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Author Topic: Myriad and the printed matter doctrine  (Read 1965 times)

patentatt

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Myriad and the printed matter doctrine
« on: 12-02-10 at 02:35 pm »

Why can't Myriad be decided on the printed matter doctrine?

The plaintiffs make such a fuss about the "informational" function and importance of DNA.  Under Federal Circuit law, such informational importance can only be given patentable weight if there is a functional relationship.  The Myriad claims are broadly worded, though, and only cover, e.g., comparing two items of information.  Would that obviously constitute the required functional relationship?  Why has nobody mentioned the printed matter doctrine?

See also (King Pharmaceuticals Inc. v. Eon Labs Inc., Fed. Cir., No. 2009-1437, 8/2/10).
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patentatt

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Re: Myriad and the printed matter doctrine
« Reply #1 on: 12-03-10 at 11:55 am »

Anyone?
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JimIvey

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Re: Myriad and the printed matter doctrine
« Reply #2 on: 12-03-10 at 12:29 pm »

Sorry, I don't do life sciences work.

My guess would be that the written matter line of cases just don't analogize to building/chopping DNA.  Is there such a thing as "blank" DNA onto which you can "print" genes? 

I'd say DNA is more like a string of beads spelling out information in Morse code.  Each string is evaluated as a thing, not a printed message on paper.  However, I'd imagine arguing each bead message is non-obvious in view of other bead messages would be challenging.  In gene splicing, I'm not so sure.

Regards.
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patentatt

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Re: Myriad and the printed matter doctrine
« Reply #3 on: 12-03-10 at 03:12 pm »

Thanks for your response.

Quote
My guess would be that the written matter line of cases just don't analogize to building/chopping DNA.  Is there such a thing as "blank" DNA onto which you can "print" genes?

The doctrine is not limited to strictly printing characters onto a blank medium.  See this quote from King Pharmaceuticals:

Quote
Although these “printed matter” cases involved the addition of printed matter, such as written instructions, to a known product, we see no principled reason for limit-ing their reasoning to that specific factual context. See In re Ngai, 367 F.3d at 1338-39; In re Gulack, 703 F.2d at 1385-87.

Quote
I'd say DNA is more like a string of beads spelling out information in Morse code.  Each string is evaluated as a thing, not a printed message on paper.  However, I'd imagine arguing each bead message is non-obvious in view of other bead messages would be challenging.  In gene splicing, I'm not so sure.

I agree with your analogy 100%.  DNA *is* like a string of beans spelling out Morse code.  But doesn't that support my point?  You can't (shouldn't?) get a patent on a new arrangement of beads that encodes your great new novel, right?  Suppose you write a new great novel.  You can get a copyright on it.  But, by your logic above, you could also encode it in beads and then get a patent on it.  But isn't that ridiculous?

Of course, the information encoded in Myriad's DNA is not "new", but that difference shouldn't be relevant to the printed matter doctrine.
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MYK

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Re: Myriad and the printed matter doctrine
« Reply #4 on: 12-03-10 at 03:24 pm »

I'd say DNA is more like a string of beads spelling out information in Morse code.  Each string is evaluated as a thing, not a printed message on paper.  However, I'd imagine arguing each bead message is non-obvious in view of other bead messages would be challenging.  In gene splicing, I'm not so sure.
Nah, DNA is more like a box of bad chocolates, lots of dried fruits with the occasional nougat thrown in, and absolutely no caramels.  :P

My guess would be that the written matter line of cases just don't analogize to building/chopping DNA.  Is there such a thing as "blank" DNA onto which you can "print" genes?  

