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