Article 70.8

(a) The United States' claim that India does not have in place a mailbox system that corresponds to the requirements of Article 70.8

- The Patents Act and the administrative practices governing patent applications permitted the filing of a patent application for a pharmaceutical or agricultural chemical product notwithstanding the fact that such products were currently not patentable. Section 6 of the Act provided for the receipt of applications for a patent for inventions. It was not a precondition of Section 6 that the application should relate to a patentable invention. The Patents Act of 1970 defined "invention" in Section 2(1)(j) and further provided in Section 3 that certain subject matters were not inventions. In Section 5, the Act recognized that there might be an invention in relation to pharmaceutical products and chemical products, but provided that such inventions were not patentable in respect of the product itself while being patentable for the methods or processes of manufacture.

- It was true that, should an application be examined under the provisions of Section 12, the examiner would be duty-bound to apply the provisions of Section 5 and at this stage raise objections to the patentability of a pharmaceutical and agricultural chemical product. However, applications for patents for pharmaceutical and agricultural chemical products were not being referred by the Controller General of Patents, Trademarks and Designs for examination. Therefore, the question of their rejection did not arise, since that question could only arise after examination and the application of Section 5. Thus, patent applications for pharmaceutical or agricultural chemical products would not be refused and withdrawn from consideration prior to the date when such protection would become available. Once patent protection or exclusive marketing rights for pharmaceutical and agricultural chemical products must be granted in accordance with Article 70.8(c) and 70.9, a complete record going back to the date of entry into force of the WTO Agreement of all patent applications for pharmaceutical and agricultural chemical products, including the date and the sequence of the applications, would thus be available.

- Article 70.8(a) of the TRIPS Agreement created, at present, only one obligation for India in respect of pharmaceutical and agricultural chemical products, namely "to 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" (emphasis added by India). A method of filing applications for pharmaceutical and agricultural chemical products had been made available and was being used.

- WTO Members were free to determine the means by which patent applications could be filed. Article 70.8(a) required Members to provide "a means" for filing; it did not prescribe the choice of a particular method. This was explicitly recognized in Article 1.1 of the TRIPS Agreement which made clear that "Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice" (emphasis added by India). India had initially decided to provide for a means for the filing of applications through an ordinance by the President and, when this ordinance had lapsed, through administrative action by instructing the patent offices to continue to receive applications and to store them separately for future action in accordance with Article 70.8. Both the legislative and the administrative approaches were available to India under Articles 1 and 70 of the TRIPS Agreement. It was therefore not correct for the United States to claim that India must create a mailbox system in its law for the filing of patent applications (emphasis by India). WTO Members were free to determine the means by which patent applications could be filed and India was free to choose an administrative method pending the change in legislation.

- The means currently provided by India was capable of attaining the objectives of Article 70.8. The main rationale of the requirement of subparagraph (a) of Article 70.8 was to ensure that the WTO Member, when it eventually granted patents for pharmaceutical and agricultural chemical products, was able to assign a filing date to the patent for the purpose of determining the remaining patent term. Any method of filing, registration and storage of applications that enabled the Member to assign a filing date to patent applications must, therefore, be regarded as a proper means for filing within the meaning of Article 70.8.

- The number of filings submitted under this system indicated that the companies concerned did not experience or anticipate any difficulty in the matter of filing their applications. ⁵

