[Random-bits] KEI Statement on Thailand Compulsory licenses
James Love
james.love@cptech.org
Thu Jan 25 07:50:15 2007
Knowledge Ecology International (KEI) Statement on Thailand =20
Compulsory licenses
FMI:
Washington DC James Love (james.love@cptech.org, mb +1.202.361.3040, =20
today +41.76.413.6584), or Judit Rius (judit.rius@cptech.org =20
+1.202.332.2670)
Geneva: Thiru Balasubramaniam (thiru@cptech.org, mb.+41.76.508.0997)
London: Michelle Childs (michelle.childs@cptech.org, mb +44 =20
790.386.4642)
January 25, 2007
=93Knowledge Ecology International (KEI) applauds the decision by the =20=
Thailand Ministry of Health to issue new compulsory licenses on =20
patents for the AIDS drug Kaletra (LPV+RTV) and the heart disease =20
drug Plavix.(clopidogrel bisulfate). We expect that Thailand will =20
issue other compulsory license on medicines in the future.
According to KEI Director James Love: =93Unless the Thailand =20
government uses the flexibility in the TRIPS to issue compulsory =20
licenses on patents, the people who live in Thailand will suffer from =20=
limited access to medicines. More than five years after the 2001 =20
Doha Declaration on TRIPS and Public Health called upon WTO members =20
to implement the TRIPS =91in a manner supportive of WTO Members' right =20=
to protect public health and, in particular, to promote access to =20
medicines for all,=92 Thailand is doing just that. Every country that =20=
applauded the landmark 2001 Doha Declaration should applaud actions =20
that turn words into actions, and actions that expand access to =20
medicines.
=93The prices that Abbott charges for Kaletra and other second line =20
AIDS drugs are too high, and no developing country with significant =20
HIV infection rates will be able to provide sustainable treatments =20
for AIDS patients, unless they stimulate a generic market for =20
products. Compulsory licenses in Thailand and other countries will =20
stimulate investment by generic companies to create new fixed dose =20
combinations that have better delivery mechanism. The benefits of =20
these compulsory licensees will grow over time, in terms of cheaper =20
prices and better products.
=93The compulsory licenses on the Plavix (clopidogrel bisulfate) =20
patents are very important also, as Thailand take steps to address =20
the issue of heart disease, a condition the WHO says is the leading =20
cause of death for both men and women. According to a new WHO =20
report, =91Heart disease, stroke and diabetes alone are estimated to =20
reduce the gross domestic product by between 1% and 5% per year in =20
low-and middle-income countries experiencing rapid economic growth.=92[1]
=93A growing number of NGOs, economists, health experts and governments =20=
now say that concerns about R&D for new products should no longer be =20
focused on measures that create high prices on medicines, but rather =20
on a new global framework to support medical innovation. This week =20
the World Health Organization (WHO) Executive Board is discussing =20
procedures to create a new global plan of action that promotes both =20
innovation and access. This should be where we push for more =20
investment in innovation.
=93Below are two documents. The first are excerpts from the recent WHO =20=
report on non-communicable diseases. The second is a background =20
document on recently disputes involving compulsory licenses on =20
patents.[2] The second document illustrates that compulsory =20
licensing is more common than is commonly thought, including =20
compulsory licenses outside of the health area." Love said.
[1] Excerpts from: EXECUTIVE BOARD EB120/22, 120th Session
Provisional agenda item 4.5
Prevention and control of noncommunicable diseases: implementation of =20=
the global strategy
Report by the Secretariat, 8 January 2007
3. The global epidemic of chronic noncommunicable diseases continues =20
to grow. In 2005, they caused an estimated 35 million deaths: 60% of =20
all deaths globally, with 80% in low- and middle income countries and =20=
about 16 million in people under 70 years of age. Cardiovascular =20
disease is the leading cause of death among both men and women, =20
accounting for more than 17 million deaths in 2005. Total deaths from =20=
chronic disease are projected to increase by a further 17% over the =20
next 10 years, while deaths from infectious diseases, maternal and =20
perinatal conditions and nutritional deficiencies combined are =20
expected to decline.
