JURISDICTION REPORT: BRAZIL
GOVERNMENT TECH TRANSFERS HIJACK IP RIGHTS IN BRAZIL
Otto Licks and Carlos Eduardo Aboim Licks Advogados
Te Brazilian government has been attacking the intellectual protection afforded by the WTO TRIPS Agreement to the research-based pharmaceutical industry. One of the means used to implement this policy is the nationalisation of the production of drugs still protected by patents and data package exclusivity. Te nationalisation programme is called PDP/PPP, by which a government owned pharmaceutical company enters into an exclusive contract with a Brazilian national pharmaceutical company for the monopoly of the sales of particular drugs to the government. Some of these nationalisation efforts have a severe impact on drug quality, increasing the risk of distribution of substandard drugs in the country.
Te Interamerican Society of Sanitary Surveillance (SIVS), a non-governmental organisation dedicated to the fight against substandard pharmaceutical drugs and to the implementation of worldwide regulatory standards based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and best practices of pharmacovigilance, achieved an important victory against a public call for 17 tech transfers—worth approximately $500 million in annual sales for the federal government—between the Official Laboratory of the Brazilian Air Force (LAQFA) and private laboratories.
Te complaints were filed before the Federal Accounts Court (TCU) and the military attorney’s office. Aſter being summoned to answer the complaints filed by the SIVS, the LAQFA revoked the public call due to reasons of “public interest”.
Tese tech transfers use the government’s purchasing power to nationalise the production of medicines. Tese partnerships are getting increased attention because (i) the selection of partners is not preceded by public procurement competitive tenders; (ii) the private partner becomes the exclusive supplier of the drug to the government; and (iii) the private partner will be kept as the active pharmaceutical ingredient (API) supplier to the public partner. Moreover, once a medicine or an API is manufactured in Brazil, priority is given to this manufacturer to the detriment of foreign manufacturers.
Te waiver of tender and the choosing of an exclusive supplier for the federal government, the main purchaser of medicines in Brazil, leads to several illegalities. Te most common are:
i. Te medicines are not actually essential;
ii. Te private partner does not possess the technology that it is supposed to be transferred to the government;
iii. Te government does not have the infrastructure necessary to receive technology in order to manufacture;
Otto Licks is a partner at Licks Advogados. He can be contacted at
otto.licks@
lickslegal.com
Carlos Eduardo Aboim is a partner at Licks Advogados. He can be contacted at
carlos.aboim@lickslegal.com
162 World Intellectual Property Review September/October 2013
www.worldipreview.com
“ONCE A MEDICINE OR AN API IS MANUFACTURED IN BRAZIL, PRIORITY IS GIVEN TO THIS MANUFACTURER TO THE DETRIMENT OF FOREIGN MANUFACTURERS.”
iv. Te private partner does not own a marketing approval for the manufacture of the medicine, the necessary plant certifications, good manufacturing practice, etc; and
v. Te medicine subject of the agreement is covered by patents or a pending application, subject to data package exclusivity, among others.
Te intervention of a non-govermental organisation before the bodies responsible for overseeing public procurement is a new development. In the public call promoted by LAQFA, the SIVS pointed out that the medicines were not essential and that a contract for ‘joint development’ of a medicine could not benefit from the waiver of tender, since a tech transfer requires a party that already owns the technology and is capable of transferring it. Te TCU summoned the LAQFA to answer the complaint filed by the SIVS. Aſter it was summoned, LAQFA published the cancellation of the procedure due to reasons of “public interest” on August 1, 2013.
It is good news to see the Brazilian institutions fulfilling their institutional goals towards the protection of the law and the promotion of public health. Te use of tech transfers solely to attain waivers of tenders and to become an exclusive supplier is detrimental to the public interest. Other economic considerations should be also made, such as the drawbacks of investing in the transfer of technologies that will be obsolete at the time that the transfer is complete, but the victory of the SIVS shows that demanding, at least, compliance with the law, can make a significant difference towards the protection of the public interest and the enforcement of IP rights in Brazil.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156 |
Page 157 |
Page 158 |
Page 159 |
Page 160 |
Page 161 |
Page 162 |
Page 163 |
Page 164 |
Page 165 |
Page 166 |
Page 167 |
Page 168 |
Page 169 |
Page 170 |
Page 171 |
Page 172 |
Page 173 |
Page 174 |
Page 175 |
Page 176 |
Page 177 |
Page 178 |
Page 179 |
Page 180 |
Page 181 |
Page 182 |
Page 183 |
Page 184 |
Page 185 |
Page 186 |
Page 187 |
Page 188 |
Page 189 |
Page 190 |
Page 191 |
Page 192 |
Page 193 |
Page 194 |
Page 195 |
Page 196