By Kevin E. Noonan --
Amgen's recombinant erythropoietin (EPO) franchise (Aranesp® and Epogen®, as well as Johnson & Johnson's Procrit®) survived another challenge last week, when a jury found that Hoffmann-LaRoche's pegylated EPO preparation (Mircera®) infringed three Amgen patents: U.S. Patent Nos. 5,547,933 (the '933 patent), 5,441,868 (the '868 patent), and 5,618,698 (the '698 patent). Two other patents asserted in the litigation were found not invalid: U.S. Patent Nos. 5,955,422 (the '422 patent, claim 1) and 5,756,349 (the '349 patent, claim 7); and the jury did not reach a determination with respect to infringement and validity for U.S. Patent No. 5,621,080 (the '080 patent).
A jury found that the following claims valid and infringed:
The '933 patent:
3. A non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin said product possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells.
7. The glycoprotein product according to claim 3 . . . wherein the host cell is a non-human mammalian cell.
8. The glycoprotein product according to claim 7 wherein the non-human mammalian cell is a CHO cell.
12. A pharmaceutical composition comprising an effective amount of a glycoprotein product effective for erythropoietin therapy according to claim 7 and a pharmaceutically acceptable diluent, adjuvant or carrier. [Infringed under the Doctrine of Equivalents.]
The '868 patent:
1. A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
(a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
(b) isolating said glycosylated erythropoietin polypeptide therefrom.2. The process according to claim 1 wherein said host cells are CHO cells.
The '698 patent:
6. A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
a) growing, under suitable nutrient conditions, vertebrate cells comprising amplified DNA encoding the mature erythropoietin amino acid sequence of FIG. 6; and
b) isolating said glycosylated erythropoietin polypeptide expressed by said cells.7. The process of claim 6 wherein said vertebrate cells further comprise amplified marker gene DNA.
8. The process of claim 7 wherein said amplified marker gene DNA is Dihydrofolate reductase (DHFR) gene DNA.
9. The process according to claims 2, 4 and 6 wherein said cells are mammalian cells.
Amgen has previously prevailed on these same patents in the same court (and before the same judge, the Honorable William G. Young) against Hoechst Marion Roussel; indeed, the Court had the parties address the precedential effect vel non of Judge Young's prior claim construction (and those portions thereof that had been affirmed by the Federal Circuit) of the asserted claims. Amgen v. Hoffman LaRoche Ltd., 480 F. Supp. 2d 462 (Fed. Cir. 2007). Ironically, in view of the ultimate result, the Court noted:
There is more to this motion practice than meets the eye. Amgen has largely prevailed in an earlier jury-waived action before this session of this Court. See Amgen, Inc., v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1295-97 (recounting procedural history). That exhaustive litigation involved the same patents that are here at issue. It is not surprising therefore, given the permissive venue requirements for patent cases, 28 U.S.C. 1400(b), that Amgen brought the instant declaratory judgment action in the District of Massachusetts and denominated it a "related" case pursuant to Local Rule 40.1(G)(1)-(3) so that it would be assigned to this session of the Court. Amgen filed a declaratory action seeking only equitable relief, for which there is no right to a trial by jury.
Roche/Hoffmann has a different agenda. For all the reasons Amgen seeks this judge in this Court, Roche/Hoffmann naturally prefers a fresh fact-finder, to wit, an American jury. What is more, in a case with both equitable (non-jury) and legal (jury) issues, the jury determination may govern the equitable decree. Dairy Queen, Inc. v. Wood, 369 U.S. 469, 479, 82 S. Ct. 894, 8 L. Ed. 2d 44 (1962).
These principles markedly change the potential complexion of this case. No matter how shallow the antitrust claims -- and, while they survive this motion to dismiss, they appear somewhat wanting -- they insure (as long as they remain in the case) that the patent issues (e.g., anticipation, infringement) will be tried to a jury. This Court will assiduously insure that the jury has presented to it all those issues which it must resolve. See, e.g., MacNeill Engineering Co., Inc. v. Trisport, Ltd., 126 F. Supp. 2d 51 (D. Mass. 2001) (case tried to a jury); MediaCom Corp. v. Rates Technology, Inc., 34 F. Supp. 2d 76 (D. Mass. 1998) (case for the jury).
The victory at trial comes at a particularly good time for Amgen. Regulatory concerns, both over risks of long-term EPO administration and the costs incurred by public payors such as Medicare and Medicaid have buffeted the company over the past several months. Since Amgen's EPO products accounted for about half of Amgen's revenues last year, these events have had negative effects on Amgen's stock price as well as its bottom line. The loss comes at a particularly bad time for Roche, since the Food and Drug Administration was reportedly ready to approve Mircera® for sale in the U.S. as early as November 14th (the product was approved for sale in Europe in July).
Amgen has indicated that it will ask the Court for a permanent injunction prohibiting sales of Mircera® until the last of the infringed patents expire (which will not occur before 2017); the injunction hearing is scheduled for November 15th. However, certain purported advantages of Roche's product - specifically, a less-frequent administration schedule due to the longer in vivo persistence of the pegylated version of EPO - may reduce the likelihood that the Court will grant an injunction, or that the injunction will be upheld on appeal, in view of the Supreme Court's proscriptions on granting injunctions in patent cases. See eBay Inc. v. MercExchange, LLC. One of the factors Judge Young will be required to balance in deciding whether to grant an injunction is the public interest, which may be weighed against Amgen in the injunction calculus. For now, however, Amgen's clear victory can be expected to keep Mircera® off the market for the foreseeable future.
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