9. WHO=92s report on preventing chronic diseases1 synthesized =20
information, presented new projections of the epidemiological and =20
economic burden of these diseases and has begun to dispel many common =20=
misunderstandings. It demonstrated that chronic diseases and poverty =20
are tied into a vicious cycle, and that their impact shackles the =20
macroeconomic development of many countries. Heart disease, stroke =20
and diabetes alone are estimated to reduce the gross domestic product =20=
by between 1% and 5% per year in low-and middle-income countries =20
experiencing rapid economic growth. In China, the Russian Federation =20
and India, estimated losses in national income over the next 10 =20
years due to these diseases are (in international dollars) $ 558 000 =20=
million, $ 303 000 million and $ 237 000 million, respectively. The =20
report also examined the large and increasing body of evidence of =20
simple, inexpensive and cost-effective measures that can produce =20
rapid health gains. It emphasizes that the full response to the =20
double burden of infectious and chronic noncommunicable diseases =20
still faced by many countries, even under severe resource =20
constraints, requires a strong primary health-care system as part of =20
an integrated health system. It has spurred policy action in many =20
countries, including several with a high burden of chronic diseases. =20
Work is under way to examine and explain the links between chronic =20
noncommunicable diseases and both development and human security, and =20=
their contribution to health inequalities.
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
[2] Recent Compulsory licenses
James Love, Knowledge Ecology International (KEI)
25 December 2006
The following are recent examples of the use of compulsory =20
licenses. This is not exhaustive list. It includes cases involving =20=
both medical technologies and other technologies, and successful and =20
unsuccessful compulsory licensing requests.
North America
United States
Mandatory compulsory license patents whose term was extended by =20
GATT implementation
For patents that were extended by the change from 17 years from the =20
patent grant to 20 years from the patent application (the =93delta=94 =20=
period), the Congress created a mandatory compulsory license. The =20
compulsory license applied to over 100 brand name pharmaceutical =20
products. However, drug registration issues that were not addressed =20
in the GATT implementation legislation undermined the benefits of the =20=
compulsory license in the pharmaceutical sector.1
Cases involving government use under 28 USC 1498
In 2001, DHHS Secretary Tommy Thompson used the threat to use 28 USC =20
1498 to authorize imports of generic ciprofloxacin, for stockpiles =20
against a possible anthrax attack.
In 2005, the US Department of Justice cited its right to use patents =20
in 28 USC 1498 when it opposed injunctive relief for infringement of =20
the patents relating to the Blackberry email services supplied to =20
both the government and private firms that used the Blackberry device =20=
to communicate with the government.2
In a November 2005 Congressional hearing, DHHS Secretary Michael =20
Levitt testified before the House of Representatives that he had =20
threatened to override the patents on treatments for Avian Flu if =20
companies had not expanded US production facilities.3
Cases involving Bayh-Dole Act
In 2001, the Department of Health and Human Services used its =20
authority to exercise March-In rights for patents on stem cell lines =20
held by the Wisconsin Alumni Foundation as leverage to secure an open =20=
license on those patents.4
In 2004, DHHS refused to grant march-in rights in two cases brought =20
by Essential Inventions, involving patents on the AIDS drug ritoanvir =20=
and the glaucoma drug latanoprost.
In 2006, the Centers for Disease Control threatened to use US Bayh-=20
Dole =93march-in=94 rights to issue compulsory licenses on patents on =20=
reverse genetics, which are needed to manufacture vaccines for avian =20
flu.
Cases involving merger reviews
In 2002, the US FTC ordered a compulsory cross-license of the Immunex =20=
tumor necrosis factor (=93TNF=94) patent, to Serono, including the =20
=93freedom to practice in the research, development, manufacture, use, =20=
import, export, distribution and sale of TNFbp-I Products and certain =20=
glycosylated and nonglycosylated fragments, derivatives and analogs =20
thereof in the United States.=94
In 2005, the FTC ordered a compulsory license of Guidant=92s =20
intellectual property surrounding the RX delivery system for Drug-=20
Eluting Stents.
Cases involving non-merger remedies to anticompetitive practices
In 2002, the US Department of Justice required Microsoft to license =20
on reasonable and non-discriminatory terms intellectual property =20
rights in a number of different protocols needed to create products =20
that were interoperable with Microsoft Windows.5
Cases involving the new US Supreme Court standard for granting =20
injunctions on patents. [eBay Inc. v. MercExchange, L.L.C., 126 S. =20
Ct. 1837, 1839-1841 (U.S. 2006)].
In June 2006, a court granted Microsoft a compulsory license to use =20
two patents owned by z4 Technologies that relate to digital rights =20
management systems used by Microsoft for its Windows and MS Office =20
software programs.
