# \[e-drug\] List of countries with compulsory licenses **URL:** \ **Category:** e-drug\ **Created:** [March 5, 2008, 1:01pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471 "2008-03-05T13:01:54Z")\ **Posts on this page:** 8\ **Page:** 1
**Author:** ![Wiedenmayer](https://avatars.discourse-cdn.com/v4/letter/w/a3d4f5/32.png) [@Wiedenmayer](https://talk.edrugplus.org/u/Wiedenmayer)\ **Post date:** [March 5, 2008, 1:01pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/1 "2008-03-05T13:01:54Z")
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 ---
**Author:** ![Robert\_Weissman](https://avatars.discourse-cdn.com/v4/letter/r/4491bb/32.png) [@Robert\_Weissman](https://talk.edrugplus.org/u/Robert_Weissman)\ **Post date:** [March 5, 2008, 2:43pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/2 "2008-03-05T14:43:45Z")
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](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](http://www.cptech.org/ip/health/cl/recent-examples.html) Robert Weissman Essential Action E-mail: rob@essential.org ---
**Author:** ![Judit\_Rius\_Sanjuan](https://avatars.discourse-cdn.com/v4/letter/j/f17d59/32.png) [@Judit\_Rius\_Sanjuan](https://talk.edrugplus.org/u/Judit_Rius_Sanjuan)\ **Post date:** [March 5, 2008, 3:49pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/3 "2008-03-05T15:49:12Z")
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](http://www.keionline.org/index.php?option=com_content&task=view&id=41) and [http://www.cptech.org/ip/health/cl/recent-examples.html](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 ---
**Author:** ![Sarah\_Rimmington](https://avatars.discourse-cdn.com/v4/letter/s/b5e925/32.png) [@Sarah\_Rimmington](https://talk.edrugplus.org/u/Sarah_Rimmington)\ **Post date:** [March 5, 2008, 4:14pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/4 "2008-03-05T16:14:40Z")
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](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&](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/](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](http://www.cptech.org/ip/health/tamiflu/hearingexcerpts11082005.html) [6] Petition available at: [http://www.scotusblog.com/movabletype/archives/Zoltek.pdf](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](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](http://stemcells.nih.gov/staticresources/research/registry/MTAs/Wicell_MOU.pdf) [8] For more information: [http://www.essentialinventions.org/drug/ritonavir.html](http://www.essentialinventions.org/drug/ritonavir.html) [9] For more information: [http://www.essentialinventions.org/drug/latanoprost.html](http://www.essentialinventions.org/drug/latanoprost.html) [10] For more information: [http://www.essentialinventions.org/eii2omb-5jan07.pdf](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](http://www.ftc.gov/opa/2002/07/amgen.htm) [13] For more information: [http://www.ftc.gov/opa/2006/04/bostonscigui.htm](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](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](http://www.usdoj.gov/atr/cases/f201300/201386.htm). [15] For more information: [http://www.ftc.gov/os/adjpro/d9302/070205opinion.pdf](http://www.ftc.gov/os/adjpro/d9302/070205opinion.pdf) and [http://www.ftc.gov/os/adjpro/d9302/070205finalorder.pdf](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](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](http://online.wsj.com/article/SB117815853947390467.html). [18] Finisar Corp. v. DirecTV Group, Inc, available at: [http://www.fr.com/news/Finisar-Judgement.pdf](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](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](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](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/](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](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](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](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](http://www.twnside.org.sg/title2/IPR/IPRS09.pdf) [37] For more information: [http://www.cptech.org/ip/health/cl/recent-examples.html#Korea](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](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](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](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/](http://www.cptech.org/ip/health/c/dr/) [45] For more information: [http://www.essentialinventions.org/drug/imatinibmesylate/index.html](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/](http://www.essentialinventions.org/docs/cameroon/) [50] Text of the actual license is available at: [http://www.cptech.org/ip/health/cl/Ghana.png](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](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](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](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](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/ ---
**Author:** ![graya11](https://avatars.discourse-cdn.com/v4/letter/g/43a26b/32.png) [@graya11](https://talk.edrugplus.org/u/graya11)\ **Post date:** [March 10, 2008, 8:22am UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/5 "2008-03-10T08:22:13Z")
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](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 ---
**Author:** ![James\_Love](https://avatars.discourse-cdn.com/v4/letter/j/f14d63/32.png) [@James\_Love](https://talk.edrugplus.org/u/James_Love)\ **Post date:** [March 11, 2008, 5:34am UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/6 "2008-03-11T05:34:47Z")
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 ---
**Author:** ![Wiedenmayer](https://avatars.discourse-cdn.com/v4/letter/w/a3d4f5/32.png) [@Wiedenmayer](https://talk.edrugplus.org/u/Wiedenmayer)\ **Post date:** [March 16, 2008, 9:10pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/7 "2008-03-16T21:10:22Z")
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 ---
**Author:** ![James\_Love](https://avatars.discourse-cdn.com/v4/letter/j/f14d63/32.png) [@James\_Love](https://talk.edrugplus.org/u/James_Love)\ **Post date:** [March 17, 2008, 10:22pm UTC](https://talk.edrugplus.org/t/e-drug-list-of-countries-with-compulsory-licenses/29471/8 "2008-03-17T22:22:05Z")
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).