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Biotechnological inventions

Biotechnological inventions refer to techniques that use living organisms, or parts of them, in order to make or modify products, or to improve or modify certain or all the characteristics of plants, or animals, in order to develop micro-organisms, and organisms intended for specific uses. The techniques use or cause organic changes in biological material, or cause changes in inorganic materials using biological means. Biotechnological inventions are applied in a wide range of fields including: agriculture, agro-industry, fertilizers, the food industry, diagnostics, zootechnics, semi-conductors, pharmaceuticals, the refuse industry, fuels, chemistry, etc. Legislative Decree n. 3 (10/01/2006) concerns the juridical protection of biotechnological inventions and entail no limit or ban on the development or setting up of research programs, no matter how questionable they may be. For biotechnological inventions, apart from what is specifically laid down, the norms relating to patents of invention are applied.

Content of the norm

The definitions are as follows:

  1. "biological material": a material containing genetic information, self-reproducing or able to reproduce in a biological system;
  2. "microbiological method": any method in which a microbiological material is used, which entails an intervention on a microbiological material or which produces a microbiological material;
  3. "plant variety": this means a set of plants within the field of a single botanic taxon of the lowest level known, which, irrespective of whether or not the conditions for granting a protection of new plant varieties are fully satisfied, can be:
    1. defined by the expression of characteristics resulting from a given genotype or a given combination of genotypes,
    2. distinct from all other plants by the expression of at least one of the above characteristics and
    3. considered as a unit in relation to its suitability to multiply unvaried.

A method to produce plants or animals is essentially biological when it entirely consists of natural phenomena such as crossing or selection. It should be noted that a method that includes a plurality of successive steps, which taken individually have a biological nature, in its entirety could also be non-biological.

Provided that they have the requisites of novelty, inventive activity and industrial applicability, it is possible to patent the following:

  1. a biological material, isolated from its natural environment or produced by means of a technical method, even if it already exists in the natural state;
  2. a technical method by means of which biological material is produced, worked or used, even if it already exists in the natural state;
  3. any new application of a biological material or a technical method already patented;
  4. an invention relating to an element isolated from the human body or otherwise produced, by means of a technical method, even if its structure is identical to that of a natural element, provided that its function and industrial application are concretely indicated, described and specifically claimed. By technical method it means what only a human being is able to execute and which nature in itself is not able to achieve.
  5. an invention concerning plants or animals, or a plant group, characterized by the expression of a particular gene and not its whole genome, if their application is not limited, from a technical point of view, to obtaining a particular plant variety or animal species and if only essentially biological methods are not used, in order to obtain them.

The following are excluded, and therefore cannot be patented:

  1. the human body, from the moment of conception and in the various stages of its development, and also merely the discovery of one of the elements of the body, including the sequence or partial sequence of a gene, in order to guarantee that the patent right is exerted in full respect of the basic rights to dignity and integrity of the human being and the environment;
  2. methods for the surgical or therapeutic treatment of the human body or animal, and methods of diagnosis applied to the human body or animal;
  3. inventions the commercial exploitation of which is against human dignity, public order and morality, the protection of health, the environment and the life of persons and animals, the conservation of plants and biodiversity and the prevention of serious environmental damage. This exclusion concerns, in particular:
    1. all technological methods for human cloning, whatever technique is used, the maximum stage of programmed development of the cloned organism and the purpose of cloning;
    2. methods to modify the germinal genetic identity of the human being;
    3. all uses of human embryos, including lines of stem cells of human embryos;
    4. methods to modify the genetic identity of animals, likely to cause suffering to the animals without substantive medical utility for the human being or the animal, and also the animals resulting from such methods;
    5. inventions concerning genetic screening protocols, the exploitation of which might lead to discrimination or stigmatization of humans on a genetic, pathological, racial, ethnic, social and economic basis, or having eugenic and non-diagnostic purposes;
  4. a simple DNA sequence, a partial sequence of a gene, used to produce a protein or a partial protein, except if an indication and a description of a function used to assess the requisite of industrial application are provided, and the corresponding function is specifically claimed; each sequence is considered autonomous for patent purposes in the event of overlapping sequences only in the parts not essential to the invention;
  5. plant varieties and animal species, and also essentially biological methods for the production of animals and plants;
  6. new plant varieties with respect to which the invention consists exclusively of the genetic modification of another plant variety, even if said modification is the fruit of a method of genetic engineering.

