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October 12, 2014


"The structural differences between the claimed "isolated" genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession."

So then, from the point of view of the geneticist, or anyone else, just what was holding us back from the new and profoundly useful genetic testing for breast cancer before we "possessed" the gene?

Not yet read the article, but the words of the title immediately bring the notion that your advice that follows will not be heeded by the Supreme Court - the Court will not allow THEIR (implicit) writing to be turned into dead letters - no matter what the actual words of Congress are. See Prometheus.


Nice article. (BTW, it's Chief Justice BURGER, not Berger.) You're citation to what former Chief Justice Burger said in Chakrabarty confirms what I've suspected: the courts (including the Royal Nine) are not to read in language which is otherwise missing from the explicit statute. These so-called "implicit" exceptions (that's how the Royal Nine characterize them) are not in the 35 USC 101. Accordingly, the holdings in Mayo, Myriad, and Alice Corp., in violating the principle of not reading in language that isn't expressly in statute, are built on a "foundation of sand" that is based on (unprincipled) judicial fiat, not principled reasoning.


Findings of fact are completely inconsequential. Legal holdings, however, are critical because they govern subsequent cases.

In Myriad Justice Bryson held that there was no new utility for full-length BRCA1, and his opinion was affirmed on appeal by Justice Jackson. That is a fact finding, and there is from a legal standpoint no point whatsoever in discussing whether or not it is correct. The next case will have a different trial record on which different fact findings may be made. The fact findings in one case have no binding effect on the next case, as any first year law student should be aware.

However, the rule of law is important. In the case of Myriad the holding was that a naturally occurring genetic sequence was not patent-eligible merely because it was isolated. That holding is critical and merits detailed analysis which it has in the main received only inadequately and superficially up to now, see my earlier guest post on this topic:


The purpose of this posting is to show that the same result can be reached more simply and straightforwardly by considering the express wording of the statute.

Despite the fact that it is of no legal significance whatsoever other than as between the parties, natural personal curiosity has in the past persuaded me to look into the question whether the Supreme Court was right to hold that full-length BRCA1 is valueless. The patent does not report its actual isolation, and Myriad had only found some 27,000 of the 81,000 base pairs in the gene. They had disclosed no protocol for obtaining the full length gene as a discrete isolated molecule. To the best of what I have been able to ascertain, no mutational analysis is based on full-length BRCA1, only on fragments containing the various individual exons, and the full-length gene has no practical utility whatsoever. If that is wrong, I am more than glad to hear the details, but that is the best I have been able to glean from the disclosure of the patent and from web searches directed to the practical analyses conducted by Myriad and others. So I entirely agree with you that the Myriad patent disclosed useful information, but that was not reflected in what was argued before the Supreme Court.

Under the test proposed by the author, would a synthesized DNA molecule having the same sequence as the DNA molecule in Myriad meet the "composition of matter" test? Such a synthesized DNA molecule would be assembled from multiple substances, nucleotides, that would be transformed into the DNA molecule. And even the nucleotides can be synthesized from other molecules.

Conversely, wouldn't many polymers fail the "composition of matter" test, because they are only formed from one "substance", i.e., a monomer?

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