25 January 2007


FMI:

Washington DC: James Love (james.love@cptech.org, mb +1.202.361.3040, today +41.76.413.6584), or Judit Rius (judit.rius@cptech.org, +1.202.332.2670)
Geneva: Thiru Balasubramaniam (thiru@cptech.org, mb. +41.76.508.0997)
London: Michelle Childs (michelle.childs@cptech.org, mb +44.790.386.4642)


Knowledge Ecology International (KEI) Statement on Thailand Compulsory licenses


Knowledge Ecology International (KEI) applauds the decision by the Thailand Ministry of Health to issue new compulsory licenses on patents for the AIDS drug Kaletra (LPV+RTV) and the heart disease drug Plavix (clopidogrel bisulfate). We expect that Thailand will issue other compulsory license on medicines in the future.


According to KEI Director James Love: Unless the Thailand government uses the flexibility in the TRIPS to issue compulsory licenses on patents, the people who live in Thailand will suffer from limited access to medicines. More than five years after the 2001 Doha Declaration on TRIPS and Public Health called upon WTO members to implement the TRIPS in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all, Thailand is doing just that. Every country that applauded the landmark 2001 Doha Declaration should applaud actions that turn words into actions, and actions that expand access to medicines.


The prices that Abbott charges for Kaletra and other second line AIDS drugs are too high, and no developing country with significant HIV infection rates will be able to provide sustainable treatments for AIDS patients, unless they stimulate a generic market for products. Compulsory licenses in Thailand and other countries will stimulate investment by generic companies to create new fixed dose combinations that have better delivery mechanism. The benefits of these compulsory licensees will grow over time, in terms of cheaper prices and better products.


The compulsory licenses on the Plavix (clopidogrel bisulfate) patents are very important also, as Thailand take steps to address the issue of heart disease, a condition the WHO says is the leading cause of death for both men and women. According to a new WHO report, Heart disease, stroke and diabetes alone are estimated to reduce the gross domestic product by between 1% and 5% per year in low-and middle-income countries experiencing rapid economic growth.


A growing number of NGOs, economists, health experts and governments now say that concerns about R&D for new products should no longer be focused on measures that create high prices on medicines, but rather on a new global framework to support medical innovation. This week the World Health Organization (WHO) Executive Board is discussing procedures to create a new global plan of action that promotes both innovation and access. This should be where we push for more investment in innovation.


Below are two documents. The first includes excerpts from the recent WHO report on non-communicable diseases. The second is a background document on recent disputes involving compulsory licenses on patents.[2] The second document illustrates that compulsory licensing is more common than is commonly thought, including compulsory licenses outside of the health area." Love said.


Excerpts from: EXECUTIVE BOARD EB120/22, 120th Session Provisional agenda item 4.5. Prevention and control of noncommunicable diseases: implementation of the global strategy. Report by the Secretariat, 8 January 2007


3. The global epidemic of chronic noncommunicable diseases continues to grow. In 2005, they caused an estimated 35 million deaths: 60% of all deaths globally, with 80% in low- and middle income countries and about 16 million in people under 70 years of age. Cardiovascular disease is the leading cause of death among both men and women, accounting for more than 17 million deaths in 2005. Total deaths from chronic disease are projected to increase by a further 17% over the next 10 years, while deaths from infectious diseases, maternal and perinatal conditions and nutritional deficiencies combined are expected to decline.


