TRIPS

TRIPS protects persons, not products. The obligation runs to the nationals of other Members, which distinguishes it from GATT, where the obligation runs to products.

Article 2(1), the incorporation. In respect of Parts II, III and IV, Members shall comply with articles 1 through 12, and article 19, of the Paris Convention (1967). Article 2(2) provides that nothing in Parts I to IV shall derogate from existing obligations under the Paris, Berne and Rome Conventions and the IPIC Treaty.

So TRIPS incorporates the older conventions rather than replacing them, and a Member that never joined the Paris Convention is nevertheless bound by most of its substance through article 2(1). That technique is sometimes called Paris-plus and Berne-plus.

Article 3, national treatment. Each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection of intellectual property, subject to the exceptions already provided in the Paris, Berne and Rome Conventions and the IPIC Treaty.

Article 3(2) confines the use of those exceptions in judicial and administrative procedures, including requirements of an address for service or a local agent, to cases where they are necessary to secure compliance with laws and regulations which are not inconsistent with the Agreement and are not applied in a manner which would constitute a disguised restriction on trade.

Article 4, most-favoured-nation treatment. With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members.

This is the first general most-favoured-nation obligation in intellectual property, and it did not exist in the Paris or Berne Conventions. Its exceptions are listed: advantages deriving from agreements on judicial assistance or law enforcement of a general nature not particularly confined to intellectual property; those granted under provisions of the Berne or Rome Conventions making treatment a function of the treatment accorded in another country rather than of national treatment; those in respect of rights of performers, producers of phonograms and broadcasting organisations not provided under this Agreement; and those deriving from agreements which entered into force before the WTO Agreement, provided they are notified to the Council for TRIPS and do not constitute an arbitrary or unjustifiable discrimination against nationals of other Members.

Article 6, exhaustion. For the purposes of dispute settlement, and subject to articles 3 and 4, nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.

Article 6 is a deliberate silence, and an important one. Exhaustion decides whether a rights holder who has sold a product may prevent its resale, including its importation from another country, which is the question of parallel imports. TRIPS leaves each Member free to adopt national, regional or international exhaustion, and that freedom is what permits a Member to allow parallel importation of patented medicines.

Article 7, objectives. The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Article 8, principles. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided such measures are consistent with the provisions of this Agreement; and appropriate measures may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology, again provided they are consistent.

Articles 7 and 8 are the interpretive counterweight to the whole instrument, and they matter because article 31(1) of the Vienna Convention requires a treaty to be read in the light of its object and purpose. A Member defending a public health measure argues from article 8(1) read with article 7, and the qualification, provided such measures are consistent with the Agreement, is what the argument turns on.

Patents: articles 27 to 34

This is the section MU is most likely to examine, because it is the section that changed Indian law.

Article 27(1), patentable subject matter. Patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. And patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

Every phrase in article 27(1) was a change for some Member.

Products as well as processes. Many States, India among them, granted only process patents for medicines and food, so that a competitor could make the same substance by a different process. Article 27(1) ended that.

In all fields of technology. A Member may not exclude pharmaceuticals, or agriculture, or any other field, as a class.

Without discrimination as to whether products are imported or locally produced, which restricts requirements of local working.

Article 27(2), the ordre public exclusion. Members may exclude inventions the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided the exclusion is not made merely because the exploitation is prohibited by their law.

Article 27(3), the permitted exclusions. Members may also exclude (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; and (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes; but Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

The sui generis option in article 27(3)(b) is the basis of India's Protection of Plant Varieties and Farmers' Rights Act 2001, which protects varieties outside the patent system and recognises farmers' rights, and it is the clearest example of a flexibility being used.

Article 28, rights conferred. For a product patent, the exclusive right to prevent third parties without consent from making, using, offering for sale, selling, or importing the product. For a process patent, the right to prevent the use of the process, and the using, offering for sale, selling or importing of at least the product obtained directly by that process.

