Law and the Multiverse Retcon #6: Genetiks and Human Gene Patents

This is the sixth post in our Law and the Multiverse Retcons series, in which we discuss changes in the law (or corrections to our analysis) that affect older posts.

Today I have a quick post about a recent Supreme Court case that was under consideration when I wrote this post about the graphic novel Genetiks.  As mentioned in the post, the Supreme Court had recently heard the case of  Association for Molecular Pathology v. Myriad Genetics, Inc., which was intended to answer the question “are human genes patentable?”  Since then the Court has handed down its decision, which many news outlets summarized as “no.”  The truth is a little more nuanced than that*, but in any event the Court’s decision doesn’t change the ultimate conclusion in my original post, which was that what the company in Genetiks was portrayed as doing would not be possible under US law.  If anything the Myriad decision has only cemented that.

Relatedly, I’ve gotten some questions from readers about the series Orphan Black, which apparently deals with some similar issues as Genetiks.  I’ve heard good things about the series and intend to review it at some point in the future.

* Tempted as I am to delve into the minutiae of patent law, since that’s my area of interest, I will limit myself to a brief(-ish) summary.

Essentially, the Court held that DNA molecules cannot be patented if they are the same as a DNA molecule (or part of one) that occurs naturally in the human body, even if the patent claims only isolated, purified DNA molecules, which do not occur naturally.  The Court based its decision on the fact that isolation and purification do not change the information content of the genetic sequence, which was the actual invention as far as it was concerned rather than the DNA molecule in a chemical sense.

However, the Court also held that cDNA molecules can be patented, even if the cDNA molecule is nothing more than an unpatentable DNA molecule run through a standard biotech process.  According to the Court, that process takes an unpatentable product of nature and makes it into a patentable manufacture or composition of matter in a way that isolation and purification do not.  This is evidently true even though the information content of the DNA molecule and its corresponding cDNA molecule are the same.  It is difficult to reconcile these results on their face.

It is worth noting that the Patent Act itself says nothing about products of nature.  The list of “inventions patentable” contains no exceptions at all, only an affirmative list.  The Court arrived at its conclusion by reading in / creating an exception that is not at all present in the statute but is instead derived only from prior Supreme Court cases.

The practical upshot of all this is that Myriad will lose its right to exclude others from performing clinical testing for the BRCA1 and BRCA2 mutations.  More broadly, single-gene testing is now anybody’s game.  But Myriad and other biotech companies will retain other, less-valuable patent rights associated with human genes.

That’s about all I can say without getting too soapboxy.  For more on this kind of thing, see my forthcoming paper, James E. Daily & F. Scott Kieff, Anything Under The Sun Made By Humans: Patent Law Doctrines As Endogenous Institutions For Commercializing Innovation, 62 Emory L.J. (forthcoming July 3, 2013).

16 responses to “Law and the Multiverse Retcon #6: Genetiks and Human Gene Patents

  1. Pingback: Genetiks and Human Gene Patents | Law and the Multiverse

  2. Arturo Magidin

    My understanding was that the Court said that cDNA may be patent elegible, or at least that it does not fall to the “product of nature” problem; but that it explicitly said that it was not ruling that cDNA is patentable (in particular, that if Myriad were to seek a patent on the cDNA sequences, they may have trouble meeting the “non obvious” threshold). That would make the two holdings easier to reconcile: the Court is not saying DNA is definitely not and cDNA definitely is patentable, but rather that DNA is definitely not patentable, being a product of nature, but that cDNA is not a product of nature (but may fail to be patentable for other reasons).

    • No, the Court expressly held that cDNA is generally patentable:

      As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

      Slip op. at 17. The Court did go on to say in footnote 9 that “We express no opinion whether cDNA satisfies the other statutory requirements of patentability”, which include novelty, nonobviousness, and enablement, but that’s to be expected in a case like this one that was focused on patentable subject matter.

      • Chris Waters

        Saying that it passes §101 is not the same as holding that it’s patentable, though. That’s merely saying that it can meet one of the criteria. Other things (like several hundred million years of prior art) can be tough to overcome. 🙂

      • There is sometimes a distinction made between “patentability” and “patent eligibility,” but note that the § 101 itself is titled “inventions patentable.” Anyway, I don’t recall ever saying that just because an invention passed § 101 that it was automatically entitled to a patent or did not need to meet the other requirements of §§ 102, 103, 112, etc. Indeed, in an earlier comment I quoted the Court in Myriad pointing out that very thing with regard to cDNA.

        Also, prior art is defined by statute in § 102, and the pre-existence of naturally occurring genetic material that was not previously known to humans does not fall into any of the § 102 categories, either under the America Invents Act or under the pre-America Invents Act law.

      • Chris Waters

        I don’t think anyone’s disagreeing with you. It’s simply a matter of wanting to clarify. Something being cDNA alone is not enough to make it patentable. I realize that’s not what you meant, but it was possible to misinterpret what you said.

