On Wednesday, the U.S. Supreme Court heard arguments in a lawsuit that will determine the legality of patents for screening tests that help physicians determine dosages, treatment options or a person's risk of acquiring a certain disease, the AP/Washington Post reports (AP/Washington Post, 12/7).
Background
The lawsuit -- filed by Prometheus Laboratories against Mayo Clinic -- alleges that Mayo infringed on Prometheus' two patents for a test to help physicians determine drug dosages for individuals with Crohn's disease.
Mayo is seeking to offer its own version of the test, arguing that Prometheus was improperly granted exclusive rights. According to leading medical groups, the patents counter prohibitions against granting exclusive rights on abstract ideas or laws of nature (Kendall, Wall Street Journal, 12/5).
Arguments
Richard Bress, a lawyer representing Prometheus, said that before the Prometheus method was available "doctors had no way to tailor for each individual based on their metabolism the right dosage of these powerful but potentially toxic drugs."
Bress conceded that the method Prometheus patented was developed from existing information, but said, "[W]hy were they used? They were used by people who were trying to come up with what we came up with."
Stephen Shapiro, a lawyer for Mayo, argued that allowing the patent to stand would damage research processes that are "fundamental to American health and to the economy and the health care industry" (Liptak, New York Times, 12/7).
Justices Weigh In
According to the Wall Street Journal, the justices were split on the matter.
Justice Stephen Breyer said he was concerned about the patents but noted that investments made by companies to discover these methods are "often a very expensive process." Justice Antonia Scalia argued against Mayo, saying that ruling in its favor would make it difficult to patent any medical innovation.
Justice Samuel Alito said that Prometheus' patent is on a "natural phenomenon." Justice Elena Kagan agreed, adding, "All [Prometheus has] done is pointed out a set of facts that exist in the world" (Kendall, Wall Street Journal, 12/8).
Justice Ruth Bader Ginsburg said, "People need to know up front that this is not a patentable subject matter."
Justice John Roberts seemed to side with Mayo, saying, "You take wood, you put it on a grate, you light it, and you get heat. So I can get a patent for that?" (New York Times, 12/7).
Implications
Denise DeFranco of the American Intellectual Property Association said the court decision could make innovative methods of diagnosing or treating diseases vulnerable to attack.
Meanwhile, AARP and the Public Patent Foundation in a court brief wrote, "Allowing patents on pure medical correlations ... threatens doctors with claims of patent infringement should they discuss mere laws of nature with their patients, burdens the public with excessive health care costs and dulls incentives for real innovation in medical care" (Bartz, Reuters, 12/7).