E-DRUG: List of countries with compulsory licenses
-------------------------------------------------------------------------
Dear e-druggers,
We are looking for a list of countries who have issued compulsory licenses
in recent years. Can anybody help?
Thank you and very best regards
Karin Wiedenmayer
Karin Wiedenmayer, MSc, PharmD
Swiss Tropical Institute
Swiss Centre for International Health
Socinstrasse 57
4002 Basel
Switzerland
T+41 61 284 81 26
F+41 61 284 81 03
www.sti.ch
E-DRUG: List of countries with compulsory licenses (2)
---------------------------------------------------------------------
Knowledge Ecology International has a very extensive list -- but
certainly still incomplete -- here:
http://www.keionline.org/index.php?option=com_content&task=view&id=41
Developing countries that have issued compulsory licenses on
pharmaceutical patents include:
Thailand
Malaysia
Indonesia
India
Mozambique
Zambia
Zimbabwe
Ghana
Eritrea
South Africa
Brazil
Links to background information on all of these cases, and often the
licenses themselves, is at:
http://www.cptech.org/ip/health/cl/recent-examples.html
Robert Weissman
Essential Action
E-mail: rob@essential.org
E-DRUG: List of countries with compulsory licenses (3)
-----------------------------------------------------------------------
Dear Karin,
For a non-exhaustive but quite complete list of recent uses of
compulsory licenses, visit our websites:
http://www.keionline.org/index.php?option=com_content&task=view&id=41
and
http://www.cptech.org/ip/health/cl/recent-examples.html
Do not hesitate to contact us if you need more information.
Regards,
Judit
Judit Rius Sanjuan
Attorney at Knowledge Ecology International
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18
Email: judit.rius@keionline.org
E-DRUG: List of countries with compulsory licenses (4)
-----------------------------------------------------------------------
The best source I know of is "Recent examples of compulsory licensing
of patents," by Jamie Love, Knowledge Ecology International (KEI)
Research Note, 2007, pasted below or available for download (PDF) at
http://www.keionline.org/index.php?option=com_content&task=view&id=41.
KEI could also likely help you update the paper to 2008... Note that
the paper includes both pharmaceutical and non-pharmaceutical product
examples.
Regards, Sarah
Recent examples of compulsory licensing of patents
KEI Research Notes - Patents
KEI Research Note 2007:2 [1]
(A PDF version of this is available here.)
Recent examples of the use of compulsory licenses on patents[1]
KEI Research Note 2007:2
James Packard Love
Knowledge Ecology International
8 March 2007, revised 6 May 2007
I. Introduction
The term "compulsory License" is used to describe a number of
mechanisms for non-voluntary authorizations to use patents. The most
important global norm for the use of compulsory licenses is Article 31
of the WTO TRIPS Agreement, which addresses uses "of a patent without
the authorization of the right holder, including use by the government
or third parties authorized by the government." Other TRIPS provisions
that are important are Articles 1, 6, 7, 8, 31 bis, 40 and 44, as well
as the provisions of the 2001 Doha Declaration on TRIPS and Public
Health.
Contrary to many popular news reports and statements by misinformed
government officials and industry lobbyists, the WTO rules are quite
liberal in terms of the grounds for granting compulsory licenses.
There are no limitations on the scope of disease. Indeed, there is no
requirement that compulsory licenses be limited to cases involving
health care problems at all.
This paper reports on a number of recent examples of the use of
compulsory licenses, in both developed and developing economies. The
examples cover a wide variety of technologies, legal mechanisms, and
grounds for non-voluntary authorizations to use patents.
II. North America
A. United States
1. Mandatory compulsory license for patents whose term was extended by
GATT implementation
In 1995, as mandated by the Uruguay Round Agreements Act, patent terms
in the United States were changed from 17 years from the date the
patent was granted to 20 years from the date the patent application
was filed. This extended patent terms for many products, including
pharmaceuticals. In 1996, Congress enacted a statutory mandatory
compulsory license for products brought to market prior to patent
expiration, provided that a generic manufacturer had previously made
"substantial investment" toward bringing a product to market in
anticipation of the pre-1995 patent expiration.[2] The mandatory
compulsory license applied to over 100 brand name pharmaceutical
products. However, the benefits of these compulsory licenses were
undermined because drug registration issues were not addressed in the
GATT implementation legislation.
2. 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.[3]
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.[4]
In a November 2005 Congressional Hearing, DHHS Secretary Michael
Levitt testified before the House of Representatives that he had
effectively required the patent owners for Tamiflu (Roche/Giliead) to
invest in US manufacturing facilities for the product, so that the
United States government would have access to Tamiflu if confronted
with an avian flu pandemic.[5]
In 2007, the US Supreme Court was petitioned to hear an appeal of
Zoltek Corp. v. U.S.[6] Zoltek has a US patent on a process for making
material used in F-22 fighter jets, but the U.S. imports the product
from an unlicensed foreign manufacturer without paying royalties to
Zoltek. The United States argues that it may, in effect, has a
royalty-free compulsory license for government use of the product
because the patented process is carried out in a foreign country,
meaning that the patent holder is not entitled to "reasonable and
entire compensation" under 28 USC 1498.
3. Cases involving Bayh-Dole Act
In 1997, a March-In rights petition by Cell-pro was denied, and
ultimately their infringing device was pulled from the market despite
its clinical advantages and lack of a licensed alternative.
