied on a case by case basis, comparing what actually is claimed, what actually nature provides (even if what nature provides is newly discovered and quite possibly outside the bounds of the novelty test!), and making a judgment (yes there will be an element of subjectivity) as to “enough.”

I think rather, you are searching NOT for an answer, but for a doctrine. You are searching for certainty that some ACTIVITY alone is enough to guarantee patent eligibility, rather than basing eligibility on the result of the activity (especially since novelty may not be enough! – 101 can use novelty, but does not have to).

[Kevin E. Noonan]

Well, Skeptical, we will agree to disagree. I would only note that, if it were as clear to the PTO and the Federal Circuit as it is to you, neither we nor they would be talking about it.

Thanks for the discussion

[Skeptical]

Affirmative Dr. Noonan, I have enjoyed our discussion.

As to my assuredness, well, let's just say I have given this considerable thought (including your viewpoint, as well as the available viewpoint as expressed in court decisions) and have made a decision based on those considerations.

I am open to additional considerations and arguments, but have not seen any that can shake the position I have provided.

(In other words I disagree with your subtle hint that I am "too" sure of myself).

[Keep It Real]

The question I asked 6 is equally applicable to Skeptical. Here it is again:

"What is the "judicially excepted subject matter" being removed from the public domain by Myriad's composition claims?"

We're still waiting for an answer to that basic question.

As Kevin notes: "it isn't an argument when you merely reiterate the conclusion" and that's all that Skeptical and 6 are doing here.

In any event, the positions are taken and we'll remember them. Perhaps Skeptical can remind us where he/she stood on the eligibility of Prometheus' claims prior to their decimation by the Supreme Court.

[Keep It Real]

Skeptical: "I cannot tell you if claim 2 is still EFFECTIVELY covering a Product of Nature."

Too funny. The power of Skeptical's "logic" is breathtaking.

[Skeptical]

Keep It Real, aka MM, aka Malcolm Mooney, please return to Patently-O for your game-playing.

As I pointed out to Dr. Noonan, I have done more than merely reiterate the conclusion.

As to the "we'll remember them" comment, please spare "us" the drama, the royal "we" and the intonation that you have been correct on some running tally.

If you want to discuss something, that is fine. But this site does not put up with what goes on at Patently-O.

If you want to discuss, then discuss.

[Keep It Real]

Skeptical : "As I pointed out to Dr. Noonan, I have done more than merely reiterate the conclusion."

As Kevin very gently pointed out (perhaps so gently that you missed it) these sorts of conclusory statements are not the same as actually as articulating an analysis. You have not succeeded in doing that, even if you believe otherwise. You're like the naked guy standing in the room shouting "Haha! I'm invisible!" Hilarious on one hand, and rather sad on the other.

I know the Worst Thing in the World (from your perspective) would be for someone to accuse you of being dishonest (OMG!!!) but .... well, let's just leave it at that for now.

The question remains for you or 6 to answer, Skeptical: "What is the "judicially excepted subject matter" being removed from the public domain by Myriad's composition claims?"

I can tell you precisely what that judicially excepted subject matter was in Prometheus. That's one reason why the claims at issue in Prometheus were very different from the those at issue in Myriad. You can respond to my argument/logic by pointing out where I have made a mistake, as I have pointed out your many mistakes in the past. It's not a response to merely put your fingers in your ears and repeat your wish without addressing the facts Kevin and I have presented you.

I'm sorry if this approach to a civil debate comes as a surprise to you. There really is more to it than saying "I enjoyed the conversation" (which wouldn't even be true if I was speaking of my conversations with you).

[Keep It Real]

Skeptical: "what is in the warehouse of nature belongs to all men"

Where is the "warehouse of nature"? Does it include city parks? Does it include the insides of abandoned buildings? What about laboratories when the power is cut off by a lightning storm? And what about women? Do they own any part of the warehouse? Please explain your answers.

Otherwise it seems like you're just waving your hands around, reciting useless aphorisms. Or is that what constitutes a "civil conversation" in your view?

[Skeptical]

Malcolm, (I cannot use your suckie name as it just does not fit),

To your “naked guy” retort, as Dr. Noonan would say, we will have to agree to disagree. Yes, I believe that I have succeeded in pointing out that my comments are not conclusory. I have emphasized the “why” which in logic terms is the reasoning TO COME TO the conclusions, and I have very plainly stated my limitations on the actual Myriad claims. You should note that I admit that I am not an expert and far from conclusions on matters that I am not expert on, my comments provide for the means TO COME TO the logical outcome based on what the experts determine according to the prevailing legal reasoning UNDERLYING the conclusions (conclusions that are yet to be reached). It is more than just a little pedantic to say “I don’t know what effectively means,” when the general meaning is clear (you cannot find a dictionary?) and there must be a case by case application of the general meaning. It goes beyond the “what the meaning of ‘is’ is” subterfuge. But diving down and kicking up the dust of details to hide in seems to be a pattern with you.