In July 2006, a court granted DirectTV a compulsory license to use =20
the Finisar patent on integrated receiver decoders (satellite set top =20=
boxes), for a royalty of $1.60 per device.
In August 2006, a court granted Toyota a compulsory license on three =20
Paice patents for hybrid transmissions, for a royalty of $25 per =20
automobile.
In September 2006, a court granted Johnson and Johnson a compulsory =20
license to use three of Jan Voda=92s patents on guiding-catheters for =20=
performing angioplasty.
Canada
In a September 2001 Speech on the Myriad Gene Patent, the Ontario =20
Health Minister called for compulsory licensing of patents on genes =20
relevant to tests for breast cancer. In January 2002, the Ontario =20
Advisory Committee on New Predictive Genetic Technologies published =20
=93the Ontario Report to Premiers: Genetics, Testing & Gene Patenting: =20=
Charting New Territory in Healthcare.=94 This report noted that the =20
Doha Declaration calls upon nations to take measures =93to protect =20
public health and, in particular, to promote access to medicines for =20
all,=94 and concluded:
In order to prevent the statement from providing a hollow right, the =20
concept of promoting access to medicines for all must include =20
providing access to the diagnostic procedures necessary to determine =20
when and which medicines to provide. The federal government should, =20
therefore, amend the Patent Act to specifically allow thepotential =20
for compulsory licensing of patents relating to the provision of =20
genetic diagnostic and screening tests should this power be necessary.
On October 18, 2001, Health Canada overrode the Bayer patents on =20
ciprofloxacin, and authorized generic manufacture for purposes of =20
building a stockpile as protection against an attack of certain =20
strains of anthrax. In announcing the action, Paige Raymond Kovach, a =20=
spokeswoman for Health Canada, said: =93These are extraordinary and =20
unusual times . . . Canadians expect and demand that their government =20=
will take all steps necessary to protect their health and safety.''
On May 14, 2004, Canada passed BILL C-9: An Act to amend the Patent =20
Act and the Food and Drugs Act. The law came into force on May 14, =20
2005 creating Canada's Access to Medicines Regime (CAMR). The purpose =20=
of the legislation is to allow Canadian manufacturers to export =20
medicines to countries lacking manufacturing capacity. Proposed =20
royalties paid to the patent holder vary according to the importing =20
country's Human Development Index. The benefits of the Act are =20
limited to products listed on =93Schedule 1,=94 the list of patented =20
pharmaceutical products that are eligible to be exported under the =20
compulsory license. Civil society groups supported the passage of the =20=
legislation, yet they also pointed out a number of flaws in the bill.
There have been three requests for compulsory licenses under the =20
CAMR. The first was a December 14, 2004 request from Essential =20
Inventions, for the manufacture and export of Imatinib Mesylate to =20
Chile. The Canadian government was not responsive. The second was a =20
request from Apotex and MSF for the manufacture and export of a fixed =20=
dose combination for the treatment of AIDS. The third was a February =20
13, 2006 request from Biolyse Pharma Corporation, for patents on =20
oseltamivir phosphate, a product sold by Roche under the brand name =20
Tamiflu.
On August 31, 2005, Schedule 1 of the Patent Act was amended to add =20
lamivudine (150 mg) + nevaripine (200 mg) + zidovudine (300 mg) =20
tablets =96 the fixed dose combination in the Apotext/MSF application.
On July 1, 2006, the Canadian government published a proposed =20
amendment to Schedule 1 of the Patent Act to add oseltamivir =20
phosphate (75 mg capsules and 12 mg/mL powder for oral suspension), =20
which is used in the treatment and prophylaxis of Type A and Type B =20
influenza. In September 2006, the product was included in Schedule 1.
Apotex claims as defense to an infringement claim, that it=92s sales of =20=
generic copies of AstraZeneca=92s Zestril and Merck=92s Prinivil tables =20=
are permitted under terms of a compulsory license. A trial started in =20=
January 2006.6
On May 7, 2004, Torpham successfully appealed a rejection of a =20
compulsory license application involving Merck patents for the =20
manufacture and sale of Lisinopril.7 Torphan had sought a license to =20
the use the patents for purposes of manufacturing and exporting to =20
the United States. The court help that the request for the compulsory =20=
license had sufficient merit to be proceed to the next stage. The =20
court held that serving export markets abroad constitutes Canadian =20
demand for the patented product.
