Le Bayh-Dole Act, loi sur les brevets, votée le 12 décembre 1980




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Le Monde daté du mardi 19 octobre 1999

Les Etats-Unis se préparent à attirer davantage de cerveaux étrangers A la différence du système français, la loi américaine sur les brevets favorise les transferts de technologie


I l y a dix ans, on disait de l'Amérique qu'elle était bonne pour faire des Prix Nobel, mais incapable de mettre des nouveaux produits sur le marché. Aujourd'hui, l'économie américaine va très bien. On a complètement changé le système d'innovation. » Ce petit rappel historique prononcé par Duncan Moore, directeur adjoint pour la technologie à la Maison-Blanche, le 13 octobre à Grenoble, lors du premier séminaire franco-américain sur l'innovation, avait de quoi redonner espoir aux chercheurs et spécialistes de transfert de technologie.


Ce conseiller de Bill Clinton a livré quelques-unes des recettes à l'origine du retournement américain aux participants de cette rencontre organisée par la mission scientifique de l'ambassade de France aux Etats-Unis et l'Institut national polytechnique de Grenoble. « Le rôle de l'Etat et du gouvernement est très important », n'a pas manqué de souligner ce représentant du modèle libéral. Maintenir un bon niveau de recherche de base est fondamental, a-t-il ajouté. Les firmes de capital-risque, les business angels (investisseurs à titre personnel dans les entreprises à haut risque) , et les incitations financières à l'innovation sont aussi des conditions nécessaires. Qu'elles soient destinées aux entreprises, comme les crédits impôts-recherche ou aux particuliers pouvant bénéficier de système d'imposition favorable pour leurs investissements dans des entreprises innovantes.


Mais les mesures non financières ont aussi joué un rôle très important. Parmi celles-ci figure le Bayh-Dole Act, loi sur les brevets, votée le 12 décembre 1980 par le Congrès. Elle a donné aux établissements de recherche le droit de devenir propriétaire des brevets résultant d'innovations issues de leurs laboratoires et ayant bénéficié de subventions du gouvernement. Même à un niveau infime « l'utilisation d'infrastructures, voire de la salle de sports, par les chercheurs peut être considérée comme une aide », a souligné Lori Pressman, chargée des contrats de licence au Massachusetts Institute of Technology (MIT).


DOUBLE AVANTAGE


Ce dispositif offre un double avantage. Primo, il libéralise le système précédent qui voulait que seul le gouvernement pouvait être propriétaire desdits brevets. Secundo, en empêchant les entreprises de devenir propriétaires des brevets, il est censé assurer la meilleure diffusion possible, auprès des citoyens, des fruits des travaux scientifiques, comme cela est inscrit dans la Constitution américaine. « Si une firme possède un brevet, nous ne pouvons protéger le public contre sa non-utilisation. Les universités doivent se bagarrer pour que leurs brevets soient utilisés. Le pire qui puisse nous arriver est qu'un brevet ne débouche sur rien », explique Lori Pressman .


Les résultats n'ont pas tardé. De 1980 à 1992, le nombre d'universités déployant des efforts pour transférer des technologies a été multiplié par dix. En deux ans (1989-1990) les universités ont octroyé dix fois plus de licences que dans la période de dix ans allant de 1974 à 1984. Cette démarche a eu des conséquences financières directes pour les laboratoires : non seulement les redevances versées aux universités ont crû dans les mêmes proportions mais aussi les industriels ont intensifié leurs aides. Une stratégie gagnante pour tous donc, concluent les autorités américaines.


