Exclusions from patentability

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There are certain inventions (although they are technical) that have been purposely excluded from patentability.

Chapter 1. Elements contrary to public order and morality

Section 1.1. Principle

TheA53 (a) EPC provides that:

European patents are not issued for:

(a) inventions the commercial exploitation of which would be contrary to public order or morality, such a contradiction not to be inferred from the sole fact that exploitation is prohibited in all or many of the Contracting States; , by a legal or regulatory provision;

Section 1.2. Exclusion criteria

1.2.1. Principle

An example may be the anti-personal mine.

In order to know whether an element should be excluded from patentability on that ground, it is useful to ask whether that invention would appear to the public to be so disgusting that it would be inconceivable to patent it (Guidelines G-II 4.1).

decision T356 / 93 indicates that the notion

  • of public order covers:
    • protection of the public interest;
    • the protection of the physical integrity of individuals as a member of society;
    • the protection of the environment.
  • good morals covers:
    • behaviors that are morally acceptable and / or acceptable.

The R28 EPC indicated especially that are not patentable:

  • methods of cloning human beings;
  • methods of modifying the genetic genetic identity of the human being;
  • uses of human embryos for industrial or commercial purposes (and products that necessarily involve, at the time of filing, the destruction of human embryos, G2 / 06);
  • methods of modifying the genetic identity of animals that are likely to cause suffering in them without substantial medical benefit to humans or animals.

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

1.2.2. Special case of the operator present in a claim

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

Imagine the following situation: we claim a process or a device explicitly involving an operator (eg 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, because violating human rights ( Articles 4 and 5 of the ECHR) (T149 / 11 and T369 / 13).

There you are ...

Section 1.3. Criteria not necessarily involving exclusion

Nevertheless, it is not becauseone of the uses of the invention is repugnant that the invention should be excluded from patentability (the other uses being "acceptable", T866 / 01 or G1 / 98 reason 3.3.3).

As an illustration, a method of breaking safes can be shocking if used by thieves, but acceptable if used by a locksmith (Guidelines G-II 4.1.2).

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

Moreover, it is not because an invention is prohibited by national legislation that it must be excluded from patentability (A53 (a) EPC).

The simple use of genetic engineering does not render an invention unpatentable under theA53 (a) EPC (G1 / 98).

Chapter 2. Plant varieties, animal breeds and essentially biological processes

TheA53 (b) EPC provides that:

European patents are not issued for:

... (b) plant or animal varieties and essentially biological processes for the production of plants or animals, which provision does not apply to microbiological processes and the products obtained by these processes;

Section 2.1. Plant varieties

2.1.1. Definition

A plant variety is (R26 (4) EPC) a plant set of one only botanical taxon of the lowest known rank, who is :

  • homogeneous (ie which can be defined by certain characters resulting from a certain genotype or combination of genotypes),
  • separate (ie which can be distinguished from other plant groups by some characters), and
  • stable (ie, which has an ability to be reproduced without change).

However, a given plant is patentable (eg genetically modified plant), knowing that the technical feasibility of the invention is not limited to a plant variety (eg the modification of the DNA can work for several varieties) (see Guidelines G-II 5.4.1 and G1 / 98): this is echoed by R27 (b) EPC.

2.1.2. Reason for this exclusion

Plant varieties already have a special protection system: plant varieties (T49 / 83) defined by the UCOV Convention.

We're still not going to combine the protections, huh?

2.1.3. Varieties obtained directly by a process

If the patentability of a plant variety is excluded, one can wonder about a process that directly makes it possible to obtain 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 G1 / 98 the provisions of theA64 (2) EPC should not be taken into consideration when considering a claim relating to a process for the production of a plant variety.

Thus, only the claims of products can not be excluded under A53 (b) EPC.

Section 2.2. Animal breeds

The notion of animal race is not to be confused with the notion of animal as such (T 19/90, oncogenic mouse).

There is no definition of "animal race" (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 give more definitions.

