Arguments by Analogy Can Win The Day For Generics Asserting Obviousness Defense

The Federal Circuit recently affirmed a decision by the District of New Jersey finding two patents owned by Hoffmann-La Roche invalid for obviousness.  The patents-at-issue in Hoffmann-La Roche v. Apotex Inc., No. 2013-1128, are directed to methods of treating osteoporosis through a once-monthly administration of ibandronate, commercially available as Boniva.  The Court applied surrogate testing parameters and simple scaling techniques to find that it would have been obvious at the time of invention to administer a large, once-monthly version of Boniva (as opposed to small daily dosages) and to set the dose at 150 mg.  This case teaches that ANDA litigants should think broadly when attempting to invalidate a patent because arguments by analogy, or requiring a certain degree of abstraction sometimes can win the day.

Despite references in the prior art alluding to monthly administration of bisphosphonates (the class of compounds of which ibandronate is a member), Roche argued that the prior art taught away from monthly dosing.  According to Roche, it was widely believed that dosage intervals longer than one or two weeks would not be effective.  The Federal Circuit, however, rejected these arguments, noting that the problem with Roche’s cited study was a problem of statistics and study design, and it did not teach that infrequent dosing was ineffective.

The Court also cited a reference (the “Riis” study) that taught intermittent administration of abandronate is as effective as continuous dosing for increasing bone mineral density: the total dose over a period of time was what mattered, not the dosing regimen.  Roche argued that this study was not an antifracture study, and so did nothing to rebut its teaching away argument.  The Court, however, found that it was well-established that bone mineral density was a powerful surrogate for assessing fracture risk.  The Court concluded: “Conclusive proof of efficacy is not necessary to show obviousness.  All that is required is a reasonable expectation of success.”  The Riss study along with studies showing bone mineral density improvements to be the primary efficacy factor for treating osteoporosis established this reasonable likelihood of success.

Roche also argued that the district court misapplied the Riis study and took a technical leap by finding that simple multiplication of an effective daily dose could predict a proper monthly dose.  The Court, however, found evidence in the prior art that such simple scaling can be used as an effective rule of thumb by one skilled in the art when attempting to determine effective monthly doses.  In light of the evidence, the Court found that it was reasonable to expect that a once monthly dose of 150 mg would have roughly the same efficacy as a daily dose of 5 mg.  Judge Newman offered a dissenting opinion writing in part that scaling a daily dose to a monthly dose by simple multiplication cannot reasonably be predictive of a proper intermittent dose.