By Kevin E. Noonan --
As Patent Docs has reported (see Part I and Part II), last week District Court Judge William G. Young (D. Mass) issued a 150-page decision on post-trial motions and a permanent injunction, and provided his rationale for a number of pretrial summary judgment motion decisions, in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product. The District Court was precluded from entering final judgment in the case, however, because Roche had appealed a preliminary injunction entered by the Court on February 28, 2008, a decision that kept Roche from putting Mircera® on the market while the Court prepared its opinion. Instead, the Court ordered the case "administratively closed" until the Federal Circuit renders its decision on the appeal.
Oral arguments on that appeal occurred yesterday, and the consequences of Judge Young's eleventh hour decision-making were fully appreciated by both the parties and the CAFC (audio of oral arguments on this appeal can be found here). The panel, consisting of Judge Rader, presiding, joined by Judges Gajarsa and Plager, began the proceedings by admonishing counsel that the only issue before the Court was the preliminary injunction; Judge Young's opinion was not in the record and was not at issue in this appeal.
The Court asked Roche's attorney, Leora Ben-Ami, what Roche wanted them to do, and she responded by saying the Court should consolidate the appeal of the preliminary injunction with Roche's appeal of Judge Young's decision(s) below. The Court aggressively challenged the idea of consolidating -- there was "nothing to consolidate." Ms. Ben-Ami responded that in Roche's view, the District Court had come to a final judgment, but the panel told her "[w]e do not have a paper that says 'Judgment?'" They said they don't have it, and (facetiously) asked her to forward it to the bench. The panel said they have an opinion, but not a judgment, and the rules require a judgment.
Ms. Ben-Ami conceded that it was "an unusual circumstance," and while the Court agreed, and agreed that they could take judicial notice of the existence of the opinion (but not taking judicial notice of its contents), they could not take judicial notice "of a judgment that doesn't exist."
Ms. Ben-Ami also asked the Court to find on the merits that Amgen's patents were invalid for obviousness-type double patenting, which produced (amongst a gale of laughter from the bench) the admonition that the Court needed a record and they did not have it. Ms. Ben-Ami persisted that they did have a sufficient record to decide substantive issues. In this case, she asserted, unlike the typical preliminary injunction case, the Court had a complete trial record. Yes, the Court agreed, but they did not have the judge's findings of fact and conclusions of law. How were they to proceed without that, the Court asked her? Ms. Ben-Ami responded that Roche had been very careful to only ask the Court to decide questions of law, for which they need give no deference to Judge Young's decision below, and so didn't need anything more from Judge Young.
The panel persisted, asking her how they could address these issues on the procedural posture of the case. She said they could vacate the preliminary injunction and require the District Court to enter judgment and move the case back up to the Federal Circuit. This suggestion was also not well-received by the panel, who asked her what basis would they have to vacate the injunction? When Ms. Ben-Ami responded with the "likelihood of success" prong of the standard, the Court countered that they have a trial verdict that Judge Young agreed with, giving them no basis for vacating the injunction on that ground.
In response to a (seemingly sincere) question of whether Roche was merely being frugal in asking the Court to get to the merits here, Ms. Ben-Ami asserted that this wasn't a case about "ball-bearings or widgets," but was a case where the proceedings were keeping a drug from patients who needed it. She reminded the Court that the FDA had approved Mircera® as a new drug with a different label than Amgen's EPO products, and that Mircera® was approved and being sold in Europe. When she brought up Judge Young's evidentiary rulings that prevented the jury from being told about FDA's determination that Mircera® is a "new chemical entity" and that it was being sold in Europe, the panel reminded her that the jury wasn't being asked to decide that question: the issue before the jury was "something called patent infringement . . . it's a little different."
The Court returned to the question of what they could do to expedite the case towards resolution. Ms. Ben-Ami repeated the idea that they vacate the preliminary injunction, based on the likelihood of success. Faced with the panel's resistance to this suggestion, Ms. Ben-Ami argued that the questions Roche asked the Court to decide -- whether continuation applications fell within the ambit of 35 U.S.C. § 121, how should the statute be construed, and the issue of claim construction -- were all questions of law. She told the panel that they had the views of the trial judge from the Markman hearing and jury instructions. Ms. Ben-Ami also contended, in answer to a question from the panel, that Roche would agree to an expedited briefing schedule should the panel give her the relief Roche sought by vacating the injunction.
The Court next heard from Amgen, represented by Rusty Day. He told the panel he had an answer to the question of what they should do. The answer was either to affirm the preliminary injunction, or dismiss the appeal and remand so Judge Young could enter judgment. Either resolution would get the case to final judgment and ready for a merits panel to address the substantive issues, he said. Consolidation would not achieve that result, Mr. Day asserted, reminding the panel that consolidation disregards Amgen's right to appeal. (To which the panel responded that there was nothing to consolidate.) Mr. Day suggested that entry of a permanent injunction would moot the appeal, but the panel disagreed -- on the record before them there was no basis for mooting the appeal. The panel also said they would be "hard-pressed" to find grounds to dismiss.
The Court then asked Mr. Day, what would be the implications if they affirmed (without deciding the substantive issues)? What would Amgen argue was the precedential effect of an affirmance? Mr. Day responded that the District Court had entered the preliminary injunction as a way to preserve the status quo, preventing Roche from launching Mircera®, while Judge Young was writing his opinion. Under these circumstances, Mr. Day said, the only question the panel needed to answer was whether it was an abuse of discretion for Judge Young to enter the preliminary injunction under these circumstances.
The panel asked Mr. Day whether he was ready to agree to an expedited briefing schedule, and while he didn't refuse, he did remind the Court that Roche had filed its notice of appeal with 26 issues to be appealed, and whether briefing could be expedited would depend on what was being appealed. He did respond to the panel that the Federal Circuit could expect that Amgen would file a notice of appeal once the District Court entered final judgment. And he reminded the panel that, although Roche had filed its notice of appeal either last Friday or Monday and it was a valid notice, it did not take effect until the District Court entered final judgment, so merely filing the notice did not "move the case forward."
In her rebuttal time, Ms. Ben-Ami again argued the equities, that Roche had been precluded from putting its FDA-approved drug on the market, and that any procedural scenario the Court was considering would result in further delay. The panel posed a hypothetical, wherein the Court did reach the merits, and found some issues in favor of Roche and some in favor of Amgen. They would have to remand, asking whether that wouldn't also result in delay, since the District Court would then have another trial and have to write another opinion, even without an injunction, that would return the case to the Federal Circuit in a year or so? What have we achieved, asked the panel? Ms. Ben-Ami argued a result expediting resolution of the case could occur from the Court deciding dispositive issues now, but the panel resisted the idea of "piecemealing" the record to reach a decision on the issues. The panel said they understood the importance of these issues, that they "don't want people dying," but that they cannot see a way to shorten the time it will take to reach a resolution on the procedural posture of the case. Ms. Ben-Ami's final argument to the Court was that they could order Judge Young to enter final judgment immediately, which raised another chuckle; the panel asked, don't you think Judge Young is waiting by his telephone for their opinion? Ms. Ben-Ami's final request, that the Court also order Judge Young to expedite his decision on any post-judgment motions Amgen might file, met with little sympathy: "They [Amgen] have their rights," said the Court, and "you have yours."
The Court's decision should be available in the next few months.
For additional information regarding this topic, please see:
• "Victory for Amgen in District Court Decision - Part II," October 8, 2008
• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "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
Comments