Section 56(2)(e) of the South African Patents Act sets out circumstances in which the rights under a patent are deemed to be abused, and on the basis of which a compulsory licence may be granted. The existence of section 56(2)(e) in the light of the provisions of Article 27.1 of the TRIPS Agreement is justified on the following basis: (a) Section 56(2)(e) does not result in the forfeiture of the patent concerned, so that patent rights continue to be available to the patentee; nor does it results in the patentee being deprived of the right to exploit the patent, so that patent rights continue to be enjoyable by the patentee, as provided for in Article 27.1 of the TRIPS Agreement. (b) In terms of section 56(5) as amended by Clause 45 of the Intellectual Property Laws Amendment Bill No. B1/97, any compulsory licence granted will be non-exclusive, so that the patentee is not deprived of his right to exploit the patent, by importation of patented products or otherwise. (c) In terms of sections 56(4) and (7) any compulsory licence granted may be subject to conditions, including a condition precluding the licensee from importing patented products into South Africa in competition with the patentee, and including the terms and conditions (e.g. appropriate remuneration) usually stipulated in voluntary licences to ensure appropriate reward to the patentee. Accordingly, the patentee will continue to enjoy benefits under the patent. (d) Mere importation of patented products by the patentee does not provide a ground for section 56(2)(e) to be invoked; the fact of importation has to be coupled with the fact of excessive pricing in comparison to the price in the country of manufacture. Section 56(2)(e) does not entail discrimination on the basis of mere importation; the abuse being addressed by section 56(2)(e) is importation coupled with excessive pricing. (e) Once the abuse addressed by section 56(2)(e) ceases to exist, e.g. if the local pricing of imported products is no longer excessive, the compulsory licence shall be terminated in terms of section 56(4)(c) as amended by Clause 45 of the Intellectual Property Laws Amendment Bill. (f) Section 56(2)(e) is in line with the provisions of Article 5 of the Paris Convention, in particular Article 5(2). (g) Imported patented products are not dealt with less favourably than domestically produced patented products. Section 56(2)(c) provides that patent rights are deemed to be abused where the demand in South Africa for the patented product is not met to an adequate extent and on reasonable terms. This subsection is applicable to domestically produced patented products; if the demand for such articles is not met on reasonable terms (e.g. as regards price), the patent rights will be deemed to be abused.

It is correct that section 43(3) of the Patents Act provides that a Convention patent application automatically becomes open to public inspection eighteen months after the earliest priority date claimed. A non Convention application, on the other hand, becomes open to public inspection when it is published in the Patent Journal pursuant to acceptance. Such acceptance must take place within eighteen months from the date of the application (except in certain specified circumstances). It is emphasized that the aforegoing differentiation is not made on the basis of the nationality of the applicant, but on the basis of the nature of the application (i.e. whether convention priority is claimed or not). Applicants of South African nationality are treated in the same manner as applicants who are nationals of other countries in regard to the type of application filed. Article 2 of the Paris Convention requires that national treatment should be extended also to nationals of other Member countries. Article 2 of the TRIPS Agreement requires that this principle be adhered to. It is submitted that the South African position is in accordance with this principle.

At present time it is only in regard to the recognition of priority rights that national of Paris Convention Member countries get treatment different from the nationals of other countries. South Africa is in the process of preparing a suitable proclamation for publication to provide that the nationals of WTO Member countries will also enjoy recognition of priority rights. In regard to all other aspects, national treatment is accorded to the nationals of all other countries.

Clause 72 of the Intellectual Property Amendment Bill amends section 20 of the Designs Act by the addition of the following subsection: "(3) Notwithstanding subsection (1), the rights of the registered proprietor of a registered design in the form of an integrated circuit topography shall not be infringed by a person who (a) makes an article embodying the registered design or a design not substantially different from the registered design for private purposes or for the sole purpose of evaluation, analysis, research or teaching; (b) imports or disposes of an integrated circuit embodying the registered design which has been unlawfully produced or an article incorporating such an integrated circuit and proves that at the time of acquiring the integrated circuit or article he or she was not aware and had no reasonable grounds of becoming aware that the integrated circuit or article embodies a registered design which had been unlawfully produced: Provided that when the person receives sufficient notice that the registered design was unlawfully produced, the person may dispose of any stock of such integrated circuits or articles but shall be liable to pay to the registered proprietor a sum calculated on the basis of a reasonable royalty which would have been payable by a licensee or sub licensee in respect of the registered design concerned." After the publication of the Amendment Bill, it was noted that the words "for private purposes or" were accidentally omitted from paragraph (a) of the proposed amendment; these words have since been inserted. It is submitted that, once the Amendment Bill is passed and section 20 of the Designs Act amended, the provisions will be in line with Article 35 of the TRIPS Agreement.