- India had made it clear that changes to its laws were necessary to establish a mailbox system consistent with the requirements of Article 70.8. India had done so through statements and actions surrounding its issuance and notification of the Patents (Amendment) Ordinance 1994 and its attempt to get the Patents (Amendment) Bill 1995 adopted by Parliament. The text of the Patents Ordinance made it clear that the relatively automatic system for the rejection of pharmaceutical and agricultural chemical product patent applications must be modified to establish a legally defensible mailbox system. The Patents Ordinance had, temporarily, amended Section 5 of the Patents Act by the insertion of a Chapter IVA stipulating special rules for the handling of mailbox applications, which overrode the operation of Section 12 of the Patents Act and prohibited the Controller to forward mailbox applications to examiners. India thus had thought that it was necessary to modify the Indian Patents Act with respect to the handling of applications for pharmaceutical and agricultural chemical products (emphasis by the United States). The Patents Ordinance would not have been issued unless the President, presumably acting on the advice of his legal experts, had determined that it was "necessary" to take "immediate action" under Article 123 of the Indian Constitution. The importance of issuing the Ordinance and implementing its provisions in India’s laws had been restated in the context of the Indian Government’s unsuccessful attempts to get the Patents (Amendment) Bill 1995 passed by Parliament. The Indian Government had also stated in its notification of 6 March 1995 of the Patents Ordinance to the Council for TRIPS that the Ordinance had been issued "with a view to meet India’s obligations under paragraphs 8 and 9 of Article 70 of the [TRIPS] Agreement". These statements made perfectly clear that India knew it had to make amendments to the Patents Act to implement its Article 70.8 mailbox obligations, and that if it did not do so it would be out of compliance with its TRIPS obligations.

- As a result of the rejection by Parliament of the Patents (Amendment) Bill 1995, Sections 5, 12 and 15 of the Patents Act 1970 remained in force and continued to require that applications drawn to pharmaceutical and agricultural chemical products be rejected. In this case, Parliament must take action to modify this statutory system before an administrative system of the type described by India could have legal effect.

- India's claim that the Patents Act 1970 permitted it to grant special treatment to applications drawn to pharmaceutical and agricultural chemical products because such applications allegedly were different from applications drawn to other types of unpatentable subject matter listed in Section 3 of the Patents Act had no legal or regulatory basis. The process for review of applications that dealt with subject matter listed in Sections 3 and 5 was identical to the review of any other type of subject matter - once filed with the Patent Office, these applications were to be forwarded to examiners for a review of patentability. Section 15 of the Patents Act stated that an examiner shall identify unpatentable subject matter, regardless of whether it fell within the subject matter listed in Sections 3 and 5. In any event, this alleged distinction between applications drawn to different types of unpatentable subject matter was irrelevant. The matters before this Panel related only to the fact that Sections 5, 12 and 15 of the Patents Act required the Controller to forward applications drawn to pharmaceutical and agricultural chemical products to examiners and ultimately reject them for being drawn to unpatentable subject matter. Therefore, Indian law did not permit the Indian Patent Office to treat, on an ad hoc basis, one set of applications any differently; once filed with the Patent Office, applications must be forwarded to the examiners for a review of patentability. India’s attempt to claim that it was able to do so was contrary to the law, and any patents granted on applications filed under this informal, unrecognized system might be subject to legal challenge based on a claim that they were filed and processed in a manner inconsistent with the current law. In such a case, a court might find that the system for handling the applications was ultra vires and applications filed under that system could not result in the grant of a valid patent. A group of 11 patent experts convened by the Indian Government in 1994 to discuss whether India's laws must be amended to implement Article 70.8 and 70.9 had known this. They specifically had considered the option of implementing the mailbox system administratively and rejected it, finding it far too likely to invite legal challenges to any applications filed under such a system. They had concluded that amendments to the Patents Act to disable the automatic process for forwarding applications to examiners and ultimately rejecting those drawn to pharmaceutical and agricultural chemical inventions were necessary to establish a mailbox system in accordance with Article 70.8.

- India's claim that it had a mailbox system in place was called into question by the fact that it had never notified such a system to the Council for TRIPS, as required by the TRIPS Agreement. The only notification India had made to the Council for TRIPS was the notification setting forth the text of the Patents (Amendment) Ordinance 1994. This notification made it clear to all governments and potential applicants that the system established by the Ordinance created the basis for accepting mailbox applications. In other words, without this system mailbox applications would not be processed or have the legal status required by the TRIPS Agreement. India had never sent a follow-up notification to the Council for TRIPS stating that, notwithstanding the clear requirements of its law, applications for unpatentable subject matter would not be refused and would receive the status required by the TRIPS Agreement.

