By Kevin E. Noonan --
Hoffmann-LaRoche has apparently given up its attempts to convince Judge William Young to lift an injunction preventing it from selling its Mircera® drug product (a form of recombinant EPO that has been covalently linked to polyethylene glycol), and has filed a Notice of Appeal with the Court of Appeals for the Federal Circuit.
On October 23, 2007, Amgen procured a jury verdict that Mircera® infringed several Amgen patents (see "Amgen Survives Another EPO Challenge"), and the District Court granted Amgen a preliminary injunction on February 28, 2008. In granting the injunction, Judge Young indicated that Amgen had clearly fulfilled three of the four factors mandated for consideration by the Supreme Court in eBay Inc. v. MercExchange, L.L.C., (Amgen's asserted claims were infringed and not invalid; Amgen's injury would not be adequately compensated merely with money damages; and the balance of the hardships weighed in favor of granting the injunction). However, the District Court did not decide in Amgen's favor as to the fourth prong, the public interest, particularly in view of Roche's representations of the advantages of its Mircera® product over Amgen's version of EPO (including inter alia less frequent dosing; see "Long-Acting Drug for Dialysis Anemia Equivalent to Weekly Agent").
The District Court set five conditions that Roche needed to fulfill before it would lift the injunction, and Roche ultimately agreed to all the Court's conditions (see "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction"). Amgen responded by informing the District Court that it intended to pursue its right to a jury determination of the money damages it is entitled to should Roche launch under a modified injunction, stating that the Court did not have the power to deny Amgen its statutorily-defined profits, and that Amgen would also seek treble damages for any Roche sales made pursuant to the Court's order as constituting willful infringement. And the District Court further postponed a final decision on lifting the injunction on March 31, 2008, issuing an order that it intended to appoint a special master to consider the question of how dosing and pricing of Amgen's and Roche's products should be compared. The District Court gave the parties 15 days to submit a list of "agreed" candidates to be appointed special master, and then the Court intended to give that candidate another 60 days to make the inquiries necessary to provide his or her findings to the Court. Only after at least a 75-day delay could the Court be expected to make its ruling. Presumably, this order has been mooted by Roche's appeal (since Judge Young originally set a timetable for considering lifting the injunction conditioned on the parties not filing a notice of appeal to the Federal Circuit).
In addition to its public interest argument, Roche can be expected to respond to Amgen's arguments submitted to the District Court on March 14th (see "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?") regarding the effect of the Federal Circuit's Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. decision on the propriety of the preliminary injunction and the underlying competence of Amgen's verdict that its claims are not invalid. The Federal Circuit in Pfizer construed the scope of the "safe harbor" provisions of 35 U.S.C. § 121 to be limited to divisional applications and not to include continuation-in-part applications; it did not directly decide the question with regard to continuation applications.
Amgen argued that this decision has no bearing on the District Court's decision that Amgen's patents-in-suit are not invalid under the judicially-created obviousness-type double patenting doctrine. Amgen also argued that its applications were not CIPs but continuations, and that the Pfizer decision was limited to precluding the § 121 safe harbor from encompassing CIP applications. Amgen further argued that its patents-in-suit were continuation applications in name only, and satisfied the conditions of the statute for benefitting from the safe harbor ("later application[s] carved out of a pending application," containing claims to "a distinct and independent invention" and "disclosing and claiming only subject matter disclosed in the earlier or parent application"). Finally, Amgen argued that the Pfizer decision is inconsistent with Federal Circuit precedent, with regard to continuation applications, in Applied Materials, Inc. v. Adv. Semiconductor Materials Am., Inc., 98 F.3d 1563 (1996) and Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991), and that the Court is bound by the earlier decisions, citing Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988) ("This court has adopted the rule that prior decisions of a panel of the court are binding precedent on subsequent panels unless and until overturned in banc. Where there is direct conflict, the precedential decision is the first."). Roche no doubt disagrees, and the controversy adds yet another ground for its attack on Amgen's patents, its verdict, and its injunction.
For additional information regarding this topic, please see:
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
• "Amgen Survives Another EPO Challenge," October 28, 2007
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