Genes not patentable

By Razib Khan | June 13, 2013 10:40 am

Supreme Court Rules Human Genes May Not Be Patented:

“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote for a unanimous court. But manipulating a gene to create something not found in nature is an invention eligible for patent protection.

The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer.

Believe it or not USA Today was out fast with a long story on this issue with quotes and everything. Here’s the full text of the decision. Needless to say this is a pretty big deal, and I’m somewhat surprised this was a unanimous decision. Perhaps the justices actually listen to scientists and their bleating sometimes?

I’ll be checking in to the Genomics Law Report regularly today….

Update: Just to note, several friends have noted that aspects of the science in the ruling seem to have some howlers. That is not surprising (see Scalia’s admission of ignorance in the concurrence). But from listening to the panel discussion on the Myriad case at ASHG 2012 this ruling is still a huge step forward. Being wrong is preferable to “not even wrong.”

CATEGORIZED UNDER: Genetics, Genomics
MORE ABOUT: Gene Patent, Myriad
  • TheBrett

    That’s great news.

  • Karch_Buttreau

    The Supreme Court said that naturally occurring DNA was not patentable subject matter, but complementary DNA (cDNA), which omits portions of the DNA that do not code for proteins, was eligible subject matter (there are other hoops than just subject matter eligibility).

    I have no idea whether or not cDNA is important for this BRCA testing (meaning whether or not there are other ways to perform BRCA testing), but Myriad’s stock is up a lot, post verdict.

    • Karch_Buttreau

      Myriad stock (MYGN) wound up reversing and was lower for the day. You would think that Wall Street and their experts could read the tea leaves correctly…

      • andrew oh-willeke

        Wall Street reads the tea leaves relative to expectations immediately in advance of the ruling. SCOTUS split the baby (in a basically sensible way). But, Myriad got less than expected by analysts from SCOTUS so its stock went down. If Myriad had a full out win, its stock likely would have gone up. Essentially, the odds of the case coming out any number of ways were reflected in the pre-ruling price and the outcome was worse than that.

  • Chad

    My primary worry with “cDNA” being patentable is how does this affect the use of RNA-seq, where one makes cDNA before sequencing.

    • Dmitry Pruss

      I doubt, because bulk cDNA isn’t “isolated / purified” in specific-gene sense; rather, it’s a mishmash of all genes.
      I think that the ruling means that the future gene patents will have, for subject matter, “cDNA prepared from unprocessed transcripts” rather than “gDNA” – i.e. the words will change, the patents’ reach won’t

      • Chad

        But then you sequence it in bulk, resulting in sequencing of the patented cDNAs….that is my worry, but I hope you are right.

  • Anthony_A

    The opinion said that claims for specific *tests* were not at issue, and following the logic of the opinion, Myriad’s tests for BRCA mutations *are* patentable, because the *test* is a new creation.

  • highly_adequate

    So does this ruling in any way restrict what companies were seeking to patent in any case? If all of the things they wish to do with a gene are covered, what does it matter if the gene can’t be patented?

    Is this anything more than a Pyrrhic victory?

    • highly_adequate

      I found this reaction to the decision on the PatentlyO blog (perhaps the best known blog on IP law):

      “What are the consequences? My immediate reaction is
      that for most practical applications, the Court’s holding means that even though the broadest possible biotechnology product claims (to the isolated DNA itself) aren’t going to be patentable, the key elements in making and using a biotechnology-based invention are still going to be protectable via patents (Part III of the Court’s opinion makes this especially clear). This will allow researchers and competitors a little bit of wiggle room to design around biotechnology patents because they can use the basic isolated sequence but there will still be substantial limitations on what they can do with that isolated sequence. For this
      reason, I’m skeptical that the Court’s opinion will have a negative effect on the incentives for creating biotechnology-based applications. To the contrary: by affirming that cDNA can be patented, it may strengthen the incentives for investing in research in this area.”

      http://www.patentlyo.com/patent/2013/06/myriad-isolated-dna-out-cdna-in.html

      It may be that testing for the presence of a gene may now be allowed — though the fact that others are now offering tests is hardly definitive on the point, since Myriad might come back with a successful lawsuit if they can show that such tests inherently involve something that remains patentable — but that may be the effective limits of what is now allowed.

  • chris_T_T

    Good news for biotechnology. I imagine this won’t actually have much of a negative effect on biotechnology. It sounds like the only thing companies need to do to make a gene patentable is add a non-coding sequence to a strand.

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This blog is about evolution, genetics, genomics and their interstices. Please beware that comments are aggressively moderated. Uncivil or churlish comments will likely get you banned immediately, so make any contribution count!

About Razib Khan

I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. In relation to nationality I'm a American Northwesterner, in politics I'm a reactionary, and as for religion I have none (I'm an atheist). If you want to know more, see the links at http://www.razib.com

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