However, an animal (eg genetically modified animal) is patentable, knowing that the technical feasibility of the invention is not limited to an animal breed (R27 (b) EPC, ex. DNA modification can work for many breeds, T315 / 03, generalization of the principle posed by G1 / 98 for plant varieties).

Section 2.3. Essentially biological processes

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

2.3.1. Exclusion

These methods clearly include "methods based on cross-breeding with gendered way plants or animals' (Guidelines G-II 5.4.2).

Thus, methods of sexually crossing complete genomes and selecting 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 (eg use of genetic molecular markers to facilitate selection, Guidelines G-II 5.4.2) related to the preparation of the plant or animal or the continuation of its treatment (G1 / 08 and G2 / 07 : Broccoli decision).

Similarly, it is not possible to make a cross-breeding and selection process patentable simply because a cross-breeding or selection sub-step is technical or aided by humans (eg use of a laboratory method for select only plants with a certain protein level above a threshold) (G2 / 07).

2.3.2. Non-exclusion

Nevertheless, theinsertion of a gene in the genome at a cross is not considered " essentially biological Because this method does not require or define stages of gene mixing by sexual crossing followed by selection (T915 / 10).

In addition, a method of treating plants by using a substance or radiation stimulating growth will not be considered excluded (Guidelines G-II 5.4.2).

Moreover, the techniques of "pollination" are not excluded (T1729 / 06).

2.3.3. Products obtained by essentially biological processes

Products obtained by excluded processes may well be patented (even if they are claimed in the form of a product-by-process) (G1 / 12, G2 / 13).

It should be noted that on 1 July 2017, the EPC Implementing Regulations had been amended (R28 (2) EPC) to reintroduce this ban:

According to Article 53b), European patents are not granted for plants or animals obtained exclusively by means of an essentially biological process.

Nevertheless, this R28 (2) EPC was found to be contrary toA53 (b) EPC (T1063 / 18). In case of divergence, the provisions of the EPC prevail (A164 (2) EPC).

2.3.4. Microbiological processes and products obtained by these non-excluded processes

1) Definition

A possible definition of microbiological processes is:

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

Microorganisms are, for example:

  • bacteria,
  • yeasts,
  • the mushrooms,
  • the seaweeds,
  • 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, which can be multiplied and manipulated in the laboratory.
2) Special case of genetic modification processes

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

This would be tantamount to circumventing the exclusion from the patentability of plant varieties (respectively animal breeds) by allowing the patentability of varieties (or breeds) obtained after genetic modification, because A53 (b) EPC has:

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

Chapter 3. Surgical or Therapeutic or Diagnostic Methods

TheA53 (c) EPC provides that:

European patents are not issued for:

[...] (c) methods of surgical or therapeutic treatment of the human or animal body and methods of diagnosis applied to the human or animal body, this provision not applying to products, in particular to substances or compositions, for the implementation of of one of these methods.

Section 3.1. Exclusion

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

3.1.1. Surgical treatment methods

1) Definition

We hear by " surgical treatment method Any method carried out 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 organism,
  • requiring specialized medical know-how,
  • with a significant health risk, even with professional diligence and expertise.

So, this definition is a definition dynamic and must be analyzed case by case boards of appeal in the light of technological developments (G1 / 07).

For example, the fact that a contrast medium can be injected intravenously by a qualified paramedical professional (T663 / 02) is a sign that this injection is a routine intervention without great risk to health (and therefore is not a surgical method).

In addition, it is necessary to look at whether the physical intervention is related to the invention (G1 / 07).

If the claimed invention (eg MRI) is not functionally related to the intervention (eg, injection of MRI visible contrast material) 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).

2) Exclusion

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

In addition, exclusion is not limited to therapeutic interventions alone (G1 / 07, ex. curative surgery as wrongly thought, T383 / 03).

3) Non-exclusion

Nevertheless, a method is not considered surgical just because an intervention (possibly invasive) on the body.

