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

Article L611-17 CPI provides that:

Inventions whose commercial exploitation would be contrary to the dignity of the human person, public order or morality are not patentable, such annoyance not being able to result from the sole fact that such exploitation is prohibited by a legislative or regulatory provision .

Section 1.2. Exclusion criteria

An example may be the anti-personnel mine or a torture tool.

Such exclusion aims to protect the dignity of the human person and the fundamental values of society (INPI Examination Guidelines IC VII-2.2).

Section 1.3. Criteria not necessarily involving exclusion

Nevertheless, it is not becauseone of the uses of the invention must be excluded that the invention must be completely excluded from patentability (the other uses being "acceptable", INPI Examination Guidelines IC VII-2.2): if the description refers to a use excluded from patentability, it will be possible to request its deletion (L612-12 CPI and R612-4 CPI 1 °).

For example, a method of breaking safes can be shocking if used by thieves, but acceptable if used by a locksmith.

Moreover, it is not because an invention is prohibited by a legislative or regulatory provision that it must be excluded from patentability (L611-17 CPI).

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

Article L611-19 CPI I excludes from patentability:

  • Animal breeds;
  • Plant varieties;
  • Essentially biological processes for obtaining plants and animals;
  • Methods for modifying the genetic identity of animals that are likely to cause suffering without substantial medical benefit for humans or animals, and animals resulting from such processes

Section 2.1. Plant varieties

2.1.1. Definition

A plant variety is (L611-19 CPI I together Council Regulation (EC) No 2100/94 of 27 July 1994, art 5) a vegetal set of a 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 INPI Examination Guidelines, IC VII-2.4.a andL611-19 CPI II).

2.1.2. Reason for this exclusion

Plant varieties already have a special protection system: plant varieties defined by the UCOV Convention (see INPI Examination Guidelines, IC VII-2.4.a).

2.1.3. Varieties obtained directly by a process

If the patentability of a plant variety is excluded, one can wonder about the patentability of a process which directly makes it possible to obtain this plant variety.

We know that the product obtained directly by a patented process is also protected (L613-3 CPI c)). Thus, this trick would cleverly circumvent the exclusion of the patentability of plant varieties.

To my knowledge, the French courts have not yet taken a position on this thorny problem.

Section 2.2. Animal breeds

Unfortunately, there is no definition of "animal race" (INPI Examination Guidelines, IC VII-2.4.b) and it is therefore difficult to define the limits of this exclusion.

However, an animal (eg genetically modified animal) is patentable, knowing that the technical feasibility of the invention is not limited to an animal breed (eg the modification of the DNA can work for several breeds, eg a rodent, a mammal, etc., INPI Examination Guidelines, IC VII-2.4.b and L611-19 CPI II).

Section 2.3. Essentially biological processes

An essentially biological process is (L611-19 CPI I) is a process that makes "exclusively using natural phenomena such as crossing or selection” .

2.3.1. Exclusion

Thus, the methods of sexual crossing of complete genomes and selection of animals (eg horses (INPI Examination Guidelines, IC VII-2.4.c) or plants are excluded from patentability.

2.3.2. Non-exclusion

A technical method which involves the man in a significant way will not be excluded (INPI Examination Guidelines, IC VII-2.4.c), for example GMOs (INPI website).

For example, a method of stimulating the reproduction of a plant is patentable (INPI Examination Guidelines, IC VII-2.4.c).

2.3.3. Products obtained by essentially biological processes

It is not forbidden to claim the products obtained by such processes (L611-19 CPI III).

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

1) Definition

By "microbiological processes" , we hear (INPI Examination Guidelines, IC VII-2.4.c):

  • industrial processes involving the use of a biological material,
  • processes producing a biological material, for example by means of genetic engineering (ie GMO), or
  • processes involving intervention on such a material

Biological material is all "material that contains genetic information and can be reproduced or reproduced in a biological system” (L611-10 CPI, in fine).

