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India - Patent Protection for Pharmaceutical Protection and Agricultural Chemical Products

AB-1997-5

Report of the Appellate Body

VI. Article 70.8

49. Article 70.8 states:

Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall:

(a) notwithstanding the provisions of Part VI, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed;

(b) apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application; and

(c) provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in subparagraph (b).

50. With respect to Article 70.8(a), the Panel found that:

... Article 70.8(a) requires the Members in question to establish a means that not only appropriately allows for the entitlement to file mailbox applications and the allocation of filing and priority dates to them, but also provides a sound legal basis to preserve novelty and priority as of those dates, so as to eliminate any reasonable doubts regarding whether mailbox applications and eventual patents based on them could be rejected or invalidated because, at the filing or priority date, the matter for which protection was sought was unpatentable in the country in question. 32

51. In India's view, the obligations in Article 70.8(a) are met by a developing country Member where it establishes a mailbox for receiving, dating and storing patent applications for pharmaceutical and agricultural chemical products in a manner that properly allots filing and priority dates to those applications in accordance with paragraphs (b) and (c) of Article 70.8 33. India asserts that the Panel established an additional obligation "to create legal certainty that the patent applications and the eventual patents based on them will not be rejected or invalidated in the future" 34. This, India argues, is a legal error by the Panel.

52. The introductory clause to Article 70.8 provides that it applies "[w]here a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27 ..." of the TRIPS Agreement. Article 27 requires that patents be made available "for any inventions, whether products or processes, in all fields of technology", subject to certain exceptions. However, pursuant to paragraphs 1, 2 and 4 of Article 65, a developing country Member may delay providing product patent protection in areas of technology not protectable in its territory on the general date of application of the TRIPS Agreement for that Member until 1 January 2005. Article 70.8 relates specifically and exclusively to situations where a Member does not provide, as of 1 January 1995, patent protection for pharmaceutical and agricultural chemical products.

53. By its terms, Article 70.8(a) applies "notwithstanding the provisions of Part VI" of the TRIPS Agreement. Part VI of the TRIPS Agreement, consisting of Articles 65, 66 and 67, allows for certain "transitional arrangements" in the application of certain provisions of the TRIPS Agreement. These "transitional arrangements", which allow a Member to delay the application of some of the obligations in the TRIPS Agreement for certain specified periods 35, do not apply to Article 70.8. Thus, although there are "transitional arrangements" which allow developing country Members, in particular, more time to implement certain of their obligations under the TRIPS Agreement, no such "transitional arrangements" exist for the obligations in Article 70.8.

54. Article 70.8(a) imposes an obligation on Members to provide "a means" by which mailbox applications can be filed "from the date of entry into force of the WTO Agreement". Thus, this obligation has been in force since 1 January 1995. The issue before us in this appeal is not whether this obligation exists or whether this obligation is now in force. Clearly, it exists, and, equally clearly, it is in force now. The issue before us in this appeal is: what precisely is the "means" for filing mailbox applications that is contemplated and required by Article 70.8(a)? To answer this question, we must interpret the terms of Article 70.8(a).

55. We agree with the Panel that "[t]he analysis of the ordinary meaning of these terms alone does not lead to a definitive interpretation as to what sort of ‘means’ is required by this subparagraph" 36. Therefore, in accordance with the general rules of treaty interpretation set out in Article 31 of the Vienna Convention, to discern the meaning of the terms in Article 70.8(a), we must also read this provision in its context, and in light of the object and purpose of the TRIPS Agreement.

