RESTRICTEDWORLD TRADE
ORGANIZATIONIP/Q3/ESP/1
18 November 1997
(97-5024)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English/Spanish
REVIEW OF LEGISLATION IN THE FIELDS OF PATENTS, LAYOUT-DESIGNS
(TOPOGRAPHIES) OF INTEGRATED CIRCUITS, PROTECTION OF
UNDISCLOSED INFORMATION AND CONTROL OF
ANTI-COMPETITIVE PRACTICES IN
CONTRACTUAL LICENCES
Spain1
The present document reproduces the questions put to the delegation of Spain and the
responses given in the review of legislation on patents, layout-designs (topographies) of integrated
circuits, protection of undisclosed information and control of anti-competitive practices in contractual
licences at the Council's meeting of 26-30 May 1997.2
_______________
I. REPLY TO THE GENERAL QUESTION ON PRIORITY RIGHTS3
Does your country recognize a right of priority on the basis of an earlier patent
application filed in any other WTO Member by a national of a WTO Member?
Spain recognizes the right of priority for a patent application filed in or for Spain which
invokes such a right on the basis of an earlier application filed in any WTO Member.
Justification:  the Union right of priority (Article 4 of the Paris Convention) has been
incorporated in the TRIPS Agreement by implication, according to Article 2.1 of the Agreement, and
consequently applies to all nationals of WTO Members, who are granted the treatment provided for in
Article 1.3 of the Agreement, which by implication includes the Union right of priority.
Moreover, pursuant to the most-favoured-nation clause (Article 4 of the TRIPS Agreement),
nationals of WTO Members must be granted the same advantages as those granted to the nationals of
any other country, in this particular case the ri ght of priority recognized to nationals of States
belonging to the Paris Union.
                                                     
1As regards laws and regulations relevant to the areas under review as notified by Spain under
Article 63.2 of the Agreement, reference is made to documents IP/N/1/ESP/1/Rev.1 and Add.1,IP/N/1/ESP/P/1-5, IP/N/1/ESP/I/1-2 and IP/N/1/ESP/L/1.
2The minutes of the meeting have been circulated in document IP/C/M/13.
3At the meeting of the TRIPS Council of 27 February 1997, Members agreed to respond to this
question in the context of the present review (document IP/C/M/12, paragraph 18).IP/Q3/ESP/1
Page 2
II. REPLIES TO QUESTIONS POSED BY JAPAN
1. In your country, are the following subject matters protectable by patent:  (1) plants and
animals, and (2) plant and animal varieties?
In Spain, under Article 5 of Patent Law 11/1986:
- plant varieties covered by Law 12/1975 on plant variety protection are not patentable
(Patent Law, Article 5.1(b));
- breeds of animals are not patentable (Patent Law, Article 5.1(c));
- plant varieties and, in general, plants that are not covered by Law 12/1975 on plant
variety protection are patentable (Patent Law, Article 5.1(b) a sensu contrario );
- animals that are not breeds and animals produced by microbiological processes that
are not breeds are patentable (Patent Law Article 5.1(c) a sensu contrario  and
Article 5.2).  There could be exceptions to this general principle in the specific case
of impediments to patentability deriving from offences against ordre public  or
morality (Patent Law, Article 5.1(a)).  Offences against ordre public  could apply to
animals as a criterion for restricting patentability in the case of the higher vertebrates.
2. In your country, is the act of offering for sale included in the exclusive rights of patent?
Yes (Articles 50 and 51 of Patent Law 11/1986).
3. In your country, what kinds of acts are rec ognized as exceptions to the exclusive rights
conferred by a patent right?
Under Article 52 of Patent Law 11/1986, rights conferred by a patent right do not extend to:
- acts undertaken privately and for non-commercial purposes;
- acts undertaken for experimental purposes relating to the subject matter of the
patented invention;
- the preparation of medicines in a pharmacy individually, case by case on the basis of
a medical prescription, or acts relating to the medicines thus prepared;
- use of the patented invention on board vessels entering Spanish territorial waters
temporarily or accidentally;
- use of the patented invention in the construction or operation of aircraft or land
vehicles temporarily or accidentally entering Spanish territory;
- acts covered by Article 27 of the Convention on International Civil Aviation of
7 December 1944 where such acts concern aircraft of a State to which the provisions
of the said Article apply.
