There are certain inventions (even though they are technical) that have been deliberately excluded from patentability.

Elements contrary to public order and morality

Principle

The A53 a) EPC states that:

European patents shall not be granted for:

a) inventions the commercial exploitation of which would be contrary to public order or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.

Exclusion criteria

Principle

An example could be the anti-personnel mine.

To determine if an element should be excluded from patentability on these grounds, it is useful to ask whether this invention would appear to the public as so abhorrent that it would be inconceivable to patent it (Guidelines G-II 4.1).

The decision T356/93 indicates that the notion:

  • of public order covers:
    • the protection of the public interest; the protection of the physical integrity of individuals as members of society; the protection of the environment. Good morals cover:
    • behaviors that conform to morality and/or are considered acceptable (e.g., a method for manufacturing a drug that requires, for each tablet, the sacrifice of six rabbits, T1553/15).

The R28 EPC indicates notably that the following are not patentable:

  • processes for cloning human beings; processes for modifying the germline genetic identity of human beings; uses of human embryos for industrial or commercial purposes (and products which necessarily imply, at the filing date, the destruction of human embryos, G2/06); processes for modifying the genetic identity of animals which are likely to cause them suffering without substantial medical benefit to man or animal.

Note that a human being is an animal, so for a claim not to fall under an exclusion, it may be useful to exclude the human being by disclaimer (e.g., « method for cloning an animal that is not a human being »).

Special case of the operator present in a claim

There is a particular case of exclusion that does not immediately come to mind.

Imagine the following situation: we claim a process or device explicitly involving an operator (e.g., a valet).

Well, my friends, this is contrary to public order because the inclusion of a person in the claimed device makes the commercial exploitation of the invention contrary to public order, as it violates human rights (Articles 4 and 5 of the ECHR) (T149/11 and T369/13).

There you have it…

Criteria not necessarily implying an exclusion

However, the fact that one of the uses of the invention is repugnant does not mean that the invention should be excluded from patentability (other uses being « acceptable », T866/01 or G1/98 reason 3.3.3).

By way of illustration, a method for fracturing safes may be shocking if used by thieves, but acceptable if used by a locksmith (Guidelines G-II 4.1.2).

However, if the application contains an explicit reference to a use that would be contrary to public policy or morality, the deletion of this reference may be required under Rule R48(1) a) EPC (Guidelines G-II 4.1.2).

Moreover, the fact that an invention is prohibited by national legislation does not mean that it should be excluded from patentability (Article 53 a) EPC).

The mere use of genetic engineering does not make an invention unpatentable under Article 53 a) EPC (G1/98).

Plant varieties, animal breeds and essentially biological processes

Article 53 b) EPC states that:

European patents shall not be granted for:

[…] b) plant or animal varieties or essentially biological processes for the production of plants or animals, this provision not applying to microbiological processes or the products thereof;

Plant varieties

Definition

A plant variety is (Rule 26(4) EPC) a plant grouping within a single botanical taxon of the lowest known rank, which is:

  • uniform (i.e., which can be defined by certain characteristics resulting from a certain genotype or a certain combination of genotypes),
  • distinct (i.e., which can be distinguished from other plant groupings by certain characteristics), and
  • stable (i.e., which has the ability to be reproduced without change).

However, a given plant (e.g., a genetically modified plant) is patentable, provided that the technical feasibility of the invention is not limited to a plant variety (e.g., the DNA modification may work for several varieties) (see Guidelines G-II 5.4.1 and G1/98): this is reiterated by Rule 27 b) EPC.

Reason for this exclusion

Plant varieties already have a specific protection system: plant breeders’ rights (T49/83) defined by the UPOV Convention.

We are not going to combine protections, are we?

Varieties obtained directly by a process

If the patentability of a plant variety is excluded, one may wonder about a process that directly results in this plant variety.

We know that the product obtained directly by a patented process is also protected (A64(2) EPC). Thus, this trick would cleverly circumvent the exclusion of the patentability of plant varieties.

