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.
Implications for Ingenuity
Many who believe strongly in patents as incentives for innovation, particularly critical in fields such as the biotechnology industry where life-saving innovations come only after significant investment in research and development, hope that careful consideration will be given to the effect that precluding these patent categories could have on motivating future discoveries.
As recounted by the court, plaintiffs in Molecular Pathology asserted that “gene patents are not necessary to create incentives for initial discoveries or the development of commercial applications, including diagnostic tests,” while patent-holder Myriad clearly disagreed, stating that “patents on isolated DNA, including the patents-in-suit, actually promote research and advance clinical development to the benefit of patients.”
This is perhaps the central debate. Although the incentives provided by a strong patent system are admittedly difficult to quantify (given that we have no “control” in the intellectual property experiment to know what a world without patents would look like), if Judge Sweet’s decision stands it may cast doubt on the future of ingenuity in the biotechnology industry. In the meantime, biotech companies must wait to see what becomes of patents in the “Information Age.”