WORLD TRADE RESTRICTED IP/Q3/NLD/1 ORGANIZATION 22 October 1997

(97-4631) Council for Trade-Related Aspects Original: English of Rights

REVIEW OF LEGISLATION IN THE FIELDS OF , LAYOUT-DESIGNS (TOPOGRAPHIES) OF INTEGRATED CIRCUITS, PROTECTION OF UNDISCLOSED INFORMATION AND CONTROL OF ANTI-COMPETITIVE PRACTICES IN CONTRACTUAL LICENCES

Netherlands1

The present document reproduces the questions put to the delegation of the 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

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I. REPLY TO THE GENERAL QUESTION ON PRIORITY RIGHTS3

Does your country recognize a right of priority on the basis of an earlier application filed in any other WTO Member by a national of a WTO Member?

Yes. Article 9 of the Rijksoctrooiwet (the Netherlands' Patent Law) provides that priority rights, that are based on patent rights granted in a country that is a Member of the WTO, are valid in the Netherlands. No distinction is made between WTO Members which are members of the Paris Convention and those which are not party to this Convention.

II. REPLIES TO QUESTIONS POSED BY

1. In your country, are the following subject matters protectable by patent: (1) plants and animals, and (2) plant and animal varieties?

1As regards laws and regulations relevant to the areas under review as notified by the Netherlands under Article 63.2 of the Agreement, reference is made to documents IP/N/1/NLD/1/Rev.1, IP/N/1/NLD/P/1-2 and IP/N/1/NLD/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/NLD/1 Page 2

(1) Article 3b of the Dutch Patent Law reads as follows:

"No patent shall be issued for: plant or animal varieties or essentially biological processes for the production of plants or animals and the products thereof, with the exception of the microbiological processes unless these are prohibited by or pursuant to the Act of Health and Welfare of Animals."

The Dutch Parliament has stated that this rule has to be interpreted as that plants and animals as such cannot be patented. The present Dutch Patent Law is in force since April 1995 and there are no court rulings on this subject yet.

(2) It is clear from the above mentioned Article 3b of the Dutch Patent Law that plant and animal varieties are not protectable by patent.

2. In your country, is the act of offering for sale included in the exclusive rights of patent?

According to Article 53.1 of the Dutch Patent Law a patent shall confer on its owner the exclusive right to put on the market, to resell or to deal in any other way in or for his business the patented product, or to offer, import or store it for any of those purposes. The same applies to products directly obtained as the result of a patented process.

3. In your country, what kinds of acts are recognized as exceptions to the exclusive rights conferred by a patent right?

The acts which can be recognized as exceptions to the exclusive rights can be found in Articles 53.3, 53.5, 54 and 55.

Article 53.3 states that the exclusive right shall not extend to acts solely serving for research of the patented matter, or to the preparation of medicines in pharmacies for immediate use in individual cases on medical prescription, nor to acts related to medicines prepared in this manner.

Article 53.5 refers to products which were manufactured by a business prior to the grant of a patent. These products may continue to be used on behalf of that business notwithstanding the patent.

In Article 54 the use of the subject matter of the patent on board of vessels, aircrafts or land vehicles from other countries are excluded from the exclusive right of the patent as well as the acts specified in Article 27 of the Chicago Convention on International Civil Aviation.

Article 55 specifies that any person who has already manufactured or applied or who has commenced implementation of his intention to manufacture or apply, in or for his business, the subject matter of a patent application filed by somebody else, on the date of filing or the date of priority, shall continue to have the right to perform the acts of Article 53.1, the right being based on prior use, unless his knowledge was obtained from matter already made or applied by the applicant or from the applicant's descriptions, drawings or models.

4. In your country, in which case is use without the authorization of the right holder permitted, including use by the government or by third parties authorized by the government?

In three cases it is permitted to use the patent without authorization of the patent holder. Firstly, if it can be considered to be in public interest to grant a compulsory licence (Article 57.1). Secondly, if neither the patent holder nor a licensee operates an industrial establishment in the Realm or in another state to be designated by Royal Decree, in which the product concerned is made or the IP/Q3/NLD/1 Page 3 process concerned is being applied, unless valid reasons are shown for not operating an industrial establishment. There will be a revise of the Royal Decree in which the list of designated countries will be extended to the Member States of the WTO (Articles 57.2 and 57.3). Thirdly, if a licence is required for the working of a patent granted in respect of an application which has the same or a later date of filing or where a right of priority exists, the date of priority, insofar as the date for which the licence is required represents an important technical advance of considerable economic significance (Article 57.4).

