Article 92 of the Industrial Property Law stipulates that diagnostic, therapeutic and surgical methods for the treatment of human beings or animals are not patentable.

In accordance with Article 91 of the Industrial Property Law, plants, animals and essentially biological processes, such as are encountered or occur in nature and do not presuppose human intervention, are not considered to be inventions, since in accordance with the definition given in Article 4 of the Law an invention means any human creation that allows matter or energy existing in nature to be transformed for use by man and to satisfy his specific needs.

Insofar as they are not included among the items listed in Articles 91 and 92 of the Industrial Property Law, micro-organisms, non-essentially biological processes, microbiological processes and plant varieties can be protected by patents, provided that they satisfy the definition of an invention in Article 4 and meet the requirements for patentability in Article 93 of the same Law, namely: novelty, inventive step and industrial application. In the case of plant varieties, because of their very nature the patentability requirements are different, since varieties for which protection is requested must be new, distinct, uniform and stable. As far as the extent of the protection is concerned, in the case of biotechnology inventions our law stipulates that: • If the patent protects biological material that possesses specific claimed characteristics, the protection granted will extend to any biological material derived by multiplication or propagation from the patented material and possessing the same characteristics; • if the patent protects a process for obtaining a biological material possessing specific claimed characteristics, the protection provided by Article 128(b)(ii) of the Industrial Property Law will also extend to any biological material derived by multiplication or propagation from material directly obtained from the process that possesses the same characteristics; and • if the patent protects a specific genetic sequence or biological material that contains such a sequence, the protection will also extend to any product that incorporates that sequence or material and expresses the corresponding genetic information. These rights are subject to the following exceptions: • If the patent protects a plant, an animal or other organism capable of reproducing itself, the holder may not prevent third parties from using that entity as an initial basis for obtaining new viable biological material and marketing the material thus obtained, unless this requires the repeated use of the patented materials; and • if the patent protects a plant or an animal or its reproductive or multiplication material, the holder may not prevent the use of the product obtained from the plant of animal protected for its subsequent reproduction or multiplication by a farmer or livestock breeder and the marketing of the product for agricultural use or consumption, provided that the product has been obtained on the farmer's or livestock breeder's own farm and the reproduction or multiplication took place on that same farm.

Under Article 128 of the Industrial Property Law, a patent confers on its holder the right to prevent third parties from exploiting the patented invention. For this purpose, the patent holder may take the appropriate legal proceedings against anyone who, without his consent, offers for sale, sells, uses, imports or stocks the patented product or a product obtained directly by a patented process. Consequently, the patent holder may bring civil or criminal actions to prohibit or suspend the importation or offering for sale of products which infringe his right, including application for provisional or precautionary measures, in accordance with the provisions relating to the enforcement of rights contained in the Industrial Property Law itself. These rights will be exhausted with respect to the products protected or obtained by a patented process once the product has been introduced into trade by the patent holder or another person with his consent. In the case of patents that protect biological material that is capable of being reproduced, the rights will be exhausted in respect of the material obtained by multiplication or propagation of the material lawfully introduced into commerce, provided that the multiplication or propagation was a necessary consequence of the use of that material and the material so derived is not used for multiplication or propagation purposes, other than the permitted use mentioned in the response to question 28 (Article 131 of the Industrial Property Law).

The Industrial Property Law does not exclude from patentability pharmaceutical or agricultural chemical products, despite the availability of an additional five-year delay under Article 65 of the TRIPS Agreement. Article 210 of the Law has a provision that meets the requirements of Article 70.8 of the TRIPS Agreement referring to the means by which applications for patents for such products can be filed in the mailbox from 1 January 1995 to 1 November 2000, the date on which the present law entered into force.

Article 128 of the Industrial Property Law stipulates that, where the patent claims a process, the holder of the patent has the exclusive right to exploit the patented process and, consequently, may bring legal proceedings against anyone who, without his consent produces or manufactures the product obtained directly from the process or offers for sale, sells, uses, imports or stocks the product obtained directly from the patented process.