In the opinion of the Enlarged Board of Appeal in the case G1/98, the provisions of A64(2) EPC should not be taken into consideration during the examination of a claim relating to a process for obtaining a plant variety.

Thus, only product claims cannot be excluded under A53 b) EPC.

Animal breeds

The concept of animal breed does not coincide with the concept of an animal as such (T 19/90, oncogenic mouse).

There is no definition of « animal breed » (G3/95).

The « Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions » does not provide any further definitions.

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 (R27 b) EPC, e.g., the DNA modification can work for several breeds, T315/03, generalization of the principle established by G1/98 for plant varieties).

Essentially biological processes

An essentially biological process is (R26(5) EPC) a process that « consists entirely of natural phenomena such as crossing or selection ».

Exclusion

These processes obviously include « processes based on the crossing by sexual means of plants or animals » (Guidelines G-II 5.4.2).

Thus, methods of sexual crossing of complete genomes and selection of animals or plants are excluded from patentability.

These methods are excluded even if the claim includes, before or after the crossing and selection steps, other technical steps (e.g., use of genetic molecular markers to facilitate selection, Guidelines G-II 5.4.2) related to the preparation of the plant or animal or to the continuation of its treatment (G1/08 and G2/07 : Broccoli decision).

Similarly, it is not possible to make a crossing and selection process patentable simply because a sub-step of crossing or selection is technical or assisted by humans (e.g., use of laboratory methods to select only plants with a certain protein content above a threshold) (G2/07).

Non-exclusion

However, the insertion of a gene into the genome during crossing is not considered « essentially biological » because this method neither requires nor defines steps of gene mixing by sexual crossing followed by selection (T915/10).

Moreover, a plant treatment method consisting of using a substance or radiation to stimulate growth will not be considered excluded (Guidelines G-II 5.4.2).

Furthermore, « pollination » techniques are not excluded (T1729/06).

The decision G2/13 clarifies that the exclusion of essentially biological processes for the production of plants does not render inadmissible a product claim that targets plants or plant material. Furthermore, the fact that the process features of a product claim define an essentially biological process does not affect the admissibility of the claim.

Products obtained by essentially biological processes

After numerous jurisprudential and legislative developments, the Enlarged Board revisited its decisions G1/12, G2/13 in a new decision G3/19 (it does not renounce its previous arguments but … proposes a « dynamic interpretation » of the texts).

Thus, products obtained by excluded processes cannot be patented (even if they are claimed in the form of a product-by-process)

Microbiological processes and products obtained by these processes non-excluded

Definition

A possible definition of microbiological processes is:

  • processes using microbiological material, involving an intervention on microbiological material or producing microbiological material (R26(6) EPC);
  • technical processes in which microorganisms are directly used (T356/93, plant cells);
  • processes involving microorganisms (G1/98).

Microorganisms are, for example:

  • bacteria,
  • yeasts,
  • fungi,
  • algae,
  • protozoa,
  • human, animal, and plant cells (plant cells are microbiological products, T356/93),
  • viruses,
  • plasmids,
  • or any generally unicellular organism, invisible to the naked eye, that can be multiplied and manipulated in the laboratory.
Special case of genetic modification processes

On the other hand, genetic modification processes cannot constitute a microbiological process (G1/98 reason 5.2).

Indeed, this would amount to circumventing the exclusion of the patentability of plant varieties (respectively animal breeds) by allowing the patentability of varieties (respectively breeds) obtained after genetic modification, because A53 b) EPC states:

essentially biological processes for the production of plants or animals [are excluded], this provision not applying to microbiological processes and products obtained by these processes.

Surgical or therapeutic or diagnostic methods

Article A53 c) EPC states that:

European patents shall not be granted for:

[… ] c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body, this provision not applying to products, in particular substances or compositions, for use in any of these methods.

Exclusion

The purpose of the exclusion of these methods is not to hinder the practice of medicine (G1/04 and Guidelines G-II 4.2.1)

Surgical treatment methods

Definition

A « surgical treatment method » is understood to mean any method performed on a living human or animal body (G1/07, point 3.4.2.7 of the reasons):

  • corresponding to a substantial physical/invasive intervention performed on the body,
  • requiring specialized medical expertise,
  • involving a considerable health risk, even if the required professional diligence and expertise are demonstrated.

