Raising the Barriers to Access to Medicines in the Developing World – The Relentless Push for Data Exclusivity

Since the adoption of the WTO‐TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others.     

Impact of the US Patent System on the Promise of Personalized Medicine

The biotechnology revolution promises unfathomable future scientific discovery. One of the potential benefits is the accelerated introduction of new diagnostics and treatments to the general public. The right medication for the right patient is the goal of personalized medicine, which directly benefits from many of biotechnology's biggest and most recent advances. The US patent system rewards innovation in medicine and other arts and sciences by granting innovators, for a period of time, the right to exclude others from using what was invented. One of the purposes of the patent system is to trade that right to exclude, and in its stead obtain the patent holder's obligation to fully and publicly disclose the essence of the innovations so that they can be improved, thus advancing the common welfare. A tension exists between personalized medicine's need for access to and use of scientific advances and the patent system's reward of exclusive use or nonuse to innovators. This tension may result in fewer diagnostic and therapeutic tools brought to the market and generally adopted. The risk seems particularly acute with respect to the diagnostic and therapeutic tools arising from genetic testing that hold specific value for a subset of the population. The judicial system has introduced ethical exceptions that overcome a patent holder's right to exclude; these judicial overrides relate to the provision of certain types of medical procedures and the development of certain types of new drugs, and not, apparently, to the use of diagnostic and therapeutic tools essential to the success of personalized medicine. A serious question exists as to whether legislative action is necessary to increase public access to genetic testing.     

Invisible genomes: the genomics revolution and patenting practice

In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney's case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a 'genome', and the ways in which it may be different from a 'gene', played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences.     

Evaluating the Usefulness of Compulsory Licensing in Developing Countries: A Comparative Study of Thai and Brazilian Experiences Regarding Access to Aids Treatments

While compulsory licensing (CL) is described in the TRIPS agreement as flexibility to protect public health by improving access to medicines in developing countries, a recent literature contends adversely that CL may harm public health. Therefore, this article intends to evaluate the usefulness of CL in the South through the prism of obligations and goals entrusted to patent holders (the effective and non‐abusive exploitation of patents in order to achieve industrial and health developments) and in light of experiences in Thailand and Brazil regarding access to antiretroviral drugs. In this way, it shows that the obligations assigned to patent holders were better served by the recipients of CL and brought significant health and industrial benefits in the two high middle‐income countries. In particular, CL allowed the scaling‐up of free and universal access to antiretroviral drugs by assuring the financial sustainability of these public health programs endangered by monopolistic practices from patent holders.     

Patents Associated with High-Cost Drugs in Australia

Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by “evergreening” blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug''s originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.     

基于专利计量分析的抗HIV 药物发展趋势研究

近年来,艾滋病感染人数急剧增加,已成为威胁人类健康的重大疾病。为了对抗HIV药物的研究现状和发展趋势进行深入分析,本文通过在Derwent Innovations Index数据库中检索2006-2012年的抗HIV药物专利。对采集的专利信息用TDA软件进行数据清洗,利用专利计量分析方法,借助可视化的分析工具,从专利申请数量、优先权国、专利技术机构和专利技术领域等方面进行分析。研究发现近几年抗HIV药物专利申请数量较为平稳;专利申请主要集中在美国、加拿大和中国;抗HIV药物的技术领域主要集中在天然产物、发酵工业和杂环化合物等方面。美国在专利申请数量方面远远领先于其他国家,足以见美国在抗HIV药物研发的活跃和强劲的技术实力。我国虽然在专利申请数量方面具有一定优势,但是与国外相比仍有较大差距。     

GLOBAL HEALTH IMPACT: A BASIS FOR LABELING AND LICENSING CAMPAIGNS?

Most of the world's health problems afflict poor countries and their poorest inhabitants. There are many reasons why so many people die of poverty‐related causes. One reason is that the poor cannot access many of the existing drugs and technologies they need. Another, is that little of the research and development (R&D) done on new drugs and technologies benefits the poor. There are several proposals on the table that might incentivize pharmaceutical companies to extend access to essential drugs and technologies to the global poor. 1 Still, the problem remains – the poor are suffering and dying from lack of access to essential medicines. So, it is worth considering a new alternative. This paper suggests rating pharmaceutical and biotechnology companies based on how some of their policies impact poor people's health. It argues that it might be possible to leverage a rating system to encourage companies to extend access to essential drugs and technologies to the poor.     

