From owner-ip-health@venice.essential.org Mon Dec 20 11:01:17 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by venice.essential.org (Postfix) with ESMTP id 82BF821B0D; Mon, 20 Dec 1999 11:01:17 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by milan.essential.org (8.9.3/8.9.3) with ESMTP id LAA29485; Mon, 20 Dec 1999 11:01:19 -0500 Date: Mon, 20 Dec 1999 11:01:19 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Ip-health] Pascale Boulet on TRIPS Transition in Thailand According to Pascale Boulet, because Thailand had product patents in place in January 1995, it is not required to provide 70.9 exclusive marketing rights. Jamie --------------- >From bouletp@who.ch Mon Dec 20 08:57:43 1999 Date: Fri, 17 Dec 1999 16:34:08 +0100 From: bouletp@who.ch To: love@cptech.org Subject: Re:More on the 5 year marketing exclusivity and Nevirapine i I think that the TRIPS provision on exclusive marketing rights (art.70.9) only applies to developing and least developed countries that did not provide patent protection for pharmaceutical products in January 1995 (entry into force of the WTO Agreement). I think this provision, as well as the "mail-box" system was included, so that pharmaceutical products can be protected as from 1995 even in these countries. This was necessary because these countries do not have to grant pharmaceutical patents until 2005 or 2006. The mail-box system allows pharmaceutical companies to file patent applications for pharmaceuticals since 1995 in countries where the patent law has not yet been put in line with TRIPS. These applications will be examined at the end of the transitionnal periods (2005, 2006) and granted for the remaining time of the 20-year patent term, starting at the date of the patent application. If a new pharmaceutical is given market authorization in Country A but the patent application for this drug in Country A is still pending in the mail-box, then the manufacturer of this pharmaceutical may be granted exclusive marketing rights in Country A, but only if a patent was granted and a market authorization given for the same drug in another WTO Member country after 1995. Therefore, this cannot apply in Thailand because patent protection for pharmaceutical products was introduced in Thailand in 1992. Therefore, TRIPS Articles 70.8 and 70.9 do not apply in Thailand. There was no need for a mail-box system since patent protection was available in 1995. If there is some sort of market exclusivity for Nevirapine in Thailand, it is probably due to the Safety Monitoring Programme (SMP) run by the Thai Food and Drug Administration, but not in relation to TRIPS Article 70.9. Therefore, the market exclusivity over nevirapine should cease as soon as the FDA release it from the SMP. Moreover, it would be surprising if a patent application was pending for the protection of nevirapine as a product, since the first US patent application dates back to 1989, before the revision of the Thai Patent Act in 1992. If this is the case, generic competition could start as soon as nevirapine is released from the SMP, without any need for compulsory licensing. Hoping this is understandable. Pascale From owner-ip-health@venice.essential.org Mon Dec 20 17:34:35 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 2074621B1C for ; Mon, 20 Dec 1999 17:34:35 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id RAA23048 for ; Mon, 20 Dec 1999 17:34:39 -0500 Sender: jl@genoa.essential.org Message-ID: <385EB1D5.179AB446@cptech.org> Date: Mon, 20 Dec 1999 17:46:45 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Dominican Republic I believe today, there were some articles in the Dominican Republic press regarding the proposed changes in patent law. One article is basically a press release or interview of Rodney Lopez, apparently the head of the domestic PhRMA type organization, called de la Asociacion de Empresas Farmaceuticas de Investigacion y Desarrollo (EFID). The other article concerns a press release issued by El Consejo Nacional de la Empresa Privada (CONEP). Both articles appeared in El Dinero, and are in spanish, which I can't read. I'd be happy to fax them to someone who can. According to Virgilio Mota of the Dominican Republic Embassy (in Washington, DC), the patent law is very controversial in the Dominican Republic right now, and there may be action before the end of this year (the TRIPS deadline). We tried to get some information for USTR, STATE and US PTO about the US government's policy on this, but no one would give us a single document, or even acknowledge what documents exist. But both US and Dominican Republic officials acknowledge the US has been very active in this dispute. We are going to continue to try to get some information on this. Jamie -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-ip-health@venice.essential.org Tue Dec 21 08:34:53 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from smtpgate.rockfound.org (mail.rockfound.org [208.216.158.10]) by venice.essential.org (Postfix) with ESMTP id 4DCC021BBE for ; Tue, 21 Dec 1999 08:34:53 -0500 (EST) Received: from ccMail by smtpgate.rockfound.org (IMA Internet Exchange 3.11) id 000BFEC0; Tue, 21 Dec 1999 08:35:08 -0500 Mime-Version: 1.0 Date: Tue, 21 Dec 1999 08:35:25 -0500 Message-ID: <000BFEC0.C21429@rockfound.org> From: DECKERLE@rockfound.org (DI ECKERLE) Subject: Re: [Ip-health] Dominican Republic To: AKOUYATE@rockfound.org (ADAMA KOUYATE), ASO@rockfound.org (ANTHONY SO), APABLOS-MENDEZ@rockfound.org (ARIEL PABLOS-MENDEZ), IP-Health list , James Love Content-Type: text/plain; charset=US-ASCII Content-Transfer-Encoding: 7bit Content-Description: cc:Mail note part Dear Jamie, Thanks for your e-mail. If you fax the documents to me, I should be able to get someone to translate them in the next two weeks if that is alright. Fax number: 212-852-8279 Best wishes for the holiday, Di Eckerle Health Equity The Rockefeller Foundation ______________________________ Reply Separator _________________________________ Subject: [Ip-health] Dominican Republic Author: James Love at INTERNET-MAIL Date: 12/20/99 5:38 PM I believe today, there were some articles in the Dominican Republic press regarding the proposed changes in patent law. One article is basically a press release or interview of Rodney Lopez, apparently the head of the domestic PhRMA type organization, called de la Asociacion de Empresas Farmaceuticas de Investigacion y Desarrollo (EFID). The other article concerns a press release issued by El Consejo Nacional de la Empresa Privada (CONEP). Both articles appeared in El Dinero, and are in spanish, which I can't read. I'd be happy to fax them to someone who can. According to Virgilio Mota of the Dominican Republic Embassy (in Washington, DC), the patent law is very controversial in the Dominican Republic right now, and there may be action before the end of this year (the TRIPS deadline). We tried to get some information for USTR, STATE and US PTO about the US government's policy on this, but no one would give us a single document, or even acknowledge what documents exist. But both US and Dominican Republic officials acknowledge the US has been very active in this dispute. We are going to continue to try to get some information on this. Jamie -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health _____________________________ Follow Me Separator _____________________________ This normal priority message was originally BCC'd to H S2 on 12/20/1999 at 5:46 PM. Attachment(s): (None) FM:2844,2595,H S2 