Country Presentation 1

Country Presentation 1

Overview of AIDS Situation First HIV case detected in Dec. 1990. Reported cases: 84,484 (0.08% population); 13,315 have developed AIDS; 7,595 have died (Aug. 2004) Estimate for infection rate: 0.25% (in 2003 ) HIV infected people found in 100% (64) Provinces, 93% districts, 49% wards IDUs make up the majority of reported HIV cases (60%) Young people: 62% PLWHA are 20-29 yrs; 8.3% are 10-19 yrs Sexually transmission are rising: 0.6% in 1994, 6% in 2003 (40% sex workers in Hanoi are drug users) HIV/AIDS expanding to the community HIV infection rate increasing not only among the vulnerable groups (IDU, sex workers), but also among others: farmers, students, government staff, etc. 2

Overview of Pharmaceutical Sector Manufacturing capacity: finished products, limited in raw materials 42 manufacturing sites comply with WHO and/or ASEAN GMP (States owned/private/foreign invested) Local production provides app. 40% of drug supply (mostly generics) Drug importation: 451 mil. USD (2003) Drug expenditure: 7.6USD/cap. (2003) Drug registration numbers: 6,107 local; 4,656 imported (2003) Drug quality control: 2 national laboratories in Hanoi and Hochiminh City and provincial labs in over 60 provinces. 3

Overview of IPR Laws Currently, Vietnam protects IP rights under Civil Code (entered into force on 1 July 1996). The implementation of the Civil Code relating to the protection of IP rights is elaborated under various decrees and circulars (see Annex). There are two regulations for the protection of patents and trade secrets relating to pharmaceuticals, including: Decree 63/CP, 24 October 1996, for the Implementation of the Provisions of the Civil Code on Industrial Property which is amended and supplemented by Decree 06/2001 (01 February 2001); and Decree 54/2000/ND-CP, 3 October 2000, for the Protection of IP rights upon Business Secrets, Geographical Indications, Trade Names, and Protection of Rights against Unfair Competition Relating to Industrial Property. 4

Overview of IPR Laws (cont.) International Agreements Until now, Vietnam has been party to four international agreements in the field of industrial property The Paris Convention for the Protection of Industrial Property The Convention establishing the World Intellectual Property Organization The Patent Cooperation Treaty (PCT) The Madrid Agreement on the International Registration of Marks Bilateral Trade Agreement between Vietnam and the United States Bilateral Agreements Agreement between the United States of America and the Socialist Republic of Vietnam on Trade Relations (BTA) Agreement between the Government of the Socialist Republic of Vietnam and the Swiss Federal Council on the Protection of Intellectual Property and on Co-operation in the Field of Intellectual Property 5

Overview of IPR Laws (cont.) Criteria that a patentable invention must satistify: Novelty Inventive Step Industrial Application Criteria that a patentable utility solution must satisfy: Novelty Industrial Application 6

Non-Voluntary (Compulsory) Licensing Provisions under Vietnamese Law A non-voluntary or compulsory is granted by the Ministry of Science and Technology (MOST) without the consent of the patent owner. A compulsory license may be granted in one of the following circumstances: i. The owner does not work or insufficiently works the patented invention/utility solution without plausible reasons. However, this provision will not apply within a certain period of time of non-working or insufficient working, namely: 4 years from the filing date of the patent application or three years from the grant of the patent, whichever period expires last; or ii. The person who has the need to use the patented invention/utility solution has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions and that such efforts have not been successful; or iii. The exploitation of the patented invention/utility solution aims to meet the need of national defence and security, health or other urgent needs of society. 7

Non-Voluntary (Compulsory) Licensing Provisions under Vietnamese Law (cont.) A compulsory license is a non-exclusive license; A compulsory license is confined to the scope and time limit needed to meet the objectives of license granting The compulsory license shall not be entitled to transfer the right to use derived from the license to the others, and shall not be entitled to grant a sub-license to the others unless the compulsory license is granted together with the transfer of the whole business that uses the license. Compulsory license must be liable to be terminated if the circumstance that justified its grant have ceased to exist and are unlikely to recur, provided that such termination does not prejudice the legitimate interest of the compulsory licensee. 8

