Well, Judge Sweet has done what many had feared (hoped?) and teed up the gene patenting case for the Federal Circuit. In a 156 page opinion issued yesterday, he ruled that, as a matter of law, the patents directed to “isolated DNA” are directed to non-patentable subject matter and are invalid under 35 U.S.C. § 101. Similarly, claims related to methods of “comparing” or “analyzing” DNA sequences are abstract ideas and are likewise unpatentable under § 101.
Regarding the “isolated DNA” claims, the court ruled as follows:
[T]he clear line of Supreme Court precedent and accompanying lower court authorities . . . establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess “markedly different characteristics” in order to satisfy the requirement of § 101.
The court rejected all of Myriad’s arguments that isolated DNA is indeed markedly different from native DNA in the body and thus invalidated the isolated DNA claims.
For the method claims, the court relied on Bilski‘s machine-or-transformation test to invalidate the claims. The court dismissed many of Myriad’s arguments regarding the transformative nature of the claims by holding that they were merely data gathering steps.
The court did struggle a bit more with the claim directed to comparing the growth rate of cells in the presence or absence of a potential cancer therapeutic, but ultimately concluded that it was likewise invalid.
The court did dismiss the plaintiffs’ constitutional claims against the PTO and also did not rule on the constitutional claims against Myriad, citing the doctrine of constitutional avoidance. When a court can rule on a statutory issue to provide the desired relief, it should refrain from ruling on a related constitutional issue.
The court recognizes that this decision will not stop the PTO from issuing claims of similar ilk to isolated DNA and methods of analyzing and comparing the DNA. It seems to believe, however, that it will be affirmed by the Federal Circuit and perhaps the Supreme Court thus putting an end to these “evil” patents.
Make no mistake about it. The ACLU only got involved in this case because it expects to take it to the Supreme Court. The first step, however, is the Federal Circuit. I agree with Patently-O and others that suggest the case will be reversed by the Federal Circuit and set up a potentially epic battle at the Supreme Court that could have enormous consequences to the biotechnology industry in the US. As far as Federal Circuit review, this decision flies in the face of too many of that court’s and its predecessor’s precendents. The Supreme Court is a bit more of a wild card.