- India's claim that it had implemented a mailbox system was inconsistent with its obligations under Article 63 of the TRIPS Agreement to publish or make publicly available the specific terms and provisions of its system "in such manner as to enable governments and right holders to become acquainted with them" (emphasis by the United States). This claim had been made for the first time on 8 April 1997 in a confidential document that would not be circulated to WTO Members, let alone to the public. The private sector had no idea of the existence of this system and those people who, despite all indications to the contrary, had invested time and money in filing applications claiming pharmaceutical and agricultural chemical inventions, had no idea of the legal status of their applications. This could not under any criteria be considered an acceptable implementation of India’s Article 70.8 obligation, particularly in light of the transparency obligations in the TRIPS Agreement, and should create a presumption that it did not have a legally valid system in place. Article 70.8 was clear in its requirement that an open and known process be developed for accepting applications for pharmaceutical and agricultural chemical product patents and granting those applications the proper legal status. The first element of this obligation was the establishment of a system that people knew about and knew how to use. A mailbox system that was unknown to the world was useless.

- The principal purpose of the requirement to establish a mailbox system was to ensure that applications that were filed in the transitional period would not lose their novelty and, consequently, to allow mailbox applicants to preserve their ability to obtain patent protection for pharmaceutical and agricultural chemical products in a Member taking advantage of some or all of the transitional period. The benefit provided by the system was such that, when patent protection for pharmaceutical and agricultural chemical products was established, such protection would also be available to persons who had filed applications during the transitional period based on the effective filing date of their applications. To this end, Article 70.8 did not require the examination and grant of the patent at the time of application; rather it required that a system be established to ensure that effective filing dates were granted in anticipation of the future benefit of eligibility for product patent protection based on those dates. A mailbox applicant must have the assurance that the application would lead to the grant of a patent if the conditions foreseen in paragraphs (b) and (c) of Article 70.8 were met (emphasis by the United States). In the case of India, which had indicated its intent to take advantage of the entire transitional period, this future benefit of the mailbox system would not be available to applicants until 2005. Once a filing date had been granted and applications were given the required legal status, the applicants would be able to factor this status into their operations and business decisions.

- The mailbox system, therefore, had a rationale common to many other WTO obligations, "namely to protect expectations of the contracting parties as to the competitive relationship between their products and those of other contracting parties". ⁶ The Superfund report had established clearly the importance of "creat[ing] the predictability needed to plan future trade". ⁷ Applicants must be able to anchor, during the transitional period, their right to receive a patent at the end of the transitional period so that they could plan their business operations accordingly (e.g., where to invest, where to move operations, whom to hire, which distribution networks to establish, etc.). As regards how applicants could make informed business decisions based on the right to seek a patent in the future, it should be borne in mind that, if the particular application proved unpatentable in other WTO Members during the transitional period, then this right might not be of much value, but that, on the contrary, if an application proved to be patentable everywhere else, then it would presumably be patentable in India at the end of the transitional period; thus, the current right to seek patent protection based on the appropriate filing date was of great strategic and commercial value to applicants. Article 70.8 established the expectation that through the grant of this legal status to their applications, applicants would be able to establish their competitive position in the country at issue and factor this competitive position into their business plans.

