Hoffmann-La Roche Inc. v. Apotex Inc., No. 13-1128 (Fed. Cir. 2014)
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Generic drug manufacturers submitted Abbreviated New Drug Applications for FDA approval to manufacture and sell of generic versions of Boniva® before expiration of Roche’s patents, which are directed to methods of treating osteoporosis by monthly administration of ibandronate, one of a class of compounds known as bisphosphonates. Bisphosphonates generally have a low bioavailability when administered and oral administration of bisphosphonates can result in adverse esophageal and gastrointestinal side effects. Patients taking bisphosphonates previously had to take the bisphosphonate tablet in a fasting state at least 30 minutes before eating or drinking, which created compliance problems. Roche sued, alleging infringement under 35 U.S.C. 271(e)(2) based on the ANDA filings.
The Federal Circuit affirmed the district court’s denial of the preliminary injunction. The district court entered summary judgment of invalidity of certain claims due to obviousness under 35 U.S.C. 103(a), finding that once monthly oral dosing of ibandronate was established in prior art and that the combination of prior art references suggested a dosage f about 150 mg per month, or at least indicated that a monthly dose of 150 mg was obvious to try. The Federal Circuit affirmed.
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