In one case it is considering, and a ruling it recently issued in another one, the U.S. Supreme Court is addressing issues important to higher education that often are lost in the glare of more politically charged pronouncements from Capitol Hill and the White House.
In a case that has split the university research community, the court is considering the constitutionality of a law dealing with the patent rights of researchers. Specifically, the court is reviewing the scope of a section of the Patent Act that provides a narrowly worded exemption from liability for patent infringement for certain research related to certain drugs.
Known as the "safe harbor" clause, it allows researchers to conduct studies using printed materials and methods without liability when such studies are related to the development and submission of information to a federal agency, such as the Food and Drug Administration.
Although complicated by technical and legal issues, the core issue of the case is "how far upstream or downstream in the research process the exemption should extend," says Bob Hardy, director of contracts and intellectual property management for COGR, the Council on Governmental Relations (www.cogr.edu), a D.C.-based association of research universities.
On one side, the American Council on Education (www.acenet.edu), has joined in signing an amicus brief urging that the exemption be limited. Other organizations and institutions participating in the brief include the Wisconsin Alumni Research Foundation, the Regents of the University of California, Boston University, the University of Oklahoma and the University of Alberta.
ACE and the other signers want the Supreme Court to uphold an Appeals Court ruling that an exception to patent infringement claimed under the safe harbor clause did not extend to pre-clinical research conducted to identify promising drug candidates for future clinical testing.
"To expand the safe harbor clause could have extremely negative effects on the research community in general, but particularly academic researchers," says Sheldon E. Steinbach, ACE's general counsel and vice president. Without the protection afforded by viable patents, Steinbach adds, "the private sector will pull back its support of university-related research, which is a key in the discovery of new drugs and other breakthrough technologies."
could have extremely negative
effects on academic researchers.
-Sheldon E. Steinbach, ACE
On the other side, groups of university faculty members, notably law and economics professors, have signed amicus briefs in support of a broad exemption. In the middle, without expressing a position, are organizations including COGR and the Association of American Universities (www.aau.edu), which focuses on issues important to research-intensive universities.
"As a university community, we are conflicted," says Hardy. "On the one hand, universities have become active in the patent area. On the other hand, in performing research, universities extensively use technologies, many of which may be patented. Given that there clearly is not a consensus on this, we don't think it is appropriate at this time to associate ourselves with either position."
The Supreme Court heard the case in April and is expected to issue a ruling before it adjourns in June.
On a different subject, the high court ruled 5-to-4 in March that the landmark Title IX law that prohibits unequal treatment of girls and women in schools and colleges also bars retaliation against teachers, coaches or anyone else who blows the whistle on such treatment.
Title IX's enforcement mechanism would "unravel" if employees were not protected from punishment when they complained about smaller budgets or less adequate facilities for women's or girls' teams, wrote Justice Sandra Day O'Connor in the majority opinion.
The ruling came a week after the Department of Education quietly issued a new rule to clarify Title IX regulations. It allows institutions to avoid offering sports opportunities to women if a sufficient number of students failed to respond to an e-mail survey to express their interest in a program.
The government agency issued its clarification "without benefit of public discussion and input," notes National Collegiate Athletic Association President Myles Brand. The rule "will likely stymie the growth of women's athletics and could reverse the progress made" since Title IX was enacted 33 years ago, he says.
Alan Dessoff is a former reporter for The Washington Post and a freelance writer based in Bethesda, Md.
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