

Currently released so far... 12453 / 251,287
Browse latest releases
2010/12/01
2010/12/02
2010/12/03
2010/12/04
2010/12/05
2010/12/06
2010/12/07
2010/12/08
2010/12/09
2010/12/10
2010/12/11
2010/12/12
2010/12/13
2010/12/14
2010/12/15
2010/12/16
2010/12/17
2010/12/18
2010/12/19
2010/12/20
2010/12/21
2010/12/22
2010/12/23
2010/12/24
2010/12/25
2010/12/26
2010/12/27
2010/12/28
2010/12/29
2010/12/30
2011/01/01
2011/01/02
2011/01/04
2011/01/05
2011/01/07
2011/01/09
2011/01/10
2011/01/11
2011/01/12
2011/01/13
2011/01/14
2011/01/15
2011/01/16
2011/01/17
2011/01/18
2011/01/19
2011/01/20
2011/01/21
2011/01/22
2011/01/23
2011/01/24
2011/01/25
2011/01/26
2011/01/27
2011/01/28
2011/01/29
2011/01/30
2011/01/31
2011/02/01
2011/02/02
2011/02/03
2011/02/04
2011/02/05
2011/02/06
2011/02/07
2011/02/08
2011/02/09
2011/02/10
2011/02/11
2011/02/12
2011/02/13
2011/02/14
2011/02/15
2011/02/16
2011/02/17
2011/02/18
2011/02/19
2011/02/20
2011/02/21
2011/02/22
2011/02/23
2011/02/24
2011/02/25
2011/02/26
2011/02/27
2011/02/28
2011/03/01
2011/03/02
2011/03/03
2011/03/04
2011/03/05
2011/03/06
2011/03/07
2011/03/08
2011/03/09
2011/03/10
2011/03/11
2011/03/13
2011/03/14
2011/03/15
2011/03/16
2011/03/17
2011/03/18
2011/03/19
2011/03/20
2011/03/21
2011/03/22
2011/03/23
2011/03/24
2011/03/25
2011/03/26
2011/03/27
2011/03/28
2011/03/29
2011/03/30
2011/03/31
2011/04/01
2011/04/02
2011/04/03
2011/04/04
2011/04/05
2011/04/06
2011/04/07
2011/04/08
2011/04/09
2011/04/10
2011/04/11
2011/04/12
2011/04/13
2011/04/14
2011/04/15
2011/04/16
2011/04/17
2011/04/18
2011/04/19
2011/04/20
2011/04/21
2011/04/22
2011/04/23
2011/04/24
2011/04/25
2011/04/26
2011/04/27
2011/04/28
2011/04/29
2011/04/30
Browse by creation date
Browse by origin
Embassy Athens
Embassy Asuncion
Embassy Astana
Embassy Asmara
Embassy Ashgabat
Embassy Apia
Embassy Ankara
Embassy Amman
Embassy Algiers
Embassy Addis Ababa
Embassy Accra
Embassy Abuja
Embassy Abu Dhabi
Embassy Abidjan
Consulate Auckland
Consulate Amsterdam
Consulate Adana
American Institute Taiwan, Taipei
Embassy Bujumbura
Embassy Buenos Aires
Embassy Budapest
Embassy Bucharest
Embassy Brussels
Embassy Bridgetown
Embassy Bratislava
Embassy Brasilia
Embassy Bogota
Embassy Bishkek
Embassy Bern
Embassy Berlin
Embassy Belmopan
Embassy Belgrade
Embassy Beirut
Embassy Beijing
Embassy Banjul
Embassy Bangkok
Embassy Bandar Seri Begawan
Embassy Bamako
Embassy Baku
Embassy Baghdad
Consulate Barcelona
Embassy Copenhagen
Embassy Conakry
Embassy Colombo