On September 16, 1998, Brantford asked a Canadian federal court for =20
an order compelling Merck to licence patents needed to manufacture =20
SESIC. On April 30, 1999, Brantford filed another application for a =20
compulsory license. The case involved a number of procedural disputes =20=
and appeals, such as a February 2, 2005 court decision rejecting =20
Merck=92s efforts dismiss the compulsory licensing application on =20
certain procedural grounds.8 A hearing on the compulsory license was =20
held in April 2005 before the Patent Appeal Board. On September 1, =20
2005, the Patent Appeal Board upheld an earlier rejection of the =20
compulsory license. Brantford appealed to the court. On November 7, =20
2006, a court in British Columbia upheld the rejection of the =20
compulsory license, holding the Commissioner of patents had not erred =20=
in determining that patent abuse had not been established, since it =20
was reasonable for the Commissioner to find on the evidence that =20
there was no genuine market demand for the product, and that it was =20
reasonable to find that not enough time had been afforded Merck to =20
respond to Brantford=92s request for a licence, and Merck=92s silence =20=
could not be construed as a refusal to license.9
EUROPE
On April 29, 2004, the European Court of Justice issued a preliminary =20=
ruling on compulsory licensing of intellectual property rights under =20
European competition law, in the IMS Health vs NBC case. The ECJ held =20=
that under certain circumstances an obligation to license an =20
intellectual property right exists. The four conditions were:
1. The intellectual property right should constitute, =20
upstream, an indispensable factor in the downstream supply of a =20
(secondary) product.
2. The potential licensee should intend to produce new goods =20=
or services not offered by the owner of the right, and for which =20
there is a potential consumer demand.
3. The refusal should not be justified by objective reasons.
4. The refusal should be of such a nature that it reserves =20
for the owner of the right the market for the provision of the =20
product, by eliminating all competition on that market.
United Kingdom
Following the passage of Directive 98/44/EC of the European =20
Parliament and of the Council of 6 July 1998 on the Legal Protection =20
Of Biotechnological Inventions, the United Kingdom amended its patent =20=
law to provide for mandatory compulsory cross-licenses of certain =20
biotechnology inventions used for agriculture. The license is =20
available to plant breeders who demonstrate a technical advance. The =20
December 6, 2006 UK Gowers Review noted the British Society of Plant =20
Breeders complained the provision is =93ineffective in the UK at =20
least=94, because to prove an advance the product must actually be =20
created, thereby infringing the patent, in calling for an expanded =20
research exception, to permit broader use of the compulsory license.
Germany
In 2000, Roche asked the German government to grant a compulsory =20
license on a patent protecting the Blood Screening HIV Probe owned by =20=
Chiron. On May 22, 2001, a licensing agreement was reached between =20
Roche and Chiron. In return for its license, Roche agreed to end its =20
attempts to obtain a compulsory license.10
France
RU 486
France considered the use of compulsory licenses in the case of the =20
abortion pill RU 486, which was developed by the French =20
pharmaceutical manufacturer ROUSSEL UCLAF. In response to threats of =20
boycotts by pro-life organizations, the company withdrew the product =20
from the market. In the subsequent efforts by the French government =20
to reverse the decision, a court ruled the government could obtain =20
access to the medicine by using the ex-officio license system. =20
Earlier, however, the product was already back on the market, so the =20
ex officio license was not needed
BRAC1 and BRAC2 patents on breast cancer tests
France was among several European countries who were outraged by the =20
high prices of breast cancer diagnostic tests, because of the Myriad =20
gene patents. In 2004, France amended its patent law to allow the =20
broader use of ex officio licenses, and in particular, to authorize =20
the government to issue ex officio licenses to patents on certain =20
dialogistic technologies. The new act provide that:
Where the interests of public health demand, and in the absence of a =20
voluntary agreement with the patent holder, the minister responsible =20
for industrial property, may, by order of the minister responsible =20
for public health, request ex officio licenses in accordance with =20
Article L. 613-17 for any patent granted for:
a) a medicine, a medical device, a medical device for in vitro =20
diagnosis, a related therapeutic product;
b) processes for obtaining them, [or] for products necessary in =20
obtaining such medicines or for processes for manufacturing such =20
products
c) a diagnostic method ex vivo.
