GREAT AT SMALL THINGS

Patent and other intellectual property rights

FAQs about patent and micro-organisms

Introduction

Questions

What may be patented?

What kind of tangible or intangible rights may be claimed on miro-organisms?

To what extend may MGRs or processes using MGRs be patented?

Deposition of micro-organisms

Relevant laws

Codes of practices / guidelines

 

FAQs concerning Intellectual Property Rights related to Microbial Genetic Resources

Introduction

This section is meant to be informative and is not authoritative in this respect. For further information please contact your legal department or an office specializing in intellectual property law.

 

What is a patent?

"A patent is an exclusive right granted for an invention, which is a product or a process that provides a new way of doing something, or offers a new technical solution to a problem."  (See WIPO brochure)

The principle of a patent is that the inventor discloses his invention in detail to contribute to the state of the art. In exchange, the inventor can exploit his invention for his own profit for a fixed period of time. After this period of exclusive use the invention falls into the public domain and may be used by any natural or legal person for any legal socio-economic purposes.

 

May micro-organisms be patented?

Yes according to the TRIPS Agreement Part II Section 5 Article 27 (3) Patentable Subject Matter microorganisms may not be excluded from patentability:

"[...] 3.  Members may also exclude from patentability: [...] (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. [...] "

 

Contribution to Knowledge Based Bio Economy

Since biotechnological developments heavily depend of the sustainable exploitation of micro-organisms and processes incorporating micro-organisms, patents play an important role in bio-economics.

BCCM provides for the necessary services related to the handling of microbiological assets in the framework of the disclosure requirements - Patent Deposit - in a patent filing according the Budapest Treaty. 

 

Questions

 

I. What may be patented?

 

  • How unique does an organism have to be to be patented? For instance if a strain is isolated from the wild, given a strain name or number and without modification, is this patentable?

Answer:

In this situation a patent cannot be obtained. The mere isolation and allocation of a name or number is not sufficient to obtain a patent, since this is considered to be a discovery. To obtain a patent for an invention, the invention has to be (1) novel, (2) not obvious/ represent an inventive step, and (3) useful/capable of industrial application. Furthermore the invention must be disclosed in the specification of the patent in a manner by which the skilled person can perform the invention.

The question of uniqueness is related to the concept of novelty. In relation to patent law, novelty is considered to be an absolute term, meaning that if exactly the same phenomenon has not been disclosed to the public in one way or another (writing, oral or any other form), then that phenomenon is novel. However, this concept is applied differently in the USA, where an oral disclosure must have been made in the USA in order to destroy novelty of a phenomenon. If an organism is isolated from the wild, it is very unlikely that an exactly identical organism has been isolated previously. This is especially true for micro-organisms.

Note that patenting a microbial strain is a controversial issue. While most agree that patenting particular inventive use of microorganisms is a sound way of ensuring a return on investment in biotech, on the other hand patenting a particular strain to prevent any use of it is too restrictive and prevents other inventors' contribution to the progress of sciences instead of promoting it.  

 

  • A strain isolated from in situ conditions is found having a specific useful characteristic. May it be patented?

Answer:

Yes, in this situation a patent can be obtained for an invention using the strain or better said the useful feature of the strain. Through the identification of the useful feature the transformation from a discovery to an invention is obtained. It will then be examined if the other criteria are fulfilled.

 

  • A strain purchased from ex situ (for instance provided by a culture collection) is found having a specific useful characteristic. May it be patented?

Answer:           

No, not the strain as such. Since the strain was available to the public, it is not new. However, it may be possible to obtain a patent related to the newly discovered useful feature, e.g. an enzyme produced by the strain or a method of cleaning soil by the use of the strain.

 

  • A strain has been described in scientific literature for a specific useful characteristic. May it still be patented for this characteristic?

Answer:

No. Since the strain has been described, it is no longer novel. Since the useful feature has also been disclosed, neither the feature nor the immediate use thereof is patentable.

 

  • A strain having been described in scientific literature for a particular use is found to have another new useful feature. May this strain be patented for this new feature?

Answer:

No. Since the strain was available to the public, it is not new. However, it may be possible to obtain a patent related to the newly discovered useful feature.

 

  • Is a sequence of a gene from a microbe eligible to be patented?

