Just about everyone interested enough in genomics and the law to read this post will know that the American Civil Liberties Union waged a long and ultimately successful legal campaign to invalidate Myriad Genetics’ patent claims to isolated BRCA genes, mutations of which are linked to breast and ovarian cancer. Now the ACLU has launched a second front, this time attacking Myriad’s post-patent business model of maintaining its vast and unique database of genotype-phenotype associations as a trade secret. GLR reported on that evolving strategy two years ago.
The new ACLU attack has, thus far, received modest attention in the scientific press, and some of what has been reported is inaccurate. In this post I will briefly review what has actually happened and then try to sort out fact from fiction in the reportage. The bottom line is that the federal government has not created new stealth regulations dealing with the disclosure of genomic data to patients. It has, however, used the practice of governance-by-guidance to make significant new policy, which is problematic enough in its own right.
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Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine)
The latest chapter in the Myriad gene patent litigation was written yesterday, with the Federal Circuit issuing its much anticipated opinion (pdf) after rehearing the case following the Supreme Court’s unanimous decision earlier this year in Prometheus v. Mayo.
Or perhaps we should say that the latest chapter was “rewritten” as, in a move that surprised approximately nobody, and as we predicted earlier this spring, the Federal Circuit reached precisely the same result in its opinion today as it did last July when it issued its first substantive ruling in the Myriad litigation. Below, we examine how the Federal Circuit applied Mayo to Myriad, what the next step in the Myriad litigation is likely to be (spoiler alert: it’s another appeal) and why we think the final opinion in this case, whenever it arrives and whatever it says, might not matter all that much.
Applying Mayo to Myriad. As mentioned, the only major change since the last time the Federal Circuit ruled in Myriad, and the reason for the re-hearing, was the Supreme Court’s decision earlier this spring in Mayo.
However, Mayo was about method patents and the boundary between a patent-eligible method and a law of nature. It was not about product patents or the product of nature doctrine. Since the Federal Circuit had already invalidated all but one of Myriad’s method patents even before the Supreme Court tightened the criteria for method patents in Mayo, it was hard to see much of substance changing the second time around.
As we suspected they might, the plaintiffs in Association for Molecular Pathology v. Myriad Genetics have filed a petition (pdf) seeking a rehearing of the recent federal Circuit decision. More surprisingly, Myriad has also, though its petition (pdf) is very narrowly focused.
The Plaintiffs’ Petition. Two things are interesting about the plaintiffs’ petition from a procedural standpoint. First, the ACLU lawyers requested rehearing by the three-judge panel that decided the case earlier this summer, not en banc rehearing by all members of the court. (But a majority of the judges of the full court could still decide to rehear the case en banc; they could do so if they found that the case “involves a question of exceptional importance.”) Second, the plaintiffs have asked for rehearing on only two of the issues they lost: that isolated genes are proper subject matter for product patents, and that only one of the named plaintiffs—Dr. Harry Ostrer, formerly of NYU—has standing to bring the case. The plaintiffs did not challenge that portion of the panel’s decision that upheld—unanimously—Myriad’s patents on a method of screening potential cancer therapeutics.
The Federal Circuit’s long-awaited decision (pdf) in Association for Molecular Pathology v. USPTO (the Myriad gene patent litigation) was issued this past Friday. As we were writing, with the economy having slowed to a barely perceptible crawl and a government default looming more likely by the hour, there were plenty of reasons to believe that the sky was falling. But the Myriad decision was not, and is not, one of them.
For the most part, the Federal Circuit’s 2-1 decision returned the law to the state it was in before District Judge Sweet’s opinion turned things upside-down last March. Although full of interesting rhetoric, the court’s three lengthy opinions (a total of 105 pages) are less remarkable for what they decide than for what they invite higher authorities—the Supreme Court and the Congress—to decide down the road.
First, the scorecard. The court’s judgment—that is, the holding, or outcome—was joined by Judges Lourie and Moore. A third member of the panel, Judge Bryson, dissented in part, meaning that he joined only a portion of the judgment (more on that below) and disagreed with another part.
[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.