Embassy Chisinau
Embassy Caracas
Embassy Canberra
Embassy Cairo
Consulate Curacao
Consulate Ciudad Juarez
Consulate Chennai
Consulate Casablanca
Consulate Cape Town
Consulate Calgary
Embassy Dushanbe
Embassy Dublin
Embassy Doha
Embassy Djibouti
Embassy Dili
Embassy Dhaka
Embassy Dar Es Salaam
Embassy Damascus
Embassy Dakar
Consulate Dubai
Embassy Helsinki
Embassy Harare
Embassy Hanoi
Consulate Ho Chi Minh City
Consulate Hermosillo
Consulate Hamilton
Consulate Hamburg
Consulate Halifax
Embassy Kyiv
Embassy Kuwait
Embassy Kuala Lumpur
Embassy Kinshasa
Embassy Kingston
Embassy Kigali
Embassy Khartoum
Embassy Kathmandu
Embassy Kampala
Embassy Kabul
Consulate Kolkata
Embassy Luxembourg
Embassy Luanda
Embassy London
Embassy Ljubljana
Embassy Lisbon
Embassy Lima
Embassy Lilongwe
Embassy La Paz
Consulate Lahore
Consulate Lagos
Mission USOSCE
Mission USNATO
Mission UNESCO
Embassy Muscat
Embassy Moscow
Embassy Montevideo
Embassy Monrovia
Embassy Minsk
Embassy Mexico
Embassy Mbabane
Embassy Maputo
Embassy Manila
Embassy Manama
Embassy Managua
Embassy Malabo
Embassy Madrid
Consulate Munich
Consulate Mumbai
Consulate Montreal
Consulate Monterrey
Consulate Milan
Consulate Melbourne
Embassy Nicosia
Embassy Niamey
Embassy New Delhi
Embassy Ndjamena
Embassy Nassau
Embassy Nairobi
Consulate Naples
Consulate Naha
Embassy Pristina
Embassy Pretoria
Embassy Prague
Embassy Port Of Spain
Embassy Port Louis
Embassy Port Au Prince
Embassy Phnom Penh
Embassy Paris
Embassy Paramaribo
Embassy Panama
Consulate Peshawar
REO Basrah
Embassy Rome
Embassy Riyadh
Embassy Riga
Embassy Reykjavik
Embassy Rangoon
Embassy Rabat
Consulate Rio De Janeiro
Consulate Recife
Secretary of State
Embassy Suva
Embassy Stockholm
Embassy Sofia
Embassy Skopje
Embassy Singapore
Embassy Seoul
Embassy Sarajevo
Embassy Santo Domingo
Embassy Santiago
Embassy Sanaa
Embassy San Salvador
Embassy San Jose
Consulate Strasbourg
Consulate St Petersburg
Consulate Shenyang
Consulate Shanghai
Consulate Sao Paulo
Embassy Tunis
Embassy Tripoli
Embassy Tokyo
Embassy The Hague
Embassy Tel Aviv
Embassy Tehran
Embassy Tegucigalpa
Embassy Tbilisi
Embassy Tashkent
Embassy Tallinn
Consulate Toronto
Consulate Tijuana
USUN New York
USEU Brussels
US Office Almaty
US Mission Geneva
US Interests Section Havana
US Delegation, Secretary
UNVIE
Embassy Ulaanbaatar
Embassy Vilnius
Embassy Vienna
Embassy Vatican
Embassy Valletta
Consulate Vladivostok
Consulate Vancouver
Browse by tag
ASEC
AORC
AMGT
APER
AU
AF
AS
ACBAQ
AFGHANISTAN