9. WHO report on preventing chronic diseases1 synthesized information, presented new projections of the epidemiological and economic burden of these diseases and has begun to dispel many common misunderstandings. It demonstrated that chronic diseases and poverty are tied into a vicious cycle, and that their impact shackles the macroeconomic development of many countries. Heart disease, stroke and diabetes alone are estimated to reduce the gross domestic product by between 1% and 5% per year in low-and middle-income countries experiencing rapid economic growth. In China, the Russian Federation and India, estimated losses in national income over the next 10 years due to these diseases are (in international dollars) $558,000 million, $303,000 million and $237,000 million, respectively. The report also examined the large and increasing body of evidence of simple, inexpensive and cost-effective measures that can produce rapid health gains. It emphasizes that the full response to the double burden of infectious and chronic noncommunicable diseases still faced by many countries, even under severe resource constraints, requires a strong primary health-care system as part of an integrated health system. It has spurred policy action in many countries, including several with a high burden of chronic diseases. Work is under way to examine and explain the links between chronic noncommunicable diseases and both development and human security, and their contribution to health inequalities.


Recent Compulsory licenses James Love, Knowledge Ecology International (KEI) - 25 December 2006


The following are recent examples of the use of compulsory licenses. This is not exhaustive list. It includes cases involving both medical technologies and other technologies, and successful and unsuccessful compulsory licensing requests.


United States


Mandatory compulsory license patents whose term was extended by GATT implementation

For patents that were extended by the change from 17 years from the patent grant to 20 years from the patent application (the period), the Congress created a mandatory compulsory license. The compulsory license applied to over 100 brand name pharmaceutical products. However, drug registration issues that were not addressed in the GATT implementation legislation undermined the benefits of the compulsory license in the pharmaceutical sector. (1)


Cases involving government use under 28 USC 1498

In 2001, DHHS Secretary Tommy Thompson used the threat to use 28 USC 1498 to authorize imports of generic ciprofloxacin, for stockpiles against a possible anthrax attack.

In 2005, the US Department of Justice cited its right to use patents in 28 USC 1498 when it opposed injunctive relief for infringement of the patents relating to the Blackberry email services supplied to both the government and private firms that used the Blackberry device to communicate with the government. (2)

In a November 2005 Congressional hearing, DHHS Secretary Michael Levitt testified before the House of Representatives that he had threatened to override the patents on treatments for Avian Flu if companies had not expanded US production facilities. (3)

Cases involving Bayh-Dole Act

In 2001, the Department of Health and Human Services used its authority to exercise March-In rights for patents on stem cell lines held by the Wisconsin Alumni Foundation as leverage to secure an open license on those patents. (4)

In 2004, DHHS refused to grant march-in rights in two cases brought by Essential Inventions, involving patents on the AIDS drug ritoanvir and the glaucoma drug latanoprost.

In 2006, the Centers for Disease Control threatened to use US Bayh- Dole =93march-in=94 rights to issue compulsory licenses on patents on reverse genetics, which are needed to manufacture vaccines for avian flu.

Cases involving merger reviews

In 2002, the US FTC ordered a compulsory cross-license of the Immunex tumor necrosis factor (TNF) patent, to Serono, including the =93freedom to practice in the research, development, manufacture, use, import, export, distribution and sale of TNFbp-I Products and certain glycosylated and nonglycosylated fragments, derivatives and analogs thereof in the United States.

In 2005, the FTC ordered a compulsory license of Guidant intellectual property surrounding the RX delivery system for Drug- Eluting Stents.

Cases involving non-merger remedies to anticompetitive practices

In 2002, the US Department of Justice required Microsoft to license on reasonable and non-discriminatory terms intellectual property rights in a number of different protocols needed to create products that were interoperable with Microsoft Windows. (5)

Cases involving the new US Supreme Court standard for granting injunctions on patents. [eBay Inc. v. MercExchange, L.L.C., 126 S. Ct. 1837, 1839-1841 (U.S. 2006)].

In June 2006, a court granted Microsoft a compulsory license to use two patents owned by z4 Technologies that relate to digital rights management systems used by Microsoft for its Windows and MS Office software programs.

In July 2006, a court granted DirectTV a compulsory license to use the Finisar patent on integrated receiver decoders (satellite set top boxes), for a royalty of $1.60 per device.

In August 2006, a court granted Toyota a compulsory license on three Paice patents for hybrid transmissions, for a royalty of $25 per automobile.