Non-Voluntary (Compulsory) Licensing Provisions under Vietnamese Law (cont.) After receiving the request for granting a compulsory license, MOST may ask the patent owner and the proposed compulsory licensee to re-negotiate in order to reach a voluntary license. If the two sides cannot reach such an agreement if the refusal by the patent owner to grant a voluntary license is not reasonable, within a period of three months from the date of receiving the request, the MOST will issue a decision compelling the patent owner to grant a compulsory license. 9

Circumstances for Granting Compulsory License under Vietnam Law Compared with International Agreements (Source: Ford Foundation) Conditions TRIPS Paris Convention Authorization for uses for public interests due to national emergency or circumstances of extreme urgency Authorization for use for public interests Compulsory license for non-working or inadequate working of patents or abuse of patent rights by the patent holder Compulsory license for refusal to issue a voluntary license Compulsory license to remedy anticompetitive practices Compulsory license in cases of public non-commercial use BTA Vietnamese Law Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes No 10

parallel importation Circular No. 825/2000/TT-BKHCNMT (3 May 2000) of Ministry of Science, Technology and Environment, amended and supplemented by Circular No. 49/2001/TT-BKHCNMT (14 September 2001), guiding the implementation of Decree No. 12/1999/ND-CP Point 8.1: Exceptional cases which do not infringe industrial property rights a) Non-commercial use of protected industrial property subject-matters (this means that the usage is not a commercial activity. Examples include where the protected industrial property subject-matters are used in laboratories, for experiments, for scientific research, for teaching in public non-profit services, for private use for personal needs, etc.). d) The use of, or carrying out of, commercial activities with respect to products or goods which have been introduced to the market (including an oversea market) by the owner of the industrial property, e.g. parallel import of goods or products containing components which are under industrial property protection from a source supplied by licensees or persons or companies/firms subordinate to mother company in the distribution chain, rather than being supplied by the holder of the industrial property rights, shall not be considered as an infringement of the industrial property rights. 11

Protection of Industrial Property Rights in the Field of Pharmaceuticals Pharmaceutical compounds (including polymorphs, isomers, crystalline forms, etc.), compositions (including unit dosage forms, etc.) and uses (as Swiss Style) are patentable Processes for obtaining pharmaceutical product (product directly obtained by process is protected if the process is protected) Products by process (for products not defined by structural features) are patentable Methods for prevention, diagnosis and treatment (including surgical treatment) for human being and animal are not patentable (Decree No. 63/CP, Art. 4.4). Protection of undisclosed test data (Decree No. 54/2000/ND-CP, Art. 18.4; and US-Vietnam BTA, Art. 9.5 and 9.6). 12

Patent status of ARV Drugs Granted patents concerning ARV (including HIV and AIDS treatment) drugs: 27/384 patents concerning pharmaceutical compositions. Patent applications concerning ARV under examination (including HIV and AIDS treatment) drugs: 52/1297 patents concerning pharmaceutical compositions. First line ARV drugs (zidovudine, lamivudine, nevirapine, efavirenz, stavudine) patented for single active compound: None. Second line ARV drugs (tenofovir, didanosine, abacavir, ritonavir, lopinavir, saquinavir) patented for single active compound: None. Example of ARV drug patented for active compound: nelfinavir, nelfinavir mesylate (patent No. 1320, valid until 07 October 2014). Example of ARV drug patented for crystalline form: crystalline form of efavirenz (patent No. 4181, valid until 10 June 2019). 13

Problems Related to IPR and Access to HIV/AIDS Drugs The IPR knowledge is not well recognized in pharmaceutical sector, especially in domestic enterprises. The patent system is not well-exploited in pharmaceutical sector. The problems concerning IPR protection of modern, effective and patented ARV drugs in the future. 14

Options Identified for Increasing Access to HIV/AIDS Drugs Improving the availability of and accessibility to ARV drugs Negotiation for lower drug prices Establishing a forum for domestic negotiation to lower drug prices Participating in international and regional forums to lower drug prices Establishing appropriate mechanism and policy for negotiation to lower drug prices Compulsory licensing Importation Local production of ARV drugs Improving the legal environment Effective and legal exploitation of patent system Capability building and international cooperation Allocation of State budget for access to ARV drugs 15

Thank you very much 16