AFIN
AR
AE
AJ
ADANA
AEMR
AG
ATRN
ADPM
APECO
AGAO
AMED
AX
AM
AL
ADCO
AA
AECL
AADP
ABUD
AMEX
ACAO
ANET
AODE
ASCH
AY
APEC
AID
AORG
ASEAN
AFSI
AFSN
AINF
AGR
AROC
AO
AMBASSADOR
AFFAIRS
ASIG
ABLD
ASUP
AND
ARM
ARF
AQ
ATFN
AC
ACOA
AORL
ADM
AUC
AGMT
ACABQ
ASEX
AFU
ALOW
AZ
APCS
AVERY
ASECKFRDCVISKIRFPHUMSMIGEG
AER
AN
AIT
AMG
AGRICULTURE
AMCHAMS
ACS
BR
BA
BD
BL
BO
BF
BU
BILAT
BEXP
BRUSSELS
BK
BN
BM
BT
BY
BX
BTIO
BIDEN
BG
BE
BP
BBSR
BC
BTIU
BWC
BB
BH
BMGT
CH
CY
CA
CU
CS
CO
CVIS
CPAS
CMGT
CE
COUNTER
CASC
COUNTRY
CJAN
COUNTERTERRORISM
CG
CI
CD
CIDA
CJUS
CDG
CBSA
CEUDA
CR
CM
CLMT
CAC
CBW
CODEL
COPUOS
CWC
CIC
CW
CBE
CHR
CFED
CT
CONS
CIA
CTM
CDC
CVR
CF
CLINTON
CITEL
CLEARANCE
COE
CN
CACS
CAN
CONDOLEEZZA
CB
CSW
CITT
CARSON
CNARC
CACM
CDB
CARICOM
COM
CROS
CAPC
CTR
CV
CKGR
CBC
CL
CICTE
CIS
ECON
EFIN
ELAB
ETRD
EIND
EC
EINV
EAGR
ENRG
ETTC
EAID
EPET
ELTN
EWWT
EAIR
EFIS
EMIN
EG
EU
ER
EUN
EPA
ENVI
EXTERNAL
ECPS
ENGR
ETRC
ECIN
EN
EI
ELN
ET
EINT
ETRDEINVTINTCS
ES
ETRDEINVECINPGOVCS
EZ
ETRO
EDU
ETRN
EFTA
EAIG
EK
EUREM
EURN
ECONCS
ECONOMICS
ENVR
ELECTIONS
EAP
ENIV
ECONOMY
ESA
EINN
ECONOMIC
EIAR
EXBS
ECA
ECUN
EINDETRD
EUR
EREL
EUC
ESENV
ECONEFIN
ECIP
ENERG
ENNP
EFINECONCS
EFIM
ENGY
EAIDS
EINVEFIN
EINVETC
EUMEM
ETRA
ETC
ERNG
ETRDECONWTOCS
EUNCH
ECINECONCS
EINVECONSENVCSJA
EXIM
ERD
EEPET
IR
IS
IZ
IAEA
IO
IAHRC
ID
IC
IT
IRAQI
IWC
IN
IL
ISLAMISTS
IV
ICAO
INDO
ITPHUM
ITPGOV
ITALIAN
IPR
ICRC
INTERPOL
IQ
IBET
IMO
INR
ITRA
INTERNAL
ICJ
ICTY
IRS
ILO
INRA
INRO
ISRAELI
IEA
INRB
ITALY
ITU
IBRD
IIP
ILC
INTELSAT
IZPREL
IMF
INMARSAT
IRAJ
IDA
ICTR
IA
IGAD
IF
IDP
ITF
ISRAEL
IEFIN
IRC
IACI
KN
KCRM
KOMC
KNNPMNUC
KIPR
KPAL
KWBG
KSCA
KFRD
KNNP
KUNR
KTIP
KWMN
KSTC
KFLU
KOLY
KISL
KPAO
KMDR
KJUS
KSTH
KDEM
KCOR
KIRF
KAWC
KU
KTFN
KWAC
KNPP
KERG
KSEO
KACT
KHLS
KZ
KGHG
KTIA
KFRDCVISCMGTCASCKOCIASECPHUMSMIGEG
KCRCM
KE
KPKO
KCIP
KDRG
KVPR
KV
KIDE
KICC
KPRP
KBIO
KSUM
KGIT
KCFE
KG
KBTS
KFLO
KMPI
KS
KGIC
KPAI
KHSA
KTLA
KSEP
KTEX
KFSC
KOCI
KHDP
KPLS
KTDB
KHIV
KCSY
KSAC
KTRD
KID
KMRS
KOM
KSAF
KRVC
KR
KMOC
KNAR
KIRC
KBCT
KSPR
KFIN
KBTR
KJUST
KNEI
KAWK
KGCC
KMCA
KREL
KMFO
KFRDKIRFCVISCMGTKOCIASECPHUMSMIGEG
KFTFN
KVRP
KCOM
KO
KLIG
KAID
KVIR
KNSD
KHUM
KSEC
KRAD
KPRV
KCMR
KPWR
KCHG
KIFR
KCFC
KICA
KPIN
KSCI
KESS
KDEV
KTBT
KCRS
KCGC
KOMS
KRIM
KTER
KREC
KPOA
KWWMN
KRGY
KPAK
KWNM
KMIG
KDDG
KRFD
KWMM
KWMNCS
KX
KRCM
KPAONZ
KNUC
KDEMAF
KNUP
MARR
MOPS
MASS
MCAP
MTCRE
MNUC
MIL
MX
MEDIA
MO
MPOS
MU
ML
MA
MP
MY
MERCOSUR
MG
MD
MW
MK
MAS
MEETINGS
MR
MT
MI
MOPPS
MASC
MTS
MLS
MILI
MAR
MTRE
MEPN
MAPP
MTCR
MEPI
MQADHAFI
