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Creation of a voluntary patent pool (emerging

1. aossa 14 februari 2009 12:36

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   UPDATE 1-Glaxo proposes patent pool for neglected diseases Fri Feb 13, 2009 5:29pm EST
   
   By Lisa Richwine
   
   WASHINGTON, Feb 13 (Reuters) - GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research, Stock Buzz) chief executive urged creation of a voluntary patent pool to spark development of new treatments for neglected diseases in the world's poorest countries.
   
   Glaxo CEO Andrew Witty said on Friday his company would contribute its own patents for technologies that might aid research into malaria, cholera and more than a dozen other diseases.
   
   He called on other companies to add patents and make them available for third-party researchers who could develop new products or formulations.
   
   "It is...right that we explore new ways of stimulating research that might otherwise not happen," Witty said in remarks prepared for a speech at Harvard Medical School.
   
   Glaxo, the world's second-largest drugmaker, also will cap the prices of patented medicines it sells in the poorest countries to no more than 25 percent of the cost in wealthy nations, Witty said. Prices already are set below that level in some areas, he said in an interview.
   
   The measures are targeted at 50 nations considered the world's least developed, many of them in Africa.
   
   Pharmaceutical companies drew fire for fiercely backing patents that blocked cheaper competitors, even in the poorest countries, where brand-name medicines were unaffordable. Glaxo and others responded by selling AIDS medicines in certain areas without a profit and offering licenses to generic makers.
   
   Witty said he was challenging the industry to go further to address global health problems by being more flexible on patent protection and pricing in the neediest countries.
   
   "Society expects us to do more in addressing these issues. To be frank, I agree. We have the capacity to do more and we can do more," he said.
   
   Glaxo also will invest 20 percent of profits made in the least-developed nations to building healthcare clinics and other infrastructure in those countries, Witty said.
   
   AIDS, afflicting millions of people across Africa, was not included in the list of ailments for the patent pool. Witty said the pool was meant to focus on diseases with a severe lack of treatments, and the need for greater access to AIDS medicines was being addressed in other ways.
   
   Dr. Tido von Schoen-Angerer, director of the Access to Essential Medicines Campaign for advocacy group Doctors Without Borders, urged Glaxo to commit its patents to a pool for AIDS drugs being established by international group Unitaid.
   
   A patent pool for other diseases would be "a good first step" but needed to be followed by funding to support new research, von Schoen-Angerer said.
   
   He welcomed Glaxo's discounted pricing, but said it may remain too high in some of the poorest nations.
   
   "Experience shows in order to make the medicines sufficiently affordable in these countries, you really need generic competition," von Schoen-Angerer said. (Reporting by Lisa Richwine, Editing by Tim Dobbyn, Leslie Gevirtz).
   
2. aossa 14 februari 2009 12:43

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   Internationale patent pool voor geneesmiddelen
   12 januari 2009
   
   De internationale uitbreiding van patentmonopolies zorgt voor een prijsstijging bij geneesmiddelen, aldus wetenschapper Ellen 't Hoen. Daarbij vormen deze monopolies een belemmering voor de ontwikkeling van aangepaste behandelingen. Dit heeft met name voor de behandeling van mensen met aids grote gevolgen. Landen die maatregelen nemen om de patentmonopolie te breken, worden zwaar bekritiseerd door de farmaceutische industrie. Aldus Ellen ‘t Hoen, research fellow aan de Amsterdamse School voor Sociaal wetenschappelijk Onderzoek (ASSR) van de UvA, in haar boek The Global Politics of Pharmaceutical Monopoly Power.
   
   Patent pool
   Ze stelt daarin een fundamentele verandering voor in de wijze waarop geneesmiddelenpatenten in ontwikkelingslanden worden behandeld. ‘t Hoen pleit onder andere voor het opzetten van een internationale patent pool waar patenten tegen betaling beschikbaar zijn voor anderen om goedkope generieke medicijnen te maken en nieuwe aangepaste tabletvormen te ontwikkelen. Op deze wijze kan het nieuwe systeem van geneesmiddelenpatenten hand in hand gaan met de bescherming van de volksgezondheid en de toegang tot geneesmiddelen voor mensen in ontwikkelingslanden.
   
   AZG
   Auteur ‘t Hoen is juriste en expert op het gebied van geneesmiddelenbeleid en intellectuele eigendom. Zij heeft de laatste tien jaar bij Artsen zonder Grenzen (AZG) leiding gegeven aan campagnes voor toegang tot geneesmiddelen in ontwikkelingslanden.
   