In accordance with Article 108 of the Industrial Property Law, the description of the invention which the applicant is required to join to his patent application must disclose the invention claimed sufficiently clearly and completely for it to be carried out by a person skilled in the art and, moreover, the best method known to the applicant for carrying out the invention claimed. In addition, drawings, which will be considered part of the description, must be submitted where they are necessary for the invention to be understood or carried out. Moreover, in accordance with Article 109 of the Law, where the invention relates to a biological product or process requiring the use of biological material that is not available to the public and the invention cannot be so described as to enable it to be understood and carried out by a person skilled in the art, the applicant must complement the description by depositing a sample of the said material at a depositary institution, established inside or outside the country and recognized by the Industrial Property Registry, no later than on the filing date of the application or, where a right of priority is invoked, on the filing date of the priority claim. In the description, together with the name and address of the depositary institution, the applicant must indicate the date of deposit and the deposit number assigned by the institution, together with the nature and characteristics of the material deposited where necessary for the disclosure of the invention. The deposit of biological material will be valid for patent granting purposes only if it is made in such a way that any interested person can obtain samples of the material, at the latest by the date of publication of the corresponding patent application.

Article 130 of the Industrial Property Law mentions, among the limitations on the rights conferred by a patent, that the holder does not have the right to prevent the following acts: (a) Those carried out in private and for non-commercial purposes; (b) those carried out exclusively for educational or scientific or academic research purposes, with no commercial purpose; and (c) those referred to in Article 5ter of the Paris Convention. When the patent protects a plant or animal or its reproductive or multiplication material, the holder cannot prevent the use of the product obtained from the protected plant or animal or the marketing of the product, provided it has been obtained on the farmer's own farm (Article 129).

Guatemala's Industrial Property Law provides for compulsory licensing to remedy any anti-competitive practice or on grounds of national emergency, public health, national security or public non-commercial use. Title III, Chapter I, Section 6, of the Law sets out the following conditions for granting compulsory licences: (a) The person applying for a compulsory licence shall demonstrate that he has previously asked the patent owner for a contractual licence and could not obtain it on reasonable commercial terms and conditions, except in the case of a compulsory licence requested on the grounds of a national emergency or for non-commercial use by the State (Article 135); (b) compulsory licences shall be granted predominantly for the supply of the domestic market (Article 136(a)); (c) the owner of the patent for which a compulsory licence has been granted shall receive adequate remuneration according to the circumstances of each case and the economic value of the licence (Article 136 (b)); (d) compulsory licences may not be granted on an exclusive basis, nor may they be assigned or sub-licensed, and they may only be transferred along with the company (Article 136 (c)); (e) the licence may be cancelled if the circumstances under which it was granted no longer exist and are unlikely to recur (Article 136, second paragraph); and (f) an appeal for reversal shall lie against decisions granting compulsory licences, as an administrative appeal to be settled by the authority higher than the one that issued the decision. This decision may be challenged judicially by an administrative action (Article 136, third paragraph, of the Industrial Property Law, and Articles 7, 19 and 20 of the Administrative Litigation Law). In cases of compulsory patent licensing involving dependent patents, Article 137 establishes the following further conditions: (a) The invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent; (b) the compulsory licence to exploit the first patent may be transferred only with the second patent; and (c) the owner of the first patent shall be entitled to a licence for the second patent.

Under Article 135 of the Industrial Property Law, anyone requesting a compulsory licence must show the following: (a) That he has previously requested a contractual licence from the patent holder; (b) that he not been able to obtain a contractual licence on reasonable commercial terms and conditions; and (c) that these efforts were not successful within a period of not less than 90 days following the first request. It will not be necessary to fulfil this requirement to obtain a compulsory licence in cases of national emergency, extreme urgency or public non-commercial use of the invention. Among the conditions applicable to compulsory licences, Article 136 of the Law establishes that they will be granted predominantly for the supply of the domestic market. A compulsory licence may be cancelled by the Industrial Property Registry if the circumstances under which it was granted no longer exist and are unlikely to recur.

There is no additional protection for innovations after the period of patent protection has lapsed.

