1. 1 Managing Procurement and Logistics of HIV/AIDS Drugs and Related Supplies Abuja, Nigeria, May 30 - June 4 2005 Module1: Intellectual Property Rights by Dr. Atangcho Nji Akonumbo Senior Lecturer in Law

2. 2 Objectives of the module To understand how an Intellectual Property Right (IPR) - patent - can impede medical supplies for the treatment of HIV/AIDS. To understand how an Intellectual Property Right (IPR) - patent - can impede medical supplies for the treatment of HIV/AIDS. To explore avenues by which governments and supply agencies can obtain quality low-priced, safe, and effective HIV/AIDS medicines by lawfully surmounting obstacles created by patents. To explore avenues by which governments and supply agencies can obtain quality low-priced, safe, and effective HIV/AIDS medicines by lawfully surmounting obstacles created by patents.

3. 3 Preliminary Issues The Intellectual Property (IP) / Right to Health nexus (for a better understanding of the underlying issues and concerns to be discussed further). The Intellectual Property (IP) / Right to Health nexus (for a better understanding of the underlying issues and concerns to be discussed further). - IPRs and right to health as human rights consecrated in the relevant international human rights instruments: UDHR/ICCPR - Incompatibility Competing claims on Patents: some arguments for and against patents Competing claims on Patents: some arguments for and against patents

4. 4 Rules governing IPRs The WTO’s TRIPS Agreement sets down the minimum rules or standards for the protection of IPRs to be complemented by national or regional laws, where necessary. Thus minimum standards agreement – article 1 provides for more extensive protection of IP in member countries. The WTO’s TRIPS Agreement sets down the minimum rules or standards for the protection of IPRs to be complemented by national or regional laws, where necessary. Thus minimum standards agreement – article 1 provides for more extensive protection of IP in member countries. These rules/standards apply to all WTO member countries no matter the level of development: LDC, Dg C or Dd C. These rules/standards apply to all WTO member countries no matter the level of development: LDC, Dg C or Dd C.

5. 5 IPRs relevant to Pharmaceutical Products/Nature Patents Patents - A Patent is an exclusive right granted for the protection of an invention ( NOT A DISCOVERY) of a technological product or process that is new (or novel), useful ( or capable of industrial application) and involves an inventive sep (or is non-obvious). -The protection is against the unauthorised, making, using, offering for sale or selling or importing the patented item. The period of protection is at least 20 years from the date of filing of the application for the patent. The patent is valid only in the country or region where protection is sought in the application. Undisclosed information Undisclosed information -Article 39 of the TRIPS Agreement: members are allowed to protect trade secrets from being disclosed to or acquired or used by others. Members requiring submission of undisclosed test or data before marketing of pharmaceutical products which utilize new chemical entities should protect them against unfair commercial use (except in 2 cases).

6. 6 Relevant IPRs cont’d Trademarks/trade names Trademarks/trade names Copyright Copyright

7. 7 IPRS: obstacles to medicines? 1. Patents Since Patents are only valid where protection is sought, a medicine may be under a patent in one country and not in another. Since Patents are only valid where protection is sought, a medicine may be under a patent in one country and not in another. Also, the availability of off-patent medicines (generic medicines) in a country (importing country) depends on whether patenting exists in that country and in the potential exporting countries. Also, the availability of off-patent medicines (generic medicines) in a country (importing country) depends on whether patenting exists in that country and in the potential exporting countries.

8. 8 IPRs obstacles? cont’d If a medicine is not under a patent in a country, there is no legal restriction as to its being produced and sold or bought or its generic version imported there. If a medicine is not under a patent in a country, there is no legal restriction as to its being produced and sold or bought or its generic version imported there. However, if the medicine is under a patent in a country, the production, sale or importation of generic versions in that country is not authorised, save where its government undertakes the necessary measures ( as it is to be seen later). However, if the medicine is under a patent in a country, the production, sale or importation of generic versions in that country is not authorised, save where its government undertakes the necessary measures ( as it is to be seen later).

9. 9 IPRs obstacles? cont’d 2. Undisclosed information National authorities requiring the submission of undisclosed information under article 39 of the TRIPS in order to authorize the importation of drugs for the treatment of HIV/AIDS are not engaging in unfair commercial use; but protection of the information against unauthorized disclosure use and acquisition by third parties should be guaranteed, else that would constitute unfair commercial use. National authorities requiring the submission of undisclosed information under article 39 of the TRIPS in order to authorize the importation of drugs for the treatment of HIV/AIDS are not engaging in unfair commercial use; but protection of the information against unauthorized disclosure use and acquisition by third parties should be guaranteed, else that would constitute unfair commercial use. Although article 39 does not expressly refer to patents, it may, nonetheless, be applied to protect existing drugs or data. Although article 39 does not expressly refer to patents, it may, nonetheless, be applied to protect existing drugs or data.

