Intellectual Property Standards Research Articles

Intellectual property issues for open science practices in genomic-related health research and innovation in Africa.

This paper considers the applicability and implications of intellectual property rights (IPRs) for open science practices in the context of genomic-related health research and innovation in Africa. The first part provides a brief background of the gaps in genomics and health research in Africa, highlighting the possible role of open science in facilitating collaborative research to address the peculiar health needs of the continent. The second part examines intellectual property protection in genomic-related health research and innovation in Africa, outlining some of the existing legal instruments and policies guiding the application of IPRs, focusing on patents and copyrights. Thereafter, the paper examined how intellectual property standards could impact the adoption of open science in genomics health research in Africa. In doing this, the paper considers the role they could play as enablers of open science practices in genomics health research and innovation and the potential challenges they pose. The paper concludes with recommendations regarding aspects of the intellectual property policies and legal frameworks in Africa that could be calibrated to overcome potential challenges and, thereby, stimulate the adoption of an open science model and promote open, collaborative genomics health research and innovation in the continent.

FOSTERING KEY VALUES OF ACADEMIC INTEGRITY THROUGH THE EDUCATIONAL PROCESS AT POLTAVA STATE MEDICAL UNIVERSITY

Academic integrity serves as the cornerstone of an individual's moral character and their approach to scholarly endeavors. It reflects the moral values that students bring with them to higher education institutions, aiming to enhance and refine them throughout their academic journey and beyond. This article aims to explore the principles underlying the development of academic integrity among teachers, lecturers, and its implementation in the scholarly and educational activities of higher education institutions. Lecturers serve as the primary examples of academic integrity for students. Their commitment to ethical standards, honesty, and openness in discussing ethical issues can influence students and serve as a model for their behavior. At Poltava State Medical University (PSMU), a repository has been established as a platform for showcasing teachers' scientific achievements, publications, research, and other academic accomplishments. Additionally, a bioethics commission oversees adherence to data collection and processing rules, animal experimentation, and the use of new technologies, fostering a conducive atmosphere in line with the ethical standards of academic integrity at PSMU. The patent department at PSMU oversees research ethics, citation rules, and plagiarism prevention, providing educational support, consultation, and assistance in developing intellectual property standards. The university's website offers online resources that encourage teachers to take greater responsibility for their actions and achievements. By making achievements publicly accessible, PSMU promotes adherence to ethical and quality standards among faculty members. Thus, fostering a virtuous academic environment requires a comprehensive approach that includes proper regulatory and legal frameworks, as well as organizational and preventive-educational measures. Establishing an educational environment based on academic integrity for future professionals enables high-quality outcomes, thereby shaping competitive specialists in the global market of social services.

Expanding Trade Remedy Scope: Cross-Border and Public Policy Subsidies

On May 9, 2023, the U.S. Department of Commerce proposed amendments to the U.S. antidumping and countervailing/anti-subsidy (ADCV) duty regulations fundamentally altering the scope of economic activities captured within the scope of trade remedy laws. The proposed regulations expand ADCD actions to include a wide range of labor, human rights, environmental and intellectual property standards. Commerce’s new regulations make the failure to rigorously enforce national public policy standards directly and indirectly remediable by trade remedy laws by treating unenforced regulations as a subsidy. Antidumping regulations are similarly modified to increase production costs where public policy regulations are deemed weak or ineffective, thereby increasing antidumping duties. Commerce also proposes to eliminate the longtime transnational subsidies regulation which held that a subsidy did not exist if the program or project was funded by a government outside of the country where the recipient was located. A transnational subsidy is financial assistance or support provided by one country to producer in another country. This modification would make transnational subsidies an actionable subsidy under the trade remedy laws. antidumping, countervailing, anti-subsidy, trade remedy laws, labor, human rights, environmental, intellectual property standards, public policy standards, subsidy, production costs, transnational subsidies, financial assistance

