UPDATED June 13, 8:24pm ET (see comment #15 & #19)
Earlier this morning the United States Supreme Court issued its much anticipated ruling in Association of Molecular Pathology v. Myriad Genetics. Justice Thomas wrote for a a nearly unanimous Court, only Justice Scalia wrote separately and he concurred in part and concurred in the judgment. The decision is not long, and approximately half of the decision is background, yet at the end of the day much damage has been done to the biotechnology industry, the medical industry and the patent system. Indeed, the assault on patents continues.
According to Todd Dickinson, Executive Director of the American Intellectual Property Law Association, the outcome was fairly predictable given the oral argument, although 9-0 was a bit surprising. Dickinson told me via telephone earlier today the the decision itself is disappointing because it “keeps framing an anti-patent narrative.” He went on: “Patents are terribly useful to incent innovation and necessary to provide funding. If we undermine the patent system further I think we will be shooting ourselves in the foot.” I couldn’t agree more!
Yesterday the United States Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. While the Association for Molecular Pathology (AMP) is the named party in the case, it is really a case brought and forwarded by the American Civil Liberties Union (ACLU).
Myriad Genetics is the patent holder on various innovations relating to isolated DNA comprising an altered BRCA1 DNA and various methods of screening for cancer built upon various observations of the altered BRCA1 DNA. Essentially, AMP and the ACLU, along with researchers, competitors of Myriad Genetics and consumers filed a lawsuit challenging the constitutionality of a number of gene patents owned by Myriad and argued that gene patents should not be granted because patenting a gene is the same as patenting something that exists in nature.
This argument succeeded at the district court, but has twice failed at the Federal Circuit. The Federal Circuit initially reversed the district court, but appeal was made to the Supreme Court by AMP/ACLU. See As Predicted, Federal Circuit Rules Isolated DNA Patentable. In the meantime the Supreme Court issued a decision in Mayo v. Prometheus and remanded this case to the Federal Circuit for further consideration in light of the Court’s decision in Mayo v. Prometheus. The Federal Circuit again sided with Myriad Genetics. See AMP v. USPTO Remand Déjà Vu. Appeal was taken to the Supreme Court, which accepted certiorari. See Supreme Court Grants Cert in Amp v. Myriad. The only issue accepted by the Supreme Court was the broadest issue: are human genes patent eligible?
I began by describing the facts of the Myriad case, which is currently before the Supreme Court, and the science behind the issues, as well as introducing the panelists. I then began the discussion by asking the panelists if genetic sequence and cDNA patents interfere with scientific research and with those who provide health care. Vern Norviel of Wilson Sonsini argued that it does not matter either way with regards to patents and new biotech product innovations. Mr. Norviel pointed out that the entire human genome was already mapped and the company who mapped it was not sued. More importantly, he argued, is that human genes are limited and it would be a very small bit of information that could be determined to not be patentable. He did, however, caution that the Court should try and restrain itself and not go too far such that it destroys what is currently a massive and successful life sciences industry. The bottom line is that regardless of whether a patent exists, professors and researchers will continue to do the research. Dr. James Mullen of Morrison & Foerster further argued that patents encourage research and innovation as venture capitalists want to know if (1) the research does what it is claimed to do and (2) if the party owns that research.
The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.
You may have heard about the “breast cancer gene patent wars.” Most likely, you have heard from various individuals and popular media asking “how can someone patent my genes?” One can’t and never could patent your genes as they are in you.
One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.”
Myriad (the “other” side) owns several patents with claims directed to “isolated” nucleic acid molecules (e.g., DNA) and fragments thereof which are referred to as either “probes” or “primers,” based on their function. Probes anneal, i.e., bind, to a particular part of a DNA and are used to detect the presence of certain genes which indicate abnormalities or disease states. Primers anneal to particular parts of a DNA and are used to make additional pieces of DNA, e.g., make multiple copies of a single abnormal sequence such that it is readily detectable and/or become capable of being utilized in other useful applications, e.g. forensic science.