4. In your country, in which case is use wi thout the authorization of the right holder
permitted, including use by the Government or by third parties authorized by the Government?IP/Q3/ESP/1
Page 3
The compulsory licence regime is regulated by Articles 83-107 of the Patent Law.  The cases
to which it applies are:  lack or insufficiency of exploitation of the patented invention;  the need to
export;  interdependence of patents;  and public interest.  This regime has practically fallen into
disuse.  Moreover, the direct applicability of the TRIPS Agreement and the Judgement of the Court of
Justice of the European Communities of 14 February 1992 (Commission vs. Italy, Commission vs.
United Kingdom)  has reduced its potential effectiveness.
5. In your country, how is the obligation under Articles 34.1 and 34.2 of the TRIPS
Agreement regarding the shift of the burden of proof in civil proceedings for patent
infringement related to a process patent implemented?
Article 61.2 of the Patent Law stipulates that if the subject matter of the patent is a process for
the manufacture of new products or substances it is presumed, unless proved otherwise, that any
product or substance with the same characteristics was obtained by the patented process.
III. REPLIES TO QUESTIONS POSED BY THE UNITED STATES
1. Article 133 of the Spanish Patent Law appears to require that the patent owner
adequately work the invention in Spain in order to give the patent owner the ability to obtain
injunctive relief against infringing parties.  Please explain how this provision complies with:
(a) Article 27.1 of the TRIPS Agreement, which prohibits discrimination in the
enjoyment of patent rights based on wh ether products are produced locally or
imported;  and
(b) Article 28 of the TRIPS Agreement, which requires that the patent owner be
given exclusive rights which are not conditioned in any form.
In Spain's view, Article 133 of the Patent Law is perfectly consistent with the provisions of
the TRIPS Agreement mentioned by the United States, i.e. Articles 27.1 and 28, for the followingreasons:
Firstly, owing to the broad interpretation give n to the concept of "industrial exploitation in
Spain".
Secondly, owing to the automatic application in Spain of certain of the obligations laid down
in the TRIPS Agreement arising from the prin ciple of national treatment which, as is well
known, is one of the cornerstones of the Agreement.
Thirdly, because in Spain the legislator, concerned with legal certainty in the jurisprudential
interpretation of substantive law, felt that it was appropriate to include in the legislative
reform  currently under way in respect of indu strial property a formal amendment in this
regard involving the deletion, for the sake of clarity, of the geographical reference "in Spain".
Going back to the first of the reasons cited above, it should be pointed out that the concept of
exploitation in Spain is made up of two elements:  firstly, satisfaction of the domestic market, and
secondly, supply of the market through domestic production or import of the product from another
State included in the framework of an international convention to which Spain is a party and from
which the said obligation to recognize the import for the purposes mentioned derives.
Moreover, it must be stressed that Article 133 of the Patent Law does not refer to "work", but
to "exploitation".  It is known that the responsibility  for exploiting a patent (i.e. the responsibility forIP/Q3/ESP/1
Page 4
keeping the reference market supplied) is consider ed by the TRIPS Agreement as an intrinsic and
traditional element of patent law.  Thus, Article 31(f) of the TRIPS Agreement does in fact permit
other use without authorization from the patent holder where necessary to supply the domestic market
of the Member authorizing such use.
[Follow-up question from the US]
In its answer to questions 1(a) and (b), the Government of Spain has identified several
grounds upon which it asserts that the obligation not to discriminate in the enjoyment of patent
rights required by Article 27.1, and the obligations in respect of the nature of the exclusive
rights to be provided through a patent in Article 28, are being respected in Spain.  The original
question focused on a provision of Spanish law that seemed to condition the enjoyment of the
exclusive rights of a Spanish patent on the "local working" of the patented invention in Spain.
Could the Spanish Government please:
(a) confirm that the judicial authorities in Spain would be obligated to interpret
Article 133 in a manner consistent with the conclusions offered in the answers of
the Spanish Government (i.e., that a failure to practice the patented invention in
Spain or in another European Community member State will not affect the
enjoyment of the exclusive rights of a patent in Spain);  and
(b) indicate whether this or other provisions of the Spanish patent law are proposed
to be modified in the near future.