In 2001, DHHS used its authority to exercise March-In rights for
patents on stem cell lines resulting from publicly funded research and
held by the Wisconsin Alumni Foundation (WARF) as leverage to secure
an open license on those patents.[7]
In 2004, DHHS and NIH refused to grant March-In rights in a case
brought by Essential Inventions involving patents on the AIDS drug
ritonavir/Norvir[8]. Abbott Laboratories had increased their U.S.
price of the drug by 400% in one day to promote sales of their new
combination therapy and undermine sales of competitors' drugs. A
similar request by Essential Inventions for march-in rights to patents
involving the glaucoma drug latanoprost (Xalatan) was also denied.[9]
In 2006, the Centers for Disease Control threatened to use March-In
rights to issue compulsory licenses on patents on reverse genetics,
which are needed to manufacture vaccines for avian flu.
In 2007, Essential Inventions requested Robert Portman, Director of
the Office of Management and Budget, to take steps to develop and
accept alternative competitive sources of supply for federal
procurement of two HIV-AIDS medicines: stavudine/d4T and
ritonavir[10]. Due to public funding for the development of both
drugs, the US government has a royalty free, nonexclusive, worldwide
statutory license to the patents for each product.[11] On March 1,
2007, Essential Inventions met with OMB officials, and extended the
proposal to include the AIDS drug emtricitabine (Emtriva).
4. Cases involving merger reviews
In 2002, the US Federal Trade Commission (FTC) ordered[12] a
compulsory cross-license of the Immunex tumor necrosis factor ("TNF")
patent, to Serono, including the "freedom 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." Note
the permission to export, which is anticipated by Article 31.k of the
TRIPS. In this case, the compulsory cross-license allows a Swiss firm
to compete with the US patent owner.
In 2005, the FTC ordered a compulsory license of Guidant's
intellectual property surrounding the RX delivery system for
Drug-Eluting Stents (DES) as a condition of Guidant's acquisition by
either Johnson & Johnson or Boston Scientific.[13] Boston Scientific,
which eventually won the bidding to acquire Guidant, was required to
license DES patents to a potential entrant, Abbott.
5. 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.[14]
In February 2007, in a case involving a failure to disclose patents on
the standard, an FTC antitrust remedial order compelled memory
chipmaker Rambus to license its patented technology on certain
specified terms and limited the maximum royalty rates that Rambus can
collect for use of its patents to 0.25 percent for SDRAM products; 0.5
percent for DDR SDRAM products, as well as SDRAM memory controllers or
other non-memory chip components; and 1 percent for DDR SDRAM memory
controllers, or other non-memory chip components. After three years,
the royalty rate will be zero percent[15].
6. Cases involving the new US Supreme Court standard for granting
injunctions on patents[16]
In May 2006, the U.S. Supreme Court issued an opinion in eBay v
MercExchange, which set the standards under which a court should
evaluate requests for injunctions to enforce a patent owners'
exclusive right to authorize the use of a patented invention. To get
an injunction, a patent owner must show the court:
1). That it has suffered an irreparable injury;
2). That other possible legal remedies, including the payment of
royalties, are inadequate to compensate for that injury;
3). That considering the balance of hardships between the plaintiff
and defendant, a remedy in equity is warranted; and
4) That the public interest would not be disserved by a permanent
injunction.
Under this standard, a court can choose to issue a compulsory license
to use the patent, rather than enforce the exclusive right, a path
that has been taken several times since May 2006.
The Wall Street Journal praised the US Supreme Court for "restoring
some sanity to America's runaway patent law" by giving "judges
much-needed flexibility in granting or denying permanent
injunctions."[17] The evolving doctrine under eBay v. MercExchange
places the U.S. closer to legal traditions in Europe and Japan, where
governments and courts have the authority to issue compulsory licenses
in a wide range of cases, including those involving uses of dependent
patents, refusals to license (such as the three recent Italian cases
on pharmaceutical patents), and to more generally protect the public
interest.
The TRIPS addresses the issue of injunctions in the two paragraphs of
Article 44. Article 44.1 says "judicial authorities shall have the
authority to order a party to desist from an infringement," which a
court may do under the eBay decision. When compulsory licenses are
issued to address "use by governments, or by third parties authorized
by a government," WTO members need not provide for injunctive relief.
However, when non-voluntary authorizations are made by a court, rather
than a government, injunctive relief shall be available, unless "these
remedies are inconsistent with a Member's law." In such cases,
"declaratory judgments and adequate compensation shall be available."
The eBay decision illustrates an additional way that WTO members can
make non-voluntary authorizations to use patents. So long as a court
provides for "adequate compensation" it can effectively issue
compulsory licenses, when dealing with remedies to infringement. The
following are some recent cases by U.S. Courts.
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[18].
In August 2006, a court granted Toyota a compulsory license on three
Paice patents for hybrid transmissions, for a royalty of $25 per
automobile.[19]
In September 2006, a court granted Johnson and Johnson a compulsory
license to use three of Dr. Jan Voda's patents on guiding-catheters
medical devices for performing angioplasty.[20]
On January 4, 2007, Judge Avern Cohn rejected an injunction to enforce
the exclusive right to use patent 5,026,109, which was held by
Sundance, Inc. and Merlot Tarpaulin and Sidekit Manufacturing Company.
