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• W300711859 abstract "TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND A. Facts and Procedural History B. Construction of Therapeutically Effective Amount C. Denial of En Banc Rehearing III. THE MARKMAN-CYBOR REGIME A. De Novo Review in Claim Construction B. The Arguments Against De Novo Review IV. ANALYSIS A. Claim Construction Accuracy in the Federal Circuit B. The Future of Markman-Cybor C. Supreme Court Review V. CONCLUSION I. INTRODUCTION In Amgen Inc. v. Hoechst Marion Roussel, Inc. (Amgen V), (1) the Court of Appeals for the Federal Circuit was once again faced with the difficult question of the proper standard of review in claim construction appeals. The case went back and forth between the district court and the Federal Circuit multiple times before eventually narrowing on the construction of a single claim term. Ultimately, a petition for rehearing en banc was filed arguing that the Federal Circuit panel should have afforded more deference to the district court's claim construction. The petition was denied, but a number of dissenting and concurring opinions underscored the conflict among the Federal Circuit judges. Subsequently, a petition for a writ of certiorari was filed. (2) Currently, claim construction is reviewed de novo on appeal. This rule was first announced in Markman v. Westview Instruments, Inc. (Markman I), (3) and was confirmed by the Federal Circuit in Cybor Corp. v. FAS Technologies., Inc. (4) But the rule has not been without detractors, especially given the high reversal rate in claim construction cases. Both academics and jurists have criticized the holding in Cybor and called for increased deference to district court claim constructions. One of the most basic assumptions often made in the debate about the proper standard of review in claim construction cases is that the district court erred when a Federal Circuit panel reverses a district court claim construction. There is reason, however, to doubt this assumption. The Federal Circuit is certain to confront the MarkmanCybor rule again, but the exact adjustments it will make remain unclear. Ultimately, though, the Federal Circuit is unlikely to do enough. For this reason, Supreme Court review is warranted. II. BACKGROUND A. Facts and Procedural History Amgen is the owner of several patents that cover the production of erythropoietin (EPO), a naturally-occurring hormone that regulates red blood cell production. (5) Amgen sells EPOGEN, an embodiment of the patented EPO, to be used in treating anemia. (6) U.S. Patent No. 5,955,422 (the '422 Patent), the patent at issue, was issued to Kirin-Amgen (7) on September 21, 1999. (8) Claim 1 of the '422 Patent reads: A pharmaceutical composition comprising a effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture. (9) In April 1997, Amgen filed a declaratory judgment action in district court alleging that an Investigational New Drug Application filed by Hoechst Marion Roussel (now known as Aventis Pharmaceuticals, Inc.) and Transkaryotic Therapies, Inc. (collectively, HMR) infringed several of Amgen's EPO patents. (10) In October 1999, Amgen amended the complaint to add the '422 Patent and one other patent that had issued after the suit was filed. (11) In January 2001, after an extensive trial, the district court issued a lengthy opinion in which it held three patents, including the '422 Patent, valid and infringed. (12) HMR appealed to the Federal Circuit on several grounds, arguing in part that the district court's validity determinations were erroneous. (13) In reference to the '422 Patent, the Federal Circuit panel held that the district court had erred in failing to construe explicitly the term therapeutically effective, which the panel deemed necessary to determine whether the '422 Patent was anticipated by a prior art clinical study. …" @default.
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• W300711859 date "2007-03-22" @default.
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• W300711859 title "Amgen V. HMR: A Case for Deference in Claim Construction" @default.
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