By Kevin E. Noonan —

The U.S. Supreme Court today denied without comment
Amgen’s petition for certiorari to review the Federal Circuit’s reversal (for
the second time) of the District Court’s construction of the term
"therapeutically effective amount" in its patent infringement suit
against Sanofi-Aventis over erythropoietin (EPO).

This lawsuit has been reviewed twice by the Federal
Circuit from a bench trial in the Massachusetts District Court (before Judge
Young), and each time the Federal Circuit has disagreed with the District
Court’s interpretation of the term "therapeutically effective amount"
in claim 1 of U.S. Patent No. 5,955,422:

A pharmaceutical composition comprising a therapeutically
effective amount of human erythropoietin and a pharmaceutically acceptable
diluent, adjuvant, or carrier, wherein said erythropoietin is purified from
mammalian cells grown in culture.

(emphasis added).  The meaning of this term is important, because the
validity of the claim rests upon whether the term requires that the claimed
erythropoietin be capable of treating or curing anemia (see "Amgen Asks Supreme Court to Reverse Cybor").  According to the Federal Circuit, the District
Court’s interpretation of the term was flawed because the District Court improperly focused on the ability of EPO to cause an increase in hematocrit,
which is one of EPO’s biological properties recited in the specification, to
the exclusion of several others.  Since
prior art EPO formulations existed that
did not have the capacity to increase hematocrit or cure anemia, the District
Court used this distinction for finding that said prior art did not anticipate
Amgen’s claim.

The Federal Circuit disagreed.  It considered causing an increase in hematocrit to be only one of
EPO’s biological properties, and remanded to the District Court to consider the
prior art in light of its construction of the claim term.

In response, Amgen first petitioned for rehearing en
banc, which was denied.  However, the
published decision denying rehearing en banc illustrated the fractured
consensus on the Federal Circuit over its decision, in Cybor Corp. v. FAS Technologies, Inc., that the
court would show no deference to lower courts’ claim construction decisions,
and would review claim construction (both the legal determinations and the
underlying factual findings) de novo.  In
its petition, Amgen cited the specific deficiencies of the Federal Circuit in
its construction of the claim term relative to the trial court (which Amgen
asserted "had received tutorials from an M.I.T. scientist, listened to 32
days of testimony from 35 scientists, and read countless pages of written
submissions").  Amgen also based its
petition on misappropriation of judicial resources, usurpation of the trial
court’s duty of assessing the evidence firsthand, and the litany of:

(1)
a steadily high reversal rate; (2) a lack of predictability about appellate
outcomes, which may confound trial judges and discourage settlements; (3) loss
of the comparative advantage often enjoyed by the district judges who heard or
read all of the evidence * * * ; and (4)
inundation of our court with the minutia of * * * disputed claim terms * * * in
nearly every patent case,

citing Judge Michel’s dissent from the Federal
Circuit’s denial of rehearing en banc.

In view of its penchant recently to review (and reverse)
Federal Circuit precedent, the Supreme Court’s decision to decline this
opportunity is both surprising and puzzling.  Perhaps the Court believes it may be time to step back from its more
aggressive oversight of the Federal Circuit, particularly since that court
seems to "gotten the message" and adapted its recent jurisprudence to
Supreme Court mandates (see "Is It Time for the Supreme Court to Stop Flogging the Federal Circuit?" and "Syngenta Seeds, Inc. v. Monsanto Co. (Fed. Cir. 2007)").  Also possible is that the Supreme Court agrees with the Federal
Circuit’s approach as being consistent with its own thinking in Markman v.
Westview Instruments, Inc.  Finally, since a significant
minority of the Federal Circuit judges have, in dissent of the en banc
rehearing decision, indicated that the application of the Cybor doctrine
has not worked well in practice and was ripe for review, the Supreme Court may
be content to permit the Federal Circuit to come to its own consensus before
stepping in.

Notwithstanding the Supreme Court’s decision to deny Amgen’s petition, Amgen’s EPO franchise would appear to be safe no matter what the District
Court decides.  There were four other
patents-in-suit in this litigation, and Amgen has prevailed on validity and
infringement with respect to two of them.

For additional information regarding this case, please see:

• "Amgen Inc. v. Hoeschst Marion Roussel, Inc. (Fed. Cir. 2006)," October 27, 2006