Patenting life

Thomas Schweiger, Greenpeace European Unit - April 1999

INTRODUCTION

Since the advent of genetic engineering (GE), an immense scientific and political debate about the safety and wisdom of this technology has been raging with intense public interest and participation. But with the technology's intrusion into plant and animal breeding, a less publicised parallel discussion has erupted on questions which go far beyond public health, environmental protection and the safety of GE foods. It is a debate that deals with the very concept of creation itself and our relationship with it. The most basic aspects of ethics and morality are involved, such as how do we, as a society, define things like "life" and "creation" and who should be able to claim "ownership" over them? How do we organise access to, and control over, our planet's biodiversity and natural resources - from the local community level through to the global trading system?

Our world's societies are challenged by these fundamental questions and the task to create a global, legal framework that sets clear rules and boundaries in an area which is fast evolving into the totally unknown and has the powerful potential to change every aspect of our daily lives. A legal system is needed that takes account of the far-reaching ethical and moral aspects of ownership of life, of free and democratic access to our human heritage and natural resources and that protects our biodiversity from "bio-pirates". It needs to secure a fair and accountable trading system by preventing economic monopoly control over the very basics of our lives.

How such a system should be implemented is fiercely debated in all quarters of the world and on all levels - from grass-root farmers' organisations all the way up to global UN conferences.

It's the debate over Patents On Life!

THE TREASURE HUNT

It is no secret that the biotech industries, which are manipulating plants, animals and even the human genome, are using gene technology to try to gain total control not only over their own "creations" - the genetically modified organisms (GMOs) - but quite simply over the planet's genetic heritage itself. "Genes are the currency of the future", a leading executive of a giant pharmaceutical company once said (1). And whoever controls this currency, controls the future.

But how can anyone argue for monopoly control over something that has been around as long as we have existed ourselves and which exists everywhere and in every single person, animal and plant?

It is perhaps comparable to the conquest of the West in America, when settlers from Europe simply rammed stakes into the ground of a newly discovered countryside and thereby demarcated and claimed "their" land - with no respect at all for who or what was there before or who else needed to live off that land. It is also perhaps no coincidence that the legal term used to describe the protected rights in a patent application is "claims".

In a decade where genes and DNA and the genomes of living organisms are being discovered, decoded and isolated at breathtaking speed, the concept in the minds of the company executives is simple - it's a treasure hunt of unprecedented dimensions: whoever finds a gene first can claim total control over it and prevent others from accessing it.

But in order to be able to defend and really exercise this control, the companies must seek to obtain secure legal rights over these organisms that would legally prevent others from using them. What the industries want are "Intellectual Property Rights" (IPRs) over living organisms. Plants, animals and genes are thus essentially being declared as "ideas" - mere "intellectual concepts".

Armed with gene technology as the Trojan Horse and the concept of "intellectual property" as the army, the so-called "Life Science Industries" (mainly chemical and pharmaceutical transnational companies) can then embark on taking over our human heritage and natural resources. Crops and foods especially are targeted by these companies and gaining monopoly control over the basics of our food production - the seeds - gives the Life Science companies unlimited power. And in the medical field, Life Science companies are also seeking to gain control over the most basic building blocks of life by patenting human genes.

The stronger the legal protection, the bigger the profits, and the strongest form of IPR is the patent. The patent system as we know it today evolved some 100 years ago and was designed to protect the possible economic interests attached to new technical inventions. Patents are government guarantees giving an inventor exclusive rights to use, sell or manufacture an invention for a set period of time. They were granted only to those who really "invented" new things. Existing living organisms, like plants and animals, were of course no-one's invention and could therefore, by definition, never be patented.

Or at least this was the societal consensus until the biotech industries started pressuring legislators into extending this IPR system to systematically include living organisms as well.