MAPS
MARAD
MASSMNUC
MEPP
MCC
MZ
MILITARY
MDC
MRCRE
MC
MV
MIK
MUCN
NATO
NL
NZ
NPT
NI
NAFTA
NU
NDP
NIPP
NP
NPA
NG
NRR
NO
NSC
NEW
NE
NH
NR
NA
NS
NSF
NZUS
NATIONAL
NSG
NC
NT
NAR
NK
NGO
NV
NSFO
NSSP
NASA
NW
NPG
NORAD
NATOPREL
OTRA
OAS
OPRC
OIIP
OVIP
OREP
OPDC
OEXC
OSCE
OFFICIALS
OMIG
ODIP
OFDP
OECD
OPIC
OBSP
OPCW
OFDA
OTR
OSAC
OSCI
ON
OCII
OES
OVP
OIC
OPAD
OIE
OHUM
OCS
PREL
PGOV
PK
PHUM
PINS
PARM
PA
PTER
PINR
PREF
PHSA
PBTS
PBIO
PO
POL
PE
PARMS
PM
PROG
PL
PAK
POLITICS
PORG
PTBS
PNAT
PUNE
POLICY
PDOV
PCI
PROP
PGOVSMIGKCRMKWMNPHUMCVISKFRDCA
PBT
PP
PS
PAO
PG
PY
PTERE
PGOF
PALESTINIAN
PKFK
PSOE
PEPR
PPA
PINT
PMAR
PRELP
PSEPC
PREFA
PGOVE
PINF
PHUMPGOV
PNG
PMIL
PGOC
PFOR
PCUL
PLN
PSA
PGIV
POLINT
PAS
POGOV
PHUMPREL
PHUMBA
PEL
PGGV
PNR
PHALANAGE
PARTY
PGOVLO
PRAM
PHUS
PDEM
PECON
PF
POV
PROV
PRL
PREO
PAHO
PHUH
PSI
PINL
PU
PRGOV
PAIGH
POLITICAL
PARTIES
POSTS
RS
RU
REACTION
REPORT
REGION
RIGHTS
RO
RW
RCMP
RF
RM
RFE
RSP
RP
RICE
ROBERT
ROOD
RELATIONS
RIGHTSPOLMIL
RUPREL
RSO
SU
SNAR
SO
SOCI
SW
SENV
SMIG
SCUL
SP
SZ
SENVKGHG
SR
SY
SA
SYRIA
SF
SI
SC
SWE
SARS
STEINBERG
SN
SG
SIPRS
ST
SEVN
SL
SPCE
SNARIZ
SSA
SNARCS
SYR
SK
SPCVIS
SHUM
SIPDIS
SHI
SH
SOFA
SEN
SNARN
SAARC
SAN
SANC
SCRS
TRGY
TBIO
TU
TF
TERRORISM
TI
TSPL
TPHY
TH
TIP
TSPA
TC
TO
TW
TX
TZ
TNGD
TT
TL
TV
TFIN
TS
TRSY
TINT
TN
TURKEY
TBID
TD
TK
TR
THPY
TP
TAGS
UNGA
UN
UK
US
UNC
UNSC
USUN
UG
UP
UY
USEU
UNESCO
USPS
USTR
UZ
UNHRC
UNO
UNMIK
UNAUS
UNHCR
UNCHR
USAID
UNVIE
UAE
USOAS
UNFICYP
UV
UNEP
UNODC
UNCHS
UNIDROIT
UNDESCO
UNDC
UNCHC
UNDP
UNCND
USNC
UNPUOS
UNICEF
UNCSD
UE
Browse by classification
Community resources
courage is contagious
Viewing cable 09BRASILIA1338, BRAZIL IPR UPDATE: PHARMACEUTICAL SECTOR
If you are new to these pages, please read an introduction on the structure of a cable as well as how to discuss them with others. See also the FAQs
Understanding cables
Every cable message consists of three parts:
- The top box shows each cables unique reference number, when and by whom it originally was sent, and what its initial classification was.
- The middle box contains the header information that is associated with the cable. It includes information about the receiver(s) as well as a general subject.
- The bottom box presents the body of the cable. The opening can contain a more specific subject, references to other cables (browse by origin to find them) or additional comment. This is followed by the main contents of the cable: a summary, a collection of specific topics and a comment section.
