Amgen Inc. (“Amgen”) sought declaratory relief to prevent F. Hoffmann-LaRoche Limited, Roche Diagnostics GmbH, and Hoffmann-La Roche Inc. (collectively, “Roche”) from marketing a drug that infringes U.S. Patent Nos. 5,441,868, 5,547,933, 5,618,698, 5,621,080, 5,756,349, and 5,955,422. These patents relate to Amgen’s recombinant erythropoietin (“EPO”), a naturally occurring protein that stimulates the production of red blood cells.  Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F. Supp. 2d 104, 106 (D. Mass. 1998). The jury found for Amgen across the board, upholding the validity of the claims-in-suit for the ‘422, ‘933, ‘868, ‘698, and ‘349 patents and finding that Roche literally infringed all of the claims-in-suit except for claim 12 of the ‘933 patent, which it found infringed by the doctrine of equivalents. Jury Verdict [Doc. No. 1542] at 2-3. The Court writes to explain its rulings on various pre-trial motions for summary judgment, specifically its findings and rulings that the Amgen patents survive Roche’s obviousness-double patenting contentions, to resolve various post-trial motions, and to explain the decision to grant Amgen’s request for a permanent injunction.

Due to the sheer number, the Court will not be able to address every motion.¹ Therefore, all motions not already granted and not resolved herein are denied. After explaining the grant of summary judgment on the issue of obviousness-type double patenting, the Court will address post-trial motions in three groups: validity, infringement, and injunctive relief. Regarding validity, the Court will write to explain three decisions.  Primarily, the Court concluded that the source “purified from mammalian cells grown in culture” limits claim 1 of the ‘422 patent. As shall be discussed, the undisputed record revealed that none of the prior art, including the Goldwasser study, satisfied this limitation. Second, sufficient evidence supported the jury’s finding that the term “human erythropoietin,” found in claim 1 of the ‘422 patent and claims 3, 7, and 9 of the ‘933 patent, is not indefinite, even though the specifications do not specify whether the glycoprotein described therein would be 165 or 166 amino acids in length.

¹ With well over 1,000 pages of post-trial briefing, responding to
every issue would be an inappropriate use of judicial resources. The
Court will focus on those issues that the parties raised at the
February 28 hearing. All of the parties’ remaining contentions have
been considered and found wanting. Because the jury’s verdict will
stand, Roche’s antitrust claims are moot.

Next, the Court will write to explain its grant of summary judgment to Amgen with respect to infringement of claim 1 of the ‘422 patent, see Electronic Order August 28, 2007, and the decision to uphold the jury’s finding that Roche literally infringed claim 3 of the ‘933 patent. See Jury Verdict at 2. As shall be discussed below, Amgen patented recombinant EPO by reference to a specific amino acid sequence. See Amgen, Inc. v. F. Hoffmann-La Roche Ltd., 494 F. Supp. 2d 54, 63 (D. Mass. 2007) [hereinafter “Amgen Markman”]. Pegylation – the chemical reaction that attaches PEG to EPO via a single bond to form CERA, the active ingredient in MIRCERA – does not alter EPO’s amino acid sequence. See Trial Ex. 53, Roche’s Biologic License Application at 00004027 [hereinafter “Roche BLA”]. The attachment of PEG to EPO does not place MIRCERA beyond the boundary of the claims because “the specification expressly contemplates that additional molecules may be attached to ‘human erythropoietin.’” Amgen Markman, 494 F. Supp. 2d at 63 (emphasis omitted). Thus, any minor modification of EPO that does not alter the specific amino acid sequence – such as the displacement of a single hydrogen atom – is immaterial and does not preclude a finding of infringement.

Finally, Amgen has satisfied all four factors necessary for a permanent injunction set forth in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006). Failure to issue a permanent injunction would cause irreparable, immeasurable harm, for which there is no adequate remedy at law. Given that Roche infringes Amgen’s valid patents, and in light of the harms that will be discussed, the balance of hardships clearly favors Amgen.  Moreover, the Court has concluded that “the public interest would not be disserved by a permanent injunction.” Id. at 391. The record compiled over the course of a four-day evidentiary proceeding reveals no benefit to patient health or the public coffers so great as to outweigh the public’s interest in a robust patent system.

Order (still nearly 300k)

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