From owner-ip-health@venice.essential.org Tue Dec 21 10:49:22 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id F165A21B21 for ; Tue, 21 Dec 1999 10:49:21 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA31006 for ; Tue, 21 Dec 1999 10:49:23 -0500 Sender: jl@genoa.essential.org Message-ID: <385FAF3E.413B3193@cptech.org> Date: Tue, 21 Dec 1999 11:47:58 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Thai activists demonstrating for compulsory license Date: Tue, 21 Dec 1999 22:33:30 +0700 From: "MSF-Drugs Bangkok" THAI ACTIVISTS DEMONSTRATING FOR THE USE OF COMPULSORY LICENSE OUTSIDE THE MINISTRY OF PUBLIC HEALTH IN BANGKOK The Thai Network for People Living with HIV/AIDS and supporting NGO's will start a several day demonstration outside the Ministry of Public Health on Wednesday, December 22, 1999 to demand the use of compulsory license for ddI. More than a month ago the Thai Government Pharmaceutical Organization (GPO) asked for the use of compulsory license for ddI; we are still waiting for a result. The PHA Network and NGO's have met twice with Public Health Minister, Korn Dabaransi to ask for the use of compulsory license according to section 51 of the Thai patent law or as a minimum to negotiate a voluntary license with Bristol Myers Squibb. The Public Health Minister suggested that compulsory license should only be used if Bristol Myers Squibb will not reduce the price significantly until the end of this month. Apparently there have been no attempts to even negotiate a voluntary license. Activists will not agree to a mere price reduction by Bristol Myers Squibb because only generic production can garantee that the price will drop further every time the raw material becomes cheaper. Following the statement by President Clinton in Seattle on trade policy and medicines, the Thai government should now act decisively on the issue of HIV drugs. Participating NGO's: Thai Network for People Living with HIV/AIDS; ACCESS; Alden House; Siam Care; CLIST; MSF; Care; Empower; Power of Life; Pilapkao Group; Friends of AIDS Group; Human Rights for AIDS; Consumer Foundation and others Below a report by Reuters that gives a good background on the current situation of ddI in Thailand THAIS URGED TO STAND UP TO AIDS DRUG FIRM By David Brunnstrom BANGKOK, Dec 15 (Reuters) - Medical activists are urging Thailand to take a stand against drug multinationals by licensing the local manufacture of a crucial AIDS drug that could let hundreds of thousands live longer if they could afford it. They say Bangkok should be emboldened to take the unprecedented step over the drug didanosine (ddI) after U.S. President Bill Clinton said Washington would alter trade policy to support greater worldwide access to life-saving medicines. However, the activists believe Thailand, like other developing countries struggling with the AIDS epidemic, will be unwilling to take the radical step of imposing ``compulsory licensing'' allowed under world trade rules, fearing retaliation. They say Washington has put pressure on Thailand in the past by threatening higher tariffs on Thai imports. ``The U.S. government is constantly bullying countries that attempt to pass laws to make medicines more affordable,'' James Love, director of the U.S. Consumer Project on Technology, said in a statement in response to Clinton's December 1 announcement. ``If Clinton is to be taken seriously, we'll have to see something concrete. For example, the U.S. could signal to Thailand it can proceed with compulsory licences for ddI ... that was invented by the U.S. government but sold at high prices by Bristol-Myers Squibb.'' Activists see continuing talks between the Thai government and Bristol-Myers Squibb (BMS) on ddI as a test case that could have profound implications for developing nations in the new trade round. ``EXTENDING AND ENHANCING HUMAN LIFE'' The U.S. drug giant, dedicated according to its motto, to ``Extending and Enhancing Human Life,'' boasts on its website http://www.bms.com of subsidising drug therapy in clinical trials in Thailand ``because of the large potential market of more than one million people infected with AIDS.'' It sells ddI in Thailand under the name Videx at about 49 baht ($1.25) a capsule, far beyond the means of most Thais infected with the human immunodeficiency virus, or HIV, which causes AIDS, acquired immune deficiency syndrome. Current pricing means people in a country where the minimum monthly wage is just 5,400 baht ($138) must pay up to 8,000 baht ($205) a month for a two-drug anti-retroviral cocktail. The bulk of the cost is for ddI, since Thailand's Government Pharmaceutical Organisation (GPO) began producing the other drug -- AZT, or zidovudine -- in 1995 at about a quarter of the price of the imported version. Krisana Kraisintu, head of research and development at the GPO, says she could produce ddI for 25 baht a capsule if local production were permitted. ``More HIV-infected people could have access to it if we were to manufacture it,'' she told Reuters. ``Now only five percent of the HIV-infected people can have access to the drug. If I can cut the price to half, maybe up to 10 percent can have access.'' Officials at Bristol-Myers Squibb in Thailand were unavailable for comment, but Thai media reports and activists say the firm aims to head off compulsory licensing by offering ddI in Thailand at a steep discount. Nobel Peace Prize-winning non-governmental organisation Medecins sans Frontieres (MSF), which is spearheading a global campaign to ensure ddI and other essential drugs reach those who need them, says this is not an answer and a stand should be made. Compulsory licensing would allow the local production of cheap, generic versions of the drug on payment of a royalty. Activists say drug companies are not only worried about a drop in profits in the country concerned but that if one developing country were to take the step, others would follow. THAI CASE IMPORTANT FOR COMPANY MSF says the argument drug firms make -- that the big profits they pile up are needed for research -- is especially spurious in ddI's case since it was developed with U.S. taxpayers' money. It says the best solution would be for the firms to grant voluntary licences for production of key drugs in developing countries. ``For Bristol-Myers Squibb, something important is at stake: the first use of a compulsory licence in a developing country,'' said Tido Von Schoen-Angerer, of MSF's Bangkok office. ``They will accept major price reductions if they can avoid the use of a compulsory licence in Thailand.'' A senior official of the Thai Commerce Ministry's Department of Intellectual Property said it would seek a compulsory licence for ddI only if talks between the GPO and Bristol-Myers Squibb failed. The official, who did not want to be named, said Thai law allowed compulsory licensing only in a ``national emergency.'' ``But nobody has talked about that. Many things in the country might be more serious -- like the economic crisis, or something like that,'' he said. Von Schoen-Angerer said Thailand's apparent leaning towards a compromise solution was a disappointment. While the GPO would only achieve a 50 percent reduction in price initially if it were to produce the drug generically -- a price BMS could probably match -- further cuts would likely be possible within a short time, he said. Chaiyos Kunanusont, director of the Health Ministry's AIDS division, said Thailand should bite the bullet in the interests of the future and not opt for