In general a compulsory licence can be granted for patents in the field of semiconductor technology only if it is granted for non-commercial use by government or to remedy a practice determined after judicial or administrative process to be anti-competitive (Article 57.a).

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?

Where proceedings are brought for the enforcement of a patent relating to a process for the manufacture of a new product, it shall be assumed that the product in question has been manufactured using the patented process, unless the defendant can establish the plausibility of the contrary (Article 70.7).

III. REPLIES TO QUESTIONS POSED BY THE

1. Article 2.2(c) of the Netherlands Patents Act of 1995 specifies that computer programs are not to be regarded as inventions. Please explain whether, under this provision, inventions within the categories specified below are not eligible to be patented in the Netherlands, notwithstanding the fact that 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;

(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 a 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.

If any of these types of inventions are excluded from eligibility to be patented, please explain how the Dutch patent law complies with the obligations of Article 27 of the TRIPS Agreement, which mandates patent eligibility for all categories of invention without discrimination.

It is difficult to say in general whether or not the above mentioned categories are eligible for patent protection under the Dutch patent law, because it's up to courts to interpret the provisions of the Dutch patent law. The judgement of courts is highly dependant on the circumstances of a case. In Dutch patent law computer programs as such are excluded from patent protection. A Dutch patent can be granted for machines and processes in which computer programs are used, under the condition that the invention has got a technical character. The purpose of the invention has to be a technical process. IP/Q3/NLD/1 Page 4

That computer programs as such are protected by law follows from the European directive on the protection of computer programs (91/250, PbEC L. 122/42). On the basis of this directive original computer programs are protected under Dutch copyright law. On this point Dutch law is in line with Article 10.1 of the TRIPS Agreement.

2. Please explain how Articles 56.2 and 65.3 of the Netherlands’s Patents Act of 1995, which impose a limitation on the right of a patent owner to conclude licensing contracts or to assign rights, respectively by making them effective only after they are entered into the patent register, are consistent with Article 28.2 of the TRIPS Agreement.

The registration of a licence contract or an assignment of rights cannot be considered as a limitation of the right of the patent holder to conclude these acts. The acts are valid, even if they have not been registered. The purpose of these two articles is to protect third persons obtaining patent rights from holders who performed these acts without registration afterwards. Provided that these third persons are in good faith, they are in these circumstances not tied to those licence contracts or assignments because they couldn't have knowledge of them from the patent register.

3. Articles 57 and 58 of the Netherlands’s Patents Act of 1995 establish a system for the granting of involuntary (compulsory) licences of Dutch patents. Article 58(a) imposes certain conditions that govern the exercise or availability of such licences. Please answer the following questions regarding this system.

(a) Paragraph 2 of Article 57 provides that a compulsory licence shall be granted if neither the patent owner nor a licensee "operates an industrial establishment in the Kingdom or in another State to be designated by administrative order in which the product concerned or where the process concerned is being applied in good faith and on a sufficient scale…". Paragraph 3 extends this provision to certain contiguous territories of the Netherlands or the Netherlands Antilles. Please explain whether the Dutch Government has decreed through an administrative order that activities in any WTO Member shall be considered sufficient to satisfy the conditions specified for issuance of a compulsory licence. If this is not the case, please explain how this condition complies with Article 27.1 of the TRIPS Agreement, which specifies that patent rights shall be enjoyable whether products are imported or locally produced.

(b) Article 31(f) imposes an obligation on WTO Members to ensure that the grant of a compulsory licence is to be limited for the purpose of supply of the domestic market of the Member, rather than authorizing unrestricted use of the invention (i.e., to permit export of the patented products to other countries). The requirement of commercial working of the invention within the Netherlands is specified as a condition to justify the grant of a compulsory licence in Article 57. No provisions are included in the Dutch patent law, even as amended in 1995, concerning the scope of authorization to be provided under a compulsory licence in the Netherlands. Please explain how Dutch law or practice complies with the requirements of Article 31(f) of the TRIPS Agreement.