A Discourse on the Malaysian Geographical Indications Act

The Malaysian Parliament approved three Bills on Intellectual Property rights. One of it is the Geographical Indications Bill 2021, repealing the Geographical Indications Act 2000 (the Old Act). The new Bill received royal assent on 16 March 2022 and came into operation on 18 March 2022, known as the Geographical Indications Act 2022 (the New Act). The revisions made in the New Act were essential to harmonise intellectual property standards in Malaysia and facilitate the country’s accession to the Marrakesh Treaty. These amendments ensure that Malaysia adheres to the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and fulfils its obligations under the Regional Comprehensive Economic Partnership (RCEP). The purpose of this paper is to examine the salient features introduced by the provisions of the New Act and to examine how the enhanced provisions attempt to realign intellectual property standards in Malaysia concerning Malaysia's broader obligations under the Regional Comprehensive Economic Partnership which have come into effect in Malaysia on 18 March 2022. The methodology employed in this research is doctrinal, especially focusing on the interpretation and analysis of the statutory provisions. In light of the changes in the New Act, New Regulations and the New Guidelines, the paper concludes by forwarding several recommended best practices to be considered by registered proprietors in the country.

Intellectual property protection for traditional medical knowledge in China's context: a round peg in a square hole?

This article is an examination of the extent to which traditional medical knowledge in China can be protected by intellectual property laws. The analysis begins by providing a global picture with regard to the historic origin of intellectual property, exploring the reasons why China does not have indigenous counterparts to the western system of intellectual property rights protecting its traditional knowledge (including traditional medical knowledge) and stating the problems of transplanting western intellectual property standards in China. A discussion follows on how China, under foreign pressure, has made efforts to comply with the changing standards mandated by various international, regional, and bilateral arrangements related to intellectual property, with examples of the development of China's patent law. China's approach towards the protection of traditional medical knowledge in various international fora related to intellectual property is explored. Finally, there is a specific examination of the compatibilities between the western system of intellectual property rights and traditional medical knowledge in China, at the national and community levels. This article argues that the system of intellectual property rights does not easily fit with China's traditional medical knowledge because of China's unique cultural traits, distinctive historical context and wide ethnic, religious, and local community diversity.

Antitrust and Innovation Competition

Abstract Innovation competition presents challenges for antitrust law and enforcement policy. Innovation has generated changes in the nature of competition as firms introduce new transaction techniques, product designs, and production processes. Innovation competition is driving the ‘Business Revolution’ in retail, wholesale, manufacturing, services, and financial technology. Transaction innovation in online platforms and multi-sided markets has raised antitrust concerns about anticompetitive conduct, vertical restraints, consumer privacy, and barriers to entrepreneurship. The article argues that although antitrust policy makers recognize the importance of innovation competition, they need to update their economic frameworks. Antitrust policy makers need to move beyond traditional analysis based on the twin frameworks of perfect competition and imperfect competition. The article provides an introduction to the emerging Economics of Technology & Innovation and examines some implications for antitrust policy. First, antitrust policy should shift its focus from price competition without technological change to address non-price aspects of innovation competition. Secondly, antitrust policy should apply economic analysis that recognizes the critical role of Intellectual Property and technology standards in innovation competition. Thirdly, antitrust policy toward horizontal and vertical mergers should consider developments in the economic analysis of innovation competition.

Legal Discourse of United States Pharmaceutical Industry Mandatory License and Trips Agreement Post Doha Declaration

<p>The public health crisis related to HIV/AIDS, Tuberculosis and Malaria, was the starting point for the World Trade Organization (WTO) Ministerial Conference in 2001 which adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) and Public Health Agreements. The pharmaceutical industry as one of the knowledge driven sectors especially pharmaceutical research is very expensive and unpredictable. Making the patent system as a legal protection tool to facilitate innovation related to pharmaceutical products. The similarities between United States patent law and the TRIPS agreement also demonstrate United States’s influence in setting intellectual property standards globally. This research is a juridical-normative research using a statutory approach. The data collection technique was carried out by means of a literature study. Data analysis technique: qualitative normative analysis. The results showed that the United States' dissatisfaction with the level of intellectual property protection provided by the TRIPS agreement encouraged the development of the provisions of the TRIPS-Plus agreement in the United States Free Trade Area (FTA). The terms of the TRIPS-Plus agreement appear to be designed to negate the effective use of mandatory licensing by blocking the marketing of third-party drugs during the term of the patent. However, the TRIPS agreement retains some flexibility for World Trade Organization members, such as the data exclusivity and mandatory licensing outlined in the Doha Declaration.</p><div> </div>