- Despite India’s claim that it had decided for the moment not to enforce the mandatory provisions of Sections 5, 12 and 15 of the Patents Act 1970 (which claim was unknown to other governments and the public), that "measure continues to be mandatory legislation which may influence the decisions of economic operators" ⁸. The economic operators in the present case - potential patent applicants - had no confidence that a valid mailbox system had been established, and thus would not file mailbox-eligible applications in India. To paraphrase the Beer II panel, a non-enforcement of a mandatory law that violated a WTO obligation did not ensure that the obligation was not being broken ⁹. Here, Sections 5, 12 and 15 mandated that applications for pharmaceutical and agricultural chemical product patents be forwarded to examiners, determined to be drawn to unpatentable subject matter, and rejected. Because India had failed to establish a fully functional mailbox system that granted mailbox applications the legal status required by the TRIPS Agreement as of their priority filing date, large numbers of applications that would have been filed were currently being withheld until India established such a system. Although India would not be obligated to grant patents on such applications meeting the criteria for patentability set out in Article 27 of the TRIPS Agreement as of their appropriate filing date until the end of the transitional period, it would not be sufficient that the legal changes necessary to provide an assurance of patentability were made at the end of the transitional period. Applicants must be given the legal assurance of a current right to the conditional future benefit that they would be able to seek patent protection on the basis of those criteria as of 1 January 1995, allowing them to plan their business operations accordingly as of that time. If a valid mailbox system were established today and an applicant who would have filed in July 1995 did so tomorrow and was assigned its July 1995 filing date, that applicant would be granted the right it must have under the TRIPS Agreement, but would have lost almost two years of shaping its business plan with the knowledge that it had an application with the legal status required by Article 70.8.

- In light of India's clear violation of the mailbox provisions of the TRIPS Agreement, a showing of actual damage was not a prerequisite to a finding that India's failure to establish a TRIPS-consistent mailbox system was nullifying or impairing benefits under the TRIPS Agreement. Article 3.8 of the DSU provided that, where there was a violation of the obligations under a covered agreement, the action was considered prima facie to constitute a case of nullification or impairment. In any event, during 1995 and 1996 the United States Patent and Trademark Office had received over 50,000 such applications ¹⁰.

- Under India’s legal system there was more than one method by which it could satisfy its obligations under Article 70.8 of the TRIPS Agreement. This could be done by statute, subordinate legislation, such as rules or regulations, and even by administrative instructions and practice. Initially, India had chosen the legislative route to provide a means for receiving applications for pharmaceutical and agricultural chemical products and according priority to them. At present, India administratively continued to receive applications for pharmaceutical and agricultural chemical products and was deferring their examination. Such an administrative decision was permissible under Article 73(1)(a) of the Indian Constitution which provided that "the executive power of the Union shall extend to the matters to which Parliament has the power to make law". Under this constitutional provision, the Executive could act administratively in cases in which Parliament had legislative competence. In the case of providing the necessary "means" under Article 70.8 of the TRIPS Agreement, the relevant legislative power would be Entry 49 of List I or List III of the Seventh Schedule to the Constitution which read "Patents, inventions and designs; copyright; trade marks and merchandise marks". In this connection, two Supreme Court opinions showed that administrative action was an available method for the Executive, namely J.R. Raghupathy vs State of Andra Pradesh and Union of India vs H.R. Patankar and Others ¹¹.

- Advancing evidence of the decision not to take up the applications for examination until 1 January 2005, India referred to a question that had been asked in Parliament about the action taken or proposed to be taken in respect of applications for pharmaceutical and agricultural chemical products (Unstarred Question No. 2601 asked by a Member of Parliament (Lok Sabha)) and the reply given by the Government in Parliament on 2 August 1996 that "the applications for patent will be taken up for examination after 1 January 2005 as per the WTO Agreement which had come into force on 1 January 1995" ¹².

- There was no requirement that Parliament should recognize an administrative practice unless explicitly required by the Constitution or statute.

- With regard to the claim of the United States with respect to Article 123 of the Constitution, India stated that Article 123 was intended to enable legislation even when Parliament (either House or both Houses) was not in session. Therefore, the determination that the President was required to make under Article 123 was that it was necessary to take immediate action to promulgate an Ordinance despite Parliament not being in session and not that legislation was the only means of satisfying a particular obligation (emphasis by India).