56. Paragraphs (b) and (c) of Article 70.8 constitute part of the context for interpreting Article 70.8(a). Paragraphs (b) and (c) of Article 70.8 require that the "means" provided by a Member under Article 70.8(a) must allow the filing of applications for patents for pharmaceutical and agricultural chemical products from 1 January 1995 and preserve the dates of filing and priority of those applications, so that the criteria for patentability may be applied as of those dates, and so that the patent protection eventually granted is dated back to the filing date. In this respect, we agree with the Panel that,

... in order to prevent the loss of the novelty of an invention ... filing and priority dates need to have a sound legal basis if the provisions of Article 70.8 are to fulfil their purpose. Moreover, if available, a filing must entitle the applicant to claim priority on the basis of an earlier filing in respect of the claimed invention over applications with subsequent filing or priority dates. Without legally sound filing and priority dates, the mechanism to be established on the basis of Article 70.8 will be rendered inoperational. 37

57. On this, the Panel is clearly correct. The Panel's interpretation here is consistent also with the object and purpose of the TRIPS Agreement. The Agreement takes into account, inter alia, "the need to promote effective and adequate protection of intellectual property rights" 38. We believe the Panel was correct in finding that the "means" that the Member concerned is obliged to provide under Article 70.8(a) must allow for "the entitlement to file mailbox applications and the allocation of filing and priority dates to them" 39. Furthermore, the Panel was correct in finding that the "means" established under Article 70.8(a) must also provide "a sound legal basis to preserve novelty and priority as of those dates" 40. These findings flow inescapably from the necessary operation of paragraphs (b) and (c) of Article 70.8.

58. However, we do not agree with the Panel that Article 70.8(a) requires a Member to establish a means "so as to eliminate any reasonable doubts regarding whether mailbox applications and eventual patents based on them could be rejected or invalidated because, at the filing or priority date, the matter for which protection was sought was unpatentable in the country in question" 41. India is entitled, by the "transitional arrangements" in paragraphs 1, 2 and 4 of Article 65, to delay application of Article 27 for patents for pharmaceutical and agricultural chemical products until 1 January 2005. In our view, India is obliged, by Article 70.8(a), to provide a legal mechanism for the filing of mailbox applications that provides a sound legal basis to preserve both the novelty of the inventions and the priority of the applications as of the relevant filing and priority dates. No more.

59. But what constitutes such a sound legal basis in Indian law? To answer this question, we must recall first an important general rule in the TRIPS Agreement. Article 1.1 of the TRIPS Agreement states, in pertinent part:

... Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

Members, therefore, are free to determine how best to meet their obligations under the TRIPS Agreement within the context of their own legal systems. And, as a Member, India is "free to determine the appropriate method of implementing" its obligations under the TRIPS Agreement within the context of its own legal system.

60. India insists that it has done that. India contends that it has established, through "administrative instructions", a "means" consistent with Article 70.8(a) of the TRIPS Agreement. According to India, these "administrative instructions" 42 establish a mechanism that provides a sound legal basis to preserve the novelty of the inventions and the priority of the applications as of the relevant filing and priority dates consistent with Article 70.8(a) of the TRIPS Agreement. According to India, pursuant to these "administrative instructions", the Patent Office has been directed to store applications for patents for pharmaceutical and agricultural chemical products separately for future action pursuant to Article 70.8, and the Controller General of Patents Designs and Trademarks ("the Controller") has been instructed not to refer them to an examiner until 1 January 2005. According to India, these "administrative instructions" are legally valid in Indian law43, as they are reflected in the Minister's Statement to Parliament of 2 August 1996 44. And, according to India:

There is ... absolute certainty that India can, when patents are due in accordance with subparagraphs (b) and (c) of Article 70.8, decide to grant such patents on the basis of the applications currently submitted and determine the novelty and priority of the inventions in accordance with the date of these applications. 45 (emphasis added)