Belgium
Belgium modified its patent law in 2005, creating a new compulsory =20
cross-license for biotechnology inventions, and also a new compulsory =20=
license for public health purposes.11
Italy
SORIN BIOMEDICA/SNIA
On June 14, 1994, Sorin Biomedica S.p.A. filed a lawsuit with the =20
Court of Milan, Italy against Chiron Corporation and Ortho Diagnostic =20=
Systems S.p.A. for a declaration of nullity and noninfringement of =20
the Italian counterpart to Chiron's European Patent 0 318 216 (the " =20
'216 patent"). Sorin additionally filed a request with the Italian =20
Ministry of Industry, Commerce and Artisanship ("ICA") for compulsory =20=
license to the '216 patent. Chiron filed a counterclaim and sought a =20
finding that the patent is valid and infringed by Sorin. The ICA =20
suspended Sorin's request for compulsory license pending the outcome =20
of the litigation.
ASIA
China
In 2005, China used the threat to a compulsory license to obtain =20
voluntary licenses to manufacture generic Tamiflu.
Malaysia
On September 29, 2004, the Malaysian Minister of Domestic Trade and =20
Consumer Affairs issued a two-year government use compulsory license =20
to import from India didanosine (ddI), zidovudine (AZT) and lamivudine=20=
+zidovidine (Combivir).
Indonesia
On October 5, 2004, Indonesia issued a compulsory license to =20
manufacture generic versions of lamivudine and nevirapine, until the =20
end of the patent term in 2011 and 2012 respectively. The license is =20
for government use, and includes a royalty rate of 0.5% of the net =20
selling value.
Korea
On January 30, 2002, the People's Health Coalition for Equitable =20
Society, the Association of Physicians for Humanism, and the Korean =20
Pharmacists for Democratic Society jointly filed for a compulsory =20
license for Glivec, a drug to treat chronic myelogenous leukemia =20
(CML), and gastrointestinal stromal tumor (GIST). The request was =20
rejected.
In October 2005, the Korea Food and Drug Administration (KFDA) =20
announced it was considering a compulsory license for the manufacture =20=
of generic versions of Tamiflu.12
India
In February 2005, India amended its patent law, to provide for patent =20=
protection for pharmaceutical inventions. The legislation created a =20
mandatory compulsory license for products that were already =20
manufactured and marketed in India.
Taiwan
On July 26, 2004, the Taiwan Intellectual Property Office (TIPO) =20
issued a compulsory license to Gigastorage for 5 patents related to =20
CD-R of Phillips. The term of the license is through the expiration =20
of the patent terms.
In November 2005, Taiwan issued a compulsory license for patents =20
needed to manufacture and sell generic versions of Tamiflu.13 =20
According to this report by Deutsche Presse-Agentur dpa:
The Intellectual Property Office (IPO) granted compulsory licensing =20
to Taiwan pharmaceutical companies after talks with Roche and Gilead =20
Science - the U.S. developer of Tamiflu - broke down. 'Roche and =20
Gilead insisted they can supply enough Tamiflu if bird flu erupts in =20
Taiwan. Our argument was: When there is a bird flu pandemic, millions =20=
of people will be hospitalized or dead, and some countries might =20
confiscate Tamiflu or ban its export. We cannot gamble our people's =20
lives on their unreliable promise,' Lai Chin-hsiang, secretary-=20
general of the Department of Health (DOH), told Deutsche Presse-=20
Agentur dpa. Under the compulsory license, valid until December 31, =20
2007, Taiwan drug firms can make Tamiflu for domestic use and should =20
use it only when there is a shortage of supply from Roche.14
LATIN AMERICA
Argentina
On October 18, 2005, Health Minister Gines Gonzalez Garcia announced =20
the government would issue compulsory licenses on the patents for =20
Tamilfu.
Dominican Republic
There have been requests for compulsory licenses on the patents for =20
Plavix, a heart disease drug. On May 14, 2002, the French embassy in =20
DR wrote to Sr. Hugo Guiliani Cury, Secretary of State of the =20
Dominican Republic, expressing opposition to the compulsory license.
Chile
In December 2004, Essential Inventions requested a compulsory license =20=
to supply Glivec to Chile.
Peru
In 2004, the government issued a compulsory license in the patents on =20=
d4T.
Ecuador
Something happened here, but we are still investigating.
