Supreme Court Denies Amgen Certiorari Petition to Reverse Cybor

    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

Comments

[Joe Miller]

Your closing paragraph may provide another reason the Supreme Court declined review, i.e., review won't make a difference to the ultimate outcome of the case. (The Court is, as I understand it, less inclined to grant review in a case where, even if they agree 100% with the petitioner, the ultimate outcome of the case won't change.)

[Babel Boy]

This is really picky. picky, picky ....but:

Hematocrit is not a "biological property" of EPO, or anything else. It is a measure of rbc production. More precisely it is a ratio of rbc vol to the vol of whole blood. EPO's property is increasing 'crit.

If this imprecise language originated w/ the CAFC, it serves as an example of why they shouldn't be determining the facts.

Babel

[Kevin E, Noonan]

Babel:

You are absolutely right, and we here at PatentDocs admit falling into the semantically incorrect thicket created by the CAFC. We will change the post to what we should have meant, which is "an increase in hematocrit."

Thanks.