61. India has not provided any text of these "administrative instructions" either to the Panel or to us.

62. Whatever their substance or their import, these "administrative instructions" were not the initial "means" chosen by the Government of India to meet India's obligations under Article 70.8(a) of the TRIPS Agreement. The Government of India's initial preference for establishing a "means" for filing mailbox applications under Article 70.8(a) was the Patents (Amendment) Ordinance (the "Ordinance"), promulgated by the President of India on 31 December 1994 pursuant to Article 123 of India's Constitution. Article 123 enables the President to promulgate an ordinance when Parliament is not in session, and when the President is satisfied "that circumstances exist which render it necessary for him to take immediate action". India notified the Ordinance to the Council for TRIPS, pursuant to Article 63.2 of the TRIPS Agreement, on 6 March 1995. 46 In accordance with the terms of Article 123 of India's Constitution, the Ordinance expired on 26 March 1995, six weeks after the reassembly of Parliament. This was followed by an unsuccessful effort to enact the Patents (Amendment) Bill 1995 to implement the contents of the Ordinance on a permanent basis 47. This Bill was introduced in the Lok Sabha (Lower House) in March 1995. After being passed by the Lok Sabha, it was referred to a Select Committee of the Rajya Sabha (Upper House) for examination and report. However, the Bill was subsequently not enacted due to the dissolution of Parliament on 10 May 1996. From these actions, it is apparent that the Government of India initially considered the enactment of amending legislation to be necessary in order to implement its obligations under Article 70.8(a). However, India maintains that the "administrative instructions" issued in April 1995 effectively continued the mailbox system established by the Ordinance, thus obviating the need for a formal amendment to the Patents Act or for a new notification to the Council for TRIPS. 48

63. With respect to India's "administrative instructions", the Panel found that "the current administrative practice creates a certain degree of legal insecurity in that it requires Indian officials to ignore certain mandatory provisions of the Patents Act" 49; and that "even if Patent Office officials do not examine and reject mailbox applications, a competitor might seek a judicial order to do so in order to obtain rejection of a patent claim". 50

64. India asserts that the Panel erred in its treatment of India's municipal law because municipal law is a fact that must be established before an international tribunal by the party relying on it. In India's view, the Panel did not assess the Indian law as a fact to be established by the United States, but rather as a law to be interpreted by the Panel. India argues that the Panel should have given India the benefit of the doubt as to the status of its mailbox system under Indian domestic law. India claims, furthermore, that the Panel should have sought guidance from India on matters relating to the interpretation of Indian law. 51

65. In public international law, an international tribunal may treat municipal law in several ways. 52 Municipal law may serve as evidence of facts and may provide evidence of state practice. However, municipal law may also constitute evidence of compliance or non-compliance with international obligations. For example, in Certain German Interests in Polish Upper Silesia, the Permanent Court of International Justice observed:

It might be asked whether a difficulty does not arise from the fact that the Court would have to deal with the Polish law of July 14th, 1920. This, however, does not appear to be the case. From the standpoint of International Law and of the Court which is its organ, municipal laws are merely facts which express the will and constitute the activities of States, in the same manner as do legal decisions and administrative measures. The Court is certainly not called upon to interpret the Polish law as such; but there is nothing to prevent the Court's giving judgment on the question whether or not, in applying that law, Poland is acting in conformity with its obligations towards Germany under the Geneva Convention. 53 (emphasis added)

66. In this case, the Panel was simply performing its task in determining whether India's "administrative instructions" for receiving mailbox applications were in conformity with India's obligations under Article 70.8(a) of the TRIPS Agreement. It is clear that an examination of the relevant aspects of Indian municipal law and, in particular, the relevant provisions of the Patents Act as they relate to the "administrative instructions", is essential to determining whether India has complied with its obligations under Article 70.8(a). There was simply no way for the Panel to make this determination without engaging in an examination of Indian law. But, as in the case cited above before the Permanent Court of International Justice, in this case, the Panel was not interpreting Indian law "as such"; rather, the Panel was examining Indian law solely for the purpose of determining whether India had met its obligations under the TRIPS Agreement. To say that the Panel should have done otherwise would be to say that only India can assess whether Indian law is consistent with India's obligations under the WTO Agreement. This, clearly, cannot be so.

67. Previous GATT/WTO panels also have conducted a detailed examination of the domestic law of a Member in assessing the conformity of that domestic law with the relevant GATT/WTO obligations. For example, in United States - Section 337 of the Tariff Act of 1930 54, the panel conducted a detailed examination of the relevant United States' legislation and practice, including the remedies available under Section 337 as well as the differences between patent-based Section 337 proceedings and federal district court proceedings, in order to determine whether Section 337 was inconsistent with Article III:4 of the GATT 1947. This seems to us to be a comparable case.

68. And, just as it was necessary for the Panel in this case to seek a detailed understanding of the operation of the Patents Act as it relates to the "administrative instructions" in order to assess whether India had complied with Article 70.8(a), so, too, is it necessary for us in this appeal to review the Panel's examination of the same Indian domestic law.

