Hoffman-La Roche Inc. v. Apotex Inc.

April 09, 2012

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Case Name: Hoffman-La Roche Inc. v. Apotex Inc., Case No. 07-4417, 2012 U.S. Dist. LEXIS 34087 (D.N.J. March 14, 2012) (Chesler, J.).  (Denial of preliminary injunction - Patents likely obvious in view of prior art despite presumption of validity and even though art was considered during examination).

Drug Product and Patents-in-suit: Boniva® (ibandronate); U.S. Patent Nos. 4,927,814 ("the '814 patent"); 7,410,957 ("the '957 patent"); and 7,718,634 ("the '634 patent")

Nature of the Case and Issue(s) Presented: In this case, Hoffman-La Roche Inc. ("Roche") sought a preliminary injunction so that it could continue precluding generic manufacturers from marketing generic ibandronate.  The existing injunction, which was based on the '814 patent, was scheduled to dissolve on March 17, 2012, the expiration date of the '814 patent.  Thus, Roche sought additional injunctive relief under the '957 and '634 patents.

In opposition to Roche's preliminary-injunction motion, the defendants argued that the '957 and '634 patents were obvious and therefore invalid.  The claims-at-issue in these patents involved the administration of 150 mg of a salt of ibandroic acid once per month.  Defendants argued that this treatment schedule would have been obvious because the prior art taught the oral administration of ibandronate in combination with literature disclosing daily dosages of ibandronate totaling 150 mg over the course of a month.  Defendants argued that the field was moving towards longer dosage schedules, including a once-per-month dose.  Roche countered, arguing that the defendants failed to cite any publication that disclosed a 150 mg dose, and relied instead on literature that disclosed only daily-dosing.  Moreover, Roche noted that the Examiner had already considered the references the defendants were relying on and the patent still issued in light of those references.  The Court found for the generic defendants and rejected Roche's argument that one of ordinary skill would not be able to extrapolate the dosage studies relating to daily-dosage amounts to determine a monthly-dosage amount for ibandronate as claimed in the patents. 

Why the Generics Prevailed:  The Court found that defendants' expert was more credible in explaining how one of ordinary skill would have understood the various dosage amounts and schedule in the prior art to arrive at 150 mg once-per-month dosing.  In addition, the Court found that Roche's expert made several important concessions at the hearing, namely that the art was moving to longer interval dosage periods and it would have been routine for one of skill to determine the correct dosage for a longer dosage interval.  The Court acknowledged that all of the prior art the defendants submitted was considered during examination, but it found that defendants had made a persuasive case that the patents were invalid due to obviousness even in light of this fact.  Finally, the Court found that Roche had offered little to rebut the defendants' case other than relying on the presumption of validity.

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