Tuesday, May 15, 2012

Boniva® Patent Deemed Obvious on Summary Judgment

The court granted defendants' motion for summary judgment of invalidity of plaintiffs' Boniva® drug patent for obviousness. "Applying [KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007)] to the instant case leads to the conclusion that demonstrating that it was obvious to try once-monthly oral administration of ibandronate at doses of 75 mg and 150 mg is legally sufficient to prove obviousness. There is no dispute that, [10 years ago], there was market pressure to solve the problem of finding an osteoporosis treatment with reduced gastrointestinal side effects and improved patient compliance. . . . [T]he combination of [a prior art article and two prior art research reports] suggests two possible treatments: once-monthly oral administration of ibandronate at doses of 75 mg and 150 mg. The set of these two options contains a finite number of identified solutions. . . . The evidence shows that there was good reason to expect success with these two solutions, because they are straightforward applications of the total dose concept proven by [one research report] to the research findings of [the other research report], and the selection of a once-monthly dose equivalent to the 5 mg daily dose is supported by the recommendation of a 35 mg weekly dose in [a prior art patent]."

Hoffmann-La Roche Inc. v. Apotex Inc., et. al., 2-07-cv-04417 (NJD May 7, 2012, Order) (Chesler, J.)

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