Magazine article University Business
Court Report: The Supreme Court Weighs in on Two Important Higher Education Issues
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 taw 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. …