Patent Cases: Prometheus Loses; Myriad on the Docket
Nestle’s Prometheus Laboratories subsidiary suffered a stinging legal defeat when a unanimous U.S. Supreme Court held as ineligible for patenting the company’s methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases. “A patent must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law,” the Court ruled in a decision written by Justice Stephen G. Breyer. It was a victory for Mayo Collaborative Services, which Prometheus sued in 2004, alleging that a never-marketed Mayo diagnostic test infringed two Prometheus patents by measuring the same metabolites as Prometheus’ test. Last month, CAFC applied the Mayo decision in PerkinElmer, Inc. v. Intema, Ltd by invalidating all claims of Intema’s patent for a diagnostic method to gauge the likelihood of Down’s syndrome in babies before they are born.
“Right now, how to protect diagnostic methods is something that patent attorneys across the United States are struggling with. Whenever they think they have good language, a court somewhere rules in a different fashion,” Michael J. Belliveau, Ph.D., a partner in the Boston law firm Clark+Elbing, told GEN.
Still unresolved is whether breast cancer susceptibility genes BRCA 1 and 2—perhaps all genes—are legally patentable. CAFC in August reaffirmed the mixed ruling it rendered a year earlier on seven BRCA-related patents held by Myriad Genetics. That court found Myriad’s gene composition-of-matter claims and methods of screening for cancer compounds patent-eligible—but not Myriad’s claims for its method of analyzing the genes for breast-cancer mutations. On December 1, the high court agreed to hear arguments in the nearly four-year case, in which 20 medical associations and individual doctors led by the Association for Molecular Pathology, and assisted by the American Civil Liberties Union and Public Patent Foundation, have sued the U.S. Patent & Trademark Office.