Biotechnological Inventions

Moral Restraints and Patent Law

Oliver Mills

• Publisher: Routledge
• Year: 2016
• ISBN:
  9781317174158
• Edition: 1
• Topic: Law
• Subtopic: Jurisprudence
• Index: Law

Advances in modern biotechnology have produced profound and far-reaching implications for the relationship between humans, animals and the environment. As a result, a debate has arisen surrounding the legal, moral and social problems connected with this technology, a central part of the debate focusing on the role of moral considerations in the patent system as a form of regulation. This fully revised and updated book examines this role and asks why in the context of biotechnological inventions, morality has become an important issue. It takes account of recent developments, including reference to the situation in Australia. By examining such specific recent cases, the author elucidates the moral concerns associated with modern biotechnology, thus providing an important contribution to the debate and a valuable resource for all those working in this exciting field.

Chapter 1
Biotechnological Inventions: The Moral Debate

Introduction

The biotechnology industry is at the cutting edge of scientific research and innovation. As a scientific art and commercial process it is problematic not merely for scientists and economists but also for lawyers and the general public. Problems for research scientists include how to discover and examine the workings of nature. One of the major challenges for economists lies in learning how to cope with the growth of new industries. In this regard, the economic role of patents is, arguably, more important than ever before, and still, patent systems are only marginally influenced by economists.1 For lawyers, the fast-moving pace of biotechnology means it is necessary to keep matters under review and to provide an appropriate legislative response. In the interests of the public, the actual and potential impact of the technology, in particular in the domain of health care, agriculture and the environment, needs to be addressed more fully. In this regard, private companies hoping to develop the huge potential for commercial applications must look beyond the technology and into the future if the science is to be brought successfully to market.2 It is equally imperative to ensure that publicly funded research, where commercialized, results in adequate, and sufficient, public benefit. In terms of regulation, the rate of development of biotechnology means that situations and problems are likely to precede primary legislation and, indeed, case law.3 Because of this it is necessary to be flexible and to keep under review the development of scientific possibilities, in the context of public understanding, so that as far as possible issues are anticipated, and research and development, and legislation, are conducted with as full as possible an appreciation of the consequences.4

In order to orchestrate an informed debate about the practice and applications of biotechnology, the non-scientist public, including lawyers, must understand what, technically speaking, biotechnology can and cannot do.5 Scientists are capable of identifying the potential advances in the fields of health care, agriculture and the environment that might flow from the commercial applications of biotechnology.6 However, they are no better equipped than anyone else to identify the social and moral issues that may result from their use. Only society can decide the degree of importance to be attached to these benefits, hazards and impacts. Such fundamental decisions within an area of inherent uncertainty can be made only within a properly constituted framework. Law can provide the mechanisms that facilitate the taking of necessary decisions about the nature and direction of both research and policy. In this sense, besides being instrumental in the policy process, law promotes legitimacy and accountability.

The result of not having a sufficiently constituted framework is that the legal and moral boundaries of biotechnology are unclear to the patent lawyer. Indeed, if the appropriate application and development of legal terms to scientific practices is problematic for those directly involved, how are the concerns of the general public to be addressed?

There are moral objections both to patenting biotechnological inventions and to the technology itself. In this regard, defining morality is one of the key problems. Morality has been described as the system of norms, values and ideals considered universally valid and important to serve as guidelines for action.7 A moral law can be thought of as a law with no sanction for its transgression other than in conscience. However, in terms of law, where certainty and clarity are foremost (and punishment for breach ensues), such a general definition is too broad to have any significant meaning. In the context of morality the extent to which the patent system (the main features of which are summarized briefly hereafter), in particular in Europe, either initially under the European Patent Convention 1973 (henceforth EPC) and later the Directive on the Legal Protection of Biotechnological Inventions 1998 (henceforth the Directive), and in the United States (henceforth US), is designed, or, indeed, even appropriate to accommodate biotechnological inventions, is examined throughout and forms the subject-matter of the book.