   Bron: Medicalfacts, 9 januari 2009
   
3. flosz 16 februari 2009 12:27

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   Glaxo to Cut Prices in Poor Countries
   If a patent pool is created, Glaxo should be able to contribute patents related to malaria and tuberculosis, the Glaxo spokeswoman said. Robert Don, a scientist with Drugs for Neglected Diseases Initiative, a nonprofit drug developer in Geneva, said such a pool would be invaluable.
   Many drug companies, including Glaxo, already share their research with Drugs for Neglected Diseases Initiative, but negotiating access to their intellectual property can take as long as a year, he said. And the group sometimes can't work with more than one company on the same disease area at a time, for fear of leaking one company's intellectual property to another.
   Mr. Witty said Glaxo wouldn't contribute its HIV patents to the pool, since the company thinks there already is innovation in HIV medicines, spurred by the profits to be made in Western markets.
   Ellen 't Hoen, a senior adviser to the international drug-purchasing consortium Unitaid, said she hopes Glaxo will still contribute its HIV patents to a new pool Unitaid is trying to create. The goal is for big companies to share patents on their latest HIV drugs with generic-drug companies, which would sell the treatments cheaply in the poorest countries and pay the patent holders a royalty.
   The generic-drug makers also could tweak the drugs to make them more usable in the poorest countries, such as in pediatric formulations. Ms. 't Hoen said Unitaid has had early talks with Glaxo and other companies, and that all have agreed to consider the idea.
   online.wsj.com/article/SB123454760558...
   
   Uit de Crucell ”pool”...
   Malaria Prime/Boost Vaccines
   Octrooinummer: US2008131461 (A1)
   Publicatiedatum: 2008-06-05
   Uitvinder(s): PAU MARIA GRAZIA [NL]; GOUDSMIT JAAP [NL]; COHEN JOSEPH D [BE]; DUBOIS PATRICE [BE]; STEWART V ANN [US]; HEPPNER DONALD [US]
   Aanvrager(s): CRUCELL HOLLAND BV [NL]; GLAXOSMITHKLINE BIOLOG SA [BE]; US GOVERNMENT [US]
   Classificatie:
   - internationaal: A61K39/23; A61P43/00; A61K39/23; A61P43/00
   - europees: A61K39/015
   
   Aanvraagnummer: US20050665393 20051013
   Prioriteitsnummer(s): US20050665393 20051013; EP20040105035 20041014; US20040619056P 20041014; WO2005EP55209 20051013
   Samenvatting van US 2008131461 (A1)
   The invention relates to novel vaccine regimens in which specific prime/boost regimens are applied using low-neutralized recombinant adenoviral vectors harboring nucleic acids encoding antigens from Plasmodium falciparum and purified recombinant protein vaccines such as RTS,S, in the context of appropriate adjuvants.
   v3.espacenet.com/publicationDetails/b...
   
   MALARIA PRIME/BOOST VACCINES.
   Octrooinummer: MX2007004031 (A)
   Publicatiedatum: 2007-11-08
   Uitvinder(s): GOUDSMIT JAAP [NL]; PAU MARIA GRAZIA; COHEN JOSEPH D; DUBOIS PATRICE M; STEWART V ANN; HEPPNER DONALD G
   Aanvrager(s): CRUCELL HOLLAND BV [NL]
   Classificatie:
   - internationaal: A61K39/015; A61K39/002
   - europees:
   Aanvraagnummer: MX20070004031 20070403
   Prioriteitsnummer(s): EP20040105035 20041014; US20040619056P 20041014; WO2005EP55209 20051013
   Samenvatting van MX 2007004031 (A)
   The invention relates to novel vaccine regimens in which specific prime/boost regimens are applied using low-neutralized recombinant adenoviral vectors harboring nucleic acids encoding antigens from Plasmodium falciparum and purified recombinant protein vaccines such as RTS,S, in the context of appropriate adjuvants.
   v3.espacenet.com/publicationDetails/b...
   