Преференциальные торговые соглашения: теория и практика

The change in the concept of globalization of the world economy has led to serious structural changes in the global governance of international trade, as well as in the theory and practice of organizing preferential trade agreements (PTAs) between countries. At all stages of economic globalization, the main motive for the creation of the PTS was the expansion of access to foreign markets. The period of slowbalization of the world economy after the global crisis of 2008–2009 led to a further increase in trade protectionism. The role of traditional determinants in the creation of PTAs is decreasing, while the lobbying activity of exporters – transnational companies – is becoming more significant, which leads to an increase in the unevenness of benefits received by participants in international exchange. The focus of the international political economy of the PTA is shifting from traditional tariff and non-tariff trade barriers to the study of the conditions for cross-border investment, rules for the protection of intellectual property, environmental issues, and production standards. The multidimensionality of trade policy at the present stage dictates the need to revise the preferences prevailing in international trade. Trade policy covers not only cross-border exchange, but also international production. Modern PTAs are an alternative design to the WTO multilateral trade regulation, which will simplify traditional international exchange procedures. In addition, in the PTAs, some aspects of competition rules that are poorly spelled out in the WTO may be especially significant, since the risks of collusion of firms in this case may already cover several jurisdictions. An important role in understanding the political and economic nature of PTAs is played by their “distributional” consequences, when the gains of different countries from participation in the PTAs becomes uneven, which is a serious challenge for real economic integration between countries. To develop new approaches to organizing PTAs requires a clear understanding of the new nature and scale of economic globalization. Therefore, in the coming years, we will face the transformation of the designs of the already created PTAs, taking into account the new challenges that have emerged in international trade.

Geographical Indications: A Major Challenge for MERCOSUR

Abstract This article focuses on the intellectual property chapter of the EU-MERCOSUR Free Trade Agreement. It is not intended to provide an exhaustive analysis of all the intellectual property rights involved but to go deeply into a specific matter, geographical indications, which is undoubtedly a controversial concession in the chapter. The entire free trade agreement negotiations took more than 20 years and ended in June 2019 with an ‘Agreement in principle’. From the very beginning it involved a red line for the MERCOSUR countries, namely the intellectual property chapter. This article will show the complexity of including the private rights of prior users (generic names, plant varieties and trademarks) as a trade-off for agricultural market access in negotiations mainly focused on tariff reduction and trade rules. In addition, the imbalance between the parties was deepened by the lack of regionally harmonized intellectual property standards within MERCOSUR. In this regard, the main objective of this article is to identify the legal challenges derived from the overlap of national, regional and bi-regional rules that the Mercosur countries will face when implementing the geographical indication commitments, given the bloc’s legal and institutional structure. Unlike tariff reduction, the commitments derived from the negotiation of private rights are a crucial issue. Against this background, some proposals are outlined to address how to determine a medium- and long-term strategy based on the needs of local producers to add value to their productions.

Shaping Intellectual Property Rights Through Human Rights Adjudication: The Example of the European Court of Human Rights

In Europe, important developments such as the entering into force of the Treaty of Lisbon—which placed the Charter of Fundamental Rights of the European Union at the very top of the hierarchy of norms—and the direct applicability by national courts of the European Convention on Human Rights (ECHR) in private law disputes have been highly influential for the rise in human rights reasoning by courts deciding intellectual property (IP) issues. The envisaged E.U. accession to the ECHR is likely to increase this process further. This article reflects on these developments by studying the role of the European Court of Human Rights (ECtHR or Strasbourg Court) in shaping European intellectual property standards. It presents an updated and modified version of the chapter entitled “Intellectual Property Before the European Court of Human Rights,” published by the authors in 2018, and provides the first comprehensive overview of ECtHR case law on IP from the court’s inception in January 1959 until today, March 2020. The article results from an analysis of more than ninety such cases, many of which have never been discussed before in the literature. Certain issues that are currently pending before the Strasbourg Court are also given exposure. The article spans subjects from the protection of the rights of IP holders under the property provision of the ECHR to the possibility of restricting such protection on the basis of the right to freedom of expression and information often invoked by the users of IP-protected content. It also analyzes the situations in which freedom of expression was invoked by the (actual or potential) IP holders themselves in order, for instance, to insure that their trademark applications are registered. The potential of the right to privacy to serve both as a defense against certain IP enforcement measures—such as search orders—and as a basis for the protection of moral rights of creators is likewise discussed. The article further reviews the most prominent IP disputes which raised questions under the right to non-discrimination and the right to a fair trial. This comprehensive overview of the case law of the ECtHR shows the emergence of a human rights framework for the intellectual property system in Europe, which—in combination with the increasing use of fundamental rights by national courts to solve private party disputes—is gaining coherence and relevance in framing the conception and use of IP law.