Thus, this definition is a dynamic definition and must be analyzed on a case-by-case basis by the boards of appeal depending on technological developments (G1/07).

For example, the fact that a contrast product can be injected intravenously by a qualified paramedical professional (T663/02) is an indication that this injection is a routine intervention with little health risk (and therefore is not a surgical method).

Furthermore, it is necessary to consider whether the physical intervention is related to the invention (G1/07).

If the claimed invention (e.g., MRI) is not functionally related to the intervention (e.g., injection of a contrast product visible in the MRI), then the claim may be acceptable (the object of the invention being to produce an MRI image and not to inject a product into the human body) (G1/07).

Exclusion

To be excluded from patentability, the claimed method must include (or encompass) at least one surgical step (G1/07, reason 4 and Guidelines G-II 4.2.1.1): one is sufficient to justify an exclusion.

Furthermore, the exclusion is not limited to interventions for therapeutic purposes only (G1/07, e.g., curative surgery as mistakenly thought in T383/03).

Non-exclusion

However, a method is not considered surgical solely because of an intervention (possibly invasive) on the body.

For example, the following are not excluded (Guidelines G-II 4.2.1.1) :

  • routine invasive techniques that are performed on non-vital parts of the body and are generally implemented in a non-medical commercial environment:
    • tattooing,
    • piercings,
    • optical radiation hair removal, and
    • skin microabrasion;
  • insignificant methods that involve only minor intervention and pose no significant health risk when carried out with the required professional diligence and expertise.

Thus, a method that does not present a major health risk should not be excluded (T2699/17).

Furthermore, if the method includes a step of sacrificing the animal, the claim is not excluded from patentability (T182/90).

Moreover, a method that only concerns the operation of a device without any functional relationship between the claimed method and the effects exerted on the body by this device (T789/96) does not constitute a method excluded from patentability:

  • a functional relationship is, for example, the control of a pacemaker performed based on a pressure measured in the heart (T82/93, cardiac stimulation);
  • a functional relationship implies a physical causal link between the implementation of this process in the device and the therapeutic effect exerted on the body (T245/87).
Embodiments excluded from patentability

If the wording of the claim covers both non-excluded embodiments and excluded embodiments, it is possible to exclude the latter embodiments by way of a disclaimer (G1/03, point 2.1 of the reasons, G1/07).

If it is not possible to exclude them satisfactorily, the process is excluded from patentability.

Furthermore, the conditions of patentability following the introduction of the disclaimer must be considered: if the subject matter of the limited claim was not achievable at the filing date, this disclaimer will not be acceptable (e.g., a method for culturing human stem cells « not obtained using destroyed human embryos » knowing that at the filing date all stem cells were obtained using the destruction of embryos, T1441/13).

Omission of the surgical step

Notably when the surgical step is not the core of the invention but only supports the invention (e.g., acquisition of a medical image following the injection of a product into a vein), it is tempting to try to avoid exclusion.

Decision G1/07 indicates that this is possible by using wording such as « a contrast product having been pre-injected » (point 4.3 of the reasons). However, it is necessary to comply with A84 EPC.

Reason for the exclusion

This exclusion is explained by the fact that it is inconceivable to prohibit doctors and veterinarians from using what they consider to be the best treatment available to them (G1/07, reason 3.3.6) to treat (or even save) their patients.

Therapeutic treatment methods

What this covers

Therapeutic methods cover (Guidelines G-II 4.2.1.2) :

  • the curative treatments allowing or aiming at curing a disease or an organic dysfunction;
  • the prophylactic treatments (i.e. those that protect against a disease without necessarily having it, such as vaccines, T19/86, which prevent the occurrence of caries by eliminating dental plaque T290/86).

The qualification of the person implementing the method has no influence on the patentability of the method (T116/85).

What this does not cover

Cosmetic treatments can be patentable (T144/83, anorectic product).

