As should be noted for all court case analysis, I am not a lawyer.
On Monday the Supreme Court issued its opinion in Bowman v. Monsanto, a case involving a farmer (Bowman) attempting to use seeds that were descended from Monsanto-engineered seeds. Monsanto believes that its intellectual property covers not only the original seeds and any of their descendants. Bowman argued that the patents do not cover seeds replicated from the patented seeds. The doctrine of patent exhaustion typically means that the intellectual property rights cover only the first sale of a product (this preserves the possibility of used markets in a variety of goods).
The Court ruled unanimously in favor of Monsanto. Instead of considering what Bowman did as resale, the Court considered the replanting and harvesting of Monsanto-engineered seeds as copying, which does not fall under the protection of patent exhaustion. When Monsanto sells the seeds originally, the licensing agreement that must be signed permits selling the resulting seeds as a commodity, and while Bowman purchased the seeds from a grain elevator, he used them for a different purpose, thus violating the license.
The Court makes a point of stating it is limiting its ruling to this particular kind of ‘self-replicating product’
“Our holding today is limited — addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose.”
While the opinion specifically mentions software programs, I can see the possibility that gene patents could be considered as self-replicating products. How that argument might fare legally is unclear to me. I can see it being interpreted as like making copies, but since the associated uses of the gene patents like the Myriad case is not in discrete products like seeds, I’d resist making such a clear parallel. We should see how the Court looks at this very soon.
In what Nature has characterized as the first time a scientist has gone to trial over an academic laboratory accident, University of California, Los Angeles faculty member Patrick Harran will stand trial over the 2008 accident involving research assistant Sheharbano Sangji. Sangji died as a result of burns suffered as a result of handling tert-butylilithiumm. Chemical and Engineering News has covered the case extensively, and I would encourage you to read it to better understand the specifics of the accident and associated charges.
Harran and the University of California Regents were charged in late 2011 with willful violation of laboratory health and safety guidelines. In the summer of 2012 the Regents were dismissed from the case after a plea agreement. This agreement included an admission of responsibility for substandard lab conditions, improved support of comprehensive lab safety, a scholarship in the victim’s name, and monetary penalties (in addition to fines already assessed). Harran’s attorneys have offered a vigorous defense, and given that the charges in question involve willful violation of regulations (rather than negligence, which could be an easier charge to prove), the outcome of the trial is far from certain. A settlement/plea bargain may still take place, Dr. Harran may be found not guilty, or he could serve as many as four and one-half years if convicted.
What is even less clear is the impact this case may have on the behavior of universities, lab directors and supervisory researchers. Lab safety seems to an afterthought in way too many labs. Perhaps someone going to jail may prompt a change in action, but I’m afraid it won’t be sufficient. It could be too easy to dismiss this case as an outlier, and continue with the lax attitude toward safety that has claimed too many lives.
Courts in the United States have been perhaps the biggest entity that has resisted the intrusion of technology into its proceedings. Even in instances where the technology has been adopted, making the results of it widely available has not been a priority. The U.S. Supreme Court is perhaps the best known example, where only in 2010 were recordings of oral arguments released in the same week as the session. However, the Court had been recording arguments for decades, making them available long after the sessions that were recorded, and typically not for duplication.
NPR has reported (H/T Language Log/Twitter) that the archive, which dates back to 1955, has been digitized and made available at the Oyez Project (more recent recordings have been available via the Supreme Court website). A cursory review indicates that recordings are not available for every case, something more clear the further back you go. Presumably this is due at least in part to there not being recordings for all cases since 1955. Oyez is looking to expand the availability of these recordings, and is working on smartphone application versions of the archive.
In what appears to be a classic case of agencies not talking to each other, the Food and Drug Administration (FDA) and the Department of Justice are sending mixed messages in response to a recent court decision on the emergency contraception Plan B.
On Tuesday the FDA announced that they have approved a petition to allow the marketing of Plan B One-Step to women 15 years and older without a prescription. The court order stipulated that emergency contraception should be made available without age restrictions, and is supposed to take effect on May 6. The FDA apparently is trying to dodge the order in its announcement by stating this is a separate petition from the one subject to the court order.