In September 2006, a court granted Johnson and Johnson a compulsory license to use three of Jan Voda’s patents on guiding-catheters for performing angioplasty.


Canada


In a September 2001 Speech on the Myriad Gene Patent, the Ontario Health Minister called for compulsory licensing of patents on genes relevant to tests for breast cancer. In January 2002, the Ontario Advisory Committee on New Predictive Genetic Technologies published “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 thepotential for compulsory licensing of patents relating to the provision of genetic diagnostic and screening tests should this power be necessary."

On October 18, 2001, Health Canada overrode the Bayer patents on ciprofloxacin, and authorized generic manufacture for purposes of building a stockpile as protection against an attack of certain strains of anthrax. In announcing the action, Paige Raymond Kovach, a spokeswoman for Health Canada, said: "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, a product sold by Roche under the brand name Tamiflu.

On August 31, 2005, Schedule 1 of the Patent Act was amended to add lamivudine (150 mg) + nevaripine (200 mg) + zidovudine (300 mg) tablets – the fixed dose combination in the Apotext/MSF application.

On July 1, 2006, the Canadian government published a proposed amendment to Schedule 1 of the Patent Act to add oseltamivir phosphate (75 mg capsules and 12 mg/mL powder for oral suspension), which is used in the treatment and prophylaxis of Type A and Type B influenza. In September 2006, the product was included in Schedule 1.

Apotex claims as defense to an infringement claim, that it’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. (6)

On May 7, 2004, Torpham successfully appealed a rejection of a compulsory license application involving Merck patents for the manufacture and sale of Lisinopril. (7) Torphan had sought a license to the use the patents for purposes of manufacturing and exporting to the United States. The court help that the request for the compulsory license had sufficient merit to be proceed to the next stage. The court held that serving export markets abroad constitutes Canadian demand for the patented product.

On September 16, 1998, Brantford asked a Canadian federal court for an order compelling Merck to licence patents needed to manufacture SESIC. On April 30, 1999, Brantford filed another application for a compulsory license. The case involved a number of procedural disputes and appeals, such as a February 2, 2005 court decision rejecting Merck’s efforts dismiss the compulsory licensing application on certain procedural grounds. (8) A hearing on the compulsory license was held in April 2005 before the Patent Appeal Board. On September 1, 2005, the Patent Appeal Board upheld an earlier rejection of the compulsory license. Brantford appealed to the court. On November 7, 2006, a court in British Columbia upheld the rejection of the compulsory license, holding the Commissioner of patents had not erred in determining that patent abuse had not been established, since it was reasonable for the Commissioner to find on the evidence that there was no genuine market demand for the product, and that it was reasonable to find that not enough time had been afforded Merck to respond to Brantford’s request for a licence, and Merck’s silence could not be construed as a refusal to license. (9)


Europe


On April 29, 2004, the European Court of Justice issued a preliminary ruling on compulsory licensing of intellectual property rights under European competition law, in the IMS Health vs NBC case. The ECJ held that under certain circumstances an obligation to license an intellectual property right exists. The four conditions were:

1. The intellectual property right should constitute, upstream, an indispensable factor in the downstream supply of a (secondary) product.

2. The potential licensee should intend to produce new goods or services not offered by the owner of the right, and for which there is a potential consumer demand.

3. The refusal should not be justified by objective reasons.

4. The refusal should be of such a nature that it reserves for the owner of the right the market for the provision of the product, by eliminating all competition on that market.


United Kingdom


Following the passage of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection Of Biotechnological Inventions, the United Kingdom amended its patent law to provide for mandatory compulsory cross-licenses of certain biotechnology inventions used for agriculture. The license is available to plant breeders who demonstrate a technical advance. The December 6, 2006 UK Gowers Review noted the British Society of Plant Breeders complained the provision is "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.