An intellectual property sharing initiative in agricultural biotechnology: development of broadly accessible technologies for plant transformation

The Public Intellectual Property Resource for Agriculture (PIPRA) was founded in 2004 by the Rockefeller Foundation in response to concerns that public investments in agricultural biotechnology benefiting developing countries were facing delays, high transaction costs and lack of access to important technologies due to intellectual property right (IPR) issues. From its inception, PIPRA has worked broadly to support a wide range of research in the public sector, in specialty and minor acreage crops as well as crops important to food security in developing countries. In this paper, we review PIPRA's work, discussing the failures, successes, and lessons learned during its years of operation. To address public sector's limited freedom-to-operate, or legal access to third-party rights, in the area of plant transformation, we describe PIPRA's patent 'pool' approach to develop open-access technologies for plant transformation which consolidate patent and tangible property rights in marker-free vector systems. The plant transformation system has been licensed and deployed for both commercial and humanitarian applications in the United States (US) and Africa, respectively.     

PatGen--a consolidated resource for searching genetic patent sequences

SUMMARY: Compared to the wealth of online resources covering genomic, proteomic and derived data the Bioinformatics community is rather underserved when it comes to patent information related to biological sequences. The current online resources are either incomplete or rather expensive. This paper describes, PatGen, an integrated database containing data from bioinformatic and patent resources. This effort addresses the inconsistency of publicly available genetic patent data coverage by providing access to a consolidated dataset. AVAILABILITY: PatGen can be searched at http://www.patgendb.com CONTACT: rjdrouse@patentinformatics.com.     

Patenting nonassociated polymeric structures (NAPS): implications for structural genomic data release

The intellectual property laws that govern patent rights should provide a reasonable balance between the competing concerns of open access and exclusivity. Open access can facilitate knowledge dissemination and collaboration in furthering science. On the other hand, exclusivity can ensure interest and financial investment in scientific research and development.In recent days, the appropriate balance between open access and exclusivity has been a focus of public debate, particularly with regard to genomic inventions and their applications. In seeking to reconcile the timing of structural genomic data release with certain efforts to secure intellectual property rights, the International Structural Genomics Organisation joins others confronting this controversy.This paper seeks to inform the discussion with an overview of the U.S. standards for patenting nonassociated polymeric structures (NAPS), which include polynucleotides or polypeptides of unknown biological significance, and their corresponding structural data. In the United States, the present ability to obtain patent rights to these discoveries appears problematic given the requirement of specific, substantial and credible utility, among other things. Without demonstrable utility, NAPS and NAPS-related data likely will not be entitled to patent protection, whether the U.S. Patent & Trademark Office rejects NAPS claims as unpatentable in the first instance, or the U.S. federal courts invalidate NAPS claims in later patent litigation. As such, the improbability of obtaining enforceable patent rights to NAPS might undermine the rationale for delaying structural genomic data release to allow for the filing of patent applications in this regard.Abbreviations: ESTs, expressed sequence tags; ISGO, International Structural Genomics Organisation; NAPS, nonassociated polymeric structures; SNPs, single nucleotide polymorphisms; USPTO, U.S. Patent & Trademark Office     

An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile

We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between “primary” (active ingredient) and “secondary” patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate “older” therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents.     

Induction of Oxidative Stress in Tumor Cells: A New Strategy for Drug Therapy of Malignant Tumors

Biophysics - Abstract—Tumor cells have a higher basal ROS level than normal cells. This phenomenon may provide grounds for the development of novel antitumor drugs that are capable of...     

生物医药公司知识产权保护方式的决策与实施

以专利为主的知识产权是生物技术和现代生物医药公司竞争优势的基础。必需结合公司的长远战略目标和目前实际,遵循成本效益原则,通盘考虑知识产权保护方式。以技术平台、药物、生物信息学软件发明等为例,介绍了商业秘密、专利和防御性出版等三种保护方式及其决策程序以及实施方案。     

ADDICTION AND AUTONOMY: CAN ADDICTED PEOPLE CONSENT TO THE PRESCRIPTION OF THEIR DRUG OF ADDICTION?

It is often claimed that the autonomy of heroin addicts is compromised when they are choosing between taking their drug of addiction and abstaining. This is the basis of claims that they are incompetent to give consent to be prescribed heroin. We reject these claims on a number of empirical and theoretical grounds. First we argue that addicts are likely to be sober, and thus capable of rational thought, when approaching researchers to participate in research. We reject behavioural evidence purported to establish that addicts lack autonomy. We present an argument that extrinsic forces must be irresistible in order to make a choice non-autonomous. We argue that heroin does not present such an irresistible force. We make a case that drug-oriented desires are strong regular appetitive desires, which do not compromise consent. Finally we argue that an addict's apparent desire to engage in a harmful act cannot be construed as evidence of irrational or compulsive thought. On these arguments, a sober heroin addict must be considered competent, autonomous and capable of giving consent. More generally, any argument against legalisation of drugs or supporting infringement of the liberty of those desiring to take drugs of addiction must be based on considerations of harm and paternalism, and not on false claims that addicts lack freedom of the will.     