4. flosz 25 februari 2009 07:54

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   Drug patent plan gets mixed reviews
   GlaxoSmithKline's bid to tackle neglected diseases receives a muted response from the rest of the industry.
   Declan Butler
   Proposals to radically change the way the drug industry approaches neglected tropical diseases have prompted intense debate within the sector.
   Andrew Witty, chief executive of GlaxoSmithKline (GSK), outlined the suggestions in a speech on 13 February at Harvard Medical School in Boston, Massachusetts. He committed GSK — the world's second-largest pharmaceutical company by sales — to sharing some of its patents to boost research into neglected diseases, and to making its drugs available more cheaply in the very poorest countries.
   He also offered to open up GSK's research centre for neglected diseases at Tres Cantos in Spain to other researchers, companies and governments. The aim would be to foster a global public–private network to supplant the present fragmented research efforts on the most neglected diseases, such as sleeping sickness, visceral leishmaniasis and dengue fever.
   Reactions from scientists and public-health experts have ranged from wildly enthusiastic to deeply sceptical. But it is undoubtedly a pioneering move, particularly for a firm that just a decade ago joined 38 other drug companies in suing the South African government to try to stop it making cheap anti-HIV drugs.
   "That was the low-water mark for multinationals and global health," says Peter Singer, an expert in public health at the University of Toronto in Canada. "This announcement may not yet be the high-water mark, but it is incontrovertible evidence that the tide has turned. It sends a clear signal that GSK wants to be part of the solution and not part of the problem."
   The most innovative aspect of GSK's proposal is the creation of a 'patent pool' for drugs and manufacturing processes related to neglected tropical diseases. Researchers and companies, including manufacturers of generic drugs, would be able to license participants' patents from the pool for free to develop new treatments for neglected diseases in the world's 50 least-developed countries (LDCs).
   "A patent pool giving access to molecule libraries and information from different groups is something we have been asking for for years," says Bernard Pécoul, head of the Drugs for Neglected Diseases Initiative based in Geneva, Switzerland. But its success depends on what companies are willing to put in, he adds. "If they put garbage in, we will get garbage out."
   Although the pool would be oriented towards drug discovery, it could also provide access to promising drug candidates, existing drugs and formulation technologies for commercialization.
   "It's a fantastic step forward," says Mary Moran, director of health policy at the George Institute for International Health in Sydney, Australia. Drug companies usually fight to defend their patent portfolios, she says, refusing to allow their free use for good causes such as tackling neglected diseases. As the patents in this sector have little monetary value, this amounts to "two bald men fighting over a comb", she observes wryly.
   Industrial unease
   But several other drug companies contacted by Nature were lukewarm about the idea. French firm Sanofi-aventis says that the proposals are "too vague" to comment on, and Swiss-based Novartis "does not consider intellectual property as an obstacle to access to medicines", according to company representatives.
   In principle, Bayer in Germany is not against the idea of pooling intellectual property, says the company's spokeswoman, Denise Renn¬mann. But it would prefer an industry-wide approach to be agreed multilaterally, she adds — something that the World Health Organization and the International Federation of Pharmaceutical Manufacturers are already discussing. Many companies highlighted their own efforts to improve access to drugs for neglected diseases (see 'Opening access').
   The patent-pool proposal has also sparked controversy because it excludes GSK's HIV patents, as the company feels that there is already enough research in this area. That is hotly contested by Michelle Childs, director of policy and advocacy at Médecins Sans Frontières' Campaign for Access to Essential Medicines, who says that there is still a great need for new antiretroviral combinations and formulations for children.
   However, GSK's HIV patents could yet dive into a different pool. UNITAID, an international organization that negotiates lower drug prices, hopes to launch a patent pool by the end of this year that would allow companies to license their AIDS drugs in return for royalties. Ellen 't Hoen, UNITAID's senior adviser on intellectual property, says that although no companies have yet signed up, several have expressed interest, including GSK.
   There is a sound incentive for companies to join such patent pools. Countries with large populations of sick patients are increasingly likely to use their rights under TRIPS, the World Trade Organization's intellectual-property agreement, to issue compulsory licences, allowing them to produce generic copies of patented drugs at low royalties.
   Western drug companies fret that such licences could limit their opportunities in what they see as their biggest future growth markets: the well-off elites in emerging economies such as India, China or Brazil. Preserving these markets may explain why GSK has limited its proposals to the LDCs, says Brook Baker, an expert on health and human rights at Northeastern University in Boston.
   Witty also announced that GSK would cut the prices of all its medicines in the LDCs to no more than 25% of their prices in the richest countries. But the focus on the LDCs means that these cuts, and the patent pool, will not benefit the vast number of poverty-stricken people living in middle-income countries, says Baker. According to the World Bank, more people live on less than $2 per day in India than in all of sub-Saharan Africa.
   Despite the cuts, GSK's drugs will still be unaffordable to most poor people, he adds. And if generic producers can only use the patent pool to produce drugs for the LDCs, they will not be able to get the economies of scale they need to sell drugs cheaply enough.
   "When Glaxo and others announced at the start of the decade that they would cut the cost of HIV drugs by 70%, initially we thought 'this is a big deal'," says Childs. "But they were still unaffordable. It was only when generic manufactures brought prices down 99% that we saw wide access to drugs."
   www.nature.com/news/2009/090223/full/...