(c) Article 58(6) of the Dutch Patent Law specifies that the court shall fix the remuneration that the licensee has to pay to the patent owner. Please indicate whether any other legal authority governs the setting of the amount of remuneration for a compulsory licence in the Netherlands, and how this provision is applied in practice. Please also explain how Dutch practice in this regard complies with the requirements of Article 31(h), which specifies not only IP/Q3/NLD/1 Page 5

that there is a right of remuneration but that the amount of the remuneration shall take "into account the economic value of the authorization" of the licence.

(a) The Royal Decree will be changed in short time in a way that the list of designated countries will be extended to the Members of the WTO.

(b) The scope of authorization of a compulsory licence is specified in Article 56.1 of the Netherlands Patents Act of 1995. Article 57.2 refers to the requirement of the commercial working of the invention. In the case the patent holder and the party who asked for a licence cannot agree and the licence is unjustifiably withheld, the licence shall be granted by the court on a claim by the interested party (Article 58.1). The court can derogate from the claim of the interested party (Article 58.4) and has got the possibility to set reasonable terms for the licence.

There is no Dutch practice concerning the grant of any kind of compulsory licences under the Netherlands Patents Act of 1995. The policy in the Netherlands has always been that the authorities were very reserved on granting compulsory licences. This is still the case.

(c) The Minister of Economic Affairs can, in the case of Article 57.1 of the Netherlands Patents Act of 1995, fix a remuneration. As indicated above, in the Netherlands there is no recent practice to refer to concerning the grant of compulsory licences.

[Follow-up question from the US]

Assuming that paragraph 2 of Article 57 of the Dutch patent law is amended to include working in any WTO Member pursuant to the answer from the Netherlands to US question 3(a), please explain how the Netherlands will comply with the obligation in Article 27.1 of the TRIPS Agreement to ensure that importation satisfy any local working requirement, even if the importation is from a non-WTO country.

From Article 57, paragraph 2, of the Dutch , in combination with the Royal Decree which now has been amended, it follows that after the expiration of three years from the grant of a patent, a patentee will not be obliged to grant a (compulsory) license when the patentee has production facilities in a WTO Member State in which he produces the patented matter or applies the patented process. Even if the patentee does not have production facilities in any WTO Member State he can prevent the granting of a by showing valid reasons for the absence of such a facility. To fulfill the requirement of the use of the patent in the Kingdom of the Netherlands, it is thus enough to have a production facility or to apply the patented process in one of the WTOMembers and it is not even necessary to import the patented matter in the Kingdom of the Netherlands. Therefore, it can be concluded that the Dutch Patent Act fulfills the requirements of Article 27.1 of the TRIPS Agreement.

4. Please indicate how many compulsory licences on a yearly basis have been granted in the Netherlands since 1 January 1993.

None. IP/Q3/NLD/1 Page 6

5. It is not clear from Part 4 of the Netherlands Patents Act of 1995 whether injunctions are available to patent owners against those who infringe their exclusive rights. Please explain if and how a patentee can stop the activities of an infringer as well as obtain damages.

Article 70.1 of the Netherlands Patents Act of 1995 specifies that the patent holder may enforce his patent against any person who, without being entitled to do so, performs any of the acts referred to in Article 53.1 of the Act (the scope of the exclusive patent right). The patent holder can for example claim a court order to abstain from certain activities, usually reinforced by conditional damages in case of non-compliance. Damages may only be claimed from persons infringing acts being aware that they have no right to do so. A person shall be deemed to have been aware if the infringing act was committed after the expiry of 30 days following the service of a writ indicating the violation of the patent. Besides damages the patent holder may claim that the defendant be ordered to surrender any profits derived from the infringement and to give an account of such profits (Article 70.4). The patent holder has also the right to claim withdrawal of the infringing products from the market, destruction or the rendering useless of these products, and withdrawal from the market of materials and production equipment primarily used for the production of the infringing products.

