Method Patents on Diagnostic Tests
Judge Sweet also invalidated, on the basis of patentable subject matter, a method patent for the diagnostic test used to screen for BRCA1 and BRCA2 mutations by using isolated DNA as a comparison. He found that the process of “analyzing” or “comparing” was not sufficiently transformative and ruled that the “claimed comparisons of DNA sequences are abstract mental processes” not constituting patentable subject matter.
Judge Sweet relied largely on the machine-or-transformation test of In re Bilski, which was recently rejected by the Supreme Court on June 28, 2010 in Bilski et al. v. Kappos in an opinion recognizing the changing nature of innovation. The Supreme Court addressed the changing nature of innovations in the Information Age, noting that “the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals” (emphasis added).
The Supreme Court, however, left open the details for implementation of its decision:
“[T]he Court today is not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies from the Information Age should or should not receive patent protection....In disapproving an exclusive machine-or-transformation test, we by no means foreclose the Federal Circuit’s development of other limiting criteria that further the purposes of the Patent Act and are not inconsistent with its text.”
As the Supreme Court reiterated the limits to patentable subject matter previously set forth (precluding “laws of nature, physical phenomena, and abstract ideas”), it remains to be seen whether Judge Sweet’s invalidation of the diagnostic method patents as “abstract mental processes” will stand on appeal.