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The Challenge of Regulatory Cosmopolitanism

Roger Brownsword

in Rights, Regulation, and the Technological Revolution

This chapter completes the discussion of the regulatory challenges presented by modern technologies by considering some particular puzzles for regulatory cosmopolitanism. The first test case focuses ... More

This chapter completes the discussion of the regulatory challenges presented by modern technologies by considering some particular puzzles for regulatory cosmopolitanism. The first test case focuses on the interpretation of the moral exclusion (against patentability) that is characteristic of European patent regimes, both regionally and locally. The second test case also concerns local moral exclusion but, this time, against the principle of market access that is enshrined in regional and international free trade agreements. The third case involves a more direct assertion of power by the local community. In this case, a nation state endeavours to enforce its own local standards, particularly where the effectiveness of its own local regulation threatens to be undermined by the technology of the internet, a technology that knows no physical borders.Less

Living with Dignity II: Patents and Contracts

Beryck Beyleveld and Roger Brownsword

in Human Dignity in Bioethics and Biolaw

This chapter considers the bearing of human dignity on the commercial exploitation of the human body. First, it discusses the patentability of human gene sequences. It then addresses contractual ... More

This chapter considers the bearing of human dignity on the commercial exploitation of the human body. First, it discusses the patentability of human gene sequences. It then addresses contractual questions, for example, whether respect for human dignity requires that freedom of contract should be limited where the body is exploited in some way and that freedom to contract should be limited where genetic information is used to guide the choice of contractual partners.Less

Why Courts and Not Congress Offer a Way Out of the Crisis

in The Patent Crisis and How the Courts Can Solve It

This chapter addresses the dangers of legislating industry-specific statutes. It also defends the proposition that courts, rather than Congress or the Patent and Trademark Office (PTO), are the right ... More

This chapter addresses the dangers of legislating industry-specific statutes. It also defends the proposition that courts, rather than Congress or the Patent and Trademark Office (PTO), are the right place to implement those policy levers. Congress has spent the last four years, from 2005 to 2008, in an ultimately futile effort to reform the patent system. The pharmaceutical and biotechnology industries opposed virtually all elements of patent reform directed at abuse. It suggests that, as a general principle, a flexible common-law approach of ongoing judicial oversight will best accommodate new and different technologies within the general framework of a patent statute. The legal standards for patentability have remained squarely with the court. The separation of functions in the patent context may yield the best of both institutions; the expertise of the agency tempered by the independence of judicial review.Less

Confronting the Questions of Life-Form Patentability

Shobita Parthasarathy

in Patent Politics: Life Forms, Markets, and the Public Interest in the United States and Europe

Chapter 2 examines the beginning of the US and European life form patent controversies. It argues that almost from the outset, the two places approached the questions at stake, and how these ... More

Chapter 2 examines the beginning of the US and European life form patent controversies. It argues that almost from the outset, the two places approached the questions at stake, and how these questions should be answered, completely differently. In the United States, life form patentability was treated as a normal legal question about the distinction between nature and technology. Despite efforts by Jeremy Rifkin and other civil society groups to raise ethics and ecosystem concerns, they and their worries were rebuffed as irrelevant by the Supreme Court and the patent system’s traditional stakeholders in the Diamond v. Chakrabarty case. In Europe, life form patentability quickly became an exceptional question, to be solved by democratically-elected legislators in the newly powerful European Parliament. Legislators grappled with questions of whether biotechnology products were forms of life, how they should make this determination, and what kinds of knowledge and expertise were relevant to their discussions and to the patent system. They decided that they were indeed dealing with matters of life, and that such matters required consideration of ethics, as well as socioeconomic and ecosystem implications. They eventually passed the European Union’s Directive for the Legal Protection of Biotechnological Inventions, but with important limitations.Less

Multilateral Agreements and Policy Opportunities

Carlos M. Correa

in Intellectual Property Rights: Legal and Economic Challenges for Development

The multilateral rules on intellectual property rights set out by the TRIPS Agreement limit the WTO members’ room to use foreign protected technologies for local production. However, governments ... More

The multilateral rules on intellectual property rights set out by the TRIPS Agreement limit the WTO members’ room to use foreign protected technologies for local production. However, governments retain certain policy space under said Agreement to promote local production. They may adopt exceptions to patentability, and rigorously define the concept of ‘invention’ and of inventive step. They may also implement a broad experimentation exception to facilitate ‘inventing around’, the acquisition of voluntary or compulsory licenses, and legal challenges against invalid patents. Compulsory licenses for failure to work a patent or for ‘refusal to deal’ may also open the necessary space for local production in various industries.Less