- Article 70.8 merely stated that a means of filing must be provided. It did not state that it must be made "clear to the public" through "press releases or international news reports". Article 70.8 merely stipulated that Members provide a means by which applications could be filed and that "to provide" means "to supply for use"; it did not mean "make known to the world". The usefulness of a means of filing did not depend on it being made "known to the world"; it was sufficient that individual companies that wished to submit an application could obtain the necessary information from the relevant authorities. The fact that as many United States' companies as could be expected on the basis of past trends had in fact filed applications under the means provided by India underscored this point.

- Article 70.8 did not state that the means of filing provided must be notified to the WTO. Besides, it should be stressed that India was continuing to apply the same means of filing that it had initially provided by virtue of the Ordinance and which had been given publicity and notified to the WTO. The transparency obligations were set out in Article 63, not in Article 70.8; moreover, these obligations related in this case to the Patents Act of 1970, which had been published, and not to the administrative arrangements made under that Act. In any event, as noted above, as a practical matter, adequate publicity had been given to the means of filing which had initially been provided by India and subsequently continued administratively.

The terms of the TRIPS Agreement

- India maintained its argument that WTO Members were free to determine the means by which patent applications could be filed and that Article 70.8(a) required Members to provide "a means" for filing without prescribing the choice of a particular method. In this context, it also reiterated that Indian law did not require a change in law to implement these obligations and reiterated that the transparency obligations in the TRIPS Agreement could not be found in Article 70.8 but in Article 63.

Context

- Subparagraph (a) of Article 70.8 must be read in conjunction with subparagraphs (b) and (c) of that provision and the transitional arrangements set out in Article 65. Subparagraph (a) of Article 70.8 obliged Members to provide a means of filing, i.e. the first step in a procedure leading to the grant of patent protection "as from the date of entry into force of the WTO Agreement", i.e. 1 January 1995. The obligation to apply the TRIPS Agreement’s criteria of patentability and to provide patent protection when those criteria were met arose only "as of the date of application of this Agreement" (subparagraphs (b) and (c)). This date was defined in Article 65. Paragraph 4 of that Article made it clear that the relevant date of application in India of the provisions on product patents in respect of pharmaceutical and agricultural chemical products was 1 January 2005. Article 70.8 thus established two different obligations that became effective on two different dates: the obligation to provide a means of filing on 1 January 1995 and the obligation to accord patent protection on 1 January 2005. Given this context, subparagraph (a) of Article 70.8 could not be interpreted to establish already now the obligation to provide for the grant of patents in the year 2005. To give this interpretation to subparagraph (a) would effectively turn an obligation that arose at the end of a transitional period into a current obligation. The rationale of Articles 65 and 70 was clearly to permit developing country Members to postpone changes in their law that other Members were required to make under Article 27 of the TRIPS Agreement. It would be inconsistent with that rationale if Article 70.8(a) were interpreted to require the establishment of a procedure that would lead to the granting of a patent (emphasis by India). The consequence of such an interpretation would be that developing country Members would have to change their law to provide for the patentability of pharmaceutical and agricultural chemical products before having to grant patentability to other products (emphasis by India) - a consequence completely at odds with the purpose of Article 65.4 which was designed to extend for these products the period of transition beyond the normal five-year period.

- The fundamental purpose of the transitional arrangements was to enable developing countries to accept the WTO Agreement without having to change their patent law at the same time. There had been a recognition among the negotiators of the TRIPS Agreement of the fact that many developing countries still needed more time to build the domestic consensus necessary to accord patent protection, in particular for products where patentability was perceived to have certain adverse implications. The United States’ complaint was an attempt to eliminate this function of the transitional arrangements of the TRIPS Agreement. During the first five years of the TRIPS Agreement, during which developing countries expected to be free from the need to make any legislative change, they thus would have to make such changes in the most sensitive area (emphasis by India). The United States’ interpretation of Articles 70.8 and 70.9, therefore, effectively turned transitional arrangements designed to create a special benefit in respect of pharmaceutical and agricultural chemical products into a source of an additional burden. To the knowledge of India, no developing country had acted under Article 70 on the basis of the interpretations proposed by the United States. Examination of the notifications submitted to the TRIPS Council under Article 63.2 of the TRIPS Agreement relating to Article 70.8 showed that not one of these notifications provided for a procedure to be established under which patents for pharmaceutical and agricultural chemical products would be made available as from 2005.