Biggest problem is that the judge in Myriad did a whole bunch of really bad analogizing already.  I mean, really, Bilski?  Really, the JUDGE wrote about the applicability of the machine-or-transformation test in his opinion about the (non)patentability of DNA?  :'(

F*ck me.  He may as well have argued that the Commerce Clause prohibits separate-but-equal treatment of defective DNA sequences.  Or that Bankruptcy Rule 2002 requires actual independent notice be given when someone's DNA sequence might make them owe money to Myriad.  Let's not forget what he could have done with Palsgraf.  "DNA is a lot like a train, it has a sequence of passenger cars filled with different people, and since it was 1928, the cars could legally be segregated with regard to phenotype. . . ."  Hell, he's even in New York, Palsgraf it is.
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JimIvey

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Re: Myriad and the printed matter doctrine
« Reply #5 on: 12-03-10 at 03:46 pm »

agree with your analogy 100%.  DNA *is* like a string of beans spelling out Morse code.  But doesn't that support my point?  You can't (shouldn't?) get a patent on a new arrangement of beads that encodes your great new novel, right?  Suppose you write a new great novel.  You can get a copyright on it.  But, by your logic above, you could also encode it in beads and then get a patent on it.  But isn't that ridiculous?

No, no more than binding known elements from the periodic table into different "bead strings" and seeking patents on those is ridiculous.  Is patenting of chemicals ridiculous?

As for "printed matter" cases, right, why should they be limited to matter that is printed?  The one I deal with in my particular practice area is, why should law regarding computer-implemented inventions be limited to inventions that are implemented in a computer?  There's even a special type of rejection for computer-implemented inventions that are not implemented in a computer.

But, I'll concede that some aspect of the printed matter cases might apply to genes in isolation.  I just don't know the technology well enough to say whether it does.

From what I understand, the printed matter cases say that, once putting printed matter on a thing is known, the particular content of the printed matter will always be obvious.  Once I know how to make a sign that reads "PUSH", a sign that reads "PULL" is obvious.  Is that true for genes?  I don't know.  Once you know how to isolate one gene, is the isolation of any other gene obvious?  I've had people skilled in these arts explain to me that it's not obvious.  I can only take their word for it.

Regards.
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Simpletown

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Re: Myriad and the printed matter doctrine
« Reply #6 on: 12-03-10 at 10:03 pm »

The problem with the printed matter doctrine and DNA is that while the code/language analogy may hold in some sense...there are significantly more issues than DNA just being a code. First off lets go with the DNA molecule itself...DNA itself is not simply a string that performs only the function of carrying information...it also has separate utilities. DNA and RNA have structural forms..they take on different three dimensional shapes which have nothing to do with their being read by polymerases or ribosomes. DNA can actually work as a catalyst, bind to proteins if it has the correct three dimensional structure...and fulfill a number of functions other than just storing genetic information...it has a function in and of itself sometimes...outside of it being a readable code. Furthermore...as with most arts in the chemical area much of it comes down to predictability. Now you may know how to string together ATGC to code for certain amino acids...but once you hit complex sequences the predictability is very very low...in some instances the sequence will code for a functional enzyme...in others a single change of one codon will lead to a useless protein, and that can be very unpredictable. It all comes down to the fact that DNA...even when considered as only a coded template with no other functions...is still not a fully decoded language...and thus it doesn't work like writing a sign in English. Now whether it (or anything in particular) should be patentable is a totally separate issue. That's a personal gut decision each Congressman or Supreme Court Justice makes on their own when they feel like deciding on such matters.
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ManOfManyBadIdeas

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Re: Myriad and the printed matter doctrine
« Reply #7 on: 12-04-10 at 05:20 pm »

The thread has made me very curious and I have read the second hand information regarding the case.
Some thoughts:

1. The DNA patents rely on chemical arts for their patentability. It makes sense, like JimIvey has pointed out, DNA is no more a Morse code than any other chemical compound. Being information carrier is nothing more than our simplistic view of just one of its functions in a living organism.

2. The judge's reasoning regarding claims to the chemical compound does make sense to me. How can you patent a chemical that occurs naturally? As far as I know it's not allowed, and DNA fragments are routinely produced by all living organisms. The judges argument is that the specification doesn't disclose any substantially new properties of the compound. So in a way a DNA chemical compound claim is an attempt to patent knowledge of how this compound operates when it naturally occurs, but knowledge isn't patentable.

