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Supreme Court says no patent on natural DNA

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Recently, Supreme Court justices rule human genes cannot be patented. Does it mean all gene patents are invalided? Someone said ""While a fair number of existing patent claims are now likely invalid...". Do you agree ?

Attorney Answers 4


  1. At the very least, patents on naturally occurring genes may be unenforceable. The SCT specifically did not rule on the method for isolating the gene, so that part of the patent remains valid.

    The answer to this question is for informational purposes only and does not form an attorney-client relationship.


  2. Q: "Does it mean all gene patents are invalided?"
    R: No. Read the blog posts on the Myriad case linked-to below.

    The above is general information ONLY and is not legal advice, does not form an attorney-client relationship, and should NOT be relied upon to take or refrain from taking any action. I am not your attorney. You should seek the advice of competent counsel before taking any action related to your inquiry.


  3. It seems quite possible that there exists claims in patents that are similar in their construction to those in the Myriad patent. Those claims, which are directed to DNA sequences that can be found in the genetic structure of a naturally-occurring organism, were held to be not patentable and thus would likely be found to be invalid of challenged. However, Myriad's claims directed to cDNA were found to be directed to patentable subject matter and were held valid. Similarly, claims directed to cDNA sequences of naturally occurring DNA sequences would likely be determined to be valid if challenged.


  4. I happen to have been following this case and publishing comments about it since its inception about 4 years ago. It was spearheaded by an outspoken professor of law who's been curiously successful at seeking to break the Constitutionally-mandated legal framework for U.S. patents. One of the sleight-of-hand tricks performed by the well-intentioned, but somewhat misinformed, lawyers for the ACLU who've been handling this case as his collaborators, has been to characterize certain patented chemical compositions, technically known as polynucleotides, as "your genes."

    The correspondingly confused members of the Supreme Court issued an opinion on June 13, 2013, that, yes, has the effect of declaring to have always been "invalid" any issued U.S. patent claims to a molecule consisting of an isolated and purified naturally occurring gene, the consecutive nucleotide sequence of which exists in nature. And from now on, the Patent Office is mandated to reject a patent application's claim to any such composition.

    As one of my colleagues on this forum pointed out above, the Court's decision was crafted to exclude from the finding of invalidity a similar but slightly different class of patent claims, namely to a polynucleotide that has been generated synthetically as a cDNA molecule. This distinction was the result of a successful "last-minute save attempt" executed by the U.S. Department of Justice. As a sort of "Queen's gambit," the Government lawyers threw in the towel and elected not to support the decades-long policy of the Patent Office to issue patent claims for isolated polynucleotides whose naturally-occurring sequences had been found to be novel, non-obvious, and useful (e.g. for testing for certain genetic abnormalities). But Justice Department lawyers articulated a distinction between such compositions and those derived from cDNA, that persuaded the Court to adopt that reasoning and thus preserve the validity of patent claims to the latter such compounds.

    As the editor of Biotechnology Law Report, I recently took the opportunity to discuss the Supreme Court's decision a month ago with Harvard Genetics Professor George Church (author of the book Regenesis: How Synthetic Biology Will Reinvent Nature and Ourselves). Prof. Church characterized the matter as just "a tempest in a teapot," and commented that whether such patent claims are valid shouldn't make much difference in the long run, except perhaps to encourage some researchers to keep their results secret rather than to publish them in patents.

    You can read my own most recent comments about the Myriad Genetics decision at http://elman.com/2013/06/supreme-court-snowed-by-smear-campaign-resurrects-archaic-requirement-of-invention-as-a-test-of-patent-eligibility/ , and more generally, my own comments and those of my colleagues at Biotechnology Law Report at http://liebertpub.com/blr

    It should be telling that on July 9th, the folks at Myriad Genetics have risen to the bait by suing for patent infringement a competitor who's jumped into the pool with a competing test for variations in the breast cancer gene. Even though the ACLU lawyers (representing certain parties who were antagonistic to "gene patenting") have hyped their success in getting the Supreme Court to declare that claims to certain "isolated and purified genes" were and are not patent-eligible, it looks likely that they have failed to deliver on their expressed goal of making readily available to the public similar genetic tests from alternative, unlicensed sources.

    Well, just as the people of the fictional venue of River City, Iowa, were cajoled by Professor Harold Hill to pay him for band instruments to keep the young ones moral after school (as an antidote to the new pool table in the town billiards parlor), so have the people of the United States been cajoled by the promoters of this litigation, to rid society of the evil of "gene patents."

    This posting is intended for general education and isn't "legal advice." It doesn't create or evidence an attorney-client relationship. You are encouraged to engage an attorney in the pertinent jurisdiction for confidential legal advice on matters of any importance. -Gerry J. Elman, J.D. Elman Technology Law, P.C. Swarthmore, PA www.elman.com