- Regarding the jurisprudence of the CONTRACTING PARTIES to GATT 1947 under which certain basic obligations under GATT, such as the national treatment obligation under its Article III and the general prohibition of quantitative restrictions under its Article XI, had been interpreted as obligations "protecting expectations" of Members as to the "competitive relationship" between their products and those of other Members and that a measure could therefore be inconsistent with these provisions even if it had not yet had a trade effect, India would not suggest that the Panel apply a different principle to the basic obligations set out in the TRIPS Agreement. However, it argued that, under the transitional arrangements of the TRIPS Agreement, the date of application of the provision to which the principle developed by the CONTRACTING PARTIES could be applied in this case, i.e. Article 27 of the TRIPS Agreement, had not yet arrived.

- It would have far-reaching implications if - for the sake of creating predictable conditions of competition - the many arrangements under the WTO agreements were interpreted to entail the immediate obligation to empower the executive authorities to carry out the obligations that would have to be observed at the end of the transitional period. To give a specific example, the Agreement on Textiles and Clothing permitted the maintenance of restrictions during a transitional period. Did that Agreement imply the obligation to change any domestic law mandatorily prescribing these restrictions? A provision creating the obligation to establish certain conditions of competition as from a specified date or as from the occurrence of a certain event could not be interpreted as entailing the obligation to provide for such conditions of competition in the domestic law in advance of that date or event. The CONTRACTING PARTIES to GATT 1947 had never used the concept of conditions of competition to advance the effective date of application of an obligation.

Object and purpose

- The purpose of subparagraph (a) of Article 70.8 emerged clearly from subparagraphs (b) and (c) of that provision and Article 70.9. According to subparagraphs (b) and (c), developing country Members must grant patents to pharmaceutical and agricultural chemical products for a period of at least 20 years "counted from the filing date" as if the criteria for patentability laid down in the TRIPS Agreement were being applied on "the date of filing". Furthermore, according to Article 70.9 only products for which a patent application had been filed in accordance with Article 70.8(a) were eligible for the grant of exclusive marketing rights. The purpose of subparagraph (a) was thus not to create a procedure ensuring that pharmaceutical and agricultural chemical products would become patentable or would be given exclusive marketing rights, but rather to ensure that each patent applicant obtained a date of filing on the basis of which patent protection could be granted as from the date on which Article 27 applied and that exclusive marketing rights could be granted to products at the point at which they were eligible for such rights (emphasis by India).

- The only evidence that India could muster to show that it had made a public decision to establish an administrative mailbox system was a question and answer in the Lok Sabha that apparently had taken place on 2 August 1996. However, it was interesting to note that the answer to the question: (a) did not state that the applications that had been filed had been granted the proper legal status; (b) had apparently never been made known to the public (let alone notified to other WTO Members through the Council for TRIPS); and (c) was of no apparent legal effect.