How (not) to steal a book? The social history of the Chinese publishing industry

This paper reviews Fei-Hsien Wang's Pirates and Publishers - A Social History of Copyright in Modern China book, and concludes that the monograph thoroughly introduces the socio-cultural and economic roots of modern Chinese copyright law. It necessitates readers (and researchers of this field) to look beyond statutory law, and makes it easier to understand the relevance of the “shanzai” culture of modern China. The book similarly helps to understand from where did the Chinese depart from on their long way to merge their copyright regime with (but never succumbed to) the Western intellectual property standards.

How (Not) to Steal a Book? The Social History of the Chinese Publishing Industry

This paper reviews Fei-Hsien Wang's Pirates and Publishers - A Social History of Copyright in Modern China book, and concludes that the monograph thoroughly introduces the socio-cultural and economic roots of modern Chinese copyright law. It necessitates readers (and researchers of this field) to look beyond statutory law, and makes it easier to understand the relevance of the “shanzai” culture of modern China. The book similarly helps to understand from where did the Chinese depart from on their long way to merge their copyright regime with (but never succumbed to) the Western intellectual property standards.

ОРГАНІЗАЦІЯ ПРОТИДІЇ КОМП’ЮТЕРНІЙ (ЦИФРОВІЙ) КОНТРАФАКТНІЙ ПРОДУКЦІЇ

За даними Міжнародної федерації фонографічної індустрії, кожен третій запис є контрафактним, а обсяги продажів піратської музичної продукції на початку XXI століття у близько 25 країнах перевищують легальний ринок і складають близько 4 500 000 000 до-ларів.
 Обсяг світової пісенної індустрії склав 6 500 000 000 000 доларів, що приблизно в 5 разів більше всього обсягу продажів військової промисловості.
 За оцінками експертів, обсяг світової торгівлі контрафактною продукцією оцінюється в 630 млрд доларів (6–7% загального товарообігу). Ринок контрафактних CD і DVD становить близько 5 млрд доларів.
 Міжнародний альянс інтелектуальної власності поставив Україну першою в списку 58 країн з низьки-ми стандартами охорони інтелектуальної власності. За даними Українського центру економічних і політичних досліджень імені Разумкова, 70 відсотків населення України купує підроблену аудіо-, відеопродукцію, марковану загальновідомими товарними знаками. Лише п’ята частина населення її ніколи не купує.
 За даними Асоціації виробників програмного забезпечення, опублікованими в щорічному звіті «Глобальне дослідження піратства за 2017 рік», рівень кібер-піратства в Україні в 2017 році склав 80%. Водночас ціна за неліцензійне програмне забезпечення досягла 108 млн доларів.Проблема організації протидії наслідкам виробництва, поширення і обігу контрафактних примірників комп’ютерного (цифрового) програмного забезпечення і програмних продуктів (комп’ютерного контрафакту) досить складна і багатогранна.
 Стаття присвячена захисту комп’ютерної (цифрової) інтелектуальної власності в контексті законодавчо-правових і організаційних заходів протидії. На основі аналізу наукових публікацій у сфері економіки, комп’ютерних технологій, охорони авторських і суміжних прав запропоновані заходи законодавчо-правового регулювання, а також організаційні заходи, які дозволять зміцнити взаємодію державних органів влади з контролюючими та правоохоронними органами як на загальнодержавному, так і на регіональному рівні.