For example, 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 performed in a non-medical business environment:
    • the tattoo,
    • the piercings,
    • optical hair removal, and
    • microabrasion of the skin.
  • insignificant methods that involve only minor intervention and pose no significant health risk when professional diligence and expertise are required.

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

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

In addition, a method that only concerns the operation of a device without there being a functional report between the claimed method and the effects on the body by that device (T789 / 96) is not a method excluded from patentability:

  • a functional ratio is, for example, the control of a pacemaker performed as a function of 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).
4) Embodiments excluded from patentability

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

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

In addition, it is necessary to look at the conditions of patentability following the introduction of the disclaimer: if the object of the limited claim was not feasible at the filing date, this disclaimer will not be acceptable (eg method of cultivation of human stem cells not being obtained using destroyed human embryos Knowing that at the time of filing the stem cells were all obtained by the destruction of embryos, T1441 / 13).

5) Omission of the surgical step

Especially when the surgical step is not the heart of the invention, but only supports the invention (eg acquisition of a medical image following the injection of a product into a vein), it is trying to avoid exclusion.

decision G1 / 07 indicates that this is possible by the use of a formulation such as "a contrast product having been pre-injected" (point 4.3 of the reasons). However, it is necessary to respect theA84 CBE .

6) Reason for 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 (even save) their patient.

7) Case of an exclusion of a device involving a surgical step

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

For example, if we have to do with electrodes configured so that these " emit stimulations producing a retrogradation of the phase of the neuronal activity of at least two subpopulations of neurons, (etc.) And that this configuration can only be realized after implementation in the brain, we will have a problem of exclusion (T1731 / 12).

3.1.2. Therapeutic treatment methods

1) What does this cover

Therapeutic methods cover (Guidelines G-II 4.2.1.2):

  • the curative treatments allowing or aiming for the cure of organic disease or dysfunction;
  • the prophylactic treatments (ie who protect from a disease without having it like vaccines, T19 / 86, which avoid the appearance of caries through the elimination of dental plaque T290 / 86).

The quality of the person who implements the process has no influence on the patentability of the method (T116 / 85).

2) What it does not cover

Aesthetic treatments can be patentable (T144 / 83anorexigenic product).

In addition, if a method allows to have effects on a disease without having a direct effect on the human body (eg modification of light rays to the eye, blocking waves for electrosensitive, etc.), this method will not be considered as a therapeutic method (T2420 / 13).

3) Case of mixed methods

If only one 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 : an unclear distinction between therapeutic and non-therapeutic use (a simple "non-therapeutic" disclaimer does not exclude therapeutic use).

3.1.3. Diagnosis method

1) Definition

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

  • the phase ofinvestigationwhich involves the collection of data on the human body;
  • the comparison of these data with the normal values;
  • the finding a discrepancy significant (symptom) in this comparison;
  • theassignment from this gap to a particular clinical picturethat is, the deductive decision phase in human or veterinary medicine (the curative diagnosis stricto sensu). This step need not result in the deduction of the original disease (T121 / 05).

In addition, 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 required (radiography, ultrasound, etc.).

Thus, methods simply to collect data (possibly to facilitate a subsequent diagnosis) can not be considered diagnostic methods (T385 / 86).

2) Verification

As a first step, it is necessary to "complete" the claim. It must be added (Guidelines G-II 4.2.1.3):

  • the essential steps in 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.

3) Qualified practitioner needed?

The participation of a practitioner (doctor, veterinarian, etc.) is not a determining factor to know if the method is a method of diagnosis (G1 / 04).

4) Application to the human body

To be excluded from patentability, the method must be applied to the human or animal body. Thus, is 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 body

Section 3.2. General non-exclusions

3.2.1. products

In view of the letter of theA53 (c) EPCsurgical instruments (prostheses, probes, scalpel, etc.), therapeutics (drugs, etc.) or diagnostics (software, imaging devices, etc.) can be patented without any problem: they are well methods that are excluded (G-II Guidelines 4.2).

3.2.2. Other methods

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

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

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