By: Sophia Jeon, Ph.D.
Patent law and Intellectual Property
Accusations of errors and deception fly in CRISPR patent fight
Clustered regularly-interspaced short palindromic repeats, better known as CRISPR, is getting a lot of attention as a promising molecular engineering technique that can easily edit genes in laboratories and potentially, for therapeutic uses. Last year, Chinese researchers successfully used the technique in human embryos, raising serious ethical concerns. Perhaps designing your own pets or human babies won’t happen in the immediate future but before CRISPR can even be considered for any commercial use, two research teams at UC Berkeley and at the Broad Institute will have to settle the issue of who gets to benefit financially from its use.
In May 2012, a team led by UC Berkeley’s Jennifer Doudna submitted a patent application for CRISPR-Cas9 technology. Several months later in December 2012, Feng Zhang’s research team at the Broad Institute also initiated the process to file for a patent but ended up getting the patent before Berkeley team since they used the expedited review program. The Berkeley team requested a patent interference, which will determine who actually invented the technology first. However, the issue becomes a bit more complicated by the fact that in March 2013, the U.S. patent law was switched to a system in which whoever files first gets the patent from a system that awarded patent to whoever invented first.
So how does one go about proving that someone invented or thought of something first, especially in this age of open access journals and public data sharing? The investigation process could be messy and could take months, or even years. However, both sides seem to have a number of strategies to weaken each other’s arguments, revealing mistakes in the application process and pointing fingers at insufficient data or misrepresented information in the application. Patent fights like this aren’t too rare with biotechnologies that could be used commercially (e.g. the recent lawsuit surrounding DNA sequencing technique between Oxford Nanopore Technologies and Illumina, Inc.) but it is interesting to see such a huge legal dispute between researchers from academia. (Kelly Servick, ScienceInsider)
Abortion law and Social Science
The Return of the D.I.Y. Abortion
In the recent years, abortion clinics have been vanishing from certain states (e.g. Texas, Mississippi, Missouri, North Dakota, South Dakota, Wyoming, Florida etc.) at a record pace. Planned Parenthood facilities are many of those clinics and these closures are partially due to passage of the bill to defund Planned Parenthood and other abortion restrictions in those States. However, the more important question is whether these restriction laws have actually result in lower abortion rates. Social scientists and health experts say there are multiple factors to consider. Some argue that abortion rates were going down even before clinic closings accelerated in the first place, due to increasing acceptance of single motherhood, the recession, and more effective birth control use.
How does law affect public health or more specifically, personal decisions regarding women’s bodies? Does limited access to abortion clinics make women turn to alternative methods such as self-induced abortion? It turns out that Google searches may provide some insight. Because there aren’t large enough surveys to track behavior in different states and also because surveys often don’t tell the real story (since people can lie), Seth Stephens-Davidowitz did an interesting study using Google searches to find correlation between the number of abortion clinics and interest in self-induced abortion. Sadly, the search terms he found related to self-induced abortion methods indicated that women might be driven to risky methods such as purchasing abortion pills online, punching one’s stomach, bleaching one’s uterus, or abortion using a coat hanger.
A previous study found that a vast majority of women would be willing to travel to other states with legal abortion if needed. However, underage girls or low-income women with unwanted pregnancy could be googling for and trying alternative abortion methods that could lead to adverse health outcomes. This June, the Supreme Court is expected to make a decision about a Texas law that restricts access to abortion clinics and whether or not it places an “undue burden” on women’s rights to abortion. The justices should make decisions based on hard evidence and well-balanced research. The study using Google search methods may be limited in certain ways as it is difficult to find out about their health outcomes or whether they actually succeeded in abortions, but it is one way to look at human behavior and how law could affect public health. (Seth Stephens-Davidowitz, New York Times)
Clinical Trials and Data Sharing
STAT investigation sparked improved reporting of study results, NIH says
The results of clinical trials are required by a federal law to be publicly reported on clinicaltrials.gov at the end of the trial. The goal is to promote transparency in any clinical research and to share data among the research community and physicians, as well as enhance patient empowerment by returning the results to the participants. However, according to a 2014 analysis published in JAMA, “a recent analysis of 400 clinical studies revealed that 30% had not shared results through publication or through results reporting in ClinicalTrials.gov within 4 years of completion.”
Last December, STAT also did a quite extensive investigation looking at clinical trials led by companies, universities, hospitals and even NIH-led trials to determine who actually reported their findings and how long after study completion. Many top research institutions failed to report on time and the federal government has not imposed fines on a single trial, which was “very troubling” according to the NIH director, Francis Collins said. Possible reasons for the delay in reporting are that the investigators continue to analyze data which can take a long time even after the trial has ended, that investigators wait until they publish their findings in a peer-reviewed journal and that in some cases drug companies intentionally want to hide negative results. Whatever the reason is, there should be consequences for withholding data that could be useful for doctors and patients.
The STAT investigation has named names and it seems to have worked. The data released by NIH showed that between December 2015 and January 2016, there was a 25 percent rise in new submissions and a 6 percent increase in reporting of corrected results for trial findings that had previously been submitted. Deborah Zarin, director of Clinicaltrials.gov, said the agency’s own outreach to researchers and training efforts are paying off as well. NIH is currently working on developing a new policy to clarify, expand, and enforce the requirements for clinical trial registration and results submission. (Charles Piller, STATnews)
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