Pending Litigation
Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis
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.)
Resolution in Florida Wrongful Birth Case
Tom Clarkson is a student at the University of Georgia School of Law.
The “Wrongful Birth” debate is in the news yet again. In a pair of previous posts (here and here) the Genomics Law Report highlighted several issues relevant to the debate over what happens when states recognize a cause of action for wrongful birth, wrongful life or wrongful conception. A recent example from Florida illustrates that the debate continues.
Aiden, Caleb and Smith-Lemli-Opitz. In 2002 Aiden Estrada was born with a number of severe birth defects. Despite multiple examinations, Dr. Boris Kousseff, Director of Medical Genetics of the University of South Florida College of Medicine, failed to diagnose the symptoms as Smith-Lemli-Opitz syndrome and informed Aiden’s parents that they could expect a “normal” pregnancy if they conceived again. Relying on these representations, Amara and Daniel Estrada conceived a second child in 2004. This second child, Caleb, was born with symptoms nearly identical to those of his brother Aiden. Within one hour of Caleb’s birth, a geneticist at the University of Florida diagnosed him with Smith-Lemli-Opitz syndrome. The Estradas sued, and a Florida jury awarded them more than $20 million dollars in their wrongful birth suit in July 2007.
Read the rest of this entry »
The Past, Present and Future of DTC Genetic Testing Regulation
[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision.
On Tuesday, Carmichael and five commentators examined what can be learned from a DTC genetic test. Yesterday, the topic was whether DTC genetic tests are trustworthy, and whether the results can be cause for concern. Today’s topic is the regulation of DTC genetic tests. In addition to several short commentaries, including a much shorter version of the piece below, Carmichael has also posted a lengthy interview with two top FDA officials on the subject of DTC genetic testing regulation.
The column below is an expanded version of what appears over at Newsweek. To see all of the commentaries in Carmichael’s series, click here.]
The recent media attention focused on direct-to-consumer (DTC) genetic tests has left companies, investors, consumers and even regulators scrambling to figure out what comes next.
As the situation stands today, companies and their investors live in a climate of unprecedented regulatory uncertainty, causing delays in the introduction of new products and rendering an already inhospitable economic climate – for both fundraising and sales – even more challenging. Commentators and regulators caution consumers that some DTC genetic tests may be unreliable or, worse, harmful, but have yet to provide clear tools and guidelines for evaluating competing tests. And regulators, including the FDA, must balance their mandate to protect the health and safety of the public with that same public’s desire for autonomy, while also recognizing that innovation is a prerequisite for a healthcare system that must continue to improve outcomes while reducing costs.
Clearly, something must change. But what will that change be? And how will the field of DTC genetic testing evolve? Will DTC be able to continue its current business while regulators and companies engage in protracted negotiations? Will oversight weed out the “snake oil salesmen” and permit legitimate companies to flourish? Will it drive all genetic testing (temporarily) out of the hands of consumers?
Or will the field change in a dramatic and completely unexpected way?
European Court Issues Gene Patent Ruling Against Monsanto—A Myriad Connection?
In another significant international development, on July 6, the Court of Justice of the European Union (more commonly known by its old name, the European Court of Justice or ECJ) ruled against Monsanto Technology LLC (pdf) in its suit against an Argentine company called Cetera and several other parties.
The Court sat in a 13-member Grand Chamber, which is eurojargon for “really big deal,” and issued a ruling which leaves gene patents essentially intact but warns national courts to construe them carefully. (Travel advisory aside: If you ever have a chance to visit the Court in Luxembourg, do. Its magnificently robed judges sit in medieval splendor in a hideous modern building. Lawyers (usually several per case), robed almost as magnificently, read long and pompous arguments that are translated into many languages. The judges, apparently having already decided the case, ask no questions and seem to pay no attention. The rulings are logically convoluted and delivered in baroque language. Everyone seems immensely pleased with the spectacle.)
The Unintended Consequences of Katie’s Law: More DNA Samples Collected, More DNA Samples Untested?
