In striking down Roche AG's method of osteoporosis treatment claims for once-monthly Boniva, the Federal Circuit may have raised the bar for using a life cycle approach to protect blockbuster drugs from generic and biosimilar competition.
In a split opinion Friday, the U.S. Court of Appeals for the Federal Circuit ruled the Swiss company's claims for Boniva (ibandronate) were invalid due to prior art that showed monthly dosing at 150 mg was "obvious to try." That opinion, written by Judge William Bryson, equated a recognized need in this case, for less frequent bisphosphonate administration with the obvious-to-try standard.
"Conclusive proof of efficacy is not necessary to show obviousness," Bryson said. "All that is required is a reasonable expectation of success."
The majority acknowledged that the monthly Boniva demonstrated a superior, and unexpected, efficacy in raising bone mass density levels, as compared with