an easier, short-term solution. "In the long term we want to manufacture some drugs -- not all of them, but some of them, in order to make ourselves independent of the monopoly activities of the drug companies. ``We are not draining all the wealth from the drug company -- we just ask for exemption on a group of medication. They can make money on many other drugs, but these are life-saving drugs.'' For the NGO Network: MSF Thailand msfdrugs@asianet.co.th -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-ip-health@venice.essential.org Tue Dec 21 10:55:53 1999 Return-Path: Delivered-To: ip-health@lists.essential.org Received: from mail.interchange.ubc.ca (mail.interchange.ubc.ca [137.82.27.15]) by venice.essential.org (Postfix) with ESMTP id 2096921B15 for ; Tue, 21 Dec 1999 10:55:38 -0500 (EST) Received: from p004.intchg1.net.ubc.ca ([207.23.94.4] helo=f4b7i2) by mail.interchange.ubc.ca with smtp (Exim 3.03 #1) id 120Rd6-0005RD-00 for ip-health@lists.essential.org; Tue, 21 Dec 1999 07:55:16 -0800 From: "Amir Attaran" To: Date: Tue, 21 Dec 1999 07:52:41 -0800 Message-ID: <000201bf4bcb$69b86640$045e17cf@f4b7i2> MIME-Version: 1.0 Content-Type: multipart/mixed; boundary="----=_NextPart_000_0003_01BF4B88.5B952640" X-Priority: 3 (Normal) X-MSMail-Priority: Normal X-Mailer: Microsoft Outlook 8.5, Build 4.71.2173.0 Importance: Normal In-Reply-To: X-MimeOLE: Produced By Microsoft MimeOLE V5.00.2615.200 Subject: [Ip-health] Reply to Jayashree Watal (II) This is a multi-part message in MIME format. ------=_NextPart_000_0003_01BF4B88.5B952640 Content-Type: text/plain; charset="iso-8859-1" Content-Transfer-Encoding: 7bit Dear Jayashree, This is an interesting point you make, but it doesn't change anything I said. I chose the environmental cases under Article XX(b) and XX(g) as the clearest example of the problem with Article XX. They are not the only example; and singling out the s. 337 case and Article XX(d) as you do doesn't avoid the problem. The conclusion is the same: trade tribunals are remarkably undeferential to non-trade objectives. I will try to explain a little more here. First, one has to appreciate that ALL of the Article XX exceptions revolve around the very same legal test: is the measure complained against "NECESSARY" to secure the the objectives of one of the exceptions in Article XX? Thus one may ask, when is a measure necessary, in the legal sense? A measure is necessary when, and only when, there is NO OTHER WAY to secure the same objective without infringing on free trade to a lesser extent. In other words, a measure cannot be necessary if there is a LESS TRADE-INFRINGING MEANS that could achieve the same result. This is a very onerous test, but one that is common to the jurisprudence of most countries. Canadian lawyers will recognize it as the "minimal impairment" stage of the Oakes test; to American lawyers, it is reminiscent of the "strict scrutiny" standard; the ECJ and ECHR have similar tests too. But whatever you call it, WTO panels are a hundred times less deferential in applying this test than are national courts. The WTO panels take the test with unreal intensity, and very rarely find that an impugned law or rule couldn't have been drafted in some less trade-impairing manner. When they reach this conclusion, the measure is GATT-violative and must fall. Why do I dwell on this? Because anyone who believes that Article XX is a real and workable exception to GATT, and is so sanguine as to rely on it in deciding issues of drug access, is risking too much indeed on a most shameful and uncertain piece of jurisprudence. It is downright careless to predict that an Article XX decision will go your way, because history teaches that meaures which one would have expected to survive Article XX scrutiny actually failed when placed under the tremendous magnifying glass of the WTO panels. The bottom line: don't put your eggs in the Article XX basket when it comes to relying on a policy of prohibiting parallel imports, as a precondition to tiered pricing. It is a course fraught with with legal risk. All the best, Amir (PS - For those interested to read more about this, I attach an excerpt from a paper I did on this subject. The full paper deals not only with GATT, but with Canadian, US and ECJ jurisprudence as well.) -----Original Message----- From: J Watal [mailto:jwatal@iie.com] Sent: December 20, 1999 9:10 AM To: aattaran@essential.org Cc: ip-health@lists.essentials.org Subject: Re: reply to Arvind Subramanian and Jayashree Watal Dear Amir, The operative part of GATT Article XX is not sub-section (b) "necessary to protect human, animal or plant life and health" but subsection (d) "necessary to secure compliance with laws and regulations which are not inconsistent with provisions of this Agreement, including.... the protection of patents, trademarks and copyrights..". In the Section 337 case referred to by Arvind, this law of the US was found to be inconsistent with Article III of GATT. ( As I recall this provision discriminated in the treatment of process patent infringement abroad and in the US). As long as the parallel import policy is not applied differently to different countries i.e. as long as m.f.n. is followed there should be no real problem. As far as I know 337 is the only IP case decided under XX (d) in GATT/WTO, so perhaps this is the more relevant case than all the environment disputes you are citing. Besides, now there is the TRIPS Agreement in the same WTO which lays down specific rules on IP and which specifically allows freedom from dispute on parallel imports. It is, therefore, difficult to conclude a priori that XX (d) will not work. I don't have the 337 case at hand or I would have provided a more detailed explanation. Those who are interested in this issue should read the case. Hope this helps. Jayashree Reply-to: aattaran@essential.org From: "Amir Attaran" To: Multiple recipients of list IP-HEALTH Subject: reply to Arvind Subramanian and Jayashree Watal Date: Sat, 18 Dec 1999 18:33:26 -0500 (EST) I am replying to the submission of Arvind Subramanian and Jayashree Watal. I'm glad to see that my initial posting has touched off this kind of debate! I do not quite that Article XX of GATT could be used to "save" a ban on parallel imports; or at very least, it is extremely unlikely it could do so. In principle, Article XX is an "exemption" that allows a country to violate GATT where it needs to do so to protect animal or human health or the environment, among other things. In practice, however, Article XX has almost never been successfully used! The environmental cases are the clearest example. Brevity requires I not list the eight or so environmental cases that have been tried in the last 50 years, unsuccessfully, under Article XX, but suffice it to say that WTO panels are extremely reluctant to approve of any derogation from GATT -- and article XX is the poor cousin of GATT jurisprudence. This adjudicative bias arises, I think, because trade lawyers like free trade. When they sit as judges on these panels, they are likely to interpret Article XX with shocking narrowness, and consequently almost never allow countries to rely on those exemptions. (I've just prepared an manuscript on this, for anyone willing to review it) Thus, while in principle the point about Article XX that Jayashree and Arvind raise is good and thoughtful, in practice it is something of a non-starter, which is a shame. Best, Amir -----Original Message----- From: Arvind_Subramanian/FS/KSG@ksg.harvard.edu [mailto:Arvind_Subramanian/FS/KSG@ksg.harvard.edu] Sent: December 16, 1999 6:44 AM To: aattaran@essential.org Cc: ip-health@essential.org Subject: Re: LEGAL NOTE: very important if you care about tiered pricing and parallel imports! I just wanted to say that Dr. Attaran is not quite right in his interpretation of the GATT and parallel imports. While it is true that Articel XI of the GATT prohibits any ban on imports, any prohibition of parallel imports will be covered by the exception in Article XX (d) of the GATT. Essentially, this latter provision says that you can depart from the baisc disciplines (such as Articles I, XI, and III) in order to enforce a law that is itself not inconsistent with the GATT. And in this case, the underlying law--the protection of rights under intellectual property law--will be seen as consistent with the GATT; and the ban on parallel imports will be seen merely as an enforcement mechanism. For more details on the interpretation of Article XX (d), you should read the GATT panel (about 1989) on Section 337 of the US Trade Act. Hope this is useful Arvind Subramanian Kennedy School of Government Harvard University 202 518 2232 Institute for International Economics 11, Dupont Circle,N.W., Washington D.C. 20036-1207 Phone: (202) 454-1327 (202) 234-4795 Ext. 327 Fax: (202) 328-5432 ------=_NextPart_000_0003_01BF4B88.5B952640 Content-Type: application/msword; name="GATT-WTO proportionality excerpt.doc" Content-Transfer-Encoding: base64 Content-Disposition: attachment; filename="GATT-WTO proportionality excerpt.doc" 0M8R4KGxGuEAAAAAAAAAAAAAAAAAAAAAPgADAP7/CQAGAAAAAAAAAAAAAAABAAAATQAAAAAAAAAA EAAATgAAAAEAAAD+////AAAAAEwAAAD///////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////// 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(Postfix) with ESMTP id C31F121C50 for ; Tue, 21 Dec 1999 10:56:49 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA31171 for ; Tue, 21 Dec 1999 10:56:48 -0500 Sender: jl@genoa.essential.org Message-ID: <385FB0FB.D435D6B8@cptech.org> Date: Tue, 21 Dec 1999 11:55:23 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] formatting fixed: THAI ACTIVISTS DEMONSTRATING FOR THE USE OF COMPULSORY LICENSE OUTSIDE THE MINISTRY OF PUBLIC HEALTH IN BANGKOK Date: Tue, 21 Dec 1999 22:33:30 +0700 From: "MSF-Drugs Bangkok" THAI ACTIVISTS DEMONSTRATING FOR THE USE OF COMPULSORY LICENSE OUTSIDE THE MINISTRY OF PUBLIC HEALTH IN BANGKOK The Thai Network for People Living with HIV/AIDS and supporting NGO's will start a several day demonstration outside the Ministry of Public Health on Wednesday, December 22, 1999 to demand the use of compulsory license for ddI. More than a month ago the Thai Government Pharmaceutical Organization (GPO) asked for the use of compulsory license for ddI; we are still waiting for a result. The PHA Network and NGO's have met twice with Public Health Minister, Korn Dabaransi to ask for the use of compulsory license according to section 51 of the Thai patent law or as a minimum to negotiate a voluntary license with Bristol Myers Squibb. The Public Health Minister suggested that compulsory license should only be used if Bristol Myers Squibb will not reduce the price significantly until the end of this month. Apparently there have been no attempts to even negotiate a voluntary license. Activists will not agree to a mere price reduction by Bristol Myers Squibb because only generic production can garantee that the price will drop further every time the raw material becomes cheaper. Following the statement by President Clinton in Seattle on trade policy and medicines, the Thai government should now act decisively on the issue of HIV drugs. Participating NGO's: Thai Network for People Living with HIV/AIDS; ACCESS; Alden House; Siam Care; CLIST; MSF; Care; Empower; Power of Life; Pilapkao Group; Friends of AIDS Group; Human Rights for AIDS; Consumer Foundation and others Below a report by Reuters that gives a good background on the current situation of ddI in Thailand THAIS URGED TO STAND UP TO AIDS DRUG FIRM By David Brunnstrom BANGKOK, Dec 15 (Reuters) - Medical activists are urging Thailand to take a stand against drug multinationals by licensing the local manufacture of a crucial AIDS drug that could let hundreds of thousands live longer if they could afford it. They say Bangkok should be emboldened to take the unprecedented step over the drug didanosine (ddI) after U.S. President Bill Clinton said Washington would alter trade policy to support greater worldwide access to life-saving medicines. However, the activists believe Thailand, like other developing countries struggling with the AIDS epidemic, will be unwilling to take the radical step of imposing ``compulsory licensing'' allowed under world trade rules, fearing retaliation. They say Washington has put pressure on Thailand in the past by threatening higher tariffs on Thai imports. ``The U.S. government is constantly bullying countries that attempt to pass laws to make medicines more affordable,'' James Love, director of the U.S. Consumer Project on Technology, said in a statement in response to Clinton's December 1 announcement. ``If Clinton is to be taken seriously, we'll have to see something concrete. For example, the U.S. could signal to Thailand it can proceed with compulsory licences for ddI ... that was invented by the U.S. government but sold at high prices by Bristol-Myers Squibb.'' Activists see continuing talks between the Thai government and Bristol-Myers Squibb (BMS) on ddI as a test case that could have profound implications for developing nations in the new trade round. ``EXTENDING AND ENHANCING HUMAN LIFE'' The U.S. drug giant, dedicated according to its motto, to ``Extending and Enhancing Human Life,'' boasts on its website http://www.bms.com of subsidising drug therapy in clinical trials in Thailand ``because of the large potential market of more than one million people infected with AIDS.'' It sells ddI in Thailand under the name Videx at about 49 baht ($1.25) a capsule, far beyond the means of most Thais infected with the human immunodeficiency virus, or HIV, which causes AIDS, acquired immune deficiency syndrome. Current pricing means people in a country where the minimum monthly wage is just 5,400 baht ($138) must pay up to 8,000 baht ($205) a month for a two-drug anti-retroviral cocktail. The bulk of the cost is for ddI, since Thailand's Government Pharmaceutical Organisation (GPO) began producing the other drug -- AZT, or zidovudine -- in 1995 at about a quarter of the price of the imported version. Krisana Kraisintu, head of research and development at the GPO, says she could produce ddI for 25 baht a capsule if local production were permitted. ``More HIV-infected people could have access to it if we were to manufacture it,'' she told Reuters. ``Now only five percent of the HIV-infected people can have access to the drug. If I can cut the price to half, maybe up to 10 percent can have access.'' Officials at Bristol-Myers Squibb in Thailand were unavailable for comment, but Thai media reports and activists say the firm aims to head off compulsory licensing by offering ddI in Thailand at a steep discount. Nobel Peace Prize-winning non-governmental organisation Medecins sans Frontieres (MSF), which is spearheading a global campaign to ensure ddI and other essential drugs reach those who need them, says this is not an answer and a stand should be made. Compulsory licensing would allow the local production of cheap, generic versions of the drug on payment of a