Value of Second Opinion Testing
Nestle’s Prometheus Laboratories unit argued in its filing to USPTO that confirmatory tests were unlikely to yield results differing from the original test, especially if found inconclusive. “A second measurement of an inconclusive result is not expected to be different from the first test if the data are processed in the same way,” Prometheus argued in a filing by Bernard Greenspan, the company’s director, intellectual property. “Reliance on a single diagnostic measurement is not how medicine is practiced, and elimination of uncertainty or inconclusive measurements will come only from further scientific research and discovery, not from repeated measurements of the same test on the same patient.”
Prometheus has spent the past nearly eight years defending two diagnostic method patents it owns against Mayo Collaborative Services (doing business as Mayo Medical Laboratories) and Mayo Clinic Rochester. In March a unanimous Supreme Court jolted the diagnostics industry by ruling that Prometheus’ methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases were ineligible for patenting, saying the measurements were too close to natural phenomena.
Echoing Prometheus, top-selling diagnostics developers Roche and Abbott argued in a 40-page joint filing that long-term, patients are better served through diverse testing procedures—not by a large number of labs performing the same tests with the same potential shortcomings.
“After all, if there are doubts about the results of a particular test, the patient likely would be better off if a different type of test for the same genetic condition is available,” Roche and Abbott concluded. “Patents coupled with competitive pressures also provide an incentive for others to ‘design around’ the patent by developing new, noninfringing tests for the same condition.
The result is a proliferation of different tests for the same condition, giving doctors and patients more options than the simple repetition of an existing test.”
Like other patient groups, Breast Cancer Action says the patent system discourages competition that can produce those new tests, reducing costs and increasing access to the technology for patients. Instead, they noted, the patent system preserves multiyear monopolies over diagnostic tests that price out too many patients.