Discussing cables
If you find meaningful or important information in a cable, please link directly to its unique reference number. Linking to a specific paragraph in the body of a cable is also possible by copying the appropriate link (to be found at theparagraph symbol). Please mark messages for social networking services like Twitter with the hash tags #cablegate and a hash containing the reference ID e.g. #09BRASILIA1338.
Reference ID | Created | Released | Classification | Origin |
---|---|---|---|---|
09BRASILIA1338 | 2009-11-20 13:01 | 2010-12-16 06:06 | UNCLASSIFIED//FOR OFFICIAL USE ONLY | Embassy Brasilia |
VZCZCXRO4128
PP RUEHRG
DE RUEHBR #1338/01 3241351
ZNR UUUUU ZZH
P 201351Z NOV 09
FM AMEMBASSY BRASILIA
TO RUEHC/SECSTATE WASHDC PRIORITY 5389
RUCPDOC/DEPT OF COMMERCE WASHDC
INFO RUEHSO/AMCONSUL SAO PAULO 0085
RUEHRI/AMCONSUL RIO DE JANEIRO 0041
RUEHRG/AMCONSUL RECIFE 0113
RUEHNE/AMEMBASSY NEW DELHI 0612
RUCPDOC/USDOC WASHDC
UNCLAS SECTION 01 OF 04 BRASILIA 001338
SENSITIVE
SIPDIS
DEPT PASS USTR FOR KATHERINE KALUTKIEWICZ AND TANUJA GARDE DEPT PASS USPTO
E.O. 12958: N/A
TAGS: KIPR ETRD ECON BR
SUBJECT: BRAZIL IPR UPDATE: PHARMACEUTICAL SECTOR
REF: A) BRASILIA 1175
B) Brasilia 1017
SENSITIVE BUT UNCLASSIFIED - NOT FOR DISTRIBUTION OUTSIDE USG
¶1. (SBU) SUMMARY: The Brazilian judicial and legislative branches are in the process of examining two key pharmaceutical patent-related issues - the role of the national health vigilance agency (ANVISA) in reviewing pharmaceutical patent applications and the constitutionality of Brazil's pipeline patent system. There has been no resolution of a disagreement between the Brazilian patent office (INPI) and the Inter-Ministerial Intellectual Property Group (GIPI) regarding patents for polymorphs and second uses. In addition, INPI's stated reasoning for a recent patent denial (lack of inventive step) raises potential questions about the treatment of incrementally innovative pharmaceutical patent applications - though underlying political pressure to lower costs for Brazil's AIDS program may have been at work in that case. With Brazil preparing for a major election in October 2010, it is possible that no definitive action will be taken on these topics in the near future. END SUMMARY.
JUDICIAL AND LEGISLATIVE REVIEWS OF ANVISA ROLE ------------------------------------------------------------------------------------------
¶2. (SBU) Article 229C of Law 9279/1996 (Brazil's IP Law) requires ANVISA's "prior informed consent" before a pharmaceutical patent can be approved. In an October meeting with Econoff, federal judge Liliane Roriz explained that there have been several federal court decisions in recent years regarding ANVISA's role in reviewing pharmaceutical patent applications. Two decisions in the first instance ruled against the intervention of ANVISA in patentability criteria and two ruled for it. At the appellate level, one decision (in which Judge Roriz participated) ruled against ANVISA's intervention and the other found such intervention to be legal. Judge Roriz's written opinion in the case, which she repeated to Econoff, stated that ANVISA should have, at most, a reference role in that ANVISA has more comprehensive files regarding prior art for pharmaceutical inventions.
¶3. (U) On November 6, the Brazilian attorney general (as a result of a formal request brought by the Brazilian patent office, INPI) issued an opinion (No. 210/PGF/AE/2009) ruling against ANVISA's current practice of reviewing patentability requirements. The opinion states that ANVISA has the authority to examine patent applications only with regards to a public health perspective. According to the opinion, the patentability requirements of a pharmaceutical invention can only be examined by INPI, since ANVISA's competency is limited to preventing the production and marketing of products and services potentially harmful to human health. The opinion has been presented for review to the office of the President.
¶4. (U) Separately, the Brazilian legislature is also examining ANVISA's role in reviewing pharmaceutical patent applications. Draft Law 3709 of 2008 (currently pending review by the House of Representatives' Committee on Economic Development, Industry, and Commerce) would strike from Brazil's IP law the requirement for ANVISA's prior consent on issuance of pharmaceutical patents. The written justification for Draft Law 3709 explains that Section 229C of the IP Law, where it is stated that pharmaceutical patent approval shall depend on the prior consent of ANVISA, was intended only to apply to pipeline patents - the direct subject of Sections 229-231.