The Patent System

Both in Europe under the EPC and in the US a patent is an intellectual property right. It is, essentially, a negative right granted by the state, which confers on the patentee8 the right to exclude others from using, or exploiting, the invention without his consent. The right is limited in time, under the EPC9 (and the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994; henceforth TRIPS),10 to 20 years from the date of filing the application. The right is also limited in terms of space, in that a patent is valid only in the jurisdiction of the patent office by which it is granted. A patent does not confer on the patentee the right to exploit the invention. The right conferred is that of preventing third parties from exploiting the invention without the consent of the patentee. For the most part, exploitation is under the control of national regulatory authorities.11

The object of the patent system, both in Europe under the EPC and the US, is to encourage invention and the growth of new industries.12 The operation of the system is quite simple. The state grants to the inventor rights in his invention in return for public disclosure of how to work the invention.13 The interests of the inventor are balanced against those of the public. The patent system creates a monopoly in favour of private individuals; hence, there are restrictions. First, a patent can be granted only for an invention.14 Second, the patentee is given certain exclusive rights in respect of his invention. Third, the exclusive rights in their nature are not permanent.

Specification

In addition, the European patent system, under the EPC and the Directive, contains further restraints in respect of patentability, one of which relates to patent specification. The specification must describe the invention sufficiently clearly to enable those ordinarily skilled in the art to practise the invention. The specification contains a description of the invention and the patentee is granted a temporary monopoly in his invention in return for teaching the public15 how to work it. The specification, therefore, discloses the invention.16 Additionally, the scope of the monopoly is defined by means of the claims. The claims must be clear, concise and supported by the description.17 Only if the specification as a whole teaches how to reproduce what the inventor claims can a patent be issued. Adequate disclosure of the invention is the quid pro quo for granting the patentee a temporary monopoly in his invention (Chapter 5).

Criteria

In Europe, both under the EPC and the Directive, and the US, to be eligible for patent protection, an invention must satisfy three criteria:

• novelty

• inventive step (non-obviousness in the US)

• industrial application (utility in the US).

The application of these criteria in practice (Chapter 5) often involves legal subtleties, but they may be simply summarized as follows:

Novelty This requires that the invention be new.18 It must not already be available to others, through any form of public disclosure or use before the date of filing the patent application.19 All such prior knowledge is known as the state of the art or prior art. Novelty requires a difference from the prior art. Another aspect of novelty is that there must not be publication of the invention before the filing date of the application. The rationale for the novelty requirement is that what is known already by the public is not new, and what is already in the public domain can not be the subject of a private monopoly.

Inventive step This is difficult to define,20 but is understood as relating to the issue of obviousness.21 The invention must not be obvious to the ordinary skilled worker having regard to the state of the art.22 In other words, the invention must not merely follow logically from what is already known in the state of the art. Put another way, inventive step requires that the difference in the art possess the character of not being obvious to a person already skilled in that art.23

Industrial application The invention must be capable of use in any type of industry, including agriculture.24 The rationale for this requirement is that an invention which cannot be applied in industry is of no benefit to society, and, therefore, is not deserving of patent protection.

Non-patentable Inventions

In addition, in contrast to the US, most European countries have a list of subject-matter considered unsuitable for patent protection. Many countries recognize that certain subject-matter is capable of forming the substratum of an invention, yet consider that such inventions ought not to amount to patentable inventions within the meaning of patent legislation.25 The rationale for exclusion is that, because the inventions are not industrially applicable, they cannot benefit society, and therefore the patentee should not receive monopoly status in respect of exploitation. Indeed, in the context of eligible subject-matter, arguably, it may be stated, as a broad proposition, that in Europe under the EPC and the Directive immoral and biological inventions are also excluded from patent protection.26 The rationale is that such subject-matter is not appropriate for patent protection. However, it should be stressed that countries differ in approach to subject-matter patentability, and what is outlined briefly here is the situation which pertains in Europe generally,27 as a result of both the EPC and the Directive, and in the US...

Table of contents

• Cover Page
• Dedication
• Title Page
• Copyright Page
• Contents
• Table of Cases
• Table of Statutes
• Table of Conventions
• Preface to the Revised Edition
• Acknowledgements
• List of Abbreviations
• 1 Biotechnological Inventions: The Moral Debate
• 2 Development of a European and UK Moral Regime
• 3 Development of Patent Law in the United States
• 4 Application of Article 53 European Patent Convention
• 5 Patent Law Criteria and Biotechnological Inventions
• 6 Protection Conferred in the United States
• 7 Protection Conferred under the Biotechnology Directive 1998
• 8 Plant Variety Protection: UPOV, Community, Directive
• 9 Recent EU Initiatives: Likely Impact on Moral Concerns
• Bibliography
• Index