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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Watching DNA Polymerase Do Its Thing | Main | A Beta-Secretase Inhibitor Hits the Skids in Alzheimer's »

June 13, 2013

The Supreme Court Rules on Myriad

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Posted by Derek

Just a little while ago, the Supreme Court issued a unanimous decision (rare these days) in the Myriad Genetics case. I summarized the state of play up until the most recent arguments here, and if you're just getting up to speed on this issue, I'd read that post first. There are a lot of things this case is not about, and there are a lot of headlines that are going to mess things up. I would not be surprised to see "Myriad Wins" and "Myriad Loses" coming up at the same time in a news search.

Here's the actual decision (PDF), and here's the key statement:

A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.

The earlier appeals court decision was broader, and found that isolated stretches of otherwise natural DNA were, in fact, patent-eligible, because they are not found as such (unwound, de-histoned, cleaved at both ends) in nature. But this ruling dials that back a bit. A cDNA, stripped of introns, etc., is indeed a work of human ingenuity, and is patent-eligible (as indeed, it had been considered to be before this decision). Here's more:

It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method pat- ent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents “were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach,” 702 F. Supp. 2d, at 202–203, and are not at issue in this case.

Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.” 689 F. 3d, at 1349. Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.

Unfortunately, many of the news blurbs on this issue are smudging these questions around. I don't actually expect this ruling to have much effect, to be honest, except as a way to help resolve the question of whether stretches of raw DNA are patentable. The glory days of trying to patent such things are long gone, in any case. And since there are many more useful forms which are patentable, any headlines about "No patents for DNA!" are misleading.

Comments (36) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. RM on June 13, 2013 11:18 AM writes...

A naturally occurring DNA segment is a product of nature and not patent eligible ... A cDNA, stripped of introns, etc., is indeed a work of human ingenuity, and is patent-eligible

So let me get this straight: an naturally occurring mRNA, being a product of nature, would probably not be patent eligible under this ruling (though no direct applicability has been mentioned). But a cDNA encoding the identical sequence is somehow a work of human ingenuity and would be.

I'm not sure I understand that logic.

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2. RTS on June 13, 2013 11:23 AM writes...

its a somewhat contrived distinction, but cDNA are a product of a reverse polymerase reaction invented for that purpose and done in a laboratory. Its as patentable as the use of restriction enzymes for building libraries or making vectors. makes reasonable sense to me.

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3. newnickname on June 13, 2013 11:36 AM writes...

Does anyone have any idea how many other issued patents will be affected (invalidated) by this decision? I'm thinking of Millennium (Takeda)'s portfolio, in particular.

What about just the important ($ valuable) ones. E.g., I think that the cystic fibrosis gene patent might be a money-maker.

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4. SP on June 13, 2013 11:38 AM writes...

So if I create a cDNA pool from a human cell to analyze some other random gene(s), and I use oligo dT or random primer to generate that cDNA pool prior to analysis, am I violating Myriad's patent because somewhere in that pool are a few copies of BRCA cDNA, even though I have no intention to analyze them? Did SCOTUS just shut down the use of qRTPCR and RNAseq unless people get permission from the holder of every patent of the cDNA of a human gene?

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5. emjeff on June 13, 2013 12:23 PM writes...

"Unfortunately, many of the news blurbs on this issue are smudging these questions around."

I would expect nothing less from today's journalists...

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6. Sideline Chemist on June 13, 2013 12:32 PM writes...

@SP Pretty sure the answer is no unless you intentionally used BRCA cDNA for some particular commercial purpose. Patented substances are made (purposefully, accidentally, or coincidentally) all the time in the normal course of research. If drug companies had to remove every patented compound from their screening libraries, the libraries would be an awful lot smaller. Making BRCA cDNA coincidentally as part of a larger gemish of other CDNAs that you prepared for some study would fall under the "who cares" category. Patent infringement would only come into play if you specifically selected that cDNA for your commercial gain, especially if that gain was covered under the patented claims.

Frankly this ruling seems to bring DNA patent claims into line with (or at least closer to) current legal thinking for small molecule patent claims. About time.

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7. Henning Makholm on June 13, 2013 12:45 PM writes...

Um, isn't the cDNA identical to the naturally occurring other strand of the original DNA?

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8. Nick on June 13, 2013 12:51 PM writes...