        Also, I’m a little confused, because I haven’t looked at the gory details of the case, but wouldn’t the statements about cDNA fall into the category of dicta? Or was it actually part of the suit?

        As an aside, on the matter of “laws of nature”, I think that may be explained by looking up the definition of the word “invention”. The Supreme Court seems to feel–as do I–that there is no overlap between those two categories.

      • wouldn’t the statements about cDNA fall into the category of dicta? Or was it actually part of the suit?

        No, both the claims covering DNA and the claims covering cDNA were part of the suit. The statement regarding cDNA was not dicta but rather an express holding of the case.

        As an aside, on the matter of “laws of nature”, I think that may be explained by looking up the definition of the word “invention”.

        (NB: I assume you mean products of nature, as that is what the Court was concerned with.)

        Here is the definition of the word “invention” from 35 USC § 100(a): “The term “invention” means invention or discovery.” The inventor(s) in the Myriad case discovered (i.e. invented, within the meaning of the Patent Act) a composition of matter (a DNA molecule) or manufacture (an isolated, purified version of a pre-existing DNA molecule). The Patent Act says in § 101, in pertinent part:

        Whoever invents or discovers any new and useful … manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

        (emphasis added). There’s nothing in there or anywhere else in the Patent Act about laws of nature or products of nature. The Court admitted that the DNA molecules were both novel and useful. Thus, the DNA molecules were new, useful, manufactures or compositions of matter. Why, then, weren’t they patentable subject matter? Because they were products of nature, and products of nature aren’t patentable. Why? Because the Court says so.

        The Court reached the result it did not on the basis of the clear language of the statute but rather on the basis of judicially-created exceptions based on judicially-determined policies, despite the fact that the Constitution expressly makes patent policy the province of the legislature, not the courts.

        Maybe the Court feels that there is no overlap between products of nature and inventions. Maybe they are correct. Maybe it would be a better economic, political, or social policy not to allow such patents. But it is not the Court’s role to make that decision, especially in the face of a clear statutory plan to the contrary.

      • Obviously you are the expert and I’m not, so I probably said something badly, because as far as I can tell, what you describe is precisely what I tried to convey, yet you tell me that what I actually said was incorrect (which I do not doubt was the case). I’ll shut up now, then. 🙂

      • as far as I can tell, what you describe is precisely what I tried to convey, yet you tell me that what I actually said was incorrect

        On further review what you said was actually quite close to what the Court held. The only significant distinction is that the Court held that cDNA is almost always patent eligible (as opposed to “may be patent eligible”), with the minor exception of extremely short sequences that are indistinguishable from DNA.

        However, I disagree that this makes the holdings easier to reconcile. The Court based its determination that DNA is a product of nature on the fact that the claims were fundamentally addressed to the information content of the genetic sequence, which was a product of nature in the Court’s view. But the information content of the corresponding cDNA sequence is the same and is still determined by nature. Effectively, the Court made a judgment call that, for some reason, isolation and purification of a DNA molecule does not turn a product of nature into something under the sun made by humans (Cf Diamond v. Chakrabarty), whereas the application of a couple of enzymes in a standard biotech process to create cDNA does.

      • Doesn’t the law or products of nature exception come from the Patent Clause itself? After all, it refers to “Authors and Inventors”. Is someone really an inventor of a product of nature?

    • The patent system is already broken. Things like activating a trigger twice in a short amount of time (AKA double click) and using two fingers to squeeze and stretch things have already been granted patents. We can’t trust obvious things are unpatentable anymore.

  3. “The practical upshot of all this is that Myriad will lose its right to exclude others from performing clinical testing for the BRCA1 and BRCA2 mutations.”

    It also, of course, means that we managed to avoid creating a dystopian hell where nightmarish patent-troll corporations can claim ownership of our genetic codes and thereby gain veto power over our cells’ right to undergo mitosis. 🙂

  4. I think we should probably expect more cases like this (though obviously not about this specifically) as technology advances.

  5. Orphan Black is definitely worth watching. Tatiana Maslany really should win the Emmy for best actress this year, although I doubt enough voters will watch to give her a chance.

    Just about every character commits some crime over the first season, so you could definitely make a few posts on it. Unfortunately, the ‘revelation’ in the last few minutes of the season will likely make you groan even louder than I did.

  6. I am okay-ase with this decision. I also like your brief recap though I have to disagree with you on the isolated DNA portion. I am of the views espoused in the Lander brief, which seems to have played a fairly significant role in the decision. But, that’s neither here nor there. cDNA is really where most of the tech companies recoup research costs. AUTM even released an official statement in support of the Court’s decision.

    Anywho, as usual, great read. I look forward to reading your LR article. (It’s surprising (but great) to see Prof. Kieff listed. Always enjoyed his lectures at Wash U).

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