Given the remand of the Federal Circuit’s original panel decision for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I’m not surprised that the Supreme Court granted the ACLU’s/Pubpat’s petition for certiorari in AMP v. Myriad. What is somewhat surprising is that the Supreme Court granted certiorari only as to the first question (“Are Human Genes Patentable”) posed by the ACLU/PubPat. The patent-eligibility under 35 U.S.C. § 101 of Myriad’s claimed method of screening potential cancer therapeutics that was (again) unanimously upheld by the Federal Circuit panel, but will not be before the Supreme Court. Nor will the issue of “lack of standing” with respect to but one of the plaintiffs be considered.
I’ve been following the various meanderings and wanderings of the Myriad case for almost three years now. One unfortunate aspect of this case is that, from the beginning, the ACLU/PubPat has manipulated and fabricated what this case is about in terms of the applicable “science,” as well as the applicable “patent law.” In fact, in distorting what this case is really about (i.e., the patent-eligibility of Myriad’s claimed “isolated” DNA sequences under 35 U.S.C. § 101), the ACLU/PubPat has also tried to hide the fact that the real plaintiffs in the Myriad case are none other than the ACLU/PubPat themselves; that has become readily apparent, given that all but one of the “alleged” plaintiffs have been knocked out of this case on “lack of standing” grounds.
Before the Myriad case becomes further obscured by the “pseudoscientific” nonsense foisted by the “real plaintiffs,” as well as the PR smokescreen of “politics, policy and philosophy” that the ACLU/PubPat has used to manipulate the applicable “patent law,” the Supreme Court needs to understand, to use Judge Lourie’s words, what this case “is not about.”
When the Supreme Court remanded the Federal Circuit’s original panel decision in AMP v. USPTO for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I said that nothing would change in that remand. In particular, I predicted that the same two-to-one majority from that Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) would again rule that the claimed isolated DNA sequences were patent-eligible under 35 U.S.C. § 101. My primary reason for my confidence in that prediction was that the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) would control on that claimed subject matter, not Mayo Collaborative Services. See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*.
So guess what happened in the AMP remand of? As I predicted, simply “déjà vu”: the same two-to-one majority ruling for essentially the same reasons, as well as confirming that Chakrabarty (not Mayo Collaborative Services) controlled on the patent-eligibility of the claimed isolated DNA sequences. For the full decision see AMP v. USPTO II (August 16, 2012).
In the immortal words of baseball great Yogi Berra, “It’s déjà vu all over again”. A little more than a year after they previously heard AMP v. USPTO, the CAFC panel of Judges Lourie, Bryson and Moore have once again taken up the question of whether isolated DNA and related methods are patent eligible subject matter under 35 U.S.C. §101.
To recap, last year, the same panel ruled that the composition claims reciting isolated DNA were patent eligible, with Judges Lourie and Moore supporting patent eligibility and Judge Bryson dissenting. All three Judges also agreed method claims involving “analyzing” or “comparing” DNA were not patent eligible. Lastly, all three Judges agreed that a screening claim (claim 20 of the ‘282 patent) was patent eligible. For a full discussion of last year’s decision (in English and Japanese), please click here. After the decision, AMP appealed to the Supreme Court, who later vacated the CAFC decision and remanded the case to the CAFC for further consideration in view of their Mayo decision (English summary;Japanese summary).
The supplemental briefs for the parties and amicus are now finally in for the remand of the AMP v. USPTO case to the Federal Circuit. As I’ve previously stated, the Supreme Court’s reasoning in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which caused this remand should not change the fact that Myriad’s isolated DNA sequence claims are patent-eligible under 35 U.S.C. § 101. That’s based on the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) being the controlling precedent, not Mayo Collaborative Services. See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*
Not surprisingly, the ACLU and PubPat’s supplemental brief assert that these Myriad’s isolated DNA sequence claims are patent-ineligible in view of Mayo Collaborative Services, arguing that these claims “patent laws of nature and products of nature.” This further mischaracterization of Myriad’s isolated DNA sequence claims perpetuates the unfortunate “myth” by the ACLU and PubPat that this case “is about the validity of certain patent claims on human genes.” See page 8 of Brief for Appellees that filed for the original Federal Circuit panel decision. But what the Federal Circuit panel should especially take note of in the remand of the AMP case is the supplemental amicus brief filed by Professor Christopher Holman of the University of Missouri-Kansas City School of Law.