As explained above in regard to patents, South Africa has not yet acceded to the ARIPO Treaty.

It is correct that Article 32 of South Africa's Constitution Act provides that everyone has the right of access to information held by the State, and to information held by another person that is required for the exercise or protection of any rights. However, it should be noted that Article 32(2) provides that national legislation must be enacted to give effect to this right, and such national legislation has not yet been enacted. Furthermore, Article 36 of the Constitution provides that the rights granted as part of the Bill of Rights (including the right of access to information) may be limited in terms of laws of general application and to the extent that the limitation is reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom, taking into account all relevant factors including (a) the nature of the right; (b) the importance of the purpose of the limitation; (c) the nature and extent of the limitation; (d) the relation between the limitation and its purpose; and (e) less restrictive means to achieve the purpose. It is submitted that laws such as the Fertilizer, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947, and the Medicines and Related Substances Control Act 101 of 1965 are laws of general application which are on the statute book of South Africa. Furthermore, it is submitted that the continued confidentiality of information held in terms of these Acts is reasonable and justifiable in an open and democratic society. Accordingly, it is submitted that the position in South Africa in regard to the access to confidential information is in substantial compliance with Article 39 of the TRIPS Agreement.

South African legal jurisprudence has developed in administrative law, in particular around sections. The legislature, mindful of this fact, enacted section 240 of the Constitution, which provides for a transitional arrangement. Section 23 of Schedule 6(3), it is submitted, empowers the relevant department to enact a legislation in this regard within three years after coming into effect of the Constitution (i.e. February 1997 – February 2000). In view of the above, relevant legislation will be enacted in due course.

The formulation of the order, and the execution of the order in Anton Piller proceedings are strictly controlled by the Courts in South Africa, specifically in view of avoiding possible abuse by applicants. The purpose of an Anton Piller proceeding in South Africa is to protect evidence, not to serve as a discovery tool. The order is usually formulated to permit a Sheriff to list and copy relevant documents, whereafter confidentiality can be imposed by a Court order obtained by the defendant, before the documentation is made available to the applicant. South African jurisprudence as applied by our Courts in fact enforces the necessary safeguards in the formulation and execution of an Anton Piller order, to maintain confidentiality of information.

Article 40 of TRIPS records the Agreement of members that some licensing practices or conditions pertaining to intellectual property rights, which restrain competition, may have adverse affects on trade and may impede the transfer and dissemination of technology. South Africa confirms this position. Article 40.2 provides that members will not be prevented from specifying in their legislation certain practices or conditions which may constitute an abuse of intellectual property rights. Members may adopt appropriate measures to prevent or control such practices. The South African Patents Act has the following relevant provisions: Section 57: This section provides that any contract, insofar as it relates to a licence under a patent, shall terminate on the date on which the patent under which the licence was granted, expires, is revoked or otherwise ceases to protect the invention. Section 90: This section provides as follows: (1) Any condition in a contract relating to the sale of a patented article or to a licence under a patent of which the effect will be: (a) to prohibit or restrict the purchaser or licensee from purchasing or using any article or class of articles, whether patented or not, supplied or owned by any person other than the seller or licensor or his nominee; (b) to prohibit or restrict the licensee from using any article or process not protected by the patent; (c) to require the purchaser or licensee to acquire from the seller, licensor or his nominee any article or class of articles not protected by the patent; (d) to require or induce the purchaser to observe a specified minimum resale price in respect of any article or class of articles protected by the patent; or (e) to prohibit or restrict the making, using, exercising or disposing of the invention concerned in any country in which the invention is not patented, shall be null and void. (2) Nothing in this section shall (a) affect any condition in a contract whereby a person is prohibited from selling any goods other than those of a particular person; or (b) affect any condition in a contract for the lease of or a licence to use a patented article, whereby the lessor or licensor reserves to himself or his nominee the right to supply such new parts of the patented article, other than ordinary articles of commerce, as may be required to put or keep it in repair. No corresponding provisions appear in the Trade Marks Act, Copyright Act or Designs Act. It should be pointed out that South Africa has a well developed common law system of unlawful competition, on the basis of which anti competitive practices may be challenged. South Africa also has on its statute book the Maintenance and Promotion of Competition Act 96 of 1979, in terms of which certain anti competitive practices may be challenged.

