Federal Circuit Says Generic Boniva Can Go Forward Despite Roche Objections

Drug Patent AttorneysOrange County – The Federal Circuit on Thursday refused to give Hoffmann-La Roche Inc. another shot at a preliminary injunction barring several generic drug makers from rolling out generic versions of Roche’s Boniva osteoporosis drug.

Roche failed to show it was reasonably likely to evade Apotex Inc., Watson Pharmaceuticals Inc. and Mylan Inc.’s claims that its patents were obvious, a 2-1 majority of the appeals court ruled.

Roche owns U.S. Patent Numbers 7,410,957 and 7,718,634, which cover the administration of Roche’s Boniva. The ’957 patent is the parent patent of the ’634 patent. Both disclose and claim methods of treating osteoporosis by orally administering once a month a tablet that contains about 150 mg of a salt of ibandronic acid, Boniva’s active ingredient.

Boniva has been approved by the U.S. Food and Drug Administration to treat osteoporosis in post-menopausal women since 2005. In 2007 the generics makers submitted abbreviated new drug applications to the FDA for generic monthly ibandronate products serving as osteoporosis treatments, at which point Roche sued them for infringement.

Roche asked for a preliminary injunction against the generics makers during the pretrial proceedings. The district court denied it on the grounds that Roche failed to establish a reasonable likelihood that it would prevail against the generics makers’ obviousness challenge to the patents, due to a series of prior art references.

While Roche’s appeal of the injunction denial was pending, the district court ruled on summary judgment that eight claims of the ‘634 patent would have been obvious based on those prior art references.

In its injunction appeal, Roche argued the court erred by applying an “obvious to try” standard, because the prior art described multiple possible dosages of the drug with unpredictable results. It also argued that the court erred in failing to consider Roche’s evidence of unexpected results.

The Federal Circuit disagreed on both points. The district court carefully evaluated each prior art reference and the testimony of Roche’s expert, it said.

“We are assuredly aware of the effort and cost of developing a new drug,” the appeals court said. “But we owe the district court deference on review of the grant or denial of a preliminary injunction unless it abuses its discretion or makes clearly erroneous findings that affected the exercise of its discretion.”

Circuit Judge Pauline Newman made her own argument for the nonobviousness of the claimed invention in a separate dissent.

The majority opinion, though, said it did not find that the district court made clearly erroneous findings in its determination that Roche did not show a likelihood of success on the question of obviousness.




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