札幌医科大学医学部

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2001年5月8日b the university needs to put people's lives over patents

 AIDSの薬のパテントの話の続きです。アメリカの大学生、市民たちは、この問題についても活発に議論し活動している姿が伝わってきます。私は前回、30人ぐらいの大学院生を相手に講義したのですが、フィードバックがないのが物足りないところです。どのぐらい私の言いたいことが理解してもらえ、そのあと、学生たちがどのように考えたのか、把握してみたいと思います。引用した本文中で Under a series of laws passed since 1980, publicly funded researchers and their institutions are encouraged to patent and commercialize discoveries.  とありますが、これは前回の講義で話した、1980年のバイ・ドール法など、一連の立法整備のことを指すのです。大学などで誕生した新技術の権利は、当の大学に与えられることになり、これがアメリカの科学技術の大躍進にもつながったわけです。ただし、この記事に示されているように、特許の仕組み自体が大きな矛盾を持つものであることを、前回の講義で詳しく説明しました。講義で一回聴いただけでは知識が自分のものに消化できるとは思えません。このような時事のニュース、話題を通して深く考えて見ていただきたいと思います。


Eliot Marshall DRUG PATENTS: Universities, NIH Hear the Price Isn't Right on Essential Drugs Science 2001 April 27; 292: 614-615. (in News of the Week) [Summary] [Full Text]

When the University of Minnesota won a drug patent fight in 1999, its president, Mark Yudof, said it was "like winning the lottery." Now that lottery prize, worth as much as $300 million over time, has put Minnesota into the middle of an international debate over whether the public should get back some of the profits generated by biomedical research it has funded. A major driving force has been the cost and availability of AIDS drugs in developing countries--an issue on which advocates of limiting drug profits claimed a victory last week in South Africa. And the U.S. National Institutes of Health is being drawn reluctantly into the fray by a congressional directive to identify big moneymaking drugs derived from NIH-funded research.

What's at stake is the process by which drug companies develop and bring new products to market. Much of the underlying research for new drugs stems from university-based work, typically funded by the government. Under a series of laws passed since 1980, publicly funded researchers and their institutions are encouraged to patent and commercialize discoveries. But billion-dollar sales and high profit margins on certain drugs created in part with public monies have led some to ask whether the government deserves a slice of the revenues. Universities are also nervous about being seen as greedy.

The public is starting to "look askance" at academic biomedicine's interest in profits, says Stanford University's dean of medicine, Eugene Bauer. Speaking last week at the National Academy of Sciences, Bauer warned that "we are perhaps entering into an era of distrust" about faculty patents and spin-off corporations. He suggested that medical schools need to build public confidence with clear conflict-of-interest rules. At the same time, faculty patent holders are bewildered by the mixed signals they're getting. Says Robert Vince, a medicinal chemist and drug inventor at Minnesota's Twin Cities campus: "I like to think that what we did was useful. ... All of a sudden, we're bad guys because we developed an AIDS drug."

Two years ago, Minnesota managed to convince Glaxo Wellcome, now GlaxoSmithKline, that Vince and his colleague Mei Hua, who had filed patents on nucleoside analogs, were partial inventors of Ziagen (abacavir), a drug approved for AIDS therapy in December 1998. But this month, a group of Minnesota students staged a teach-in to pressure the university to forgo some of these royalties and not enforce its Ziagen patent in poor countries. These demands echo a campaign 10,000 kilometers away in South Africa, where activists are cheering a decision last week by 39 companies to withdraw from a suit to protect their patent rights. And activists at Yale University won another concession: They persuaded the university to rewrite a license agreement with Bristol-Myers Squibb Co. for the AIDS drug d4T so that generic knock-offs could be sold with impunity in South Africa.

The debate is most acute in Africa, but U.S. politicians are getting involved, too. Last December, the U.S. Senate asked NIH to keep tabs on "blockbuster" drugs that arise from government-sponsored research and to draw up a plan to recapture some of the money. The proposal was advanced by Senator Ron Wyden (D-OR), who has long been concerned about government research "walking out the door" without an adequate return to taxpayers, one observer says. A decade ago, as a member of the House, Wyden investigated the NIH-funded discovery of Taxol, the toxic compound derived from the Pacific yew that was developed into an anticancer compound by Bristol- Myers Squibb. Wyden failed last fall to attach his proposal to an NIH spending bill, but his colleagues agreed to include it in an accompanying report on the bill.

With the goal of "securing an appropriate return on the NIH investment in basic research," the report asks NIH to draw up a list of FDA-approved drugs with annual U.S. sales of $500 million that also received NIH backing and to prepare a plan to "ensure that taxpayers' interests are protected." The report is due in July, but the high threshold could limit it to one or two drugs. NIH officials declined to comment, saying only that they are working on the report.

Back in the Twin Cities, meanwhile, the University of Minnesota is holding firm. Christine Maziar, vice president for research, says the university "applauds" Glaxo's plans to reduce the cost of other drugs and "would welcome" a price reduction of Ziagen in sub-Saharan Africa, "despite a potential reduction in royalties." But the university will not abandon its intellectual property: "As a public institution, we are not able to give away a public asset," Maziar says about the patent on Ziagen. "If a farmer were to donate land, we wouldn't be able to give that away, either."

Amanda Swarr, a graduate student in women's studies at Minnesota and leader of the Ziagen protest, argues that "negligible" revenues are at stake in Africa. Besides, she says, "the university needs to put people's lives over patents."

Vince says he's trying to do exactly that by putting his share of the Ziagen money to work on three potential new AIDS drugs and a drug design center. Those dreams, however, rest on the expected royalties from university-owned patents.



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