Brazil
On January 8, 2001, 12 days before President Clinton left office, =20
USTR filed a complaint over the Brazil compulsory licensing law in =20
the WTO Dispute Settlement Body. USTR officials called this the =20
=93Merck=94 case. At issue was Article 68 of Brazil's patent law, which =20=
allows compulsory licenses to be issued in situations where the =20
patent holder does not locally manufacture the patented product =20
(known as a "local working" provision). The US received a large =20
amount of negative publicity, and on June 25, 2001, the Bush =20
administration withdrew the complaint. However, under the agreement =20
between the two countries, Brazil agreed to provide the US with =20
advance notice if a license is issued under Article 68 of the Brazil =20
patent act, and disputes would be discussed through a bilateral =20
"Consultative Mechanism." The agreement was not made public.
In early 2001, Brazil announced it was considering compulsory =20
licenses for patents on nelfinavir and efavirenz.
In March 2001, the Brazil government reached a settlement with Merck, =20=
for price discounts on efavirenz, in return for not issuing a =20
compulsory license.
On August 22, 2001, Brazilian Health Minister Jose Serra announced =20
the Brazilian government would issue a compulsory license for the =20
manufacture of the antiretroviral drug nelfinavir (sold under the =20
brand name Viracept by Roche) to the Brazilian pharmaceutical =20
producer Far Manguinhos. On August 28, the two parties resumed talks, =20=
and on August 31, they reached an agreement; Roche will sell the drug =20=
in Brazil at an additional 40% discount, and Brazil will not issue =20
the compulsory license.
On September 5, 2003, the Brazilian government issued a decree that =20
would allow it to produce or import generic anti-AIDS drugs without =20
the consent of companies holding the patent on those medications. The =20=
health minister made it clear that the decree was meant to apply to =20
antiretroviral drugs - specifically lopinavir, efavirenz and =20
nelfinavir. The ministry said in a statement it had negotiated with =20
the name-brand companies in August seeking a reduction of more than =20
40%, but was offered a maximum discount of 6.7%. Brazil and Merck =20
reached an agreement in November.
In 2005, Health Minister Humberto Costa signed a decree declaring the =20=
patent of Kaletra in the public interest and appropriate for =20
compulsory licensing. A subsequent settlement with Abbott reduced the =20=
price of by 46 percent.
In 2005, the government of Brazil declared that they were considering =20=
issuing compulsory licenses to permit the manufacture of Viread. =93As =20=
a result of discussions with the Brazilian government Gilead reached =20
agreement with the Brazilian Health Ministry in May 2006 to reduce =20
the price of Viread in Brazil by approximately 50%.=9415
Brazil also used the threat of compulsory licenses on the patents for =20=
Gleevic to obtain a price discount of more than 65 percent.
AFRICA
Compulsory licensing in Africa is now fairly common, but often not =20
widely publicized. A typical compulsory license may be based upon =20
model authorizations prepared by organizations who are engaged in =20
providing treatment for AIDS, in order to satisfy donor requirements =20
that purchases of generic medicines are consistent with trade rules.
Cameroon
On January 2005, the nonprofit corporation Essential Inventions =20
requested the Minister of Public Health to grant ex officio licenses =20
for the patents relevant for importation, manufacture or sale of =20
generic versions of the following medicines used in the treatment of =20
HIV/AIDS: Nevirapine (Brand name Viramune=AE) Lamivudine (Brand name =20
3TC=AE) Fixed dose combinations of Lamivudine and Zidovudine (Brand =20
name Combivir=AE). The request is still pending.
Guinee
On April 18, 2005, the Ministry of Health issued compulsory licenses =20
on patents on drugs to treat AIDS.
Ghana
On October 26 2005, the Minister of Health issued a government use =20
compulsory licenses for importation into Ghana of generic HIV-AIDS =20
medicines.
Eritrea
On June 5 2005, the Minister of Health issued a compulsory license =20
for for importation into Eritrea of generic HIV-AIDS medicines.
Mozambique
On April 5, 2004, Mozambique's Deputy Minister of Industry and =20
Commerce issued Compulsory License no. 01/MIC/04 for patent rights to =20=
lamivudine, stavudine and nevirapine. The license was granted to =20
Pharco Mo=E7ambique Lda, a local producer that plans on manufacturing =20=
the antiretrovirals as a fixed-dose combination. Royalties are not to =20=
exceed 2% of sales.
SouthAfrica
On March 7, 2001, Indian pharmaceutical manufacturer CIPLA formally =20
requested the South African Department of Trade and Industry issue =20
compulsory licenses to patents on the following HIV drugs: =20
nevirapine, lamivudine, zidovudine, stavudine, didanosine, efavirenz, =20=
indinavir and abacavir.