(a) We can confirm that the judicial authorities in Spain are obligated to interpret Article 133 of
Patent Law 11/1986 in the broad manner described by Spain in the reply to question No. 1 posed by
the United States.
It should be stressed in this connection  that the TRIPS Agreement, as an international
normative instrument, prevails over domestic law.  Under Article 96.1 of the Spanish Constitution and
Article 1.5 of the Civil Code, the provisions of international treaties are binding for Spain as soon as
they enter into force and, as treaty provisions, they form part of the country's internal legal order and
are fully effective within that order.
The case history of the Constitutional Court and the Supreme Court shows that in case of
contradiction or conflict between international agreements and domestic legislation applicable in the
same area, the former prevail, provided they  (the international agreements) are clear and
unconditional in their direct application (Constitutional Court Judgement 28/1991, BOE 13.3.1991;
Constitutional Court Judgement 180/1993, BOE 5.7.1993;  Supreme Court Judgement of
22 May 1989 and Supreme Court Judgement of 26 March 1991).
However, should a Spanish court not take account of Articles 27.1 and 28 of the TRIPS
Agreement in a given case and fail to adopt the requested precautionary measures, it would be up to
the party requesting such measures to make an appeal against the denial of the measures under
Article 1428 of the Civil Procedure Law (of 1881, amended in 1984 and 1992).
(b) Article 133 of the Patent Law is indeed to be modified to the extent of deleting, for the sake
of clarity and of legal certainty, the geographical reference "in Spain".
The Spanish Patent Law is currently undergoing thorough revision.IP/Q3/ESP/1
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2. Could the Spanish Government please explain whether inventions within the categories
specified below are eligible to be patented in Spain, if the invention is novel, involves an
inventive step, and is useful:
(a) process inventions which, in whole or in part, consist of steps that are performed
by a computer and are directed by a computer program;  and
(b) product inventions consisting of elements of a computer-implemented invention,
including in particular:
(i) machine-readable computer program code stored on a tangible medium
such as floppy disk, computer hard drive or computer memory;  and
(ii) a general purpose computer whose novelty over the prior art arises
primarily due to its combination with a specific computer program.
(a) Patent Law 11/1986 does not consider computer programs to be patentable inventions where
the subject matter of the patent covers only that category (Article 4.2(c) and Article 4.3 of the PatentLaw).  This provision was taken from the Munich Convention on the Grant of European Patents of
5 October 1973 (Article 52.2 and 3).
In other words, inventions that pertain to, use, or can be implemented by a computer program
are considered patentable.  When the computer program is part of a device and provides the solution
to a technical problem it is possible, in principle, to protect it by patent provided the inventioncomplies with the other legal protection requirements.
The Spanish Patents and Trademarks Office must ex officio check that the invention does not
consist exclusively of a computer progra m (ex Article 31.2 of the Patent Law).
In solving this type of case, the Spanish Patents and Trademarks Office takes account of the
precedents established by the Boards of Appeal of the European Patent Office (EPO).  The EPO hasmade a highly restrictive interpretation of Article 52.2(c) of the Munich Convention and has taken a
favourable stance with respect to the granting of patents claiming computer programs
(Decisions T-26/86, T-208/84, T-209/91, T- 158/88, T-769/92, T-59/93, T-6/83, etc.).
(b) The above reply applies, mutatis mutandis , to part (b) of the question as well.  However, a
few clarifications are needed:
(i) When a product invention contains an electronic device for reading computer
program codes it is, in principle, patentable, in conformity with the precedents
established by the Boards of Appeal of the EPO - see in this connection
Decision T-26/86 (OJ EPO 1988, 19), according to which a computer-driven X-ray
device was patentable in spite of the fact that the device itself (without the computerprogram) was based on existing technology.  In this case, the novelty lay in the
computer program.