Article 30, exceptions. Members may provide limited exceptions to the exclusive rights, provided they do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Article 30 is a three-step test, and it is the basis of the research exemption and of the regulatory review exception allowing a generic manufacturer to prepare an application for marketing approval before the patent expires.

Article 31, other use without authorisation of the right holder. Where a Member's law allows such use, including use by the government or third parties authorized by the government, the article lists the conditions to be respected, and the ones to know are these.

(a) Authorisation shall be considered on its individual merits, so no blanket licences.

(b) Such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and such efforts have not been successful within a reasonable period of time. That requirement may be waived in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, and in an emergency the right holder must still be notified as soon as reasonably practicable.

(c) The scope and duration shall be limited to the purpose for which it was authorized.

The remaining subparagraphs require the use to be non-exclusive, non-assignable except with the enterprise, predominantly for the supply of the domestic market, terminable when the circumstances cease, subject to adequate remuneration to the right holder taking account of the economic value of the authorisation, and subject to judicial or other independent review.

This is compulsory licensing, and the term itself is not in the article. The heading is other use without authorization of the right holder, and a good answer uses the Agreement's own language.

Article 33, term. The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date.

Article 34 reverses the burden of proof in process patent infringement in defined circumstances.

The other categories of right: articles 9 to 40

MU names TRIPS, not intellectual property law, so the remaining sections of Part II are set out compactly. Each follows the same pattern: a definition of the protectable subject matter, the rights conferred, exceptions, and a minimum term.

Copyright and related rights, articles 9 to 14. Members comply with articles 1 to 21 of the Berne Convention (1971) and its Appendix, with no rights or obligations in respect of the moral rights conferred by Berne article 6bis. Article 10 requires computer programs to be protected as literary works, and protects compilations of data which by reason of the selection or arrangement of their contents constitute intellectual creations, without extending to the data itself. Article 11 gives rental rights in respect of computer programs and cinematographic works. Article 12 sets a term, where calculated other than on the life of a natural person, of no less than fifty years from authorised publication or from making. Article 13, the three-step test: Members shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder. Article 14 protects performers, producers of phonograms and broadcasting organizations, with a term of fifty years for performers and producers and twenty years for broadcasters.

Article 13 is the copyright counterpart of article 30 for patents, and both are three-step tests. A student who can state one can state the other.

Trademarks, articles 15 to 21. Article 15 makes protectable any sign, or combination of signs, capable of distinguishing the goods or services of one undertaking from those of others. Article 16 gives the owner of a registered mark the exclusive right to prevent all third parties not having his consent from using in the course of trade identical or similar signs for identical or similar goods or services where such use would result in a likelihood of confusion, with confusion presumed where an identical sign is used for identical goods, and extends protection to well-known marks. Article 17 permits limited exceptions, such as fair use of descriptive terms, taking account of the legitimate interests of the owner and of third parties. Article 18: initial registration and each renewal for no less than seven years, renewable indefinitely. Article 19: cancellation for non-use only after an uninterrupted period of at least three years, unless valid reasons based on obstacles to use are shown. Article 20: use shall not be unjustifiably encumbered by special requirements, such as use with another trademark or in a special form. Article 21: Members may determine conditions on licensing and assignment, and compulsory licensing of trademarks shall not be permitted.

Geographical indications, articles 22 to 24. Article 22(1) defines them as indications which identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin, and requires legal means to prevent indications that mislead the public or constitute unfair competition. Article 23 gives additional protection for wines and spirits, prohibiting use of a geographical indication for wines or spirits not originating in the place indicated even where the true origin is indicated or the indication is accompanied by expressions such as kind, type, style or imitation. Article 24 provides for international negotiations and a series of exceptions, including continued prior use and terms that have become generic.

Article 23's two-tier structure is the standing grievance of Members whose products are not wine or spirits, and India is among the Members that have pressed for the higher protection to be extended to other goods.

