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.

Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.

Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.

Disputes over memory ownership: What memories are disputed?

The ownership of memories is sometimes disputed, particularly by twins. Examination of 77 disputed memories, 71 provided by twins, showed that most of the remembered events are negative and that the disputants appear to be self-serving. They claim for themselves memories for achievements and suffered misfortunes but are more likely to give away memories of personal wrongdoing. The research suggests that some of the memories in which we play a leading role might in fact have been the experiences of others.

Patent litigation in Europe

We compare patent litigation cases across four European jurisdictions – Germany, France, the Netherlands, and the UK – covering cases filed during the period 2000-2008. For our analysis, we assemble a new dataset that contains detailed information at the case, litigant, and patent level for patent cases filed at the major courts in the four jurisdictions. We find substantial differences across jurisdictions in terms of case loads. Courts in Germany hear by far the largest number of cases in absolute terms, but also when taking country size into account. We also find important between-country differences in terms of outcomes, the share of cases that is appealed, as well as the characteristics of litigants and litigated patents. A considerable number of patents are litigated in multiple jurisdictions, but the majority of patents are subject to litigation only in one of the four jurisdictions.

Joint ownership and beneficial entitlement: Stack v Dowden.

Explores the issue of the share of beneficial entitlement to the family home where the legal title is jointly owned, but where there has not been an express declaration of a beneficial joint tenancy. Discusses the House of Lords judgment in Stack v Dowden which addressed this point. Explains how the judges moved the focus away from the court imposing its own sense of fairness on the parties or imputing an intention based on the circumstances to one where the concentration will be on the parties' relevant conduct. Outlines three other points of interest referred to in the judgment: (1) whether an indirect financial contribution could support a constructive trust; (2) whether proprietary estoppel and common intention constructive trusts should be assimilated; and (3) whether a mortgage liability is equivalent to a financial contribution.

Beneficial ownership and detriment

Considers the factors which contribute to a court finding that a cohabitee has a beneficial interest in property, in particular the detriment which is required to establish a constructive trust, with reference to the Chancery Division decision in Levi v Levi and previous case law. Outlines the provisions on express or inferred common intention. Considers whether a loan of money from the non-owning to the owning cohabitant, made at a lower level than commercial loans, towards the purchase the property was sufficient detriment to entitle her to proceeds of sale from the property.