CAPITAL HUMAIN


Le problème de la France est aussi largement culturel, ont rappelé les participants : « On ne remplace pas l'initiative individuelle et la volonté de se battre dans un domaine à haut risque. »


Outre-Atlantique, désormais, les préoccupations ne sont plus financières, ni réglementaires, mais... humaines. « Nous manquons de capital humain », devait ajouter très crûment Duncan Moore. Les indicateurs sont en effet alarmants. Le pourcentage d'ingénieurs dans la population de jeunes diplômés n'est que de 5,4 % aux Etats-Unis, contre 18,9 % en France et 13,8 % dans la moyenne des 10 pays formant le plus de diplômés. Conséquence, le gouvernement américain va déployer tous les moyens possibles pour attirer encore plus de cerveaux étrangers. La décision d'augmenter considérablement le nombre de visas accordés à des scientifiques pourrait être votée d'ici à la fin de l'année.


Une nouvelle fuite de cerveaux en perspective, qui en revanche ne sera pas de nature à rassurer les investisseurs français. Annie Kahn


November 3, 1999

Bill Would Bar Dumping of Inappropriate Drugs in World Crisis By REED ABELSON

Legislation was introduced in Congress on Tuesday to discourage American drug companies from sending donations of unwanted or inappropriate drugs during world crisis situations.

During the Kosovo crisis, drug companies and relief agencies worked together to provide badly needed medicine to the hundreds of thousands of refugees streaming into Albania and Macedonia. But huge quantities of outdated, unlabeled or inappropriate drugs were also sent, including items like Chapstick, Preparation H and anti-smoking inhalers, relief workers reported at the time.

"U.S. tax laws provide an incentive for foreign dumping that must end," said Rep. Lloyd Doggett, D-Texas, a member of the House Ways and Means Committee, who introduced the bill.

American companies receive generous tax deductions for donating medicines for needy people, including those hit by emergencies like an earthquake or a war.

Under Doggett's bill, only drugs donated under guidelines developed by the World Health Organization, which has been a vocal critic of drug dumping, would be eligible for this deduction.

The problem of unwanted drugs has been a longstanding issue, and the health organization has estimated that hundreds of tons of unusable drugs have been sent in response to emergencies. A recent study by the Harvard School of Public Health concluded that a significant percentage of donations in recent years in the three countries studied -- Armenia, Haiti and Tanzania -- were also not high-priority drugs.

"To those in need around the world, the dumping of useless drugs is actually worse than no help at all, since such toxic junk must be destroyed by the very people requesting help," said Doggett, whose staff said he was prompted to introduce the bill by an article in The New York Times in June about the problem during the Kosovo crisis.

As much as half of shipments of donated drugs to the region were inappropriate and likely to take up space in warehouses or have to be destroyed at considerable expense, according to WHO.


November 3, 1999 Senate Panel Approves Bill on Patent System Revisions

By ERIC SCHMITT

WASHINGTON -- Legislation that would revamp the U.S. patent system and bring it closer in line with European and Japanese practices is moving quickly through Congress.

But critics say the measure, which overwhelmingly passed the House in August and unanimously cleared the Senate Judiciary Committee on Tuesday, would hurt the livelihood of small-scale inventors, subjecting them to greater risk of theft and litigation.

"They're ripping up our patent system and giving away our future," said Beverly Selby, executive director of the Alliance for American Innovation, a coalition of independent inventor groups and small businesses.

The legislation would establish new protections for inventors, who are often victims of predatory promoters, and set a guarantee of 17 years' protection after the Patent and Trademark Office grants a patent. The current protection is 20 years from when an application is filed, which can be shorter than 17 years if the Patent Office takes longer than three years to process the application.

Critics point to one measure that they say would force some inventions to be made public before they are fully protected by a patent. But supporters say the changes will help level the international playing field.

"What this will do is improve the operation of the patent system for American business, and therefore improve American competition," said Michael Kirk, a former deputy commissioner of the Patent Office who is executive director of the American Intellectual Property Law Association, an advocacy group whose members include patent experts at major corporations.

The U.S. patent system dates to the Founding Fathers, and tinkering with the practices that rewards innovation and protects the exclusive rights to discoveries, has proved emotional and divisive.