Industrial designs, articles 25 and 26. Article 25 requires protection for independently created industrial designs that are new or original, with special provision permitting Members to meet the requirements for textile designs through industrial design or copyright law. Article 26 gives the owner the right to prevent third parties from making, selling or importing articles bearing or embodying a design which is a copy, or substantially a copy, of the protected design, when such acts are undertaken for commercial purposes, with limited exceptions on the familiar test, and a duration of at least ten years.

Layout-designs of integrated circuits, articles 35 to 38. Article 35 requires protection in accordance with the specified provisions of the Treaty on Intellectual Property in Respect of Integrated Circuits. Article 36 makes unlawful, without authorisation, the importing, selling or otherwise distributing for commercial purposes a protected layout-design, an integrated circuit incorporating it, or an article incorporating such a circuit. Article 37 protects the innocent infringer, who did not know and had no reasonable ground to know that the article incorporated an unlawfully reproduced layout-design, requiring only equitable remuneration for stock on hand after notice, and applies article 31 mutatis mutandis to compulsory licences. Article 38 sets a term of at least ten years.

Undisclosed information, article 39. In the course of ensuring effective protection against unfair competition under article 10bis of the Paris Convention (1967), Members shall protect undisclosed information and data submitted to governments. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices, so long as it is secret, has commercial value because it is secret, and has been the subject of reasonable steps to keep it secret. And where a Member requires the submission of undisclosed test or other data whose origination involves considerable effort as a condition of approving pharmaceutical or agricultural chemical products using new chemical entities, it shall protect such data against unfair commercial use and against disclosure, except where necessary to protect the public or where steps are taken to ensure protection against unfair commercial use.

Article 40, anti-competitive practices in licences. Members agree that some licensing practices or conditions pertaining to intellectual property rights which restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology, and nothing in the Agreement prevents a Member from specifying in its legislation licensing practices or conditions that may in particular cases constitute an abuse having an adverse effect on competition and adopting appropriate measures to prevent or control them, consistently with the Agreement. The article provides for consultations between Members on such practices.

Article 40 belongs with article 8(2), and together they are the Agreement's competition provisions: a rights holder's licence may be an abuse, and a Member may legislate against it.

Enforcement, disputes and transition

Part III, articles 41 to 61. Members shall ensure that enforcement procedures are available under their law so as to permit effective action against any act of infringement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements, applied so as to avoid the creation of barriers to legitimate trade and to provide safeguards against their abuse. The Part covers fair and equitable procedures, evidence, injunctions, damages, provisional measures, border measures to stop counterfeit and pirated goods at customs, and criminal procedures at least for wilful trademark counterfeiting or copyright piracy on a commercial scale.

Article 41(5) is the limit States insisted on. Nothing in Part III creates any obligation to put in place a judicial system for the enforcement of intellectual property rights distinct from that for the enforcement of law in general, nor affects the capacity of Members to enforce their law in general, and nothing creates any obligation with respect to the distribution of resources as between enforcement of intellectual property rights and the enforcement of law in general.

Part V, articles 63 and 64. Transparency, requiring publication of laws and regulations and notification to the Council for TRIPS; and dispute settlement, applying the Dispute Settlement Understanding.

Article 65, transitional arrangements. No Member was obliged to apply the Agreement before one year after the entry into force of the WTO Agreement. A developing country Member was entitled to delay a further four years, except for articles 3, 4 and 5. And where a developing country Member was obliged to extend product patent protection to areas of technology not so protectable in its territory, it could delay the product patent provisions for those areas for an additional five years. Article 65(5) contains the non-backsliding rule: changes made during a transitional period must not result in a lesser degree of consistency with the Agreement.

Article 66, least-developed country Members. They shall not be required to apply the provisions, other than articles 3, 4 and 5, for a period of 10 years from the date of application under article 65(1), and the Council for TRIPS shall, upon duly motivated request, accord extensions, which it has repeatedly done. Article 66(2) requires developed country Members to provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members.

