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A legal perspective synthetic biolegy ownership

Pantents are a hot topic in synthetic bioligy and will be for years to come.

Such discussions are often marred by lack of knowledge and insigth. In order to elevate the level of legal knowledge of biological patents we have to produce this page Since pantent law is complicated subject that v we decided to constrain ourselves to european patents law. We hope it will help the synthetic biolegy comunity form a more balanced opinion that will help both scientist and legislators to produce simpler and fairer rules.

Introduction

The basic idea behind pantents is a simple one: an inventor who applies for, and is granted, a patent is given a 20 year monopoly on the invention specified in the patent application. In return for this he is obliged to disclose the details of his invention so other can learn from it and improve upon it. Such improvements are in turn patentable but anyone who would like to use an improvement must, in most cases, be licensed by the holders of both patents.

The common justification for such a system is that it stimulates innovation. It does this by protecting the large investments that are often required to develop a new patentable product. Without the protection a patent can offer companies or individual posses would have to go to great lengths to keep the details of their invention secret.

Over the last few year there has been much addoo about biological patents But over the last decades the addtion of GMO to the mix has created much controversy. This section of our wiki tries to give biolegist a understandable legal perspective on the current state of patent law in europe. It does this by ex For

Patent law in general

Some historian argue that patent law originated as early as the italian renaisance but the use of patents as a means of protecting investment was never aplied on large scale until after the second world war. Since then the the number patents granted worldwide has exploded. According to data from the World Intellectual Property Organization over 1.5 million patents where granted world wide last year alone. This number contains many duplicate patents since a patent is not global: its needs to be requested in almost every courty separately.

Although patent law differs greatly from country to country some aspects are harmonized by the TRIPS agreement which most countries in the world have signed. In this way, patent holders have at least some garantee that their pantent are treated with similar respect in different countries where they have applied for them.

What action do patents restrict?

What action do patents not restrict?

• You can still us patented cells for research purposes

European patent law

The first thing to note about european patents is that there is formaly no such thing. Pantents in europe are still first and formost a national affair. Each country has its own separate laws and regulations on the subject. So when we refer to European patent law what we actually mean is a patchwork of several international agreements in addtion to before mentioned many national laws. The most important of these agreements are:

• The European Patent Convention (In force since October 7th 1977)
• The TRIPS agreement (In effect since January 1st 1995)

Addtionally biological patents specifcally are heavely influenced by:

• Directive 98/44/EC (In force since Juli 30th 1998)
• Convention on Biological Diversity (In effect since 29th December 1993)

While some of these law sources extend beyond the current 27 member of the european union they are all applicable for these 27 members. Below is a quick description of each of these treaties:

European Patent Convention

The European Patent Convention covers mostly Procedural Law it formulates

Directive 98/44/EC

European directives are legal acts that require european member states to make their national legislation conform to certain requirments. Most of the time this means ajusting existing regulations but sometimes it requires member states to make new laws or even scrap existing ones. Directive 98/44/EC tries to harmonize legal protection of biotechnological inventions. It governs:

• Lmits to Patentability
• Scope of Protection
• Licensing
• Deposit, access and re-deposit of biological material

Especcially article Article 13 It States that:

Inventions which are new, involve an inventive step and are susceptible of industrial application are patentable even if they concern a product consisting of or containing biological material *. Biological material which is isolated from its natural environment or produced by means of a technical process may also be the subject of an invention.

The following are not patentable:

plant and animal varieties; essentially biological processes for the production of plants or animals, such as crossing or selection. This exclusion from patentability does not, however, affect the patentability of inventions which concern a microbiological process *; the human body and the simple discovery of one of its elements, including the sequence or partial sequence of a gene. However, an element isolated from the human body or produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention.

The following inventions include those that are unpatentable where their exploitation would be contrary to public policy or morality:

processes for cloning human beings; processes for modifying the germ-line genetic identity of human beings; uses of human embryos for industrial or commercial purposes; processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. Ethical aspects

The Commission's European Group on Ethics in Science and New Technologies is to evaluate all ethical aspects of biotechnology.

Extent of protection

The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention extends to any biological material derived from that biological material through propagation or multiplication and possessing those same characteristics.

The protection conferred by a patent on a product containing genetic information extends to all material in which the product is incorporated.

The protection referred to in points 8 and 9 does not, however, extend:

to biological material obtained from the propagation or multiplication of biological material, where the multiplication or propagation necessarily results from the application for which the material was marketed by the holder of the patent or with his consent, provided that the material obtained is not subsequently used for other propagation or multiplication; to plant-propagating material or breeding stock sold to a farmer by the holder of the patent or with his consent, provided that the farmer uses the biological material or livestock for his own agricultural purposes. Compulsory cross-licensing

Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may apply for a compulsory licence for non-exclusive use of the invention protected by this patent, subject to payment of an appropriate royalty.

This also applies where the holder of a patent concerning a biotechnological invention cannot exploit it without infringing a prior plant variety right.

Procedures for depositing biotechnological inventions

The application for a patent must meet a certain number of conditions (the biological material has been deposited no later than the date on which the patent application was filed with a recognised depositary institution, transmission of information on the characteristics of the biological material deposited, etc.).

Practical patent law

In practice patent law is rarely working as it was invisioned. Patent bureau's quite often grant papents on technolegy that was either alreaddy published, or subject to local or international exemtions on patentabilety. This happens for three reasons:

1. The pantenting authorety

It is for this reason that duplicate patents still occur very rarely: The collection of submitted patents

In some industries, most notably the software industry, companies have taken a quatitative approuch to patent law. Since all of them have so many patent that every other company is bount to accidentally infringe on some of them This is costing