- The opinions provided by India clarified that amendments to the Patents Act were necessary to establish a mailbox system. They did not support India's assertion that it could create a mailbox system through administrative guidance. In Union of India vs. H.R. Patankar and Others, the Supreme Court had held that "if there are no statutory rules in force.... or even if there are statutory rules but they are silent on any particular subject, it is competent to the Government [to make appropriate rules] to fill in the lacuna in the statutory rules" ¹³. Rather than an instance of statutory silence or a gap in statutory rules, the present case concerned a specific statutory provision that directed the Controller to forward applications to the examiners, where applications drawn to pharmaceutical or agricultural chemical products would be identified as being drawn to unpatentable subject matter and ultimately rejected. By implication, Union of India stood for the proposition that the Government was not authorized to issue administrative guidance that was contrary to the letter of the law. In J.R. Raghupathy vs. State of A.P., the Supreme Court had addressed the issue of the ability of the High Court to review the Government's exercise of discretion conferred upon it, even when that exercise of discretion was contrary to its own guidelines. Citing prior authorities, the Court had held that administrative guidelines had no statutory force and conferred no right on any citizen to complain that they were not being met ¹⁴. Thus, even if India had issued instructions to its Controller to ignore the mandatory nature of Article 12(1) of the Patents Act 1970, which the United States doubted, those instructions would have no legal effect and a court would be unable to compel the Patent Office to follow them. The J.R. Raghupathy case also stood for the proposition that, where a statute was to be implemented by a designated authority, Parliament "must have assumed that the designated authority would act properly and responsibly, with a view to doing what was best in the public interest and most consistent with the policy of the statute" ¹⁵. This language did not provide any support for the Indian Government's assertion that it was permitted to act administratively in a manner that thwarted or circumvented clear and direct statutory instruction to take a particular action. As a result, the Indian patent experts referred to earlier had been correct in their conclusion that the Patents Act 1970 must be amended if India was to fully implement the mailbox obligations under Article 70.8 of the TRIPS Agreement.

- The written answer from the Government to Unstarred Question No. 2601 in the Lok Sabha on 2 August 1996 put beyond any doubt that the applications received had a proper legal status. The Government had stated in this written answer that until 15 July 1996 as many as 893 applications had been received from Indian as well as foreign companies in the fields of drugs and medicine. It had further been stated that these applications would be taken up for examination after 1 January 2005 as per the WTO Agreement which had come into force on 1 January 1995. It was to be borne in mind that the Indian legal system was based upon common law systems and that any statement, more particularly written statement, made in any House of the central legislature, by the Minister who was an authorized functionary of the Government, put that Government under the obligation of the common law doctrine of "estoppel", in the sense that the Government at no stage could perform any act in contravention of the position already taken under that statement.

- As regards the United States' assertion that the answer to Unstarred Question No. 2601 had apparently never been made known to the public, all answers to questions put by Members of Parliament were given in writing and were laid on the table of the relevant House and circulated amongst all Members of that House. The national and international electronic, print and other media had open access to the answers given in the House and widely reported them. Questions and answers given were reported in the Reporters published by the secretariat of the respective House and formed a permanent printed record which was accessible to the public.

- Regarding the United States' assertions based on the two Indian Supreme Court opinions, India stated that it was a settled proposition in Indian law that the executive power of the central government under Article 73 was co-extensive with the legislative power of the Parliament. In other words, it extended over the whole of the territory of India with respect to the matters enumerated in List I (including Entry 49 "Patents, inventions and designs; copyright, trademarks and merchandise marks") and List III of the Seventh Schedule to the Indian Constitution. In J.R. Raghupathy vs State of Andra Pradesh, the Supreme Court had stated that the executive powers of the Union under Article 73 were much wider than the prerogative powers in England. The provisions of Article 73 of the Constitution as interpreted in Union of India vs H.R. Patankar and Others and J.R Raghupathy vs State of Andra Pradesh were in the nature of support mechanisms for the legislative provisions in the Patents Act 1970 which formed the basis for the current filing system. The United States had quoted the J.R.Raghupathy opinion out of context. The essence of the Supreme Court opinion was that if there were certain deviations from the guidelines set for in-house management of the government departments, the courts did not need to interfere. However, where administrative instructions impinged upon the rights of persons, there was no way out and the courts were bound to come into active play. The explicit position taken by the Supreme Court in Union of India vs H.R. Patankar made it clear that even if there were any statutory rules, but they were silent on any particular subject, the Government was competent to fill in the lacunae in the statutory rules.