It is correct that section 2 of the Maintenance and Promotion of Competition Act excludes from the provisions of the Act any right acquired under the Trade Marks Act, Designs Act, Patent Act and Copyright Act. However, in terms of section 2(2) of the Competition Act, the exclusion shall be construed so that any person shall not retain or be granted any right of enhancing or maintaining prices or restricting competition directly or indirectly by way of a restrictive practice as defined in the Act. It is evident, therefore, that although the statutory rights are in fact placed in a category separate from similar common law intellectual property rights, the limitation of section 2(2) applies to the statutory rights, i.e. they may not be used in a manner to constitute a restrictive practice. It should be understood that the Maintenance and Promotion of Competition Act is intended to promote free and fair competition, and such is not perceived to be contrary to the spirit of Article 40 of the TRIPS Agreement. Although an exception is made in relation to statutory intellectual property rights, abuse of such rights will not be tolerated, in accordance with section 2(2) of the Act.

Answer to questions 11, 12 and 13 Section 15c to be introduced into the Medicines and Related Substances Control Act 101 of 1965 by the Amendment Act No. 90 of 1997, grants the Minister of Health the power to determine that the rights granted in terms of the Patents Act to the patentee of a patented medicine will not apply in certain circumstances, namely to acts in respect of such medicine which has been put onto the market by the owner of the medicine or with his consent. This is viewed (e.g. by pharmaceutical manufacturers) as being contrary to South Africa’s obligation in terms of Articles 27 and 28 of TRIPS. However, TRIPS does allow the use of patented subject matter without the authorisation of the patentee, under certain circumstances (Articles 30 and 31). TRIPS also allows the adoption by member countries of measures necessary to protect inter alia public health, and measures to prevent the abuse of intellectual property rights by right holders (Article 8). It should be noted that the Medicines Amendment Act has not yet been put into effect, partly because regulations to provide for its implementation have not yet been finalised. Accordingly, the parameters within which the power granted to the Minister of Health will be exercised, are still to be laid down. Until such time as the regulations have been finalised, a more complete response to this question is not possible.

See the reply to question No. 3 from the EC.

See the reply to question No. 3 from the EC.

Section 102(e) cannot serve to preclude the grant of a patent on an application for which an applicant has established through a valid claim for priority to a foreign filed application an effective filing date that is prior to the filing date of an issued United States patent. On this basis alone, section 102(e) is consistent with Article 4B of the Paris Convention, as any party who has made an effective priority claim will not lose rights due to the filing during the priority year by another of an application in the United States that results in a patent. The second issue raised in the question is the prior art date of a United States patent in which a claim has been made for priority to a foreign-filed application. The effective filing date for purposes of section 102(e) of such an application is the actual filing date of the United States application, not the priority date claimed in such an application. The definition of the effective date as a prior art reference under the so-called "Hilmer" rule is not inconsistent with the obligations of Article 4B of the Paris Convention, as it will not affect the ability of an applicant to obtain a patent where the applicant has made a priority claim that establishes an effective filing date prior to the effective prior art date of the patent. The final issue raised by this question is whether the exclusive rights guaranteed to patent owners through Article 28 of the TRIPS Agreement are prejudiced because of the effect of the Hilmer rule. The basis for this question appears to be the assumption that an applicant who has obtained a patent in which a valid priority claim has been made will not be able to preclude the issuance of a second patent on the same invention, or an obvious variant thereof, through operation of section 102(e)/103 to a party who has filed an application after the first patentee’s priority date but before his US filing date. As a result, it is assumed that patents will be granted that are obvious in view of each other. This assumption is incorrect, as section 102(e)/103 is not the only legal grounds governing the two applications in the situation described above. Section 102(g) also will serve to ensure that only one patent will issue on one invention. Operation of section 102(g) in a situation where section 102(e), standing alone, would not preclude the issuance of two patents is illustrated in the figure below. [Part of the response is in Diagram format] The changes implemented by the Uruguay Round Agreements Act of 1994 permit nationals from any WTO Member to prove a date of invention relying on evidence concerning the invention from outside the United States. In view of these points, the answer to the question of whether United States patent law due to the situation described above "unreasonably prejudices the exclusive right conferred under TRIPS Article 28" is clearly no.

