Myriad Gene Patent Litigation
On May 12, 2009, a group of plaintiffs led by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit against Myriad Genetics, the U.S. Patent and Trademark Office (USPTO) and other defendants. The lawsuit – Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al. – alleges that patents on two human genes associated with breast and ovarian cancer (BRCA1 and BRCA2) are invalid and unconstitutional. This page aggregates all of the Genomics Law Report’s coverage of the Myriad litigation, as well as coverage of other relevant legal and policy developments pertaining to the issue of gene patents.
What We Learned From The Myriad Oral Argument
Yesterday brought the long-anticipated oral argument in the Myriad gene patent litigation. After much speculation, the final panel consisted of Judges Lourie, Bryson and Moore. Following the Myriad argument, Judge Lourie was replaced on the panel for the remainder of the day’s cases by Judge O’Malley, lending support to speculation that Judge O’Malley recused herself from the Myriad argument because her lawyer-spouse filed an amicus brief in the case.
What We Learned from the Myriad Oral Argument. For all of the attention focused on the Myriad oral argument, most spectators have only one very practical question: did Monday’s argument provided any meaningful clues with respect to how the Federal Circuit might rule on appeal of the lower court’s startling ruling?
In a word: no. In a few more: we learned nothing from the Myriad argument that leaves us better able to predict how the Federal Circuit will rule in this case.
A Spectator’s Guide to the Myriad Oral Argument
On Monday at 10 a.m., the lawyers for both sides will argue the Myriad case (Association for Molecular Pathology v. USPTO) before a three-judge panel of the United States Court of Appeals for the Federal Circuit in Washington. Here are a few things about oral argument in general, and this case in particular, that interested observers may want to keep in mind.
Who’s on the Panel? Federal cases on appeal are almost always heard initially by a panel of three randomly selected judges. (In rare cases all the judges of a circuit will rehear the case together, or en banc—no way to predict if that will eventually happen here.) The Federal Circuit will announce the panel for this case on Monday morning on its website. As of now, all we know is that Myriad—and only Myriad—will be heard by “Panel B+.” The + means that the makeup of that panel will be different from that of Panel B, which will hear the three other cases also scheduled for this 10 a.m. session (a panel customarily hears four arguments in a session). The + designation sometimes means that one member of the regular panel (here, B) has recused (disqualified) him or herself from the case because of some conflict, necessitating a replacement.
How Will Myriad Respond to the Next Generation of BRCA Testing?
Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is Director of the Center for Genome Ethics, Law & Policy at Duke University Institute for Genome Sciences and Policy’s and is currently on leave at the Fondation Brocher in Hermance, Switzerland.
The past few months have brought a number of significant research and commercial developments in the BRCA diagnostic testing market, particularly in Europe. These developments have been met by enigmatic comments from the management of Myriad Genetics, the sole provider of commercial BRCA diagnostic testing in the United States and a defendant in ongoing and closely-scrutinized gene patent litigation. What can these recent developments tell us about Myriad’s future plans in both Europe and the U.S.?
The Next Generation of BRCA Testing. Myriad’s current BRCA diagnostic test, BRACAnalysis (pdf), uses a combination of two traditional technologies—Sanger sequencing and PCR—to identify mutations associated with a significant risk of breast cancer and/or ovarian cancer in the BRCA1 and BRAC2 genes. Although Myriad has dabbled with next-generation sequencing technologies, Myriad has yet to announce any concrete plans to apply any of the increasingly numerous and powerful next-generation sequencing technologies to its BRACAnalysis testing.
Others, however, are moving rapidly in exactly this direction.
Personalized Medicine Regulation Needs More Than Band-Aids
[Editor's Note: This post originally appeared as a guest column at Xconomy.]
Last week, New York State assemblyman J. Gary Pretlow introduced the descriptively named “act to amend the insurance law, in relation to requiring coverage for genetic testing in accident and health insurance polices.”
While not accompanied by a press release, or widely covered by media outlets, the bill merits close attention. While the substance of the bill is striking, its greater import lies in what it reveals about the United States’ current framework for personalized medicine regulation and in what the bill portends for the future of personalized medicine innovation and investment in this country.
Government Refuses to March-In Under Bayh-Dole—Again
The Bayh-Dole Act was in the news at the end of 2010. Three patients suffering from Fabry disease, a rare genetic condition that impairs the victim’s ability to metabolize fat and can lead to kidney failure and heart disease, petitioned the National Institutes of Health (NIH) to exercise the government’s “march-in” rights under Bayh-Dole (pdf) and compel the holder of the patent on the only FDA-approved Fabry treatment to grant licenses to other manufacturers. Just as it has in response to every previous march-in petition, the NIH refused the march-in request (pdf).