But the United States is out of sync with the rest of the world when it comes to patents, many business groups contend, and a growing number of major American corporations, including IBM, Ford and Xerox, have pressed Congress to overhaul the rules to keep pace with the fast-changing global marketplace.

Similar legislation died in the Senate in 1997 after clearing the House. But supporters of the measure have brokered new compromises, including watering down challenges to existing patents, to win broad bipartisan backing for the legislation this year.

With Congress in its waning days before its end of the year recess, Sen. Orrin G. Hatch, R-Utah, who heads the Judiciary Committee, said on Tuesday there is only a "50-50" chance the measure will be enacted this year. The Clinton administration supports the legislation.

"It's a high-tech patent bill that will make us competitive with the rest of the world," Hatch said after his panel approved, by an 18-0 vote, a bill that he sponsored with Sen. Patrick J. Leahy, D-Vt.

Several of the legislation's provisions are contentious. Under the House and Senate bills, the American system would track its Japanese and European counterparts by publishing applications after 18 months, even if a patent had not yet been awarded. Inventors who sought patents only in the United States could still claim confidentiality.

Kirk said this provision would end an advantage extended to foreign companies seeking a patent here. Under the current American system, applications are not published until and unless a patent is awarded, which can extend beyond the 18-month period that European and Japanese systems give confidentiality to American inventors' applications. The change would also inform potential rivals that someone had already staked a claim, Kirk said. Critics say this would gut the confidentiality of an inventor's idea.

Critics also contend that the legislation would allow greater challenges to Patent Office decisions by third parties, typically wealthy corporations who could steal a small inventor's idea. Kirk said this provision was narrowly focused to prevent such abuses.


N Y Times February 7, 2001

Indian Company Offers to Supply AIDS Drugs at Low Cost in Africa


By DONALD G. McNEIL Jr.


