By Kevin E. Noonan —

Since the Federal Circuit’s en banc decision in Cybor Corp. v. FAS Technologies, Inc. that no aspect of a district court’s claim construction was entitled to any deference, courts, commentators, and other critics have
disagreed with the Federal Circuit.  Today, Amgen has enlisted the aid of the Supreme Court to rein in what it termed a "power grab" by the Federal Circuit in its petition for certiorari
in Amgen Inc. v. Hoechst Marion Roussel, Inc.

This case has gone back and forth from the Massachusetts District Court to the Federal Circuit twice, 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.

The meaning of this term is important, because the validity of the claim rests upon whether the term requires that the claimed erythropoietin (EPO) be capable of treating or curing anemia.  EPO is a naturally-occurring hormone that stimulates the body to produce red blood cells, and its absence (or insufficiency) causes anemia.  The standard clinical measure of anemia is the hematocrit, or the percent of whole blood comprised of red blood cells.  In construing the term "therapeutically-effective amount," the District Court had required that EPO falling within the scope of claim 1 increase hematocrit and have any other biological properties of naturally-occurring EPO.  Prior art EPO formulations existed that did not have the capacity to increase hematocrit or cure anemia, and this distinction was the basis for the District Court’s finding that said prior art did not anticipate Amgen’s claim.

The Federal Circuit disagreed.  Under the Court’s interpretation, the District Court had improperly focused on hematocrit, which is one of EPO’s biological properties recited in the specification, to the
exclusion of several others, including increasing stimulation of reticulocyte response, development of ferrokinetic effects, erythrocyte mass changes, and stimulation of hemoglobin.  The CAFC noted in particular that the specification recited that the therapeutic properties of recombinant EPO "included" all of these, and that the specification further stated that recombinant EPO was therapeutically useful even if it lacked some but not all of these properties.  For the second time, the Federal Circuit remanded to the District Court for further proceedings based on its more expansive construction of the term "therapeutically effective amount." 

In its petition, Amgen focused on the differences in understanding between the trial court judge (who 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") and the Federal Circuit.  According to Amgen, the Federal Circuit’s de novo review jurisprudence misappropriated judicial resources and usurped the trial court’s duty of assessing the evidence firsthand.  Amgen cleverly analogized to the Supreme Court’s Daubert jurisprudence, where the Court has commented on its confidence in district court judges’ ability to understand complex scientific and factual evidence.  In the Daubert analysis, the Supreme Court has directed appellate courts to defer to such factual findings by the district courts, the outcome Amgen advocates here.

Amgen also recites the now-familiar litany of negative consequences of the Federal Circuit’s de novo review standard, including "(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.  Finally, Amgen stresses that this issue is ripe for Supreme Court review in light of the disagreement between the Federal Circuit judges, reminding the Supreme Court that it used this rationale for granting certiorari in Warner-Jenkinson and Festo.

Amgen also asked the Supreme Court to review the Federal Circuit’s determination that prosecution history estoppel prevented it from prevailing on another of its claims in suit.  This claim recites recombinant EPO containing 166 amino acids, as determined from the predicted amino acid sequence encoded by the EPO cDNA.  In fact, human EPO as it is found in nature contains only 165 amino acids,
since the 166th amino acid is cleaved during the protein’s maturation process.  The District Court twice found that prosecution history estoppel did not prevent Amgen from asserting this claim against the defendants under the doctrine of equivalents, and twice the Federal Circuit disagreed.  In its certiorari petition, Amgen contends that the manner in which the Federal Circuit is implementing the Supreme Court’s edicts regarding the application of the prosecution history estoppel doctrine is tantamount to the Federal Circuit’s own, draconian, and Supreme Court-repudiated "no equivalents" standard for any claim amended during prosecution.  In Festo, the Supreme Court had explicitly rejected this approach, mandating that the Federal Circuit’s analysis consider whether the amendment was unforeseeable, was tangential to patentability, or for some other reason should not raise an estoppel.  Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 740-41 (2002).  By including the prosecution history estoppel issue in its certiorati petition, Amgen has significantly increased its chances of having the petition granted, since the Supreme Court has been diligent in the past ten years in
defending the doctrine of equivalents from a consistent effort by the
Federal Circuit to minimize or eliminate application of the doctrine.

Supreme Court review of the Federal Circuit’s application in Cybor of the principles it set forth in Markman has been anticipated and welcomed by many.  A significant minority of the Federal Circuit judges have, in dissent, indicated that the Court’s application of the Cybor decision (i.e., that the Court owes the District Court no deference even for factual matters related to claim construction) did not work well in practice and was ripe for review.  The Court might have lost its opportunity to address these issues itself, and inadvertently provided the Supreme Court with another opportunity to overturn Federal Circuit precedent, a pastime it has become accustomed to in the last few years.