69. To do so, we must look at the specific provisions of the Patents Act. Section 5(a) of the Patents Act provides that substances "intended for use, or capable of being used, as food or as medicine or drug" are not patentable. "When the complete specification has been led in respect of an application for a patent", section 12(1) requires the Controller to refer that application and that specification to an examiner. Moreover, section 15(2) of the Patents Act states that the Controller "shall refuse" an application in respect of a substance that is not patentable. We agree with the Panel that these provisions of the Patents Act are mandatory. 55 And, like the Panel, we are not persuaded that India's "administrative instructions" would prevail over the contradictory mandatory provisions of the Patents Act. 56 We note also that, in issuing these "administrative instructions", the Government of India did not avail itself of the provisions of section 159 of the Patents Act, which allows the Central Government "to make rules for carrying out the provisions of [the] Act" or section 160 of the Patents Act, which requires that such rules be laid before each House of the Indian Parliament. We are told by India that such rulemaking was not required for the "administrative instructions" at issue here. But this, too, seems to be inconsistent with the mandatory provisions of the Patents Act.

70. We are not persuaded by India's explanation of these seeming contradictions. Accordingly, we are not persuaded that India's "administrative instructions" would survive a legal challenge under the Patents Act. And, consequently, we are not persuaded that India's "administrative instructions" provide a sound legal basis to preserve novelty of inventions and priority of applications as of the relevant filing and priority dates.

71. For these reasons, we agree with the Panel's conclusion that India's "administrative instructions" for receiving mailbox applications are inconsistent with Article 70.8(a) of the TRIPS Agreement.

72. India raises the additional argument that the Panel erred in its application of the burden of proof in assessing Indian municipal law. In particular, India alleges that the Panel, after having required the United States merely to raise "reasonable doubts" suggesting a violation of Article 70.8, placed the burden on India to dispel such doubts. 57

73. The Panel states:

As the Appellate Body report on Shirts and Blouses points out, "a party claiming a violation of a provision of the WTO Agreement by another Member must assert and prove its claim". In this case, it is the United States that claims a violation by India of Article 70.8 of the TRIPS Agreement. Therefore, it is up to the United States to put forward evidence and legal arguments sufficient to demonstrate that action by India is inconsistent with the obligations assumed by India under Article 70.8. In our view, the United States has successfully put forward such evidence and arguments. Then, ... the onus shifts to India to bring forward evidence and arguments to disprove the claim. We are not convinced that India has been able to do so (footnotes deleted). 58

74. This statement of the Panel is a legally correct characterization of the approach to burden of proof that we set out in United States - Shirts and Blouses. 59 However, it is not sufficient for a panel to enunciate the correct approach to burden of proof; a panel must also apply the burden of proof correctly. A careful reading of paragraphs 7.35 and 7.37 of the Panel Report reveals that the Panel has done so in this case. These paragraphs show that the United States put forward evidence and arguments that India's "administrative instructions" pertaining to mailbox applications were legally insufficient to prevail over the application of certain mandatory provisions of the Patents Act. India put forward rebuttal evidence and arguments. India misinterprets what the Panel said about "reasonable doubts". The Panel did not require the United States merely to raise "reasonable doubts" before the burden shifted to India. Rather, after properly requiring the United States to establish a prima facie case and after hearing India's rebuttal evidence and arguments, the Panel concluded that it had "reasonable doubts" that the "administrative instructions" would prevail over the mandatory provisions of the Patents Act if a challenge were brought in an Indian court.

75. For these reasons, we conclude that the Panel applied the burden of proof correctly in assessing the compliance of India's domestic law with Article 70.8(a) of the TRIPS Agreement.

VII. Article 70.9

76. Article 70.9 of the TRIPS Agreement reads:

Where a product is the subject of a patent application in a Member in accordance with paragraph 8(a), exclusive marketing rights shall be granted, notwithstanding the provisions of Part VI, for a period of five years after obtaining marketing approval in that Member or until a product patent is granted or rejected in that Member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member.

