In the name of Allah the most Merciful and Beneficial

1. In the name of Allah the most Merciful and Beneficial

2. TRIPS Flexibilities and the National Law, THE PHARMACEUTICAL PERSPECTIVE

3. Early Protection of IPRs • 1760- Industrial Revolution in England, spread over Europe, Japan and USA. • 1474- Inventors rights in Venice, “Parte Ceneziana”. • 1663- Patent in England, King James the First • 1790- United States through the Act dated 10 August. • 1790- France through the Decree adopted by the King, Louis XVI, on 31 December and on 7 January, 1791.

4. From Paris Convention to the TRIPS Agreement • TRIPS has not appeared out of a vacuum. • Culmination of a long maturation, roots go way back GATT, 1947. • Berne convention for the protection of Literary and Artistic works of 1886. • Paris convention for the Protection of Industrial Property of 1883. • Long time for the seeds to grow and for maturation in 1995. • In the meantime, nowadays called “Industrialized Nation” had largely profited from the lack of robust and full protection at the International Level in order to copy British Technology from one another and disseminate it throughout their local Industry.

5. Agreement of WIPO and WTO The World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO), entered into agreement in Geneva on 22th December 1995 to establish a mutually supportive relationship between them, and with a view to establishing appropriated arrangements for cooperation between them.

6. TRIPS(Trade Related Aspects of Intellectual Property Rights)1994 What were the objectives of TRIPS • To reduce distortion and impediments to international trade • To promote effective and adequate protection of intellectual property rights • To ensure that measure and procedures to enforce intellectual property rights do not themselves become barrier to legitimate trade.

7. IPs covered by TRIPS • Copyright and Related Rights • Trademarks • Geographical Indications • Industrial Designs • Patents

8. Striking a balance • IPRs provide exclusivity as incentive for inventors to engage in R&D • Technological development also needs competition and follow-on innovation • Governments must provide balance between need for protection and need for access by competitors to technology-related information

9. Striking a balance • TRIPS flexibilities are tools for striking this balance: leeway where to draw the line between IP-protected area and public domain

10. Striking a balance • Balance between IP protection and essential information is needed in various areas of public policy • Health (access to affordable medicines) • Biotechnology (use of genetic research tools) • Education (access to scientific materials) • Food & agriculture (food security& preservation of biodiversity)

11. Patent Protection Rights conferred • Article 28 1. Patent shall confer on its owner following exclusive rights: • where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product;

12. Patent Protection • where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the act of: using the process and from the acts using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process. 2. patent owner shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts.

13. Introduction of flexibilities • Patent protection for pharmaceutical and agricultural chemical products. The main flexibilities include • Compulsory licensing • Parallel importation • Provisions relating to patentable subject matter • Provisions relating to exceptions to patent rights • Provisions relating to data protection • Provisions relating to abuse of rights • Competition and the control of anti-competitive practices.

14. Doha Declaration • To protect public health. • The TRIPS 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.

15. TRIPS Article 31 Where the law of a Member allows for the use of the subject matter of patent without the authorization of the right holder, including use by the government or third parties authorized by the government. Patents Ordinance 2000 Section 58 Exploitation by Government agency or third person Section 59 Powers of Controller in granting compulsory license Compulsory Licensing

16. where attempts to obtain voluntary licenses on reasonable commercial terms are unsuccessful; non exclusive use use predominantly for domestic supply temporary use subject to the special circumstances that warranted the licensing, and subsequent to payment of adequate remuneration to the title holder. Although Article 31(h) of TRIPS makes no mention of what constitutes adequate remuneration, the internationally accepted royalty payable to the patent holder ranges from 0.2%-4% of the fee earned by the generic company Compulsory Licensing

17. The TRIPS Agreement gives member countries the freedom to determine for themselves, the grounds on which compulsory licenses can be granted beyond those that are explicitly mentioned. Developing countries can frame patent laws that allow for compulsory licensing according to their specific developmental and public interest needs. Some of the challenges that arose from Article 31(f ) have been subsequently resolved by the 30 August Decision as countries are now able to import and export Patented Products based on the needs that exist. Allowing compulsory licensing is also a critical ingredient in the overall formulation of an effective generics policy, discussed in detail later in the paper. But it is important to note that an effective generics policy requires countries to have a pharmaceutical industry with the capacity to ‘reverse engineer’ the patented drugs, and manufacture them on a large scale. Compulsory Licensing

18. Although provisions exist in the Patents law a clear-cut mechanism has not been provided to enact compulsory licensing . Furthermore the requisite interaction between the relevant govt. functionaries is not defined. Compulsory Licensing

19. Some Recent Compulsory Licensing for AIDS drugs

20. TRIPS Article 6 For the purpose of dispute settlement under this Agreement subject to the provisions of Article 3 and 4 nothing in this Agreement shall be used to address the issue of exhaustion of intellectual property rights. Patents Ordinance 2000 Not Addressed Parallel Importation

21. Both generic and brand name drug companies charge lower prices for a drug in one country than in another, after taking into account a range of market factors. This means that a country with limited resources can sometimes afford more of a patented or generic drug by purchasing it abroad at a lower price and importing it, rather than buying it directly in its domestic market at the higher price. Parallel importation is regarded as an important flexibility under TRIPS for sustained access to affordable medicines. Parallel Importation

22. It is the import and resale of a patented product from another country where it was put on the market by the owner in a legitimate manner, where the import and resale occurs without the consent of the patent holder. Article 6 of the TRIPS Agreement clearly states that nothing in the Agreement shall be used to address the issue of exhaustion of intellectual property rights19. More specifically, Article 8.1 allows members to “adopt measures necessary to protect public health and nutrition”. Where allowed, parallel imports cover legitimate products. Parallel Importation