royalty. Activists say drug companies are not only worried about a drop in profits in the country concerned but that if one developing country were to take the step, others would follow. THAI CASE IMPORTANT FOR COMPANY MSF says the argument drug firms make -- that the big profits they pile up are needed for research -- is especially spurious in ddI's case since it was developed with U.S. taxpayers' money. It says the best solution would be for the firms to grant voluntary licences for production of key drugs in developing countries. ``For Bristol-Myers Squibb, something important is at stake: the first use of a compulsory licence in a developing country,'' said Tido Von Schoen-Angerer, of MSF's Bangkok office. ``They will accept major price reductions if they can avoid the use of a compulsory licence in Thailand.'' A senior official of the Thai Commerce Ministry's Department of Intellectual Property said it would seek a compulsory licence for ddI only if talks between the GPO and Bristol-Myers Squibb failed. The official, who did not want to be named, said Thai law allowed compulsory licensing only in a ``national emergency.'' ``But nobody has talked about that. Many things in the country might be more serious -- like the economic crisis, or something like that,'' he said. Von Schoen-Angerer said Thailand's apparent leaning towards a compromise solution was a disappointment. While the GPO would only achieve a 50 percent reduction in price initially if it were to produce the drug generically -- a price BMS could probably match -- further cuts would likely be possible within a short time, he said. Chaiyos Kunanusont, director of the Health Ministry's AIDS division, said Thailand should bite the bullet in the interests of the future and not opt for an easier, short-term solution. "In the long term we want to manufacture some drugs -- not all of them, but some of them, in order to make ourselves independent of the monopoly activities of the drug companies. ``We are not draining all the wealth from the drug company -- we just ask for exemption on a group of medication. They can make money on many other drugs, but these are life-saving drugs.'' For the NGO Network: MSF Thailand msfdrugs@asianet.co.th -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-ip-health@venice.essential.org Tue Dec 21 11:47:44 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 47FA121C6C for ; Tue, 21 Dec 1999 11:47:44 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA32059 for ; Tue, 21 Dec 1999 11:47:46 -0500 Sender: jl@genoa.essential.org Message-ID: <385FBCED.9412D407@cptech.org> Date: Tue, 21 Dec 1999 12:46:21 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: ip-health@venice.essential.org References: <000201bf4bcb$69b86640$045e17cf@f4b7i2> Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Tiered pricing and PI, was: Reply to Jayashree Watal (II) Amir Attaran wrote: > The bottom line: don't put your eggs in the Article XX basket when it comes > to relying on a policy of prohibiting parallel imports, as a precondition to > tiered pricing. It is a course fraught with with legal risk. Maybe I'm missing something here. 1. Why would a poor country want to prohibit parallel imports? 2. What percent of pharmaceutical sales in any country would likely be subject to tiered pricing? 3. Aren't there plenty of other ways to manage tiered pricing that do no involve eliminating international exhaustion of patent (and trademark) rights? Jamie -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-ip-health@venice.essential.org Tue Dec 21 22:11:01 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by venice.essential.org (Postfix) with ESMTP id F0E5921B12; Tue, 21 Dec 1999 22:11:00 -0500 (EST) Received: from cptech.org (ppp-6.essential.org [216.0.125.6]) by milan.essential.org (8.9.3/8.9.3) with ESMTP id WAA03122; Tue, 21 Dec 1999 22:11:05 -0500 Sender: jamie@milan.essential.org Message-ID: <386040B7.1026701D@cptech.org> Date: Tue, 21 Dec 1999 22:08:39 -0500 From: James Love X-Mailer: Mozilla 4.07 [en] (X11; I; Linux 2.0.36 i586) MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] HIV/AIDS/Trade Policy section of Africa Trade bill This is the current version of the language passed by the Senate on the African trade bill that deals with HIV/AIDS. The bill is H.R.434, the Trade and Development Act of 1999 (Engrossed Senate Amendment). The relevant section is 116. The bill has passed both the House and the Senate, and is now in Conference. The Senate conferees are: Roth; Grassley; Lott; Helms; Moynihan; Baucus and Biden. I'm not sure who the House conferees are. Earlier I had posted a note that was based upon a fax we received from the Senate, that contained items that were apparently rejected. The language that passed is considerly better than what I had thought had passed. One of the items on the fax was a PhRMA proposal that did not get included in the legislation. This wasn't clear at the time. Rob, Thiru and I were invited to meet with a Senate staffer today, and we learned a little about the status of the amendment. It seems that PhRMA and its member companies think they can get the House members to take Section 116 out of the bill. The key section is (c), which limits the use of public funds, and while it could be improved, it isn't bad. Senator Roth's position will be pretty important, as he is Chair of the Senate Finance Committee, where the trade bills are considered, and he was the chief sponsor of the Senate version of the African trade bill. Roth is also apparently in a tough reelection campaign in Delaware. Senator Moynihan, who is retiring, is the ranking Democrat on the Finance Committee. Apparently he (his staff) was hostile to the amendment, which isn't good news. Note that Lott and Helms are also Senate conferees. However, there is considerable support for the amendment in the Senate, particularly given the increased news coverage of the African AIDS crisis. Jamie ---------------------- http://thomas.loc.gov/cgi-bin/bdquery/z?d106:HR00434: H.R. 434 SEC. 116. ACCESS TO HIV/AIDS PHARMACEUTICALS AND MEDICAL TECHNOLOGIES. (a) FINDINGS- Congress finds that-- (1) since the onset of the worldwide HIV/AIDS epidemic, approximately 34,000,000 people living in sub-Saharan Africa have been infected with the disease; (2) of those infected, approximately 11,500,000 have died; and (3) the deaths represent 83 percent of the total HIV/AIDS-related deaths worldwide. (b) SENSE OF CONGRESS- It is the sense of Congress that-- (1) it is in the interest of the United States to take all necessary steps to prevent further spread of infectious disease, particularly HIV/AIDS; (2) there is critical need for effective incentives to develop new pharmaceuticals, vaccines, and therapies to combat the HIV/AIDS crisis, especially effective global standards for protecting pharmaceutical and medical innovation; (3) the overriding priority for responding to the crisis on HIV/AIDS in sub-Saharan Africa should be the development of the infrastructure necessary to deliver adequate health care services, and of public education to prevent transmission and infection, rather than legal standards issues; and (4) individual countries should have the ability to determine the availability of pharmaceuticals and health care for their citizens in general, and particularly with respect to the HIV/AIDS epidemic. (c) LIMITATION ON USE OF FUNDS- Funds appropriated or otherwise made available to any department or agency of the United States may not be obligated