Article 70(8) and (9), the mailbox provisions, required a Member using the article 65(4) delay to provide a means for filing product patent applications in the meantime, and to grant exclusive marketing rights in defined circumstances.

Article 62, acquisition and maintenance of rights. Members may require compliance with reasonable procedures and formalities as a condition of acquiring or maintaining the rights provided for in Sections 2 to 6 of Part II, consistent with the Agreement; where acquisition depends on grant or registration, the procedures shall permit the granting or registration within a reasonable period of time so as to avoid unwarranted curtailment of the period of protection; and administrative decisions shall be subject to review by a judicial or quasi-judicial authority.

Articles 67 to 69, cooperation. Article 67 requires developed country Members, on request and on mutually agreed terms and conditions, to provide technical and financial cooperation in favour of developing and least-developed country Members, including assistance in the preparation of laws and in the establishment of domestic offices. Article 68 establishes the Council for TRIPS, which monitors the operation of the Agreement and Members' compliance, affords Members the opportunity of consulting on trade-related aspects of intellectual property, and carries out the responsibilities assigned to it. Article 69 requires Members to establish and notify contact points and to cooperate with a view to the elimination of international trade in goods infringing intellectual property rights.

Article 71, review and amendment. The Council for TRIPS shall review the implementation of the Agreement after the expiration of the transitional period in article 65(2), and again two years after that date and at identical intervals thereafter, and may review in the light of any relevant new developments warranting modification or amendment. Amendments merely adjusting to higher levels of protection achieved and in force in other multilateral agreements, and accepted by all Members, may be referred to the Ministerial Conference under article X(6) of the Marrakesh Agreement.

Article 72, reservations. Reservations may not be entered in respect of any of the provisions of this Agreement without the consent of the other Members. Compare article XVI(5) of the Marrakesh Agreement, which forbids reservations to that Agreement outright, and [Reservations to Treaties], where the default is freedom.

Article 73, security exceptions. Nothing in the Agreement shall be construed to require a Member to furnish information the disclosure of which it considers contrary to its essential security interests, or to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests relating to fissionable materials, to traffic in arms and in implements of war, or taken in time of war or other emergency in international relations, or to prevent action in pursuance of obligations under the Charter of the United Nations for the maintenance of international peace and security.

Note the words it considers. Article 73 is drafted in the self-judging form, unlike article XX of GATT in [General Principles of International Trade Law], which is not, and that difference of a few words is the difference between a reviewable exception and a nearly unreviewable one.

The Doha Declaration and access to medicines

The Ministerial Conference adopted the Declaration on the TRIPS Agreement and Public Health on 14 November 2001, and its content should be stated accurately because it is frequently overstated.

What it did. It affirmed that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all; that each Member has the right to grant compulsory licences and the freedom to determine the grounds on which they are granted; the right to determine what constitutes a national emergency or other circumstances of extreme urgency, public health crises including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics being capable of representing such circumstances; and the freedom to establish its own regime for exhaustion without challenge, subject to articles 3 and 4. It also extended the transition period for least-developed country Members in respect of pharmaceutical products.

What it did not do. It did not amend the Agreement, and it did not create any new right. Its legal character is that of a ministerial declaration, which is relevant to interpretation, and the freedoms it affirms are the ones articles 6, 8, 30 and 31 already contained.

The unfinished business it identified, in its paragraph on Members with insufficient or no manufacturing capacity in the pharmaceutical sector, was answered later by a mechanism permitting export under compulsory licence, since article 31(f) confines such use predominantly to the domestic market and a country without factories cannot benefit from a domestic licence.

What TRIPS did to Indian law

India's Patents Act 1970 granted only process patents for food, medicines and drugs, and short terms for them, which is why the Indian generic pharmaceutical industry grew as it did.