3. Not sure about method claims of the patent, and it seems they weren't given all that much attention anyway.
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patentatt

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Re: Myriad and the printed matter doctrine
« Reply #8 on: 12-05-10 at 01:50 pm »

The problem with the printed matter doctrine and DNA is that while the code/language analogy may hold in some sense...there are significantly more issues than DNA just being a code. First off lets go with the DNA molecule itself...DNA itself is not simply a string that performs only the function of carrying information...it also has separate utilities. DNA and RNA have structural forms..they take on different three dimensional shapes which have nothing to do with their being read by polymerases or ribosomes. DNA can actually work as a catalyst, bind to proteins if it has the correct three dimensional structure...and fulfill a number of functions other than just storing genetic information...it has a function in and of itself sometimes...outside of it being a readable code. Furthermore...as with most arts in the chemical area much of it comes down to predictability. Now you may know how to string together ATGC to code for certain amino acids...but once you hit complex sequences the predictability is very very low...in some instances the sequence will code for a functional enzyme...in others a single change of one codon will lead to a useless protein, and that can be very unpredictable. It all comes down to the fact that DNA...even when considered as only a coded template with no other functions...is still not a fully decoded language...and thus it doesn't work like writing a sign in English. Now whether it (or anything in particular) should be patentable is a totally separate issue. That's a personal gut decision each Congressman or Supreme Court Justice makes on their own when they feel like deciding on such matters.

None of those other functions or utilities are recited in the claims.

The composition claim recites:

Code: [Select]
An isolated DNA coding for BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
Thus, the claim doesn't recite any function of the DNA, other than coding for the polypeptide.  I'm not sure whether that function would or should be enough to escape the printed matter doctrine.
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patentatt

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Re: Myriad and the printed matter doctrine
« Reply #9 on: 12-05-10 at 01:54 pm »

Quote
From what I understand, the printed matter cases say that, once putting printed matter on a thing is known, the particular content of the printed matter will always be obvious.  Once I know how to make a sign that reads "PUSH", a sign that reads "PULL" is obvious.  Is that true for genes?  I don't know.  Once you know how to isolate one gene, is the isolation of any other gene obvious?  I've had people skilled in these arts explain to me that it's not obvious.  I can only take their word for it.

Even if it is not de facto obvious, it might be de jure obvious.  Consider: before anyone wrote War & Peace, it was not de facto obvious to print War & Peace on a blank paper.  But, according to the printed matter doctrine, it was de jure obviousness.

So the fact that the isolation of a particular gene was not de facto obvious doesn't settle the question of whether it was de jure obviousness according to the printed matter doctrine.
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ManOfManyBadIdeas

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Re: Myriad and the printed matter doctrine
« Reply #10 on: 12-05-10 at 02:09 pm »

None of those other functions or utilities are recited in the claims.

The composition claim recites:

Code: [Select]
An isolated DNA coding for BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
Thus, the claim doesn't recite any function of the DNA, other than coding for the polypeptide.  I'm not sure whether that function would or should be enough to escape the printed matter doctrine.


I think "coding for BRCA1 polypeptide" simply means that this DNA fragment would be responsible for production of BRCA1 protein in a cell. I think a number of DNA fragment variations would be capable of producing said protein, and the claim wording is just a way to concisely capture all of them (the spec should be disclosing a way to determine if the DNA fragment is going to produce the said protein). I suspect that's how a PHOSITA would construe this claim.
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Isaac

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Re: Myriad and the printed matter doctrine
« Reply #11 on: 12-05-10 at 04:27 pm »

I think "coding for BRCA1 polypeptide" simply means that this DNA fragment would be responsible for production of BRCA1 protein in a cell.

I agree with ManyBad.  I don't see any fundamental difference between language used here and the functional language used in Beauregard claims.

Yes you can torture the printed matter doctrine so that DNA sequencoes, programmed computers, player pianos, and cam wheel controlled machines are not patentable subject matter, but courts have not done so.  My impression is that the printed matter doctrine is best used for things a bit closer to those old cases.  It really isn't all that helpful for looking at cases as far from the original facts as Myriad. 

Getting back to the original question, when the printed matter gets used in cases like Myriad, it's probably because the court has decided for policy reasons not to allow patenting of DNA.  If an appellate court does not agree with the policy decision, the appellate court could easily overturn the case.
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patentatt

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Re: Myriad and the printed matter doctrine
« Reply #12 on: 12-05-10 at 05:15 pm »

Quote
I don't see any fundamental difference between language used here and the functional language used in Beauregard claims.