or expended to seek, through negotiation or otherwise, the revocation or revision of any intellectual property or competition law or policy that regulates HIV/AIDS pharmaceuticals or medical technologies of a beneficiary sub-Saharan African country if the law or policy promotes access to HIV/AIDS pharmaceuticals or medical technologies and the law or policy of the country provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay Round Agreements Act. -- James Love Consumer Project on Technology http://www.cptech.org love@cptech.org 202.387.8030; fax 202.234.5176 From owner-ip-health@venice.essential.org Wed Dec 22 11:46:13 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id BAD4921B07; Wed, 22 Dec 1999 11:46:13 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA13182; Wed, 22 Dec 1999 11:46:16 -0500 Sender: jl@genoa.essential.org Message-ID: <38610E1D.ACB0BFCF@cptech.org> Date: Wed, 22 Dec 1999 12:45:01 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Thais protest U.S. firm's AIDS drug monopoly http://biz.yahoo.com/rf/991222/bq.html Wednesday December 22, 2:19 am Eastern Time Thais protest U.S. firm's AIDS drug monopoly By Sutin Wannabovorn BANGKOK, Dec 22 (Reuters) - Representatives of the estimated one million Thais infected with HIV set up camp outside Thailand's Health Ministry on Wednesday to demand that the government break a U.S. drug firm's monopoly on an AIDS drug. About 100 protesters, wearing yellow T-shirts, called on the government to issue a compulsory licence to allow cheap local production of the drug didanosine which is produced and marketed by U.S. drug giant Bristol-Myers Squibb (NYSE:BMY - news). They erected tents and vowed to continue their protest around the clock until Friday. ``We are demanding the government impose a compulsory licence to give the Public Health Ministry the right to produce the essential drug didanosine,'' said Paisal Tanhood, chairman of the HIV Infection Network, which has more than 20,000 members. Didanosine, also known as ddI, is one of a two-drug anti-retroviral cocktail prescribed for Thais with HIV to help them live longer. But campaigners say the vast majority of those infected cannot afford the treatment because of the high price of ddI. Thailand's Government Pharmaceutical Organisation (GPO) began producing the other drug -- AZT, or zidovudine -- in 1995 at about a quarter of the price of the imported version. Compulsory licensing would allow the local production didanosine on payment of a royalty, but no developing country has yet taken the radical step, fearing trade retaliation by the United States to protect the interests of drug companies. DRUG TOO EXPENSIVE FOR MOST THAIS In Thailand, ddI costs about 49 baht ($1.25) per tablet, putting the monthly cost of the two-drug cocktail in a country where the minimum monthly wage is 5,400 ($138), at about 8,000 baht ($205). Activists say Bristol-Myers has offered to cut ddI's price, but not to the extent local production would eventually allow. A ministry spokesman said talks were continuing between the GPO and Bristol-Myers but he declined to elaborate. Bristol-Myers officials were not available for comment on the licensing issue. Paisal, 34, who was diagnosed HIV positive eight years ago, told Reuters he was unable to afford ddI, but his wife was using it free under a trial programme at a government hospital. ``Only five percent of about one million people with HIV have access to ddI because it's so expensive, so cutting the price a bit is not a good solution for under-privileged people,'' he said. Activists said making ddI in Thailand was the best solution, but they doubted the government would be bold enough to stand up to the threat of U.S. pressure. ``DdI is the hope for those with HIV, but I don't think Thailand will dare take the radical action in colliding head-on with the United States because of the fear of trade retaliation,'' Saree Aongsomwang of the Foundation for Consumers, told Reuters. International pressure groups, including the 1999 Nobel Peace Prize winning aid group Medicins Sans Frontiers (Doctors Without Borders), have been urging Thailand to make a stand on the issue. They say Bangkok should be emboldened after U.S. President Bill Clinton pledged on World AIDS Day on December 1 a change in U.S. trade policy to support greater worldwide access to lifesaving medicines. -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-ip-health@venice.essential.org Wed Dec 22 10:48:59 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 4721121B7B; Wed, 22 Dec 1999 10:48:59 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA12352; Wed, 22 Dec 1999 10:49:01 -0500 Sender: tb@genoa.essential.org Message-ID: <3860F339.B331AED8@cptech.org> Date: Wed, 22 Dec 1999 10:50:17 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] DS 114 A reader kindly provided the url for a Canadian government website on Dispute Settlement Cases. This particular page refers to DS 114 regarding the EU's complaint against Canada regarding Canada's early working and stockpiling provisions for generic versions of patented pharmaceuticals. http://www.dfait-maeci.gc.ca/tna-nac/summary-e.asp Thiru From owner-ip-health@venice.essential.org Wed Dec 22 12:49:31 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 7211421B3A; Wed, 22 Dec 1999 12:49:31 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA14200; Wed, 22 Dec 1999 12:49:34 -0500 Sender: tb@genoa.essential.org Message-ID: <38610F79.CA8641C6@cptech.org> Date: Wed, 22 Dec 1999 12:50:49 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY , Multiple recipients of list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Submission for Canada (DS 114) http://www.dfait-maeci.gc.ca/tna-nac/summary-e.asp Panel Cases to which Canada is a Party WTO Canada - Patent Protection of Pharmaceutical Products Submission for Canada 1.In these proceedings, the European Communities and their Member States (hereinafter the EU) contend that two provisions of Canada's Patent Act do not conform with the requirements of the Agreement on Trade-Related Intellectual Property Rights (TRIPS). The provisions in issue stipulate that it is not an infringement of a patent for a person, not having the consent of the patent owner, to make, construct, use or sell the patented invention a.solely for uses reasonably related to the development and submission of information required under any law that regulates the manufacture, construction, use or sale of a product (subsection 55.2(1) of the Patent Act), or b.during a limited, prescribed period immediately preceding the expiry of the patent, for the manufacture and storage of articles intended for sale after the patent expires (subsection 55.2(2) of the Patent Act). 2.The essential question is whether these two provisions are "limited exceptions to the exclusive rights conferred by a patent", within the meaning of Article 30 of TRIPS. 