Thus, the biological material can be, for example:

  • bacteria,
  • yeasts,
  • the mushrooms,
  • the seaweeds,
  • protozoa,
  • human, animal and plant cells,
  • 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, are not patentable:

  • the genetic modification processes of the human being (L611-18 CPI);
  • the genetic modification processes animals (L611-19 CPI) if it provokes in them sufferings without substantial medical utility.

Thus, genetic modification processes of plants and animals (without unnecessary suffering) are patentable (INPI Examination Guidelines, IC VII-2.4.a and IC VII-2.4.c).

Chapter 3. Surgical or Therapeutic or Diagnostic Methods

Article L611-16 CPI provides that:

The methods of surgical or therapeutic treatment of the human or animal body and the methods of diagnosis applied to the human or animal body are not patentable.

Section 3.1. Exclusion

The purpose of excluding these methods is not to hinder the practice of medicine.

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, whatever its purpose (eg aesthetic or medical, INPI Examination Guidelines, IC VII.2.1.2.a).

2) Exclusion

If in a claim a only step is a surgical step, the claim as a whole must be rejected (INPI Examination Guidelines, IC VII.2.1.2.b).

On the other hand, if the only application of a method described in the description is a surgical application, the process must be rejected (Court of Appeal of Paris, ch. 04, October 29, 1997).

3) Non-exclusion

If the method includes a step of sacrificing the animal, the claim is not excluded from patentability (INPI Examination Guidelines, IC VII.2.1.2.b).

In addition, a method which does not consist solely of describing the mode of use by the practitioner of the device (INPI Examination Guidelines, IC VII.2.1.2.b) is not a method excluded from patentability:

  • a method of controlling a high frequency generator supplying an electrosurgical clip, the human body intervening only to provide the regulation parameter of the apparatus;
  • a method of circulating or pumping organo-biological liquids.
4) 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 seems it is possible to exclude this step by placing it in the past participle (eg "the contrast product having been injected").

3.1.2. Therapeutic treatment methods

1) Principle

Therapeutic methods are (INPI Examination Guidelines, IC VII.2.1.1.a) cover:

  • the curative treatments allowing or aiming for the cure of organic disease or dysfunction;
  • the prophylactic treatments (ie, which protect against a disease).

In addition, aesthetic / cosmetic treatments can be patentable (INPI Examination Guidelines, IC VII.2.1.1.c). However, the therapeutic effect must not be inextricable with the aesthetic effect (INPI Examination Guidelines, IC VII.2.1.1.c).

Dosage use?

After some uncertainty regarding the possible uptake of the dosing uses with the therapeutic methods, the judges indicated (Paris Court of Appeal, January 30, 2015) that the dosage uses are well patentable as indicated by the Enlarged Board of Appeal of the EPO (G2 / 08).

Of course, to be patentable, such dosage use must provide "technical education" (or technical effect).

3.1.3. Diagnosis method

1) Definition

A diagnostic method is a method with all the following steps (INPI Examination Guidelines, IC VII.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). It is not necessary that this step lead to the deduction of the original disease: this step consists simply in determining the nature of a particular medical or veterinary condition in order to identify or discover a pathology (INPI Examination Guidelines, IC VII.2.1.3).
2) Accuracy of exclusion

In addition, it is necessary that the technical steps (ie steps that are not purely intellectual) are applied to the human or animal body, requiring the presence of the latter (INPI Examination Guidelines, IC VII.2.1.3). Direct physical contact with the body is not required (radiography, ultrasound, etc.).

If the claimed method allows diagnosis from substances (tissues, body fluids) extracted from the human or animal body, this method should not be excluded from patentability (INPI Examination Guidelines, IC VII.2.1.3).

Section 3.2. General non-exclusions

3.2.1. products

In view of the letter of the article L611-16 CPIsurgical 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 (INPI Examination Guidelines, IC VII.2.1.3).

3.2.2. Other methods

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

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