Because of the decades-long struggles of the technology to live up to its hype, the term “gene therapy” has been heavily criticized for encouraging the “therapeutic misconception” and for conveying unwarranted “therapeutic optimism.” In addition, there is evidence of how clinical trial participants and investigators both overestimated benefits from research but also how research was framed as treatment. As a result, many recommended the alternative term “gene transfer” to more accurately represent the purpose and benefit of the intervention. We may never know exactly how much the use of the term “gene therapy” contributed to potential bias in perceptions of effectiveness and intent, but it does highlight the potential impact of language on the ethical conduct of research.
Similarly, the rhetoric surrounding the genetic “revolution” has been justly criticized. Our research published in Genetics in Medicine, the peer-reviewed journal of the American College of Medical Genetics and Genomics (ACMG), suggests that researchers and advocates should not only avoid hyperbole, but also be more cautious and reflective about the use of metaphors. We asked patients in a Northern California health system to tell us what the word biobank made them think of, and received a range of notable responses. Some people associated the term with financial banks or gold mines, and others expressed suspicion of commercial motives of pharmaceutical or insurance companies for collecting and using biosamples. Others associated the term with computers or databases, and some may have been misled by the association of biobank with the concept of electronically-accessible information, saying that a benefit of a health system’s research biobank-linked database was that patients could look up personally-relevant information in it directly and therefore not have to see a doctor. Continue reading →
Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.
Citation:Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019
Since its creation in 1982, the Court of Appeals for the Federal Circuit (CAFC) has been a magnet for controversy and criticism. While I do not align myself with those critics, it would be foolish to not acknowledge the problems that are present with the CAFC. For instance, for the vast majority of federal law, when law develops differently in different circuits, the Supreme Court is able to observe those developments, and decide which interpretation is most desirable. Because the CAFC has sole jurisdiction over patent law appeals, patent law is not subject to these circuit splits. While splits temporarily hamper uniform justice, they do allow for experimentation, enabling different legal interpretations to be tested in real life. In this way, splits can allow an appellate body to make a more informed decision regarding which interpretation should be followed.
The lack of circuit splits in patent law can be problematic, given accusations that the CAFC has succumbed to a form of institutional capture by the patent lobby. Critics highlight the CAFC’s decision in Amazon and eBay as evidence of this capture. In Amazon, the CAFC found a broad presumption of irreparable harm, allowing for broad extension of preliminary injunctions in future cases of patent infringement (even though they overturned the injunction at issue in the case). This patent-holder-friendly standard was ultimately overruled in eBay, after the CAFC applied its nearly automatic injunction standard. The Supreme Court overturned this decision, and dialed back the presumption, in large part because it was seen as too favorable to patent holders.
For those interested in the FDA’s decision to regulate 23andMe’s direct-to-consumer genetic testing service, it is worth reading a recent comment in Nature by Robert Green and Nita Farahany. The piece raises two core objections to the FDA’s decision that deserve further attention.
One objection is that the FDA’s decision runs contrary to “the historical trend of patient empowerment that brought informed-consent laws, access to medical records and now direct access to electronic personal health data.” Green and Farahany suggest that 23andMe and manufacturers of other consumer medical products (such as mobile health apps) “democratize health care by enabling individuals to make choices that maximize their own health,” and that we must not “stifle all innovations that do not fit into the traditional model of physician-driven health care.”
While I agree with Green and Farahany that we should not be locked into physician-driven health care, I am not sure that the information provided by 23andMe and medical apps is unambiguously “patient-empowering” and “democratizing” (a framing of personalized medicine that pervades both marketing materials and academic journals). Continue reading →