Article 27(1) required product patents in all fields of technology. India used the transitional periods in article 65, and amended the Act in 1999, 2002 and 2005, the 2005 amendment introducing product patents for pharmaceuticals, with the mailbox and exclusive marketing rights arrangements in the interim under article 70.

The flexibilities India used, and each has an article behind it. Compulsory licensing provisions in the Act rest on article 31; the exclusion of methods of treatment and of plants and animals rests on article 27(3); the Protection of Plant Varieties and Farmers' Rights Act 2001 is the sui generis system article 27(3)(b) permits; and a strict test of what counts as an invention, so that a new form of a known substance is not patentable unless it differs significantly in efficacy, is India's use of the freedom left by article 27(1)'s requirement of an inventive step, since the Agreement does not define that term.

State the last point carefully. TRIPS requires patents for inventions that are new, involve an inventive step and are capable of industrial application, and it does not define those criteria, so a Member setting a demanding standard is exercising a freedom the Agreement leaves rather than departing from it.

A worked example

Member AA, a developing country, grants patents only for processes in pharmaceuticals. It refuses a patent to a company from Member BB for a new medicine. It gives companies from Member CC an advantage in registering trademarks under a bilateral treaty concluded in 2010. Faced with an epidemic, it authorises a domestic firm to make a patented medicine without asking the patent holder, and permits the import of the same medicine sold more cheaply abroad.

The process-only regime. Article 27(1) requires patents for inventions whether products or processes, in all fields of technology, so a pharmaceutical exclusion is a breach unless a transitional period under article 65 still runs. The transitional periods have long expired.

The trademark advantage for Member CC. Article 4 requires any advantage granted to the nationals of any other country to be accorded immediately and unconditionally to the nationals of all other Members. The exception for pre-existing agreements covers only those in force before the entry into force of the WTO Agreement, and 2010 is far too late.

The authorisation to make the medicine. Article 31 permits other use without authorisation on its conditions. Prior efforts to obtain authorisation on reasonable commercial terms are ordinarily required, but that requirement may be waived in the case of a national emergency or other circumstances of extreme urgency, and the Doha Declaration affirms that each Member has the right to determine what constitutes such circumstances, public health crises being capable of representing them. The right holder must still be notified as soon as reasonably practicable, the use must be non-exclusive, limited in scope and duration, predominantly for the supply of the domestic market, and subject to adequate remuneration and to independent review.

The parallel import. Article 6 provides that, subject to articles 3 and 4, nothing in the Agreement shall be used to address exhaustion in dispute settlement, so Member AA is free to adopt international exhaustion and permit parallel importation.

Change one fact: Member AA has no pharmaceutical factories. A domestic compulsory licence is then useless to it, because article 31(f) confines such use predominantly to the domestic market of the licensing Member. That is the gap the Doha Declaration identified and a later mechanism addressed by permitting export under compulsory licence.

Distinctions table

What it does NOT mean

TRIPS is not optional. It is Annex 1C and binding on all Members under article II(2) of the Marrakesh Agreement.

It does not replace the Paris and Berne Conventions. Article 2 incorporates and preserves them.

It is not a ceiling. Article 1(1) permits more extensive protection consistent with the Agreement.

It does not prescribe how to implement. Article 1(1) leaves the method to each legal system.

It does not settle exhaustion. Article 6 removes the question from dispute settlement.

Compulsory licensing is not forbidden. Article 31 regulates it and the Doha Declaration affirms the freedom to determine the grounds.

The Doha Declaration did not amend TRIPS. It is a ministerial declaration relevant to interpretation.

Limits and criticism

The bargain is contested to this day. TRIPS was accepted as part of the single undertaking, and the criticism from developing States is that they gave up a permanent capacity to make cheap medicines and technology in exchange for market access concessions that were partly reversed by later measures.