All technical methods which use embryonic human cells are in any case excluded from patentability.

The procedures and formal requirements that regulate the filing and formal examination of an application for a patent of biotechnological invention are as follows:

  1. When evaluating the patentability of biological inventions, can request the opinion of the relevant National Committee for biosecurity and biotechnologies.
  2. The provenance of the biological material of animal or vegetable origin on which the invention is based, must be declared when the patent is applied for, both with regard to the State of origin, thus allowing to verify that the relative legislation concerning import and export has been respected, and also with regard to the biological organism from which it has been isolated.
  3. The patent application relating to an invention that concerns or uses biological material of human origin must be accompanied by the express consent, free and informed, to said sampling and use from the person from whom the material was taken, according to current legislation.
  4. The patent application relating to an invention that concerns or uses biological material containing micro-organisms or genetically modified organisms must be accompanied by a declaration guaranteeing that all the obligations, deriving from national or EU norms, concerning said modifications have been respected.
  5. The use by the farmer for the reproduction or multiplication on his farm of patented material of vegetable origin must be made in full respect of the provisions of the EU norms on this matter, and according to the methods established by the regulations of the respective Countries.
  6. (In Italy) If the patent application concerns the use or modification of genetic identities of autochthonous national varieties which are to be preserved, or biological plant materials or animals to which the norms adopted in the Country refer, in conformity with the dispositions on the denomination of protected origin and protected geographical indication pursuant to the EU regulations and refers to purposes other than diagnostic or therapeutic ones, the opinion of the relevant Authority must first be sought. After consultation with a consultative commission and after hearing the associations of producers, the relevant Authority expresses its opinion within a predetermined period from the date of receiving the relative request. When this period has passed, with no opinion having being given, the patent is granted.
  7. The norm disciplines the framework and the methods used with regard to the sale or other form of marketing of livestock or other reproduction material of animal origin, by the proprietor of the patent or with his consent. In particular, the norm bans the further sale of the livestock as part of an activity of commercial reproduction, unless animals having the same properties have been obtained by exclusively biological means: the possibility remains of direct sale by the breeder for living animals which are part of normal agricultural activity.

An obligatory license is envisaged for patents of biotechnological invention. In particular the norm states that the National Patent Office issues an obligatory license for:

  1. the constitutor, for the non-exclusive exploitation of the invention protected by the patent, if said license is necessary for the exploitation of a plant variety;
  2. the proprietor of a patent concerning a biotechnological invention for the use of the right on a plant invention.

The license is issued upon payment of a fee. If an obligatory license is granted, the proprietor of the patent and the proprietor of the right for plant inventions have the right, reciprocally, to a license on conditions which, if there is no agreement between the parties, are determined by the relevant Authority. The license is granted is conditional upon the proof, by the applicant:

  1. that he asked the proprietor of the patent or the right on plant inventions to obtain a contractual license, but in vain;
  2. that the plant variety or invention constitutes significant technical progress, of considerable economic or health or social interest with respect to the invention indicated in the patent or the protected plant variety.

It should be noted that juridical acts and contractual operations done in violation of prohibitions laid down in the norm are null and void. The limits of the protection are as follows:

  1. the protection attributed to a patent concerning a biological material which, after the invention, has determinate properties, extends to all the biological materials deriving therefrom by means of reproduction or multiplication in identical or different form and having the same properties;
  2. the protection attributed to a patent concerning a method which allows to produce a biological material which, due to the effects of the invention, has determinate properties, extends to the biological material directly obtained by said method and to any other biological material deriving from the biological material obtained directly by means of reproduction or multiplication in identical or different form and having the same properties;
  3. apart from otherwise regulated, the protection attributed by a patent to a product containing or consisting of genetic information extends to any material in which the product is incorporated and in which the genetic information is contained and performs its function.