77. With respect to Article 70.9, the Panel found:

Based on customary rules of treaty interpretation, we have reached the conclusion that under Article 70.9 there must be a mechanism ready for the grant of exclusive marketing rights at any time subsequent to the date of entry into force of the WTO Agreement. 60

78. India argues that Article 70.9 establishes an obligation to grant exclusive marketing rights for a product that is the subject of a patent application under Article 70.8(a) after all the other conditions specified in Article 70.9 have been fulfilled. 61 India asserts that there are many provisions in the TRIPS Agreement that, unlike Article 70.9, explicitly oblige Members to change their domestic laws to authorize their domestic authorities to take certain action before the need to take such action actually arises. 62 India maintains that the Panel’s interpretation of Article 70.9 has the consequence that the transitional arrangements in Article 65 allow developing country Members to postpone legislative changes in all fields of technology except the most "sensitive" ones, pharmaceutical and agricultural chemical products. India claims that the Panel turned an obligation to take action in the future into an obligation to take action immediately. 63

79. India's arguments must be examined in the light of Article XVI:4 of the WTO Agreement, which requires that:

Each Member shall ensure the conformity of its laws, regulations and administrative procedures with its obligations as provided in the annexed Agreements.

80. Moreover, India acknowledged before the Panel and in this appeal that, under Indian law, it is necessary to enact legislation in order to grant exclusive marketing rights in compliance with the provisions of Article 70.9. This was already implied in the Ordinance, which contained detailed provisions for the grant of exclusive marketing rights in India effective 1 January 1995. However, with the expiry of the Ordinance on 26 March 1995, no legal basis remained, and with the failure to enact the Patents (Amendment) Bill 1995 due to the dissolution of Parliament on 10 May 1996, no legal basis currently exists, for the grant of exclusive marketing rights in India. India notified the Council for TRIPS of the promulgation of the Ordinance pursuant to Article 63.2 of the TRIPS Agreement 64, but has failed as yet to notify the Council for TRIPS that the Ordinance has expired.

81. Given India's admissions that legislation is necessary in order to grant exclusive marketing rights in compliance with Article 70.9 and that it does not currently have such legislation, the issue for us to consider in this appeal is whether a failure to have in place a mechanism ready for the grant of exclusive marketing rights, effective as from the date of entry into force of the WTO Agreement, constitutes a violation of India's obligations under Article 70.9 of the TRIPS Agreement.

82. By its terms, Article 70.9 applies only in situations where a product patent application is filed under Article 70.8(a). Like Article 70.8(a), Article 70.9 applies "notwithstanding the provisions of Part VI". Article 70.9 specifically refers to Article 70.8(a), and they operate in tandem to provide a package of rights and obligations that apply during the transitional periods contemplated in Article 65. It is obvious, therefore, that both Article 70.8(a) and Article 70.9 are intended to apply as from the date of entry into force of the WTO Agreement.

83. India has an obligation to implement the provisions of Article 70.9 of the TRIPS Agreement effective as from the date of entry into force of the WTO Agreement, that is, 1 January 1995. India concedes that legislation is needed to implement this obligation. India has not enacted such legislation. To give meaning and effect to the rights and obligations under Article 70.9 of the TRIPS Agreement, such legislation should have been in effect since 1 January 1995.

84. For these reasons, we agree with the Panel that India should have had a mechanism in place to provide for the grant of exclusive marketing rights effective as from the date of entry into force of the WTO Agreement, and, therefore, we agree with the Panel that India is in violation of Article 70.9 of the TRIPS Agreement.

VIII. Article 63

85. India argues that, under Articles 3, 7 and 11 of the DSU, a panel may make findings only on issues that have been submitted to it by the parties to the dispute. With this in mind, India contends that the Panel exceeded its authority under the DSU by ruling on the subsidiary claim by the United States under Article 63 of the TRIPS Agreement after having first accepted the principal claim by the United States of a violation of Article 70.8 of the TRIPS Agreement. 65

86. The facts are these. The Panel's terms of reference 66refer to the request by the United States for the establishment of a panel. 67 The United States did not include a claim under Article 63 in its request for the establishment of a panel in this case. 68 The United States did not mention Article 63 in its first written submission to the Panel. The United States did not raise Article 63 as an alternative claim for the first time until its oral statement at the first substantive meeting of the parties with the Panel.