The patent was infringed by DeMonte Fabricating and Quick Draw
Tarpaulin Systems. In deciding the case, the Court noted the
injunction affect the ability of DeMonte to compete, and "would harm
third parties (DeMonte's employees and customers)."[21]
On January 12, 2007, Abbott Laboratories lost a bid in a federal
district court for a compulsory license on a patent held by
Innogenetics, Inc. that a judge and jury said Abbott infringed to
manufacture and sell Hepatitis C virus (HCV) genotyping test kits.
Abbott's request for the compulsory license was denied by the Court of
Federal Appeals on March 8, 2007.[22] According to the January 12,
2007 Court Decision by Judge Barbara Crabb:[23]
Defendant [Abbott] made an effort to show through cross examination of
plaintiff's witnesses that it would be risky to public health to
enjoin defendant from the market both because reliance on one major
manufacturer was risky in and of itself and because plaintiff's
manufacturing facility had quality control problems with another
product over a period of years.
In rejecting the Abbott request for the compulsory license, the Court
said "Hepatitis C is a chronic disease that does not require instant
genotyping," and "other diagnostic techniques exist and would suffice,
even if they are not as effective as the patented technique."
According to Harold Wegner, "Innogenetics represents the first medical
case where injunctive relief has been granted where the court has
expressly acknowledged that the patient-public will be deprived of the
best medical technique on the market."[24]
B. 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
"the Ontario Report to Premiers: Genetics, Testing & Gene Patenting:
Charting New Territory in Healthcare." This report noted that the Doha
Declaration calls upon nations to take measures "to protect public
health and, in particular, to promote access to medicines for all,"
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 the potential
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: "These 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 "Schedule 1," 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 and 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 - 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[25]. In September 2006, the product was included in Schedule 1.
Apotex claims as defense to an infringement claim, that it's sales of
generic copies of AstraZeneca's Zestril and Merck's Prinivil tables
are permitted under terms of a compulsory license. A trial started in
January 2006.[26]
On May 7, 2004, Torpham successfully appealed a rejection of a
compulsory license application involving Merck patents for the
manufacture and sale of Lisinopril.[27] Torphan had sought a license
to the use the patents for purposes of manufacturing and exporting to
the United States. The court held 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's efforts dismiss the compulsory licensing application on
certain procedural grounds.[28] 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's request for a licence, and Merck's silence
could not be construed as a refusal to license.[29]
III. EUROPE
A. ECJ Decision in IMS Health
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.
B. The Regulation (Ec) No 816/2006 Of The European Parliament And Of
The Council of 17 May 2006 on compulsory licensing of patents relating
to the manufacture of pharmaceutical products for export to countries
with public health problems.
This regulation set out the following requirements and conditions for
implmening the WHO's 30 August 2003 decision on the export of
medicines to countries that lack sufficient manufacturing capacity.
1. There are no limits on the scope of diseases. It extends to all
medicinal products as defined in Article 1(2) of Directive 2001/83/EC
on medicinal products for human use (1), active ingredients and
diagnostic kits ex vivo.
2. The compulsory licenses are mandatory: "Member States shall grant a
compulsory licence to any person making an application in accordance
with Article 6 and subject to the conditions set out in Articles 6 to
10."
3. Prior negotiation with right owners is waived "in situations of
national emergency or other circumstances of extreme urgency or in
cases of public non-commercial." In these cases, "the remuneration
shall be a maximum of 4 % of the total price to be paid by the
importing country." In other cases, remuneration may consider
"humanitarian or noncommercial circumstances relating to the issue of
the licence."
4. The "safety and efficacy of medicinal products" may be evaluated
through evaluation of "the scientific opinion procedure as provided
for under Article 58 of Regulation (EC) No 726/2004, or . . . any
similar procedures under national law, such as scientific opinions or
export certificates intended exclusively for markets outside the
Community."
5. In Article 18.2, when compulsory licenses to data are issued under
this regulation, EU "protection periods" for test data "shall not
apply." This waiver of data exclusivity for a case involving a
compulsory license is quite important. Note that the remuneration for
the patent is the sole remuneration in such cases.
C. 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 "ineffective in the UK at least",
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.
D. 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.[30]
E. France
1. 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
2. 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.
F. 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.[31]
G. Italy
1. Sorin/Chrion dispute
On 14 June 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.
2. Merck antibiotic (Imipenem Cilastatina) patents
On 23 February 2005, the Autorità garante della concorrenza e del
mercato (the AGCM) opened an investigation into abuses of a dominant
position by refusals to license rights to active pharmaceutical
products by two large pharmaceutical companies -- GlaxoSmithKline and
Merck & Co Inc (Cases A363 and A364).
On 21 June 2005, the AGCM ordered a compulsory license for Merck
patents on antibiotics that use the active ingredients Imipenem
Cilastatina.