23. TRIPS Article 27 Patent 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. Patent 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. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect order public or morality., including to protect human, animal or plant lif or health to avoid serious prejudice to the environment provide such exclusions is not made merely because the exploitation is prohibited by their law Patents Ordinance 2000 Section 7 : Patentable Invention Section 8 : Novelty Section 9 : Inventive Steps Section 10 : Industrial Application Provisions Relating to Patentable Subject Matter

24. TRIPS Members may also exclude from patentability. diagnostic, therapeutic and surgical methods for the treatment of humans or animals; 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. However, Member shall provide for the protection of plant varieties either by patents of by an effective sui generis system or by any combination thereof. The provision of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. Patents Ordinance 2000 Provisions Relating to Patentable Subject Matter

25. TRIPS Article 30 Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent and do no unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. Patents Ordinance 2000 Section 105– Power of the Federal Government to make rules. (2)(xiv) Section 7(2) Patentable Inventions 8(2)Novelty 30(5)(a) & (f) Rights Conferred by patent Provisions Relating to Exceptions to Patent Rights

26. TRIPS Experimental Use TRIPS does not explicitly allow or disallow the use of patented products for research and experimentation without compensating the inventor. Early Working ‘Bolar’ Provision This provision allows the use of an invention without the patentee’s authorization in order to obtain approval of a generic product before the patent expiration date. This is done so that marketing of a generic version can begin immediately after the patent expires. Since generic competition lowers prices, the Bolar exception increases the affordability of off-patent medicines. Since the commercialization of the product doesn’t happen while it is on patent, this early working provision is compatible with Article 30. 30(5)(f) Rights Conferred by patent Provisions Relating to Exceptions to Patent Rights

27. While TRIPS does not explicitly refer to this exception, the WTO Dispute between Canada and the European Union ruled that an early working exception is consistent with TRIPS even in the absence of an extended period of protection for the patent. However, the right to manufacture and stockpile before the expiration of the patent was not deemed consistent Provisions Relating to Exceptions to Patent Rights

28. TRIPS Article 39(3) Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test of other date, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. Un addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial uses. Patents Ordinance 2000 Not Addressed Provisions Relating to Data Protection

29. TRIPS This would delay the entry of generics into the market and affect the price of generics- not to mention the ethical issues involved in repeating clinical trials. Developing countries should make a concerted effort to demand expediting data disclosure procedures so that local manufacturers are able to use the information for generics production once the drugs are off patent. Countries should also guard against the inclusion of test data protection in bilateral trade agreements as there is no obligation in terms of Article 39.3 of the TRIPS Agreement obliging countries to provide additional protection to test data. Patents Ordinance 2000 Provisions Relating to Data Protection

30. TRIPS Article 41 Members shall ensure that enforcement procedures as specified in this Part are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse. Procedures concerning the enforcement of intellectual property rights shall be fair and equitable. They shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays. Decisions on the merits of a case shall preferably be in writing and reasoned. They shall be made available at least to the parties to the proceeding without undue delay. Decisions on the merits of a case shall be based only on evidence in respect of which parties were offered the opportunity to be heard. Patents Ordinance 2000 Not Addressed Provisions Relating to Abuse of Rights

31. TRIPS Parties to a proceeding shall have an opportunity for review by a judicial authority of final administrative decisions and, subject to jurisdictional provisions in a Member's law concerning the importance of a case, of at least the legal aspects of initial judicial decisions on the merits of a case. However, there shall be no obligation to provide an opportunity for review of acquittals in criminal cases. It is understood that this Part does not create 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 does it affect the capacity of Members to enforce their law in general. Nothing in this Part creates any obligation with respect to the distribution of resources as between enforcement of intellectual property rights and the enforcement of law in general. Patents Ordinance 2000 Provisions Relating to Abuse of Rights

32. TRIPS Article 40 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. Patents Ordinance 2000 Not Addressed Provisions Relating to Competition and the Control of Anti-Competitive Practices.

33. TRIPS Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market. As provided above, a Member may adopt, consistently with the other provisions of this Agreement, appropriate measures to prevent or control such practices, which may include for example exclusive grantback conditions, conditions preventing challenges to validity and coercive package licensing, in the light of the relevant laws and regulations of that Member. Patents Ordinance 2000 Provisions Relating to Competition and the Control of Anti-Competitive Practices.

34. TRIPS 3. Each Member shall enter, upon request, into consultations with any other Member which has cause to believe that an intellectual property right owner that is a national or domiciliary of the Member to which the request for consultations has been addressed is undertaking practices in violation of the requesting Member's laws and regulations on the subject matter of this Section, and which wishes to secure compliance with such legislation, without prejudice to any action under the law and to the full freedom of an ultimate decision of either Member. The Member addressed shall accord full and sympathetic consideration to, and shall afford adequate opportunity for, consultations with the requesting Member, and shall cooperate through supply of publicly available non-confidential information of relevance to the matter in question and of other information available to the Member, subject to domestic law and to the conclusion of mutually satisfactory agreements concerning the safeguarding of its confidentiality by the requesting Member. Patents Ordinance 2000 Provisions Relating to Competition and the Control of Anti-Competitive Practices.

35. TRIPS 4. A Member whose nationals or domiciliaries are subject to proceedings in another Member concerning alleged violation of that other Member's laws and regulations on the subject matter of this Section shall, upon request, be granted an opportunity for consultations by the other Member under the same conditions as those foreseen in paragraph 3. Patents Ordinance 2000 Provisions Relating to Competition and the Control of Anti-Competitive Practices.