Originally published May 17, 2010
In Association for Molecular Pathology et al. v. United
States Patent And Trademark Office et al.1,
Association for Molecular Pathology and other plaintiffs, including
some physicians and cancer patients, asked a federal district court
in New York, in a motion for summary judgment, to invalidate
several so-called "gene patents" owned by the University
of Utah and Myriad Genetics. The patents are directed to two
isolated gene sequences, BRCA1 and BRCA2, that researchers had
discovered to be correlated with a heightened susceptibility to
breast cancer. In addition to composition claims directed to the
isolated genes, the patents also include method claims for
analyzing BRCA1 and BRCA2 genes (or RNA) extracted from an
individual to identify the presence of mutations, if any, in those
genes as well as for determining the individual's
predisposition to breast cancer based on the mutations.
Judge Robert Sweet granted the motion of summary judgment and
concluded that the composition claims as well as the method claims
were not eligible for patenting and hence were invalid. The judge
relied, at least in part, on a Supreme Court decision from 1931,
American Fruit Growers, Inc. v. Brodgex Co.2,
to invalidate the composition claims. In that case, the Supreme
Court had held that oranges whose skin had been treated with
mold-resistant borax had not been sufficiently transformed into a
new and different article to be eligible for patenting. Similarly,
Judge Sweet held that isolated DNA did not possess "markedly
different characteristics" from its naturally occurring
counterpart to be eligible for patenting.
Judge Sweet relied on the recent case of In re
Bilski3, which is presently before the U.S. Supreme
Court, to invalidate the method claims. In In re Bilski,
the U.S. Court of Appeals for the Federal Circuit held that a
method claim is patent eligible if (1) it is sufficiently tied to a
particualr machine or apparatus or (2) it transfoms an article into
a different state or thing. Though this
"machine-or-transformation" test was enunciated in the
context of a so-called "business method" patent that was
directed to a method of hedging risks in commodity trading, it has
been applied post-Bilski by a number of courts to medical
diagnostic methods.
In this case, the defendants relied on a recent post-Bilski case, Prometheus Laboratories, Inc. v. Mayo Collaborateive Services4, to argue that the steps of "analyzing" and "comparing" recited in the method claims were transformative. In Prometheus, the Federal Circuit had held that the step of "determining the levels of metabolites" in a method claim directed to adjusting the dosage level of certain therapeutic drugs, in order to enhance efficacy and minimize side effects, was transformative as it involved extraction and measurement of metabolite concentrations, e.g., via high pressure liquid chromatography. Judge Sweet, however, did not agree and held that the steps of "analyzing" and "comparing" were merely mental steps. The judge went even further and indicated that even if the challenged claims "were read to include the transformations associated with isolating and sequencing human DNA," these transformations would not render the claims patent eligible as they would be merely what Bilski characterizes as "data gathering step[s]" that are not "central to the purpose of the claimed process."
The Federal Circuit is likely to grant certiorari on this case. Look for continued updates on this important case, as well as the Supreme Court's upcoming decision in Bilski, in future issues of Nutter's IP Bulletin.
Footnotes
1. 669 F.Supp.2d 365 (S.D.N.Y. 2009).
2. 283 U.S. 1 (1931).
3. 545 F.3d 943 (Fed. Cir. 2008).
4. 581 F.3d 1336 (Fed. Cir. 2008).
This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.
We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.