Open Access News

The boundaries of academic freedom may be vastly circumscribed by the U.S. Supreme Court this term in a case that is not even on most universities' radar. Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc. is not a traditional case of academic freedom involving professors as parties and raising First Amendment concerns. In fact, nobody from a university is a party in this commercial dispute, a patent case between two for-profit laboratories. But at the heart of the case is the essence of campus life: the freedom to think and publish. The saga began when researchers from Columbia University and the University of Colorado Health Sciences Center developed a test to measure the level of homocysteine, an amino acid, in a patient's body. In research on thousands of people, the investigators learned that a high level of homocysteine is correlated with a vitamin deficiency: low levels of cobalamin or folate. Other tests for homocysteine existed and were used for a variety of medical disorders. But considering theirs to be an improvement, the researchers applied for a patent. In their application, they also claimed that, because they were the first to recognize that a high level of homocysteine is connected to a vitamin deficiency, they should be allowed to patent that basic physiological fact. Thus they would be owed a royalty anytime anyone used any test for homocysteine and concluded that an elevated level signified a vitamin deficiency. They received U.S. Patent No. 4,940,658 — known as the '658 patent — and later licensed it to Metabolite Laboratories....[A]fter LabCorp published an article stating that high homocysteine levels might indicate a vitamin deficiency that could be treated by vitamins, Metabolite sued LabCorp for patent infringement and breach of contract, and was awarded more than $5-million in damages. LabCorp appealed to the U.S. Court of Appeals for the Federal Circuit, which hears all patent appeals. Astonishingly, it held that LabCorp had induced doctors to infringe the patent by publishing the biological fact that high homocysteine levels indicate vitamin deficiency. The court also ruled that the doctors had directly infringed the patent by merely thinking about the physiological relationship....By considering publishing and thinking about a law of nature to be actionable under patent law, the Federal Circuit court has severely threatened academic freedom. Professors everywhere should be concerned about the case, and how the Supreme Court will rule on LabCorp's appeal. The decision has set off a rush to the patent office to assert ownership over other scientific facts and methods of scientific and medical inquiry....Upholding the '658 patent would discourage the sharing of scientific information through publication.