10. 10 IPRs obstacles? cont’d 3. Trademarks and Copyright are lesser obstacles to access to HIV/AIDS medicines since they can be easily avoided by generic manufacturers. But trademarks and copyright may be evoked by holders thereof, to object parallel importations where international exhaustion of rights is inapplicable. In the case of copyright, for example, resale rights («droits de suite») may be evoked to defeat exhaustion of rights. In the case of copyright, for example, resale rights («droits de suite») may be evoked to defeat exhaustion of rights.

11. 11 Principal Worries of patent holders Registration and authorisation concerns Registration and authorisation concerns - Nearly every country requires that pharmaceutical products should first be registered or submitted for commercialization authorisation with a national or regional regulatory body. Although the goal of this process is essentially to ensure the biosafety and bioequivalence of a generic version of a drug, it may, however, be varied, tedious and costly. Although the goal of this process is essentially to ensure the biosafety and bioequivalence of a generic version of a drug, it may, however, be varied, tedious and costly. There concerns about the adequate protection of submitted undisclosed information in the process of registration or authorization. There concerns about the adequate protection of submitted undisclosed information in the process of registration or authorization. Possible violations of patents, trademarks and copyright Possible violations of patents, trademarks and copyright

12. 12 Principal concern(s) of governments and supply agencies IPRs system and particularly, patents, restrict access to essential medicines against HIVAIDS especially in the poorer regions due to the high prices they engender. IPRs system and particularly, patents, restrict access to essential medicines against HIVAIDS especially in the poorer regions due to the high prices they engender. Patents promote monopoly & secrecy of information. Patents promote monopoly & secrecy of information. IP and patents are a barrier to public health objectives those regions. IP and patents are a barrier to public health objectives those regions.

13. 13 Striking the balance: the TRIPS flexibilities Voluntary licensing Voluntary licensing Compulsory licensing (CL) /government use: Article 31 Compulsory licensing (CL) /government use: Article 31 * Ground: Where the law of a member allows for other use of the subject of the patent without authorisation of the right holder, including use by the government or other third parties authorised by the government. * There must be an effort first to obtain voluntary license from the right holder under reasonable conditions and period of time, except for: 1) national emergency or circumstances of extreme urgency 2)public non-commercial use * Conditions of Compulsory licensing/government use (to safeguard the legitimate interests of the patent holder). - granted on individual merits - non exclusive right - non assignable - limited duration and for purposes for which granted - termination on seizure of circumstances and unlikelihood or recurrence. - predominantly for supply of domestic market - adequate remuneration - legal validity of authorization to use and remuneration are subject to judicial review, etc.

14. 14 Striking the balance (cont’d) The problem of Article 31(f) The problem of Article 31(f) The implication of paragraph (f) is that CL can only be resorted to by countries that do not have the requisite or no technological capacity at all to produce the subject matter of the patent for which CL is sought. Consequence? moratorium (transition period) for LDCs and DCs moratorium (transition period) for LDCs and DCs - 10 years (from Jan. 1, 1995 date of entry into force of the TRPS Agreement) = Jan 1. 2005. + possibility of extension for LDCs. Exhaustion of rights and parallel imports Exhaustion of rights and parallel imports Problems of interpretations of flexibilities and they way to DOHA Problems of interpretations of flexibilities and they way to DOHA

15. 15 The DOHA Declaration on the TRIPS and public health Background Background – The African Group led by Zimbabwe. Purpose of the Declaration: Purpose of the Declaration: - Expiration of the transitional period for some countries and the constraints of Article 31 (f) - Respond to concerns that heightened IPRs protection would undermine and frustrate health needs due to reduced access to essential medicines in poorer countries. - The drastic reduction of patented (generic drugs) by Jan 1, 2005 due to the mail box system and the application of patents for new drugs produced by WTO membres. Status: Status: The Declaration is not an amending Act: it did not amend the TRIPS; it barely explained how the flexibilities of the TRIPS could be implemented i.e. used effectively.

