The Doha Declaration Ten Years on and Its Impact on Access to Medicines and the Right to Health

Access to medicines is a human right, enshrined in legally binding international human rights treaties, select regional agreements and numerous national constitutions. The realization of access to medicines, including antiretroviral treatment, as part of the human right to health depends heavily on the legal framework for the production and distribution of medicines, including intellectual property rights. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) within the framework of the World Trade Organization (WTO) changed dramatically the international landscape with regard to intellectual property, particularly in relation to access to medicines. Although one of the stated goals of the TRI PS Agreement was “to reduce tensions arising from intellectual property protection”, the possible conflict between such protection and essential public health objectives, particularly access to medicines, moved developing-country WTO Member States to request the Council for TRIPS to specifically consider the relationship between the TRI PS Agreement and public health in general, and access to medicines more specifically. After negotiations, in 2001 the 4th WTO Ministerial Conference adopted the Declaration on the TRIPS Agreement and Public Health. This Discussion Paper briefly describes the content of the Doha Declaration and examines its implications for the realization of the right to health. The Paper discusses a number of repercussions of the Doha Declaration with regard to the international discourse on the right to health and access to medicines, and its implications within the WTO system and for national legislation. It presents some examples of use of the flexibilities confirmed by the Doha Declaration, and discusses the issue of compulsory licences with regard to patents relating to products for non-communicable diseases. Finally, a number of conclusions and recommendations are presented

Sovereign Immunity for Rent: How the Commodification of Tribal Sovereign Immunity Reflects the Failures of the U.S. Patent System

Last year, a Fortune 500 pharmaceutical company attempted to rent the sovereign immunity of an American Indian tribe in order to shield its patents on a dry-eye drug from invalidation by generic competitors in inter partes review. Pharmaceutical firms are notorious for pursuing unconventional methods to extend the duration of their patents and, in this sense, the maneuver is unsurprising. The exploitation, however, of an historically disenfranchised community with limited economic opportunities is particularly unsettling. This Article will provide, firstly, a factual summary of the legal background of this case; secondly, a review of the February 2018 decision of the Patent Trial and Appeal Board (“PTAB”) to deny the application of tribal sovereign immunity in this case; thirdly, a review of the July 2018 decision of the U.S. Court of Appeals for the Federal Circuit, affirming the PTAB’s decision; fourthly, a discussion of the ways in which the precedent set by Allergan’s maneuver may adversely affect consumer welfare by undermining the process of inter partes review; fifthly, an analysis of the history of tribal sovereign immunity and how its exploitation in this case reflects the historic oppression of American Indians; and finally, strategies to deter such transactions from recurring in the future

Current policy issues in the governance of the European patent system

The European Parliament has been working towards building a discussion platform and a resource for further policy actions in the field of intellectual property rights. The Science and Technology Options Assessment Panel has set the goal of further enlarging the area of investigation in light of recent policy developments at the European level. In particular, the current study covers current policy issues in the governance of the European patent system, such as the backlog issue, the enhancement of patent awareness within the European Parliament, patent enforcement, the regional dimension of intellectual property in Europe, patents and standardisation, the use of existing patents, and patents and competition. These issues were discussed in the conference with stakeholders from European to national patent offices, from private to public sector actors. As a result of the conference, it was stated the need for an IP strategy for Europ

Harmonization Without Consensus: Critical Reflections on Drafting a Substantive Patent Law Treaty

In this Article, we contend that the World Intellectual Property Organization\u27s proposed Substantive Patent Law Treaty (SPLT) is premature. Developing countries are struggling to adjust to the heightened standards of intellectual property protection required by the TRIPS Agreement of 1994. With TRIPS, at least, these countries obtained side payments (in the form of trade concessions) to offset the rising costs of knowledge products. A free-standing instrument, such as the SPLT, would shrink the remaining flexibilities in the TRIPS Agreement with no side payments and no concessions to the catch-up strategies of developing countries at different stages of technological advancement. More controversially, we argue that a deep harmonization would boomerang against even its developed country promoters by creating more problems than it would solve. There is no vision of a properly functioning patent system for the developed world that commands even the appearance of a consensus. The evidence shows, instead, that the worldwide intellectual property system has entered a brave new scientific epoch, in which experts have only tentative, divergent ideas about how best to treat a daunting array of new technologies. The proposals for reconciling the needs of different sectors, such as information technology and biotechnology, pose hard, unresolved issues at a time when the costs of litigation are rising at the expense of profits from innovation. These difficulties are compounded by the tendency of universities to push patenting up stream, generating new rights to core methodologies and research tools. As new approaches to new technologies emerge in different jurisdictions, there is a need to gather empirical evidence to determine which, if any, of these still experimental solutions are preferable over time. Our argument need not foreclose other less intrusive options and measures surveyed in the Article that can reduce the costs of delaying harmonization. However, the international community should not rush to freeze legal obligations regarding the protection of intellectual property. It should wait until economists and policymakers better understand the dynamics of innovation and the role that patent rights play in promoting progress and until there are mechanisms in place to keep international obligations responsive to developments in science, technology, and the organization of the creative community

The Doha Round’s Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines Under the Amended TRIPS Provisions

