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  • Kirk Hartley

More on Prometheus and the Denial of Patents on Laws of Nature

The opinion in Prometheus continues to frustrate those in the patent bar who think the Federal Circuit deserves deference, for some unexplained reason – an example is here. A smart friend who is a patent lawyer reminded me of the maxim: "When you only have a hammer, everything looks like a nail."

Others consider the outcome not surprising and very desirable for patients and research. For example, consider the excerpts below from a article by Jan Wolfe:

"The U.S. Supreme Court delved into one hypothetical after another during oral arguments last December in Mayo Collaborative Services v. Prometheus Laboratories. The justices debated would-be patents involving fireplaces, chicken feed, and people whose fingers change color when they take aspirin. Always quick with a retort, and even an alternative hypo of his own, was Stephen Shapiro of Mayer Brown, who scored a landmark win for Mayo this week along with Jonathan Singer of Fish & Richardson. The Supreme Court handed down a 9-0 decision on Tuesday throwing out Prometheus’s patents for a diagnostic test for determining how thiopurine drugs are metabolized within the body. The case, which came out the opposite way in two different trips to the U.S. Court of Appeals for the Federal Circuit, has been closely watched because of its impact on the burgeoning field of personalized medicine. The justices concluded that Prometheus’s patents "claim the underlying laws of nature themselves" and therefore must be deemed invalid. Fish & Richardson’s Singer told us the win "feels fantastic after seven and a half years of hard work." He’s been pressing Mayo’s case as lead counsel since 2004, when Prometheus sued for infringement after Mayo developed its own diagnostic test. A district court judge ruled for Prometheus in 2005, but the court later changed course and invalidated the two Prometheus patents. In 2009 the Federal Circuit reversed. The Supreme Court ordered the Federal Circuit to reconsider in light of the high court’s opinion in Bilski v. Kappos, but the Federal Circuit again ruled for Prometheus in 2010. All the while, the Mayo team stuck to its guns. "If you read the district court opinion, and the Supreme Court’s opinion, you’ll find them very similar in terms of the arguments we made," Singer told us. Mayo’s Federal Circuit briefs highlighted that Mayo halted crucial research because of Prometheus’ infringement claims. That history colored the litigation, Singer said, likely shaping both press coverage and the policy arguments eventually adopted by the Supreme Court. "You can appreciate the effect it has on a trier-of-fact when doctors have to stop their research," he said. "These particular patents had a startling effect not just on commercial competition, but also on patient care. That’s what this case is really about." The unanimous ruling that Prometheus’s test is not patentable subject matter "is a big surprise for a whole lot of people," said Herbert Hovenkamp, who wrote an amicus brief for Mayo in the case on behalf of nine law professors. He said that at oral argument Justice Stephen Breyer, who wrote the majority opinion, seemed a bit more inclined to agree with the U.S. government than with Mayo. The U.S. Solicitor General had argued that Prometheus’s test could be patentable subject matter, but that the patents are invalid because they were anticipated."


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