Patent Protection

Stuart O. Schweitzer and Z. John Lu

in Pharmaceutical Economics and Policy: Perspectives, Promises, and Problems

Patent protection, innovation, and profitability are all intimately connected in the pharmaceutical industry. Without patent protection there would be no marketing exclusivity, and competitors would ... More

Patent protection, innovation, and profitability are all intimately connected in the pharmaceutical industry. Without patent protection there would be no marketing exclusivity, and competitors would immediately enter any market where there was a new successful drug, eventually driving price down to the marginal production cost. Future R&D would never take place because there would be no way for firms to earn a yield on those investments in developing new pharmaceuticals. Patents, however, entail societal cost, because they raise the diffusion cost of knowledge and makes some innovative drugs prohibitively expensive in the short run. This chapter examines key patent laws applicable to the pharmaceutical industry, including category, duration, scope, infringement, and ground for challenge, both in the United States and in other advanced economies. Examples of strategic behavior by branded and generic firms are discussed. The chapter also provides a review of recent literature critical of the patent system.Less

TRIPS and TRIPS-Plus Protection and Impacts in Latin America

Carlos M Correa

in Intellectual Property, Trade and Development

The adoption of a set of minimum binding standards for the protection of intellectual property rights (IPRs) in the context of the World Trade Organization (WTO) led to massive changes in the ... More

The adoption of a set of minimum binding standards for the protection of intellectual property rights (IPRs) in the context of the World Trade Organization (WTO) led to massive changes in the national regimes of Latin American countries in the last twenty years. Major differences with the protection granted in developed countries (e.g. non-patentability of pharmaceutical products) were erased, thereby limiting the policy space available to Latin American countries to implement IPRs standards better suited to their levels of technological and economic development. While some of these countries have used, to a certain extent, the flexibilities allowed under the WTO rules, others entered into free trade agreements that further eroded such space. There is little evidence so far on the impact of these changes, but several studies point to considerable costs derived from the implementation of higher standards of protection, notably increased prices and more limited access to medicines.Less

Observing the Patent System in Social and Political Perspective: A Case Study of Europe

Shobita Parthasarathy and Alexis Walker

in Patent Law in Global Perspective

Most legal scholars treat the major patent systems across the world as substantially similar. These systems reward inventors with intellectual property rights for a limited period of time, bring ... More

Most legal scholars treat the major patent systems across the world as substantially similar. These systems reward inventors with intellectual property rights for a limited period of time, bring scientific and legal knowledge to bear on the assessment of patent applications, and have substantially similar approaches to patentability. But this is not the full story. Using the European patent system as a case study, this chapter argues that when patent systems are understood through a social and political lens, they exhibit many important differences. We demonstrate that the European patent system’s distinct history and social and political context have shaped its policies and practices, but also its responses to the growing activist challenges that have plagued patent systems over the past three decades. Understanding these differences, and the reasons for them, enhances our understanding of both the patent system’s role in the governance of innovation and our ability to predict its evolution in the face of controversy over its responsibility to the public interest.Less

The Resurgence of the Public

Feroz Ali

in The Access Regime: Patent Law Reforms for Affordable Medicines

Indian reforms to patent law have drawn polarized reactions, however, the reforms have been in the making since India gained Independence and can hardly be classified entirely as a response to the ... More

Indian reforms to patent law have drawn polarized reactions, however, the reforms have been in the making since India gained Independence and can hardly be classified entirely as a response to the TRIPS Agreement. Indeed, the Indian model shows that there can be an alternative to patent systems propounded by developed nations that favour the public and adhere to socio-democratic principles. This chapter highlights the transition of the patent model in India and describes the rationale for its current patent system. Further, this chapter examines the amendments brought forth to comply with the TRIPS and the amendments meant to ameliorate such compliances. The provisions of the Patent Act that were amended following the TRIPS and the manner in which they affect the Indian public are examined.Less

Heightened Standards of Patentability: Raising the Bar on Inventions

Feroz Ali

in The Access Regime: Patent Law Reforms for Affordable Medicines

Patents are not granted uniformly across nations as the standards for patentability varies across nations. This chapter analyses standards of patentability, specifically nonobviousness and the ... More

Patents are not granted uniformly across nations as the standards for patentability varies across nations. This chapter analyses standards of patentability, specifically nonobviousness and the enhancement of efficacy, for pharmaceutical patents. The new definition of nonobviousness laid down by the Patents Act has serious ramifications in terms of raising the bar on inventions that can be patented. A further significance of the new definition is that it places the burden of disclosure squarely on the patent applicant. This chapter then examines the threshold requirement of enhancement of efficacy. The provision itself has been introduced to curb any initiative to patent bioequivalents. The judicial determination of the meaning of the term ‘efficacy’ and the legislative intent behind the provision are explained herein.Less