This entry into force of the World Trade Organization (WTO) TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified \u27free riding.\u27 Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address the priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against the restrictive elements of the TRIPS Agreement. Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a \u27net benefit\u27 for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in production and distribution of medicines. The authors doubt that the international political environment would support renegotiation of an \u27improved\u27 solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale

Modeling Probabilities of Patent Oppositions in a Bayesian Semiparametric Regression Framework

Most econometric analyses of patent data rely on regression methods using a parametric form of the predictor for modeling the dependence of the response given certain covariates. These methods often lack the capability of identifying non-linear relationships between dependent and independent variables. We present an approach based on a generalized additive model in order to avoid these shortcomings. Our method is fully Bayesian and makes use of Markov Chain Monte Carlo (MCMC) simulation techniques for estimation purposes. Using this methodology we reanalyze the determinants of patent oppositions in Europe for biotechnology/pharmaceutical and semiconductor/computer software patents. Our results largely confirm the findings of a previous parametric analysis of the same data provided by Graham, Hall, Harhoff&Mowery (2002). However, our model specification clearly verifies considerable non-linearities in the effect of various metrical covariates on the probability of an opposition. Furthermore, our semiparametric approach shows that the categorizations of these covariates made by Graham et al. (2002) cannot capture those non--linearities and, from a statistical point of view, appear to somehow ad hoc

Just how difficult can it be counting up R&D funding for emerging technologies (and is tech mining with proxy measures going to be any better?)

Decision makers considering policy or strategy related to the development of emerging technologies expect high quality data on the support for different technological options. A natural starting point would be R&D funding statistics. This paper explores the limitations of such aggregated data in relation to the substance and quantification of funding for emerging technologies. Using biotechnology as an illustrative case, we test the utility of a novel taxonomy to demonstrate the endemic weaknesses in the availability and quality of data from public and private sources. Using the same taxonomy, we consider the extent to which tech-mining presents an alternative, or potentially complementary, way to determine support for emerging technologies using proxy measures such as patents and scientific publications

Rethinking Novelty in Patent Law

The novelty requirement seeks to ensure that a patent will not issue if the public already possesses the invention. Although gauging possession is usually straightforward for simple inventions, it can be difficult for those in complex fields like biotechnology, chemistry, and pharmaceuticals. For example, if a drug company seeks to patent a promising molecule that was disclosed but never physically made in the prior art, the key possession question is whether a person having ordinary skill in the art (PHOSITA) could have made it at the time of the prior disclosure. Put differently, could the PHOSITA rely on then-existing knowledge in the field to fill in any missing technical details from the prior disclosure? This Article argues that existing novelty jurisprudence mishandles the possession question in two ways. First, it tends to overestimate the PHOSITA\u27s then-existing knowledge by failing to fully appreciate the complex nature of certain technologies. Second, the current examination framework vitiates the presumption of novelty by placing proof burdens on the would-be inventor that can thwart innovation and frustrate important objectives of the patent system. To resolve these problems and to fill a gap in patent scholarship, this Article proposes a new paradigm that reframes the novelty inquiry during patent examination. Its implementation will not only improve the quality of issued patents, but also make the patent literature a more robust source of technical information. This Article contributes to broader policy debates over patent reform and joins a larger effort to bridge the disconnect between patent law and the norms of science

Recalibrating Patent Venue

For most of patent law’s 200-plus year history, patent holders could sue only in the district inhabited by the defendant. In 1990, the United States Court of Appeals for the Federal Circuit decided that the scope of permissible venue extended to all districts with personal jurisdiction over the defendant. In recent years, patentees have flocked to certain districts, fueling the widespread perception that patentees, particularly those that do not practice their patents, called non-practicing entities (“NPEs”), are abusing forum. Responsive to these concerns, Congress and the courts have moved to reinstate a more restrictive rule, culminating in the Supreme Court’s 2017 TC Heartland LLC v. Kraft Foods Group Brands LLC decision to limit venue to locations of the defendant. Yet, incredibly, to date there has been no measure of the overall pervasiveness of forum shopping and whether TC Heartland or any other venue reform will change this phenomenon. We address this gap by estimating the differential impacts of reform on filing patterns. We find, based on an analysis of approximately 1500 patent and non-patent cases filed in 2015 that about 86% of patent cases—a striking share—were brought outside of the defendant’s home district. This practice is not limited to non-practicing entities, however; corporations, universities, and individuals all filed outside of defendant districts. Things would have been different if venue were reformed, but much depends on how reform is implemented. If the Supreme Court’s decision to restrict venue to where the defendant resides or has an established place of business were already in effect, an estimated 58% of 2015 cases would have had to have been filed in a different venue. If the Congressional proposal to change venue to include home districts with research or manufacturing connections to the case had been in effect, about half the NPE cases in our sample would have needed to be refiled in another district, but only 14% of the operating company cases would. Cases would have become less concentrated in a single district, with the top district, Delaware, capturing 20–24% of cases, but the top three districts, the District of Delaware, the Eastern District of Texas, and the Northern District of California, would still have the majority of cases. Regardless of the reform, we expect smaller defendants to get more from venue relief than larger defendants because of their relatively smaller footprints. Among NPEs, universities, individuals, and small companies should be impacted to a lesser extent than patent assertion entities (“PAEs”), considerably so if the VENUE Act were enacted