6. Please explain how undisclosed information is protected in the Netherlands, and the legal basis for such protection.

An employer will in the contract he enters into with his employee insert an agreement to the effect that the employee is under the obligation not to provide undisclosed information to third parties (agreed maintenance of secrecy). Instead of this or in addition to it the employer will insert an agreement to the effect that the employee is entitled to enter into rivalry with the employer when he takes up a new post (competition condition). When the employee does not meet these contractual obligations, he will be liable in contract. A third party who would make use of the information acquired from an employee, would be liable in tort. The same applies to a party who misuses information he acquired when negotiating or which he acquired by theft, bribery or espionage. The plaintiff can bring a claim for damages, but can also seek an injunction restraining the defendant from using the information he acquired unlawfully.

[Follow-up questions from Korea]

According to the answer to question 6 posed by the United States, an employee who provides undisclosed information to a third party is a liable "in contract" and the third party who makes use of such information acquired from the employee is liable"in tort".

To clarify whether this protection of undisclosed information is sufficient to be consistent with Article 39.2 of the TRIPS Agreement in which persons shall have the possibility of preventing information lawfully in control from being disclosed to, acquired by, or used by others without their consent, please answer the following questions:

Are criminal sanctions against those who are related to the disclosure of such protected information possible under the Netherlands' legal system?

In the first place, theft (Art. 310 and further Criminal Code) or swindling (Art. 326 and further Criminal Code) could be charged, depending on the circumstances, as defined in the jurisprudence. The maximum penalties are fifteen years imprisonment or a fine of fl. 100.00,- for theft, and three years imprisonment or a fine of fl. 10.000,- for swindling.

In the second place, one could be charged of disclosure of professional and official secrets (Article 272 Criminal Code; maximum penalties are one year imprisonment or a fine of fl. 25.000,-) IP/Q3/NLD/1 Page 7 or disclosure of business secrets (Article 273 Criminal Code; maximum penalties are six months imprisonment or a fine of fl. 25.000,-).

What kind of remedies are available to the plaintiff (the employer) when the defendant (the employee or the third party) is found to be liable either in contract or in tort, but the defendant has no financial capability to compensate for the plaintiff's loss?

If a claim for damages was brought and a party does not have the means to pay, there is no remedy available to make him pay. Imprisonment for debt is no longer possible. The claim itself continues to exist, the claim will become barred by lapse of time (depending upon the claim) after 5-20 years. However, sometimes an injunction to prevent the defendant from using undisclosed information which he acquired unlawfully will be more effective than a claim for damages.

How can an employer prevent employees from disclosing such information when the employer and the employee do not enter into contractual relationship with regard to the protection of undisclosed information?

He can bring an injunction ex Article 6.162 Civil Code when there is a reasonable suspicion that the employee will disclose information.

7. Please indicate the nature of measures, if any, that are taken by judicial authorities in the Netherlands to protect the confidentiality of undisclosed information furnished by a party to the court during legal proceedings, when the information has been provided either to enforce rights in such information, or for other purposes.

The court can rule that the information will be available to the defendants' lawyer only, who then is allowed to pass it to his client.

8. Please explain the measures, if any, that have been implemented in the Netherlands to protect against unfair competition those parties that have provided confidential test or other data concerning a pharmaceutical or agricultural chemical product to Dutch regulatory authorities pursuant to a request for marketing approval and how such measures are consistent with Article 39.3 of the TRIPS Agreement. Please explain whether the information is protected against disclosure indefinitely, or is only protected for a specific period of time.

Dutch regulatory authorities concerning pharmaceutical or agricultural chemical product have the obligation by Article 2.5 of the General Administrative Act (AWB) to maintain secret the information they obtain in fulfilling their duties. For civil servants there is a special provision with the same contents (Article 125a of the Civil Servant Act). The obligation to maintain secrecy lasts in principle as long as the information has not been made public by the owner of the information.

[Follow-up question from the US]

Please verify that test data and other information submitted by an applicant for marketing approval of pharmaceuticals and agricultural chemicals cannot be relied upon by other applicants for marketing approval without the agreement of the party that submitted the data.

Date and other information submitted by an applicant to the competent authorities have to be maintained secret by these authorities, unless the applicant decides otherwise. When other persons want to have access to this information, they have to ask the owner to provide this information.