In terms of section 25(4)(b) any variety of animal and plant shall not be patentable under the Patents Act, nor any essentially biological process for the production of animals or plants. Plant varieties can be protected under the Plant Breeders' Rights Act No. 22 of 1964.

It is confirmed that micro-organisms, and non-biological and microbiological processes and the products thereof constitute patentable subject matter in South Africa. Section 25(4)(b) of the Patents Act provides as follows: "(4) A patent shall not be granted (a) ... (b) for any variety of animal or plant or any essential biological process for the production of animals or plants, not being a micro-biological process or the product of such a process". This provision is interpreted to mean that the following do not fall within the exclusion: - micro-organisms - micro-biological processes and the products of such processes - non-biological processes for the production of animals or plants.

See reply to question No. 1 from the EC.

See reply to question No. 3 from the EC.

See reply to question No. 3 from the EC.

In terms of the common law of South Africa, confidential information or trade secrets are given protection against unauthorised disclosure or use by others. The requirements to rely on such protection on the basis of common law principles are in substantial compliance with the provisions of Article 39.2 of TRIPS.

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.

The general principle in infringement proceedings is that the patentee has the onus of proving infringement. However, the burden of proof is shifted in the case of a patent for a process of obtaining a new product, but only in regard to proving that such a product produced by a third party was obtained by the patented process. In this regard section 67(2) and (3) provides as follows: "67.(2) If the invention for which a patent is granted is a process for obtaining a new product, the same product produced by a person other than the proprietor of the patent or a licensee under that patent shall, unless the contrary is proved, be deemed, in any proceedings, to have been obtained by that process. (3) In considering whether any person has discharged the onus imposed upon him by subsection (2), the commissioner shall not require him to disclose any secret process used by him in producing the product concerned, if it appears to the commissioner that it would be unreasonable to do so."

In the response to Japan in reply to the question regarding the protection of undisclosed information, it is indicated that confidential information (including trade secrets) is protected against unauthorized disclosure or use on the basis of the common law in South Africa. Insofar as the use in the response of the terms "substantial compliance" in regard to Article 39.2 of the TRIPS Agreement may have created uncertainty, the request is made for the word "substantial" to be cancelled from the relevant paragraph of the response. The relevant common law principles require, for undisclosed information to qualify as protectible subject matter in the absence of express contractual provisions providing for confidentiality, that the information should meet with requirements in accordance with the standards set out in Article 39.2 of the TRIPS Agreement. The legal position does not deviate from the provisions of Article 39.2. The protection extends to unauthorized use of trade secrets by third parties.

Specific provision is made for the preservation of confidentiality in regard to information submitted by an applicant for purposes of the registration of a pharmaceutical substance or an agricultural chemical in the following manner: 5.1 Medicines and Related Substance Control Act No. 101 of 1965: Section 34 provides as follows: "Preservation of secrecy 34. No person shall, except for the purpose of the exercise of his powers or the performance of his functions under this Act, or for the purpose of legal proceedings under this Act, or when required to do so by any competent court or under any law, or with the written authority of the Director General, disclose to any other person any information acquired by him in the exercise of his powers or the performance of his functions under this Act and relating to the business or affairs of any person, or use such information for self gain or for the benefit of his employer." 5.2 Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act No. 36 of 1947: Section 17 provides as follows: "Preservation of secrecy 17. Any person who discloses except to the Minister or to any other person for the purpose of the performance of his duties or the exercise of his functions under this Act or when required to do so by any court or under any law, any information acquired by him in the exercise of any duty or function under this Act, in relation to the business or affairs of any other person shall be guilty of an offence and liable on conviction to a fine not exceeding five hundred pounds or imprisonment for a period not exceeding twelve months." Unfair commercial use is not addressed expressly, except for the prohibition on self gain or any benefit to the employer in the Medicines Act. The circumstances under which such information could be disclosed are set out in the two sections quoted above.

It is correct that section 25(2) of the South African Patents Act provides that computer programs shall not constitute inventions for the purposes of the Act. However, section 25(3) provides that subsection (2) shall prevent such a program to be treated as an invention "only to the extent to which a patent or patent application relates to that thing as such". This position is in line with the position in Britain. It is submitted that the instances as set out in question No. 1(a) and (b) from the US could qualify for patent protection in terms of South African law, inasmuch as these instances do not relate to mere computer programs as such. Accordingly, it is submitted that the South African position complies with Article 27 of the TRIPS Agreement, inasmuch as inventions based on or involving computer programs are patentable.

See reply to question No. 1 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.

The Polish civil procedure regarding enforcement of intellectual property rights (claims) seems to comply with the requirements of Article 41.2 of the TRIPS Agreement. The enforcement of these claims follows the ordinary course of civil trial proceedings. Enforcement of intellectual property rights in Poland takes place before ordinary courts under the provisions of the Act of 17 November 1964 - Code of Civil Procedure (Journal of Laws, 1964 No. 43, item 296 with further amendments), hereinafter referred to as the abbreviation "CCP". There are no specialised 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 (Article 17 point 2; Article 27 § 1; Articles 30 and 35 CCP). Action on behalf of these claims is initiated by a written statement of claim submitted to the provincial court having territorial jurisdiction corresponding with the place of residence of the plaintiff or with regard to the place where the act causing the damage or of infringement of the protected right occurred. Cases regarding intellectual property rights do not invoke any additional costs or other deadlines, compared with proceedings in other cases. Polish law does not enforce a statutory limit on the duration of proceedings. Nevertheless, it requires that the proceedings continue without undue interruptions, and the actions are taken by the court without delay. The cases of enforcement of intellectual property rights are heard in the order of their submission to the court. The only time-limits that may cease proceedings stem from the necessity to adhere to the principle of equal rights of the parties to the proceedings. Enforcement of valid and immediately enforceable court decisions fails within the responsibilities of court authorities, i.e. courts and court enforcement officers (bailiffs).