16. 16 Clarifications of DOHA Note Paras. 1-4: Preamble acknowledgements and remarks + language style. Note Paras. 1-4: Preamble acknowledgements and remarks + language style. WTO member has the right to grant CL and the freedom to determine the grounds upon its grant (Para 4 (b). WTO member has the right to grant CL and the freedom to determine the grounds upon its grant (Para 4 (b). Each member has the right to determine what constitutes national emergency or circumstances of extreme urgency, it being understood that public health crises including those relating to HIV/AIDS, tuberculosis, malaria, and other epidermis can represent such situations of national emergency or circumstances of extreme urgency (Para. 4 (c) Each member has the right to determine what constitutes national emergency or circumstances of extreme urgency, it being understood that public health crises including those relating to HIV/AIDS, tuberculosis, malaria, and other epidermis can represent such situations of national emergency or circumstances of extreme urgency (Para. 4 (c) Each member is free to establish its own regime of exhaustion of rights Subject to NT and MFN (Para. 4 (d) Each member is free to establish its own regime of exhaustion of rights Subject to NT and MFN (Para. 4 (d) Instruct council of TRIPS to find a solution before the end of 2002 to the Article 31 (f) problematic i.e. countries with insufficient or no manufacturing capacities in the pharmaceutical industry. (Famous para. 6). Instruct council of TRIPS to find a solution before the end of 2002 to the Article 31 (f) problematic i.e. countries with insufficient or no manufacturing capacities in the pharmaceutical industry. (Famous para. 6). Members agree to extend the transitional period for LDCS from Jan 1, 2006 to Jan 1,2016 for patents and undisclosed information (pursuant to Art. 66(1) of TRIPS) + further possibilities of extension thereto(Para. 7) Members agree to extend the transitional period for LDCS from Jan 1, 2006 to Jan 1,2016 for patents and undisclosed information (pursuant to Art. 66(1) of TRIPS) + further possibilities of extension thereto(Para. 7)

17. 17 Post DOHA flexibilities Implementation of para. 6 Implementation of para. 6 * Decision of the General Council of the TRIPS of August 30, 2003 on the implementation of para 6 of the DOHA declaration on the TRIPS and Public Health. - The Council acknowledges that circumstances exist that justify waivers relating to Art 31 (f) and adequate compensation (31 (h) - Any member country is an “eligible importing” in addition to LDCs, if it has notified the Council of TRIPS of its intention to use the system as an importer. An exporting member is a member that uses the CL system in the Decision to produce pharmaceutical products for and export them to an eligible importing member. - obligations of exporting member under Articled 31(f) of TRIPS is waived where: 1) eligible importing country has notified the TRIPS Council as to the specifications of the names and expected quantities of the pharmaceutical product, that it has not got the requisite manufacturing capacity where its is not an LDC or developed country. 2) the CL issued by the Exporting member shall contain the following conditions: manufacture only the necessary amount to meet the demands of the importing country; specific identification of products (labelling or marking, packaging colouring shaping etc.); posting on the web before shipment quantities supplied to each destination and specifications. 3) remuneration is not payable by importing country where it has granted CL for the same products as the exporting country if the latter has already paid. 4) prevention of re-exportation of the products into other markets

18. 18 Post DOHA flexibilities cont’d Implementation of para 7 Implementation of para 7 *Decision of TRIPS Council extending transition period to 2016 for LDCs

19. 19 Apportioning flexibilities The fact that a product is not patented in a country does not imply that it can be freely imported; it depends on the legal framework of the importing country The fact that a product is not patented in a country does not imply that it can be freely imported; it depends on the legal framework of the importing country Also, if a product is patented in a country, the possibilities of avoiding the IPR obstacles would depend on whether it is an LDC or a DC. Also, if a product is patented in a country, the possibilities of avoiding the IPR obstacles would depend on whether it is an LDC or a DC.

20. 20 Flexibility options for LDCs Not to introduce patenting until the end of the moratorium i.e. 2016. this would facilitate the importation of generic medicines. Not to introduce patenting until the end of the moratorium i.e. 2016. this would facilitate the importation of generic medicines. A voluntary patent may be sought from the owner of the patent A voluntary patent may be sought from the owner of the patent Compulsory licensing by government for government use or by Private generic producers under government authorization to produce and commercialize pharmaceutical products, may be sought. Compulsory licensing by government for government use or by Private generic producers under government authorization to produce and commercialize pharmaceutical products, may be sought. Parallel importation (authorised under national legislation) through international exhaustion of rights. The patent holder’s rights fade with a first legal sale and so he/she cannot object to the importation (second sale) of the product because the benefits have already accrued with the first sale. The product can also be purchased where it is sold cheaper abroad and imported “in parallel”. Parallel importation (authorised under national legislation) through international exhaustion of rights. The patent holder’s rights fade with a first legal sale and so he/she cannot object to the importation (second sale) of the product because the benefits have already accrued with the first sale. The product can also be purchased where it is sold cheaper abroad and imported “in parallel”. To enable suppliers operate in legality and without fear of infringing patents over products they may want to commercialize, governments in LDCs could undertake a clear policy indicating that for health reasons, patenting will not be applied on their territories. To enable suppliers operate in legality and without fear of infringing patents over products they may want to commercialize, governments in LDCs could undertake a clear policy indicating that for health reasons, patenting will not be applied on their territories. comparing and negotiating prices with patent holders on the basis of prices of generic drugs under special price reduction agreement schemes. comparing and negotiating prices with patent holders on the basis of prices of generic drugs under special price reduction agreement schemes. Negotiating prices with manufacturers on the understanding that it is possible to resort to CL or generic versions. Negotiating prices with manufacturers on the understanding that it is possible to resort to CL or generic versions. NB: CL may be used to produce or import patented products but it may also be used as a pressure tool during price negotiations.

