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1. Patentable and non-patentable inventions according to Art. 52(4) of the European Patent Convention (EPC)

The European Patent Convention states that :
"Methods for treatment of the human or the animal body by surgery or therapy and diagnostic methods practised upon the human or the animal body shall not be regarded as inventions which are susceptible of industrial application". A therapeutic method is related to a prophylactic and curative method of treating diseases directed to the maintenance or the restoration of health as well as alleviation of the symptoms of pain and suffering (Decision T144/83 (OJ 1986, 301) and Decision T820/92 (OJ 1993, 113)).

These methods were already excluded from patentability under national laws of many European countries before the European Patent Convention came into force.

The policy behind the exclusion of such methods was clearly to ensure that those who carry out such methods as part of the medical treatment of humans or the veterinary treatment of animals should not be inhibited by patents (Decision T82/93 (OJ 1996, 274).

Patentable methods

However, the exception of Art. 52(4) does not exclude the patentability of other methods applied upon alive human beings or animals (contraceptive or cosmetical methods) or methods applied upon extra-corporal elements of the human or animal body (diagnostic test upon a biological sample obtained from a patient).
Furthermore, methods for obtaining information (data, physical quantities, etc.) from the living human or animal body are patentable, if the obtained information merely provide intermediate results which on their own do not enable a decision to be made on the necessary treatment (X-ray investigations, blood pressure measurements, etc.) (Decision T385/86 (OJ 1988, 308)).
However, if said decision has to be made by a doctor in order to allow a specific medical treatment, said method is not patentable (the one carrying out said method can not be inhibited in the practise of medicine by a patent).

Patentable products

The Art. 52(4) of the European Patent Convention also states that the previous provisions shall not apply to products, in particular to substances or compositions for use in any of these methods for treatment or diagnostic methods. Therefore, products like genes, proteins, drugs, surgery instruments, prosthesis or diagnostic kits used in any of these methods are patentable.

Swiss-type claims

However, if a therapeutic product is already known and described in the state of the art, the innovation of the invention can be only protected for its new specific use.
It will therefore be necessary to present a specific wording of the claims in order to obtain an efficient patent protection.
For example, if the innovation is related to the discovery of a compound X, which could find various applications in the field of pharmacy, especially for the treatment or the prevention of the specific disease Y, you can have three types of protection:

1. If the compound has never been described in the state of the art, it is possible to have a protection for the compound X as such and for any of its various applications, especially in the pharmaceutical field.

2. If the compound X has already been described in the state of the art, it is not possible anymore to have a protection for this specific compound X as such, the claims must be drafted as follows: "Compound X" followed by the indication of the use ("for use as a medicament", "for curing or preventing disease Y",...). (First medical use)
"A pharmaceutical composition comprising a pharmaceutically adequate carrier or diluant and a sufficient amount of the compound X".
This type of claim will be regarded as restricted to the compound or composition comprising it when presented or packaged for a therapeutic use.

3. If the compound X has already been described in the state of the art for another different therapeutic use, it is possible to have also a patent protection for said "second medical use" (treatment of a disease Y) if the claims are drafted as follow : "Use of compound X for the manufacture of a medicament in the treatment of disease Y", said claim being allowable for either a "first" or "subsequent second or further application". (Second medical use) (Decision G 05/83 (OJ 3/1985, 64) and Guidelines for Examination of the EPO, C-IV 4.2).
This consideration does not mean that claims related to the first medical use or second medical use of a known compound do not need to fulfil all other requirements of patentability, especially the requirement of inventive step (Decision T128/82 (OJ 4/1984, 164)).

Patentable gene therapy methods

The provisions of Art. 52 (4) are also relevant for drafting claims in a relatively new field of biotechnology : gene therapy.
Two methods of gene therapy can be envisaged :

• in vivo therapy by which a vector carrying a therapeutic gene is to be directly administrated to a patient,
• ex vivo method which involves taking cells from a patient, treating them in vitro with a vector carrying a therapeutic gene and returning the treated cells to the patient.

The provisions of Art. 52 (4) EPC have the consequences that claims related to in vivo treatment of patients by gene therapy are not patentable.
Claims directed to gene, vector, protein encoded by said gene and cell transformed with the gene or vector are allowable as well as claims related to the method used for making all of these compounds.
In an ex vivo gene therapy, the in vitro step(s) for preparing the treated cell is(are) also patentable.

However, the steps involved in said method and which are not patentable are:

• in vivo treatment of a patient, and
• the possible reinjection of ex vivo treated cells to the patient,

these two steps being applied directly upon a human or animal body.

Therefore, before any European filing in this field, we always recommend that you obtain a revised drafting of any set of claims by your European Patent Attorney before completing the filing of a European patent application.

2. Exceptions to patentability according to Art. 53 of the European Patent Convention (EPC)

Public order and morality

The European Patent Convention states that the European patents should not be granted in respect of:

inventions the publication or exploitation of which would be contrary to "ordre public" or morality.

Intensive discussions in various forums in Europe were induced by the approved Directive of the European Parliament regarding the legal protection of biotechnological inventions (98/44/CE). The European Patent Convention has been modified in order to incorporate the content of said Directive.

The content of Article 6 of the Directive (98/44/CE) corresponds to the content of the Art. 53a of the European Patent Convention, but presents also a non-exhaustive list of examples of inventions which are contrary to public order or morality and considered unpatentable.

(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) use of human embryos for industrial or commercial purposes;
(d) 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 animals resulting from such processes.

The Directive has also referred to other processes, the use of which offence against human dignity, like chimeras obtained from germ cells or totipotent cells of humans and animals (§38 of the preamble of the European Directive).