¶5. (U) Brazil implemented the pipeline system as part of adopting the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Under the pipeline system Brazil began recognizing in 1996 pharmaceutical patents that had been filed in other countries before Brazil allowed such patents. Affected patents were recognized based on the date of first foreign filing, so long as the patent was approved in a foreign country, the patent subject matter was not previously marketed in Brazil, and the application was filed within one year of the publication of the Intellectual Property Act of 1996. Such pipeline patents would expire on the date corresponding to their original foreign-issued patent or not more than 20 years from the date of their filing in Brazil.
¶6. (U) On November 10, Econoff attended a public hearing at the Brazilian Chamber of Deputies. Former Deputy Ney Lopes, who served as rapporteur for the law that introduced Section 229C, testified that the intention at the time was for the section to be limited in scope to pipeline patents. He said that the current application of Section 229C implies doubt of INPI's competency and needlessly duplicates work. Professor Aluizo Borem, representing the Brazilian National Technical Committee on Biosafety (CTNBio), emphasized the long process for creating new drugs and treatments and argued that Brazil should aim for a regulatory environment conducive to innovation. He argued that a plain reading of the IP Law shows that Section 229C applied only to pipeline patent applications and that to require ANVISA's consent on non-pipeline patents serves only to add bureaucratic steps without legal justification or benefit to society. Deputy Moreira Mendes agreed that the requirement for ANVISA's prior consent is not well-grounded in the law, nor does it recognize the separate competencies of ANVISA and INPI. In making broader comments on patents and public interest, he pointed out that generics would not exist without the breakthroughs and investments of original drug manufacturers.
¶7. (U) Celia Chaves, President of the Brazilian National Federation of Pharmacists (FENAFAR) and representing the IP Working Group of the Brazilian Network for the Integration of All People, argued that international standards and agreements confirm the primacy of public health over commercial interests. She said that Section 229C was not specific to pipeline patents and should be maintained in its entirety, since ANVISA's review is more rigorous than that of INPI and is conducted with public health in mind. She decried the "delaying strategies" of brand-name drug makers and claimed that only 15% of drugs approved by the U.S. Food and Drug Administration between 1989 and 2000 were "truly innovative." The remainder, she argued, are for things like new salt forms or polymorphs of existing molecules, which are "not that hard" to create and "do not have new therapeutic benefits." (Note: This statistic is drawn from a May 2002 report published by the U.S. National Institute for Health Care Management Research and Education. The Pharmaceutical Research and Manufacturers of America [PhRMA] issued a critique of this report noting that the referenced statistics arbitrarily exclude large numbers of medicines, specifically vaccines and biologics, and misuses the FDA's Priority Review Classification System in assessing what drugs are innovative. End note.) As for the competencies of INPI and ANVISA, Ms. Chaves interpreted that Section 101 of the IP Law, which defines the competency of INPI, does not give INPI exclusive dominion over patents.
¶8. (U) Odinir Finotti, President of the Brazilian Generic Manufacturers Association (ProGenericos), said that the generic industry wants to follow the law as it is written but that brand-name manufacturers are using deceptive strategies to extend the life of their patents, including pipeline patents. He argued that patents granted today would have no benefit for public health in Brazil until their expiration in 20 years and that Brazil is best served by maintaining ANVISA's review in order to be more cautious about the concession of patent rights.
---------------- PIPELINE PATENTS ----------------
¶9. (SBU) In April 2009, the Brazilian Attorney General submitted to the Federal Supreme Court (STF) a challenge to the constitutionality of the pipeline patent system. According to the Attorney General's submission, inventions patented under the pipeline system did not meet the requirement for novelty since they were publicly released once the patent application was submitted outside of Brazil. The STF has not yet ruled on this case. Federal Judge Roriz told Econoff that she finds the case "ridiculous" and feels that it would not make sense to declare pipeline patents unconstitutional thirteen years after the measure was implemented. It is an indication of the weakness of the case, she says, that it took so long to bring a file to the STF. 10. (U) The STF has not yet issued any opinions on the case.
