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.
Induced Infringement Heads to Supreme Court Amid Myriad Takeover Speculation
On Monday we wrote about the Salzberg Screen—a do-it-yourself alternative to Myriad’s BRACAnalysis test to identify deleterious mutations in the BRCA genes. We wondered whether the Salzberg Screen, which is intended to allow users to “circumvent [Myriad’s] gene patents,” could expose its designers to indirect patent infringement liability.
In a related development, this week the Supreme Court decided to hear a case (Global-Tech Appliances, Inc. v. SEB S.A.) that asks whether the legal standard for the ‘state of mind’ element of an inducement of infringement claim under Section 271(b) of the Patent Act requires “purposeful, culpable expression and conduct” or merely “deliberate indifference.” The Court’s decision, which will not come until next year, will bear on the degree of knowledge of an alleged infringer required to make out a claim for inducement of infringement.
A Do-It-Yourself Genomic Challenge to Myriad, the FDA and the Future of Genetic Tests
Over the weekend, Steven L. Salzberg and Mihaela Pertea published a short but significant article in the journal Genome Biology. In “Do-it-yourself genetic testing,” Salzberg and Pertea describe the creation of “a computational screen that tests an individual’s genome for mutations in the BRCA genes, despite the fact that both are currently protected by patents.”
The software-based test can be downloaded from the website of the University of Maryland’s Center for Bioinformatics & Computational Biology, where Salzberg is the director and Pertea is on the faculty. The test purports to test genomic sequence data against a set of known mutations in the BRCA genes. In addition to representing a conceptual alternative for those seeking to evaluate their risk of hereditary breast cancer, the so-called “Salzberg Screen” is also a direct challenge to Myriad Genetics, the FDA and the existing legal, regulatory and policy regimes that continue to struggle to keep pace with the science and technology of genomics and personalized medicine.
Below, we examine how the Salzberg Screen fits—or does not—within the current legal and regulatory landscape, as well as what it signals for the future of do-it-yourself genomics, whole-genome sequencing and the law.
Update: Continued Speculation on Myriad’s Motives Down Under
Last week, we wondered what Myriad Genetics had in mind by offering to surrender one of its Australian breast cancer patents as a “gift…to the people of Australia.” This week, in an interview with Turna Ray of the Pharmacogenomics Reporter, Luigi Palombi, director of the Genetic Sequence Right Project at The Australian National University, attempted to shed some light on the issue.
According to Palombi, “Myriad’s objective in surrendering the ['004 Patent] is to bring the proceedings to a premature end.” Palombi contends that Myriad’s effort to surrender the ’004 Patent (pdf) is designed to avoid Australian litigation that could set a harmful (even if non-binding) precedent in similar and ongoing U.S. litigation. Myriad, for its part, has so far refused to comment publicly.
A Successful Strategy? As we wrote last week, even if this is what Myriad intends, we are not so sure they will succeed. Offering up the ‘004 Patent for surrender may be a first step in heading off litigation, but without more it is difficult to explain (1) why the plaintiffs would accept the patent surrender, particularly given their stated objective (pdf) to use this litigation as a “test case” for the validity of gene patents or, (2) even if the surrender is successful, why the plaintiffs would refrain from bringing a second “test case” challenging one or more of Myriad’s other patents covering BRCA-1 and BRCA-2 and methods for diagnosing mutations in those genes. (The plaintiffs’ current complaint identifies several of these patents, but challenges the validity of only the ’004 Patent.)
Surrendering a Gene Patent: An International Twist in Myriad Debate
Several months ago we reported that a group of Australian plaintiffs had initiated litigation challenging the validity of Myriad’s Australian BRCA patents. Much like its U.S. counterpart, the Australian lawsuit represents a frontal attack on the patentability of genes.
Here in the U.S., the gene patent litigation shows no signs of reaching a swift resolution. Over the summer, Myriad appealed March’s widely-discussed district court ruling invalidating several of its key BRCA patents and claims, and the current appeal is unlikely to be the last, regardless of the outcome. In Australia, however, Myriad appears to be taking a different tack: offering to surrender its BRCA patent.
An Offer to Surrender. The development was first reported by the Australian news program Four Corners, which earlier this month ran a program (transcript) on the gene patenting debate and its impact on the availability of genetic testing in Australia. The program concluded with the following:
HHS Pulls the Plug on Genetics Advisory Committee
The clock has run out the Secretary’s Advisory Committee on Genetics, Health, & Society (SACGHS). As reported by Turna Ray of Pharmacogenomics Reporter, the committee, which reports to Health and Human Services (HHS) Secretary Kathleen Sebelius, will have its charter extended only long enough to conduct one final meeting next month.
According to Ray, SACGHS members were notified this week that Secretary Sebelius and NIH Director Francis Collins had determined that “the major topics related to genetic and genomic technologies had been successfully addressed by the committee through its comprehensive reports and recommendations over the years” and, for that reason, the decision was made “to sunset the committee’s charter.”