Patents

Eran Liss and Dan Adin

in Intellectual Property Law and Practice in Israel

This chapter discusses various issues relating to Israel's patent law. It first explains what is protected under patent law, subject matter eligibility, and substantial patentability requirements. It ... More

This chapter discusses various issues relating to Israel's patent law. It first explains what is protected under patent law, subject matter eligibility, and substantial patentability requirements. It then considers how patent protection can be obtained, including procedural patentability requirements pertaining to the contents of the patent application, along with a range of issues that arise in the course of the registration process of a patent application and those relating to opposition and cancellation proceedings. It also examines what constitutes patent infringement and additional patent-relevant topics such as ownership and licenses, double patenting, inventorship, antitrust laws, and special rules concerning security and state-related inventions.Less

Major Issues in the Pharmaceutical Industry

Eran Liss and Dan Adin

in Intellectual Property Law and Practice in Israel

This chapter discusses major intellectual property issues that arise in relation to the pharmaceutical industry in Israel, from patent term extension to data exclusivity, the patentability of ... More

This chapter discusses major intellectual property issues that arise in relation to the pharmaceutical industry in Israel, from patent term extension to data exclusivity, the patentability of pharmaceutical inventions, and trademarks. It explains who may apply for patent term extension, the scope of the extension order and how to obtain it, and the level of drug efficacy that is required to be included in a patent application. It also examines the eligibility of second medical use for patent protection, “obvious to try” v. hindsight, Israeli Trademark Office rules and practice with respect to trademark applications in class 5, and likelihood of confusion between trademarks.Less

Chemical Inventions

Philip W. Grubb, Peter R. Thomsen, Tom Hoxie, and Gordon Wright

in Patents for Chemicals, Pharmaceuticals, and Biotechnology

This chapter considers the law governing the patentability of chemical inventions, including novel compounds, polymeric compounds, new salt forms, new physical forms, new synthetic processes, ... More

This chapter considers the law governing the patentability of chemical inventions, including novel compounds, polymeric compounds, new salt forms, new physical forms, new synthetic processes, analogy processes, new compositions and mixtures, and new uses and new application processes. A novel compound, for instance, cannot be patented unless it is industrially applicable. Despite being new and useful, a compound may not be patentable if it is so close to the prior art that there is no inventive step involved in making it. For polymers, it is still possible to obtain new and patentable polymers using various kinds of modification, provided that these give useful and non-obvious results. If a group of compounds is new and inventive, then not only are claims to the compounds per se patentable, but also claims to the process for the preparation of the compounds, even if it is known as a method for making similar compounds. Less

Pharmaceutical Inventions

Philip W. Grubb, Peter R. Thomsen, Tom Hoxie, and Gordon Wright

in Patents for Chemicals, Pharmaceuticals, and Biotechnology

This chapter considers the law governing the patentability of pharmaceutical inventions, including new chemical entities, pharmaceutical compositions, and dosage regimes. Provisions in the UK ... More

This chapter considers the law governing the patentability of pharmaceutical inventions, including new chemical entities, pharmaceutical compositions, and dosage regimes. Provisions in the UK Patents Act 1977 and the European Patent Convention (EPC) exclude from patentability ‘methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body’, although this does not prevent a substance or composition from being patentable for use in any of these methods. Under the EPC, such methods were excluded by being defined as not industrially applicable; the new approach introduced by EPC 2000 is more logical and also clarifies the patentability of further medical uses. Novel compounds that have a pharmaceutical utility are patentable per se in all countries that have implemented the TRIPs Agreement. Less

Biotechnological Inventions

Philip W. Grubb, Peter R. Thomsen, Tom Hoxie, and Gordon Wright

in Patents for Chemicals, Pharmaceuticals, and Biotechnology

This chapter considers the law governing the patentability of biological inventions, including microbiological inventions, recombinant DNA technology, and monoclonal antibody technology. Patent ... More

This chapter considers the law governing the patentability of biological inventions, including microbiological inventions, recombinant DNA technology, and monoclonal antibody technology. Patent protection for biotechnological inventions is of immense commercial importance. But patent law and practice have been unable to keep up with the rapid scientific progress in this field; issues such as inventive step, sufficiency of disclosure, and permissible breadth of claims have proved troublesome. There has been much litigation of biotech patents and courts have found it difficult in such a rapidly moving field to determine what was the general knowledge of the skilled person at the time that the invention was made. Another problem is the opposition of special interest groups to anything related to genetic engineering, particularly the existence of patents in this area. Less