87. In United States - Shirts and Blouses, we said that "[a] panel need only address those claims which must be addressed in order to resolve the matter in issue in the dispute". 69 This means that a panel has the discretion to determine the claims it must address in order to resolve the dispute between the parties -- provided that those claims are within that panel's terms of reference. We have stressed, on more than one occasion, the fundamental importance of a panel's terms of reference. In European Communities - Regime for the Importation, Sale and Distribution of Bananas ("European Communities - Bananas"), we found that "[i]t is the panel's terms of reference, governed by Article 7 of the DSU, which set out the claims of the complaining parties relating to the matter referred to the DSB". 70 In Brazil - Measures Affecting Desiccated Coconut ("Brazil - Desiccated Coconut"), we stated:

A panel's terms of reference are important for two reasons. First, terms of reference fulfil an important due process objective -- they give the parties and third parties sufficient information concerning the claims at issue in the dispute in order to allow them an opportunity to respond to the complainant's case. Second, they establish the jurisdiction of the panel by defining the precise claims at issue in the dispute. 71

88. We stated also in Brazil - Desiccated Coconut that all claims must be included in the request for establishment of a panel in order to come within the panel's terms of reference, based on the practice of panels under the GATT 1947 and the Tokyo Round Codes. 72 That past practice required that a claim had to be included in the documents referred to, or contained in, the terms of reference in order to form part of the "matter" referred to a panel for consideration. Following both this past practice and the provisions of the DSU, in European Communities - Bananas, we observed that there is a significant difference between the claims identified in the request for the establishment of a panel, which establish the panel's terms of reference under Article 7 of the DSU, and the arguments supporting those claims, which are set out and progressively clarified in the first written submissions, the rebuttal submissions, and the first and second panel meetings with the parties as a case proceeds. There we said:

Article 6.2 of the DSU requires that the claims, but not the arguments, must all be specified sufficiently in the request for the establishment of a panel in order to allow the defending party and any third parties to know the legal basis of the complaint. If a claim is not specified in the request for the establishment of a panel, then a faulty request cannot be subsequently "cured" by a complaining party's argumentation in its first written submission to the panel or in any other submission or statement made later in the panel proceeding. 73

89. Thus, a claim must be included in the request for establishment of a panel in order to come within a panel’s terms of reference in a given case. In this case, after describing the obligations of Articles 27, 70.8 and 70.9 of the TRIPS Agreement, the request for establishment of a panel by the United States reads, in pertinent part:

... India’s legal regime appears to be inconsistent with the obligations of the TRIPS Agreement, including but not necessarily limited to Articles 27, 65 and 70 ....

Accordingly, the United States respectfully requests the establishment of a panel to examine this matter in light of the TRIPS Agreement, and to find that India’s legal regime fails to conform to the obligations of Articles 27, 65 and 70 of the TRIPS Agreement, and nullifies or impairs benefits accruing directly or indirectly to the United States under the TRIPS Agreement. 74

90. With respect to Article 63, the convenient phrase, "including but not necessarily limited to", is simply not adequate to "identify the specific measures at issue and provide a brief summary of the legal basis of the complaint sufficient to present the problem clearly" as required by Article 6.2 of the DSU. If this phrase incorporates Article 63, what article of the TRIPS Agreement does it not incorporate? Therefore, this phrase is not sufficient to bring a claim relating to Article 63 within the terms of reference of the Panel.

91. In European Communities - Bananas, we accepted the view of the panel in that case that it was "sufficient for the Complaining Parties to list the provisions of the specific agreements alleged to have been violated without setting out detailed arguments as to which specific aspects of the measures at issue relate to which specific provisions of those agreements", and we also agreed with the panel that the request in that case was sufficiently specific to comply with the "minimum standards" established by Article 6.2 of the DSU. 75 In this case, in contrast, there is a failure to identify a specific provision of an agreement that is alleged to have been violated. This falls below the "minimum standards" that we were willing to accept in European Communities - Bananas.