On September 19, 2002, Hazel Tau, working with the Treatment Action =20
Campaign (TAC), filed a complaint with South Africa's Competition =20
Commission against GlaxoSmithKline (GSK) and Boehringer Ingelheim =20
(GI). Twelve parties would join the complaint, which charged GSK and =20
BI with excessive pricing in respect of ritonavir, lamivudine, =20
ritonavir+lamivudine and nevirapine.
On October 16, 2003, after an extended investigation, the South =20
Africa Competition Commission issued a statement, saying:
pharmaceutical firms GlaxoSmithKline South Africa (Pty) Ltd (GSK) and =20=
Boehringer Ingelheim (BI) have contravened the Competition Act of =20
1998. The firms have been found to have abused their dominant =20
positions in their respective anti-retroviral (ARV) markets.
In particular the Commission has found the firms have engaged in the =20
following restrictive practices;
* Denied a competitor access to an essential facility
* Excessive pricing
* Engaged in an exclusionary act
On December 10, the competition commission announced it had reached a =20=
settlement with GSK. The settlement required GSK to
* extend a voluntary licence granted to Aspen Pharmacare in =20
October 2001 in respect of the public sector to include the private =20
sector;
* grant up to three more voluntary licences on terms no less =20
favourable than those granted to Aspen Pharmacare;
* permit the licensees to export the ARVs to sub-Saharan African =20=
countries;
* permit the importation of the drugs for distribution in South =20
Africa if the licensee does not have manufacturing capability in =20
South Africa;
* permit licensees to combine the relevant ARV with other =20
antiretroviral medicines; and
* charge royalties of no more than 5% of the net sales of the =20
relevant ARVs.
Shortly thereafter, a similar settlement was reached with BI.
Swaziland
On April 20, 2004, the Ministry of Health and Social Welfare in =20
Swaziland noted the existence of an emergency relating to AIDS, and =20
authorized procurement of medicines for HIV/AIDS =93in the best cost/=20
effective way possible on the international market irrespective of =20
the existence of any patent or other Intellectual Property protection =20=
applicable in Swaziland until such time as it will no longer be =20
considered essential to address the current Public Health crisis =20
related to HIV/AIDS.=94
Zambia
On September 21, 2004 the Zambian Minister of Domestic Trade and =20
Consumer Affairs issued a compulsory license for lamivudine, =20
stavudine and nevirapine. The license was granted to Pharco Ltd., a =20
local producer, which will produce a triple fixed-dose combination. A =20=
maximum royalty rate of 2.5% applies.
Zimbabwe
On May 27, 2004, Zimbabwe's Minister of Justice, Legal and =20
Parliamentary Affairs declared a Period of Emergency in order to =20
override antiretroviral drug patents. With assistance from India, =20
Zimbabwe has begun local production of antiretrovirals.
Middle East
Israel
=93In January 1992, BTG-Israel filed an application in the Israeli =20
Patent Office for a compulsory license to manufacture BTG's Bio-Hep-B =20=
under Biogen's Israeli patent which license, upon approval, would =20
enable BTG to produce the vaccine in Israel and likely to export the =20
vaccine to countries in which neither Biogen nor others have been =20
granted a blocking patent. In September 1995 the Registrar ruled in =20
an interlocutory decision that BTG-Israel is entitled to a compulsory =20=
license to the Biogen patent. Biogen's appeal of the interlocutory =20
decision was rejected.=9416
=93Biogen appealed the Registrar's decision to the District Court of =20
Tel Aviv, Israel, and moved for a stay of the license, which was =20
granted ex parte pending hearings with both parties. Following =20
hearings which took place in December 1996, the motion was denied in =20
January 1997; however, the ex parte stay was left in force pending =20
Biogen's appeal to the Supreme Court and maintained by the Supreme =20
Court pending the decision by the District Court on the merits of =20
Biogen's appeal. The District Court heard the appeal in early March =20
1997, and in June 1997 the District Court denied Biogen's appeal and =20
subsequent motion for a stay pending Biogen's appeal of the District =20
Court decision to the Supreme Court on the merits. In March 1998 the =20
Supreme Court granted Biogen the right to appeal the District Court's =20=
decision. A date has not yet been set for the hearing. In the absence =20=
of any action by the Supreme Court, the compulsory license is now =20
effective and allows BTG-Israel to produce the vaccine in Israel upon =20=
receipt of regulatory approval and to export the vaccine to countries =20=
in which neither Biogen nor others have been granted a blocking =20
patent.=9417
The Biogen Israeli patent expired in December 1999, before the =20
Supreme Court ruled on the compulsory license.