Under Article 210 of the Industrial Property Law, patent applications filed on or after 1 January 1995, in accordance with Article 70.8 of the TRIPS Agreement, must be given absolute priority from the entry into force of that Law (1 November 2000), by applying the patentability criteria which it establishes, as if they had been in force on the application filing date.

In accordance with Article 199 of the Industrial Property Law, when the subject-matter of a patent is a process for obtaining a new product and that product has been produced by a third party without the consent of the patent owner, then, in the absence of proof to the contrary, it will be deemed to have been obtained by the patented process. Therefore, the defendant will be required to prove that he has used a different process.

Guatemala has not yet passed any specific legislation to regulate the protection of lay-out designs, and protection is therefore granted for a term of ten years from the first commercial exploitation of the lay-out design, as specified in Article 38.2 of the TRIPS Agreement, which forms part of Guatemalan law. Under the Guatemalan legal system, international agreements automatically apply, except in cases where, under the Agreement, specific legislation has to be elaborated. In fact, Article 46 of the Constitution establishes that, in regard to human rights (which include copyright and inventors' rights), treaties and agreements accepted by Guatemala prevail over domestic law.

In accordance with Article 36 of the TRIPS Agreement, the holder of a right in a protected lay-out design may object to the importation, sale or commercial distribution of the protected lay-out design, an integrated circuit in which the protected lay-out design is incorporated, or an article incorporating the integrated circuit. This provision is automatically applicable and therefore can be applied directly even though there is no specific legislation. This means that the right holder may request the application of the measures he considers necessary to protect his rights, including the precautionary measures for which the Industrial Property Law provides.

Article 37 of the TRIPS Agreement allows Members not to consider unlawful the importation, sale or commercial distribution of a protected lay-out design, whether incorporated in an integrated circuit or in an article incorporating such an integrated circuit, if the person performing these acts did not know and had no reasonable ground to know that in acquiring the integrated circuit or article incorporating such an integrated circuit he was acquiring an unlawfully reproduced lay-out design. This provision is automatically applicable and means that such acts do not constitute infringements, so long as the person had not been notified that the lay-out design imported or offered for sale was unlawfully reproduced. Once the person has been notified of the unlawful reproduction, Article 37 allows Members to provide for that person to perform any of the acts with respect to the stock on hand or ordered prior to notification (such as, for example, using it up), on condition that he pays the right holder a sum equivalent to the royalty payable under a contractual licence. This provision is not automatically applicable, since it requires Members to incorporate it in their specific legislation. It does not mean that the right holder and the innocent infringer may not arrive at an agreement.

See the response to question 39.

Under Article 174 of the Industrial Property Law, trade secrets are protected indefinitely in so far as they meet the three requirements necessary to be considered as such, namely: (a) The information has commercial value because it is secret; (b) as a body or in the precise configuration and assembly of its components, the information is not generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; and (c) the information has been subject to reasonable steps to keep it secret by the person who is lawfully in control of it. If the information relates to test or other data obtained by considerable effort and supplied to the authority responsible for approving the marketing of pharmaceutical or of agricultural chemical products which contain a new chemical component, the information will be protected against any disclosure or unfair commercial use for a period of 15 years. During this period, no person other than the one who supplied the information may, without the written consent of the latter, rely on such data or information or invoke it in support of an application for approval of his product, even though this may not involve its disclosure. The period in question is reckoned from the date on which the holder of the information was granted approval to market the product (Article 177 of the Industrial Property Law).

The Industrial Property Law does not define undisclosed information. However, in accordance with Articles 4 and 174, a trade secret means any undisclosed information in the possession of an individual or legal person which has commercial value because it is secret, can be used in some productive activity, whether industrial, commercial or services, and can be transmitted to a third party.

Although there is no definition of this type of information, Article 177 of the Industrial Property Law refers to it as those undisclosed test or other data which have, in whole or in part, the characteristics of a trade secret and have been requested by an administrative authority under the procedure for obtaining approval for marketing or sale of a pharmaceutical or agricultural chemical product that contains a new chemical component.