Regarding Prometheus, you think you have a foundation for your, let’s be frank, wacky ideas, and have plastered the patent blogs with them. I note however, that both here and at Patently-O people HAVE answered you and pointed out the flaws in your ideas and in your attempted portrayal of Prometheus as supporting those ideas. Your answers, as they purport to be answers, of insults and ever-more questions (but no real discussion) fall short. Far short. Do you honestly expect me to spend any effort in chasing you when I can see that others already try and you just keep running?

Regarding your sorrow and your statement of “There really is more to it than saying ‘I enjoyed the conversation’,” I would agree with the sentiment and I would point out that that sentiment applies in spades to you. But you already know this as your persona at Patently-O is infamous in “accusing others of that which he does.”
As I said, I would be happy to discuss this with you. Please feel free to take issue (an actual issue and not pointless basic terminology rephrasing) and express yourself professionally and I will engage. Insults and questions, particularly your style of questions, do not constitute discussion and will result in at most very limited engagement.

For example, you ask “Where is the “warehouse of nature?”. At Patently-O, you labeled similar ideas as gobbledygook (recall such terms as “hands of man”). I recognize the parlor trick of demanding explanations of terms of art that encompass sweeping ideas as a pure divisionary tactic. You used the same lame sexist jokes at Patently-O (e.g., what about women). These are terms of art that you should know and understand. These terms of art are rather more than mere “useless aphorisms.” If you want to re-invent the entire lexicon on the subject, and it appears that you do in order to preserve your “neighborhood,” you will have to do the lifting and provide the answers to the questions you ask. But be professional about it, or you will be only talking to yourself.

Can you do that? Judging from your long history of how you comport yourself, well, I’m skeptical.

[Keep It Real]

Skeptical : "Yes, I believe that I have succeeded in pointing out that my comments are not conclusory. I have emphasized the “why” which in logic terms is the reasoning TO COME TO the conclusions"

Again, you say that you have done these things but looking upthread and reading your comments I don't see any logic. I see a bunch of handwaving. I see your conclusion. But not logic. Just because you can propose a "why" (e.g., "a little bird told me") does not mean that your conclusion is logical. I realize this news may offend you. Facts are troubling that way.

Let's break it down for you. Feel free to refute any of the following statements with objectively supported facts of your own.

1. Myriad's composition claims do not literally describe compositions known to exist without the assistance of human beings. (are you aware of compositions that refute this statement? if so, please provide evidence)

2. The 101 judicial exceptions refer to "phenomena of nature." Unless you disagree with (1), Myriad's composition claims do not literally describe any "phenomenon of nature." If there is an error in the logic of this latter statement, please state clearly what the error is.

Let's start there, Skeptical. Baby steps! Prove to everyone that you can keep up.

[Keep It Real]

Skeptical "this site does not put up with what goes on at PatentlyO"

Hmm. I have to disagree with that since you are still allowed to comment here.

[Skeptical]

“Hmm. I have to disagree with that since you are still allowed to comment here.”

It’s a wonder that you have not been asked to avoid such useless insults. They are childish and worthless, reflecting more on your lack of tact, intelligence, taste and decorum than anything else. Perhaps Dr. Noonan allows this (at least for a little while) because you really are making yourself look like an ass. That you think that using such comments makes you a winner is really quite pathetic.

Your point on Myriad is offpoint from our “discussion” and you attempt to inject red herrings, so, as they say, move the goal posts back (for example, “known to exist” is immaterial, as the 101 bar is not time dependent as your attempted move into 102/103 is). Likewise, your second point tries to shoehorn into 101 a time dependence where none exist. Your “error” is compounded with the plain fact that phenomena of nature includes things. I covered this earlier in my comments (crystals and plants and yes, even molecules) and you are welcome to disagree with the fact that this is so, but I do not see where disagreeing with such facts will help you.

[Keep It Real]

Let's be clear, Skeptical: are you able to refute either of the statements I have presented in my comment? You clearly have not done so in your comment. It's okay to simply admit that you can not refute the comments. You will not be punished if you make a "mistake."

For the record, you did allude to an alleged "error" (your quotes, strangely enough) in my two statements, but you did not state what the "error" is. Instead, you appear to be addressing an argument that I am not making. That's called "attacking a strawman." It's what people do in arguments that they are losing. Don't feel bad about that. You are not the first to attempt to divert attention in this manner.

As for this: "Your “error” is compounded with the plain fact that phenomena of nature includes things", that is a nonsensical statement. We need to converse in English, Skeptical. If you need assistance in that regard, a librarian can help you.

