Certain inventions (even if they are technical) have been deliberately excluded from patentability.
Inventions Contrary to Public Policy or Morality
Principle
Article L611-17 CPI provides that:
Inventions whose commercial exploitation would be contrary to human dignity, public policy, or morality shall not be patentable, such contrariety not being derivable solely from the fact that such exploitation is prohibited by a legislative or regulatory provision.
Exclusion Criteria
An example could be an antipersonnel mine or a torture device.
Such exclusion aims to protect human dignity and the fundamental values of society (INPI Examination Guidelines I-C VII-2.2).
Criteria Not Necessarily Leading to Exclusion
However, the fact that one of the uses of the invention must be excluded does not mean that the invention must be completely excluded from patentability (other uses being « acceptable, » INPI Examination Guidelines I-C VII-2.2). If the description mentions a use excluded from patentability, it may be possible to request its removal (L612-12 CPI and R612-4 CPI 1°).
For example, a method for breaking into safes may be shocking if used by thieves but acceptable if used by a locksmith.
Furthermore, the fact that an invention is prohibited by a legislative or regulatory provision does not mean it must be excluded from patentability (L611-17 CPI).
Plant Varieties, Animal Breeds, and Essentially Biological Processes
Article L611-19 CPI I excludes from patentability:
- animal breeds;
- plant varieties;
- essentially biological processes for the production of plants and animals;
- processes for modifying the genetic identity of animals of such a nature as to cause them suffering without substantial medical benefit to humans or animals, as well as animals resulting from such processes.
Plant Varieties
Definition
A plant variety is (L611-19 CPI I together with Council Regulation (EC) No 2100/94 of 27 July 1994, Art 5) a plant grouping within a single botanical taxon of the lowest known rank, which is:
- homogeneous (i.e., definable by specific characteristics resulting from a given genotype or combination of genotypes),
- distinct (i.e., distinguishable from any other plant grouping by the expression of at least one of these characteristics), and
- stable (i.e., capable of being reproduced without change).
However, a specific plant (e.g., a genetically modified plant) is patentable, provided that the technical feasibility of the invention is not confined to a single plant variety (e.g., the DNA modification may work for several varieties) (see INPI Examination Guidelines, I-C VII-2.4.a and L611-19 CPI II).
Reason for This Exclusion
Plant varieties already have a specific protection system: plant variety rights defined by the UPOV Convention (see INPI Examination Guidelines, I-C VII-2.4.a).
Varieties directly obtained by a process
While the patentability of a plant variety is excluded, one may question the patentability of a process that directly results in obtaining such a plant variety.
We know that the product directly obtained by a patented process is also protected (L613-3 CPI c)). Thus, this approach could cleverly circumvent the exclusion of patentability for plant varieties.
To my knowledge, French courts have not yet taken a position on this thorny issue.
Animal breeds
Unfortunately, there is no definition of « animal breed » (INPI Examination Guidelines, I-C VII-2.4.b), making it difficult to define the limits of this exclusion.
However, an animal (e.g., a genetically modified animal) is patentable, provided that the technical feasibility of the invention is not limited to a single animal breed (e.g., the DNA modification may apply to multiple breeds, such as a rodent, a mammal, etc., INPI Examination Guidelines, I-C VII-2.4.b and L611-19 CPI II).
Essentially biological processes
An essentially biological process (L611-19 CPI I) is a process that « relies exclusively on natural phenomena such as crossing or selection. »
Exclusion
Thus, methods of sexual crossing of complete genomes and selection of animals (e.g., horses (INPI Examination Guidelines, I-C VII-2.4.c)) or plants are excluded from patentability.
Non-exclusion
A technical method that involves significant human intervention will not be excluded (INPI Examination Guidelines, I-C VII-2.4.c), for example, GMOs (INPI website).
For example, a method for stimulating the reproduction of a plant is patentable (INPI Examination Guidelines, I-C VII-2.4.c).
Products obtained by essentially biological processes
It is not prohibited to claim products obtained by such processes (L611-19 CPI III).
Microbiological processes and products obtained by such processes (non-excluded)
Definition
By « microbiological processes, » we mean (INPI Examination Guidelines, I-C VII-2.4.c):
- industrial processes involving the use of biological material,
- processes producing biological material, for example, through genetic engineering (i.e., GMOs), or
- processes involving an intervention on such material.
Biological material is any « material containing genetic information and capable of reproducing or being reproduced in a biological system » (L611-10 CPI, in fine).
Thus, biological material may include, for example:
- bacteria,
- yeasts,
- fungi,
- algae,
- protozoa,
- human, animal, and plant cells,
- viruses,
- plasmids,
- or any generally unicellular organism, invisible to the naked eye, that can be multiplied and manipulated in a laboratory.