It should be noted that these exclusions refer to processes, but also exclude the obtained products by said processes.

A lot of attention has been paid to ethical issues in the Directive, since there were the main reasons for the failure of the first proposal for the Directive. Especially, item (d) listed above may lead to noticeable limitations on patentability, since only a substantial medical benefit can compensate for the suffering of a genetically modified animal.

Item (c) excludes from patentability the use of human embryos for industrial or commercial purposes, and the §42 of the preamble states that such an exclusion does not affect inventions for diagnostic purposes which are applied to the human embryo and are useful to it.

Unfortunately, the limits of a commercial purpose of the human embryo are difficult to define.

Since exceptions from patentability for ethic reasons represent a ground for opposition and revocation, such issues, especially the limitation provided by sub-paragraph (d) of Art. 6(2) of the Directive, may play an increasing role in litigious proceedings.

Protection of plants and animal varieties

The content of the Article 4 of the Directive (98/44/CE) also refers to the content of the Art. 53b of the European Patent Convention.

"European patents should not be granted in respect of:

plant or animals varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof."

Such a limitation was introduced in the European Patent Convention in order to avoid the patentability of inventions which are clearly related to natural essentially biological processes for obtaining plants or animal, for instance by cross-breeding or selection techniques.

Furthermore, the European Patent Office wants to avoid a double protection of plants by the European Patent Convention and by the UPOV Convention related to the protection of plant varieties.

Therefore, until recently, the European Patent Office has refused to recognise the patentability of genetically modified plants, because the definition of a genetically modified plant may possibly also require_once the definition of a plant variety.

However, the second paragraph of Art. 4 of the Directive has confirmed that inventions which concern plants or animals should be patentable, if the technical feasibility of the invention is not confined to a particular plant or animal variety.

Such an interpretation has been confirmed by recent cases law from the enlarged Boards of appeal of the European Patent Office (Decision G1/98 (OJ 3/2000)).

Patentability of a product isolated from nature

The novelty requirements (Art. 54 §2 of the European Patent Convention) state that an invention has to be considered to be new, if it does not form part of the state of the art.

The European Directive (98/44/CE) has stated that a biological material which is isolated from its natural environment or produced by means of technical processes may be the subject of an invention, even if it previously occurred in nature (§2 of Art. 3 of the European Directive).

Since there is no provision or exclusion in national or European patent law (especially Munich Convention), which precludes a priori the patentability of a biological matter, biological materials, like bacteria, fungi or viruses purified from possible contaminants and which are for the first time isolated, are patentable.

Said requirement is in accordance with many cases law issued by the European Board of Appeal.

Patentability of the elements isolated from the human body

The patentability of the human body or elements of the human body has been also the subject of intensive discussions.

As such, the human body and the discovery of one or its elements, including a partial sequence of a gene, are not patentable, but an element isolated from the human body satisfies the requirements of patentability (novelty), because said isolation is a result of a technical process used to identify, purify and classify said element.

The reproduction of said element outside the human body is necessary obtained by techniques which human beings are capable of putting into practice and which nature is incapable of accomplishing by itself (§21 of the preamble and Art. 5 of the Directive).

Furthermore, the Directive states that if an invention is based on a biological material of human origin, and if such material is used (and where patent applications are filed for said invention), the person from whose body the material is taken, must have had the opportunity of over-expressing free and informed consent thereto in accordance with national law (§26 of the preamble).

Inventive step and industrial applicability (Art. 56 and 57 EPC)

The European Patent Office now presents heavy requirements regarding the inventive step of biotechnological inventions.

Usually, the European Examiners compare the invention to the state of the art and may require from the applicant the presentation of improved characteristics of the invention in view of the state of the art (in the form of comparative tests or unexpected advantageous properties of the invention).

Furthermore, in order to comply with the industrial application criterion, it is necessary in case the invention is related to a sequence or partial sequence of a gene (to produce a protein or a part of a protein), to specify which protein or part of the protein is produced and what function it performs (said function should not be biological, but technical).

3. Sufficiency of disclosure (Art. 83 EPC)

Art. 83 of the European Patent Convention states that:

"A European patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art".

Usually, in the fields of chemistry and pharmacy, the specification should provide enough examples which fall under the scope of the claims in order to show that all the compounds protected by such claims present the characteristics of the invention.

For biological inventions, a disclosure is declared as sufficient, if at least one way for carrying out the invention is clearly indicated in the specification and enables the person skilled in the art to carry it out (Decision T292/85 (OJ 1989, 275)).

However, an invention in the field of biotechnology related to living organisms can not be easily described in such a way that it can be reproduced from the written description alone.

Deposit of biological material

A deposit according to Rule 28 EPC is required whenever a biological material, which is essential for carrying out the invention, is not publicly available (for example from a commercial source) and cannot be prepared by specific describing instructions in the patent specification to enable the person skilled in the art to carry out the invention.

Said biological material deposit should be done before the filing of your initial patent application.

However, a deposit alone can not ensure sufficiency of disclosure. It must be accompanied by a written description as it is available to the applicant which should be in accordance with standard literature.

If there is a mistake in the written description, the disclosure of the patent application could not satisfy the requirements of sufficiency of disclosure (Decision T 418/89 (OJ 1993, 20)).

Genetic sequence listing

If the description refers to genetic sequences, amino acids or nucleotide sequences should be presented upon a specific sequence listing in the description and upon a data carrier (diskette) according to the requirements of Art. 27 EPC.

The preparation and the filing of said sequence listing is usually made by the European Patent Attorney with the filing of the European patent application.