A legal perspective synthetic biology ownership

Patents are a hot topic in synthetic biology and will be for years to come.

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

Introduction

The basic idea behind patents 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 add about biological patents But over the last decades the addition of GMO to the mix has created much controversy. This section of our wiki tries to give biologist a understandable legal perspective on the current state of patent law in Europe.

Patent law in general

Some historian argue that patent law originated as early as the Italian renaissance but the use of patents as a means of protecting investment was never applied 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 country 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 guarantee that their patent 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 formally no such thing. Patents in Europe are still first and foremost 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 addition 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)

Additionally biological patents specifically are heavily influenced by:

Directive 98/44/EC (In force since July 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 (EPC from here on) covers mostly Procedural Law (Rules that describe how). It formulates very little substantial law.

Of special interest are articles 53b and C of the EPC

 European patents shall not be granted in respect of:  
 [...]
 (b)
 plant or animal varieties or essentially biological processes for the production of plants or 
 animals; 
 this provision shall not apply to microbiological processes or the products thereof; 
 (c)
 methods for treatment of the human (or animal) body by surgery or therapy and diagnostic methods 
 practised on the human or animal body; this provision shall not apply to products, in particular 
 substances or compositions, for use in any of these methods.

In article b a casual reader might mean to see that

Directive 98/44/EC

European directives are legal acts that require European member states to make their national legislation conform to certain requirements. Most of the time this means adjusting 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:

Limits to Patentability
Scope of Protection
Licensing (How other peoples can you use your patents by paying for them)
Deposit, access and re-deposit of biological material

Specially article Article 13 It States that:

Convention on Biological Diversity

Additional to the substantive body of the agreement, it establishes established three international governing organisations namely:

Conference of the Parties: The body of all the nations participating in the Convention, the main legi
Secretariat: The Conventions administrative body, based in Montreal
Subsidiary body for Scientific, Technical and Technological Advice (SBSTTA): Advises the Conference of the Parties on

Over the years These bodies have produced a steady trickle of protocols and conventions for participation countries to follow but very little of it is effect actual national patent legislation.

Practical patent law

In practice patent law is rarely working as it was envisioned. Patent bureau's quite often grant patents on technology that was either already published, or subject to local or international exemptions on implementability. This happens for three reasons:

The patenting authorities cannot review all the worlds publications and sometime approves patents on idea's that have already been published in some obscure material(Some companies have low circulation publications exactly for this purpose) Most of the time the patenting office start with reviewing only exiting patents, this can already be quite a challenge with many languages and systems publication. Checking the Chinese patent database for instance, is still quite a challenge for a European patent agency. It is for this reason that duplicate patents still occur very rarely.
The patenting authorities has limited amount of resources. At some point of the patent cannot find a valid reason to withhold a patent (even though they)

In Europe the EPC actually gives parties to opportunity to challenge a patent in court before it is granted (while not)

The patenting authorities sometimes do not have the technical knowledge required to understand the submitted patent fully. This is especially the case in fields such as synthetic biology where sometimes difficult to see the full implications of a patent. The before mentioned problems

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

Team:Groningen/human practices legal perspective

From 2011.igem.org