3.It is Canada's submission that these two measures a.are "limited exceptions" within the meaning of Article 30, since they allow patent owners complete freedom to exploit their rights throughout the full term of patent protection, leaving the monopoly of commercial exploitation and the exclusivity of economic benefits unimpaired for the life of the patent; b.do not conflict with a normal exploitation of a patent or prejudice the legitimate interests of the patent owner, since they only affect the patent owner's commercial exploitation after the patent has expired; c.in any event, take into account Canada's national interest in measures conducive to social welfare and the achievement of a balance between rights and obligations, both of which are recognized objectives in Article 7; and d.in particular, as required by Article 30, take account of the legitimate interests of third parties, in that: i.they allow potential competitors to compete freely with the patentee after the patent expires, consistent with the policy of full competition underlying Article 29's requirement that, in return for the grant of patent protection, patentees must disclose their inventions to the public; Article 33's provision that the exclusive rights be conferred for a specified term only; and Article 40's authorization of national measures to prevent abuse of intellectual property rights having an adverse effect on competition; and ii.they seek to protect public health -- a value recognized in Article 8.1 -- through promoting access to cost-effective generic medicines following patent expiry, and in this connection they take into account the legitimate interests of individuals, private insurers and public sector entities that finance health care in maintaining access to affordable medicines. 4.Article 30 allows uses that do not unreasonably conflict with a normal exploitation of the patent or unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. Canada submits that Article 30 therefore authorizes measures that limit exclusive rights, provided that no commercial exploitation -- i.e., sales -- take place during the patent term. Any other interpretation would: a.ignore the existence of the word "unreasonably" in Article 30 and thereby the fact that conflict with normal exploitation and prejudice to the patent owner's interests are allowed; b.disregard the public policy principles inherent in Articles 29 and 33, which encourage free and open competition with the patent owner immediately upon expiry of the patent; and c.as a consequence, promote the practice of enforcing patent rights within the patent term so as to extend the monopoly of the patent owner beyond the term, a policy which the EU sought to have included in the Agreement but which was not so included, i.e., as the EU makes plain in paragraph 41 of its First Submission, it seeks to win through litigation the windfall period of protection that it could not secure by negotiation. 5.Canada's submission is based on the interpretative rule set out in Article 31 of the Vienna Convention on the Law of Treaties that the terms of any international treaty, including TRIPS, are to be interpreted in good faith in accordance with their ordinary meaning in their context and in light of the object and purpose of the treaty. When the exception provisions in Part II of the TRIPS Agreement are interpreted in accordance with this rule, it becomes apparent that Article 30 provides a general and flexible authority for Members to adopt measures that balance the interests of patent owners with the interests of others, as Article 7 expressly states is an objective of TRIPS. 6.The language of Article 30 is markedly different from other provisions which allow exceptions to treaty rights. For example, GATT 1994, Article XX, requires -- as in paragraph (b) -- that the exception measures be necessary to protect human health, and it contains additional restrictions in its chapeau portion. No similar restrictions are required under Article 30. Similarly, TRIPS Article 13 (and Article 9(2) of the Berne Convention for the Protection of Literary and Artistic Works (1971), upon which the latter was modelled), does not allow conflict with a normal exploitation of the work. 7.Thus, TRIPS contemplates that Members may, in implementing their obligations within their legal systems, adopt measures which, like those in issue here, introduce limited exceptions to the exclusive rights conferred by a patent and confine the patent monopoly to the specific term for which it is granted, in the interests of promoting full competition in regulated-product markets after the expiry of that term and of realizing the cost-saving benefits that competition in those markets (particularly the health care products market) confers on society. TRIPS does not contemplate that these important societal interests should be overridden by an alleged right of patentees to exploit time-consuming regulatory review systems -- which are neither designed nor intended to protect intellectual property rights -- in order to extend the term of patent protection and to gain a windfall monopoly. 8.Equally, TRIPS does not contemplate that these important societal interests should be overridden by the anti-discrimination requirement of Article 27.1. The latter provision is not intended to require "across the board" derogations from patent rights. That would only defeat Article 30's purpose of permitting exceptions that are "limited", and would compel the application of exceptions where they are not needed. Instead, since Article 27.1 does not purport to define the "patent rights" that it requires to be made available and enjoyable without discrimination, those rights are the ones enumerated in Article 28.1, subject to any exception that may be made under Article 30, 31 or 40. This interpretation gives effect to the language of Article 27.1 in its context rather than in isolation, and achieves the balance contemplated by Article 7 as an objective of the TRIPS Agreement. From owner-ip-health@venice.essential.org Thu Dec 23 13:28:07 1999 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 0707321B5E for ; Thu, 23 Dec 1999 13:28:07 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA26752 for ; Thu, 23 Dec 1999 13:28:10 -0500 Sender: jl@genoa.essential.org Message-ID: <38627777.22288D8D@cptech.org> Date: Thu, 23 Dec 1999 14:26:47 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.7 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Pierre Chirac's paper on candidates for compulsory licensing Pierre Chirac has written a paper on candidates for compulsory licensing. A copy of the paper can be obtained here: http://www.cptech.org/ip/health/cl/edcl3.doc CPT is looking for people who could review the paper and provide us and the author with comments. Jamie -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-ip-health@venice.essential.org Mon Jan 3 21:07:32 2000 Return-Path: Delivered-To: ip-health@venice.essential.org Received: from imsp075.netvigator.com (imsp075.netvigator.com [208.139.127.58]) by venice.essential.org (Postfix) with ESMTP id 9BB2521AFF for ; Mon, 3 Jan 2000 21:07:30 -0500 (EST) Received: from hivnet.ch (mel-0103-161.ports.iprimus.net.au [203.134.28.161]) by imsp075.netvigator.com (8.8.8/8.8.8) with ESMTP id JAA08016; Tue, 4 Jan 2000 09:40:32 +0800 (HKT) Message-ID: <38715268.26E16326@hivnet.ch> Date: Tue, 04 Jan 2000 09:52:41 +0800 From: Joe Thomas Reply-To: joethomas@hivnet.ch Organization: (sea-aids) http://www.hivnet.ch:8000/sea-aids/tdm X-Mailer: Mozilla 4.04 [en]C-NECCK (Win95; I) MIME-Version: 1.0 To: IP-Health list , James Love Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Ip-health] Federal Labs and NIH are Number One in Bio-Technology Transfer Dear Jamie, The following is the details of Fed- supported labs role in bio-technology transfer. This is a bit old data, but mustbe of interest to you. All the best for the millinium year Joe Thomas Text from the fall 1994 press release/study. Originally released 8/22/94; revised 9/8/94 including new data for 43 NIH CRADAs. --------------------------------------------------------------------------- Federal