PARIS, Feb. 6 — In a move that could force big drug multinationals to cut the prices of their AIDS drugs in poor countries, an Indian company offered today to supply triple-therapy drug "cocktails" for $350 a year per patient to a doctors' group working in Africa. The Indian company, Cipla Ltd. of Bombay, a major manufacturer of generic drugs, made the offer to Doctors Without Borders, which won the Nobel Peace Prize in 1999 for its work in war-torn and impoverished areas. In Africa the group sets up small pilot programs to develop models for broader approaches to combat AIDS, and would distribute the Cipla drugs free. As part of its program, Cipla would also sell the drugs to larger government programs for $600 a year per patient, about $400 below the price offered by the companies that hold the patents. "This is the way to break the stranglehold of the multinationals," said Dr. Yusuf K. Hamied, chairman of Cipla, who will meet with the doctors' group on Feb. 15 to discuss strategy. For two years, Doctors Without Borders has led an aggressive campaign to force multinationals to cut prices on life-saving drugs for the world's poorest patients. Other parties in the campaign are the Philadelphia and Paris chapters of the AIDS Coalition to Unleash Power, and the Consumer Project on Technology, a Washington group started by Ralph Nader. The normal cost of the AIDS cocktail in the West is $10,000 to $15,000 a year. Last May five multinationals, backed by the World Health Organization and other United Nations agencies, offered to sell their components to poor nations at sharply reduced prices. But Cipla and other makers of generic drugs in Brazil, Thailand and other countries have not been part of the talks with W.H.O., a situation that Cipla hopes to change with its aggressive entry onto the scene. The country-by-country negotiations about how the multinationals distribute the drugs have gone slowly, and so far only Uganda, Senegal and Rwanda have agreements. The companies refuse to release figures, but the cost of a typical cocktail in Senegal is $1,000 a year, according to Doctors Without Borders. Dr. Bernard Pecoul, director of the Access to Essential Medicines project for Doctors Without Borders, said the Cipla offer, which he learned of only today, "will let us start up our pilot projects on a larger scale." The doctors' group has 40 AIDS projects around the world, about half in Africa, where the infection rate reaches as high as 36 percent. Only five of these pilot programs are giving out antiretroviral cocktails. With the Cipla offer, or matching ones from other companies, up to 20 could be distributing the drugs by the end of year. Cipla is offering to sell the agency as many doses as it is wants at $350 a year. Dr. Hamied said that his company would lose money at that price, but that he would supply "10,000 doses or 20,000 or 30,000, however many they want." The $600 price to governments is near Cipla's break-even point, he said, but costs could drop with greater production. If that happens, he would cut prices further. In India he sells the same cocktail for about $1,100 a year. But he denied that he was trying to grab market share in Africa. "What do I want with market share?" he asked. "I don't have a monopoly, and the only way to make real money in drugs is with a monopoly. In this disaster, there is room for everybody." Wide distribution of the drugs in Africa is not without critics, given the attendant need for careful monitoring. Some experts argue that it would be better to spend the money on providing clean water, controlling malaria and increasing the use of condoms. But Doctors Without Borders says that the dangers and side effects of the drugs pale beside the immensity of the epidemic itself, and that Western testing standards are overcautious. The typical AIDS cocktail is a combination of any three of about nine protease inhibitors or reverse transcriptase inhibitors. The chemicals suppress the human immunodeficiency virus but, as with any chemical therapy, they are toxic and can damage the liver. In the West, doctors carefully monitor the levels of the drug in the blood, test for organ damage and check the levels of the virus in the bloodstream. If the virus mutates to resist the therapy, the combinations are changed. Careful monitoring may not be possible in many African settings. But with 25 million Africans infected with the AIDS virus, Doctors Without Borders and other agencies argue, imperfect treatment is better than none. Dr. Pecoul pointed out that large numbers of infected Africans live in urban areas where, "with a quite simple clinic, you can deal with anti retrovirals." He is also "not convinced" that the batteries of tests routinely ordered for Western patients are really necessary. "Some people suggest that H.I.V. testing and clinical followup can be enough," he added. The Cipla drug combination is two tablets of 40 milligrams of stavudine, two tablets of 150 milligrams of lamivudine and two tablets of 200 milligrams of nevirapine. In the United States and many other countries, the Bristol-Myers Squibb Company holds the patent on stavudine, also known as Zerit or d4T; Glaxo-Wellcome of Britain holds the patent on lamivudine, also known as Heptovir or 3TC, and Boerhinger Ingelheim G.m.b.H. of Germany holds the patent on nevirapine, or Viramune. Western drug companies have shown themselves determined to defend their patent rights to be sole distributors throughout the world, and Dr. John Wecker, head of Boerhinger Ingelheim's efforts to negotiate cheaper prices in Africa, said he did not yet know what his company would do if Cipla undercut its prices. "We offer a standard quality from the original manufacturer and can meet any demand that exists out there that can be delivered with safe procedures," he said. He refused repeatedly to say at what price Boerhinger Ingelheim sells nevirapine to Senegal or Uganda, saying, "Affordability is an issue, but not the major issue." Representatives from Glaxo-Wellcome and Bristol-Myers did not return phone calls, but the three companies can be expected to wage a hard fight against the distribution of generic versions of their drugs. Late last year, Glaxo-Wellcome threatened to sue Cipla when it tried to sell Duovir, its generic version of Glaxo's Combivir, a lamivudine/zidovudine combination, in Ghana. Cipla offered the drug for $1.74 a day; Glaxo had cut its price to $2, from $16. But even though the African regional patent authority said Glaxo's patents were not valid in Ghana, Cipla backed down and stopped selling Duovir. Asked what he would do if the three drug companies sued to stop him, Dr. Hamied said: "We won't fight it. I don't look at it as a fight. There's room for everybody. This is a holocaust in Africa. It's like the earthquake in India right now — everybody is helping out. I'm not looking to pick anybody's business; there's room for the multinationals at their price and room for us at our price, a partnership."
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