@Henning: No, because the cDNA contains no introns, so it is not sequence-identical to the genomic DNA. I'm not clear on whether this decision impacts DNA cloned from genes/organisms that don't use introns. In that case, the cDNA sequence would be the same.

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9. D on June 13, 2013 12:53 PM writes...

@Henning no, cDNA is complementary to mRNA, which generally does not have the same sequence as either strand of DNA.

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10. gippgig on June 13, 2013 1:27 PM writes...

cDNA can be a product of nature. See "processed pseudogenes".

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11. RM on June 13, 2013 1:41 PM writes...

I guess I was thinking of things in the sequencing/diagnostics perspective. From the point of view of the sequences, there's no real distinction between the sequence of the mRNA and that of a corresponding cDNA. The intron stripping is *not* a product of human ingenuity, as it's happening naturally in the cell. The whole DNA vs. RNA form thing is a product of human work, I guess, but claiming somehow that the intron-processed *sequence* from the cDNA is patentable seems to me to be a spurious as claiming that you can patent a sequence "... as represented on a computer file." (It's not naturally occurring! Human ingenuity was needed to render them as ASCII characters!)

I'm guessing the whole cDNA distinction will be of historic interest, anyway. Making cDNA from mRNAs should now be "obvious to anyone with ordinary skill in the art", making whatever tenuous grounds previous cDNA patents were granted on inapplicable going forward.

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12. alig on June 13, 2013 2:27 PM writes...

@Nick: the ruling explicity says that when cDNA is identical to isoloated DNA it is not patentable.

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13. pete on June 13, 2013 2:47 PM writes...

@6 Sideline Chem
I follow the sentiment/logic about bringing cDNAs & small molecules closer into alignment re: patentability.

But still I think it's totally wrongheaded. The ruling in effect equates cDNAs with novel molecular entities created by chemists. ** cDNAs are not novel small molecules ** -- even though they're made via non-native methods.

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14. robopox on June 13, 2013 2:50 PM writes...

So... the (hypothetical) plasmid I find in an obscure bacteria, that encodes a cellulase that rapidly turns the most recalcitrant straw, corn shucks, wood chips, lawn clippings, and old newspapers into a glucose solution (aerobically, with 100% conversion, and with a ferocious turnover number)... is not patentable. Right? That's what they said?
It's 100% unmodified, naturally occurring, and not a cDNA copy. But it's not patentable?

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15. James Cajal on June 13, 2013 2:55 PM writes...

So, if a cDNA sequence is discovered in some as yet unknown virus, would the patent on that "Human created sequence" be revoked? Nature works in strange ways, it's wonders to behold-and so does the Supreme Court.

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16. Anonymous on June 13, 2013 3:31 PM writes...

Does this mean patents on all isolated natural products are not valid?

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17. Sili on June 13, 2013 4:01 PM writes...

Why would it be, robopox? Yeast is not patentable, frogs are not patentable. If you find it in nature, why should it be?

Now, the processes whereby you breed and employ your bacterium may be, though. For all I know.

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18. Anonymous on June 13, 2013 4:01 PM writes...

So we can do genome sequencing, but not exome sequencing from cDNA and still screen for the BRCA mutations w/o violating a patent?

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19. Chrispy on June 13, 2013 4:06 PM writes...

I find this all a bit confusing. The cDNA has a sequence that is defined by the RNA, even if you do an action to get from one to the other. And that RNA exists in Nature -- the sequence of your cDNA is implicit in the RNA.

I agree with RM that this is only a temporary situation -- it is certainly obvious to anyone skilled in the art how to get from one to the other.

Permalink to Comment

20. Andy on June 13, 2013 5:53 PM writes...

@James #15:
So, if a cDNA sequence is discovered in some as yet unknown virus, would the patent on that "Human created sequence" be revoked?

IANAL, however, the *sequence* is unpatentable, but the *use* of the protein could be. This is how it works in large-molecule biotech: you can get a patent on the sequence of your antibody, but you can also patent the specific use, so someone else can't just make a few amino acid changes to get around the patent.

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21. Mike C on June 13, 2013 5:59 PM writes...

@#3 Newnickname: I think only the broadest claims will be thrown out entirely; most patents have claims on more useful forms of DNA (cDNA, fluorescent tagged, attached to a nanotube...) that will survive the decision.

Permalink to Comment

22. weirdo on June 13, 2013 6:02 PM writes...

#16: Anon: Natural products have never been patentable in the U.S. -- not sure of your point.

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23. Another Derek on June 13, 2013 6:27 PM writes...

