Case Name: Hoffman-La Roche Inc. v. Apotex Inc., Case Nos. 07-4417, 07-4516, 07-4539, 07-4540, 07-4582, 07-4661, 08-3065, 08-3607, 08-4051, No. 08-4052, 08-4053, 08-4054, 08-4055, 10-5623, 10-6206, 10-6241, 10-4050, 11-0579, 2012 U.S. Dist. LEXIS 64382 (D.N.J. May 7, 2012) (Chesler, J.)
Drug Product and Patent(s)-in-Suit:Boniva® (ibandronate); U.S. Patent No. 7,718,634 ("the '634 patent")
Nature of the Case and Issue(s) Presented: In this case, Roche charged several generic manufacturers of infringing its patents related to ibandronate, including the '634 patent. In response, defendants argued that the asserted claims, claims 1-8, were invalid as obvious in light of several prior art references. The asserted claims contained two main elements: (i) once/month dosing; and (ii) an effective dosage amount of 150 mg. Defendants argued that numerous prior art references taught the effectiveness of ibandronate and preference of once/month dosing. Defendants further argued that a person of ordinary skill would combine those prior art references with other prior art references that teach an effective daily amount of 5 mg. The motivation to combine references came from a publication that disclosed the idea of "total dose concept," wherein one of skill would understand that an effective dosage of 5 mg/day is the same as 150 mg/month.
Roche argued that the asserted claims of the '634 patent were not invalid because the prior art taught away from the claimed invention, including the dosage schedule and the dosage amount. Also, Roche argued that the prior art did not teach using ibandronate to treat osteoporosis because the art showed that ibandronate did not produce statistically significant anti-fracture effects. Lastly, Roche argued that the commercial success of Boniva supported its position. The Court held that the asserted claims of the '634 patent were invalid because the overwhelming evidence showed that the claimed invention was merely the result of applying common sense and ordinary skill to solve the problem.
Why Defendants Prevailed: The Court found that numerous prior art references taught that one of skill should consider using extended dosage schedules with ibandronate, including once/month dosage. The Court rejected Roche's argument that some prior art references taught away from a once/month dosage schedule because there was no clear statement in any of the references that such a dosage schedule would not work. At best, the references were silent on a once/month dosing, but that was not sufficient to demonstrate "teaching away" under the law.
As to the effective-amount claim element, the Court rejected Roche's argument that the prior art did not teach a "total dose concept." The Court noted that the prior art explicitly taught the total dose administered over a period of time required to provide effective results is independent of the dosing schedule. Thus, the prior art provided a clear motivation to determine the effective amount of a once/month dosing based on the effective amount of a once/day dosing. Likewise, the prior art provided one of skill with only two choices to determine the effective amount for a once/month dosing. Such limited choices demonstrate that it would have been obvious for one of skill to try both options to arrive at the claimed effective amount limitation.
The Court rejected Roche's argument that prior art did not teach using ibandronate to treat osteoporosis because the art did not show that ibandronate produced a statistically significant anti-fracture effect. It did so because the asserted claims did not include any claim elements directed at statistically significant anti-fracture effects. Instead, the claims were directed at treating osteoporosis with ibandronate, which was known in the art.
Lastly, the Court found that the limited commercial success of Boniva did not support the non-obviousness of the asserted claims. Roche had other patents on the use of ibandronate, which precluded others from attempting to determine alternative dosage schedules. Additionally, Boniva has had limited commercial success, and another drug from Merck used to treat osteoporosis has been significantly more successful than Boniva. Moreover, Merck's drug predates Boniva, so the Court found no basis that a reasonable jury could agree with Roche's posited secondary considerations of non-obviousness.
