Amgen Inc. v. Hoechst Marion Roussel, Inc.

• Decision Date: 22 November 2006
• Docket Number: No. 05-1157.,05-1157.
• Citation: 469 F.3d 1039
• Parties: AMGEN INC., Plaintiff-Appellee, v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.) and Transkaryotic Therapies, Inc., Defendants-Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

469 F.3d 1039

AMGEN INC., Plaintiff-Appellee, v. HOECHST MARION ROUSSEL, INC. (now known as Aventis Pharmaceuticals Inc.) and Transkaryotic Therapies, Inc., Defendants-Appellants.

No. 05-1157.

United States Court of Appeals, Federal Circuit.

November 22, 2006.

Lloyd R. Day, Jr., Day Casebeer Madrid & Batchelder LLP, of Cupertino, California, filed a combined petition for panel rehearing and rehearing en banc for plaintiff-appellee. With him on the petition were Edward M. O'Toole, McCracken & Frank, of Chicago, Illinois; Michael F. Borun, Marshall, Gerstein & Borun LLP, of Chicago, Illinois; and Stuart L. Watt, Amgen Inc., of Thousand Oaks, California.

Carter G. Phillips, Sidley Austin LLP, of Washington, DC, filed a response to the petition for defendants-appellants. With him on the response was Joseph R. Guerra.

Before MICHEL, Chief Judge, NEWMAN, MAYER, LOURIE, Circuit Judges, CLEVENGER, Senior Circuit Judge,^* RADER, SCHALL, BRYSON, GAJARSA, LINN, DYK, PROST, and MOORE, Circuit Judges.

ON PETITION FOR PANEL REHEARING AND REHEARING EN BANC.

ORDER

A combined petition for panel rehearing and rehearing en banc was filed by the Appellee, and a response thereto was invited by the court and filed by the Appellants. The petition for rehearing was referred to the panel that heard the appeal, and thereafter the petition for rehearing en banc and response were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed.

Upon consideration thereof,

IT IS ORDERED THAT:

(1) The petition for panel rehearing is denied.

(2) The petition for rehearing en banc is denied.

(3) The mandate of the court will issue on November 29, 2006.

MICHEL, Chief Judge, with whom RADER, Circuit Judge, joins, dissents in the denial of the petition for rehearing en banc in a separate opinion.

NEWMAN, Circuit Judge, dissents in the denial of the petition for rehearing en banc in a separate opinion.

LOURIE, Circuit Judge, concurs in the denial of the petition for rehearing en banc in a separate opinion.

RADER, Circuit Judge, dissents in the denial of the petition for rehearing en banc in a separate opinion.

GAJARSA, Circuit Judge, with whom LINN, and DYK, Circuit Judges, join, concur in the denial of the petition for rehearing en banc in a separate opinion.

MOORE, Circuit Judge, dissents in the denial of the petition for rehearing en banc in a separate opinion.

MICHEL, Chief Judge, and RADER, Circuit Judge, dissenting from the denial of the petition for rehearing en banc.

Rehearing this case en banc would have enabled us to reconsider Cybor's rule of de novo review for claim construction in light of our eight years of experience with its application. I have come to believe that reconsideration is appropriate and revision may be advisable.

In my view, four practical problems have emerged under the Markman-Cybor regime: (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 may have spent more time on the claim constructions than we ever could on appeal; and (4) inundation of our court with the minutia of construing numerous disputed claim terms (in multiple claims and patents) in nearly every patent case.

Our standard of review of no deference to the trial judge's claim constructions, expressed in Cybor, rests upon the premise that claim construction is always a purely legal exercise, devoid of factual content. We have likened claim construction to statutory construction. I believe that this analogy is open to serious question. In interpreting statutes, a judge, whether trial or appellate, essentially asks himself/herself, "What does the disputed term mean to me, the judge, as an artisan in the law?" With claim construction, on the other hand, the judge is supposed to inquire, essentially, "How would the average artisan in the relevant field of technology understand the disputed claim terms in the context of the rest of the patent, the prosecution history, and the prior art?"