To complicate matters a bit, the Justice Department has announced it will appeal the court order. It has filed a petition for a stay of the order pending the appeal. It’s grounds for appeal relate to what the Department sees as an overreach of the judge’s authority. There’s a touch of irony here as the judge claimed that the actions of the Secretary of Health and Human Services in this matter were unprecedented, at least implying an overreach of her authority (pages 37 and 39).
Independent of the litigation over access to Plan B without age restrictions, the FDA announcement lowering the age restriction (without a prescription) to 15 will take effect immediately. Per the announcement:
“The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.”
The petition requesting a stay of the court order requested a decision by the end of today, as the order is due to take effect soon.
In late 2011 Health and Human Services Secretary Kathleen Sebelius overruled the judgment of the Commissioner of the Food and Drug Administration (FDA) to prevent the availability of emergency contraception over the counter for girls under 17 without a prescription. The decision was the culmination of a review ordered by a federal judge in 2009 in part to counter political interference in a scientific review of emergency contraception. The Secretary attempted to provide scientific justification for her decision, which included concerns that the studies used in the review did not cover all ages that could possibly be provided access if the drugs were made available over-the-counter. As I noted shortly after the decision, she made her decision a fight over science. That reflected my lack of knowledge of the ongoing case.
Last week the federal judge that ordered the review issued another order chastising the Department for its decision. As it did back in 2011, the Obama Administration stands by Secretary Sebelius and her decision.
The judge essentially concluded that the kinds of political interference that prompted the first review – connected to a previous administration – persisted into the current administration. From page 11 of the Order:
“In my 2009 opinion, I traced the evidence demonstrating that the conduct of the FDA was influenced by the Bush White House, acting through the Office of the Commissioner of the FDA, and I held that this kind of political interference called into serious question the legitimacy of the FDA’s decision. In the present circumstances, the political interference came directly from the Secretary of Health and Human Services, a member of the President’s Cabinet.”
The case that he is dealing with is a Citizen Petition (filed in 2001, with the lawsuit following in 2005) to have the FDA “make all levonorgestrel-based emergency contraception, including Plan B, available for over-the-counter sales without age or point of sale restrictions.”
The judge has ruled that the FDA must make levonorgestrel-based emergency contraception available over-the-counter without a doctor’s prescription or point-of-sale or age restrictions. The agency has 30 days from the date of the order (April 4) to comply.
Four updates addressing recent developments in ongoing stories:
Several of the Obama Administration’s recent agency nominations have moved forward in the confirmation process. Energy Secretary nominee Ernest Moniz testified at his confirmation hearing last week. In a nice contrast to recent Cabinet-level confirmation hearings, there was little drama. Gina McCarthy’s recent confirmation hearing to become the next head of the Environmental Protection Administration (EPA) was not so genteel. Given that both McCarthy and Moniz come to their agency’s top jobs with prior agency experience, I believe the difference can be attributed to the relatively hostile reaction the EPA generates in many quarter. The Senate confirmed new Secretary of the Interior Sally Jewell last Wednesday. Still no official word on the next nominee to be Director of the National Science Foundation.
The Supreme Court will hear arguments this week in the Myriad Genetics case. It will be limited to whether the genes at issue in the case would be patentable. I would not expect an opinion before the end of June.
This is not a post about arguments heard this week by the Supreme Court on matters related to same-sex marriage. It’s about two cases recently decided on the use of dogs to sniff out contraband or illegal products (H/T The Atlantic).
On Tuesday the Court ruled on Florida v. Jardines (H/T SCOTUSBlog) The case concerned the use of a dog in obtaining a search warrant for a residence. The residence was staked out based on an anonymous tip. A drug-sniffing dog and his handler walked onto the porch. The dog went into alert at the base of the door. That sniff was used to obtain a search warrant. But in the majority opinion (and the concurring opinion), the dog was not the critical element. The porch is considered part of the house based on prior cases, so the act of walking on the porch without a warrant invalidated anything that would have resulted from information gathered there. The dissenting opinion disagreed on both the notion of the porch being part of the house and on whether odors from within the house that drift out retain Fourth Amendment protection.