For the record, I acknowledge that "phenomena of nature" includes "things," at least for the purposes of this argument. It's a debatable point, but we need not debate it now. Let's just assume that compositions of matter are not per se eligible. Perhaps that will relax you and allow you to write more clearly. Or perhaps not. We'll find out!

Here are the statements again, for your consideration. Try to focus and please try to be civil. I know that is difficult for you.

1. Myriad's composition claims do not literally describe compositions known to exist without the assistance of human beings. (are you aware of compositions that refute this statement? if so, please provide evidence)

2. The 101 judicial exceptions refer to "phenomena of nature." Unless you disagree with (1), Myriad's composition claims do not literally describe any "phenomenon of nature." If there is an error in the logic of this latter statement, please state clearly what the error is.

Thanks, Skeptical. I appreciate the civil discussion.

[Skeptical]

That was impressive. You actually did not stoop to overt childish insults.

Of course, what you actually say is completely wrong. I refuted what you said by showing the fallacy of your thinking (and that is not a strawman, unless you think that I misrepresented your statements - if so, please be more clear as to which statements I have misrepresented and how I have misrepresented them).

I made no mistakes in refuting your statements.

I find it intersting that at first you say that "phenomena of nature includes things" is a nonsensical statement, but then immediately turn around and say it is debatable, but we both know that the line I reference was used by the Supreme Court (so unless you what to show how they too were nonsensical, the point is mine).

I appreciate your desire to have me have a clear focus. Thank you, but such is not necessary. I extend the same well wishes to you so that you can understand that your statements have been shown to be in error for at least the tme factor (you apparently relinquish the phenomena of nature includes things point).

Your turn.

[Keep It Real]

Skeptical: "I refuted what you said by showing the fallacy of your thinking"

I'm sorry, Skeptical, but we are discussing two very specific statements. We are not discussing your paranoid obsessions about what I may or may not be "thinking".

Again, here is the first statement:

1. Myriad's composition claims do not literally describe compositions known to exist without the assistance of human beings.

You have not yet refuted this statement. That is a fact. You have not yet even stated whether you believe the statement to be true or false, much less provided any evidence of the fallacy of the statement (and yes, evidence would be required to refute the statement). Please state whether the statement is true or false. If it's false, please provide evidence that at least *suggests* that the statement false.

I thought we could take two baby steps at once, Skeptical, but apparently that is too much. We will hold your hand now and take one baby step at a time.

I look forward to your answer (true or false) to the statement above. Your failure to answer true or false, with a clear explanation of your answer, will constitute a third strike and, quite frankly, will prove to everyone reading this (probably three or four people total) that you are incapable of discussing the subject honestly or rationally.

[Skeptical]

Who is "we" and what unholy god complex do you have to think that you dictate the exact timing of the discussion and the penalties of my noncompliance?

Oh, there are things being proven alright, just not the things you think. Your statements? Refuted without a doubt. Your "honesty and rationality"? Well, about their existence, you can say I'm skeptical.

[Keep It Real]

Let the record show that Skeptical was unwilling to answer a very simple question about a fundamental fact relevant to the Myriad case.

So much for civil discourse! Keep waving your hands around, Skeptical. We'll laugh even harder when the final decision comes down.

[Skeptical]

Let the record show what it actually shows:

I refuted your statements and you indulged yourself in typical Patently-O style.

[AAA JJ]

I'm still reading. Would like Skeptical's answers.

[Skeptical]

AAA JJ,

My answers have already been provided.

Thanks,

[Tonny Johnson]

“Gene patents are discoveries, not inventions and patenting discoveries may hamper future innovations in developing cost-effective patient care products and services. Scientific and technological innovations in molecular cloning, sequencing, PCR, bioinformatics, biochemical methods etc., have created innovative ways to identify genes and assign functions, without these inventions genes would have been a still unknown factor. Thus, gene patents are not true inventions; rather these are discoveries made possible through other technological and scientific inventions. Banning gene patents may offer incredible opportunities for innovations that can attract investments to create sustainable entrepreneurial establishments and scientific jobs, which may be significantly higher that gene patents alone can offer. In contrast, granting gene patents may lead to innovation bottlenecks that favor fewer inventions, restricted entrepreneurial initiatives, limited job growth, and non-competitive monopoly. Unfortunately, gene patents and the complex legal interpretations of simple scientific principles surrounding gene patents may slow down or hamper future innovations in patient care, specifically the development of cost-effective novel diagnostic and therapeutic products that enable physicians to provide best possible care for their patients”. The original blog can be viewed at: http://www.sciclips.com/sciclips/blogArticle.do?id=1025&blog=Gene%20patents%20may%20hamper%20innovations%20in%20patient%20care