It seems to me that the claim construction question often cannot be answered without assessing, at least implicitly, what the average artisan knew and how she thought about the particular technology when the patent claims were written. To make such determinations, the trial judge necessarily relies upon prior art documents and other evidence concerning the skill of the ordinary artisan at the relevant time. Indeed, trial judges are arguably better equipped than appellate judges to make these factual determinations, especially in close cases. In such instances, perhaps we should routinely give at least some deference to the trial court, given its greater knowledge of the facts. Or, perhaps other adjustments to our current practice should be considered.

Whatever our resolution, however, I believe the time has come for us to reexamine Cybor's no deference rule. I hope that we will do so at our next opportunity, and I expect we will.

NEWMAN, Circuit Judge, dissenting from denial of the petition for rehearing en banc.

The issue for rehearing en banc is the Federal Circuit's rejection of the district court's construction of the claim term "a therapeutically effective amount." My concern is with this court's methodology and rationale of claim construction, and with the sources on which the panel majority relied (or failed to rely) in arriving at its changed claim construction. The district court had correctly applied this court's precedent, requiring affirmance.

I

In brief, the panel majority construed the claims more broadly than the invention that was patented; thus the court ignored the patentee's purpose of writing claims that avoid the prior art—a purpose essential to every claim in every patent—by now construing the claims so that, as the panel majority recognized, they may read on the prior art. The patentee's purpose of including the critical limitation to "a therapeutically effective amount" of the genetically engineered erythropoietin (EPO) was to distinguish the prior art EPO isolates, which were not therapeutically effective to "heal or cure," in the district court's words. Thus this court's claim construction diverges from the specification and the prosecution history, and presents a claim construction that impinges on the prior art and thereby fosters invalidity. From this analytic method of claim construction and the denial of rehearing en banc I must, respectfully, dissent.

The methodology of claim construction that the court has here adopted raises issues that were laid to rest in Phillips v. AWH Corp., 415 F.3d 1303 (Fed.Cir.2005), where the en banc court disavowed the view that a patent claim can be construed more broadly than the invention to which it gives legal effect. In Phillips that unwarranted breadth was found in claim construction based on general dictionary definitions of claim terms, rather than relying on the specific technical usage in the specification; in this case the unwarranted breadth is found in the court's claim construction that may embrace the prior art, despite the exclusion of that subject matter by the prosecution history.

The district court, construing the claims in light of the specification and the prosecution history, construed "a therapeutically effective amount" as "a quantity that produces a result that in and of itself helps to heal or cure." That construction was the basis on which the patentee distinguished its genetically engineered EPO from the chemically identical EPO in known isolates of naturally occurring EPO, for the prior art product contained insufficient EPO to heal or cure. Thus the claim limitation to "a therapeutically effective amount" of EPO was critical to allowance. During an extensive prosecution, the applicant stated that

naturally occurring human erythropoietin is not a viable human therapeutic product; human recombinant erythropoietin, on the other hand, has been proven to be clinically effective, and is the first therapeutic product which can be used to effectively treat the hundreds of thousands of patients who suffer from anemia and other disorders involving low blood counts.

App. No. 113,178, Amendment under Rule 16 at 4, June 5, 1989 (emphasis in original).

The record in the district court contains evidence, presented by persons experienced in this field of science, that the limitation to "a therapeutically effective amount" distinguishes the genetically engineered EPO from known EPO isolates. The district court construed the claims from the viewpoint of the skilled artisan, upon reading and understanding the specification and the restrictions flowing from the prosecution history. My concern about this court's methodology is that the panel majority does not apply these standard tools of claim construction. The court's holding that "a therapeutically effective amount" includes any amount of EPO that exhibits a physiologic effect, whether or not the amount of EPO is adequate to provide therapy for any disorder, imparts to the claims the scope that was excluded during prosecution.

Although this court has urged caution in construing claims in order to preserve their validity, no precedent or logic requires that when more than one claim construction is available, the court must choose the broader one although it may invalidate the claim. See Phillips, 415 F.3d at 1327 (court may not construe claims as would be appropriate to preserve their validity unless "after applying all the available tools of claim construction . . . the claim is still ambiguous"); see also Smith v. Snow, 294 U.S. 1, 14, 55 S.Ct. 279, 79 L.Ed. 721 (1935) ("if the claim were fairly susceptible to two constructions, that should be adopted which will secure to the patentee his actual invention"); Modine Mfg. Co....