CHANGING THE RULES AND BREAKING THE CONSENSUS

It all started in the USA in the mid eighties when a court ruled that a genetically modified bacteria constituted a sufficiently new invention to be patentable. Since then, everything from bacteria to plants, animals and even human cells has been patented in the USA. This has introduced a totally new conception of "creation" - suddenly, the creator of a plant or animal was no longer God or natural evolution, but a technical scientist in a laboratory. Plants and animals became "inventions" of an individual person, and the attached rights meant that this person could exercise total control over what happened with the "invention". This is less of a problem when, for example, technical machines are involved but when dealing with living matter, it becomes a totally different question. It means controlling access to our planet's heritage, the power to decide who can use plants, animals and even our own human genes, and for what purposes. It is a frightening concept. (See also briefings on "Biopiracy" and "The Patent as an Economical Weapon")

The chance to export this change in the concept of ownership and creation from the USA to the rest of the world came with the Uruguay round of the GATT Agreement. The resulting legal framework, the Trade Related aspects of Intellectual Property rights Agreement (TRIPs), enshrined within the World Trade Organisation (WTO), stipulated that virtually everything became patentable. Strong resistance to this purely materialistic approach came from the developing countries of the South, but in an era where economic might decided the scope and effect of the new international rules, all that could be achieved was to secure an important possibility of choice in the TRIPs Agreement - WTO Member States were free to exclude plants and animals from patentability under certain conditions (Article 27(3)b). Most countries of the world made extensive use of this possibility in order to protect their own biodiversity from being patented by rich multinational companies.

EUROPE: ONGOING LEGAL AND POLITICAL BATTLES

In Europe, things have not gone as smoothly for the biotech industry as in the US. In the European Union (EU), a fierce and ongoing legal and political battle has been raging for 10 years over whether to allow such patents on "life". In 1988, the European Commission first proposed a patent directive (law) which would have allowed such patents. Seven years later, in 1995, the European Parliament (EP) rejected this legislative proposal because it deemed the patenting of life-forms unethical. But in 1998, the Parliament succumbed to pressure from the biotech industry and adopted the "Life Patents Directive". However, the Directive is now being challenged before the European Court of Justice and it is still not certain whether the industry will get what it wants. In addition, matters are made even more complicated by the existence of a parallel patenting system, the much older European Patent Convention (EPC), which does not allow patents on plants but is undecided on patents on animals and genes.

When the EPC was created in the 70s, no-one expected that one day there would be a debate over whether or not to allow patents, not on technical inventions, but on existing life-forms. The definitions and logic of the patent system, and international law, excluded plants and animals from patentability.

Suddenly, this concept was severely challenged when chemical giant DuPont applied for a patent on their cancer-mouse ("Onco Mouse"). To the surprise of a stunned public, the European Patent Office (EPO) [Link] in Munich granted the patent in 1992 (2). The patent included not only the technical process to manipulate or genetically engineer mice that would inevitably develop cancer, but it also included the mice itself, all offspring of these mice and all medical drugs that would ever be developed with the help of such mice. Furthermore, the patent extended monopoly control to cover all mammals and not only mice. It was a patent that covered an unusually large range of claims because it granted the patent holder monopoly control not only over their inventive and developmental work - the technical process - but over a virtually indefinite area by enabling the patent holder to profit from other people's work as well (e.g. those that would use the cancer mouse to develop a drug against cancer) and to profit from the natural reproduction and growing of animals: each time a mouse would became pregnant, the cash would flow - that was the thinking.

This patent on a living organism and the far-reaching claims attached to it amounted to a legal revolution and an economic earthquake at the same time.

The patent was swiftly challenged by a consortium of organisations. Under the banner of "No Patents On Life", animal welfare and environmental organisations started campaigning against this fundamental shift in patent law. A landmark hearing at the EPO in Munich in 1995 ended in tumult and the hearing was abandoned. Subsequent political events have so far scared the EPO into a state of limbo and it has still to rule on the matter.

Even earlier, the EPO had started to grant patents on plants. These were also challenged for similar reasons and, in 1995, Greenpeace won a landmark legal precedent. Greenpeace had challenged the first European patent on herbicide-resistant plants (EP 0242 236), again questioning the very idea that living organisms could be classed as human "inventions" and emphasising that plant varieties are clearly excluded from patent protection. The Board of Appeal at the EPO finally ruled that genetically engineered plants, their seeds and offspring are not patentable under the European Patent Convention. The patent granted to the Belgian company PGS (Plant Genetic Systems) was revoked and the EPO stopped granting new patents on plants (with the exception of a few applications which escaped this ruling as they were already too far advanced).