3. Glaxo patents on migraine drug
On 8 February 2006, the AGCM closed the investigation into the Glaxo
Group's refusal to grant a licence to Fabbrica Italiana Sintetici SpA
(FIS), a chemical company, for the manufacture in Italy of an active
ingredient, Sumatriptan Succinate, used in the production of migraine
medicines. According to the AGCM press release, "To remedy the earlier
refusal to license, Glaxo granted the licences originally requested by
FIS, but also set conditions such as to allow the time to be made up
which had been lost because of the original refusal. Those conditions
include the granting of a number of additional procedural licences,
whereby Glaxo has allowed FIS to save the time otherwise required to
research and test an efficient manufacturing process for Sumatriptan
Succinate. FIS will thus be enabled to offer the active ingredient to
manufacturers of generics as early as if Glaxo had never refused the
original request for a licence."[32] The AGCM sought to prevent delays
in bringing generic pharmaceuticals to market, thus paving the way for
substantial price reductions. FIS initially used the compulsory
license entirely for the export market, supplying generic firms that
were selling products in markets outside of Italy (such as Spain),
where the patents had expired. It did so outside of the framework of
the WTO 30 August 2003 decision on exports on medicines manufactured
under a compulsory license, which Spain and other EU members had
"opted out" as an importer. This was possible in part because the
TRIPS waives all restrictions on exports in cases where the licenses
were issued to remedy to anticompetitive practices.
4. Merck patents on prostate and male-pattern baldness drug
On 21 March 2007, the AGCM required Merck to "grant free licences to
allow the manufacture and sale in Italy of the active ingredient
Finasteride and related generic drugs two years before the 2009
expiration of the Complementary Protection Certificate."[33]
Finasteride is the active ingredient of a drug marketed initially
under the brand name Proscar and Propecia. It is used to treat
hypertrophy of the prostate, cancer of the prostrate, and male-pattern
baldness. The Merck royalty free compulsory licenses were remedies to
Merck's earlier refusal to license the patents to Italian manufactures
of active pharmaceutical ingredients. Again, the licenses anticipate
exports to "other European countries."
IV. ASIA
A. China
In 2005, China used the threat to a compulsory license to obtain
voluntary licenses to manufacture generic Tamiflu.
B. 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. The new provision was added under
Section 11 A of the Indian Patent Act read as follows::
"(7) On and from the date of publication of the application for patent
and until the date of grant of a patent in respect of such
application, the applicant shall have the like privileges and rights
as if a patent for the invention had been granted on the date of
publication of the application:
Provided that the applicant shall not be entitled to institute any
proceedings for infringement until the patent has been granted:
Provided further that the rights of a patentee in respect of
applications made under sub-section (2) of section 5 before the 1st
day of January, 2005 shall accrue from the date of grant of the patent:
Provided also that after a patent is granted in respect of
applications made under sub-section (2) of section 5, the
patent-holder shall only be entitled to receive reasonable royalty
from such enterprises which have made significant investment and were
producing and marketing the concerned product prior to the 1st day of
January, 2005 and which continue to manufacture the product covered by
the patent on the date of grant of the patent and no infringement
proceedings shall be instituted against such enterprises[34]."
[Emphasis added]
C. Indonesia
On October 5, 2004, Indonesia issued a government use compulsory
license to manufacture generic versions of two HIV-AIDS drugs,
lamivudine and nevirapine, until the end of the patent term in 2011
and 2012 respectively. The license includes a royalty rate of 0.5% of
the net selling value[35]. Production of the ARVs has started by PT
Kimia Farma.
In March 2007, Indonesia reportedly issued a compulsory license for
patents on the AIDS drug efavirenz.
D. 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) [36]. The Ministry of Health proposed
a royalty rate of 4% of the value of the generic product.
E. 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[37].
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.[38]
F. 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.[39]
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.[40]
G. Thailand
On November 29, 2006, the Thailand Ministry of Health announced a
government use compulsory license to import (from India) and locally
produce efavirenz until 2011. [41] The proposed royalty was 0.5
percent of the price of the generic product, a figure that is subject
to additional negotiations with the patent owner.
On January 25, 2007 the Thailand government announced two additional
government use compulsory licenses on patents for the AIDS drug
Kaletra (LPV+RTV)[42] and the heart disease drug Plavix (clopidogrel
bisulfate),[43] also with a proposed royalty of 0.5 percent.
On January 29, 2007, the Minister of Public Health's Department of
Disease Control, issued a decree regarding the exploitation of patents
on drugs & medical supplies by the government on the combination drug
lopinavir & ritonavir, which is marketed under the trade name of
Kaletra by Abbott.
The Thailand government has repeated said that the patent owners my
negotiate for higher royalties, but so far have show no interest in
doing so, while waging an intense lobbying and public relations
campaign against the Thailand government. Thailand's actions have been
widely supported in treatment and public health circles, and attacked
by the pharmaceutical industry.
V. LATIN AMERICA
A. Argentina
On October 18, 2005, Health Minister Gines Gonzalez Garcia announced
the government would issue compulsory licenses on the patents for
Tamiflu. However, it was later determined that patents on Tamiflu had
not been not granted in Argentina.
B. 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
Dominican Republic wrote to Sr. Hugo Guiliani Cury, Secretary of State
of the Dominican Republic, expressing opposition to the compulsory
license[44].
C. Chile
In December 2004, Essential Inventions requested a compulsory license
to supply Glivec to Chile[45].