92. We note also the Panel's statement that it "ruled, at the outset of the first substantive meeting held on 15 April 1997, that all legal claims would be considered if they were made prior to the end of that meeting; and this ruling was accepted by both parties". 76 We do not find this statement at all persuasive in advancing the argument made by the United States on this issue. Nor do we find this statement consistent with the letter and the spirit of the DSU. Although panels enjoy some discretion in establishing their own working procedures, this discretion does not extend to modifying the substantive provisions of the DSU. To be sure, Article 12.1 of the DSU says: "Panels shall follow the Working Procedures in Appendix 3 unless the panel decides otherwise after consulting the parties to the dispute". Yet that is all that it says. Nothing in the DSU gives a panel the authority either to disregard or to modify other explicit provisions of the DSU. The jurisdiction of a panel is established by that panel's terms of reference, which are governed by Article 7 of the DSU. A panel may consider only those claims that it has the authority to consider under its terms of reference. A panel cannot assume jurisdiction that it does not have. In this case, Article 63 was not within the Panel's jurisdiction, as defined by its terms of reference. Therefore, the Panel had no authority to consider the alternative claim by the United States under Article 63.

93. The United States argues that, in the consultations between the parties to this dispute in this case, India had not disclosed the existence of any "administrative instructions" for the filing of mailbox applications for pharmaceutical and agricultural chemical products. Therefore, the United States asserts that it had no way of knowing that India would rely on this argument before the Panel. The United States maintains that, for this reason, it had not included a claim under Article 63 in its request for the establishment of a panel. 77 All that said, there is, nevertheless, no basis in the DSU for a complaining party to make an additional claim, outside of the scope of a panel's terms of reference, at the first substantive meeting of the panel with the parties. A panel is bound by its terms of reference.

94. All parties engaged in dispute settlement under the DSU must be fully forthcoming from the very beginning both as to the claims involved in a dispute and as to the facts relating to those claims. Claims must be stated clearly. Facts must be disclosed freely. This must be so in consultations as well as in the more formal setting of panel proceedings. In fact, the demands of due process that are implicit in the DSU make this especially necessary during consultations. For the claims that are made and the facts that are established during consultations do much to shape the substance and the scope of subsequent panel proceedings. If, in the aftermath of consultations, any party believes that all the pertinent facts relating to a claim are, for any reason, not before the panel, then that party should ask the panel in that case to engage in additional fact-finding. But this additional fact-finding cannot alter the claims that are before the panel -- because it cannot alter the panel's terms of reference. And, in the absence of the inclusion of a claim in the terms of reference, a panel must neither be expected nor permitted to modify rules in the DSU.

95. It is worth noting that, with respect to fact-finding, the dictates of due process could better be served if panels had standard working procedures that provided for appropriate factual discovery at an early stage in panel proceedings.

96. For these reasons, we find that the Panel erred in its findings and conclusions relating to the alternative claim by the United States under Article 63 of the TRIPS Agreement. In the light of this finding, it is not necessary for us to consider whether the Panel erred also in recommending simultaneously that India bring itself into compliance with its obligations under both Articles 70.8(a) and 63 of the TRIPS Agreement.

IX. Findings and Conclusions

97. For the reasons set out in this Report, the Appellate Body:

(a) upholds the Panel's conclusion that India has not complied with its obligations under Article 70.8(a) to establish "a means" that adequately preserves novelty and priority in respect of applications for product patents in respect of pharmaceutical and agricultural chemical inventions during the transitional periods provided for in Article 65 of the TRIPS Agreement;

(b) upholds the Panel's conclusion that India has not complied with its obligations under Article 70.9 of the TRIPS Agreement; and

(c) reverses the Panel's alternative findings that India has not complied with paragraphs 1 and 2 of Article 63 of the TRIPS Agreement.

98. The Appellate Body recommends that the Dispute Settlement Body request India to bring its legal regime for patent protection of pharmaceutical and agricultural chemical products into conformity with India's obligations under Articles 70.8 and 70.9 of the TRIPS Agreement.

