As the dust begins to settle on the Supreme Court’s recently issued opinion in AMP v. Myriad, and hopefully as the misguided “gloating” by the media and the ACLU settles down to a dull “roar,” what does the Myriad decision really means? The ruling that was handed down by the Supreme Court in Myriad was pretty much as I expected, and could have been far, far worse. Again, let’s not get lost in the mistaken (and misrepresentative) hype and hyperbole of the media and the ACLU, i.e., the “patenting of human genes has been blocked by the Supreme Court” which the Myriad case was never about in the first place. Frankly, the “doom and gloom” I’m seeing and hearing from the patent law world (including a depressing and mind-boggling statement I saw from the AIPLA about the potential impact of the Myriad decision on biotechnology) isn’t warranted in my opinion. And please also note that Myriad’s stock initially shot upwards in price significantly Thursday after the Myriad decision came out (although it also fell back again Friday) which suggests investors may not be necessarily as “bearish” about the financial impact of this decision compared to the media, and at least some in the patent law world.
The Opinion for Court written by Justice Thomas pretty much cabined the patent-ineligible part of the holding, more so than you might think. Also, besides saying that Myriad’s claimed cDNA was patent-eligible (versus the claimed “isolated” DNA which wasn’t), I actually take solace from the following two sentences at pages 14-15 of the slip opinion
“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2.”
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In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like an altered chemical molecule to be divorced from the native DNA, i.e., the claimed “isolated” DNA sequences were not a “difference in kind rather than degree” which comes straight out of the “product of nature” doctrine cases. See Guttag, “The Patentability of Microorganisms: Statutory Subject Matter and Other Living Things,” University of Richmond Law Review, Vol. 13, page 247 (1979) which discusses the “product of nature” doctrine and how it is applied. I realize that Thomas’ opinion may require defining that “chemical molecule” in ways that go beyond how nucleotide sequences have traditionally been claimed in the world of molecular biology and genetics, but we in the patent prosecution world can cope with that and have done so in the past. Also, much to my delight, those two sentences are somewhat of an unintended “slap” at Breyer’s derogatory comment in Mayo Collaborative Services v. Prometheus Laboratories, Inc. about not letting patent-eligibility under 35 U.S.C. 101 depend on the “draftsman’s art,” i.e., how the claims are written does matter.
By holding that Myriad’s claimed cDNA was patent-eligible, Thomas’ opinion reaffirms the major holding in Diamond v. Chakrabarty that claimed subject matter which truly only the “hand of man” can make (not simply snipped out of “mother nature”) will make it to the patent-eligibility zone. (Whether that same cDNA makes it to patentability zone under 35 U.S.C. § 102 and especially under 35 U.S.C. § 103 is another and far more important story.) I would also be careful in reading too much into Thomas’ statement (which is also dicta) about “very short series of DNA which may have no intervening introns to remove in creating the cDNA” might be patent-ineligible. By definition, cDNA (i.e., complementary DNA) is a DNA molecule which is created from mRNA (i.e., messenger RNA) and therefore lacking the introns in the DNA of the genome. Thomas (or his clerks) may not have realized that what they were talking about isn’t what would be defined (at least by a molecular biologist) as cDNA. So the impact of that statement should have minimal, if any impact. (Scalia was at least forthright in his concurring opinion about not being able to affirm the “fine details of molecular biology.”)
As I know, and many others far more knowledgeable in the field of molecular biology might know, the Myriad opinion essentially addresses only that 2% of the human genome that follows the pre-ENCODE approach to genetics. That includes Myriad’s claimed BRCA genetic material which (like the BRCA gene) is basically a linear genetic segment. The other 98% of the human genome which doesn’t follow the pre-ENCODE linear approach and which is actually three-dimensional in structure is still in play (and in view of ENCODE would likely require splicing together at least two distinct DNA sequences to code for the polypeptide which “mother nature” doesn’t do). That means that the Myriad opinion is really inapplicable (i.e., not on point) as to 98% of the human genome that doesn’t follow the pre-ENCODE linear approach to genetics. So the “game” of patenting genetic material (human or otherwise) isn’t over yet by a long shot.
