Short Summary: Summary judgment of invalidity affirmed.

CaseHoffmann-La Rouche Inc. v. Apotex Inc., No. 2013-1128 (Fed. Cir. April 11, 2014) (precedential). On appeal from D.N.J. Before Newman, Lourie, and Bryson.

Procedural Posture: Plaintiff appeals the district court’s grant of summary judgment of invalidity as to claims 1-8. CAFC affirmed.

  • Obviousness: The district court correctly found that it would have been obvious at the time of the invention to select a 150mg, once monthly dosing regimen of ibandronate to treat osteoporosis.
    • The prior art taught monthly dosing and did not teach away. While plaintiff argued that the prior art did not contain sufficient data to show efficacy of monthly dosing, the Federal Circuit pointed out that the patent also did not provide this data. The Federal Circuit confirmed that proof of efficacy is not necessary to prove obviousness, only a reasonable expectation of success.
    • The prior art provided a limited set of possibilities to scale known effective doses to a once a month regimen. None of plaintiff’s arguments that the prior art taught away from the claimed dosing regimen were persuasive.
    • There were no material issues of fact regarding the safety of the claimed dose.
    • Secondary considerations of non-obviousness were not sufficient to overcome the strong showing that the claimed regimen would have been obvious.

Newman, dissenting:

  • The court misapplied KSR’s “obvious to try” standard by not requiring that there be a limited number of defined alternatives and a suggestion that the desired result is likely to be achieved through the proposed trial. The court has engaged in judicial hindsight to reconstruct the patented subject matter. The court’s holding will discourage improvements in crowded fields.