Not too surprisingly, the Supreme Court granted certiorari in AMP v. USPTO, vacated the Federal Circuit’s panel decision, and remanded for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc. On remand, the Federal Circuit is unlikely to “resurrect” the claims to the methods of “comparing” or “analyzing” DNA sequences that were deemed unanimously by the Federal Circuit panel to be invalid as being patent-ineligible under 35 U.S.C. § 101, and nothing in Mayo Collaborative Services changes that result, but simply reaffirms it. But the story should also be no different for the claim directed to the method of screening potential cancer therapeutics that was unanimously upheld by this same panel as being patent-eligible under 35 U.S.C. § 101 because the Supreme Court’s reasoning in Mayo Collaborative Services is distinguishable for reasons given in the original AMP decision, as well as for reasons given in Judge Newman’s opinion in the remand of Classen Immunotherapies, Inc. v. Biogen IDEC. See The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand*.
Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101. What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision? For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed. I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words: NONE AT ALL. And the Federal Circuit can (and should) say likewise, perhaps in far more words.
The July 29, 2011 Federal Circuit decision in Assoc. for Molecular Pathology et al. v. U.S.P.T.O. and Myriad Genetics has been eagerly awaited by the biotechnology community and by persons concerned with the ethical implications of DNA technology. Although a significant part of the decision involved standing to sue, I will only discuss the scientific portions of the decision that deals with the very real ethical question of whether human genes and/or gene sequences should be patented.
The decision in Myriad was written by Judge Alan Lourie with concurrences-in-part by Judges Moore and Bryson. Judge Bryson also filed a dissent-in-part. Judge Lourie, who has a Ph.D. in chemistry, is well suited to understand all the issues associated with genetic sequence cases and has written some key biotechnology decisions, such as the Regents of the University of California v. Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997) (Cloned human insulin product did not infringe patented rat insulin.) and In re Deuel , 51 F.3d 1552 (Fed. Cir. 1995) (Settled an issue of obviousness between genetic sequences). Judge Bryson was also part of the Lily decision.
Structure of a DNA double helix,
Fig. 1 from the CAFC majority opinion.
After much anticipation, the United States Court of Appeals for the Federal Circuit earlier today issued a decision in Association for Molecular Pathology v. Myriad Genetics. The decision on first glance will seem to be a split decision, particularly by Federal Circuit standards. The majority opinion was written by Judge Lourie, Judge Moore wrote a concurring opinion and Judge Bryson concurred in part and dissented in part. Having said that, the outcome largely seems to be what was predicted by the patent community. On the major substantive issue — are isolated DNA molecules patent eligible subject matter — the Federal Circuit reversed the decision of the district court and ruled that isolated DNA molecules do constituted patent eligible subject matter. The Federal Circuit also ruled that methods relating to the screening for potential cancer therapeutics are, likewise, patent eligible subject matter. All three Judges also found the “comparing” and “analyzing” claims to be ineligible for patent protection because they were not transformative, and thus were merely abstract mental steps.
On April 4, 2011, the United States Court of Appeals for the Federal Circuit heard oral arguments in the case dubbed Association for Molecular Pathology v. United States Patent and Trademark Office. This case has been commonly referred to here and elsewhere as either the ACLU case or the Myriad Genetics case. Myriad Genetics is the patent holder on various innovations relating to isolated DNA comprising an altered BRCA1 DNA and various methods of screening for cancer built upon various observations of the altered BRCA1 DNA. The patents challenged are U.S. Patent Nos. 5,747,282, 5,837,492, 6,593,473, 5,709,999, 5,710,001, 5,753,441 and 6,033,857.
Essentially, the American Civil Liberties Union (ACLU), along with researchers, competitors of Myriad Genetics and consumers filed a lawsuit challenging the constitutionality of gene patents and argued that gene patents should not be granted because patenting a gene is the same as patenting something that exists in nature. While this argument did succeed at the District Court, it won’t succeed at the Federal Circuit. The District Court Judge fundamentally based his ruling on the fact that, as he understood it, Supreme Court precedent “establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter.” First, this is truly an oversimplification of the purification issue and, second, it demonstrates an acute lack of understanding of the science involved.