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INTERNATIONAL CONFERENCE ON INTELLECTUAL PROPERTY IN THE PHARMACEUTICAL INDUSTRY Warsaw, April 24, 2009

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INTERNATIONAL CONFERENCE ON INTELLECTUAL PROPERTY IN THE PHARMACEUTICAL INDUSTRY Warsaw, April 24, 2009

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    1. INTERNATIONAL CONFERENCE ON INTELLECTUAL PROPERTY IN THE PHARMACEUTICAL INDUSTRY Warsaw, April 24, 2009 Patents for Pharmaceuticals Products - Legal options and flexibilities WIPO Secretariat

    2. Leading products in 2005 by global pharmaceutical sales**

    3. LIFE CYCLE OF A DRUG*

    4. Patents to Pharmaceuticals in the international context The Multilateral Context: Paris Convention Trips Agreement; and The Bilateral Context

    5. 5 The Paris Convention and the asymmetries Some developing countries had excluded from patentability pharmaceutical products, without any challenge to the Paris Convention (Art. 4 bis, 4 ter, 5, 5 ter). This situation that has been gradually changing due multilateral commitments that were adopted in the framework of the TRIPS Agreement or because unilaterally some countries decided to do so. The Paris Convention, in the area of patents, was designed in this manner because in 1883 two of the founding members of the Paris Union (Switzerland and the Netherlands) did not have national patent systems. In the area of trademarks, in contrast, the Paris Convention provides for mandatory minimum standards because, before it was adopted, there was already a significant number of bilateral agreements establishing international protection. The Paris Convention, in the area of patents, was designed in this manner because in 1883 two of the founding members of the Paris Union (Switzerland and the Netherlands) did not have national patent systems. In the area of trademarks, in contrast, the Paris Convention provides for mandatory minimum standards because, before it was adopted, there was already a significant number of bilateral agreements establishing international protection.

    6. TRIPS AGREMMENT Patentable Subject Mater. Art. 27. 1), 2) y 3) Ordre public or morality Diagnostic, therapeutic and surgical methods (Art.27.3 (a)) Plants and animals (other than micro-organism) and essentially biological processes for the production thereof (other than non-biological and microbiological) second uses of known substances; (Art. 27.1) Delay product protection (Art.65.4)(LDC Art. 66.1) Exceptions to rights Conferred (Art. 30) Other uses without authorization (Art. 31) TRANSITIONAL ARRANGEMENTS Article 65 Transitional Arrangements 4. To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years. 5. A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement. Article 66 Least-Developed Country Members In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period. The patentee right could be limited in the following cases: a) non commercial purposes; b) use solely for scientific research and experimentation; c) exhaustion of rights; d) prior users.TRANSITIONAL ARRANGEMENTS Article 65 Transitional Arrangements 4. To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years. 5. A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement. Article 66 Least-Developed Country Members In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period. The patentee right could be limited in the following cases: a) non commercial purposes; b) use solely for scientific research and experimentation; c) exhaustion of rights; d) prior users.

    7. 7 Doha Declaration on TRIPS and Public Health “We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices” “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm 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”. DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH Adopted on 14 November 2001 We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices. We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm 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. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. we recognize that these flexibilities include: In its interpretation, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles. Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH Adopted on 14 November 2001 We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices. We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm 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. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. we recognize that these flexibilities include: In its interpretation, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles. Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement.

    8. 8 Doha and Public Health. Decisions of the WTO Bodies Decision of the Trips Council of 1 July 2002 for the extension of the transition period (Art. 66.1) for Least Develop Countries respect to pharmaceuticals products (2016) Decision of the Trips Council of 8 July 2002, which waive for least Developed Countries the obligation under paragraph 9 of article 70 (2016) Decision of the General Council of 30 August 2003 for the implementation of the paragraph 6 of the Doha Declaration GENERAL COUNCIL DECISION OF 30 AUGUST 2003 The obligations of an exporting Member under Article 31(f) of the TRIPS Agreement shall be waived with respect to the grant by it of a compulsory license to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out below in this paragraph:   (a) the eligible importing Member(s) (4) has made a notification (2) to the Council for TRIPS, that:   (i)   specifies the names and expected quantities of the product(s) needed (5); (ii)  confirms that the eligible importing Member in question, other than a least developed country Member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Annex to this Decision; and (iii) confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory licence in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision (6);   (b) the compulsory licence issued by the exporting Member under this Decision shall contain the following conditions:   (i)   only the amount necessary to meet the needs of the eligible importing Member(s) may be manufactured under the licence and the entirety of this production shall be exported to the Member(s) which has notified its needs to the Council for TRIPS; (ii)  products produced under the licence shall be clearly identified as being produced under the system set out in this Decision through specific labelling or marking. Suppliers should distinguish such products through special packaging and/or special colouring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price; and (iii) before shipment begins, the licensee shall post on a website (7) the following information: - the quantities being supplied to each destination as referred to in indent (i) above; and - the distinguishing features of the product(s) referred to in indent (ii) above;   (c) the exporting Member shall notify (8) the Council for TRIPS of the grant of the licence, including the conditions attached to it (9). The information provided shall include the name and address of the licensee, the product(s) for which the licence has been granted, the quantity(ies) for which it has been granted, the country(ies) to which the product(s) is (are) to be supplied and the duration of the licence. The notification shall also indicate the address of the website referred to in subparagraph (b)(iii) above.   3.   Where a compulsory licence is granted by an exporting Member under the system set out in this Decision, adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall be waived in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.   GENERAL COUNCIL DECISION OF 30 AUGUST 2003 The obligations of an exporting Member under Article 31(f) of the TRIPS Agreement shall be waived with respect to the grant by it of a compulsory license to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out below in this paragraph:   (a) the eligible importing Member(s) (4) has made a notification (2) to the Council for TRIPS, that:   (i)   specifies the names and expected quantities of the product(s) needed (5); (ii)  confirms that the eligible importing Member in question, other than a least developed country Member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Annex to this Decision; and (iii) confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory licence in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision (6);   (b) the compulsory licence issued by the exporting Member under this Decision shall contain the following conditions:   (i)   only the amount necessary to meet the needs of the eligible importing Member(s) may be manufactured under the licence and the entirety of this production shall be exported to the Member(s) which has notified its needs to the Council for TRIPS; (ii)  products produced under the licence shall be clearly identified as being produced under the system set out in this Decision through specific labelling or marking. Suppliers should distinguish such products through special packaging and/or special colouring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price; and (iii) before shipment begins, the licensee shall post on a website (7) the following information: - the quantities being supplied to each destination as referred to in indent (i) above; and- the distinguishing features of the product(s) referred to in indent (ii) above;   (c) the exporting Member shall notify (8) the Council for TRIPS of the grant of the licence, including the conditions attached to it (9). The information provided shall include the name and address of the licensee, the product(s) for which the licence has been granted, the quantity(ies) for which it has been granted, the country(ies) to which the product(s) is (are) to be supplied and the duration of the licence. The notification shall also indicate the address of the website referred to in subparagraph (b)(iii) above.   3.   Where a compulsory licence is granted by an exporting Member under the system set out in this Decision, adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall be waived in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.  