Another somewhat hidden “silver lining” in the Myriad decision that my patent attorney brother Mark astutely pointed out is that there should be less impetus from Congress to enact legislation like the inane bills authored by Congressman Xavier Becerra (D-California, aka “The Gene Patent Terminator”) that would truly plunge us into an “anti-gene patenting hell” with far greater potential to destroy American biotech industry than does the limited holding in the Myriad decision. See Foaming at the Mouth II: My Alternative to the New But Inane Becerra Bill . In other words, the patenting of genetic material (human or otherwise) will hopefully slip “under the radar” of Congress. Meanwhile we in the patent prosecution world will have the opportunity to figure out new claim drafting techniques that will make the claimed genetic material look less like something from “mother nature” (like happened with Myriad’s claimed “isolated” linear DNA sequence) and more like something that is truly the “hand of man” (more like Chakrabarty’s genetically engineered oil-eating bacteria that that added plasmids from 4 different bacteria to a host bacterium containing none of these plasmids).
Let’s finally consider three areas Thomas’s opinion expressly said were not implicated by the Myriad decision:
- There were no method claims before the Supreme Court in Myriad. That includes Myriad’s claimed method for screening potential cancer therapeutics using trans-formed eukaryotic host cell containing an altered BRCA1 gene which all three panel members (Lourie, Moore, and Bryson) affirmed in both Federal Circuit panel decisions in Myriad was patent-eligible under 35 U.S.C. § 101. See also the statement in this portion of Thomas’ opinion that, had “Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.”
- No “new applications of knowledge about the BRCA1 and BRCA2 genes” were involved. In fact, this portion of Thomas’s opinion affirmed approvingly Judge Bryson’s statement that ““[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences Myriad was in an excellent position to claim applications of that knowledge,” and that many of Myriad’s “unchallenged claims are limited to such applications.” Such “new applications” might include, for example, the use of BRCA1 and BRCA2 gene probes, such as DNA microarrays, which “mother nature” cannot make, i.e., truly require the “hand of man.”
- There was no “consider[ation of] the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Instead, this portion of Thomas’s opinion said that “[s]cientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of [35 U.S. C. § 101] to such endeavors.”
Admittedly, many of us in the patent law world might have hoped that Myriad’s claimed “isolated” DNA sequences would have at least passed muster under 35 U.S. C. § 101. (Whether those claimed “isolated” DNA sequences would be deemed patentable under 35 U.S.C. § 102 and especially under 35 U.S.C. § 103 is, to use Justice Thomas’ words, “a different inquiry.”) But there is much to take comfort from in Thomas’ opinion in Myriad, as well as new opportunities and ways to seek the patenting of such genetic material, including its beneficial uses. (We may also need to “butt heads” with the USPTO which sent, in my opinion, a poorly thought through memorandum to the patent examiners for how to apply the holding in the Myriad decision which completely misses the legal rationale for when the “product of nature” doctrine applies, i.e., the difference between the “isolated” DNA sequence or fragment and the native DNA is a matter of “degree” not “kind.”)
Unlike Bilski v. Kappos where the Supreme Court couldn’t define what a patent-eligible “abstract idea” was except “we know it when we see it,” we at least know from the Myriad decision what genetic material is in the patent-eligibility “zone,” i.e., Myriad’s claimed cDNA, so we now have some idea what the “target” is. So don’t let those in the media, at the ACLU, and elsewhere who will “crow” about the Supreme Court “blocking the patenting of human genes” get you down. And do remind those folks who do “crow” that at least Myriad’s claimed cDNA (which even ACLU’s attorney had to confess at oral argument before the Supreme Court was truly from the “hand of man”) made it to the patent-eligibility zone.
*© 2013 Eric W. Guttag. Posted June 16, 2013 on IPWatchdog.com.