Chakrabarty Controls on Isolated DNA Sequences, not Mayo*

Ananda Chakrabarty

Not too surprisingly, the Supreme Court granted certiorari in AMP v. USPTO, vacated the Federal Circuit’s panel decision, and remanded for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc.  On remand, the Federal Circuit is unlikely to “resurrect” the claims to the methods of “comparing” or “analyzing” DNA sequences that were deemed unanimously by the Federal Circuit panel to be invalid as being patent-ineligible under 35 U.S.C. § 101, and nothing in Mayo Collaborative Services changes that result, but simply reaffirms it.  But the story should also be no different for the claim directed to the method of screening potential cancer therapeutics that was unanimously upheld by this same panel as being patent-eligible under 35 U.S.C. § 101 because the Supreme Court’s reasoning in Mayo Collaborative Services is distinguishable for reasons given in the original AMP decision, as well as for reasons given in Judge Newman’s opinion in the remand of Classen Immunotherapies, Inc. v. Biogen IDEC.  See The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand*.

Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101.  What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision?  For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed.  I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words:  NONE AT ALL.  And the Federal Circuit can (and should) say likewise, perhaps in far more words.

First, the relevant claimed subject matter in each of these two cases is entirely different.  In fact, the relevant claimed subject matter in these two cases falls into two entirely different statutory classes described in 35 U.S.C. § 101.  The claimed subject matter of Mayo Collaborative Services is a method.  By contrast, the claimed isolated DNA sequences in AMP are compositions (i.e., chemical molecules), no matter how much the plaintiffs (and others) disingenuously focus attention on the so-called “informational content” of these isolated DNA sequences.  That means the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) is far more analogous in terms of the claimed subject matter, and thus controls, not Mayo Collaborative Services.

[Bio-Pharma]

Second, and certainly unlike the characterization of the methods in Mayo Collaborative Services, these isolated DNA sequences are definitely not “laws of nature,” or merely “laws of nature.”  Instead, like the organisms in Chakrabarty, the claimed isolated DNA sequences are man-made, don’t exist in nature, must, at the very least, be extracted and isolated from native DNA by using man-made techniques (and potentially by man-originated synthetic techniques), and are “structurally distinct from native DNA, and have different properties and utilities.”  In other words, and unlike what some have disingenuously said, we’re not simply “plucking a leaf” in making the claimed isolated DNA sequences, and far from it.  Mother Nature does not, (and more significantly cannot) “isolate” the claimed DNA sequences.  Once again, the controlling ruling in Chakrabarty says that which is “man-made” is patent-eligible under 35 U.S.C. § 101, and the claimed isolated DNA sequences are most definitely “man-made.”

Third, I do hope we hear no more reference to the “product of nature” line of cases that was proffered by the plaintiffs and unfortunately relied upon by the district court in ruling that these claimed isolated DNA sequences were patent-ineligible under 35 U.S.C. § 101.  See Foaming at the Mouth: The Inane Ruling in the Gene Patents Case.  The applicability of the “product of nature” doctrine was not accepted by a majority of the Federal Circuit in the original AMP decision, and it should definitely not be accepted now.  Again, we’re not talking about purified natural elements such as vanadium, uranium, or even tungsten.  The claimed isolated gene sequence are not merely “products of nature,” or any such thing, but are, again, man-made, chemical molecules that “nature” cannot make.

The plaintiffs in AMP may be dreaming that the remand by the Supreme Court for reconsideration in view Mayo Collaborative Services will change the result by the Federal Circuit on the patent-eligibility of the claimed isolated DNA sequences.  In my opinion, that is no more than very wishful thinking for at least the reasons I’ve stated.  But it wouldn’t hurt for the Federal Circuit to explicitly tell SCOTUS “loud and clear” that Chakrabarty, not Mayo Collaborative Services, controls the patent-eligibility of the claimed isolated “man-made” DNA sequences in AMP.

*© 2012 Eric W. Guttag.  Posted April 3, 2012 on IPWatchdog.com.