Germany


In 2000, Roche asked the German government to grant a compulsory license on a patent protecting the Blood Screening HIV Probe owned by Chiron. On May 22, 2001, a licensing agreement was reached between Roche and Chiron. In return for its license, Roche agreed to end its attempts to obtain a compulsory license. (10)


France


RU 486

France considered the use of compulsory licenses in the case of the abortion pill RU 486, which was developed by the French pharmaceutical manufacturer ROUSSEL UCLAF. In response to threats of boycotts by pro-life organizations, the company withdrew the product from the market. In the subsequent efforts by the French government to reverse the decision, a court ruled the government could obtain access to the medicine by using the ex-officio license system. Earlier, however, the product was already back on the market, so the ex officio license was not needed.

BRAC1 and BRAC2 patents on breast cancer tests

France was among several European countries who were outraged by the high prices of breast cancer diagnostic tests, because of the Myriad gene patents. In 2004, France amended its patent law to allow the broader use of ex officio licenses, and in particular, to authorize the government to issue ex officio licenses to patents on certain dialogistic technologies. The new act provide that:

Where the interests of public health demand, and in the absence of a voluntary agreement with the patent holder, the minister responsible for industrial property, may, by order of the minister responsible for public health, request ex officio licenses in accordance with Article L. 613-17 for any patent granted for:

a) a medicine, a medical device, a medical device for in vitro diagnosis, a related therapeutic product;

b) processes for obtaining them, [or] for products necessary in obtaining such medicines or for processes for manufacturing such products

c) a diagnostic method ex vivo.


Belgium


Belgium modified its patent law in 2005, creating a new compulsory cross-license for biotechnology inventions, and also a new compulsory license for public health purposes. (11)


Italy


SORIN BIOMEDICA/SNIA

On June 14, 1994, Sorin Biomedica S.p.A. filed a lawsuit with the Court of Milan, Italy against Chiron Corporation and Ortho Diagnostic Systems S.p.A. for a declaration of nullity and noninfringement of the Italian counterpart to Chiron's European Patent 0 318 216 (the "216 patent"). Sorin additionally filed a request with the Italian Ministry of Industry, Commerce and Artisanship ("ICA") for compulsory license to the 216 patent. Chiron filed a counterclaim and sought a finding that the patent is valid and infringed by Sorin. The ICA suspended Sorin's request for compulsory license pending the outcome of the litigation.


China


In 2005, China used the threat to a compulsory license to obtain voluntary licenses to manufacture generic Tamiflu.


Malaysia


On September 29, 2004, the Malaysian Minister of Domestic Trade and Consumer Affairs issued a two-year government use compulsory license to import from India didanosine (ddI), zidovudine (AZT) and lamivudine+zidovidine (Combivir).


Indonesia


On October 5, 2004, Indonesia issued a compulsory license to manufacture generic versions of lamivudine and nevirapine, until the end of the patent term in 2011 and 2012 respectively. The license is for government use, and includes a royalty rate of 0.5% of the net selling value.


Korea


On January 30, 2002, the People's Health Coalition for Equitable Society, the Association of Physicians for Humanism, and the Korean Pharmacists for Democratic Society jointly filed for a compulsory license for Glivec, a drug to treat chronic myelogenous leukemia (CML), and gastrointestinal stromal tumor (GIST). The request was rejected.

In October 2005, the Korea Food and Drug Administration (KFDA) announced it was considering a compulsory license for the manufacture of generic versions of Tamiflu.12


India


In February 2005, India amended its patent law, to provide for patent protection for pharmaceutical inventions. The legislation created a mandatory compulsory license for products that were already manufactured and marketed in India.


Taiwan


On July 26, 2004, the Taiwan Intellectual Property Office (TIPO) issued a compulsory license to Gigastorage for 5 patents related to CD-R of Phillips. The term of the license is through the expiration of the patent terms.