The flexibilities are legally available and practically hard to use. Article 31 imposes a list of conditions, adequate remuneration is undefined, article 31(f) confines the supply to the domestic market, and a Member that grants a compulsory licence faces pressure that has nothing to do with the Agreement, which is why the provisions are used far less than they might be.

Articles 7 and 8 are drafted so as to be almost impossible to breach. Both are qualified by consistency with the Agreement, so a measure that would otherwise be inconsistent is not saved by them, and their real work is confined to interpretation under article 31(1) of the Vienna Convention.

One standard for very unequal Members. The minimum standards are the same for every Member whatever its level of development, subject only to transitional periods that have expired for all but the least-developed, which is the central objection to the design: the same rule for a country with laboratories and a country without.

Quick revision

Annex 1C to the Marrakesh Agreement, binding on all Members under article II(2), enforceable through the Dispute Settlement Understanding. Brought intellectual property from the WIPO conventions into a system with teeth.

Article 1: give effect; a floor and not a ceiling; method of implementation free. Article 2: comply with Paris articles 1 to 12 and 19; no derogation from Paris, Berne, Rome, IPIC. Article 3: national treatment for nationals. Article 4: most-favoured-nation, immediately and unconditionally, with four listed exceptions. Article 6: exhaustion outside dispute settlement.

Article 7, objectives: promotion of technological innovation and transfer and dissemination of technology, to the mutual advantage of producers and users, conducive to social and economic welfare and to a balance of rights and obligations. Article 8, principles: measures necessary to protect public health and nutrition and to promote the public interest, and to prevent abuse of rights, provided they are consistent with the Agreement.

Article 27: patents for any inventions, products or processes, in all fields of technology, if new, involving an inventive step and capable of industrial application, and without discrimination as to place of invention, field of technology or whether imported or locally produced; 27(2) ordre public or morality; 27(3) methods of treatment, and plants and animals other than micro-organisms, with plant varieties by patents, an effective sui generis system, or a combination.

Article 28: exclusive rights to prevent making, using, offering for sale, selling, importing. Article 30: limited exceptions not unreasonably conflicting with normal exploitation nor unreasonably prejudicing legitimate interests. Article 31: other use without authorisation, on individual merits, after efforts to obtain authorization on reasonable commercial terms, waivable in national emergency, extreme urgency or public non-commercial use, non-exclusive, predominantly for the domestic market, with adequate remuneration and independent review. Article 33: twenty years from the filing date.

Part III: effective enforcement, including provisional and border measures and criminal procedures for wilful trademark counterfeiting or copyright piracy on a commercial scale; article 41(5), no obligation to build a separate judicial system or to shift resources.

Article 65: one year, plus four for developing countries, plus five more for product patents in new fields; no backsliding. Article 66: ten years for least-developed Members, extendable, plus technology transfer incentives.

Doha Declaration, 14 November 2001: TRIPS can and should be interpreted and implemented in a manner supportive of the right to protect public health and promote access to medicines for all; freedom to determine the grounds for compulsory licences and what constitutes a national emergency; freedom on exhaustion. It did not amend the Agreement.

India: process patents only under the Patents Act 1970; amendments in 1999, 2002 and 2005 brought product patents for pharmaceuticals; the Protection of Plant Varieties and Farmers' Rights Act 2001 is the article 27(3)(b) sui generis system.

Test yourself

1. What did TRIPS change?

Three things. It raised the minimum standards of protection across every category of intellectual property, requiring in particular that patents be available for any invention, whether product or process, in all fields of technology. It added obligations of enforcement in Part III, requiring Members to make effective procedures and remedies available within their own legal systems, including provisional and border measures and criminal procedures for wilful trademark counterfeiting and copyright piracy on a commercial scale. And it brought intellectual property inside the World Trade Organization, so that non-compliance became a matter for the Dispute Settlement Understanding and, ultimately, for authorised suspension of concessions. The third change is the decisive one: the Paris and Berne Conventions had standards without enforcement, and TRIPS supplied the enforcement.