(ii) When a product invention consists of a computer whose novelty over the prior art
arises primarily due to its combination with a specific computer program, that
invention, is also, in principle, patentable - see in this connection Decision T-6/83
(OJ EPO 1990, 5) of the Board of Appeals of the EPO, according to which an
invention consisting of the coordination of internal communications betweenprograms within a data processing system was patentable.IP/Q3/ESP/1
Page 6
3. Article 11 of Royal Decree 767/1993 links the availability of protection for confidential
test or other data submitted to a Spanish regulatory agency to the existence of a patent in force
that covers the product subject to the regulatory  review.  Please explain how this provision of
the Spanish law complies with Article 39.3 of the TRIPS Agreement, which requires protection
be provided against unfair competition arising from use of confidential information submitted
pursuant to the party seeking marketing approval, and which does not condition the enjoymentof this protection on the existence of patent rights.
The United States asks if Article 11 of Royal Decree 767/1993 on the evaluation, approval,
registration and conditions for dispensing proprietary medicines complies with Article 39.3 of the
TRIPS Agreement, and points specifically to the fact that this Article does not condition the
enjoyment of protection on the existence of patent rights.
In our view, the United States has incorrectly interpreted Article 11 for the following reasons:
Firstly, Article 11 does not deal with the obligation to protect confidential information (as
mentioned below, that obligation is contained in another law), but is intended, rather, to
regulate the accelerated procedure for sanitary approval.  Applications for sanitary approval
are transmitted in accordance with the said Arti cle "without prejudice" (in the meaning of the
provision) or independently of whether the products already approved enjoy patent rights or
not.
Secondly, Article 32 ("confidentiality"), of Law 25/1990 on Medicaments (BOE 22.12.1990)
contains an obligation of confidentiality:  it stipulates that "the content of the applications for
approval in respect of proprietary medicines sh all be confidential, without prejudice to the
information required for inspection purposes".
Thirdly, a subsequent applicant for approval may refer certain parts of his application to the
original file only with the express consent of the holder of the previous approval.  The
assumption, in other words is that the holder of the previous approval has transmitted the
necessary information to the subsequent applicant.
[Follow-up question from the US]
Please explain the measures, if any, that have been implemented in Spain to protect
against unfair competition those parties that ha ve provided confidential test or other data
concerning a pharmaceutical or agricultural chemic al product to Spanish regulatory authorities
pursuant to a request for marketing approval.  Please explain how such measures, if any, are
consistent with Article 39.3 of the TRIPS Agreement.
Spain was already complying with the confidentiality obligation of Article 39.3 of the TRIPS
Agreement before that Agreement was applicable in the country, i.e. before 1 January 1996.
Indeed, Article 15 of Royal Decree 767/1993 of 21 May on the evaluation, approval,
registration and conditions for dispensing proprietary medicines for human use, entitled "Guarantee of
Confidentiality", contains the obligation to keep the application for approval and the accompanying
documentation secret.
As mentioned in the reply above, the Law on Medicaments (Law 25/1990) also contains this
principle of confidentiality in Article 32.IP/Q3/ESP/1
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As regards confidentiality of authorization procedures for agricultural chemical products,
Article 32.1 of Royal Decree 2163/1994 of 4 No vember on phytosanitary products requires
confidentiality when such confidentiality is requested by a party.
Finally, it should be mentioned that generally speaking, the violation of industrial and
business secrets is an act of unfair competition punishable under Article 13 of Law 3/1991 of
10 January on Unfair Competition (BOE 11.11.1991).  Articles 18 to 21 of that Law lay down the
actions that can be taken against such acts.
Please explain whether Spain conditions the protection for test data against use by a
subsequent applicant for marketing approval for the same product on the existence of patent
rights by the first applicant for marketing approval in respect of a new pharmaceutical or
agricultural chemical product.
No.  In Spain, the protection of documentation submitted by an applicant for marketing
approval is not conditioned on the holding of patent rights, as is clear from Article 11 (acceleratedapplications) of the above-cited Royal Decree 767/1993.  Specifically, this Article contains two
precautions with respect to the indicated procedure:
- First precaution:  "Without prejudice to the right to the protection of industrial and
commercial property ( sic)".  In other words, the procedure with respect to the second
sanitary approval is regulated independently of whether or not there exists a patentright.
- Second precaution:  "A second applicant for approval of a medicament essentially
similar to another already approved medicament (...) may, with the express consent of
the holder of the approval, refer certain part s of his application to the original file".
In other words, the secrets of the file cannot be revealed without the express consentof the first applicant for sanitary approval.