Patent searches as a complement to literature searches in the life sciences--a 'how-to' tutorial

This communication provides an easy-to-follow protocol for using the free Internet-accessible scientific search engine, Scirus, to search for and subsequently retrieve published patents from several patent offices in portable document format (PDF). Hints on how to 'read' patents and how to extract relevant information, as well as how to export bibliographic data from Scirus and how to cite patents, are also given. The reason for providing such a protocol is that a vast amount of information, also of potential interest to life scientists, is largely hidden for those not knowing how to access these data. Several examples are provided that highlight the reasons to include patent searches into the workflow of life scientists. These include early access to data before publication, patents as a source of data that never appear in the literature and patents as a source of critical information otherwise hard to get from commercial suppliers. Finally, alternative free patent search services are briefly discussed, and their differences are highlighted.     

The Pricing of Breakthrough Drugs: Theory and Policy Implications

Pharmaceutical sales exceed $850 billion a year, of which 84% are accounted for by brand drugs. Drug prices are the focus of an ongoing heated debate. While some argue that pharmaceutical companies exploit monopolistic power granted by patent protection to set prices that are “too high”, others claim that these prices are necessary to motivate the high R&D investments required in the pharmaceutical industry. This paper employs a recently documented utility function of health and wealth to derive the theoretically optimal pricing of monopolistic breakthrough drugs. This model provides a framework for a quantitative discussion of drug price regulation. We show that mild price regulation can substantially increase consumer surplus and the number of patients who purchase the drug, while having only a marginal effect on the revenues of the pharmaceutical company.     

Are Patents Impeding Medical Care and Innovation?

Background to the debate: Pharmaceutical and medical device manufacturers argue that the current patent system is crucial for stimulating research and development (R&D), leading to new products that improve medical care. The financial return on their investments that is afforded by patent protection, they claim, is an incentive toward innovation and reinvestment into further R&D. But this view has been challenged in recent years. Many commentators argue that patents are stifling biomedical research, for example by preventing researchers from accessing patented materials or methods they need for their studies. Patents have also been blamed for impeding medical care by raising prices of essential medicines, such as antiretroviral drugs, in poor countries. This debate examines whether and how patents are impeding health care and innovation.     

In-house chemical databases at Imperial Chemical Industries

ICI has mounted several online databases for end-user access under its new graphics system, Sapphire. Sapphire uses the Maces^™ software for chemical structure registration and searching. This paper concentrates on those databases which use Maces software for both structure and data handling, rather than on the larger Company Compound Centre database which will use Maces in conjunction with a relational database management system.     

Interstitial but Resilient: Nomadic Shepherds in Piedmont (Northwest Italy) Amidst Spatial and Social Marginalization

Mobility, nomadic pastoralists’ main adaptive strategy, has been compromised by agricultural expansion and rangeland fragmentation, among other factors, in many pastoral contexts. Among nomads’ coping strategies, is re-shaping mobility in shrinking grazing grounds. Through semi-structured interviews, we examine adaptation and resilience to the effects of increasingly intensive land use and marginalization focusing on Alpine nomadic pastoralists in Piedmont, Northwest Italy. Our results show that Alpine nomads access a wide variety of grazing grounds through a web of social relations with multiple stakeholders, acting in the interstices of mainstream society and navigating marginal contexts: geographically, they use fallow, abandoned, and post-harvest plots; economically and socially, they interact with other marginal groups (e.g., migrants) and are stigmatized by diverse sectors of society. This use of interstitial spaces is in itself a form of adaptation that is taking place in diverse geographical contexts as nomads reconfigure their mobility and social relations to access the scattered pieces of land left unused by industrial, agricultural, and conservation land uses.     

Patent portfolio-based indicators to evaluate the commercial benefits of national plant genetic resources

According to property rights theory, national plant genetic resources (PGRs) are sovereign properties rather than resources belonging to the common heritage of humankind. Consequently, provider states can claim compensation from users of their national PGRs, leading to the need for bilateral or multilateral agreements to share national PGRs' commercial benefits. However, as benefit-sharing agreements are made exante, estimating the potential profit is difficult. Thus, issues around asymmetric information about the commercial value of such resources have emerged. In this paper, we use a patent portfolio as a proxy to estimate the potential commercial benefits of national PGRs and propose new evaluation indicators. We propose a comprehensive evaluation process that covers constructing a patent portfolio for each PGR, establishing indicators in terms of marketability, technology, and exclusiveness, and assigning weights to the indicators using fuzzy analytic hierarchy. In addition, we illustrate this process using a case of Korean national PGRs based on the opinions of stakeholders and experts. This research is expected to help promote national PGR transactions with equitable access and benefit sharing agreements.