Labs and NIH are Number One in Bio-Technology Transfer The first comprehensive study clearly shows that federal (U.S. government) laboratories are by far the leaders in technology transfer in the biomedical, biotechnology and pharmaceutical areas. In these areas, the federal laboratories and the Public Health Service (PHS) and its main component, the National Institutes of Health (NIH), are number one in: * inventions available for licensing; * patents received and patent applications pending; * inventions that have been licensed out; and * therapeutics in active development (even compared to the largest pharmaceutical companies), both in terms of those licensed out and those being developed internally. The federal labs, PHS and NIH are: * the U.S. biotechnology and pharmaceutical industries' leading sources for new technologies, both new products and broadly enabling technologies; * the leaders in collaborative research and development with the biotechnology and pharmaceutical industries, including therapeutics in development and clinical trials; and * the source for many products and technologies in the marketplace. However, federal technology transfer is relatively new, and many (hundreds) more technologies and products are currently in development, both licensed inventions and those being developed collaboratively through CRADAs with industry. This includes well over 100 therapeutics having reached clinical trials. Mr. Ronald A. Rader, President, Biotechnology Information Institute, Rockville, MD, has presented data from the Federal Bio-Technology Transfer Directory, a recently published reference book he authored describing all federal biomedical, biotechnology and pharmaceutical U.S. patents, patent applications, licenses granted and Collaborative Research and Development Agreements (CRADAs) from 1980-1993. This is the largest directory of biotechnology and pharmaceutical inventions available for licensing. The Directory describes 2,100 federal inventions (1,200 patents; 900 applications); nearly 1,000 licenses (including 270 exclusive and 640 nonexclusive patent licenses); and over 500 CRADAs; along with information about the commercial potential of inventions and the status of products/technologies in development and the marketplace. Much of this information has never before been published, particularly patent licenses and CRADAs. The 678-page book has over 400 pages of text/abstracts and 250 pages of indexes, including a 37,000 entry subject index. he Federal Bio-Technology Transfer Directory database will be available this fall. The Federal Bio-Technology Transfer Directory shows that: * Federal agencies and labs have 2,100 U.S. patents granted or pending in the biomedical, biotechnology and pharmaceutical ("biomedical/biotech") areas from 1980-1993. PHS (with 60%) and NIH (with 49%) are by far the leaders among federal agencies. * Biotechnology is involved in the majority of federal bio-technology transfer. This includes over 50% of inventions; about 70% or more of patent licenses granted; and up to 70% of CRADAs. Biotechnology involvement is highest and has been increasing in recent years. * The numbers of inventions, licenses and CRADAs are related to R&D funding, mandates and technology transfer efforts. The federal labs' biomedical/biotech R&D budget is about $2.5 billion/year. The NIH intramural R&D budget ($1.3 billion) is comparable to that of the largest pharmaceutical companies and over 40% of total U.S. biotechnology industry R&D funding. * Most federal bio-technology transfer is recent and continues to increase steadily. Over 60% of inventions are from 1990-1993; 75% of CRADAs were active in 1993; and well over 1,000 federal biomedical/biotech patent applications are currently pending. * The federal labs and PHS and NIH are consistently the leading recipients of U.S. patents in biotechnology and genetic engineering, including those with pharmaceutical uses. * The federal labs, PHS and NIH are consistently among the leading recipients of drug and other bio-active agent patents, ranking with many of the world's largest pharmaceutical companies. Licensing, particularly exclusive licensing, of federal inventions is an issue involving much public debate. This is especially true as PHS/NIH is currently considering dropping or significantly modifying its "reasonable pricing" clause in exclusive licenses and CRADAs. The Federal Bio-Technology Transfer Directory shows that: * About 27% of federal inventions have been licensed one or more times, including 34% of PHS and 32% of NIH inventions. These are rather high percentages of invention licensing, since only about 10% or less of inventions are ever used commercially. * Nearly 1,000 licenses have been granted to industry, mostly from PHS (84%) and NIH (75%). * The majority of invention licenses are nonexclusive (no restrictions on granting further licenses). PHS and NIH inventions are more likely to be licensed nonexclusively and to have more licenses/invention (licensed to more companies). A few inventions, mostly broadly enabling technologies and screening assays, have been licensed by up to 20 companies. * About one-quarter of invention licenses are exclusive licenses, and about 40% of licensed inventions have been exclusively licensed. Many of these involve major commercial products in development. About 75% of federal and 87% of NIH exclusive licenses involve therapeutics-related inventions (mostly therapeutic agents). Many of these therapeutics-related licenses involve biopharmaceuticals and drugs in development. * Over two-thirds of licensed inventions are therapeutics-related and about one-third of exclusively licensed therapeutics-related inventions have reached the clinical trials stage of development. Regarding CRADAs, the Federal Bio-Technology Transfer Directory shows that: * Collaborative R&D with industry ranges from basic speculative research through product development and testing, including clinical trials. * PHS with 51% (279) and NIH with 37% (228) lead all federal agencies/labs with CRADAs in the biomedical/biotech areas. However, CRADAs remain an insignificant part of the PHS/NIH total R&D, unlike some other federal agencies/labs where CRADAs are up to 10% of total R&D. * About two-thirds of federal, 73% of PHS and 80% of NIH CRADAs involve therapeutics-related technologies (mostly therapeutic agents). About one-third of all federal, PHS and NIH therapeutics-related CRADAs involve therapeutics that have reached the clinical trials stage. Many of these CRADAs involve ongoing clinical trials, with most conducted by PHS and NIH. Mr. Rader has also documented that: * The federal labs, PHS and NIH each rank number one or among the leaders in the number of drugs and biopharmaceuticals in development (even compared to the largest pharmaceutical companies), both in terms of those licensed out and those being developed internally. * PHS and NIH rank among the top recipients of licensing income among U.S. universities and nonprofit research organizations--$12.2 million licensing royalty income in FY1992, with about 80% or more of this from the licensing of HIV diagnostic patents. * Federal labs are filing over 450 new patent applications/year (PHS alone over 300), licensing activity is increasing, and CRADAs are growing rapidly (except for PHS/NIH). * The PHS/NIH "reasonable pricing" exclusive licensing clause has contributed to many biotechnology and pharmaceutical companies of all sizes