    9. Patents to Pharmaceuticals in the bilateral context (USA bilateral Agreements) Pending Congressional Approval Colombia Panama Republic of Korea In Force Israel NAFTA Jordan Chile Singapore Australia Morocco Bahrain Pending Implementation Peru Oman Other FTA Negotiations Malaysia Thailand SACU UAE

    10. 10 Patent provisions on recent U.S. FTAs

    11. 11 Democrat's wish to incorporate key priorities on IP in FTAs (letter March 12 to USTR) The proposal Data protection. The inclusion of caps in the periods available; measures to facilitate the approval of generics to stimulate competition. Patent extension. To limit the total duration permitted. Linkage. To mitigate the burden on the regulatory authorities, like the obligation to withhold the approval if a patent could be violated. Compulsory licensing. Recalled each country freedom to determine the grounds upon which such licenses are granted. Avoid the use of side letters which are “non binding to the parties”. Consumer safeguards. Bolar provision; the applicant indications of the best mode to reproduce the invention and measures to avoid evergreening patents. Democrat's wish to incorporate key priorities in FTAs (letter March 12 to USTR) “The need for expanded access to affordable drugs is dire, and demands careful attention when international trade policies address IP”. They recalled that “Congress directed the Administrative branch to adhere to the Doha Declaration as a principal negotiating objective in US trade negotiations” (TPAA 2002). “Regrettably, recent US FTAs…strip away flexibilities to which countries are entitled under TRIPS”. “The FTAs provisions also appear to upset an important balance between innovation and access by elevating intellectual property at the expense of public health”. The May 10, 2007, bipartisan agreement “We applaud your leadership in promoting a trade policy that places public health over private profits and recognizes that developing countries need more flexibility to ensure their populations access to affordable medicines” Oxfam America (May 31 letter to Ms. Pelosi). The new trade policy “is proof that a balance between fostering drug innovation and ensuring access to affordable medicines can be achieved”. GPhA (May 31 press Release) Democrat's wish to incorporate key priorities in FTAs (letter March 12 to USTR) “The need for expanded access to affordable drugs is dire, and demands careful attention when international trade policies address IP”. They recalled that “Congress directed the Administrative branch to adhere to the Doha Declaration as a principal negotiating objective in US trade negotiations” (TPAA 2002). “Regrettably, recent US FTAs…strip away flexibilities to which countries are entitled under TRIPS”. “The FTAs provisions also appear to upset an important balance between innovation and access by elevating intellectual property at the expense of public health”. The May 10, 2007, bipartisan agreement “We applaud your leadership in promoting a trade policy that places public health over private profits and recognizes that developing countries need more flexibility to ensure their populations access to affordable medicines” Oxfam America (May 31 letter to Ms. Pelosi). The new trade policy “is proof that a balance between fostering drug innovation and ensuring access to affordable medicines can be achieved”. GPhA (May 31 press Release)

    12. 12 The Agreement (just for pharmaceutical products). DATA EXCLUSIVITY. Five years of data exclusivity for NCEs, considering the nature of the data and efforts and expenditure. If the parties grants the approval within six months when relying in FDA approval, the terms will count from them (concurrent period). PATENT EXTENSIONS. The obligation “shall” would be changed to “May”. Cooperation and assistance to avoid “unreasonable delays” is envisaged.

    13. 13 The Agreement (just for pharmaceutical products). Cont… THE LINKAGE. There is no obligation to establish a linkage between drug regulatory agencies and patent issues, particularly, no requirement that the agency withhold approval of the generic until it can certify that no patent would be violated. NEW KING OF LINKAGE. The party would be required: to provide procedures and remedies (judicial or administrative) and preliminary injunctions (equivalent) do dealt with patent infringement and validity disputes; and A transparent system to give patent holders sufficient time and opportunity to enforce their rights (notifications, website info, etc). LINKAGE OPTION. A party can be free to chose to fulfill this obligations (procedures and remedies) through a linkage system, if at the same time: adopt an expeditious system to challenge the validity or the infringement of a patent and a system to reward to those who successfully challenge a patent.

    14. IP DECISION TREE FOR ACCESS TO ESSENTIAL DRUGS* Subject to Regulatory Drug Approval

    15. 15 Thank you! Marco M. Aleman Deputy Director, Division for Public Policy and Development marco.aleman@wipo.int

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