In November 2005, Taiwan issued a compulsory license for patents needed to manufacture and sell generic versions of Tamiflu.13 According to this report by Deutsche Presse-Agentur dpa:

"The Intellectual Property Office (IPO) granted compulsory licensing to Taiwan pharmaceutical companies after talks with Roche and Gilead Science - the U.S. developer of Tamiflu - broke down. 'Roche and Gilead insisted they can supply enough Tamiflu if bird flu erupts in Taiwan. Our argument was: When there is a bird flu pandemic, millions of people will be hospitalized or dead, and some countries might confiscate Tamiflu or ban its export. We cannot gamble our people's lives on their unreliable promise,' Lai Chin-hsiang, secretary-general of the Department of Health (DOH), told Deutsche Presse-Agentur dpa. Under the compulsory license, valid until December 31, 2007, Taiwan drug firms can make Tamiflu for domestic use and should use it only when there is a shortage of supply from Roche." (14)


Argentina


On October 18, 2005, Health Minister Gines Gonzalez Garcia announced the government would issue compulsory licenses on the patents for Tamilfu.


Dominican Republic


There have been requests for compulsory licenses on the patents for Plavix, a heart disease drug. On May 14, 2002, the French embassy in DR wrote to Sr. Hugo Guiliani Cury, Secretary of State of the Dominican Republic, expressing opposition to the compulsory license.


Chile


In December 2004, Essential Inventions requested a compulsory license to supply Glivec to Chile.


Peru


In 2004, the government issued a compulsory license in the patents on d4T.


Ecuador


Something happened here, but we are still investigating.


Brazil


On January 8, 2001, 12 days before President Clinton left office, USTR filed a complaint over the Brazil compulsory licensing law in the WTO Dispute Settlement Body. USTR officials called this the “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%." (15)

Brazil also used the threat of compulsory licenses on the patents for Gleevic to obtain a price discount of more than 65 percent.


Cameroon


On January 2005, the nonprofit corporation Essential Inventions requested the Minister of Public Health to grant ex officio licenses for the patents relevant for importation, manufacture or sale of generic versions of the following medicines used in the treatment of HIV/AIDS: Nevirapine (Brand name Viramune®) Lamivudine (Brand name 3TC®) Fixed dose combinations of Lamivudine and Zidovudine (Brand name Combivir®). The request is still pending.


Guinee


On April 18, 2005, the Ministry of Health issued compulsory licenses on patents on drugs to treat AIDS.


Ghana


On October 26 2005, the Minister of Health issued a government use compulsory licenses for importation into Ghana of generic HIV-AIDS medicines.


Eritrea


On June 5 2005, the Minister of Health issued a compulsory license for for importation into Eritrea of generic HIV-AIDS medicines.


Mozambique


On April 5, 2004, Mozambique's Deputy Minister of Industry and Commerce issued Compulsory License no. 01/MIC/04 for patent rights to lamivudine, stavudine and nevirapine. The license was granted to Pharco Moćambique Lda, a local producer that plans on manufacturing the antiretrovirals as a fixed-dose combination. Royalties are not to exceed 2% of sales.


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;

* Denied a competitor access to an essential facility
* Excessive pricing
* Engaged in an exclusionary act

On December 10, the competition commission announced it had reached a settlement with GSK. The settlement required GSK to

* extend a voluntary licence granted to Aspen Pharmacare in October 2001 in respect of the public sector to include the private sector;
* grant up to three more voluntary licences on terms no less favourable than those granted to Aspen Pharmacare;
* permit the licensees to export the ARVs to sub-Saharan African countries;
* permit the importation of the drugs for distribution in South Africa if the licensee does not have manufacturing capability in South Africa;
* permit licensees to combine the relevant ARV with other antiretroviral medicines; and
* charge royalties of no more than 5% of the net sales of the relevant ARVs.
Shortly thereafter, a similar settlement was reached with BI.


Swaziland


On April 20, 2004, the Ministry of Health and Social Welfare in Swaziland noted the existence of an emergency relating to AIDS, and authorized procurement of medicines for HIV/AIDS "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."