21. 21 Flexibility options for DCs The situation of DCs is more complex that that of LDCS The situation of DCs is more complex that that of LDCS DCs continue to be wholly governed by the TRIPS Agreement subject to the transitory provisions, the DOHA Declaration and other flexibilities. DCs continue to be wholly governed by the TRIPS Agreement subject to the transitory provisions, the DOHA Declaration and other flexibilities. If a drug is not patented in the DC, it can import or produce it locally. But the problem is that all DCs are out of the transitional period and are now required (since 1 Jan, 2005) to introduce patenting. If a drug is not patented in the DC, it can import or produce it locally. But the problem is that all DCs are out of the transitional period and are now required (since 1 Jan, 2005) to introduce patenting. If the drug is patented, then the DC can issue an authorisation for government use or CL and /or authorise parallel importation. If the drug is patented, then the DC can issue an authorisation for government use or CL and /or authorise parallel importation. NB: CL for government use involves less cumbersome procedures than CL accorded to third parties. A voluntary license can be negotiated with the owner of the patent A voluntary license can be negotiated with the owner of the patent Price negotiation may also be undertaken with the patent owner for a reduction thereof. Price negotiation may also be undertaken with the patent owner for a reduction thereof.

22. 22 Further flexibilities for both LDCs and DCs Under the 2003 TRIPS Council Decision, an authority in charge of supply may require a foreign government to deliver a CL in order to supply a drug which is under a patent in its country, to the authority in question. An LDC, a DC and a developed country may be supplier here. However, a non-LDC seeking this system must prove that it has not got the requisite manufacturing capacity. Also,the safeguards of the TRIPS Council Decision of 2003 must be complied with. Under the 2003 TRIPS Council Decision, an authority in charge of supply may require a foreign government to deliver a CL in order to supply a drug which is under a patent in its country, to the authority in question. An LDC, a DC and a developed country may be supplier here. However, a non-LDC seeking this system must prove that it has not got the requisite manufacturing capacity. Also,the safeguards of the TRIPS Council Decision of 2003 must be complied with. For both LDCs and DCs generic versions can still be available from producers in countries where there is no patent protection. For both LDCs and DCs generic versions can still be available from producers in countries where there is no patent protection. For both LDCs and DCs antiretroviral and other drugs that have not been patented or whose patents have expired and are now within the public domain shall be available from generic producers For both LDCs and DCs antiretroviral and other drugs that have not been patented or whose patents have expired and are now within the public domain shall be available from generic producers A foreign generic producer may be issued CL by the country where it resides and legally export a non-predominant quantity of its production. A foreign generic producer may be issued CL by the country where it resides and legally export a non-predominant quantity of its production.

23. 23 Conclusion IPRs, particularly, patents may be obstacles to access to essential medicines against HIV/AIDS, but there are flexibilities within the international patent system that could be explored if used tactfully by LDCs and DCs IPRs, particularly, patents may be obstacles to access to essential medicines against HIV/AIDS, but there are flexibilities within the international patent system that could be explored if used tactfully by LDCs and DCs The TRIPS does not really obviate countries from taking the best advantage of the flexibilities. It was, perhaps, a problem of interpretation by the strong to the detriment of the weak and the poor. DOHA has now paved the way for better understanding of the flexibilities and it is for national authorities in charge of supply of HIV/AIDS drugs tp: The TRIPS does not really obviate countries from taking the best advantage of the flexibilities. It was, perhaps, a problem of interpretation by the strong to the detriment of the weak and the poor. DOHA has now paved the way for better understanding of the flexibilities and it is for national authorities in charge of supply of HIV/AIDS drugs tp: -assess the country’s status and IPRs landscape to know if and how to apply the flexibilities; - follow-up; the issue of patenting and the rules thereof, work with the relevant government ministries (health, industry/commerce, customs etc) as well as supervise registrations or authorisations of drugs entering the country to ensure easy effiient procedures and quality control - serve as pressure groups in reminding government not de-prioritize the HIV/AIDS sector.

24. 24 Thank you Je vous remercie