The statement by Japan in their follow up question that “[t]he US answer appears to apply only to a case where the claims of the two applications are found interfering and the first inventor is granted a patent right through the interfering proceeding” is not an accurate statement of the law regarding section 102(g) of title 35, United States Code. The Court of Appeals for the Federal Circuit has held that the application of section 102(g) is not limited to interference proceedings and that it also provides a basis for a type of anticipation. New Idea Farm Equip. Corp. v. Sperry Corp., 916 F.2d 1561, 16 USPQ2d 1424 (Fed. Cir. 1990); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 231 USPQ 81 (Fed. Cir. 1986). With that understanding of the operation of section 102(g), we stand by our original response to questions 9 and 10.

The issue addressed by section 102(g) is the date of invention. The evidence that can be relied upon to prove a date of invention is not limited to evidence of an earlier filing in another country, but can be any type evidence that will persuasive in establishing the date of invention by the applicant. Taking into account the changes made to 35 U.S.C. 104 through the Uruguay Round Agreements Act, if an applicant is able to demonstrate a date of invention that is prior to the effective filing date established through a claim to priority under 35 U.S.C. 119, that date of invention will be used in the context of application of section 102(g), rather than the priority date. The issue raised in the second part of the question, thus, does not arise under US law as amended to comply with US obligations under the TRIPS Agreement. The answer provided in relation to question No. 9 regarding prejudice of exclusive rights under Article 28 is equally applicable to this question.

The above response to the follow up question to questions 9 and 10 is also applicable to this follow up question. Further, note that the Statement for Administrative Action that accompanied the URAA addresses the last issue raised in the follow up. That is, the SAA states: As foreign inventive activity may now be considered in a determination of which inventor was the first to invent, fairness to both U.S. and foreign inventors demands a certain identity of treatment with regard to reliance on inventive activity in the United States and abroad. Consequently, the inability of an inventor to rely on a date of invention in the United States where the invention has been subsequently abandoned, suppressed or concealed the invention under patentability determinations under Section 102(g) should apply equally to the inventor relying on foreign inventive activity. See SAA, Part B(1)(f).

"In respect of any acts in respect of specific objects embodying protected subject matter which become infringing under the terms of legislation in conformity with this Agreement, and which were commenced, or in respect of which a significant investment was made, before the date of acceptance of the WTO Agreement by that Member, any Member may provide for a limitation of the remedies available to the right holder as to the continued performance of such acts after the date of application of this Agreement for that Member. In such cases the Member shall, however, at least provide for the payment of equitable remuneration." The WTO Agreement became applicable to the United States, as it did for all developed countries, on 1 January 1996. The date on which the United States "accepted" the WTO Agreement was 30 December 1994. Under the terms of Article 70.4, acts that were commenced or for which a significant investment was made before the date of acceptance of the WTO Agreement by the United States can serve as a basis for enjoying limited liability in respect of infringement of a patent whose term was extended through operation of Article 70.2 of the TRIPS Agreement. Section 154(a)(3) recognizes acts that occurred six months after the date of passage of the legislation - which is five months and nine days after the WTO agreement was accepted by the United States. To our knowledge, this grant of a minimal amount of additional time has not had a commercial effect.

The United States has answered question 11 clearly. We do not understand the Government of Japan’s hypothetical question regarding the superiority of Article 30 in relation to Article 70.4. We are, therefore, unable to answer.