The protection granted does not extend to biological material obtained by means of reproduction or multiplication of biological material commercialized in the territory of a member State by the proprietor of the invention or with his consent, if the reproduction or multiplication necessarily derives from the use for which the biological material was commercialized, provided that the material obtained is not subsequently used for other reproductions or multiplications. Access to and the new deposit of biological material are disciplined as follows:

  1. if an invention concerns a biological material not accessible to the public and which cannot be described in the patent application in such a manner as to allow a person of skill to carry out the invention, or implies the use of such material, the description is deemed to be sufficient for the application of patent rights only if:
    1. the biological material has been deposited with a recognized depositary institution no later than the date the patent application was presented. International depositary institutions who have achieved this qualification pursuant to the Budapest Treaty are recognized;
    2. the application filed provides all the relevant information available to the filer on the characteristics of the biological material deposited; in the patent application the name of the depositary institution and the registration number of the deposit must be included;
  2. access to the biological material deposited is guaranteed by the issue of a sample;
    1. until the first publication of the patent application, exclusively to persons so authorized pursuant to the national patent right;
    2. between the first publication of the application and the grant of the patent, to any person who applies to do so or, if the depositor so requests, only to an independent expert;
    3. after the patent has been granted and even if it has been revoked or annulled, to any person who so requests;
  3. consignment is accepted only if the applicant undertakes, for the duration of the patent:
    1. not to make accessible to third parties samples of the biological material deposited or materials deriving therefrom;
    2. to use samples of the biological material deposited, or materials deriving therefrom, exclusively for experimental purposes, unless the applicant or the proprietor of the patent explicitly gives up this undertaking;
  4. in the event of a rejection or withdrawal of the patent application, access to the material deposited is limited, upon request of the depositor, to an independent expert for a period of twenty years starting from the filing date of the patent application;
  5. applications from the depositor can be presented only until the date when the technical preparations for the publication of the patent application are considered to be terminated;
  6. if the biological material deposited pursuant to this article is no longer available at the recognized depositary institution, it is possible to make a new deposit of the material under the same conditions laid down by the Budapest Treaty;
  7. every new deposit must be accompanied by a declaration signed by the depositor attesting that the biological material of the new deposit is identical to that of the original deposit.

When the patent application refers to a microbiological method, or a product obtained according to said method, it will be considered described when:

  1. a culture of the micro-organism has been deposited at the latest on the same day that the patent application is filed, at a Center for the collection of such cultures;
  2. the application filed contains the pertinent information available to the applicant on the characteristics of the micro-organism;
  3. the application is completed with the indication of a recognized collection Center where a culture of the micro-organism has been deposited, and also the number and date of deposit of said culture; the National Patent Office has the right to request a receipt of the deposit.

Recognized centres are those recognized for the purposes of obtaining a European patent or an international authority recognized by a convention ratified by the Country of interest. The indications under c) can be communicated within a time limit of two months starting from the date of filing of the patent application. The communication of this indication is considered as an irrevocable and unreserved consent by the proprietor of the application to make the culture deposited available to any person who, starting from the date when the patent application is made public, presents a request to the collection centre where the micro-organism has been deposited. The request from the third party must be notified to the proprietor of the application or of the patent and must include the following indications:

  1. the name and address of the person making the request;
  2. the undertaking by the person making the request, with regard to the proprietor of the patent or the patent application, not to make the culture accessible to any third person;
  3. the undertaking to use the culture through a qualified expert, indicated by name exclusively for experimental purposes until the date when the patent application is rejected or withdrawn or the patent has definitively lapsed or been declared null and void and no possibility of re-establishment in a specific form for the applicant or the proprietor of the patent exists.

The expert designated for use is solidly responsible for any abuse committed by the applicant.

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