-------------------- VOICES IN THE DEBATE ----------------------
¶11. (SBU) Post has reported previously (ref A) that the Ministry of Exterior Relations (MRE) and the Ministry of Health (MOH) frequently argue that IP protection is only one path (and an optional one at that) to innovation and economic development and that it must be balanced against the public interest. While the Ministry of Development, Industry, and Commerce (MDIC) has seemed more willing to consider IP protection as a key component of economic development, MDIC's Secretary of Industrial Technology Francelino Grando recently supported the MRE and MOH view during opening remarks at a November 5 seminar on IP and Innovation hosted by the Brazilian Association of Fine Chemical Industries (ABIFINA - an organization whose members include major Brazilian generic drug manufacturers like Ache, Eurofarma, and EMS). Secretary Grando stated that the GOB should resist international pressure for more concessions (i.e. TRIPS-plus) on IP and underlined the legitimacy of subordinating patent policy to the interests of economic and social development.
¶12. (U) The ABIFINA seminar was structured into three panels on the judicial, economic, and social aspects of intellectual property. The majority of the panelists focused on what they called the anti-competitive nature of pharmaceutical patents and the impact to society of decreased access to medications. One panelist, Professor Bruno van Pottelsberghe of the Free University of Brussels, focused his presentation on the factors in various patent systems that affect the quality of approved patents (which he found to be worst in the U.S. Patent and Trademark Office), but he also pointed out that pharmaceutical companies take on tremendous financial investments and risks to develop and test new drugs. Unless governments are willing to take on that role themselves, he said, they must acknowledge the public interest in access to as-yet-undeveloped medicines.
¶13. (U) Ronaldo Fiani, a professor of economics at the Federal University of Rio de Janeiro, said there are two "myths" dominating the patent conversation - the myth that patents are "good monopolies" and the myth that IP protection is an effective incentive for innovation. Professor Fiani expressed dismay that Brazil's own competition authority (CADE) has made public arguments for the benefits of the temporary monopoly granted by IP protection. He went on to say that only technical capacity-building can promote innovation and that economists invented the myth of IP protection as an incentive to innovate. Professor van Pottelsberghe responded that while some elements of the current patent system may be flawed, IP protection is not a carrot enticing a horse to run, but rather the road itself. That is, IP protection is a fundamental pre-condition for innovation and economic development.
-------------POLYMORPHS AND SECOND-USE PATENTS -----------------
¶14. (U) The December 2008 Inter-Ministerial Group on Intellectual Property (GIPI) decision against patentability of polymorphs and new medical indications of existing drugs (second-use patents) has yet to be implemented by a change in Brazil's patent law. INPI tells IPR Attach that they continue to evaluate applications on a case-by-case basis, approving patent applications that meet the patentability requirements of novelty and inventive step. Draft Law 2511 of 2007 would amend the Brazilian patent law to disallow second-use patents. The draft law has been awaiting consideration by the Brazilian House of Representatives' Committee on Economic Development, Industry, and Commerce since August 2009.
------------------------------- TENOFOVIR -------------------------------------------
¶15. (SBU) As reported previously (ref B), the case of U.S. pharmaceutical company Gilead's rejected patented application for the AIDS drug tenofovir has raised concerns about INPI's stance on patents for incrementally innovative drugs. (Note: Gilead has not yet filed a planned judicial appeal in Brazil. End note.) A patent application for the same drug was refused by the Indian patent office in September 2009, based partly on pre-grant opposition filed by the Brazilian AIDS advocacy group Brazilian Interdisciplinary AIDS Association (ABIA) in cooperation with an Indian NGO. ABIA's opposition filing stated that a patent in India would have a direct impact on the ability of Brazil to produce and access generic versions of tenofovir.
-------------------------------- COMMENT ------------------------------------------
¶16. (SBU) The issues surrounding patents for pharmaceutical products are unlikely to be resolved during the lead-up to the October 2010 elections. With the media and elite's attention focused on the campaigns for president, all 26 state governors, two-thirds of the Senate, and all federal deputies, Post expects that action in most controversial areas will be stalled until after a new government is in place in January 2011. President Lula's BRASILIA 00001338 004 OF 004 sustained popularity is largely based on his personal connection with the country's lower classes and his party (with current Presidential Chief of Staff Dilma Rousseff as its presidential candidate) will not want to jeopardize that populist touch. Given the popularly-held belief that pharmaceutical patents benefit multi-national drug companies at the expense of the Brazilian public, reforms to strengthen Brazil's patent system are not vote-winners and therefore are unlikely to be pursued over the next twelve months. END COMMENT. KUBISKE