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.
JUSTICE SCALIA, concurring in part and concurring in the judgment.
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.
Section 101: "Whoever invents or discovers any new and useful ... composition of matter ... may obtain a patent therefor ...". (emphasis added).
The Court admits Myriad discovered the claimed DNA molecule (i.e. the gene was a new discovery, as required by § 101). The Court admits the claimed DNA molecule is useful. The Court admits the claimed DNA molecule is a composition of matter. Thus all of the requirements of § 101 are, in fact, met.
Let me make an extended computer metaphor to explain this properly.
The human genome is comprised of many different types of information, which we can liken to pieces of text in different languages. Consider a case where we have a long document written in Russian that discusses source code for a program that was heavily commented—but in Greek. (For those of you following along in the lab, Russian is the untranscribed DNA, Greek is transcribed but noncoding, and the ASCII program itself is the coding sequence.) All of this is in UTF-32.
When the cell functions normally, it uses the program's source as a build script: it copies the code out of the document into CP-1253 (the Windows Greek code page), and then cuts out any remaining "??????" left by the transcription, as well as all of the Greek comments in the middle of the code. There are some comments at the start of the code and at the end, but most of the copy is the code itself.
In the Myriad case, they've found a program that works the other way, called reverse transcriptase. It turns the 8-bit Greek/ASCII mixture back into UTF-32, but the Russian and the intragenic comments are still gone, leaving us with a usable sequence that we can do a bitwise search comparison with. This is very convenient to do because there's already a complete set of such sequences available. These are called cDNA libraries, and we rely on them everyday to tell us where the Greek comments are.
What researchers will be forced to [do] instead is to cut the sequences out by hand directly from the wide Unicode source, using a lab technique called PCR splicing. The stupid thing is that there's no chemical difference between the two—it would be impossible to prove one way or the other where the diagnostic sequence came from, unless you knew the sequence's history. It just means that researchers now have to fumble around with splicing a bit more.
Hours after the ruling, one company — DNATraits, part of Houston-based Gene By Gene, Ltd. — said it would offer BRCA gene testing in the United States for $995 — less than a third of the current price.
Please note, all samples received starting June 13, 2013 for BreastNext, CancerNext and OvaNext will automatically include BRCA1/2 gene sequencing and deletion/duplication analyses at no additional cost. Additionally, Ambry will contact clinicians to discuss any clinically-significant BRCA1/2 incidental findings on all in-house samples.
Let me make an extended computer metaphor to explain this properly.
"composition of matter" has been construed consistent with its common usage to include "all compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids." In choosing such expansive terms as "manufacture" and "composition of matter," modified by the comprehensive "any," Congress plainly contemplated that the patent laws would be given wide scope.
The relevant legislative history also supports a broad construction. The Patent Act of 1793, authored by Thomas Jefferson, defined statutory subject matter as "any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof]." The Act embodied Jefferson's philosophy that "ingenuity should receive a liberal encouragement." Subsequent patent statutes in 1836, 1870 and 1874 employed this same broad language. In 1952, when the patent laws were recodified, Congress replaced the word "art" with "process," but otherwise left Jefferson's language intact. The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to "include anything under the sun that is made by man."
Furthermore, isolated, purified DNA molecules are "made by man." Even though the original gene was found in nature, the isolated, purified DNA molecules are produced through various laboratory processes. It is no less a man-made product than cDNA molecules.
The Court worked out the policy result it wanted and invented new law in order to reach that conclusion. That's fine if the Court is working in a common law area, but there is a clear statutory scheme here.
In other words, it cuts off the analysis before one even considers whether the DNA molecule is novel, useful, nonobvious, etc.
In the case of BRCA1/2, it is absurd that Myriad would be awarded a patent. The serious intellectual spade work was done by Mary-Claire King in identifying the gene. The sequencing, as I understand it, was mechanical and just a matter of time and resources. It was a race between Myriad and several other groups, including Dr. King. The group with the best resources won, but that should hardly entitle them to patent the gene Dr. King discovered.
That's fair when the Court is considering a matter of constitutional law or common law, areas where it has considerable leeway to interpret or craft the law on its own. But in this case there was a straightforward statutory scheme put in place by Congress. The Court overstepped its bounds.
In this case, Myriad (or scientists whose work was ultimately assigned to Myriad) discovered a DNA molecule with certain useful properties. It patented the molecule in isolated, purified form. It excluded others from making, using, selling, etc that molecule in isolated, purified form. The Supreme Court ruled that Myriad's kind of molecule, unlike all other kinds of molecule, are not patentable because reasons.
Good thing none of the claims covered genes as they exist in the human body, then, since the human body does not contain isolated, purified copies of the DNA molecules that correspond to the BRCA1 or BRCA2 genes.
« Older Cheetahs’ Secret Weapon: A Tight Turning Radius [N... | About 30 miles west of Charles... Newer »
This thread has been archived and is closed to new comments
Buy a Shirt