Moreover, if a method has effects on a disease without having a direct effect on the human body (e.g. modification of light rays intended for the eye, blocking of waves for electrosensitive individuals, etc.), this method will not be considered a therapeutic method (T2420/13).

Case of mixed methods

If a single therapeutic step is claimed, the claim must be refused (T820/92).

Finally, if the therapeutic effect is intrinsic to the claimed method, the method is then excluded from patentability:

  • T290/86: elimination of dental plaque, « inevitable therapeutic effect »;
  • T475/12: « inevitable » laxative effect, even if the patient is not constipated;
  • T158/13: a non-clear distinction between a therapeutic and non-therapeutic use (a simple disclaimer « non-therapeutic » does not exclude therapeutic use).

However, the method can have both a therapeutic and a non-therapeutic effect that are not intertwined (i.e., the non-therapeutic effect can be obtained without necessarily having the therapeutic effect):

Diagnostic method

Definition

A diagnostic method is a method comprising all the following steps (G1/04 and Guidelines G-II 4.2.1.3) :

  • the investigation phase, which involves collecting data on the human body;
  • the comparison of these data with normal values;
  • the observation of a significant deviation (symptom) during this comparison;
  • the attribution of this deviation to a particular clinical picture, namely 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 original disease (T121/05).

Furthermore, it is necessary that the technical steps (only the first step according to T1197/02) be applied to the human or animal body, requiring the presence of the latter. Direct physical contact with the body is not, however, required (X-ray, ultrasound, etc.).

Thus, methods aimed solely at collecting data (possibly to facilitate a subsequent diagnosis) cannot be considered as diagnostic methods (T385/86).

Verification

First, it is necessary to « complete » the claim. It is necessary to add to it (Guidelines G-II 4.2.1.3) :

  • the steps essential to the definition of the invention;
  • the implicit steps.

If after this completion a step is missing, then the claimed method is not a diagnostic method.

Qualified practitioner necessary?

The participation of a practitioner (doctor, veterinarian, etc.) is not a determining criterion for knowing whether the method is a diagnostic method (G1/04).

Application to the human body

To be excluded from patentability, the method must be applied to the human or animal body. Thus, the following are not excluded:

  • a method applied to a dead body (Guidelines G-II 4.2.1);
  • a method applied to tissues and/or body fluids not reintroduced into the organism;

General non-exclusions

Products

Principle

In view of the letter of A53 c) EPC, surgical instruments and devices (prostheses, probes, scalpels, etc.), therapeutic (drugs, etc.) or diagnostic (software, imaging devices, etc.) can be patented without any problem: it is indeed the methods that are excluded (Guidelines G-II 4.2).

Case of exclusion of a device involving an excluded step

It may happen that a device is excluded from patentability when it involves (for its manufacture or configuration) a step excluded from patentability.

For example, if we have electrodes configured so that they « emit stimulations producing a retrograde phase of the neuronal activity of at least two subpopulations of neurons, (etc.) » and this configuration can only be achieved after implementation in the brain, we will have a problem of exclusion (T1731/12).

Case of exclusion of a device having a functional link between effect and body

Even if the guidelines (Guidelines G.II 4.2.1) provide that it would not be possible to raise an exclusion objection if the invention relates to « medical devices, computer programs or recording media that include elements corresponding to those of a method for surgical or therapeutic treatment of the human or animal body or a diagnostic method applied to the human or animal body« , it is necessary to consider whether there is a functional link with the effects of the device on the body (G1/07, 4.3.2).

For example, in decision T944/15, the invention related to the administration of radiation to a patient and took into account the patient’s movements for the determination of this radiation.

The result aimed at by the invention cannot be obtained if the patient’s movements are not taken into account to control the radiation.

There are therefore implicit steps of starting the monitoring and using the result, steps that create a functional link with the treatment method.

The necessary consideration of these steps means that the invention is a treatment method excluded by A53 c) EPC.

Other methods

Other methods (i.e., other than surgical, therapeutic or diagnostic) are patentable.

In particular, methods for treating a sheep to promote its growth, to improve the quality of its meat or increase wool yield are patentable (Guidelines G-II 4.2.1).