The CAFC, and certainly the Supreme Court, has not (to my knowledge) directly addressed the question of whether Beauregard claims are patent eligible.  The PTO withdrew their objection before the CAFC could decide the case.

Quote
Yes you can torture the printed matter doctrine so that DNA sequences, programmed computers, player pianos, and cam wheel controlled machines are not patentable subject matter, but courts have not done so.


Of course, the fact that they haven't done so in the past isn't a great argument against them not doing so in the future.  Maybe nobody raised the argument before in this context.  The Supreme Court has not shown much hesitation in erasing decades of CAFC jurisprudence. 

Quote
My impression is that the printed matter doctrine is best used for things a bit closer to those old cases.  It really isn't all that helpful for looking at cases as far from the original facts as Myriad.

I agree that the facts in Myriad have strayed somewhat from the original thrust of the printed matter cases - I agree that the applicability of the doctrine to Myriad is not obvious.  Still, I don't think that the doctrine is obviously inapplicable either.  What surprises me is that nobody, other than me, has (to my knowledge), even raised the argument - even if it is a Hail Mary.  If the ACLU is willing to use a First Amendment argument against the patent eligibility of isolated DNA, surely (I would think) they would be willing to cite the printed matter doctrine, when isolated DNA is just a "sequence" of characters, not so different from characters on a page.
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ManOfManyBadIdeas

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Re: Myriad and the printed matter doctrine
« Reply #13 on: 12-05-10 at 06:45 pm »

I agree that the facts in Myriad have strayed somewhat from the original thrust of the printed matter cases - I agree that the applicability of the doctrine to Myriad is not obvious.  Still, I don't think that the doctrine is obviously inapplicable either.  What surprises me is that nobody, other than me, has (to my knowledge), even raised the argument - even if it is a Hail Mary.  If the ACLU is willing to use a First Amendment argument against the patent eligibility of isolated DNA, surely (I would think) they would be willing to cite the printed matter doctrine, when isolated DNA is just a "sequence" of characters, not so different from characters on a page.

Approaching the question from two sides. First, from the practical standpoint, if the argument succeeds, it would likely invalidate not only DNA patents, but also any chemical claims drawn to chemical structure, and possibly composition. I do not think that's the intent of the plaintiffs, and the wider the reach of the argument, the less likely it is to succeed, so that would explain them avoiding the use of the argument. Second, from the legal standpoint, printed matter argument is a very specialized and rare variant of obviousness argument. Unless the applicability is immediately clear, one would expect the plaintiff to craft a full fledged obviousness argument instead of saying the magic words "printed matter". So, why not directly make the proper obviousness argument instead? (which I doubt would be possible when applied to DNA, or other chemical structure claims)
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Isaac

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Re: Myriad and the printed matter doctrine
« Reply #14 on: 12-05-10 at 06:50 pm »

What surprises me is that nobody, other than me, has (to my knowledge), even raised the argument - even if it is a Hail Mary.  If the ACLU is willing to use a First Amendment argument against the patent eligibility of isolated DNA, surely (I would think) they would be willing to cite the printed matter doctrine, when isolated DNA is just a "sequence" of characters, not so different from characters on a page.

Of course the ACLU is going to use a Constitution law argument.  That's what they do best, and it seems to be working so far.

As I understood the original post, the question was not why printed matter was not argued, but rather why the case was not decided on the printed matter doctrine.  In my opinion, the printed matter doctrine would be a very weak basis for invalidating the claims.  Yes, there is an argument there, but it is pretty weak.  There isn't any question in my mind that the functionality of DNA is closely coupled to structure of the molecule.

And Beauregard claims aren't the only problem.  Essentially all software based claims of any form are suspect if the printed matter doctrine were applied liberally enough to squash the patenting of DNA.  Yet we know that the SC believes that some software inventions are patentable.

Ultimately the case is going to be decided as a matter of public policy, and the goal will probably be to do as little harm elsewhere.   Hopefully, the courts will confine the printed matter doctrine playing in its current, tiny sandbox.
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