Preserving patent policy space and securing access to medicines in developing countries: the role of states and pharmaceutical corporations

This thesis examines the tension between patent rights and the right to health and it recognizes patent rights on pharmaceutical products as one of the factors responsible for the problem of lack of access to affordable medicines in developing countries. The thesis contends that, in order to preserve their patent policy space and secure access to affordable medicines for their citizens, developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws. The thesis provides a systematic analysis of court decisions from four key developing countries (Brazil, India, Kenya, and South Africa) and it assesses how the national courts in these countries resolve the tension between patent rights and the right to health. Essentially, this thesis demonstrates how a model of human rights can be incorporated into the adjudication of disputes involving patent rights in national courts. Focusing specifically on Brazil, the thesis equally demonstrates how policy makers and law makers at the national level can incorporate a model of human rights into the design or amendment of their national patent law. This thesis also contributes to the ongoing debate in the field of business and human rights with regard to the mechanisms that can be used to hold corporate actors accountable for their human rights responsibilities. This thesis recognizes that, while states bear the primary responsibility to respect, protect, and fulfil the right to health, corporate actors such as pharmaceutical companies also have a baseline responsibility to respect the right to health. This thesis therefore contends that pharmaceutical companies that own patent rights on pharmaceutical products can be held accountable for their right to health responsibilities at the national level through the incorporation of a model of civic participation into a country’s patent law system.

Legal regulation of the software "patentable subject matter" requirement in the US and in Europe: The need for certainty, predictability and uniformity

This thesis critically investigates the divergent international approaches to the legal regulation of the patentability of computer software inventions, with a view to identifying the reforms necessary for a certain, predictable and uniform inter-jurisdictional system of protection. Through a critical analysis of the traditional and contemporary US and European regulatory frameworks of protection for computer software inventions, this thesis demonstrates the confusion and legal uncertainty resulting from ill-defined patent laws and inconsistent patent practices as to the scope of the “patentable subject matter” requirement, further compounded by substantial flaws in the structural configuration of the decision-making procedures within which the patent systems operate. This damaging combination prevents the operation of an accessible and effective Intellectual Property (IP) legal framework of protection for computer software inventions, capable of securing adequate economic returns for inventors whilst preserving the necessary scope for innovation and competition in the field, to the ultimate benefit of society. In exploring the substantive and structural deficiencies in the European and US regulatory frameworks, this thesis develops to ultimately highlight that the best approach to the reform of the legal regulation of software patentability is two-tiered. It demonstrates that any reform to achieve international legal harmony first requires the legislature to individually clarify (Europe) or restate (US) the long-standing inadequate rules governing the scope of software “patentable subject matter”, together with the reorganisation of the unworkable structural configuration of the decision-making procedures. Informed by the critical analysis of the evolution of the “patentable subject matter” requirement for computer software in the US, this thesis particularly considers the potential of the reforms of the European patent system currently underway, to bring about certainty, predictability and uniformity in the legal treatment of computer software inventions.

Treatment trials for neonatal seizures: the effect of design on sample size

Neonatal seizures are common in the neonatal intensive care unit. Clinicians treat these seizures with several anti-epileptic drugs (AEDs) to reduce seizures in a neonate. Current AEDs exhibit sub-optimal efficacy and several randomized control trials (RCT) of novel AEDs are planned. The aim of this study was to measure the influence of trial design on the required sample size of a RCT. We used seizure time courses from 41 term neonates with hypoxic ischaemic encephalopathy to build seizure treatment trial simulations. We used five outcome measures, three AED protocols, eight treatment delays from seizure onset (Td) and four levels of trial AED efficacy to simulate different RCTs. We performed power calculations for each RCT design and analysed the resultant sample size. We also assessed the rate of false positives, or placebo effect, in typical uncontrolled studies. We found that the false positive rate ranged from 5 to 85% of patients depending on RCT design. For controlled trials, the choice of outcome measure had the largest effect on sample size with median differences of 30.7 fold (IQR: 13.7–40.0) across a range of AED protocols, Td and trial AED efficacy (p<0.001). RCTs that compared the trial AED with positive controls required sample sizes with a median fold increase of 3.2 (IQR: 1.9–11.9; p<0.001). Delays in AED administration from seizure onset also increased the required sample size 2.1 fold (IQR: 1.7–2.9; p<0.001). Subgroup analysis showed that RCTs in neonates treated with hypothermia required a median fold increase in sample size of 2.6 (IQR: 2.4–3.0) compared to trials in normothermic neonates (p<0.001). These results show that RCT design has a profound influence on the required sample size. Trials that use a control group, appropriate outcome measure, and control for differences in Td between groups in analysis will be valid and minimise sample size.