This ruling constituted an enormous legal setback for the aims of the industry. By the same logic, it would have followed that the EPO would also soon revoke the patent on the "Onco-Mouse". In a parallel development, the industry also suffered a severe and totally unexpected political setback when, in March 1995, the European Parliament rejected, in an unprecedented vote, the draft law that would have made the patenting of living organisms legal in the European Union. The EP considered this to be unethical.

THE LIFE SCIENCE INDUSTRY STRIKES BACK

Stunned by these setbacks, the powerful biotech industries embarked on a major lobbying campaign. The European Commission in Brussels, always a strong supporter of Patents on Life, was swift to put forward a new draft law, with new wording but the same content. Dubbed "The Life Patents Directive", it again aimed to legalise in Europe the patenting of living organisms, plants, animals and even parts of the human body. It thus stood in total contradiction to the recent rulings of the EPO (which is independent from the EU).

The lobby campaigns of the biotech industry focused on the health implications of biotechnology. "No patents - No cure" was the powerful (but misleading) slogan used by the industry to emotionally blackmail the EP. [Link to Medicines, R&D? if we have such a box] It was later disclosed that the lobbyists, who claimed to be speaking in the name of European patients, were in fact paid by the pharmaceutical industry and had no mandate from the patient organisations they purported to represent to lobby in favour of the patent directive.

The industry's tactics were successful and, in May 1998, the EP adopted the "Life Patents Directive". By doing so, it ignored the concerns of virtually all parts of society and all those it is supposed to "represent". A broad array of civil and professional organisations, environmental groups, animal welfare organisations, medical and doctors' associations, farmers' representatives, plant and animal breeders, churches and religious organisations, development aid groups and countries from the South, and many more had all strongly and repeatedly voiced their grave concerns and opposition to the idea of patenting life. But the European Parliament and 12 out of the 15 EU Member States' Governments decided to side with the industry.

THE DISPUTE GOES ON

However, the 10-year saga has not ended there. While the Directive is not yet even implemented in the EU Member States, the governments of the Netherlands and Italy, supported by Norway, have both challenged the legality of the Directive (98/44/EEC) at the European Court of Justice (ECJ) on a number of legal and moral grounds (Case C-377/98; OJ 98/C378/23, 5.12.1998). The ECJ is not expected to rule soon.

Parallel to these dramatic political developments, the legal battles at the EPO have continued. Greenpeace has now challenged another patent, this time a patent granted in 1996 to US chemical giant Monsanto for its genetically engineered soy, which had escaped the 1995 PGS ruling.

A number of other patents have also been challenged at the EPO, including a patent granting monopoly rights to the company Biocyte on the blood taken from the umbilical cord of newborn babies (EP 0343 217). It gives the patent owner the right to decide who may use this blood, for which purposes and at what costs. Since the stem cells from this blood are used especially for bone marrow transfusions, the patent has significant consequences for the freedom of doctors to work in the best interest of their patients. It is no surprise then that a medical association working with blood taken from the umbilical cord has challenged the patent. So have a number of NGOs throughout Europe. A ruling from the EPO is expected in June 1999.

Another landmark decision at the EPO is also imminent, since the Enlarged Board of Appeal will have to rule later this year on a patent application by Swiss chemical giant Novartis (EP 488 511). This ruling will either confirm or overturn the 1995 ruling in the Greenpeace-PGS case. Greenpeace has put forward an official "Comment", arguing strongly that the EPO must uphold its 1995 ruling that only the technical process to genetically manipulate plants may be patented and not the plants themselves. Otherwise, it would be seen to be giving in to the biotech industry's pressure, thereby flouting the rules of its own Convention (EPC) and creating a multitude of legal problems with international law.

The EPO now has the unique opportunity to clearly define the borders between patentable "inventions" and non-patentable "discoveries" in the domain of living matter and gene technology. Once the EPO has completed this vital demarcation process with regard to plants, it can then confidently move on to the still pending challenge on the "Onco-Mouse", thereby creating case law for animals as well. This would then leave the question of human cells and genes to be decided.

It is high time that clear legal rules are established in Europe.

References

1. George Poste, research director of SmithKline Beecham, in an interview in Der Spiegel, 44/93.
2. European Patent Office, Method for producing transgenic animals, Harvard College, European Patent No. 0169 672