Answer:

Yes, if it meets the three criteria indicated above. This means that the discovery of a new DNA sequence in itself is a discovery and the DNA sequence is not patentable, even if you can indicate a reading frame. However, the finding of a useful feature in the new isolated DNA molecule making it susceptible to industrial application may make it patentable.

 

  • May a protein found in a micro-organism be patented?

    Answer:

    Yes, if it meets the three criteria indicated above. This means that the discovery of a new protein in itself is a discovery and the protein sequence is not patentable, even if you can indicate its sequence. However, the finding of a useful feature in the new isolated protein making it susceptible to industrial application may make it patentable.

     

  • Are compounds or metabolites isolated from micro-organisms or naturally produced by a micro-organisms eligible to be patented?

    Answer:

    Yes, if they meet the three criteria indicated above. This means that the discovery of a new molecule in itself is a discovery and the molecule is not patentable, even if you can indicate its structure and composition. However, the finding of a useful feature in the new isolated molecule making it susceptible to industrial application may make it patentable.

     

  • When a micro-organism is used in biotechnological processes or for the production of products, is it eligible to be patented? Is the biotechnological process eligible to be patented?

    Answer:

    Yes, if it meets the three criteria indicated above. This means that the criteria must apply to whatever is being patented. If the microorganism is new, it may be patented, but if the microorganisms is not new, then a new process may be patented, or if the product is new, the process for producing it is considered new, even if in principle the new product was also produced before, but nobody knew it.

     

  • Is a naturally occurring microbial resource traditionally in use by indigenous peoples eligible to be patented?

Answer:

No and yes, depending on where a patent is applied for, where the indigenous people live and how they have treated their knowledge. If a US patent is applied for the answer is yes, if the indigenous people live outside the USA. For the rest of the world the answer is no.

However, if the indigenous people live in the USA, then the answer is also no. But, if the indigenous people have actively tried to conceal their use and keep it secret, then it is patentable everywhere, since that knowledge is not considered to be part of the public domain.

 

  • When a strain is isolated from a mixture known in traditional knowledge and that this strain is found to produce an active compound:               

1. May the strain be patented?

2. May the mixture be patented? 

Answer:

1. The isolated strain: Yes, under the assumption that the strain is novel. The criterion to be investigated in this situation is the "obviousness/inventive step" issue. Whether an inventive step is involved will depend of the individual situation.

2. The active compound: Yes, under the assumption that the compound is novel. The criterion to be investigated in this situation is again the "obviousness/inventive step" issue, but it is not possible to say beforehand that a specific compound is responsible for the known activity/usefulness of the mixture, whether an inventive step is involved will depend on the individual situation.

3. The known mixture: The answer is the same as for question 10

 

II. What kind of tangible or intangible rights may be claimed on MGRs?

 

  • When a user purchases a strain from a culture collection. Does the user own the strain and may he/she further sell or distribute the strain?

    Answer:

As a general rule the purchaser buys the sample, and therefore it is his/her property, and he/she can do whatever is desired for as long as it is not violating any law of the country in which he/she lives. This includes multiplication, sale, distribution to friends, etc. However, These rights depend on the conditions under which the culture collection makes the strain available. In the past and even today for most culture collections, the strains are being made available without any restrictions, unless the depositor has obligated the culture collection in some way, such as if the deposit is made under the Budapest Treaty. In relation to deposits made prior to the Biodiversity Convention became effective by December 1993, there are no international legal instruments regulating the deposition and release of deposits, except for the Budapest Treaty. However, many culture collections had entered into bilateral agreements concerning deposits made for patent purposes, and most culture collections do also provide special types of deposits governed by specific conditions. The culture collections are free to decide under which conditions they will issue samples to any requestor, e.g. that the sample is used only for scientific purposes, or that the sample may not be distributed further by sale or free. The Biodiversity

Convention changed the ownership regime for all biological materials, and provides that the national states have full sovereignty to all biological material within their borders. Therefore any sampling of such material must be performed in accordance with the national legislation in respect of access to biological resources of the country in which the samples were collected. Similarly the deposition of the material must comply with the national legislation of the country in which the culture collection is situated. In my view the culture collections have an obligation to ensure that the depositor has acquired the sample lawfully. Unfortunately the transformation of the Biodiversity Convention into national legislation is proceeding at very slow pace in all countries, and to my knowledge no culture collection has yet implemented rules to secure that a depositor has acquired the deposit lawfully.