2. Explain articles 3 and 4 and how they differ from the corresponding GATT rules.

Article 3 requires each Member to accord to the nationals of other Members treatment no less favourable than it accords its own nationals with regard to the protection of intellectual property, subject to the exceptions already provided in the Paris, Berne and Rome Conventions and the IPIC Treaty. Article 4 requires that any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country be accorded immediately and unconditionally to the nationals of all other Members, subject to four listed exceptions including agreements in force before the WTO Agreement which are notified and do not constitute arbitrary or unjustifiable discrimination. They differ from GATT articles I and III in their object: the GATT rules protect products, while the TRIPS rules protect nationals. Article 4 was also new in substance, since the Paris and Berne Conventions contained a national treatment obligation but no general most-favoured-nation obligation.

3. What does article 27 require, and what may a Member still exclude?

Article 27(1) requires that patents be available for any inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application, and that patents be available and rights enjoyable without discrimination as to the place of invention, the field of technology, and whether products are imported or locally produced. Article 27(2) permits exclusion of inventions the prevention of whose commercial exploitation is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided the exclusion is not made merely because exploitation is prohibited by law. Article 27(3) permits exclusion of diagnostic, therapeutic and surgical methods for the treatment of humans or animals, and of plants and animals other than micro-organisms and essentially biological processes for their production, but requires protection of plant varieties by patents, by an effective sui generis system, or by a combination.

4. Set out the conditions in article 31.

Article 31 governs other use of the subject matter of a patent without the authorisation of the right holder, including use by or authorised by the government. Authorisation must be considered on its individual merits. The proposed user must first have made efforts to obtain authorisation from the right holder on reasonable commercial terms and conditions without success within a reasonable period, though this may be waived in a national emergency or other circumstances of extreme urgency or for public non-commercial use, the right holder being notified as soon as reasonably practicable in an emergency. The scope and duration must be limited to the purpose authorised. The use must be non-exclusive and non-assignable except with the enterprise, must be predominantly for the supply of the domestic market, must be terminable when the circumstances cease, must carry adequate remuneration to the right holder taking account of the economic value of the authorisation, and must be subject to judicial or other independent review.

5. What is the Doha Declaration and what is its legal effect?

It is the Declaration on the TRIPS Agreement and Public Health adopted by the Ministerial Conference on 14 November 2001. It affirms that the Agreement can and should be interpreted and implemented in a manner supportive of Members' right to protect public health and to promote access to medicines for all; that each Member has the right to grant compulsory licences and the freedom to determine the grounds on which they are granted; that each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, public health crises including those relating to HIV/AIDS, tuberculosis and malaria being capable of representing such circumstances; and that each Member is free to establish its own exhaustion regime without challenge, subject to articles 3 and 4. Its legal effect must be stated with care: it is a ministerial declaration, it did not amend the Agreement, and it created no new right. Its value is interpretive, since it records the Members' understanding of the flexibilities that articles 6, 8, 30 and 31 already contained.

6. How did TRIPS change Indian law?

The Patents Act 1970 granted only process patents for food, medicines and drugs, which allowed Indian manufacturers to make a known substance by a different process and is the origin of India's generic pharmaceutical industry. Article 27(1) of TRIPS required patents for inventions in all fields of technology, whether products or processes, so that regime could not survive. India used the transitional periods in article 65, including the additional five years available where a developing country Member had to extend product patent protection to a field not previously protectable, and amended the Act in 1999, 2002 and 2005, the last introducing product patents for pharmaceuticals, with the mailbox filing and exclusive marketing rights arrangements under article 70 operating in the interim. India also used the flexibilities: compulsory licensing provisions resting on article 31, the exclusions permitted by article 27(3), the Protection of Plant Varieties and Farmers' Rights Act 2001 as the sui generis system contemplated by article 27(3)(b), and a demanding standard of what counts as an invention, which is available because TRIPS requires an inventive step without defining it.