Deep trade agreements and vertical FDI: The devil is in the details

AbstractAlthough pre‐1990s preferential trade agreements focused mostly on tariff liberalization, recent agreements increasingly contain deep provisions in diverse areas, such as intellectual property rights, investment and standards. At the same time, there has been a remarkable increase in the internationalization of production through foreign direct investment and outsourcing. This paper studies how deep trade agreements affect the international organization of production. Using new measures of the depth and content of preferential trade agreements and of vertical foreign direct investment, the analysis finds evidence that the depth of trade agreements is correlated with vertical foreign direct investment. Furthermore, this relationship is driven by the provisions that improve the contractibility of inputs provided by suppliers, such as standards, while provisions that increase the contractibility of headquarter services, such as intellectual property rights and investment protection, are generally negatively correlated with foreign investment. This finding is consistent with the so‐called “property rights” theory of the multinational firm according to which improving the contractibility of an input reduces the importance of giving incentives through ownership.

China engages with the global intellectual property governance: The recent trend

AbstractAs China becomes the second largest economy in the world, there have been increasing domestic demands requesting China to engage with the global governance of various issues more closely. In intellectual property (IP), China has recently engaged with global IP governance both responsively and actively. This paper answer the questions (a) how did China respond to the global IP up‐ratchet which sets higher IP standards; and (b) how did China actively promote its agenda for the global IP governance. This paper argues that China has a clearer and more consistent position in its responsive engagement than in active engagement. In other words, China is more affirmative in making defensive coalitions opposing TRIPS‐plus standards proposed by developed countries than promoting its own IP initiatives regionally or plurilaterally. China's positions in these defensive coalitions are the classic pro‐development, developing country positions. Its active IP engagement is more diversified. Specifically, China keeps a low profile and does not attempt to take the lead in IP negotiations at the Regional Compressive Economic Partnership. By contrast, China has emerged as a model exporter, focusing on IP capacity building in its IP arrangements in the Belt and Road Initiative (BRI) and BRICS.

Biologics Under a New NAFTA

Scientific developments, such as biologics and personalized medicine, have created an entirely new category of pharmaceutical drugs that were not considered when the North American Free Trade Agreement (“NAFTA”) was adopted in 1994. However, the rise of biologics has increased demand for a reconfigured NAFTA, particularly with respect to Chapter 17, which outlines NAFTA’s robust intellectual property standards, as well as Chapter 11, which both lays out the framework for foreign investment under NAFTA and introduces a controversial mechanism referred to as the investor-state dispute settlement mechanism (“ISDS”). The intellectual property provisions of the original NAFTA should be revised to mirror the similar provisions of the Trans-Pacific Partnership (“TPP”) Agreement, which better accommodates new medical advances. However, despite criticism of their lack of transparency, the investment provisions of the original NAFTA are likely sufficient to grant medical patent-rights holders the investment protection that they seek because they strengthen transparency, which is ultimately good for business.

Data Exclusivities in the Age of Big Data, Biologics, and Plurilaterals

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards. One topic linking all three developments together concerns the establishment of international standards to protect clinical trial data that have been submitted to regulatory authorities for the marketing approval of pharmaceutical products. During the negotiations for the Trans-Pacific Partnership (TPP), for example, the protection of clinical trial data submitted for the marketing approval of biologics was highly contentious. Although the United States’ withdrawal in January 2017 has since placed the TPP Agreement and its data exclusivity provisions for pharmaceuticals and biologics on life support, the debate on the protection of clinical trial data will continue and will emerge in future bilateral, regional, and plurilateral trade negotiations, including the renegotiations on the North American Free Trade Agreement (NAFTA). Part I of this Article reviews the protection of clinical trial data under Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO). Even though the provision covers both pharmaceutical and agricultural chemical products, this Article focuses only on the former. Part II examines the additional protection clinical trial data have received through TRIPS-plus bilateral, regional, and plurilateral trade agreements. Part III outlines five specific recommendations to help advance the debate on such protection in the age of big data, biologics, and plurilateral trade agreements.