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.
Breaking: Biotech and the Supremes: Prometheus Follows Bilski to Highest Court (For Just a Moment)
Yesterday the Supreme Court issued its decision in the highly anticipated patent case, Bilski v. Kappos. Contrary to some expectations, the Court decided Bilski on narrow grounds, leaving the state of biotechnology patents largely untouched. Here is part of what we wrote yesterday:
Although the Court’s narrow ruling left a direct treatment of the difficult issues surrounding biotechnology patents for another day, those issues continue to loom large. As of this writing, a petition for certiorari in the Prometheus case is currently pending before the Supreme Court. In Prometheus, the Federal Circuit court applied the MoT test in a biotechnology context, upholding a patent on a method for improving administration of a drug. If the court grants review of the Prometheus decision, the biotechnology world will have another Supreme Court nail-biter on its hands, beginning with the oral argument next fall. Even if the Court denies certiorari in Prometheus, a number of alternate channels for biotechnology patent reform remain open, including the ongoing Myriad gene patent litigation (which itself might eventually reach the Supreme Court), the SACGHS gene patent recommendations and even private, industry-driven discussions (of which rumors abound).
The Court wasted no time resolving the will-they-or-won’t-they Prometheus question. In an order issued today (pdf) the Supreme Court granted certiorari and then immediately vacated the decision and remanded the case to the Federal Circuit for consideration in light of Bilski. With Bilski in the rearview, and Prometheus back to the Federal Circuit, speculation will now shift to the question of what, if anything, the Federal Circuit will do differently with Prometheus the second time around. Let the waiting begin anew.
Bilski and Biotech: Business As Usual, For Now
Earlier today the Supreme Court handed down its opinion in what some patent observers have termed “the most highly anticipated patent decision of all time“: Bilski v. Kappos (pdf). The Bilski case was widely watched not for the significance of the particular patent at issue but for the far-reaching effect on patent law that the case might have.
Would the Court treat Bilski as a referendum on the patentability of so-called “business methods”? Would it speak more broadly still, using Bilski as an opportunity to clarify the patentability of a range of emerging technologies, particularly in the areas of software and biotechnology? These questions took on added significance for biotechnology companies, investors, researchers and observers earlier this spring when a federal court in New York used Bilski’s machine-or-transformation test to invalidate several of Myriad Genetics’ diagnostic method claims.
Breaking: Supreme Court Affirms Bilski
This morning the Supreme Court released it’s highly anticipated opinion (pdf) in the Bilski v. Kappos case. The Court affirmed the Federal Circuit’s rejection of petitioners’ patent (a method for commodities hedging), although Justice Kennedy’s majority opinion rejects the Federal Circuit’s conclusion that the so-called “machine-or-transformation test” is the sole test for determining patent eligibility of a “process” under §101 of the Patent Act.
Justice Kennedy’s opinion does make clear, however, that simply rejecting the machine-or-transformation test as the exclusive test does not mean that the Court is taking a broad view of business method patents, or of process patents more generally. As he writes:
With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles. Nothing in this opinion should be read to take a position on where that balance ought to be struck.
Bilski has been closely watched because of what it might mean for the future of biotechnology patents. Now that we finally have an opinion from the Supremes, what, if anything, can we conclude? We’ll check back in later today with more detailed analysis of the opinion and some preliminary answers to that question. In the meantime, happy reading.
Is Something Brewing with Bilski?
A few tidbits of news for conspiracy theorists and others who are still waiting for the Supreme Court’s Bilski decision:
According to the Court’s case information service, Bilski is still “awaiting decision.” No news there. But in a recent comment, Chief Justice Roberts indicated that the Court would finish its work for the term by the end of June. The Court typically issues opinions on Mondays and Thursdays, and the last one of those in June is next Monday, June 28th. So whatever the Court is going to do with Bilski, it will apparently do it at the start of next week. Still no clue as to what that might be. Except . . .
Read the rest of this entry »
Myriad Gene Patent Litigation Goes Down Under
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.