The other dog matter, Florida v. Harris, concerned a sniffer dog outside of a truck, rather than a house. Since the truck was in public, the question of whether the dog sniffing the outside of the truck constituted a search requiring a warrant doesn’t apply. At issue was the dog’s expertise, for lack of a better word. Because the dog sniffed the truck on two separate occasions. Complicating matters, the second time the dog sniffed, he signaled that there was something, but there wasn’t. And even with the first incident, none of the drugs the dog was trained to sniff were found. An arrest was made based on the large amount of materials present that could be used to make crystal meth. The dog was trained to sniff out methamphetamine, but none was found in the truck in either stop.
The judge in the Italian trial that sentenced seven scientists and engineers to six years in prison over their earthquake risk assessment has issued the formal explanation of his verdict. Judge Marco Billi, over the course of 950 pages, explains how the defendants were guilty – not of failing to predict an earthquake – but of not effectively assessing and communicating the risk of quakes during a swarm of them in the L’Aquila region in April 2009. As Judge Billi wrote (per The Guardian)
“The task of the accused … was certainly not to predict the earthquake and indicate the month, day, hour and magnitude, but rather, more realistically, to go ahead … with the ‘prediction and prevention of the risk’”
The judge goes on to link the failure of the defendants to 29 of the 309 fatalities in the April 6 quake, and four of the injuries. He argues that the defendants failed to consider existing studies on earthquake risks, and did not effectively communicate that risk to the public. Judge Billi wrote, per ScienceInsider, that
“The deficient risk analysis was not limited to the omission of a single factor,” he writes, “but to the underestimation of many risk indicators and the correlations between those indicators.”
While the defendants are resistant to the judge’s arguments, there is a relative silence from those who vociferously objected to the verdict, if not the entire proceedings. As the judge’s reasoning undercuts the dominant narrative of this trial being all about earthquake prediction, it would not surprise me to see the silence continue. You may not consider this trial an effective means of holding officials accountable for their actions (I’m not sure all those responsible have been so held). Regrettably, the rhetoric it sparked has not allowed for an effective discussion of the obligations of scientists and engineers in their public statements. The judge’s official reasoning isn’t likely to change that.
The defendants have 45 days to lodge their appeal (which is expected), and will remain free until that process is completed. It will likely take years.
A little over a year ago I speculated as to when the Supreme Court would hear the lawsuit over the Obama Administration policy allowing federal funds to be used to support embryonic stem cell research. While my prediction of early 2013 may seem accurate based on last week’s action, in truth the Court had to have the case since last fall in order to review the matter and decide whether to hear the case. The petition was filed by plaintiffs in October.
According to SCOTUSBlog, the Court gave no comment when it denied the petition to hear the case. While the issue of NIH stem cell research policy could still be opposed, those not in favor will need to pursue their case through either Congress or the Executive Branch. The latter is not happening during the current administration, and the former seems unlikely given the inability of Congress to pass much of anything.
Of course, the injunction that plaintiffs sough after filing the lawsuit back in 2009 didn’t last long in court. While the resolution of this case reduces the uncertainty involved in pursuing federal money for embryonic stem cell research, I’m not sure that was much of a problem for researchers.
The Department of Justice recently announced its plea agreement with Transocean Deepwater Inc. (Transocean), the contractor that operated the Deepwater Horizon oil rig on behalf of BP (H/T ScienceInsider). Deepwater Horizon failed spectacularly in a 2010 spill, and will be paying $1.4 billion in fines and penalties for violations of the Clean Water Act. Nearly three-quarters of the money in the agreement for BP were designated for various research and restoration efforts. The National Fish and Wildlife Foundation and the National Academies received the bulk of this money.
The money Transocean must pay will also have set-asides for research, and the same entities are getting additional money. You can read the full agreement here. Transocean will pay the National Academies $150 million as part of the Academies’ 30-year program on health and environmental protection in the Gulf of Mexico. The National Fish and Wildlife Foundation will also receive $150 million to support restoration efforts along the Gulf Coast, especially in Louisiana.
The plea agreement is specific to the criminal violations. The civil settlement relates to fines under the Clean Water Act, and per legislation passed last year, eighty percent of the fine money will be committed to the five states of the Gulf region. (Ordinarily such fines would be pooled in a nationwide fund.) Those fines total $1 billion dollars.
The investigation into the spill continues, so there may be more agreements and settlements forthcoming. Whether research and restoration gets more of any additional money will depend on what the investigation finds.