In Poland protection of intellectual property rights falls into judicial procedures which means that cases in this category are examined by the courts of law. Enforcement of these claims takes place in ordinary civil contentious proceedings. Enforcement of intellectual property rights in Poland takes place before courts of common law under the provisions of the Act of 17 November 1964 - Code of Civil Procedure (Journal of Laws from 1964 No 43, item 296 with further amendments), hereinafter referred to as the abbreviation "CCP". There are no specialized courts in this respect. The courts competent to give decisions in these cases are voievodship courts competent for the place of residence or the seat of the defendant or the place of the occurrence of the event causing injury (Articles 17, point 2; 27 § 1; 30 and 35 CCP). It should be noted that the structure of the courts of common law separates commercial courts. It is the subject criteria which decides about subordinating the case to the commercial court. Therefore, if both parties to the dispute are entrepreneurs then the competent court will be Commercial Court (then also voievodship court) and the case will come before this court and will be heard in accordance with the regulations on separate proceedings in commercial cases (Title VII, Section IV a CCP). The claim is reported in the form of a written statement of claim submitted to the voievodship court competent for the place of residence of the plaintiff or competent for the place of the occurrence of the event causing injury or the infringement of the protected right (Articles 17, point 2; 27 § 1; and 35 CCP). The statement of claim must comply with the formal requirements specified in Articles 126-129 CCP. Moreover, the statement of claim should contain the reported demand (claims) along with its amount, statement of the facts on the basis of which one demands the required protection and indication of evidence necessary to prove their statements (Article 126 § 2 CCP) and should have an attached power of attorney if the statement of claim is lodged by attorney (Article 126 § 3 CCP). In proceedings before the courts of common law, obligatory representation by an attorney is not required. An exception is the obligation to use services of attorney or legal advisor in case of appealing by cessation to the Supreme Court against the decision given by a court of the second instance. However, with respect to intellectual rights protection the party's attorney may be the following persons: attorney, legal advisor, close family member (Article 87 CCP), patent attorney, social institution concerned with support of inventiveness and also organization of collective management of copyrights and related rights. The laws of Poland do not specify statutory duration of legal proceedings. It requires, however, that proceedings take place without any unnecessary breaks and actions be taken by courts instantaneously. Cases involving intellectual property protection are examined by courts in the order they are brought to the court. The only dates adjourning the course of the proceedings result from the necessity to maintain equality of both parties in the civil proceedings. Voievodship courts are the second organizational level of the state courts and are established in voievodship towns. Courts of higher instances than voievodship courts are courts of appeal. In this context a special "quasi-court" procedure relating to the enforcement of industrial property rights should also be mentioned, which has been established and practised with the Patent Office. The details of this procedure are regulated in: - the Law on Inventive Activity, - the Law on Trademarks, and - the Law on the Protection of Topographies of Integrated Circuits. The procedure as mentioned is as follows: The Patent Office applies, as the first instance the litigation procedure, when taking a decision on: (a) the invalidation of a patent or of a right of protection for utility model, the invalidation of the right in a topography registration or of the right in the registration of a trademark where the statutory requirements for the registration have not been met or the right in a mark that is well known in Poland has been infringed; (b) the transfer of a patent or of a right of protection for a utility model or a right in a topography registration obtained by a person not entitled thereto; (c) the recognition of a patent or a right of protection for a utility model as a dependent patent or a dependent right of protection; (d) the right to exploit an invention or a utility model in specific cases as mentioned in Articles 43, 70 and 74 of the Law on Inventive Activity; (e) the ascertainment that a specific production is not covered by a particular patent or a particular right of protection; (f) the grant of a compulsory licence for a topography of an integrated circuit; (g) the ascertainment that no similarity exists between a registered trademark and a mark that another enterprise uses or intends to use; (h) the recognition of the lapse of the right in a trademark registration where the mark has lost its distinctive character or the owner of the right in the trademark registration has ceased economic activities. In the matters referred to above, the Patent Office takes its decisions in adjudication boards on which the chairmen are judges appointed by the Minister of Justice from among the judges of the district (voyevodian) court of the capital city of Warsaw, and on which are represented social organizations whose activities include the encouragement of inventive activity as well as autonomous organs operating within economic entities, and providing assistance to creators of inventive proposals. Decisions and determinations made by the Patent Office are appealable to the Board of Appeals with the Patent Office, which reaches its decisions in boards, chairmen of which are judges appointed by the First President of the Supreme Court from among the judges of that Court and on which the above-mentioned organizations are represented. In the case of any final decision given by the Patent Office or the Board of Appeals which terminates the procedure or is clearly contrary to law, an extraordinary procedure for review may be initiated by the President of the Patent Office, the First President of the Supreme Court, the General Public Prosecutor or the Ombudsman. To the extraordinary procedure the provisions of the Code of Civil Procedure are applicable.