Biotech welcomes ruling. Credit: Lee Pettet/istockphoto

The US Supreme Court has ruled on a long-awaited and controversial patent litigation case, a decision greeted with relief by the biotech industry but vague enough that both sides can claim victory. The Bilski v. Kappos case was closely watched by the biotech community after the US Court of Appeals for the Federal Circuit ruled in 2008 that only methods tied to a machine or transformed into a different state are patentable, a standard which appeared to exclude crucial aspects of medical diagnostics. Commentators feared a restrictive ruling could have severely limited the ability to obtain patents on methods that use genes, proteins and metabolites to diagnose disease. Instead, the Supreme Court struck down patent claims on narrow grounds. “The Court was clearly conscious of the potential negative and unforeseeable consequences of a broad and sweeping decision,” stated Washington, DC–based Biotechnology Industry Organization president and CEO Jim Greenwood. The court ruled on two issues. First, it ruled against patenting only those inventions that are “tied to a particular machine” or those that transform “a particular article into a different state or thing.” Second, the court held that the word “process” as used in the US Patent Act should be read broadly to include modern day inventions. The ruling does not address the eligibility of patents for diagnostic methods, however, which leaves a number of questions unanswered with regard to a string of pending cases, including the closely watched dispute against Myriad Genetics and its breast cancer gene patents. Dan Ravicher of the Public Patent Foundation, a co-plaintiff with the American Civil Liberties Union in the suit against Myriad Genetics, believes “the opinion reinforces the line of case law that Judge Sweet relied upon in his decision striking down gene patents [in the Myriad case]. It rejects the argument that 'anything' is patentable.” Justices Stevens, Breyer, Ginsburg and Sotomayor would have struck down not only the specific Bilski business method claims, but all business method patents on historical grounds that this class of patents was never contemplated by the framers of the US Constitution. The same argument would be difficult to support in biotech-specific cases as there is ample evidence that Thomas Jefferson, who reformed the Patent Act of 1793, considered medicine a “useful art” as was originally stated, a language later changed to “process.”