 

  • When someone isolated a strain from in situ. Does he/she own the strain and may further sell or distribute the strain?

    Answer:

    This depends on the national legislation on access to biological resources. Since most countries do not have any legislation in place, the general rule is that, if the sampling was done with the permission of the landowner, then it belongs to the person that did the sampling. In most countries land to which the public has access is considered to be available to everybody, and no permission would be required to collect samples of soil or plant parts.

     

  • When a legal or a natural person (1) purchases a patented strain, may he/she use the strain for research purposes?

    Answer:

    Yes (in the USA the situation is not clear, and one should proceed very carefully).

    However, care should be taken, since many scientists do not realise, when the border between research and commercial/economic exploitation is crossed.

    Example: A scientist obtains a patented strain that produces a protease with a rare specificity. Now research here means that it is allowed to confirm that the protease is being produced and that it has the properties indicated in the patent. It is also allowed to investigate if the strain produces other interesting compounds. The scientist is even allowed to patent such other compounds, but must get the permission of the patentee to exploit his invention commercially, if the strain is necessary in the production (in the USA probably even if the strain is not necessary) for as long as the first patent is in force.

    But under the research exemption it is not allowed to use the strain for producing the patented protease for use in other research, e.g. because you need a protease with that specificity for some research purpose. In that case you should buy the protease from the patentee, or get his permission to produce it for your purpose (if you want to use it privately in your kitchen that is an allowed private use - not research or commercial)

(1)  Legal terminology to designate a living human being, as opposed to a legal entity such as a legal person. « Legal person)) designates a legal structure authorised by state law that allows a group to organise its activities (synonyms: corporation, artificial legal person).

 

  • When a legal or a natural person acquires a strain, may he/she use it for any bona fide purpose?

Answer:

The patent laws do not recognise a bona fide purpose, if the strain is patented or to be patented, such information should be provided together with the strain, and the person then knows that there are limitations. Even if the patentee has not deposited the strain for patent purposes under any agreement and obtains a patent, this is no excuse (the situation is almost impossible). If infringement proceedings are initiated against the person by the patentee, the bone fide issue will influence the amount of damages, but it will be extremely difficult to prove a bone fide use, since the purchaser have received information about the patenting of the strain.

 

  • May a depositor of a strain made publicly available in a culture collection and listed in a published catalogue still claim any kind of ownership or IPR on this strain?

Answer:

Yes.

In most countries the patent law requires that a deposit is made in a recognised depositary institution prior to the filing of a patent application, but it is not a requirement that it is deposited for patent purposes.

If it becomes available to the public prior to the filing, then in most countries it is not considered to be new, and therefore not patentable, but in the USA a patentee may even have made the strain available to the public for up to one year prior to the filing a patent application.

 

III. To what extent may MGRs or processes using MGRs be patented?

 

  • When a strain is patented, does the patent prevent others than the patent's owner to use it?

    Answer:

    Yes, if the use is commercial.

     

  • How long does an intellectual property rights protection last? How long is a patent valid?

    Answer:

A patent has duration of 20 years from the date of filing. Because of certain peculiarities this means that the duration normally is 21 years from the very first filing. The question of validity is quite different. If a patent is granted on the basis of a patent application, then the patent is assumed to be valid, unless proven to be invalid. If the patent is deemed to be invalid, then it has always been invalid, but was mistakenly granted.

 

Deposit of micro-organisms for patent purposes

Since March 1, 1992, the BCCM consortium has been recognised as an "International Depositary Authority" (IDA) by the World Intellectual Property Organisation (WIPO). It is entitled to handle and preserve biological material for patent filing purposes following the patent deposit procedure

 

Relevant laws

WTO administated Agreement

Trade-Related Aspects of Intellectual Property Rights - TRIPS Agreement

The TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.

English version

 

WIPO administrated Treaty relevant for Intellectual Property Rights related to micro-organisms and Patent Procedure

Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.

Done at Budapest on April 28, 1977, and amended on September 26, 1980
Official website managed by WIPO:

English version

Regulations under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure)

Adopted on April 28, 1977 and amended on January 20, 1981 and October 1, 2002

Official website managed by WIPO

English version

 

European laws and regulations

Intellectual Property Rights

European Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998

DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998
on the legal protection of biotechnological inventions

English Version

 

Codes of practice / guidelines

IDA Code of Practice

English version