Territoriality in Intellectual Property Law: Examining the Tension between Securing Societal Goals and Treating Intellectual Property as an Investment Asset

By Emmanuel Kolawole Oke. The principle of territoriality is one of the foundational principles of International Intellectual Property Law. This principle allows countries to design their intellectual property laws in a manner that facilitates the achievement of specific societal goals. However, while it is true that this principle has managed to survive the incorporation of intellectual property into the international trade law system (via the WTO’s TRIPS Agreement), some scholars have expressed concern that the incorporation of intellectual property into the international investment law system via investment agreements (such as bilateral investment treaties) constitutes a potential threat to the principle of territoriality in the international intellectual property system. This paper will investigate the tension between the principle of territoriality and the global harmonisation of intellectual property standards in the context of the current iteration of intellectual property as an asset in investment agreements. Specifically, it will critically examine how this tension was resolved in two recent investment arbitration disputes. The first is the dispute between Philip Morris and Uruguay which concerned the latter’s implementation of certain measures to curb the consumption of tobacco products in its country but which Philip Morris construed as an expropriation of its trademarks. The second is the dispute between Eli Lilly and Canada which concerned the interpretation of the utility requirement under Canadian patent law. These cases will be used to assess whether there is still scope for the preservation of the principle of territoriality within the investor-state dispute settlement system.

Priroda vanjskotrgovinskih odnosa SAD-a i EU-a s osvrtom na TTIP

Međuovisnost SAD-a i EU-a na ekonomskoj, političkoj i sigurnosnoj razini povijesno je bila izvor suradnje, ali i tenzija između dvaju globalno važnih gospodarstava. Snažne ekonomske, političke i sigurnosne spone SAD-a i EU-a omogućile su tim gospodarstvima stjecanje globalne nadmoći jer se radilo o sponama među najmoćnijima prema ekonomskim i obrazovnim kriterijima. Sa svrhom zadržavanja globalne premoći, SAD i EU se nastoje uskladiti što se tiče suvremenoga bilateralnog trgovinskog sporazuma visokih standarda, takozvanog TTIP-a. Cilj Transatlantskog sporazuma o trgovinskom i investicijskom partnerstvu je postići dogovor o daljnjoj liberalizaciji i povećanju tržišnog pristupa putem eliminacije prepreka u trgovini dobrima, uslugama i poljoprivrednim proizvodima te investicijama kao i o procedurama vezanim uz javnu nabavu. Važni ciljevi sporazuma su i povećanje regulatorne usklađenosti i kooperacije na području: vanjskotrgovinske i sigurnosne politike, investicija i razvoja novih pravila vezanih uz izravne strane investicije, prava koja proizlaze iz intelektualnog vlasništva, radničkih prava i ekoloških standarda. U ovom članku istaknut će se najvažnije nesuglasice između SAD-a i EU-a vezane uz tzv. TTIP s primarnom svrhom definiranja potencijalnih rizika za održivi rast gospodarstva EU-a u budućnosti.

Patentability Standards for Follow-On Pharmaceutical Innovation

Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays an important, but at times underappreciated, role in providing innovative solutions to compelling medical needs. Examples of follow-on innovation include new forms of a drug with improved safety-efficacy profiles, new formulations and dosages providing improved patient outcomes, and new methods of using an established drug more safely or to treat new indications. Patents play a critical role in incentivizing the research, development, testing, and ultimately commercialization of follow-on pharmaceutical innovation, and in doing so provide substantial benefits for public health and patients' quality of life. There is, however, a body of literature characterizing patents directed towards follow-on innovations as “secondary pharmaceutical patents.” Some have even gone so far as to propose that the criteria for patentability should be enforced more stringently with respect to follow-on pharmaceutical inventions as compared to other inventions. The underlying assumption of such proposals is that follow-on pharmaceutical innovations are somehow secondary to other pharmaceutical innovation, and thus less deserving of patent protection. In this article, we refute the notion that follow-on pharmaceutical innovation should be categorically singled out for unfavorable treatment under the patent laws, and provide numerous examples of the value that follow-on innovation brings to medicine, and ultimately to patients. We also propose, in view of the international treaty obligations set out in, inter alia, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), standards and best practices for assessing the patentability of inventions arising out of follow-on pharmaceutical innovation. These are essentially the same stringent standards applicable to “primary” pharmaceutical innovation, and inventions in general. This article provides numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.