NOTES
1 See: 104TH CONGRESS, Report, SENATE, 2d Session, 104-394, =20
PHARMACEUTICAL INDUSTRY SPECIAL EQUITY ACT OF 1996, REPORT together =20
with MINORITY VIEWS [To accompany S. 1277].
2 The United States=92 Statement Of Interest, November 2005., NTP, =20
INC., Plaintiffs, V. RESEARCH IN MOTION, LTD., Defendant., Civil =20
Action No. 3:01CV767.
3 See video excerpts from November 8, 2005 Hearings of the =20
Subcommittee on Health of the House Committee on Energy and Commerce, =20=
http://www.cptech.org/ip/health/tamiflu/hearingexcerpts11082005.html
4 September 5, 2001, "National Institutes of Health and WiCell =20
Research Institute, Inc., Sign Stem Cell Research Agreement," http://=20
www.nih.gov/news/pr/sep2001/od-05.htm.
5 United States Of America, Plaintiff V. Microsoft Corporation, =20
Defendant. Civil Action No. 98-1232 (CKK), FINAL JUDGMENT, (November =20
12, 2002). For a detailed account of work to implement the order, =20
see: INTERIM JOINT STATUS REPORT ON MICROSOFT'S COMPLIANCE WITH THE =20
FINAL JUDGMENTS, http://www.usdoj.gov/atr/cases/f201300/201386.htm.
6 AstraZeneca Annual Report and Form 20-F Information 2005
7 Torpham v. Commissioner of Patents and Canada (AG), May 7, 2004 =20
FCTD (MacKay J.) Abuse of Exclusive Rights/Section 65 of the Patent =20
Act/Compulsory Licence /Request to Supply Bulk Lisinopril for =20
Production of Tablets in Canada for Export to the U.S.
8 Merck v. Brantford Chemicals and Commissioner of Patents and Canada =20=
(Attorney General), February 2, 2005 FCA (Rothstein, Evans, Malone =20
JJ.A.) Compulsory Licence/Patent Act/Res Judicata/Functus Officio/=20
Final Decisions.
9http://decisions.fct-cf.gc.ca/en/2006/2006fc1341/2006fc1341.html. =20
Citation: 2006 FC 1341, Vancouver, British Columbia, November 7, =20
2006, BRANTFORD CHEMICALS INC. (sub. nom. APOTEX PHARMACHEM INC.)=20
Appellant, and THE COMMISSIONER OF PATENTS, ATTORNEY GENERAL OF =20
CANADA and MERCK & CO., INC. Respondents. REASONS FOR JUDGMENT AND =20
JUDGMENT.
10 ARTICLE 5 - OTHER ACTIONS
5.1 Patent Validity; Enforceability. Immediately upon the Effective =20
Date, or as soon as possible thereafter, ROCHE shall discontinue any =20
opposition, challenge,
compulsory license application or the like with respect to the CHIRON =20=
Licensed Patents.
5.2 Compulsory Licensing. ROCHE covenants and agrees on behalf of =20
itself and its Affiliates to not support any third party in seeking =20
compulsory licensing of the
CHIRON Licensed Patents in any jurisdiction. As used in this Section, =20=
"support" shall have the same meanings as in Section 7.2(b).
11 VAN OVERWALLE, G. & VAN ZIMMEREN, E., =91Reshaping Belgian Patent =20
Law: The Revision of the Research Exemption and the Introduction of a =20=
Compulsory License for Public Health', IIP Forum (Japanese journal) =20
2006;64:42-4.
12 Kim Cheong-won, "Health Regulator Seeks to Produce Bird Flu Drug," =20=
the Korea Times.
13 Kathrin Hille, "Taiwan employs compulsory licensing for Tamiflu," =20
FT, November 25 2005.
14 Taiwan issues compulsory license for making Tamiflu, Nov 25, 2005.
15 SEC Form 10-Q -- Quarterly report [Sections 13 or 15(d)], Period =20
of Report: 2006-09-30.
16 BIO-TECHNOLOGY GENERAL CORP., 10-K Report, April 1, 1996.
17 SAVIENT PHARMACEUTICALS INC, Form:10-K Filing Date: 3/26/1998.
---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org / =20
tel. +1.202.332.2670 / mobile +1.202.361.3040
"If everyone thinks the same: No one thinks." Bill Walton"