Hoffman-La Roche Inc. v. Apotex Inc. (D.N.J.)

January 07, 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Hoffman-La Roche Inc. v. Apotex Inc., Civ. Nos. 07-4417 (SRC) (MAS), 08-3065 (SRC) (MAS), 08-4053 (SRC) (MAS), 10-6241 (SRC) (MAS), (consolidated with 07-4417 for all purposes), 07-4516 (SRC) (MAS), 08-3607 (SRC) (MAS), 08-4055 (SRC) (MAS), 10-5623 (SRC) (MAS) ), (consolidated with 07-4416 for all purposes), 07-4539 (SRC) (MAS), 07-4540 (SRC) (MAS), 08-4054 (SRC) (MAS), 10-6206 (SRC) (MAS), ), (consolidated with 07-4539 for all purposes), 07-4582 (SRC) (MAS), 08-4051 (SRC) (MAS), 10-4050 (SRC) (MAS), ), (consolidated with 07-4582 for all purposes), 07-4661 (SRC) (MAS), 08-4052 (SRC) (MAS), 11-0579 (SRC) (MAS), ), (consolidated with 07-4661 for all purposes), 2012 U.S. Dist. LEXIS 141669 (D.N.J. October 1, 2012) (Chesler, J.)

Drug Product and Patent(s)-in-Suit: Boniva® (ibandronate); U.S. Pat. No. 7,410,957 (“the ’957 patent”)

Nature of the Case and Issue(s) Presented:  The court previously found that U.S. Patent No. 7,718,634 (“the ‘634 patent”), the child patent to the ‘957 patent, was invalid as obvious. This matter on the ‘957 patent came before the court on its own motion pursuant to Rule 56(f). Defendants asserted, as an affirmative defense, invalidity of the ’957 patent based on obviousness. Recognizing the similarities between the ’634 patent and the ’957 patent, the court requested that the parties brief the question of “whether the court’s rationale for granting summary judgment of invalidity in the ’634 patent actions should be applied to the asserted claims in the ’957 patent.” The court determined that plaintiffs’ response was largely an argument to reconsider the ’634 patent opinion. The court rejected plaintiffs’ arguments that the claim scope of the patents was different, applied the findings in the ’634 patent opinion, and determined that the ’957 patent was invalid as obvious in view of the prior art.

Why Defendants Prevailed:  Defendants prevailed because plaintiffs could not convince the court that (i) the scope of the patents was meaningfully different and (ii) that the factual questions regarding anti-fracture efficacy have a material impact on the obviousness analysis for the ’957 patent. Plaintiffs argued that the patents had one significant difference – claim scope. The ’634 patent claims “a method for treating or inhibiting” osteoporosis, whereas the ’957 patent claims “a method for treating” osteoporosis. Plaintiffs argued that the court erred in finding that anti-fracture efficacy was not material to the obviousness inquiry and that the court’s findings regarding the ’634 patent, which were directed to preventing osteoporosis, were inapplicable to the ’957 patent’s “method of treating” claims. The court was not persuaded, and found that its findings in the ’634 patent opinion were focused on the aspects directed to treating osteoporosis. In addition, the court reaffirmed its holding in the ’634 patent opinion that anti-fracture efficacy, though required for FDA approval, was irrelevant to the obviousness inquiry. Plaintiffs primarily cited evidence supporting the proposition that bone mineral density is an imperfect predictor of anti-facture activity and argued that the teachings from the prior art could not provide absolute predictability of success in achieving fracture reduction. To demonstrate that one of ordinary skill in the art would not have had a reasonable expectation of success, plaintiffs pointed to prior art teaching that the administration of intravenous ibandronate did not achieve statistically significant anti-fracture efficacy. The court was not persuaded by this argument. First, the court noted that there was no published data on anti-fracture efficacy of any oral ibandronate regimen; only data from intravenous administration, which was not enough to persuade a reasonable jury that a skilled artisan would not have had a reasonable expectation of success. Second, the data of intravenous administration showed anti-fracture efficacy, just not at a level of statistical significance. The court found that one of ordinary skill would have had a reasonable expectation of success since ibandronate was known to be a powerful antiresorptive agent, and antiresorptive agents were known to be effective to treat osteoporosis. The court also determined that plaintiffs failed to demonstrate that anti-facture efficacy was an unexpected result. Though it may not have been empirically proven, the court noted that “surprise is a continuum.” The quantum of surprise that a “drug known to have a powerful effect on bone resorption, and known to be effective as a treatment for osteoporosis, should be found to prevent fractures does not seem all that great—it just does not seem very surprising.” The court also noted that the 150 mg dose was the alleged inventive step and that plaintiffs provided no persuasive explanation as to how anti-fracture efficacy indicates that the choice of 150 mg was nonobvious.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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