Innovative treatments (ITs) have a distinct SIROT pattern: they often show, and are expected to show, significantly improved results over time. Of the four IT categories discussed, two stand out: SIROT treatments which are currently not in the patient’s best interest (BI) but will become superior treatment over time (category 3), and treatments which are already arguably BI but will clearly become the superior option as they improve with time (category 2).
There is a strong fairness argument to compensate patients injured from ITs because their injury led to improved knowledge benefitting future patients. By analogy to private necessity, IT patients should be considered ‘rescuers’ entitled to costs reimbursement, since future patients receive an incontrovertible benefit inextricably linked to their loss. Crucially, category 2 patients also deserve compensation, notwithstanding that their treatment was BI.
From an efficiency perspective, patients should avoid only irresponsible ITs (category 4) but they are not well-placed to identify such treatments. Patients’ incentives to submit to ITs are no worse, and perhaps slightly improve under strict liability (SL): SL might incentivise patients to undergo a treatment whose prospect as BI is in doubt but is likely to be SIROT. Finally, while under SL (but not negligence) category 2 cases yield liability, which may deter physicians from offering ITs, reputation loss under SL is lessened, so physicians’ incentives may improve (and they also have strong non-legal incentives to offer ITs).
No-Fault (Strict) Liability for Injuries From Innovative Treatments: Fairness or Also Efficiency by Tsachi Keren-Paz :: SSRNJanuary 2, 2019
In the three years since the US Supreme Court’s decision in AMP v Myriad, there has been much debate and speculation about the impact of the Myriad case on the biotech industry, particularly on the status of gene patents. Was it a significant decision or, as Lord Tennyson might have argued, just another decision in a myriad of single instances that make up a confused and confusing law of patents?
This paper connects ideas from recent literature on the economics of intellectual property (IP) to address the question: Did the strengthening and broadening of IP rights from important patent policy changes in the US promote greater innovation? The analysis rests on the theory of cumulative innovation, which shows that if IP rights on a pioneer invention extend to follow‐on research and impediments to contracting exist, then strengthening patents can actually reduce overall innovation. Recent empirical studies are consistent with the theory: patents can significantly deter follow‐on research in “complex” technology areas where contracting is difficult (computers, electronics, telecommunications) but not in drugs, chemicals and human genes. I outline remedies from court decisions and antitrust policy for addressing inefficiencies from patent trolling, patent thickets and the anti‐commons of fragmented ownership. I then apply the analysis to the antibiotics market, drawing on recent research, to examine how patent and competition policies can be used to improve incentives for drug development in the battle against antibiotic resistance. The literature provides persuasive evidence that the policy changes overreached in broadening and strengthening IP rights and reveals important patent reforms for improving the effectiveness of patent systems in the US and Canada.
The need to supply consumers with healthier food and beverages constitutes an urgent priority as many people in both industrialized and developing countries struggle with obesity and other non-communicable diseases (NCDs) caused by the consumption of unhealthy products.This article makes the point that patents may contribute to fighting such illnesses. Three proposals are put forward. The first and second proposals give healthy food inventions a preferential treatment with a view to speeding up or facilitating their patenting process. The third proposal would consist of excluding from patentability certain food inventions if it is proven that the relevant products or processes are harmful to human health. Such proposals would comply with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and are in line with the general aim of the patent system, namely encouraging (before) and rewarding (later) the creation of inventions really useful to society.
Protecting Patient Privacy in Cyber Environments by Jos Aarts, Samantha Adams, Bonnie Kaplan, Paul R. DeMuro, Anthony E. Solomonides :: SSRNDecember 1, 2016
Confidentiality in the medical encounter is crucial to providing adequate patient care. Health data is therefore privileged and protected by legal mechanisms. Health systems use electronic records and large-scale databases. Increasingly consumers use also IT to collect, store and share data about daily life and health behaviors. Sharing data via network-based systems or storing it ‘in the cloud’ produces multiple ‘digital selves,’ health ‘data doubles’ and ‘virtual patients.’ With so many stakeholders involved much data is produced without clear governance structures, blurring the view of what is done with the data. These problems are exacerbated through the networked, distributed nature of health data collection and convergence of protected hospital systems, commercial collection and aggregation of data and consumer health technologies. This brings patient privacy into the realm of cybersecurity. This panel explores how cybersecurity impacts the governance of critical IT infrastructures and mitigation of threats, what sociotechnical challenges are related to protection of large-scale HIT systems, how surveillance and bioethics studies seek to understand threats to personal privacy in the context of networked technologies and finally what changes to laws and regulations would be required.
Metaphor after Myriad: The Effect of Legal Rhetoric on Intellectual Property Protection for Biological Sequences by Charlotte A. Tschider :: SSRNNovember 13, 2016
The Association for Molecular Pathology v. Myriad Genetics (‘Myriad’), the U.S. Supreme Court’s first code-level determination of patent eligibility for biological sequences, ultimately barred isolated DNA patents in the United States while granting patent protection of cDNA. Myriad’s decision has, since 2013, continued to pose questions regarding legal protection for biological sequences as a whole: which types of biological sequences are patent-ineligible, and what legal strategy organizations should use to protect these sequences. As biotechnology companies continue to perform genetic testing and market pharmacogenomics products to the general public, the industry will likely demand appropriate legal instruments to safeguard significant investment in research and development. Although no clear direction has emerged for protecting biological sequences holistically, analyzing metaphors used in the Myriad decision may suggest a legal direction compatible with court reasoning. Based on metaphors used most prevalently in Myriad, courts seem to suggest thin compilation copyright and trade secret protection offer potential solutions for legally protecting biological sequences.
We describe the broad range of uncertainties faced by the developers of medical technologies. Empirically, we estimate the asset market incidence of two realizations of uncertainties we classify as within-market policy risks. The events we analyze concern the intellectual property of Myriad Genetics, Inc., an American molecular diagnostics firm. In July 2013, the Supreme Court invalidated several of Myriad’s intellectual property claims. Subsequently, the Center for Medicare and Medicaid Services reevaluated the reimbursements it pays for the services at issue in this patent litigation. We estimate that these events substantially moved Myriad’s market capitalization, by just under 25 percent in the case of the Supreme Court’s decision and nearly 20 percent in the case of CMS’s reimbursement rate re-determination. Myriad’s exposure to the realization of these intellectual property risks reflects its unusually high reliance on revenues linked to the services at issue. We discuss the implications of these risks for the total volume of medical innovation and for its organization across firms.