Prometheus Laboratories' decision 10-plus years ago to patent a blood test that determines the maximum dose of a gastrointestinal drug is likely giving it major heartburn today. That's because the U.S. Supreme Court tossed out the California company's patent claim, giving The Mayo Clinic and independent research groups a major victory.
The diagnostics industry likely gained a headache from the decision, which caught the eye of the Associated Press and other news sources. In essence: The Supreme Court ruled that the company's patent, now owned by parent Nestlé, is invalid because it was based on the laws of nature, which are just not patentable.
"The court has repeatedly emphasized a concern that the patent law not inhibit future discovery by improperly tying up the use of laws of nature and the like," the decision reads (as composed by Justice Stephen Breyer). "Rewarding with patents those who discover laws of nature might encourage their discovery. But because those laws and principals are 'the basic tools of scientific and technological work,' there is a danger that granting patents that tie up their use will inhibit future innovation."
The Prometheus test is designed to maximize the dosage of thiopurine drugs to treat Crohn's disease and other gastrointestinal disorders by determining if a given dose produces the recommended amount of metabolites. Mayo Clinic doctors used the test until 2004, when the institution came out with its own version that recommended different metabolite levels. Prometheus sued.
Mayo Clinic president and CEO John Noseworthy told the AP he was happy with the decision, which "will enable physicians and other healthcare providers to offer and use tailored diagnostic tests to benefit patients." Prometheus issued a statement, not surprisingly, saying it was disappointed by the decision, because "strong patent protection is important to encourage the investment of energy and resources to develop lifesaving diagnostics tests and treatment protocols."
So, what is better? Is it right that doctors and providers gain the ability to develop personalized diagnostic tests and treatment guidelines? Or should companies have been able to patent the process themselves? Diagnostics companies seeking to advance personalized tests will likely be consulting their lawyers to figure out what to do next, because the landscape just got murky for them. Independent researchers and institutions, however, gained a potential windfall.