D. Ecuador
In 2003, Acromax, a local manufacturer, petitioned the patent office
to grant a compulsory license for the fix-dose combination of
Lamivudine (3TC) and AZT (sold under the trade-name Combivir by
Glaxo). The request was rejected and Glaxo granted Ecuador
preferential prices on all their HIV-AIDS medicines. ACROMAX appealed
and the request was rejected again.[46]
E. 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 "Merck" 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. "As 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%."[47]
Brazil also used the threat of compulsory licenses on the patents for
Gleevic to obtain a price discount of more than 65 percent.
On April 25, 2007, the Brazilian The Minister of Health, José Gomes
Temporão, signed Decree 866, published in the Federal Official Gazette
Government, declaring the AIDS drug efavirenz to be of public
interest. This started a process that culminated in the compulsory
licensing of the patent of the antiretroviral drug Efavirenz on May 4,
2007, in a dramatic televised ceremony attended by the Health Minister
José Gomes Temporão and President Luiz Inácio Lula Da Silva. The
Brazil action on Efavirenz followed a similar decision by Thailand.
Because of the Thailand compulsory license authorized competition from
generic suppliers, Merck was forced to offer Efavirenz at a much lower
price in Thailand. The Brazil government was unable to obtain similar
price concessions from Merck, and issued the compulsory licenses.
In Spring 2007, 75,000 (about 38 percent of those receiving treatment)
of Brazilian AIDS patients were taking Efavirenz, in combination with
other products. Efavirenz is sold by Bristol Myers Squibb in the
United States for $15.67 per day.[48] Before the compulsory license,
Merck had been charging $1.59 per day in Brazil, a deep discount from
the U.S. price, but still difficult for the Brazil government, given
the differences in average incomes and the large number of persons
receiving treatment in Brazil. Merck had offered to sell Efavirenz for
$.65 per day in Thailand. The current generic prices were about $.45
per day, and falling as demand for the generic versions grow. Generic
competition may drive prices for Efavirenz below $.25 per day.
VI. 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.
A. 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/Viramune®, Lamivudine/3TC®, and Fixed dose
combinations of Lamivudine and Zidovudine/Combivir®. The request is
still pending[49].
B. Ghana
In October 2005, the Minister of Health issued a government use
compulsory licenses for importation into Ghana of Indian generic
HIV-AIDS medicines[50].
C. Guinee
On April 18, 2005, the Ministry of Health issued compulsory licenses
for importation on patents on drugs to treat HIV-AIDS.
D. Eritre
On June 5 2005, the Minister of Health issued compulsory licenses for
importation into Eritrea of generic HIV-AIDS medicines[51].
E. 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 Moçambique Lda, a local producer that plans on manufacturing
the antiretrovirals as a fixed-dose combination. Royalties are not to
exceed 2% of sales[52].
F. South Africa
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:
1. Denied a competitor access to an essential facility
2. Excessive pricing
3. Engaged in an exclusionary act
On December 10, the competition commission announced it had reached a
settlement with GSK. The settlement required GSK to:
1) extend a voluntary licence granted to Aspen Pharmacare in October
2001 in respect of the public sector to include the private sector;
2) grant up to three more voluntary licences on terms no less
favourable than those granted to Aspen Pharmacare;
3) permit the licensees to export the ARVs to sub-Saharan African
countries;
4) permit the importation of the drugs for distribution in South
Africa if the licensee does not have manufacturing capability in South
Africa;
5) permit licensees to combine the relevant ARV with other
antiretroviral medicines; and
6) charge royalties of no more than 5% of the net sales of the
relevant ARVs.
Shortly thereafter, a similar settlement was reached with BI.
G. 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 "in 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."
H. 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[53].
I. Zimbabwe
In May 2002, Zimbabwe's Minister of Justice, Legal and Parliamentary
Affairs declared a Period of Emergency in order to override
antiretroviral drug patents for a period of 6 months[54]. The
declaration included a government use compulsory license to make, use
or import generic HIV/AIDS medicines. In 2003, the period of emergency
was extended by five years (until 31 December 2008). With assistance
from India, Zimbabwe has begun local production of antiretrovirals
though the generic company Varichem Pharmaceuticals (Private) Limited.
VII. MIDDLE EAST
A. Israel
"In 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."[55]
"Biogen 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."[56]
The Biogen Israeli patent expired in December 1999, before the Supreme
Court ruled on the compulsory license.
Notes
[1] This work is licensed under the Creative Commons
Attribution-Noncommercial 3.0 License.
[2] 104TH Congress, Report, Senate, 2d Session, 104-394,
Pharmaceutical Industry Special Equity Act Of 1996, Report Together
With Minority Views [To accompany S. 1277]. For more information:
http://thomas.loc.gov/cgi-bin/cpquery/?&item=&&sid=cp104pqlQi&&refer=&r_n=sr394.104&&dbname=cp104&&sid=cp104pqlQi&&sel=TOC_0&
[3] For more information: http://www.cptech.org/ip/health/cl/cipro/
[4] The United States' Statement Of Interest, November 2005., NTP,
INC., Plaintiffs, V. RESEARCH IN MOTION, LTD., Defendant., Civil
Action No. 3:01CV767.
[5] 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
[6] Petition available at:
http://www.scotusblog.com/movabletype/archives/Zoltek.pdf
[7] 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. Memorandum of
Understanding between WiCell Research Institute, Inc. and Public
Health Service:
http://stemcells.nih.gov/staticresources/research/registry/MTAs/Wicell_MOU.pdf
[8] For more information:
http://www.essentialinventions.org/drug/ritonavir.html
[9] For more information:
http://www.essentialinventions.org/drug/latanoprost.html
[10] For more information:
http://www.essentialinventions.org/eii2omb-5jan07.pdf
[11] See U.S. Code tit. 35. §§ 202(c)(4) and 209(d)(I).