Zambia


On September 21, 2004 the Zambian Minister of Domestic Trade and Consumer Affairs issued a compulsory license for lamivudine, stavudine and nevirapine. The license was granted to Pharco Ltd., a local producer, which will produce a triple fixed-dose combination. A maximum royalty rate of 2.5% applies.


Zimbabwe


On May 27, 2004, Zimbabwe's Minister of Justice, Legal and Parliamentary Affairs declared a Period of Emergency in order to override antiretroviral drug patents. With assistance from India, Zimbabwe has begun local production of antiretrovirals.


Isreal


"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." (16)

"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." (17)

The Biogen Israeli patent expired in December 1999, before the Supreme Court ruled on the compulsory license.


Notes


1. See: 104TH CONGRESS, Report, SENATE, 2d Session, 104-394, PHARMACEUTICAL INDUSTRY SPECIAL EQUITY ACT OF 1996, REPORT together with MINORITY VIEWS [To accompany S. 1277].

2. The United States’ Statement Of Interest, November 2005., NTP, INC., Plaintiffs, V. RESEARCH IN MOTION, LTD., Defendant., Civil Action No. 3:01CV767.

3. See video excerpts from November 8, 2005 Hearings of the Subcommittee on Health of the House Committee on Energy and Commerce, http://www.cptech.org/ip/health/tamiflu/hearingexcerpts11082005.html

4. September 5, 2001, "National Institutes of Health and WiCell Research Institute, Inc., Sign Stem Cell Research Agreement," http://www.nih.gov/news/pr/sep2001/od-05.htm.

5. United States Of America, Plaintiff V. Microsoft Corporation, Defendant. Civil Action No. 98-1232 (CKK), FINAL JUDGMENT, (November 12, 2002). For a detailed account of work to implement the order, see: INTERIM JOINT STATUS REPORT ON MICROSOFT'S COMPLIANCE WITH THE FINAL JUDGMENTS, http://www.usdoj.gov/atr/cases/f201300/201386.htm.

6. AstraZeneca Annual Report and Form 20-F Information 2005

7. Torpham v. Commissioner of Patents and Canada (AG), May 7, 2004 FCTD (MacKay J.) Abuse of Exclusive Rights/Section 65 of the Patent Act/Compulsory Licence /Request to Supply Bulk Lisinopril for Production of Tablets in Canada for Export to the U.S.

8. Merck v. Brantford Chemicals and Commissioner of Patents and Canada (Attorney General), February 2, 2005 FCA (Rothstein, Evans, Malone JJ.A.) Compulsory Licence/Patent Act/Res Judicata/Functus Officio/Final Decisions.

9. 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.

10. ARTICLE 5 - OTHER ACTIONS

5.1 Patent Validity; Enforceability. Immediately upon the Effective Date, or as soon as possible thereafter, ROCHE shall discontinue any opposition, challenge,

compulsory license application or the like with respect to the CHIRON Licensed Patents.

5.2 Compulsory Licensing. ROCHE covenants and agrees on behalf of itself and its Affiliates to not support any third party in seeking compulsory licensing of the

CHIRON Licensed Patents in any jurisdiction. As used in this Section, "support" shall have the same meanings as in Section 7.2(b).

11. VAN OVERWALLE, G. & VAN ZIMMEREN, E., ‘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.

12. Kim Cheong-won, "Health Regulator Seeks to Produce Bird Flu Drug," the Korea Times.

13. Kathrin Hille, "Taiwan employs compulsory licensing for Tamiflu," FT, November 25 2005.

14. Taiwan issues compulsory license for making Tamiflu, Nov 25, 2005.

15. SEC Form 10-Q -- Quarterly report [Sections 13 or 15(d)], Period of Report: 2006-09-30.

16. BIO-TECHNOLOGY GENERAL CORP., 10-K Report, April 1, 1996.

17. SAVIENT PHARMACEUTICALS INC, Form:10-K Filing Date: 3/26/1998.