Hoffmann-La Roche Inc. v. Apotex Inc.

January 07, 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Hoffmann-La Roche Inc. v. Apotex Inc., Civ. No. 2012-1270, 2012-1271, 2012-1272, 2012 U.S. App. LEXIS 21051 (Fed. Cir. October 11, 2012) (Circuit Judges Newman, Lourie and O’Malley presiding; Opinion by Lourie, Dissent by Newman) (Appeal from D.N.J., Chesler, J.)

Drug Product and Patent(s)-in-Suit: Boniva® (ibandronate); U.S. Pat. Nos. 7,410,957 (“the ’957 patent”) and 7,718,634 (“the ’634 patent”)

Nature of the Case and Issue(s) Presented:  Plaintiffs appealed the district court’s denial of a preliminary injunction. This patent appeal related to methods of treating osteoporosis in post-menopausal women. The ’957 patent and the ’634 patent cover the administration of plaintiffs’ osteoporosis drug, Boniva. Both patents claim methods of treating osteoporosis by orally administering a once-a-month tablet that contains 150 mg of the active ingredient ibandronate. During pretrial proceedings, plaintiffs filed a motion for a preliminary injunction. The court denied the motion, finding that plaintiffs failed to establish a reasonable likelihood that they would prevail against defendants’ obviousness challenge. A timely appeal was filed. While the appeal was pending, the district court concluded on summary judgment that the ’634 patent was obvious. Since no judgment was entered on that decision, the Federal Circuit expressed no opinion on the summary-judgment proceedings. Plaintiffs’ appeal was based not on the district court’s analysis and weighing of the preliminary-injunction factors, but on the district court’s finding that plaintiffs were not likely to defeat defendants’ obviousness challenge. First, plaintiffs argued that the district court incorrectly applied an “obvious to try” standard because the prior art taught multiple dosing regimens with unpredictable results. Second, plaintiffs argued that the district court failed to consider its evidence regarding unexpected results.   

Why Defendants Prevailed:  The Federal Circuit found that the district court carefully evaluated each piece of prior art and the testimony of plaintiffs’ expert. The Federal Circuit did not find clear error in the district court’s findings that the cited references disclosed each claim element and that, while uncertainties existed, the field was trending toward intermittent dosing, including a once-monthly dose of 150 mg. The Federal Circuit noted that plaintiffs’ expert conceded as much and that the district court properly determined that a finite number of identified predictable solutions existed. In regard to the second argument that the district court failed to consider secondary considerations, the Federal Circuit found that the purported evidence was neither submitted nor mentioned as part of the preliminary-injunction motion. Plaintiffs attempted to include their secondary considerations evidence by incorporating by reference, in its reply brief, a forty-page brief relating to the separate summary-judgment motion. But the court noted that (“’[d]istrict judges are not archeologists,’ and it was not the court’s burden to ‘excavate masses of papers in search of revealing tidbits’ to help Roche satisfy its burden to obtain a preliminary injunction.”).  The Federal Circuit, however, conducted a cursory review of the evidence that plaintiffs presented in this brief and determined that plaintiffs failed show that the district court clearly erred.

In her dissent, Judge Newman stated that the majority panel’s decision amounted to a one-sided argument against patent validity. According to Judge Newman, equity favored the side of the plaintiffs in order to preserve the status quo. As such, Judge Newman would have issued the injunction. Pointing to plaintiffs’ risks and expenditures in developing Boniva, Judge Newman said that plaintiffs’ “initiative and commitment and investment, as compared with the defendants who seek only the successful products of others, warrant appropriate weight in deciding whether the status quo should be preserved until the challenge to validity has been decided.” Further, Judge Newman gave greater weight to plaintiffs’ argument of unexpected results. The dissent noted that the district court had accepted the practice of incorporating briefs by reference and each party referred to their summary-judgment briefing in the context of the preliminary-injunction motion. Judge Newman also faulted the majority for failing to note that all of the asserted prior art was before the patent examiner—“the finding that the examiner considered and rejected the asserted prior art weighs strongly against a preliminary finding that the patented subject matter is likely to be ruled as obvious as a matter of law.”


Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

Back to Top