[12] For more information: http://www.ftc.gov/opa/2002/07/amgen.htm
[13] For more information:
http://www.ftc.gov/opa/2006/04/bostonscigui.htm
[14] United States Of America, Plaintiff V. Microsoft Corporation,
Defendant. Civil Action No. 98-1232 (CKK), Final Judgment, (November
12, 2002), available at:
http://www.usdoj.gov/atr/cases/f200400/200457.htm. For a detailed
account of work to implement the order, see: Interim Joint Status
Report On Microsoft's Compliance With The Final Judgments, available
at: http://www.usdoj.gov/atr/cases/f201300/201386.htm.
[15] For more information:
http://www.ftc.gov/os/adjpro/d9302/070205opinion.pdf and
http://www.ftc.gov/os/adjpro/d9302/070205finalorder.pdf
[16] eBay Inc. v. MercExchange, L.L.C., 126 S. Ct. 1837, 1839-1841
(U.S. 2006), available at:
http://www.supremecourtus.gov/opinions/05pdf/05-130.pdf
[17] "Patently Obvious," Wall Street Journal, May 3, 2007; Page A16,
http://online.wsj.com/article/SB117815853947390467.html.
[18] Finisar Corp. v. DirecTV Group, Inc, available at:
http://www.fr.com/news/Finisar-Judgement.pdf
[19] Paice LLC v. Toyota Motor Corp., 2006 WL 2385139(E.D.Tex. Aug 16,
2006) (NO. 2:04CV211DF).
[20] Voda v. Cordis Corp., No. CIV-03-1512, 2006 WL 2570614 (W.D.
Okla. Sept. 5, 2006)
[21] Sundance, Inc. v. DeMonte Fabricating Ltd., 2007 WL 37742. (E.D.
Mich. Jan. 4, 2007).
[22] Innogenetics, N.V v. Abbott Laboratories, Fed. Cir. App.
2007-1145, 2007 U.S. Dist. LEXIS 3148 (W.D.Wis. 2007)(Crabb, J.).
[23] Innogenetics, N.V v. Abbott Laboratories, 12 January 2007.
W.D.Wis. 2007.
[24] Harold Wegner, Innogenetics v. Abbott, April 24, 2007,
IPFrontline.com
http://www.ipfrontline.com/depts/article.asp?id=14866&deptid=7
[25] Official publication:
http://canadagazette.gc.ca/partI/2006/20060701/html/regle11-e.html
[26] AstraZeneca Annual Report and Form 20-F Information 2005
[27] 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.
[28] 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.
[29] http://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.
[30] 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).
[31] VAN OVERWALLE, G. & VAN ZIMMEREN, E., 'Reshaping 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.
[32] AGCM. 21 February 2006. PRESS RELEASE: Pharmaceuticals: Antitrust
says Glaxo has made amends and abuse of dominant position discontinued
Granting of licence opens way for manufacture of generic migraine
drugs. PROCEEDING reference n. A363, case GLAXO-PRINCIPI ATTIVI.
[33] 26 March 2007. Press Release, A364 - Merck - Active Ingredients
(Conclusion Of Investigation): Antitrust Authority Rules Merck Must
Grant Free Licences For The Active Ingredient Finasteride. The
Authority accepts and renders obligatory a commitment presented by the
companies Merck & Co. Inc. and Merck Sharp & Dohme (Italia) in order
to conclude the investigation launched in February 2005 into possible
abuse of a dominant position. Expected price reductions for the drug
to benefit consumers and the National Health System.
http://www.agcm.it/agcm_eng/COSTAMPA/E_PRESS.NSF/
92e82eb9012a8bc6c125652a00287fbd/28653b373e56772ac12572ab003a4d68
[34] The Indian Patents (Amendments) Act 2005, available at:
http://www.ipindia.nic.in/ipr/patent/patent_2005.pdf
[35] Translated text of the actual license is available at:
http://lists.essential.org/pipermail/ip-health/2004-December/007233.html
[36] Translated text of the actual license is available at:
http://www.cptech.org/ip/health/c/malaysia/arv-license.html. For more
information: Chee Yoke Ling, Malaysia's Experience in Increasing
Access to Antiretroviral Drugs: Exercising the "Government Use" Option
(Third World Network, IPR Series No 9, 2006), available at:
http://www.twnside.org.sg/title2/IPR/IPRS09.pdf
[37] For more information:
http://www.cptech.org/ip/health/cl/recent-examples.html#Korea
[38] Kim Cheong-won, "Health Regulator Seeks to Produce Bird Flu
Drug," the Korea Times.
[39] Kathrin Hille, "Taiwan employs compulsory licensing for Tamiflu,"
FT, November 25 2005.
[40] Taiwan issues compulsory license for making Tamiflu, Nov 25, 2005.
