Intellectual property rights should provide predictability in protecting valuable knowledge assets from unauthorized commercial use. However, a number of recent court cases in the US cast doubt on that assertion, requiring pharma companies to adjust to growing uncertainty about what the law really says—particularly for new and emerging technologies like diagnostic methods.
The latest example is last month's Supreme Court decision, in Bilski v. Kappos, that many patent experts had hoped would resolve the question of what constitutes patentable subject matter for these new areas of discovery. The Court affirmed a decision of the US Federal Circuit Court of Appeals but criticized the rule that the Court applied, explaining that it feared automatic application of this rule "would create uncertainty as to the patentability of" several emerging technologies, including "advanced diagnostic medicine techniques." The end result is that the Federal Circuit will have to decide these issues on a case-by-case basis.
Insight into how the courts will apply the patent eligibility requirement to medical diagnostics can be found through examination of other cases. The day after the Supreme Court issued its Bilski decision, it vacated another decision by the Federal Circuit, Prometheus Laboratories Inc. v. Mayo Collaborative Services, and remanded it for further consideration by the lower courts in light of Bilski. Prometheus has a patent covering a medical diagnostic method for determining the appropriate dose of thiopurine, a pre-existing treatment for some gastrointestinal and autoimmune diseases. One representative claim requires measuring a known thiopurine metabolite in a patient who had been administered the drug, "wherein the level" of the metabolite "indicates a need" to modify the amount of thiopurine. Mayo successfully argued to the district court that the patent was invalid for failing to claim patentable subject matter because it attempted to claim an abstract idea—the correlation between thiopurine drug metabolite levels and appropriate dosing levels.The Federal Circuit reversed the district court after applying its "definitive test" for determining if a process claim covers patentable subject matter. It had articulated that test in its Bilski decision, which the Supreme Court, by modifying the Federal Circuit's reasoning, has now eliminated as a universal requirement. According to that test, a claimed process "is surely patent-eligible" if it is tied to a particular machine or transforms an article into a different substance . However, "'the use of a specific machine or transformation of an article must impose meaningful limits on the claim's scope to impart patent-eligibility"' and "'the involvement of the machine or transformation in the claimed process must not merely be a insignificant extra-solution activity.'" Although the Supreme Court in Bilski ruled that this "machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible 'process,'" it still left the test intact but only as one way to analyze the question of patentable subject matter. It explained that "the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under [the law]." Hence despite the Supreme Court's vacating of the Prometheus decision, the "machine-or-transformation test" remains a valid tool for determining patent eligibility.