As we wrote yesterday, last week the Equal Employment Opportunity Commission (EEOC) issued definitive rules and regulations (pdf) with respect to Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). In our previous post we offered a brief overview of the new regulations, as well as some preliminary suggestions for employers just now coming to grips with GINA.
We also promised to take a closer look in today’s post at several substantive features of the EEOC’s new regulations.
Defining the Terms. The EEOC, the government agency generally responsible for enforcing federal employment nondiscrimination laws, was the logical choice to promulgate regulations under GINA’s Title II, which governs the use of genetic information by employers and similar entities. But not all of GINA’s statutory provisions were within the EEOC’s area of expertise.
Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of the Myriad holding: that isolated DNA sequences are not necessarily patentable.
Judge Dyk’s comments were a bolt out of the blue, as he raised an issue that had not been addressed by the parties or the lower court. Because he is a member of the court that will decide Myriad in the next year or so, Judge Dyk’s comments might be more significant than the district court opinion itself. (The case is Intervet Inc. v. Merial Ltd., Fed. Cir. 8/4/2010.)
Last month, we discussed a bill nicknamed “Katie’s Law” that would give states financial incentives to collect DNA samples from individuals arrested for certain crimes. At the moment, less than half of the states currently collect DNA samples from these arrestees. If Katie’s Law were enacted, the remainder of the states would likely expand the scope of their DNA collection practices, greatly increasing the number of samples collected.
But once DNA samples are collected, when are they actually analyzed? As discussed by Christopher Heaney and Sara Huston Katsanis in The Contra Costra Times, many states currently have considerable backlogs in testing DNA samples, including those collected from convicts, arrestees and victims. Katie’s Law, by increasing the number of samples that require analysis, is likely to exacerbate these backlogs. Worse yet, Heaney and Katsanis point out that other federal funding awards are determined by the size of a state’s backlog—the larger the backlog, the more funds the state can receive. While the intent of Katie’s Law is to expedite the delivery of justice, there is concern that its practical effect may indeed be just the opposite.
On Tuesday, June 9, 2010, several plaintiffs, including a breast cancer patient and a cancer advocacy group, sued in a Sydney, Australia federal court to invalidate Myriad Genetics’ patents on the breast cancer susceptibility genes BRCA-1 and 2. According to published reports and comments by Australian patent law experts, the suit substantially tracks the much-publicized one filed in New York by the American Civil Liberties Union. In particular, this suit is also a frontal attack on the Myriad patents, seeking a judgment that genes in isolation from the body are products of nature and thus not patentable inventions.
The factual background in Australia seems a bit different. Myriad has granted an exclusive license to perform BRCA gene tests to a Melbourne company called Genetic Technologies Limited, which is a co-defendant in the case. But GTL has been reported to have “gifted” its patent rights to health care institutions, and not to charge royalties. Nonetheless, the plaintiffs’ lawyers have expressed concern about the possibility of GTL exploiting their monopoly as in the U.S., where the tests cost over $3,000. They note that on two earlier occasions GTL sent letters to hospitals telling them to stop testing. A number of Australian sources have also worried aloud about the implications of the patents for medical research.
A few weeks back, we posted a discussion of the issues surrounding the current system of forensic DNA profiling, with an emphasis on the Combined DNA Index System (CODIS). In that post, we noted that the federal government had enacted a policy of taking DNA samples from individuals arrested for certain crimes and retaining the samples in CODIS. To date, 23 states have enacted similar laws, and the federal government may soon give the other 27 states incentives to follow suit.
On May 18, the House of Representatives passed the Katie Sepich Enhanced DNA Collection Act of 2010, informally known as Katie’s Law.1 Under the bill, those states that collect DNA from individuals arrested for certain serious crimes (murder, voluntary manslaughter, serious sexual offenses or serious kidnapping offenses) and compare the samples to those in the CODIS database at least once receive a 5% bonus on certain federal crime prevention grants.2 States that also collect samples from individuals arrested for less serious crimes and submit all profiles collected from arrestees for inclusion in CODIS would instead receive a 10% bonus. The bill is now with the Senate Committee on the Judiciary.