[41] Translated text of the actual license is available at:
http://www.cptech.org/ip/health/c/thailand/thaicl4efavirenz.html
[42] Translated text of the actual license is available at:
http://www.cptech.org/ip/health/c/thailand/thai-cl-kaletra_en.pdf
[43] Translated text of the actual license is available at:
http://www.cptech.org/ip/health/c/thailand/thai-cl-clopidogrel_en.pdf
[44] The letter (in Spanish) is available at:
http://www.cptech.org/ip/health/c/dr/
[45] For more information:
http://www.essentialinventions.org/drug/imatinibmesylate/index.html
[46] Lucia Gallardo, El negocio del VIH/SIDA Patentes farmaceuticas
¿para que y para quien? (2006, Universidad Andina Simon Bolivar).
[47] SEC Form 10-Q -- Quarterly report [Sections 13 or 15(d)], Period
of Report: 2006-09-30.
[48] Price at Drugstore.com, 5 May 2007.
[49] For more information,
http://www.essentialinventions.org/docs/cameroon/
[50] Text of the actual license is available at:
http://www.cptech.org/ip/health/cl/Ghana.png
[51] Text of the actual license is available at:
http://www.cptech.org/ip/health/cl/Eritrea.png
[52] Translated text of the actual license is available at:
http://www.cptech.org/ip/health/c/mozambique/moz-cl-en.pdf
[53] Text of the actual license is available at:
http://www.cptech.org/ip/health/c/zambia/zcl.html
[54] Text of the actual license is available at:
http://www.cptech.org/ip/health/c/zimbabwe/zim05242002.html
[55] Bio-Technology General Corp., 10-K Report, April 1, 1996.
[56] Savient Pharmaceuticals Inc, Form:10-K Filing Date: 3/26/1998.
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/
E-DRUG: List of countries with compulsory licenses (5)
------------------------------------------------------------------------
Hi all,
I think Karin Wiedenmayer's question is an important one - we should, however, be very specific in how we answer it.
I was surprised, for example, to see South Africa in Robert Weissman's list. The Knowledge Ecology International document cited (www.keionline.org/index.php?option=com_content&task=view&id=41 ), captures the details well, but these need to be teased out carefully.
The South African Commissioner of Patents has issued no compulsory licences for medicines in recent years, in terms of the Patents Act (Act 57 of 1978, as amended - see www.cipro.co.za/legislation%20forms/patents/Patent%20act.pdf ). The Minister of Health has also not exercised her right to provide for "government use" licensing (section 4 of the Act reads: "4. State bound by patent. A patent shall in all respects have the like effect against the State as it has against a person: Provided that a Minister of State may use an invention for public purposes on such conditions as may be agreed upon with the patentee, or in default of agreement on such conditions as are determined by the commissioner on application by or on behalf of such Minister and after hearing the patentee). Note that the issue of a CL in terms of this Act is a judicial process (the Commissioner is a judge appointed by the High Court for this purpose)
What success has been achieved (and there is now considerable competition between certain generic antiretroviral products, made under voluntary licences) relied on the use of the Competition Act (Act 89 of 1998, as amended - see www.compcom.co.za/thelaw/ConsolidatedAct.doc ). This is South Africa's "anti-trust" law. The details of the Hazel Tau application can be accessed at www.alp.org.za/modules.php?op=modload&name=News&file=article&sid=225
A similar application in respect of efavirenz was submitted by the Treatment Action Campaign to the Competition Commission late last year (see www.tac.org.za/nl20071107.html; and for the details - http://www.tac.org.za/documents/TACvMSDFinalCompCompapersFinalOf041107.zip).
The SA Treasury has recently issued a tender for the supply of antiretrovirals, but has again (as in 2004) included very stringent IP conditions:
* "Bidders must comply with the requirements of the Patents Act, 1978 (Act 57 of 1978) and the Trade Marks Act, 1993 (Act 194 of 1993). Bidders must submit a copy of the actual patent or an agreement with the patent holder with the bid document at the closing date and time of the bid."
* "Bidders must comply with any legal requirements with regard to voluntary licences obtained, and proof of agreements in this regard must be supplied with the bid document at the closing date and time of the bid."
The tender closes on 20 March 2008. Manufacturers of generic ARVs that are registered on that day by the SA Medicines Control Council, but which have no signed voluntary licence in place, will be excluded from the tender. At least 1 potential supplier of efavirenz (which has been estimated to account for 64% of all expenditure on ARVs in the SA public-sector programme) may be in that position on 20 March. Adding another potential tenderer to the originator and the existing licensed generic firm would be expected to exert downward pressure on the prices submitted.
regards
Andy
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Consultant Pharmacist
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
E-DRUG: List of countries with compulsory licenses (6)
-----------------------------------------------------------------------
Allow me to respond to Andy Grey's comment about the KEI list of
compulsory licenses.
The term "compulsory license" is one that is explicitly used in some
national statutes, but it is not the only or even the most common legal
term used for non-voluntary authorizations to use patents. There are a
wide variety of legal doctrines and statutory provisions that
collectively involve non-voluntary authorizations to use patents.
In the TRIPS, each may fit under one or more of the following Articles:
Article 30 (Exceptions to Rights Conferred), Article 31 (Other Use
Without Authorization of the Right Holder), Article 40 (Control of
Anti-Competitive Practices in Contractual Licenses), Article 44
(Injunctions, see in particularly paragraph 2), and the new Doha
paragraph 6 decision that may become 31.bis.