Patenting of Genes, Plants, and Animals

Philip W. Grubb, Peter R. Thomsen, Tom Hoxie, and Gordon Wright

in Patents for Chemicals, Pharmaceuticals, and Biotechnology

This chapter considers the law governing the patentability of human genes, plants, and animals. Here one can no longer stay at the objective level of scientific findings and patent laws, but must ... More

This chapter considers the law governing the patentability of human genes, plants, and animals. Here one can no longer stay at the objective level of scientific findings and patent laws, but must consider the broader issues of ethics, social policy, and politics. Many persons, for different reasons, are opposed to the granting of patents for living organisms; the same persons believe that someone who patents a human gene somehow acquires control of human life, or even of an individual from whose tissue the gene was isolated. Where the invention can be useful in the diagnosis or treatment of disease, the majority of the public may accept the need for such patents, but opposition to genetic modification of food crops and to patents on the resulting transgenic plants is more widespread. Less

Foundational Patents in Artificial Intelligence

Raphael Zingg

in Artificial Intelligence and Intellectual Property

Despite advocating openness, technology leaders have been patenting artificial intelligence (AI) inventions at an exponentially increasing rate. Patents on foundational techniques with broad ... More

Despite advocating openness, technology leaders have been patenting artificial intelligence (AI) inventions at an exponentially increasing rate. Patents on foundational techniques with broad applications have the potential to deter innovation in the field, should the privatization of key components of artificial intelligence be used to exclude third-party innovators. This chapter studies patent applications in the US and demonstrates the extent to which the field has grown over the last twenty years. It then seeks to explore foundational patents by focusing on triadic patents: patents filed jointly with the United States Patent and Trademark Office, the European Patent Office, and the Japanese Patent Office. The results of this chapter indicate an increasingly globalized AI field. A proverbial land grab seems to be occurring; an increase in AI patenting, particularly the protection of triadic patents, illustrates industry players aggressively attempting to own the building blocks of a rapidly emerging market. A number of policy levers are presented, highlighting how the patent offices and courts can counter the patenting of foundational patents by relying on strict and narrow patentability standards.Less

Patent Examination of Artificial Intelligence-related Inventions: An Overview of China

Jianchen Liu and Ming Liu

in Artificial Intelligence and Intellectual Property

To date, artificial intelligence (AI) has caused fundamental changes in inventing processes, and many issues are arising therefrom, especially whether and in what way inventions implemented by AI are ... More

To date, artificial intelligence (AI) has caused fundamental changes in inventing processes, and many issues are arising therefrom, especially whether and in what way inventions implemented by AI are patent-eligible under the current patent regime. To deal with the issue of patentability, some countries have adjusted their patent regime to AI-related inventions. As a major economy with a world-leading AI industry, China has accumulated abundant experience in examining applications with respect to AI-related inventions. This chapter focuses on China’s experience in the examination of AI-related inventions and its latest regulatory movements in this regard. More specifically, it revolves around China’s practice of modifying its Guidelines for Patent Examination (‘Guidelines’) to clear the way for AI-generated inventions in April 2017, reaching consensus on applying the Patent Law, Implementing Rules of the Patent Law, and the Guidelines to examining the applications of AI-generated inventions, and further revising the Guidelines in December 2019 to make them more suitable for AI-related inventions. This chapter argues that these experiences can be a useful benchmark for other jurisdictions to grant patent rights to AI-related inventions.Less

Obtaining a Granted Patent: Patent Cooperation Treaty Procedure

Philip W. Grubb, Peter R. Thomsen, Tom Hoxie, and Gordon Wright

in Patents for Chemicals, Pharmaceuticals, and Biotechnology

The Patent Cooperation Treaty (PCT) is a special agreement under Article 19 of the Paris Convention and is open only to states that are members of the Convention. Its main purpose is to make the ... More

The Patent Cooperation Treaty (PCT) is a special agreement under Article 19 of the Paris Convention and is open only to states that are members of the Convention. Its main purpose is to make the patent application process simpler and cheaper by having a single set of formal requirements, and a single search and publication procedure, and by postponing translation requirements until thirty months from the priority date. This chapter first discusses the procedure for filing an international application, that is, a PCT application. It then explains the International Preliminary Report on Patentability (IPRP)—a preliminary, non-binding opinion by the international preliminary examining authority (IPEA) on the novelty, inventive step, and industrial applicability of the claimed invention. Less