Special case of genetic modification processes
However, the following are not patentable:
- processes for genetically modifying humans (L611-18 CPI);
- processes for genetically modifying animals (L611-19 CPI) if they cause suffering without substantial medical benefit.
Thus, processes for genetically modifying plants and animals (without unnecessary suffering) are patentable (INPI Examination Guidelines, I-C VII-2.4.a and I-C VII-2.4.c).
Surgical, therapeutic or diagnostic methods
Article L611-16 CPI provides that:
Methods of surgical or therapeutic treatment of the human or animal body and methods of diagnosis applied to the human or animal body are not patentable.
Exclusion
The purpose of excluding these methods is to avoid hindering the practice of medicine.
Surgical methods
Definition
A « surgical method » refers to any method performed on a living human or animal body, regardless of its purpose (e.g., aesthetic or medical, INPI Examination Guidelines, I-C VII.2.1.2.a).
Exclusion
If a single step in a claim is a surgical step, the claim as a whole must be rejected (INPI Examination Guidelines, I-C VII.2.1.2.b).
Furthermore, if the only application of a process described in the description is a surgical application, the process must be rejected (Paris Court of Appeal, 4th Chamber, 29 October 1997).
Non-exclusion
If the method includes a step involving the sacrifice of the animal, the claim is not excluded from patentability (INPI Examination Guidelines, I-C VII.2.1.2.b).
Additionally, a method that does not solely describe the practitioner’s mode of using the device (INPI Examination Guidelines, I-C VII.2.1.2.b) does not constitute a method excluded from patentability:
- A method for controlling a high-frequency generator powering an electrosurgical forceps, where the human body only provides the regulation parameter for the device;
- A method for circulating or pumping organobiological fluids.
Omission of the surgical step
In particular, when the surgical step is not the core of the invention but merely supports it (e.g., acquiring a medical image following the injection of a product into a vein), it appears possible to exclude this step by phrasing it in the past participle (e.g., « the contrast agent having been injected »).
Therapeutic methods
Principle
Therapeutic methods (INPI Examination Guidelines, I-C VII.2.1.1.a) cover:
- Curative treatments that enable or aim to cure a disease or organic dysfunction;
- Prophylactic treatments (i.e., those that protect against a disease).
Furthermore, cosmetic/aesthetic treatments may be patentable (INPI Examination Guidelines, I-C VII.2.1.1.c). However, the therapeutic effect must not be inextricably linked to the aesthetic effect (INPI Examination Guidelines, I-C VII.2.1.1.c).
Dosage use?
After some uncertainty regarding the possible assimilation of dosage uses with therapeutic methods, the courts have indicated (Paris Court of Appeal, 30 January 2015) that dosage uses are indeed patentable, as stated by the EPO Enlarged Board of Appeal (G2/08).
Of course, for such a dosage use to be patentable, it must provide a « technical teaching » (or technical effect).
Diagnostic method
Definition
A diagnostic method is a method comprising all the following steps (INPI Examination Guidelines, I-C VII.2.1.3):
- the investigation phase, which involves the collection of data on the human body;
- the comparison of such data with normal values;
- the detection of a significant deviation (symptom) during this comparison;
- the attribution of this deviation to a specific clinical picture, i.e., the deductive decision-making phase in human or veterinary medicine (diagnosis for strictly curative purposes). It is not necessary for this step to result in the deduction of the underlying disease: this step simply consists in determining the nature of a particular medical or veterinary condition in order to identify or discover a pathology (INPI Examination Guidelines, I-C VII.2.1.3).
Clarification of the Exclusion
Furthermore, it is necessary that the technical steps (i.e., the steps that are not purely intellectual) be applied to the human or animal body, requiring the presence of the latter (INPI Examination Guidelines, I-C VII.2.1.3). Direct physical contact with the body is not, however, required (X-ray, ultrasound, etc.).
If the claimed method allows for a diagnosis based on substances (tissues, bodily fluids) extracted from the human or animal body, such a method shall not be excluded from patentability (INPI Examination Guidelines, I-C VII.2.1.3).
General Non-Exclusions
Products
Under the wording of Article L611-16 CPI, surgical instruments and equipment (prostheses, catheters, scalpels, etc.), therapeutic products (medicines, etc.), or diagnostic products (software, imaging devices, etc.) may be patented without issue: it is the methods that are excluded (INPI Examination Guidelines, I-C VII.2.1.3).
Other Methods
Other methods (i.e., other than surgical, therapeutic, or diagnostic methods) are patentable.