The term "compulsory licensing" is often used as a descriptive way to
lump together many types of non-voluntary authorizations, including
those with names like ex officio licenses, government use, crown use,
remedy for use by or for a government, alternative to the enforcement of
injunctions (a rapidly growing category under the US eBay decision),
remedies to anti-competitive practices, compulsory licenses, mandatory
licenses, statutory licenses, licenses of right, etc.
The KEI list includes all of these non-voluntary authorizations. We
refer to them generically as compulsory licenses in some cases because
the term is often used as a synonym for non-voluntary authorizations,
including those that don't even involve licenses. I believe this is
explained in our "Recent examples of compulsory licensing of patents,"
KEI Research Note 2007:2.
With regard to the RSA cases, there has been some disagreement about the
way to characterize the TAC/Hazel Tau licenses. Some people prefer to
describe these licenses as "voluntary." Others, including KEI,
describes these licenses as non-voluntary licenses issued to remedy to
anti-competitive practices.
I was the lead consultant to the RSA competition commission for the
TAC/Hazel Tau case, working with a team that included Rob Weissman, Sean
Flynn, Iris Boutris, Thiru Balasubramaniam, Michael Palmedo, Joy
Spencer, and literally dozens of experts. In addition to the CPTech
evaluations of the specific allegations of anti-competitive violations
of the RSA competition Act and our team's expert reports, the following
persons provided expert reports for the case: Brook K. Baker, Carlos
Correa, Eleanor Fox, Shubha Ghosh, Aidan Hollis, William Jack, Oxford
Public Interest Lawyers, Jerome Reichman, Juan Roveria, F.M. Scherer,
and Alicia Ely Yamin. (In August 2004, the RSA competition commission
received a fully redacted version of the entire consultant and expert
reports).
The legal issues are a little dense, but the short story is this. In
2002, TAC/Hazel Tau filed a very important complaint with the RSA
competition commission, alleging that two companies were in violation of
RSA competition law, by charging "excessive" prices on several AIDS
drugs. In September 2003, the Commission announced a decision in favor
of the TAC/Hazel Tau complaint, and also found GSK and BI in violation
of two other provisions in the RSA competition act -- exclusionary acts
(refusals to license patents) and failure to provide access to an
essential facility (the patents on several AIDS drugs). The competition
commission and TAC/Hazel Tau separately settled the case. I was told
recently by Jonathan Berger that the TAC/Hazel settlement is today the
relevant legal obligation. Among the remedies to settle the case were
the licenses to generic competitors. Are those licenses "voluntary?"
That depends upon your definition of voluntary. One could argue that
GSK and BI "voluntarily" settled the case, rather than allowing it to
reach its final legal resolution in the RSA legal system. In our view,
the licenses were issued because of the TAC/Hazel Tau lawsuit and the
Commission's actions, which went even beyond the TAC/Hazel Tau
complaint. This is not dissimilar from the many actions in the United
States, Europe, Korea (oseltamivir), China (oseltamivir) and elsewhere
where governments announce that failures to license patents violate
laws, and cases are resolved with agreements that licenses will be
issued. In the absence of the actions or threats by governments or
private litigants to enforce a licensing obligation, it would truly
voluntary. That was not the case in the TAC/Hazel Tau case, and our
research note details a large number of other cases around the world
where decisions to license were forced by a legal obligation to license.
If we updated our research note today we would include several new
"eBay" cases of non-voluntary use of patents, several important recent
actions regarding the non-voluntary use of patented technologies for
cell phones, some of the new EU obligations on Microsoft to license
technologies, and more details of Abbott's efforts to obtain compulsory
licenses for patents used in a Hepatitis C virus (HCV) genotyping test
kit.
James Love, Knowledge Ecology International (KEI)
www.keionline.org james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673
US mobile +1.202.361.3040, Geneva mobile +41.76.413.6584
E-DRUG: List of countries with compulsory licenses (7)
---------------------------------------------------------------------
Dear all,
Do I understand correctly from the Knowledge Ecology International (KEI)
list hat the following industrialized countries have issued compulsory
licences on pharmaceutical patents so far?
- USA
- Canada
- Italy
Thank you for your feedback!
Karin Wiedenmayer, MSc, PharmD
Swiss Tropical Institute
Swiss Centre for International Health
Socinstrasse 57
4002 Basel
Switzerland
T+41 61 284 81 26
F+41 61 284 81 03
www.sti.ch
E-DRUG: List of countries with compulsory licenses (8)
---------------------------------------------------------------------
We try to explain the cases as clearly as possible, and the data
is about a year out of date. There have been plenty of CL disputes on
medical technologies involving different industrialized countries,
including recently Korea, Belgium, France, Germany and the three you
mention. Some involve stem cells, medical devices or diagnostic devices
(US, Germany, France, and Belgium) or vaccines (avian flu vaccine in
US). Canada has several CL proceedings and disputes, but little in the
way of production under a CL (the ciprofloxcin license was short lived,
for example, and some of the export licenses cases have not resulted in
much in the way of production). Korea used a CL threat for stockpiles
of generic oseltamivir for avian flu. The three recent Italian cases
(2005, 2006 and 2007) involved pharmaceuticals, and were for export to
other European countries (Merck antibiotic Imipenem Cilastatina, Glaxo's
Sumatriptan Succinate for migraines, Merck's prostate and male-pattern
baldness drug).