#22:
Natural products as such are unpatentable, but e.g. compounds existing impure in nature have been considered to be patentable when claimed in isolated pure form. Which makes #16's question interesting: if isolated purified DNA is unpatentable (Myriad), does this mean that isolated purified compounds existing only impure in nature are also unpatentable? It's probably a less significant question than it once was - there are not that many new drugs (I'm thinking of antibiotics and anticancers) that are products of nature - but it's not of no importance.

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24. will on June 13, 2013 6:42 PM writes...

on the natural product issue - today's ruling casts doubt on a claim, perhaps, to isolated taxol - but i think a claim to a pharmaceutical composition of taxol or a method of using isolated taxol to treat cancer would still be fine...

going forward, people should be able to draft their claims accordingly, the problem is for patents pre-myriad that may have problems, depending on what kind of claims they have

Permalink to Comment

25. SP on June 13, 2013 6:50 PM writes...

No problem, just make deuterated cDNA/taxol/etc.

Permalink to Comment

26. tim on June 14, 2013 12:34 AM writes...

#10: rather to my surprise, they address the pseudogene question quite directly in footnote 8 on page 16.

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27. Zemyla on June 14, 2013 2:36 AM writes...

Well, Antonin Scalia made the right decision, but for the wrong reasons. He wrote his own concurrence to state basically that he doesn't believe in genes or molecular biology.

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28. gippgig on June 14, 2013 3:36 AM writes...

Now here's an interesting thought experiment (which may exist in the not too distant future)... Suppose synthetic biologists create an organism with a completely different genetic code (none of the codons code for the same amino acid they do in the standard genetic code). You could then make a totally different DNA sequence that codes for exactly the same protein.

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29. gippgig on June 14, 2013 4:07 AM writes...

Then there's the human PGK2 gene, a functional naturally-generated cDNA (Nature 326 501).

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30. Jeff Green on June 14, 2013 6:26 AM writes...

Actually the Supremes didn't say cDNA was patentable (read the footnotes) they said that cDNA isn't excluded from patentability by this ruling. It may well still not be patentable because it is obvious, non-inventive or merely an exact copy of nature, but this section of legislation rules out naturally occurring substances from patentability.

Jeff

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31. JAB on June 14, 2013 7:46 AM writes...

I certainly hope that composition of matter claims are not off the table for natural products. The supremes definitely didn't address anything but DNA in the ruling, so it would take a further challenge to patents on natural products to get there. Strategies of patenting will have to adapt in the meantime. Taxol was never patented, per se, by Wall and Wani, because they couldn't imagine getting enough of the compound to be commercially viable. Many NPs get to the clinic as analogues (e.g., camptothecin,which WAS patented by Wall & Wani) and the analogue compositions would still be patentable.

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32. ed on June 14, 2013 10:43 AM writes...

IP and patent law seems to be a particularly messy area, especially recently. Some of the more bizarre events included somebody who copied a large chunk of a program's source code, verbatim, from a piece of open-source (not public domain) software, got a copyright, and sued the original authors.

Nice to know that software isn't the only area where patents generate controversy.

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33. Kevin on June 14, 2013 12:55 PM writes...

#27: Of course, Scalia said no such thing. What he did say, in its entirety, is

I join the judgment of the Court, and all of its opinion except Part I-A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.

Is it odd for a Justice to admit they don't understand something? Sure. But it's a real stretch to suggest that he's saying what you claim.

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34. Zemyla on June 14, 2013 2:55 PM writes...

#33: I find it odd, then, that he adds "or my own belief" to that. It makes it very much sound like he doesn't believe in what is being discussed here.

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35. ed on June 14, 2013 3:08 PM writes...

I find it rather refreshing that one of the Supremes recognizes that he|she has finite knowledge, and that they occasionally have to admit there is knowledge that hasn't been codified by legislators. Or, in the case of Scalia, people who for whom eschewing the powdered wig was a radical fashion statement.

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36. MikeS on June 14, 2013 8:12 PM writes...

#34: It rings odd to a non-lawyer because he is alluding to the phrase "upon information or belief," which is a legal term of art used when you state a claim to a court and you don't actually know some element of your claim to be true, but you have some information that leads you to believe it is.

Since "belief" in that context refers to a low degree of knowledge, saying that he lacks knowledge or even a belief about the "fine details of molecular biology" is basically an admission of scientific ignorance, not denialism.

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