Bayh-Dole, From the Beginning. Enacted in 1980, Bayh-Dole was intended to promote the commercialization of government-funded research by allowing universities and other non-profits that receive federal grants—rather than the government itself—to own any resulting patents. This then-radical change in the law gave rise to the practice of technology transfer, whereby universities conduct sponsored research, patent the results, and then license the use of the patented inventions to spin-offs (which often involve the faculty inventors as principals) and other private companies.
2011 Personal Genomics Preview: It’s Déjà Vu…
Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:
1. Will the $1,000 genome live up to the hype?
2. Will personal genomics stay DTC?
3. How will the ongoing gene patent debate affect the progress of personalized medicine?
4. When and where will the next regulatory shoe fall?
5. Who will control the data?
A year later the question that comes first to mind is, has anything really changed?
The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.
With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.
Prometheus Unbound—Again
The latest news from the field of biotechnology patents is in: the Federal Circuit has handed down its opinion (again) in Prometheus v. Mayo (pdf), the closely watched diagnostic method case. The verdict is the same as before: Prometheus’s patents satisfy the § 101 test for patentable subject matter.
On Monday, we wrote about the Federal Circuit’s first post-Bilski method patent decision: Research Corporation Technology v. Microsoft. In analyzing RCT we argued that it was “a good bet that the Prometheus and Myriad patents, and others like them, will survive § 101.” That bet paid off today in Prometheus and, based on the signals the Federal Circuit sent in that opinion, we think it is increasingly likely to pay off again in Myriad in the form of at least a partial reversal (more on this below).
Applying Bilski means Business as Usual. Way back in June, when the Supreme Court decided Bilski, it not only failed to provide lower courts (including the Federal Circuit) with meaningful guidance for biotechnology method patents, it arguably failed to provide meaningful guidance about anything at all. Despite predictions that Bilski might fundamentally reshape the patent landscape, the Court’s fractured opinions produced little in the way of binding law. The clearest statement from the Court was that the machine-or-transformation test for method patentability, which the Federal Circuit had previously deemed an exclusive test, was in fact only a “useful and important tool.” (Other useful and important tools were not, however, enumerated.)
A Hint About Where the Federal Circuit Is Going with Method Patents?
GLR readers will recall that just last summer the Supreme Court passed-up a major opportunity to clarify the status of method or process patents. The patentability of business methods, computer-implemented processes, and diagnostic and other medical methods has long been both controversial and uncertain. In Bilski v. Kappos, the Court confronted a method for hedging against fluctuations in commodities prices. All nine justices thought the method was too abstract to comprise patentable subject matter as defined in section 101 of the Patent Act, but they couldn’t agree on why. The five-member majority held that the machine-or-transformation test (which states that the method must be tied to a particular machine or change something into a different state) propounded by the Federal Circuit in its initial Bilski decision could not be the exclusive test for patentability, but it failed to come up with a test of its own.
The day after issuing its decision in Bilski, the Supreme Court dealt, temporarily, with another closely watched case, Prometheus v. Mayo. In Prometheus, the Federal Circuit used Bilski’s machine-or-transformation test to uphold a method for administering a drug, measuring its level in the body, and then adjusting the dosage. The Supreme Court granted certiorari in Prometheus, as well as in a similar biotechnology method case (Classen Immunotherapies v. Biogen IDEC), and then immediately vacated both decisions and remanded the cases to the Federal Circuit for reconsideration in light of Bilski. Neither of those decisions have yet been issued by the Federal Circuit.
Restricting Gene Patents: A Pro-Market Agenda
This commentary is contributed by James P. Evans, clinical professor genetics and medicine at the University of North Carolina and Editor-in-Chief of Genetics in Medicine.
Gene patents have been controversial since they were first granted in the US over two decades ago. The controversy is now reaching a fevered pitch after a surprising US District Court decision which held that human genes are not legitimately patentable and an amicus brief by the Department of Justice largely in support of this contention. How this case will be decided by the Court of Appeals for the Federal Circuit and the Supreme Court (should it accept the inevitable appeal) is anyone’s guess.
But in spite of what might be suggested by the rhetoric often accompanying this debate, the questions at hand are amenable to logical analysis and the application of evidence. Such an analysis argues strongly that if patents on naturally occurring genes are ultimately ruled out of bounds, the net effect on commerce would be positive.
Swine Soar Higher in Myriad Thanks to US Government’s Amicus Brief
This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC).
After several months of courtroom quiet, the briefs began rolling in to the CAFC last week. Most, including Myriad’s own appellant brief (pdf), presented the argument we would expect. Myriad and its supporters frame Judge Sweet’s ruling as an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” (pdf) for the continued development of biotechnology.
And then there is the United States government. In an amicus brief filed on Friday (pdf) the Department of Justice (DOJ), on behalf of the United States, dropped a minor bombshell. Contradicting the longstanding policy of the United States Patent and Trademark Office (PTO), the government’s brief argues that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under § 101 of the Patent Act.
