Papers

Papers

Is This the End of Free Streaming? The Role of Internet Service Providers in Copyright Infringement

[Anca Cazacu] Abstract: Copyright in Ireland is is protected by legislation Copyright and Related Rights Act 2000. But is the current legislation sufficient to cover the fast development of sharing online information? In this paper I have analysed how Internet Service Providers have been affected by recent changes in Irish Copyright Law and how have the Irish Courts decided to grant injunctions against a third party. I also discussed and showed examples of how breaches of Copyright have been applied in other European and US jurisdictions.

Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan

[Ping-Hsun Chen] Abstract: The Trans-Pacific Partnership (“TPP”) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures.

Nigerian Copyright Reform and Implications for Access to Teaching and Learning Materials (TLMs) in the Digital Age

[Helen Chuma-Okoro] Abstract: This article examines the extent to which the provisions of Nigeria’s draft Copyright Bill promote access to teaching and learning materials (TLMs), with such access framed as an important public interest goal. The article highlights the weaknesses in the extant Nigerian copyright statute with regard to TLM access, and examines the extent to which the provisions of the draft Bill would provide improvement. The article concludes that while the draft Bill provides significant improvements in respect of TLM access, it also contains significant weaknesses and gaps which Nigerian lawmakers should seek to address.

Evolution of Africa’s Intellectual Property Treaty Ratification Landscape

[Jeremy De Beer, Jeremiah Baarbé, and Caroline Ncube] Abstract: Intellectual property (IP) policy is an important contributor to economic growth and human development. However, international commitments harmonised in IP treaties often exist in tension with local needs for flexibility. This article tracks the adoption of IP treaties in Africa over a 131-year span, from 1884 to 2015, through breaking it down into four periods demarcated by points in time coinciding with key events in African and international IP law: the periods 1884–1935, 1936–1965, 1966–1995, and 1996–2015. The article explores relevant historical and legal aspects of each of these four periods, in order to assess and contextualise the evolutions of the IP treaty landscape on the continent. The findings show that treaties now saturate the IP policy space throughout the continent, limiting the ability to locally tailor approaches to knowledge governance.

Issuance of Compulsory Patent Licenses and Expropriation in Asian BITs and FTA Investment Chapters: A Study of India, China, Malaysia and Thailand

[Prabhash Ranjan] Abstract: Given the increasing interface between intellectual property rights and international investment law, the aim of this chapter is to examine whether issuance of compulsory patent licenses could be challenged as indirect expropriation under investor state dispute settlement of investment treaties/free trade agreements of India, China, Malaysia and Thailand.

Democratising Knowledge: A Report on the Scholarly Publisher, Elsevier

[Jonathan Tennant] Executive Summary: Elsevier are the largest and most powerful scholarly publisher, a status achieved through a long history of mergers and acquisitions and rigorously capitalistic business practices. The core issues surrounding Elsevier are that it operates its business primarily through charging for what should be public knowledge and education, with aggressive pricing strategies and marketing tactics that are anti-competitive and a drain on the higher and further education sectors. It has a long history of fighting against public access to knowledge, through a combination of political lobbying, public campaigns against openness, and regressive business models and strategies.

Defining the Relevant Market in Fair Use Determinations

[Xiyin Tang] Abstract: The fair use defense is frequently invoked as the most important First Amendment safeguard in copyright law, and the effect a defendant’s use has upon the potential market for the copyrighted work is often cited as the most important factor in that determination. Yet courts and commentators alike have struggled with how to define the potential market for a copyrighted work, either underdefining, overdefining, or altogether failing to define what that market is, or should be.

Australian Competition and Consumer Commission v Pfizer: Evergreening and Market Power as a Blockbuster Drug Goes Off Patent

[Thomas Faunce] Abstract: In Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd [2015] FCA 113 the ACCC alleged that Pfizer’s ‘Project LEAP’ involved a scheme to lock pharmacists into substituting its generic version of the high sales volume anti-cholesterol drug patent-expired Atorvastatin (Lipitor) which took advantage of a substantial degree of market power for a purpose proscribed by s 46(1)(c) of the Competition and Consumer Act 2010 (Cth). The ACCC also claimed that Pfizer’s actions constituted a course of exclusive dealing pursuant to s 47(1)(d) and (e) for the proscribed purpose of lessening competition. Flick J in the Federal Court of Australia in a judgment heavy with quotations but sparse in reasoning, dismissed the ACCC’s Amended Originating Application alleging abuse of market power and ordered the ACCC to pay Pfizer’s costs. This column explores that case in the context of Pfizer’s broader strategies to preserve its income globally from this high sales volume drug.

Moderating the Impact of Patent Linkage on Access to Medicines: Lessons from Variations in South Korea, Australia, Canada, and the United States

[Kyung-Bok Son, Ruth Lopert, Deborah Gleeson and Tae-Jin Lee] The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States’ TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines.

The More Things Change: Improvement Patents, Drug Modifications, and the FDA

[Dmitry Karshtedt] Abstract: Pharmaceutical companies often replace prescription drugs that are already on the market with modified versions that have the same active pharmaceutical ingredient. On the surface, such activity seems benign and perhaps even salutary. Nonetheless, antitrust litigation has revealed that firms sometimes modify existing drugs not because new formulations would demonstrably improve health outcomes, but principally because so-called secondary patents covering the new version of the drug enable them to maintain some effective market power over the active ingredient for which original, primary patent protection has expired. This “product-hopping” strategy runs counter to the goal of the legislative framework for regulating branded and generic drug approvals, which is to create appropriate incentives for discoveries that raise the quality of patient care and human health by providing a period of reward for the brand followed by timely and effectual generic entry.

Recoupment Patent

[Miriam Marcowitz-Bitton, Yotam Kaplan and Maayan Perel (Filmar)] ... by any standard our patent system is broken. At present it encourages the filing of a plethora of low-quality patents that have no true innovative value, is plagued by opportunistic patent trolls, and produces endless amounts of costly litigation. This article demonstrates how these phenomena are due to central design flaws in the current system. First, although the patent system is designed to encourage investment in innovation, it lacks a mechanism for directly examining an inventor’s level of investment. This major flaw systematically ignores the single most important factor the patent system seeks to promote. Second, the current system offers one-size-fits-all protection, granting the same 20-year monopoly to any and all inventions. This inflexible legal standard is outdated and inappropriate, given the wide variety of inventions it addresses and the immense differences between them.

Biological Drugs – Challenges to Access

[Third World Network] In this paper Dr. Sengupta examines the landscape of biological medicines, and locates this analysis in the characteristics of biological drugs which set them apart from small molecule drugs (SMDs). These characteristics of biological drugs impact on the way these drugs are manufactured; on the development of follow-on versions of innovator biological drugs; on the way biological drugs – both innovators and follow-ons – are regulated; on the way these drugs are protected by different kinds of intellectual property rights (IPRs) and data protection mechanisms; and on the opportunities and challenges in the introduction of biological drugs, including biosimilars, in a range of countries.