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Ethics and Patents

Ethics and Patents
December 5, 2006

Yale University is attempting to make a potential anti-HIV drug available in developing nations, but the institution is still finding itself questioned for not doing enough. The university plans to help out AIDS patients by patenting its product, to provide legal protection, and then making the patent publicly available in several poor countries. The move has garnered praise from some experts on patent procedures, but criticism from student activists.

Jon Soderstrom, managing director of the Yale office of cooperative research, said that Yale is filing patents on the compound -- Ed4T -- around the world, including in several developing countries. He said that the university wants to ensure that people will have access, should a drug based on Ed4T ever come to market. Once the patents are approved, Yale plans to release them to the public with the idea that companies in countries like India will produce the drugs and market them at low prices in developing nations.

Yale has licensed the compound to Oncolys BioPharma, a Tokyo pharmaceutical firm, but Soderstrom said that it will take years to develop the compound into a marketable drug. Oncolys has not even begun clinical trials. Yale’s licensing agreement will allow the company to sell the drug for a premium in Western countries.

W. Mark Crowell, associate vice chancellor for economic development at the University of North Carolina at Chapel Hill and former president of the Association of University Technology Managers, said that universities are trying to find new ways of licensing their drugs to companies. Institutions want to ensure that they can earn a profit from their patents while also providing access to technologies in developing countries.

“Yale has been a leader in this area,” he said. “They should be applauded for what they are doing.”

“We thought we were taking a novel approach that people would applaud, but that has not been the case,” Soderstrom said.

In an article in Nature, a student group called Universities Allied for Essential Medicines criticized Yale for not ensuring that the compound would be affordable to people in poor countries. But officials at the university said that the group is misguided and that Yale is committed to innovative steps to make drugs accessible to people in the developing world.

“I can’t help what other people print,” Soderstrom said . He added that patent law and drug development are highly complicated subjects and that the press and student activists have been missing the point. If anything, Yale is committed along with the student group to making drugs affordable.

“We violently agree with them,” Soderstrom said.

The controversy at Yale is part of a broader push by UAEM to increase access to medicine in low income nations. In November, the group released its Philadelphia Consensus Statement, which has been signed by over 100 health experts, including four Nobel laureates and two former editors of the New England Journal of Medicine. The statement challenges universities to:

  • Promote equal access to medical technologies in the developing world.
  • Promote research on neglected diseases.
  • Measure research success based on impact to human welfare, not number of patents and dollars earned.

Michael Steffen, a Yale law student and member of UAEM, said that the government subsidizes research and that universities have an obligation to make their results available for the public good. This new compound, Ed4T, is related to a blockbuster HIV drug, d4t. Yale holds the patent and licensed the compound to Bristol Myers Squibb which marketed it under the name Zerit.

In an interview last month with the Yale Alumni Magazine, Yale President Richard C. Levin noted that the university has garnered approximately $210 million from patent royalties over the last 10 years. Most of Yale’s 311 patents cover pharmaceutical inventions and one of the most profitable was Zerit, one of the main drugs used in the AIDS cocktail. For several years, Yale was receiving almost $30 million a year from licensing Zerit. Under pressure from Doctors Without Borders in 2001, Bristol Myers Squibb allowed companies to begin selling a generic form of Zerit for much lower prices in the developing world.

Steffen said that his group wants any pharmaceutical developed from Ed4T to be cheap and available in low income countries. Soderstrom said that Yale is committed to that goal as well.

 

 

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