Signed in the original at Geneva this 4th day of December 1997 by:

Julio Lacarte-Muró
Presiding Member

James Bacchus
Member

Christopher Beeby
Member


Notes:

32. Panel Report, para. 7.31.

33. India's appellant's submission, pp. 4-5.

34. India's appellant's submission, p. 5.

35. Pursuant to Article 65.1, all Members were entitled to delay the application of most of the provisions of the TRIPS Agreement for one year after the date of entry into force of the WTO Agreement. Pursuant to Article 65.2, developing country Members are generally entitled to a delay of a further four years. Where a developing country Member is obliged to extend patent protection to areas of technology to which it did not extend such protection on the general date of application of the TRIPS Agreement for that Member, Article 65.4 states that that developing country Member may delay the application of the provisions on product patents to such areas of technology for an additional period of five years.

36. Panel Report, para. 7.25.

37. Panel Report, para. 7.28.

38. Preamble to the TRIPS Agreement.

39. Panel Report, para. 7.31.

40. Ibid.

41. Ibid.

42. This is India's term for its measure. India's appellant's submission, p. 10.

43. Response by India to questioning at the oral hearing.

44. Panel Report, Annex 2.

45. India's appellant's submission, p. 8.

46. IP/N/1/IND/1, 8 March 1995.

47. We note that an Expert Group advised the Indian Government that a formal legal basis was required to make the mailbox system valid under Indian law. See Panel Report, para. 7.36.

48. Response of India to questioning at the oral hearing.

49. Panel Report, para. 7.35.

50. Panel Report, para. 7.37.

51. India's appellant's submission, pp. 13 and 15.

52. See, for example, I. Brownlie, Principles of Public International Law, 4th ed. (Clarendon Press, 1990), pp. 40-42.

53. [1926], PCIJ Rep., Series A, No. 7, p. 19.

54. Adopted 7 November 1989, BISD 36S/345.

55. Panel Report, para. 7.35.

56. Panel Report, para. 7.37.

57. India's appellant's submission, p. 12.

58. Panel Report, para. 7.40.

59. Adopted 23 May 1997, WT/DS33/AB/R, p. 16.

60. Panel Report, para. 7.60.

61. India's appellant's submission, p. 19.

62. Ibid.; for example, India asserts that according to Articles 42-48 of the TRIPS Agreement, the judicial authorities of Members "shall have the authority" to grant certain rights. Article 51 obliges Members to "adopt procedures" to enable right holders to prevent the release of counterfeited or pirated products from customs. Article 39.2 requires Members to give natural and legal persons "the possibility of preventing" the disclosure of information. According to Article 25.1 "Members shall provide for the protection" of certain industrial designs and Article 22.2 obliges Members to "provide the legal means for interested parties to prevent" certain misuses of geographical indications. India further asserts that a comparison of the terms of Article 70.9 with those of Article 27 according to which "patents shall be available" for inventions is revealing.

63. India's appellant's submission, p. 21.

64. IP/N/1/IND/1, 8 March 1995.

65. India's appellant's submission, p. 24.

66. WT/DS50/5, 5 February 1997.

67. WT/DS50/4, 8 November 1996.

68. Ibid.

69. Adopted 23 May 1997, WT/DS33/AB/R, p. 19. A footnote to this statement reads: "The 'matter in issue' is the 'matter referred to the DSB' pursuant to Article 7 of the DSU".

70. Adopted 25 September 1997, WT/DS27/AB/R, para. 145.

71. Adopted 20 March 1997, WT/DS22/AB/R, p. 22.

72. Ibid.

73. Adopted 25 September 1997, WT/DS27/AB/R, para. 143.

74. WT/DS50/4, 8 November 1996.

75. Adopted 25 September 1997, WT/DS27/AB/R, para. 141; Panel Reports, adopted 25 September 1997, WT/DS27/R/ECU, WT/DS27/R/GTM, WT/DS27/R/HND, WT/DS27/R/MEX, WT/DS27/R/USA, para. 7.29.

76. Panel Report, para. 7.9.

77. Response by the United States to questioning at the oral hearing.